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DNA Healthcare Advertising PortfolioTRANSCRIPT
DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brands: CDS, HHS, Neurology, Cardiology, Breast Cancer
Client: GE Healthcare
Web buttons
GSF logo
CDS adverts
GE CV portfolio
Neurology web page
A5 leave piece
CD sleeve and sleeve
Letter template
GE imagination at work
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GE Healthcare
Dear
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Sincerely,
NameTitle
Mr. Bob SmithV.P. Environmental ControlsABC Company123 AnyStreetAnycity, NY, 10001
Title or tagline
Email flyer
Clinical Department Solutions
Let us complete the picture.
Let us complete the picture for you. If you have a great vision of what your hospital development should be, we’ll help you realize it.
Our CDS (Clinical Department Solutions) teams have completed over 200 internationally successful projects already. Their knowledge and ability to access to everything your project will need are second to none. CDS teams add significant value throughout the life of projects. Effectively coordinating with all stakeholders, to ensure you get exactly what you envisiged - on time and on budget. Click here for more information, or come see us at stand xxx
GE Healthcare
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Clinical Department Solutions
Diagnostic Imaging
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Clinical Department Solutions
Let us completethe picture.Neonatal ICU/ICU
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Clinical Department Solutions
Artwork.
© DNA Healthcare Advertising Ltd. 2012.DNA Healthcare Advertising Ltd. 6 - 8 Paxton Place, London, SE27 9SS. t +44 (0) 20 3004 4743.
Clinical
Department
Solutions
Artwork.
GE imagination at work
© DNA Healthcare Advertising Ltd. 2012.
DNA Healthcare Advertising Ltd. 6 - 8 Paxton Place, London, SE27 9SS.
t +44 (0) 20 3004 4743.
Neurology web page illustrations
© DNA Healthcare Advertising Ltd. DNA Portfolio.
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Women in commercial poster
THE AUTHENTIC FEMALE LEADERAN EVENT BY COMMERCIAL WOMENHosted by GE Leaders, Mark Elborne, Pascale Witz and Sandy Lucas.
Moderated by Maxine Benson MBE, co-founder everywoman.
Date: 27th June 2012Location: The Ark, HammersmithTime: 5 - 7.30 pmSpaces are limited so please register by selectinghttp://sc.ge.com/*RegisterforRosaleenBlairEvent
For further information contact Gabrielle Silver or Rachel Stracey.
Maxine Benson Co-founder of everywoman
Karen GillCo-founder of everywoman
Rosaleen BlairFounder and CEO of Alexander Mann Solutions
Hester Larkin Founder Hester Larkin Associates
Melanie EusebeManaging Consultant, Ernst & Young
Visit us online sc.ge.com/*WNUKIRE
Five successful business women from across industry will share their thoughts and stories on how they have led business growth, developed people and challenged leadership stereotypes, to become highly respected, authentic female leaders. You will be able to ask them for insight on any of your own personal challenges or observations.
History /Examination
CardiologyAppointment
CardiologyDepartment
HolterMonitoring
ECG /Stress Test
ECG /Stress Test
DataTransfer
DataTransfer
DataTransfer
DataTransfer
DataTransfer
Physician
Physician’sAppointment
ECG
History /Examination
ECG
Blood Tests
History /Examination
ECG
Stable Angina
Stress Test Low Risk
Risk Assessment Pre-opMonitoring
Discharge
Post-opMonitoring
UA
NSTEMI
STEMI PCI CABG
DiagnosticAngiography
High Risk
Discharge
ACS
NoninvasiveImaging
Blood Tests
NoninvasiveImaging
Monitoring
Monitoring
Monitoring
Care Pathway: Coronary Artery Disease
Chest Pain
Out of Hospital Hospital Out of Hospital
Home Ambulance Emergency Department/Outpatient Department
Non-invasive Diagnostics Operating RoomCatheterisation Lab CoronaryIntensive Care Unit
Outpatient ClinicPhysician’s Office Home Rehab Facility Physician’s OfficePathologyDepartment
Ward
SMO-Cardiovascular®For internal GE use only.
Coronary artery disease care pathway poster
Pathway poster sticker examples
1
History /Examination
CardiologyAppointment
CardiologyDepartment
HolterMonitoring
ECG /Stress Test
ECG /Stress Test
DataTransfer
DataTransfer
DataTransfer
DataTransfer
DataTransfer
Physician
Physician’sAppointment
ECG
History /Examination
ECG
Blood Tests
History /Examination
ECG
Stable Angina
Stress Test Low Risk
Risk Assessment Pre-opMonitoring
Discharge
Post-opMonitoring
UA
NSTEMI
STEMI PCI CABG
DiagnosticAngiography
High Risk
Discharge
ACS
NoninvasiveImaging
Blood Tests
NoninvasiveImaging
Monitoring
Monitoring
Monitoring
Care Pathway: Coronary Artery Disease
Chest Pain
Out of Hospital Hospital Out of Hospital
Home Ambulance Emergency Department/Outpatient Department
Non-invasive Diagnostics Operating RoomCatheterisation Lab CoronaryIntensive Care Unit
Outpatient ClinicPhysician’s Office Home Rehab Facility Physician’s OfficePathologyDepartment
Ward
SMO-Cardiovascular®For internal GE use only.
History /Examination
CardiologyAppointment
CardiologyDepartment
HolterMonitoring
ECG /Stress Test
ECG /Stress Test
DataTransfer
DataTransfer
DataTransfer
DataTransfer
DataTransfer
Physician
Physician’sAppointment
ECG
History /Examination
ECG
Blood Tests
History /Examination
ECG
Stable Angina
Stress Test Low Risk
Risk Assessment Pre-opMonitoring
Discharge
Post-opMonitoring
UA
NSTEMI
STEMI PCI CABG
DiagnosticAngiography
High Risk
Discharge
ACS
NoninvasiveImaging
Blood Tests
NoninvasiveImaging
Monitoring
Monitoring
Monitoring
Care Pathway: Coronary Artery Disease
Chest Pain
Out of Hospital Hospital Out of Hospital
Home Ambulance Emergency Department/Outpatient Department
Non-invasive Diagnostics Operating RoomCatheterisation Lab CoronaryIntensive Care Unit
Outpatient ClinicPhysician’s Office Home Rehab Facility Physician’s OfficePathologyDepartment
Ward
SMO-Cardiovascular®For internal GE use only.
FACT 2Frontiers on Advising Cardiovascular Technologies
Medical Advisory Board for Coronary Artery Disease
ECG MRI FFR
Technology stickers - 148mm diameter
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Information owner stickers - 148mm diameter
PCP/GP Nurse
PET-CT OCT SPECT IVUS CT-FFR MonitorIT
Stress Rest 2D 3D 4D Contrast Biomarker
EDParamedics Sonographer IC CTS PTRadiologistGeneral
CardiologistPatient
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Echo
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Pathologist
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On-line
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ECG MRI FFR
Technology stickers - 148mm diameter
Sub-technology stickers - 100mm diameter
Information owner stickers - 148mm diameter
PCP/GP Nurse
PET-CT OCT SPECT IVUS CT-FFR MonitorIT
Stress Rest 2D 3D 4D Contrast Biomarker
EDParamedics Sonographer IC CTS PTRadiologistGeneral
CardiologistPatient
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Echo
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Pathologist
Blank spare stickers - 90 x 50 mm
x 10
On-line
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ECG MRI FFR
Technology stickers - 148mm diameter
Sub-technology stickers - 100mm diameter
Information owner stickers - 148mm diameter
PCP/GP Nurse
PET-CT OCT SPECT IVUS CT-FFR MonitorIT
Stress Rest 2D 3D 4D Contrast Biomarker
EDParamedics Sonographer IC CTS PTRadiologistGeneral
CardiologistPatient
Blank x 10x 5x 5x 5x 5x 5x 5x 5x 5
x 5x 5x 5x 5x 5x 5x 5x 5x 5x 5 x 5x 5
Blank x 20x 5x 5x 5x 5x 5x 5x 5x 5x 5 x 5x 5x 5x 5x 5x 5
Echo
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Pathologist
Blank spare stickers - 90 x 50 mm
x 10
On-line
x 5
ECG MRI FFR
Technology stickers - 148mm diameter
Sub-technology stickers - 100mm diameter
Information owner stickers - 148mm diameter
PCP/GP Nurse
PET-CT OCT SPECT IVUS CT-FFR MonitorIT
Stress Rest 2D 3D 4D Contrast Biomarker
EDParamedics Sonographer IC CTS PTRadiologistGeneral
CardiologistPatient
Blank x 10x 5x 5x 5x 5x 5x 5x 5x 5
x 5x 5x 5x 5x 5x 5x 5x 5x 5x 5 x 5x 5
Blank x 20x 5x 5x 5x 5x 5x 5x 5x 5x 5 x 5x 5x 5x 5x 5x 5
Echo
Blank x 10
Pathologist
Blank spare stickers - 90 x 50 mm
x 10
On-line
x 5
ECG MRIFFR
Technology stickers - 148mm diameter
Sub-technology stickers - 100mm diameter
Information owner stickers - 148mm diameter
PCP/GP Nurse
PET-CTOCT SPECT IVUS CT-FFR
MonitorIT
Stress Rest 2D 3D 4D Contrast Biomarker
EDParamedics
SonographerIC CTS PT
RadiologistGeneral
Cardiologist
Patient
Blank x 10x 5
x 5x 5
x 5x 5
x 5x 5
x 5
x 5
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Blank x 10
Pathologist
Blank spare stickers - 90 x 50 mm
x 10
On-line
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Cardiology adboard A4 workbook
GE Healthcare
Clinical Department Solutions
Let us completethe picture.
©2013 General Electric Company – All rights reserved.
General Electric Company reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. GE and GE Monogram are trademarks of General Electric Company. GE Healthcare, a division of General Electric Company.
* Trademark of General Electric Company About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the worldat a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems. Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries.For more information about GE Healthcare, visit our website at www.gehealthcare.com GE Healthcare,Levent Ofis – Esentepe Mah,Talatpasa Cd.Harman Sk.No 8 Levent.34394Istanbul
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Brand Guidelines.
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CDS Brand Guidelines
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A new vision for Cardiology
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DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brand: TomudexClient: Hospira
Logo design
Press advert - A4 portrait - mesothelioma (MPM)
Press advert - landscape - colorectal cancer (CRC)
Detail aid
Exhibition stand panel
A5 leave piece
A positive choice for your 5–FU
intolerant patients
Prescribing information is available on this stand.
UK/12/003. Date of preparation: March 2012.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Hospira UK Ltd. Telephone Medical Information: +44 (0) 1926 834400
Detail aid slide set
© DNA Healthcare Advertising Ltd. DNA Portfolio.
Brand guidelines manual and CD
Conference speaker support and printed assets
RPC mailer
Q&A document
Conference Stand Design
24
Tomudex Abbreviated Prescribing Information
Please refer to full Summary of Product Characteristics (SmPC) before
prescribing. Presentation: 2 mg raltitrexed powder for solution for injection in each vial.
Indications: The palliative treatment of advanced colorectal cancer where
5-Fluorouracil and folinic acid based regimens are either not tolerated or
inappropriate.
Dosage: 3 mg/m2 intravenously. In the absence of toxicity, treatment may
be repeated every 3 weeks. Dose and dosage interval modifications are
required in patients with renal impairment and those with gastrointestinal or
haematological toxicities.
Administration: Intravenous infusion over 15 minutes in 50 to 250 ml of either
0.9% sodium chloride solution or 5% glucose solution.
Contraindications: Pregnancy and breastfeeding. Pregnancy should be
excluded before treatment is commenced. Severe renal impairment.
Interactions: Folinic acid or folic acid preparations must not be given
immediately prior to, or during administration.
Warnings and Precautions: Should only be used under supervision of physicians
experienced in management of patients with the treated conditions. Monitor
full blood count, liver transaminases, serum bilirubin and serum creatinine
prior to each treatment. Caution is necessary in patients with depressed
bone marrow function, poor general condition, prior radiotherapy, elderly
patients or in mild to moderate hepatic impairment. Not recommended
in severe hepatic impairment. Pregnancy should be avoided for at least
6 months after cessation of treatment of either partner.
Adverse effects: Nausea, diarrhoea, vomiting, anorexia, gastrointestinal
bleeding, dyspepsia, constipation, leucopenia, neutropenia, anaemia,
thrombocytopenia, reversible increases in AST and ALT, rash, asthenia,
fever, abdominal pain, headache, infections, cellulitis and sepsis. The SmPC
should be consulted for details of other undesirable effects.
Legal category: POM
Marketing Authorisation Number/Pack/Basic NHS Price PL 04515/0225.
Single vial containing raltitrexed 2mg. £175.
Marketing Authorisation Holder: Hospira UK Limited, Queensway, Royal
Leamington Spa, Warwickshire, CV31 3RW. United Kingdom.
Further information is available on request from Hospira UK Ltd.
Date of preparation: March 2012 (UK/12/013).
Adverse events should be reported. Reporting forms and information
can be found at www.mhra.gov.uk/yellowcard. Adverse events should
also be reported to Hospira UK Ltd. Telephone Medical Information:
+44 (0) 1926 834400. A discussion of Tomudex usage in patients
with advanced colorectal cancer, for which
5-fluorouracil-based regimens are either not
tolerated or inappropriate.
Your questions about Tomudex
Prescribing information can be found on page 24.
Tomudex
Hospira UK Ltd.
Queensway
Royal Leamington Spa,
Warwickshire
CV31 3RW, UK
www.hospira.com
UK/13/027. February 2013.
DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brand: XifaxantaClient: Norgine Pharmaceuticals Ltd
A5 leave piece
Xifaxanta. BMJ (GP) Whole/full page advert. 280 x 210mm. 3mm bleed.
Xifaxanta™ gets to work here ...and only here1,2
XIFAXANTA™ Prescribing InformationREFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING.Presentation: Film-coated tablet containing rifaximin 200 mg. Uses: Xifaxanta is indicated for the treatment of travellers’ diarrhoea that is not associated with fever, bloody diarrhoea, eight or more unformed stools in the previous 24 h, occult blood or leucocytes in the stool. Dosage and administration: Adults over 18 years of age: 200 mg every 8 hours for three days (total 9 doses). Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken. Not recommended in children under 18 years of age. Contraindications: Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of the excipients. Warnings and precautions for use: Not recommended for the treatment of travellers’ diarrhoea caused by invasive enteric pathogens. If symptoms worsen, treatment with rifaximin should be interrupted. If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course is not recommended. The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis
cannot be ruled out. Interactions: Due to the negligible gastrointestinal absorption of orally administered rifaximin (less than 1%), the systemic drug interaction potential is low. Rifaximin should not be administered concomitantly with other rifamycins and the tablets should not be administered for at least two hours after the administration of charcoal. Pregnancy and lactation: Rifaximin is not recommended during pregnancy and in women of childbearing potential not using contraception. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding. Undesirable effects: Common effects reported in clinical trials are dizziness, headache, abdominal pain, constipation, defecation urgency, diarrhoea, flatulence, bloating, distension, nausea, vomiting, rectal tenesmus and pyrexia. Other effects that have been reported are candidiasis, herpes simplex infections, clostridial infections, palpitations, increased blood pressure, liver function test abnormalities, blood disorders (e.g. thrombocytopenia) and anaphylactic reactions, (e.g. angioedemas,hypersensitivity and skin reactions). Licensing and legal category: Legal category: POM. Cost: Basic NHS price £15.15 (9 tablets). MA number: PL 20011/0021. For further
information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606. E-mail: [email protected]. Date of preparation/revision: XIF/2553/AUG/11.
References 1. Jiang ZD et al. Antimicrob Agents Chemother 2000;44
(8):2205-2206.2. Descombe JJ et al. Int J Clin Pharmacol Res 1994;14
(2):51-56.3. Xifaxanta™ Summary of Product Characteristics.
XIF/2563/AUG/11. Date of preparation: August 2011.
XIFAXANTA is a trademark of Alfa-Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies.
NEW
For Travellers’ Diarrhoe
a
The first and only virtually non-absorbed antibiotic licensed for the treatment of non invasive Travellers’ Diarrhoea3
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk.
Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606.
A4 UK advert
Detail Aid
1
XIFAXANTA™ (rifaximin- )
FORMULARYINFORMATION
The only virtually non-absorbed antibiotic for the treatment
of non invasive Travellers’ DiarrhoeaPrescribing information can be found on page 24.
XIF/2496/JUN/11. Date of preparation: August 2011.
XIFAXANTA is a trademark of Alfa-Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies.
FRONT COVER
Web card Formulary pack
21/12/2011 13:02Practice Nursing News
Page 1 of 1file:///Users/Kee/Desktop/Kee/Job%20and%20project/2011/DNA/xifaxanta_newsletter/xifaxnata_html/xifaxanta_211211.html
Every year approximately 80 million people travel from developed to developing countries, and it is estimated that nearly half
contract travellers’ diarrhoea (TD); making it the most common illness affecting travellers.1,2 Aside from the physical cost, there
are high costs in terms of time, money and distress. One third of TD sufferers are forced to abandon their travel plans altogether.5
TD is caused by the ingestion of pathogens through consumption of contaminated food and drink. Bacteria are the
commonest cause of this problem with the enterotoxigenic (ETEC) strain of E.Coli being the most implicated.3 Even
when a pathogenic cause can not be identified, antibiotic therapy is still effective.4
The medical consequences of TD are far from trivial: research shows that longer term complications may also occur – a small of
travellers with TD have long-term bowel problems. Some research shows that up to 10% of TD sufferers may go on to
develop Post-Infectious Irritable Bowel Syndrome. However, this is a topic of ongoing debate. Yet despite the physical and
financial cost of TD, only half of travellers to high-risk countries are seeking advice from their GP or travel clinic before they
travel.1 Travellers returning from most European countries and the United States had very low rates of infection, but the rates are
drastically higher in those returning from popular tourist destinations like Egypt (up to 40% risk) followed by Turkey, India,
Thailand, Morocco, Kenya and Tunisia.5
Xifaxanta™ - ‘Zi-fax-anta’ - is the first oral antibiotic for the treatment of non-invasive TD which remains almost entirely inside the
gut (<99%) and is active against enterotoxigenic E.Coli (ETEC):6 as such, the potential for resistance is low, despite Xifaxanta™’s
use in many countries over several years.7,8 In addition, the risk of systemic side effects and/or drug-drug interactions is reduced.
Xifaxanta™ presents prescribers with an opportunity to treat TD efficiently, but without the concerns of inducing systemic bacterial
resistance. Importantly, over the last 10 years there has been increasing global resistance with commonly first-line used
antibiotics like ciprofloxacin9 (resistance among Campylobacter strains to flouroquinolones in Southern Europe and Thailand6).
Xifaxanta™ has not been associated with clinically significant cross-resistance to other members of the rifamycin class, in
particular rifampicin.
Xifaxanta™ has been available in the USA and other European countries since 2004, but can now be prescribed by UK general
practitioners and travel clinics to patients travelling to high risk destinations as a ‘stand by treatment’.10
Administration is via a course of tablets - one to be taken three times a day for three days - with or without food.10 The course
should be started as soon as symptoms arise.
The following patients in particular could benefit from taking Xifaxanta™:
Those visiting high risk regions
Those with increased susceptibility to infection (eg immunocompromised)
Those for whom an episode of TD would adversely disrupt their planned activities
Those returning from travel with uncomplicated TD
EFFICACY: COMPARISON WITH CIPROFLOXACIN AND LOPERAMIDE
A clinical trial has found no significant difference between the efficacy of Xifaxanta™ and ciprofloxacin in TREATING
non-invasive TD.11,12 The median time from taking Xifaxanta™ until the last unformed stool is between 32 and 32½ hours.10
Clinical ‘wellness’ was achieved significantly faster with Xifaxanta™-containing regimens compared with loperamide alone.13
CONTRAINDICATIONS & SIDE EFFECTS
Xifaxanta™ is generally well-tolerated, and is associated with a low incidence of adverse events14 which are generally mild to
moderate in severity.15 The most commonly-reported events are gastrointestinal in nature, such as flatulence and abdominal
pain, and distinction from the condition can be difficult.
References:
1. Wang M, Szecs TD, Steffen R. Economicaspects of travellers’ diarrhoea. J TravelMed. 2008; 15(2): 110-118
2. Du Pont HL. Systematic review :prevention of travellers’ diarrhoea. AlimentPharmacol Ther 2008;27:741-751
3. Shah N et al. Global Etiology of Travelers’Diarrhea: Systematic Review from 1973 tothe Present. Am J Trop Med Hyg2009;80(4):609–614
4. DuPont HL, Haake R, Taylor DN, et al.Rifaximin Treatment of Pathogen-NegativeTravelers’ Diarrhea. International Societyof Travel Medicine 2007;14:1195-1982.
5. Steffen R. Epidemiology of Traveler’sDiarrhea. CID 2005: 41 (Suppl 8): S536-40
6. Robbins GW et al. Drugs2005:65(12)1697-1713
7. Ericsson CD. Drug Saf 2006; 29 (£):201-207
8. Dupont HL et al. Clin Micro Infect2004 ;10:1006-1035
9. Ouyang-Latimer J et al. In VitroAntimicrobial Susceptibility of BacterialEnteropathogens Isolated fromInternational Travelers to Mexico,Guatemala, and India from 2006 to 2008.Antimicrob Agents Chemother2011;55:874–8.
10. XIFAXANTA™ SMPC11. Layer P, et al. Aliment Pharmacol Ther
2010;31:1155-116412. DuPont et al. Clin Infect Dis 2011;33:1807-
181513. DuPont et al. Clin Gastroenterol Hepatol
2007;5(4):451-45614. Koo HL, DuPont HL. Rifaximin: a unique
gastrointestinal-selective antibiotic forenteric diseases. Current Opinion inGastroenterology. 2010; 26: 17-25
15. Ericsson CD. Safety and tolerability of theantibacterial rifaximin in the treatment oftravellers' diarrhoea. Drug Saf.2006;29(3):201-7.
Prescribing Information:
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFOREPRESCRIBING.
Presentation: Film-coated tablet containing rifaximin 200 mg. Uses: Xifaxanta isindicated for the treatment of travellers' diarrhoea that is not associated with fever,bloody diarrhoea, eight or more unformed stools in the previous 24 h, occult blood orleucocytes in the stool. Dosage and administration: Adults over 18 years of age: 200mg every 8 hours for three days (total 9 doses). Rifaximin must not be used for morethan 3 days even if symptoms continue and a second course of treatment must not betaken. Not recommended in children under 18 years of age. Contraindications:Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin)or to any of the excipients. Warnings and precautions for use: Not recommendedfor the treatment of travellers' diarrhoea caused by invasive enteric pathogens. Ifsymptoms worsen, treatment with rifaximin should be interrupted. If symptoms havenot resolved after 3 days of treatment, or recur shortly afterwards, a second course isnot recommended. The potential association of rifaximin treatment with Clostridiumdifficile associated diarrhoea and pseudomembranous colitis cannot be ruled out.Interactions: Due to the negligible gastrointestinal absorption of orally administeredrifaximin (less than 1%), the systemic drug interaction potential is low. Rifaximinshould not be administered concomitantly with other rifamycins and the tablets shouldnot be administered for at least two hours after the administration of charcoal.Pregnancy and lactation: Rifaximin is not recommended during pregnancy and inwomen of childbearing potential not using contraception.The benefits of rifaximintreatment should be assessed against the need to continue breastfeeding.Undesirable effects: Common effects reported in clinical trials are dizziness,headache, abdominal pain, constipation, defecation urgency, diarrhoea, flatulence,bloating, distension, nausea, vomiting, rectal tenesmus and pyrexia. Other effects thathave been reported are candidiasis, herpes simplex infections, clostridial infections,palpitations, increased blood pressure, liver function test abnormalities, blooddisorders (e.g. thrombocytopenia) and anaphylactic reactions, (e.g. angioedemas,hypersensitivity and skin reactions). Licensing and legal category: Legal category:POM. Cost: Basic NHS price £15.15 (9 tablets). MA number: PL 20011/0021. Forfurther information contact: Norgine Pharmaceuticals Limited, Norgine House,Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606. E-mail:[email protected]. Date of preparation/revision: XIF/2553/AUG/11.
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also
be reported to Medical Information at Norgine PharmaceuticalsLtd on 01895 826606.
eNewsletter
Travellers’ diarrhoea (TD) is the most common infectious disease in those travelling abroad from the UK. Every year, 5 million UK holiday and business travellers will suffer from a bout of TD.
Up to 40% of travellers to high risk regions (such as Latin America, Africa and Southern Asia) suffer with TD
However, you don’t need to go to a developing or an ‘exotic’ country to be at risk
Bacteria are the most common cause of TD, around 80% of cases are thought to be caused by a form of E. coli
You may be confined to your room and unable to continue fully with your plans. This could be a disaster for your holiday or business trip and prove to have been a waste of time and money.
Although it is usually a short illness, TD can sometimes last many weeks - some people may even develop long term bowel troubles
Don’t let travellers’ diarrhoea spoil your holiday or business trip
Get travellers’ diarrhoea advice BEFORE you leave.
For more information please ask at this clinic, read the travellers’ diarrhoea leaflets available here, or visit www.travellersdiarrhoea.co.uk
Where would you rather spend your holiday?
XIF/2873/APR/12. Date of preparation: April 2012.
Get travellers’ diarrhoea advice BEFORE you leave.
Every year, 5 million UK holiday and business travellers will suffer from a bout of travellers’ diarrhoea (TD). And it’s not just those who travel to developing or exotic countries.
Wherever you’re travelling, get advice from your doctor or practice nurse first - before you go.
A patient information service from Norgine.Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 6NS.
Email: [email protected]. Tel: 01895 826606
Waiting room poster
Clinic leaflet
For more information visit www.travellersdiarrhoea.co.uk
Where would you rather spend your holiday?
XIF/3126/OCT/12. Date of preparation: November 2012.
Get travellers’ diarrhoea advice BEFORE you leave.
Every year, 5 million UK holiday and business travellers will suffer from a bout of travellers’ diarrhoea (TD). And it’s not just those who travel to developing or exotic countries.
Wherever you’re travelling, get advice from your doctor or practice nurse first - before you go.
A patient information service from Norgine.Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 6NS.
Email: [email protected]. Tel: 01895 826606
Xifaxanta The Travel Show. Bench poster. 450 x 450mm. CMYK
at the Travel Health
Zone Stand AP105
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Destinations Travel Show, bench posterDetail aid interactive PDF
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Patient Information Private PrescriptionCollecting your Xifaxanta™
Patient details
Surgery Stamp
NAME
ADDRESS
DATE OF BIRTH
POSTCODE
You can present your private prescription at any pharmacy. However, although the drug costs will be the same, different pharmacies may charge different fees for dispensing your medication. It may be worth shopping around for the best price.
Alternatively, you may wish to use a service called Pharmacy2U. This service can dispense and deliver your medication discreetly and securely to an address that is convenient to you (e.g. your home or work address).
Pharmacy2U will charge for your private prescription:
Details about the Pharmacy2U service are available overleaf, including an order form.
1 course of Xifaxanta™ treatment (9 tablets) £18.95
Key facts about Travellers’ Diarrhoea (TD)
Travellers’ Diarrhoea is the most common medical condition in those who venture abroad from the UK
Around 5 million people from the UK will suffer from a bout of TD every year
Bacteria are the most common cause of TD; around 80% of cases are thought to be caused by a harmful form of E. coli
Travellers’ diarrhoea infections can be passed from person to person by touching contaminated surfaces or objects, or by eating or drinking contaminated food or water
High-risk foods include: – Raw or undercooked meat – Poultry – Seafood – Unwashed raw fruits and vegetables – Tap water (including ice!)
– Unpasteurised milk and dairy products
NAME OF MEDICINE
NO. OF ORIGINAL PACKS
DOSING INSTRUCTIONS
OF DOSE STRENGTH (mg)
Prescription for:
SIGNATURE OF DOCTOR
NAME OF DOCTOR
Doctor details
DATEGMC NUMBER
FOR ASSISTANCE WITH ORDERING CONTACT:
0845 803 9033
A4 private patient presciption pad
Global Relative Risk of Travellers’ Diarrhoea
High and intermediate risk countries by continent
Risk level:n Low – diarrhoea rates <4%n Intermediate – diarrhoea rates 8-15%n High – diarrhoea rates ~40%
XIF/2557/AUG/11. Date of preparation: August 2011.
Latin America AsiaAfghanistanArmeniaAzerbaijanBahrainBangladeshBhutanBruneiBurmaCambodiaEast TimorEastern RussiaGeorgiaIndiaIndonesiaIranIraq
IsraelJordanKazakhstanKuwaitLebanonMalaysiaMaldivesMongoliaNepalNorth KoreaOmanPakistanPapua New GuineaPeople’s Republic of ChinaPhilippines
QatarRussiaSaudi ArabiaSingaporeSri LankaSyriaTajikistanThailandTurkeyTurkmenistanUnited Arab EmiratesUzbekistanVietnamYemen
AfricaAlgeriaAngolaBeninBotswanaBurkina FasoBurundiCameroonCape VerdeCentral African RepublicChadComorosCôte d’IvoireDemocratic Republic of the CongoDjibouti
EgyptEquatorial GuineaEritreaEthiopiaGabonGambiaGhanaGuineaGuinea-BissauKenyaLesothoLiberiaLibyaMadagascarMalawiMali
MauritaniaMauritiusMayotte (Fr.)Morocco (excluding Western Sahara)MozambiqueNamibiaNigerNigeriaRéunion (Fr.)RwandaSaint Helena, Ascension & Tristan da Cunha (UK)São Tomé & PríncipeSenegalSeychelles
Sierra LeoneSomaliaSudanSouth AfricaSouth SudanSwazilandTanzaniaTogoTunisiaUgandaWestern SaharaZambiaZimbabwe
Anguilla Antigua & BarbudaArgentina Aruba BahamasBarbadosBermudaBoliviaBrazilBritish Virgin Islands Cayman Islands Chile ColombiaCosta RicaCubaDominica
Dominican RepublicEcuadorFrench Guiana (Fr.)GrenadaGuadeloupeGuatemalaGuyanaHaitiHondurasJamaica MartiniqueMexicoMontserratNetherlands AntillesNicaraguaPanama
ParaguayPeruPuerto Rico South Georgia and the South Sandwich Islands (UK)St. Kitts & NevisSt. Lucia St. Vincent & the GrenadinesSurinameTrinidad & Tobago Turks & Caicos Islands Uraguay U.S. Virgin Islands Venezuela
EuropeBelarus Ukraine Moldova Romania Greece Bulgaria Hungary Serbia Austria Czech Republic Croatia Bosnia and Herzegovina Slovakia Albania Macedonia
Slovenia Montenegro
The only virtually non-absorbed antibiotic for the treatment of non invasive Travellers’ Diarrhoea
Prescribing information is available on this stand.
Xifaxanta™ gets to work here ...and only here1,2
NEW
For Travellers’ Diarrhoe
a
XIF/2527/JUL/11. Date of preparation: July 2011.
XIFAXANTA is a trademark of Alfa-Wassermann Hungary KFT, exclusively licensed in the UK to the Norgine group of companies.
Travellers’ Diarrhoea is the most
frequent illness for travellers visiting
developing countries3
UK residents made over 14 million
trips to intermediate or high-risk
regions in 20104
Xifaxanta™ is active against
enterotoxigenic E. coli (ETEC)5, the
major cause of non invasive TD6
References 1. Descombe JJ et al. Int J Clin Pharmacol Res 1994;14(2):51-56.2. Jiang ZD et al. Antimicrob Agents Chemother 2000;44(8):2205-2206.3. Health Protection Agency UK - Foreign travel-associated illness: A focus on travellers’ diarrhoea:
2010 Report: National Travel Health Network & Centre; 2010.4. Norgine Pharmaceuticals Ltd. Data on file: N124.
Contains public sector information licensed under the Open Government Licence v1.0.5. Robins GW et al. Drugs 2005;65(12):1697-1713.6. Shah N et al. Am J Trop Med Hyg 2009;80(4):609-614.
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk. Adverse events should also be reported to Medical
Information at Norgine Pharmaceuticals Ltd on 01895 826606.
Exhibition stand and rep stand panel
A2 poster
6pp RPC mailer
Dear Pharmacist,
New Xifaxanta™ for travellers’ diarrhoea (TD)
Norgine are pleased to announce the launch of Xifaxanta™ (rifaximin-α) - the first and only virtually non-absorbed antibiotic for the treatment of non-invasive travellers’ diarrhoea in adults.1
Travellers’ diarrhoea is the most common illness affecting travellers from industrialised countries to high-risk destinations such as Latin America, Africa and Southern Asia. 2
UK residents made over 14 million trips to intermediate or high-risk regions in 20103
making appropriate (pre-travel) preparation an essential element of any trip.
New Xifaxanta™:
Is active against non-invasive E coli4, the major cause of travellers’ diarrhoea5
Resolves the symptoms of travellers’ diarrhoea in just under half the time of Loperamide6 (32.5 ± 4.14hr vs. 69 ± 4.11hr, p = 0.0019)
Has demonstrated comparable efficacy to ciprofloxacin in treating non-invasive travellers’ diarrhoea7 (32.0hr vs. 28.8hr, p = 0.35)
When you next see a patient planning a trip to an “at risk” region, please discuss the impact travellers’ diarrhoea could have and recommend they seek advice from their GP or a local travel clinic who will be able to determine if a prescription for Xifaxanta™ is appropriate.
If you would like further information about Xifaxanta™, please contact your local Norgine representative or call 01895 826 606.
Yours faithfully,
Andrew MiddletonGroup Brand ManagerNorgine Pharmaceuticals Limited
Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS, UK
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Clinic support items RPC mailer
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Postcard item request RPC mailer
MOVIPREP® and MOVIPREP® Orange Abbreviated Prescribing Information. REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: A box containing two transparent bags, each containing two separate sachets, A and B. Sachet A contains macrogol 3350 100g; sodium sulphate anhydrous 7.5g; sodium chloride 2.691g and potassium chloride 1.015g as white to yellow powder. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g as white to light brown powder. MOVIPREP also contains aspartame (E951), acesulfame potassium (E950) and a lemon or orange flavour. Uses: Bowel cleansing prior to any clinical procedure requiring a clean bowel. Dosage and administration: Adults and elderly: A course of treatment consists of two litres of MOVIPREP. A further litre of clear fluid is recommended during the course of treatment. A litre of MOVIPREP consists of one Sachet A and one Sachet B dissolved in water. This reconstituted solution should be drunk over a period of one to two hours. This should be repeated with a second litre of MOVIPREP. The two litres of MOVIPREP may be consumed either as a divided dose, 1L the evening before the procedure and 1L in the early morning of the procedure, or as a single dose the evening before the procedure. There should be at least one hour between the end of intake and the start of the procedure. No solid food should be taken from the start of the treatment and until after the procedure. Children: Not recommended in children below 18 years of age. Contraindications, warnings etc: Contra-indications: Known or suspected gastrointestinal obstruction or perforation; disorders of gastric emptying; ileus; phenylketonuria; glucose-6-phosphodehydrogenase deficiency; toxic megacolon complicating severe inflammatory conditions of the GI tract or hypersensitivity to any of the ingredients.
Do not use in unconscious patients. Warnings: Diarrhoea is an expected effect. Administer with caution in fragile patients in poor health or serious clinical impairment such as severe renal insufficiency, cardiac impairment (NYHA grade III or IV), severe acute inflammatory disease or dehydration and those with an impaired gag reflex or impaired consciousness. Dehydration, if present, should be corrected before using MOVIPREP. Patients prone to aspiration should be closely monitored during administration, particularly if this is via a naso-gastric tube. If symptoms indicating shifts of fluid or electrolytes occur, plasma electrolytes should be measured and any abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment and those at risk of electrolyte imbalance, the physician should consider performing baseline and post-treatment electrolyte and renal function test. If patients experience symptoms which make it difficult to continue the preparation, they may slow down or temporarily stop consuming the solution and should consult their doctor. MOVIPREP containing orange flavour is not recommended for patients with glucose and galactose malabsorption. Interactions: Oral medication should not be taken within one hour of administration as it may be flushed from the GI tract and not absorbed. Pregnancy and lactation: There is no experience of use in pregnancy or lactation so it should only be used if judged essential by the physician. Side effects: Very common or common: abdominal pain, nausea, abdominal distension, anal discomfort, malaise, vomiting, dyspepsia, hunger, thirst, sleep disorder, headache, dizziness, and rigors. Uncommon or unknown: Dysphagia, discomfort, abnormal liver function tests, allergic reactions including rash, urticaria, angioedema and anaphylaxis, electrolyte disturbances which are more common in patients taking concomitant medication affecting the kidneys, convulsions associated with severe hyponatraemia, transient increase in blood
pressure, flatulence and retching. Refer to the Summary of Product Characteristics (SmPC) for full list and frequency of adverse events. Overdose: In case of gross accidental overdosage, conservative measures are usually sufficient. In the rare event of severe metabolic derangement, intravenous rehydration may be used. Pharmaceutical Particulars: Sachets: Store in the original package below 25oC. Reconstituted solution: Keep covered. May be stored for up to 24 hours below 25oC or in a refrigerator. Legal Category: P Packs: One pack of MOVIPREP or MOVIPREP Orange contains a single treatment. Basic NHS Price: UK £9.87 Marketing Authorisation Number: PL 20142/0005 (MOVIPREP). PL 20011/0006 (MOVIPREP Orange). For further information contact: Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex, UB9 6NS. Tel: 01895 826606. E-mail: [email protected] MOVIPREP® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MP/3001/JUL/12.
MP/3344/MAR/13
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Medical Informationat Norgine Pharmaceuticals Ltd
on 01895 826 606.
CONFIDENCE THROUGH CLARITY
Moviprep UK A4 advert
PROVEN EFFICACY IN BOWEL CLEANSING1,2,3
References:1. Worthington J et al. Curr Med Res Opin 2008;24(2):481–488.2. Bitoun A et al. Aliment Pharmacol Ther 2006;24:1631–42.3. Ell C et al. Am J Gastroenterol 2007;102:1–11.
Date of preparation: March 2013
A4 AdvertConference stand panels
ORANGE
CONFIDENCE THROUGH CLARITY
Prescribing Information can be found on page 13.
Moviprep. 3x3 (Conference) stand. 3440 x 2300mm. CMYK.
CONFIDENCE THROUGH CLARITY
Date of preparation: March 2013. MP/3343/MAR/13.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826 606.
Prescribing Information is available from the stand.Adverse events should be reported to Medical Information at Norgine
Pharmaceuticals Ltd on 0044 1895 826606.
Ireland:
UK:References:1. Worthington J et al. Curr Med Res Opin 2008;24(2):481–488.2. Bitoun A et al. Aliment Pharmacol Ther 2006;24:1631–42.3. Ell C et al. Am J Gastroenterol 2007;102:1–11.
PROVEN EFFICACY IN BOWEL CLEANSING1,2,3
Brand: Moviprep (UK assets adapted from global material)
Client: Norgine Pharmaceuticals Ltd
AM and PM 6pp DL dosing leave pieces
Detail aid A5 6pp leave piece
© DNA Healthcare Advertising Ltd. DNA Portfolio.
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A3 desktop presenter
Prescribing Information can be found on page 16.
Front CoverTop edge binding
Date of preparation: April 2013.
BOWEL CANCER PATIENT INFORMATION MATERIALS
REQUEST CARD
Produced by Norgine Pharmaceuticals as a service to medicine in association with Beating Bowel Cancer.
Code: MP/XXXX/APR/13.
XIF/3159/DEC/12. D
ate of preparation: Decem
ber 2012.
F.A.O
.N
orgine Pharmaceuticals Ltd
FREE POST (H
A 4696)
Uxbridge
Middlesex
UB9 6BR
Bowel cancer patient info materials request RPC card
Reps desk top stand panel
Hints and advice 12pp booklet
Harefield Cleansing Scale A5 4pp leave piece
Moviprep. Reps desk top panel. 1000 x 850mm. CMYK
CONFIDENCE THROUGH CLARITY
Date of preparation: March 2013. MP/3342/MAR/13. Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on 0044 1895 826606.Prescribing Information is available from the stand.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826 606.
Ireland:
UK:References:1. Worthington J et al. Curr Med Res Opin 2008;24(2):481–488.2. Bitoun A et al. Aliment Pharmacol Ther 2006;24:1631–42.3. Ell C et al. Am J Gastroenterol 2007;102:1–11.
PROVEN EFFICACY IN BOWEL CLEANSING1,2,3
1.
3.
MOVIPREP®
LEADERBOARD
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2.
4.
CONFIDENCETHROUGH CLARITY
PROVEN EFFICACY INBOWEL CLEANSING1,2,3
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3.
MOVIPREP®
LEADERBOARD
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4.
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PROVEN EFFICACY INBOWEL CLEANSING1,2,3
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MOVIPREP®
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PROVEN EFFICACY INBOWEL CLEANSING1,2,3
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3.
MOVIPREP®
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PROVEN EFFICACY INBOWEL CLEANSING1,2,3
CLICK HEREFOR PRESCRIBINGINFORMATIONMP/3347/APR/13
DNA Portfolio. © DNA Healthcare Advertising Ltd.
NEW
NEW
TA/3181/DEC/12. Date of preparation: December 2012.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606.
Targaxan 3x3 stand. 3440 x 2300mm. CMYK
Reference: 1. Bass NM et al. N Engl J Med 2010;362:1071-81.
Prescribing Information is available on this stand.
Effective protection against recurrentepisodes of hepatic encephalopathy1
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
Brand: Targaxan (UK assets adapted from global material)
Client: Norgine Pharmaceuticals Ltd
A5 Abbreviated Advert master. 210 x 148mm. 5mm bleed CMYK.
Effective protection against recurrent episodes of
hepatic encephalopathy
NEW
NEW
TA/3190/DEC/12.
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Legal category: POM. Please consult Summary of Product Characteristics before prescribing, particularly in relation to side effects, precautions and contra-indications. Information about this product, including adverse reactions, precautions, contraindications and method for use can be found at http://www.medicines.org.uk. Further information is available on request from Norgine pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex, UB9 5NS.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information
at Norgine Pharmaceuticals Ltd on 01895 826606.
TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.2Prescribing Information can be found on the back cover.
Effective protection against recurrent episodes of
hepatic encephalopathy1NEW
NEW
A4 Advert master. 297 x 210mm. CMYK.
TA/3189/DEC/12.Date of preparation: December 2012.
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
TARGAXAN 550 mg film-coated tablets. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: Film-coated tablet containing rifaximin 550 mg.
Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.
Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass or water, for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic impairment. Use with caution in patients with renal impairment.
Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction.
Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin
with other rifamycins is not recommended. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. The effectiveness of oral oestrogenic contraceptives could be decreased after Rifaximycin administration. It is recommended to take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 μg.
Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.
Side effects: Common effects reported in clinical trials are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis and pneumonia. Blood disorders e.g. anaemia, thrombocytopenia. Anaphylactic reactions, angioedemas, hypersensitivity. Hypo and hypertension. Pyrexia. Liver function abnormalities.
Licensing and legal category: Legal category: POM.
Cost: Basic NHS price £259.23 for 56 tablets.
MA number: PL 20011/0020.
For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606E-mail: [email protected]
Date of preparation/revision: TA/3206/JAN/13.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine
Pharmaceuticals Ltd on 01895 826606.
Reference:1. Bass NM et al. N Engl J Med 2010;362:1071-81.
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A5 abbreviated advert
Online banner advert
3 x 3 exhibition stand and rep stand panels
Formulary pack
728px x 90px
NEW
NEW
PRESCRIBING INFORMATION
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
TA/3191/DEC/12. Date of preparation: January 2013.
TARGAXAN6 550 mg film-coated tablets.REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: Film-coated tablet containing rifaximin 550 mg.
Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.
Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass or water, for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic impairment. Use with caution in patients with renal impairment.
Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction.
Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin with other rifamycins is not recommended. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. The effectiveness of oral oestrogenic contraceptives could be decreased after Rifaximycin administration. It is recommended to take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 μg.
Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.
Side effects: Common effects reported in clinical trials are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis and pneumonia. Blood disorders e.g. anaemia, thrombocytopenia. Anaphylactic reactions, angioedemas, hypersensitivity. Hypo and hypertension. Pyrexia. Liver function abnormalities.
Licensing and legal category: Legal category: POM.
Cost: Basic NHS price £259.23 for 56 tablets.
MA number: PL 20011/0020
For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606E-mail: [email protected]
Date of preparation/revision: TA/3206/JAN/13
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine
Pharmaceuticals Ltd on 01895 826606.
References:1. Bass NM et al. N Engl J Med 2010;362:1071-81.
TA/3155/NOV/12. Date of preparation: January 2013.
Prescribing information can be found at the end of this document.
Formulary Pack to support the use of TARGAXAN®6 550 mg bd (rifaximin-a)
Licensed in the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age1
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
NEW
Prescribing Information can be found on the back cover.
Letterhead and digital Word template
Norgine are pleased to announce the launch of new TARGAXAN® 550 mg (rifaximin-aα) for the reduction in recurrence of episodes of overt Hepatic Encephalopathy (HE) in patients ≥ 18 years of age.1
HE is the occurrence of confusion, altered level of consciousness and potentially coma, due to the influence on the brain of toxic compounds that accumulate in the blood due to the inability of the cirrhotic liver to remove them from the blood, as would occur in healthy individuals.2
Overt HE occurs in 30-45% of patients with cirrhosis.3
TARGAXAN® 550 mg bd significantly reduces the risk of an episode of HE. 4
• TARGAXAN® 550 mg bd plus lactulose significantly reduced (p<0.001) the relative risk of recurrence of overt HE episodes by 58% (absolute risk reduction 23.8%) vs. placebo plus lactulose over 6 months4
TARGAXAN® 550 mg bd significantly reduces the risk of hospitalisation.4
• TARGAXAN® 550 mg bd plus lactulose significantly reduced (p=0.01) the relative risk of hospitalisation involving HE by 50% (absolute risk reduction 9%) vs. placebo plus lactulose over 6 months4
TARGAXAN® 550 mg bd is a new convenient option for reducing the recurrence of episodes in patients with hepatic encephalopathy.1
If you would like further information about TARGAXAN®, please contact your local Norgine representative or call 01895 826 606.
Yours faithfully,
Neil SmithUK and Ireland Marketing ManagerNorgine Pharmaceuticals Limited
NEW
NEW
Prescribing Information can be found on the back.
Norgine Pharmaceuticals LimitedNorgine House, Widewater Place, Moorhall Road,
Harefield, Uxbridge, UB9 6NS, UK
TA/3186/DEC/12.
Dear Doctor X,
Dr. A MedicA Hospital, Invented Road, Sometown, Someplace, ABC DEF, UK
12th December 2012
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NEW
NEW
TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.1Prescribing Information can be found on the back cover.
TARGAXAN® 550 mg bd:
Simple dosing regimen1
PRESCRIBING INFORMATION
TA/3178/DEC/12. Date of preparation: December 2012.
TARGAXAN 550 mg film-coated tablets.
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: Film-coated tablet containing rifaximin 550 mg.
Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.
Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass or water, for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic impairment. Use with caution in patients with renal impairment.
Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction.
Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin with other rifamycins is not recommended. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. The effectiveness of oral oestrogenic contraceptives could be decreased after Rifaximycin administration. It is recommended to take additional contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 μg.
Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding.
Side effects: Common effects reported in clinical trials are dizziness, headache, depression,dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have been reported include: Clostridial infections, urinary tract infections, candidiasis and pneumonia. Blood disorders e.g. anaemia thrombocytopenia. Anaphylactic reactions, angioedemas, hypersensitivity. Hypo and hypertension. Pyrexia. Liver function abnormalities.
Licensing and legal category: Legal category: POM.
Cost: Basic NHS price XXX.
MA number: PL XXXX.
For further information contact: Norgine
Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS. 01895 826606E-mail: [email protected]
Date of preparation/revision: TAR/XXX/XXX. Draft 26 Oct 2012.
Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information
at Norgine Pharmaceuticals Ltd on 01895 826606.
DOSING
REFERENCES1. Targaxan® Summary of Product Characteristics.
2. Bass NM et al. N Engl J Med 2010;362:1071-81.
PI not complete
Product under licence from Alfa Wassermann S.p.A. TARGAXAN® is a registered trademark of Alfa Wassermann Hungary KFT, licensed to the Norgine group of companies.
Dosing, (plus MoA and Efficacy) leave pieces
NEW
NEW
TARGAXAN® is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age.2
Effective protection against recurrent episodes of hepatic
encephalopathy1
Efficacy: breakthrough data 1
HE & QoL
Prescribing Info & References
Summary
Resitance & Dosing
Safety & Tolerability
Health-related QoL
Study Design
Introducing TARGAXAN®
Hepatic encephalopathy
Home
Efficacy: breakthrough data 2
Efficacy: hospitalisation data 1
Efficacy: hospitalisation data 2
Prescribing information can be found by selecting the Prescribing Info & References tab.
TA/3182/DEC/12. Date of preparation: December 2012.
Detail aid Interactive PDF for iPad
A5, 6pp Hepatology, Gastroenterology and Nurses RPC mailers
and envelopes
Trail making test app
Norgine (Targaxan) Trail Making App/Interactive Test
Patient information content on long scroll.
TARGAXAN® and Hepatic Encephalopathy
Patient Compliance Aid
Patient Medication Record for TARGAXAN® 550 Rifaximin-a Your doctor has diagnosed you with a condition called Hepatic Encephalopathy (often referred to as HE) and has prescribed a medicine called TARGAXAN® 550 (rifaximin-a) for you to take twice every day.
Hepatic Encephalopathy is a condition which leads to the impairment of brain function because toxins accumulate in the blood. Normally these toxins are removed from the body by your liver, but your liver is not performing this function as effectively as it used to, which means that you may suffer from breakthrough episodes of HE, which may require hospitalisation and may lead to more serious complications. Symptoms of HE include forgetfulness, confusion, personality changes and some problems with muscles and movement of the limbs. In more severe cases this may result in coma.
As part of your management, your doctor or nurse will discuss possible changes to your lifestyle, such as your diet, exercise levels and other things that may contribute to you having an episode of HE. You have also been advised to take a medicine called TARGAXAN® 550 every day. Your medication is an antibiotic that works by killing the bacteria in your gut and it has been shown to reduce the recurrence of HE episodes.
To help you manage your medicine, it may help to keep a record of how often you have taken your medicine.
If you experience any side effects, you may need to stop taking this medicine. Please discuss this with your doctor, nurse or pharmacist as quickly as possible.
DateMorning
tablet taken?Evening
tablet taken?Comments
Provided as a service to medicine by Norgine Pharmaceuticals LimitedTA/3156/DEC/12. Date of preparation: December 2012.
Outside frontOutside back table tableFOLD
FOLD
FOLD
Patient Medication Recordfor TARGAXAN® 550 (Rifaximin-a)
Your doctor has diagnosed you with a condition called Hepatic Encephalopathy (often referred to as HE) and has prescribed a medicine called TARGAXAN® 550 (rifaximin-a) for you to take twice every day.
Hepatic Encephalopathy is a condition which can lead to the impairment of brain function as toxins accumulate in the blood. Normally these toxins are removed from the body by your liver, but your liver is not performing this function as effectively as it used to, which means that you may suffer from breakthrough episodes of HE, which may require hospitalisation and may lead to more serious complications.
Symptoms of HE include forgetfulness, confusion, personality changes and some problems with muscles and movement of the limbs. In more severe cases this may result in coma.
As part of your management, your doctor or nurse will discuss possible changes to your lifestyle, such as your diet, exercise levels and also other things that may contribute to you having an episode of HE. You have also been advised to take a medicine called TARGAXAN® 550 every day. Your medication is an antibiotic that works by killing the bacteria in your gut and it has been shown to reduce the recurrence of HE episodes.
To help you manage your medicine, it may help to keep a record.
Weeks 2, 3 and 4 on reverse.
Week 1
DateMorning
tablet taken?Evening
tablet taken?
Provided as a service to medicine by Norgine Pharmaceuticals LimitedTA/3157/DEC/12. Date of preparation: December 2012.
A4 Patient Medication Record. CMYK. Front.
DL patient compliance aid Patient medication record
DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brand: Movicol / Movicol Orange / Movicol Liquid (Assets adapted from global material)
Client: Norgine Pharmaceuticals Ltd
Please consult Summary of Product Characteristics before prescribing, particularly in relation to side effects, precautions and contra-indications. Further information is available on request from: Norgine Pharmaceuticals Limited, Moorhall Road, Harefield, Middlesex UB9 6NS. Legal category: POM. MO/3061/SEP/12.
Blends proven efficacy with fast-mix convenience
macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride
For the treatment of chronic constipation
Adverse events should be reported to Medical Information at Norgine
Pharmaceuticals Ltd on +44 1895 826606.www.MOVICOL.co.uk
Movicol Irish Abbreviated Advert: 188 x 82mm. 3mm bleed. CMYK
A2 poster
MOVICOL® Liquid, Orange Flavour, concentrate for oral solution. Abbreviated Prescribing Information. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) BEFORE PRESCRIBING. Presentation: A clear, concentrated liquid, which is diluted in water to make an orange flavoured drink. Each 25 ml of MOVICOL Liquid is diluted in 100 ml of water before use and contains the following active ingredients: 13.125 g macrogol (polyethylene glycol) 3350, 178.5 mg sodium hydrogen carbonate, 350.7 mg sodium chloride and 46.6mg potassium chloride. Uses: Treatment of chronic constipation. Dosage and administration: Adults, adolescents and the elderly: 25 ml diluted in 100 ml of water 1-3 times daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 doses per day, each consisting of 25 ml diluted in 100 ml of water. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL Liquid treatment does not normally exceed 2 weeks, but can be repeated if required.Children (below 12 years): not recommended. See MOVICOL Paediatric Plain.Contra-indications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions
of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances or any of the excipients. Warnings and precautions for use: If patients develop any symptoms indicating shifts of fluids/electrolytes MOVICOL Liquid should be stopped immediately. MOVICOL Liquid contains 8.125 mmol of sodium in each diluted dose of 125 ml and should be considered when administered to patients on a controlled sodium diet. MOVICOL Liquid contains benzyl alcohol. Do not exceed the maximum recommended daily dose. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, dyspepsia, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Licensing and legal category: Legal Category: UK P, IE Prescription-only Cost: 500ml UK £4.45, IE€ €10.81 (Trade price). MA numbers: PL20011/0007, PA 1336/2/4 For further information
contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex UB9 6NS. Telephone: 01895 826606. E-mail: [email protected] MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MO/3011/AUG/12.United Kingdom
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information
at Norgine Pharmaceuticals Ltd on 01895 826606. Ireland
Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on +44 1895 826606.
www.MOVICOL.co.uk
A systematic review of RCTs concluded that overall, macrogol was superior to lactulose in the management of chronic constipation1
macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride
MOVICOL®Liquid and the original powder formulation of MOVICOL®(macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride) produce the same active solution once reconstituted.
The first liquid macrogol
Orange-flavoured
Now included in the Nurse Prescribers’ Formulary2
NHS cost comparable to lactulose3
Flexible
- Treat chronic constipation with various causes in children, adults and elderly4
- Tailor to individual patient’s needs across a spectrum of severity4
References: 1. Lee-Robichaud H, et al. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.: CD007570. DOI:10.1002/14651858.CD007570.pub2. 2. Nurse Prescribers Formulary. Available at: http://www.medicinescomplete.com/mc/bnf/current/119717.htm. Accessed Mar 2012. 3. Taylor RR, Guest JF. Aliment Pharmacol Ther 2009; 31: 302-312. 4. MOVICOL® Liquid Summary of Product Characteristics.
MO/3062/SEP/12
UK & Ireland A5 abbreviated advert
Irish A4 advert Dosing wheel (new PI)
macrogol 3350, sodium hydrogen carbonate, sodium chloride, potassium chloride
www.MOVICOL.co.uk
Established MOVICOL® efficacy1
Convenient liquid formulation
Tailor to individual patient’s needs2
... move to
If your patients prefer a liquid laxative …
MOVICOL® Liquid, Orange Flavour, concentrate for oral solution. Abbreviated Prescribing Information. REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) BEFORE PRESCRIBING. Presentation: A clear, concentrated liquid, which is diluted in water to make an orange flavoured drink. Each 25 ml of MOVICOL Liquid is diluted in 100 ml of water before use and contains the following active ingredients: 13.125 g macrogol (polyethylene glycol) 3350, 178.5 mg sodium hydrogen carbonate, 350.7 mg sodium chloride and 46.6mg potassium chloride. Uses: Treatment of chronic constipation. Dosage and administration: Adults, adolescents and the elderly: 25 ml diluted in 100 ml of water 1-3 times daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 doses per day, each consisting of 25 ml diluted in 100 ml of water. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL Liquid treatment does not normally exceed 2 weeks, but can be repeated if required. Children (below 12 years): not recommended. See MOVICOL Paediatric Plain. Contra-indications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to the active substances or any of the excipients. Warnings and precautions for use: If patients develop any symptoms indicating shifts of fluids/electrolytes MOVICOL Liquid should be stopped immediately. MOVICOL Liquid contains 8.125 mmol of sodium in each diluted dose of 125 ml and should be considered when administered to patients on a controlled sodium diet. MOVICOL
Liquid contains benzyl alcohol. Do not exceed the maximum recommended daily dose. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, dyspepsia, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Licensing and legal category: Legal Category: Prescription medicine. MA number: PA 1336/2/4. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex UB9 6NS. Telephone: 01895 826606. E-mail: [email protected]. MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MO/3085/SEP/12.
Adverse events should be reported to Medical Information at Norgine Pharmaceuticals Ltd on +44 1895 826606.
References: 1. Attar A et al. Gut 1999; 44: 226-230.2. MOVICOL® Liquid Orange flavour,
Summary of Product Characteristics.
MO/3066/SEP/12
Movicol (Norgine) 10x4 advert (205 x 130mm). 5mm bleed. CMYK.Irish Medical News
Home Tips on
125ml
UK & Ireland DL leave piece
UK & Ireland nursing home mini detailaid / 6pp leave piece
Flavo
ur
Who fo
r
Chro
nic c
onstipatio
n
Faec
al im
paction
NHS pric
e
MOVICOL®
macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride
formulation and dosage guideto help you choose from the whole MOVICOL® family of products including
macrogol 3350, sodium hydrogen carbonate,sodium chloride, potassium chloride
Prescribing Information appears overleaf
MO
VICO
L® Chocolate
MO
VICOL
®
MOVICOL® Liquid
MOVICOL® Plain
MOVICOL®
Pae
diat
ric
Plai
nM
OV
ICO
L® -H
alf
Unflavoured
Unfla
vour
ed
Orange
Lem
on &
lim
e Lemon &
lime
Chocolate
(add to favourite cordial)
(add
to fa
vour
ite c
ordi
al)
Child
ren
Ado
lesc
ents
, adu
lts &
the
elde
rly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
2-6
sach
ets/d
ay in
div
ided
dose
s
2-6
year
s – 1
sach
et/d
ay
1-3 sachets/day in divided doses
1-3 sachets/day in divided doses
25ml diluted in 100ml of water 1-3 times daily
1-3 sachets/day in divided doses
(1-2 sachets/day for long term use)
7-11
year
s – 2
sach
ets/
day
(1-2 sachets/day for long term use)
(1-2 sachets/day for extended use)
(1-2 times a day for extended use)
8 sachets within 6h for up to 3 days
8 sachets over 6h for up to 3 days
8 sachets over 6h for up to 3 days5-11 ye
ars –
4 sa
chet
s in
divi
ded
dose
s 16
sac
hets
ove
r 6h
for u
p to
3 days
over 1
2h
, incr
easin
g by
2 s
ache
ts/d
ay
for u
p to
7 d
ays.
M
ax. 1
2 sa
chet
s/da
y20
sac
hets
£2.
92
30 sachets £6.68
30 sa
chet
s £4.
38
30 sachets £6.6820 sachets £4.45
500ml £4.45
50 sachets £11.13
30 s
ache
ts £
4.38
30 sachets £6.68
50 sachets £11.13
Not indicated
2-4
sach
ets f
or e
xten
ded
use
MOVICOL®, MOVICOL® Plain, MOVICOL® Chocolate,
MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated Prescribing Information
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: MOVICOL Sachet of white powder which dissolves in about 125ml
(approximately ½ glassful) water to make a lemon/lime flavoured drink. Each sachet contains: 13.125g
macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg sodium chloride and 46.6mg potassium chloride.
MOVICOL Plain Sachet of white powder which dissolves in about 125ml (approximately ½ glassful) water. Each sachet contains:
13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate, 350.8mg sodium chloride and 50.2mg potassium chloride. Does not
contain flavourings or sweeteners. MOVICOL Chocolate Sachet of white to light brown powder which dissolves in about 125ml (approximately ½
glassful) water to make a chocolate flavoured drink. Each sachet contains: 13.125g macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg
sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of white powder which dissolves in about 62.5ml (approximately ¼ glassful) of
water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride
and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet
contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride and 25.1mg potassium chloride. Does not contain flavourings or
sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Treatment of chronic constipation and faecal impaction in adults, adolescents and the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children aged 2-11 years. For the treatment of faecal impaction in children from the age of 5 years. Dosage and administration: MOVICOL, MOVICOL Plain and MOVICOL Chocolate Chronic Constipation: Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 8 sachets per day. A course of treatment for faecal impaction does not normally exceed 3 days. The 8 sachets should be taken over 6 hours (2 sachets per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL Paediatric Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents and the elderly: 2-6 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 2 or 4 sachets. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple
sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL-Half treatment
does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 16 sachets per day. A
course of treatment for faecal impaction does not normally exceed 3 days. The 16 sachets should be taken over 6 hours (4 sachets per
hour maximum in cardiovascular impairment). The 16 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. MOVICOL Paediatric Plain Chronic Constipation: The usual starting
dose is 1 sachet daily for children aged 2-6 years, and 2 sachets daily for children aged 7-11 years. The
dose should be adjusted up or down as required to produce regular soft stools. If the dose
needs increasing this is best done every second day.
The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months). Faecal Impaction: Escalating dose regimen starting with 4 sachets per day for children aged 5-11 years. Refer to Summary of Product Characteristics (SmPC) for full dosing recommendations. For patients of 12 years and older it is recommended that MOVICOL is used. Not recommended in children with cardiovascular impairment or renal insufficiency. Doses for prevention of re-impaction should be as for patients with chronic constipation. Contraindications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to macrogol, or any of the excipients. Warnings and precautions for use: Diagnosis of impaction should be confirmed. If patients develop any symptoms indicating shifts of fluids/electrolytes the product should be stopped immediately. When using MOVICOL Paediatric Plain to treat faecal impaction, use with caution in patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL Paediatric Plain: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: 20 sachets £4.45, 30 sachets £6.68, 50 sachets £11.13. MA number: PL 00322/0070. MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68, 50 sachets £11.13. MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets £6.68. MA number: PL 00322/0086. MOVICOL-Half Legal Category: P. Cost: 20 sachets £2.92, 30 sachets £4.38. MA number: Number PL 00322/0080. MOVICOL Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number PL 20011/0005. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS 01895 826606 E-mail: [email protected] MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MO/2812/MAR/12
MO/3064/SEP/12
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd
on 01895 826606.
www.MOVICOL.co.uk
Flavo
ur
Who fo
r
Chro
nic c
onstipatio
n
Faec
al im
paction
NHS pric
e
MOVICOL®
macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride
formulation and dosage guideto help you choose from the whole MOVICOL® family of products including
macrogol 3350, sodium hydrogen carbonate,sodium chloride, potassium chloride
Prescribing Information appears overleaf
MO
VICO
L® Chocolate
MO
VICOL
®
MOVICOL® Liquid
MOVICOL® Plain
MOVICOL®
Pae
diat
ric
Plai
nM
OV
ICO
L® -H
alf
Unflavoured
Unfla
vour
ed
Orange
Lem
on &
lim
e Lemon &
lime
Chocolate
(add to favourite cordial)
(add
to fa
vour
ite c
ordi
al)
Child
ren
Ado
lesc
ents
, adu
lts &
the
elde
rly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
2-6
sach
ets/d
ay in
div
ided
dose
s
2-6
year
s – 1
sach
et/d
ay
1-3 sachets/day in divided doses
1-3 sachets/day in divided doses
25ml diluted in 100ml of water 1-3 times daily
1-3 sachets/day in divided doses
(1-2 sachets/day for long term use)
7-11
year
s – 2
sach
ets/
day
(1-2 sachets/day for long term use)
(1-2 sachets/day for extended use)
(1-2 times a day for extended use)
8 sachets within 6h for up to 3 days
8 sachets over 6h for up to 3 days
8 sachets over 6h for up to 3 days5-11 ye
ars –
4 sa
chet
s in
divi
ded
dose
s 16
sac
hets
ove
r 6h
for u
p to
3 days
over 1
2h
, incr
easin
g by
2 s
ache
ts/d
ay
for u
p to
7 d
ays.
M
ax. 1
2 sa
chet
s/da
y20
sac
hets
£2.
92
30 sachets £6.68
30 sa
chet
s £4.
38
30 sachets £6.6820 sachets £4.45
500ml £4.45
50 sachets £11.13
30 s
ache
ts £
4.38
30 sachets £6.68
50 sachets £11.13
Not indicated
2-4
sach
ets f
or e
xten
ded
use
MOVICOL®, MOVICOL® Plain, MOVICOL® Chocolate,
MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated Prescribing Information
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: MOVICOL Sachet of white powder which dissolves in about 125ml
(approximately ½ glassful) water to make a lemon/lime flavoured drink. Each sachet contains: 13.125g
macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg sodium chloride and 46.6mg potassium chloride.
MOVICOL Plain Sachet of white powder which dissolves in about 125ml (approximately ½ glassful) water. Each sachet contains:
13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate, 350.8mg sodium chloride and 50.2mg potassium chloride. Does not
contain flavourings or sweeteners. MOVICOL Chocolate Sachet of white to light brown powder which dissolves in about 125ml (approximately ½
glassful) water to make a chocolate flavoured drink. Each sachet contains: 13.125g macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg
sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of white powder which dissolves in about 62.5ml (approximately ¼ glassful) of
water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride
and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet
contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride and 25.1mg potassium chloride. Does not contain flavourings or
sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Treatment of chronic constipation and faecal impaction in adults, adolescents and the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children aged 2-11 years. For the treatment of faecal impaction in children from the age of 5 years. Dosage and administration: MOVICOL, MOVICOL Plain and MOVICOL Chocolate Chronic Constipation: Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 8 sachets per day. A course of treatment for faecal impaction does not normally exceed 3 days. The 8 sachets should be taken over 6 hours (2 sachets per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL Paediatric Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents and the elderly: 2-6 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 2 or 4 sachets. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple
sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL-Half treatment
does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 16 sachets per day. A
course of treatment for faecal impaction does not normally exceed 3 days. The 16 sachets should be taken over 6 hours (4 sachets per
hour maximum in cardiovascular impairment). The 16 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. MOVICOL Paediatric Plain Chronic Constipation: The usual starting
dose is 1 sachet daily for children aged 2-6 years, and 2 sachets daily for children aged 7-11 years. The
dose should be adjusted up or down as required to produce regular soft stools. If the dose
needs increasing this is best done every second day.
The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months). Faecal Impaction: Escalating dose regimen starting with 4 sachets per day for children aged 5-11 years. Refer to Summary of Product Characteristics (SmPC) for full dosing recommendations. For patients of 12 years and older it is recommended that MOVICOL is used. Not recommended in children with cardiovascular impairment or renal insufficiency. Doses for prevention of re-impaction should be as for patients with chronic constipation. Contraindications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to macrogol, or any of the excipients. Warnings and precautions for use: Diagnosis of impaction should be confirmed. If patients develop any symptoms indicating shifts of fluids/electrolytes the product should be stopped immediately. When using MOVICOL Paediatric Plain to treat faecal impaction, use with caution in patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL Paediatric Plain: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: 20 sachets £4.45, 30 sachets £6.68, 50 sachets £11.13. MA number: PL 00322/0070. MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68, 50 sachets £11.13. MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets £6.68. MA number: PL 00322/0086. MOVICOL-Half Legal Category: P. Cost: 20 sachets £2.92, 30 sachets £4.38. MA number: Number PL 00322/0080. MOVICOL Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number PL 20011/0005. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS 01895 826606 E-mail: [email protected] MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MO/2812/MAR/12
MO/3064/SEP/12
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd
on 01895 826606.
www.MOVICOL.co.uk
Flavo
ur
Who fo
r
Chro
nic c
onstipatio
n
Faec
al im
paction
NHS pric
e
MOVICOL®
macrogol 3350, sodium bicarbonate, sodium chloride, potassium chloride
formulation and dosage guideto help you choose from the whole MOVICOL® family of products including
macrogol 3350, sodium hydrogen carbonate,sodium chloride, potassium chloride
Prescribing Information appears overleaf
MO
VICO
L® Chocolate
MO
VICOL
®
MOVICOL® Liquid
MOVICOL® Plain
MOVICOL®
Pae
diat
ric
Plai
nM
OV
ICO
L® -H
alf
Unflavoured
Unfla
vour
ed
Orange
Lem
on &
lim
e Lemon &
lime
Chocolate
(add to favourite cordial)
(add
to fa
vour
ite c
ordi
al)
Child
ren
Ado
lesc
ents
, adu
lts &
the
elde
rly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
Adolescents, adults & the elderly
2-6
sach
ets/d
ay in
div
ided
dose
s
2-6
year
s – 1
sach
et/d
ay
1-3 sachets/day in divided doses
1-3 sachets/day in divided doses
25ml diluted in 100ml of water 1-3 times daily
1-3 sachets/day in divided doses
(1-2 sachets/day for long term use)
7-11
year
s – 2
sach
ets/
day
(1-2 sachets/day for long term use)
(1-2 sachets/day for extended use)
(1-2 times a day for extended use)
8 sachets within 6h for up to 3 days
8 sachets over 6h for up to 3 days
8 sachets over 6h for up to 3 days5-11 ye
ars –
4 sa
chet
s in
divi
ded
dose
s 16
sac
hets
ove
r 6h
for u
p to
3 days
over 1
2h
, incr
easin
g by
2 s
ache
ts/d
ay
for u
p to
7 d
ays.
M
ax. 1
2 sa
chet
s/da
y20
sac
hets
£2.
92
30 sachets £6.68
30 sa
chet
s £4.
38
30 sachets £6.6820 sachets £4.45
500ml £4.45
50 sachets £11.13
30 s
ache
ts £
4.38
30 sachets £6.68
50 sachets £11.13
Not indicated
2-4
sach
ets f
or e
xten
ded
use
MOVICOL®, MOVICOL® Plain, MOVICOL® Chocolate,
MOVICOL®-Half and MOVICOL® Paediatric Plain Abbreviated Prescribing Information
REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING
Presentation: MOVICOL Sachet of white powder which dissolves in about 125ml
(approximately ½ glassful) water to make a lemon/lime flavoured drink. Each sachet contains: 13.125g
macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg sodium chloride and 46.6mg potassium chloride.
MOVICOL Plain Sachet of white powder which dissolves in about 125ml (approximately ½ glassful) water. Each sachet contains:
13.125g macrogol 3350, 178.6mg sodium hydrogen carbonate, 350.8mg sodium chloride and 50.2mg potassium chloride. Does not
contain flavourings or sweeteners. MOVICOL Chocolate Sachet of white to light brown powder which dissolves in about 125ml (approximately ½
glassful) water to make a chocolate flavoured drink. Each sachet contains: 13.125g macrogol 3350, 178.5mg sodium hydrogen carbonate, 350.7mg
sodium chloride and 31.7mg potassium chloride. MOVICOL-Half Sachet of white powder which dissolves in about 62.5ml (approximately ¼ glassful) of
water to make a lemon and lime flavoured drink. Each sachet contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride
and 23.3mg potassium chloride. MOVICOL Paediatric Plain Sachet of white powder, which dissolves in about 62.5 ml (approximately ¼ glassful) of water. Each sachet
contains: 6.563g macrogol 3350, 89.3mg sodium hydrogen carbonate, 175.4mg sodium chloride and 25.1mg potassium chloride. Does not contain flavourings or
sweeteners. Uses: MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Treatment of chronic constipation and faecal impaction in adults, adolescents and the elderly. MOVICOL Paediatric Plain: Treatment of chronic constipation in children aged 2-11 years. For the treatment of faecal impaction in children from the age of 5 years. Dosage and administration: MOVICOL, MOVICOL Plain and MOVICOL Chocolate Chronic Constipation: Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 1 or 2 sachets. Children (below 12 years): not recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL, MOVICOL Plain or MOVICOL Chocolate treatment does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 8 sachets per day. A course of treatment for faecal impaction does not normally exceed 3 days. The 8 sachets should be taken over 6 hours (2 sachets per hour maximum in cardiovascular impairment). The 8 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not recommended. See MOVICOL Paediatric Plain. MOVICOL-Half Chronic Constipation: Adults, adolescents and the elderly: 2-6 sachets daily in divided doses, according to individual response. For extended use: adjust dose down to 2 or 4 sachets. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. Extended use may be necessary in patients with severe chronic or resistant constipation, secondary to multiple
sclerosis or Parkinson’s Disease, or induced by regular constipating medicine, in particular opioids and antimuscarinics. A course of MOVICOL-Half treatment
does not normally exceed 2 weeks, but can be repeated if required. Faecal Impaction: Adults, adolescents and the elderly: 16 sachets per day. A
course of treatment for faecal impaction does not normally exceed 3 days. The 16 sachets should be taken over 6 hours (4 sachets per
hour maximum in cardiovascular impairment). The 16 sachets may be dissolved in 1 litre of water. Children (below 12 years): Not
recommended. See MOVICOL Paediatric Plain. MOVICOL Paediatric Plain Chronic Constipation: The usual starting
dose is 1 sachet daily for children aged 2-6 years, and 2 sachets daily for children aged 7-11 years. The
dose should be adjusted up or down as required to produce regular soft stools. If the dose
needs increasing this is best done every second day.
The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months). Faecal Impaction: Escalating dose regimen starting with 4 sachets per day for children aged 5-11 years. Refer to Summary of Product Characteristics (SmPC) for full dosing recommendations. For patients of 12 years and older it is recommended that MOVICOL is used. Not recommended in children with cardiovascular impairment or renal insufficiency. Doses for prevention of re-impaction should be as for patients with chronic constipation. Contraindications: Intestinal perforation or obstruction due to structural or functional disorders of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon. Hypersensitivity to macrogol, or any of the excipients. Warnings and precautions for use: Diagnosis of impaction should be confirmed. If patients develop any symptoms indicating shifts of fluids/electrolytes the product should be stopped immediately. When using MOVICOL Paediatric Plain to treat faecal impaction, use with caution in patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Interactions: There is a possibility that the absorption of concomitantly administered medication could be transiently reduced. Pregnancy and lactation: There is insufficient data on use in pregnancy and lactation, and should only be used if considered essential. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, abdominal distension, nausea, vomiting, diarrhoea, flatulence, borborygmi and anal discomfort. Allergic reactions, including anaphylactic reaction, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Pharmaceutical particulars: Do not store sachet above 25°C. MOVICOL, MOVICOL Plain, MOVICOL Chocolate and MOVICOL-Half: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 6 hours. MOVICOL Paediatric Plain: Reconstituted solution should be stored covered in a refrigerator (2-8°C) for up to 24 hours. Licensing and legal category: MOVICOL Legal category: P. Cost: 20 sachets £4.45, 30 sachets £6.68, 50 sachets £11.13. MA number: PL 00322/0070. MOVICOL Plain Legal Category: P. Cost: 30 sachets £6.68, 50 sachets £11.13. MA number: PL 20142/0004. MOVICOL Chocolate Legal Category: P. Cost: 30 sachets £6.68. MA number: PL 00322/0086. MOVICOL-Half Legal Category: P. Cost: 20 sachets £2.92, 30 sachets £4.38. MA number: Number PL 00322/0080. MOVICOL Paediatric Plain Legal Category: POM; Cost: 30 sachets £4.38; MA number: Number PL 20011/0005. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS 01895 826606 E-mail: [email protected] MOVICOL® is a registered trademark of the NORGINE® group of companies. Date of preparation/revision: MO/2812/MAR/12
MO/3064/SEP/12
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd
on 01895 826606.
www.MOVICOL.co.uk
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Brand: Napp Respiratory & CorporateClient: Napp Pharmaceuticals
Logo design
A breath of fresh air in respiratory medicine
Code: UK/RES-11007a. Date of preparation: February 2011.
Napp Respiratory. BMJ (GP) Whole/full page advert. 280 x 210mm. 3mm bleed.
A breath of fresh air in respiratory medicine
Code: UK/RES-11007k. Date of preparation: February 2011.
Napp Respiratory. C&D half page horizontal page advert. 210 x 143mm. 3mm bleed.Second stage adverts
Delivering Innovation in Pain Management
We have built our business around the concept of putting known, trusted and effective molecules into innovative delivery mechanisms so that patients can benefit from improved effectiveness through reduced or improved dosing methods. In recent years, we have started to branch out into other areas of expertise, including oncology and respiratory medicine, with the same innovative spirit that we have applied to our analgesics business.
1923 1970 1980 1990 2000 2009
Napp registeredin the UK.
WORLD 1st prolonged release Morphine Sulphate
tablets (MST® Continus® tablets)
WORLD 1st
7-day analgesic patch (Butrans® patches)
UK 1st opioid agonist / antagonist
combination (Targinact® tablets)
WORLD 1st bi-phasic delivery mechanism for an
opioid analgesic (OxyContin® tablets)
WORLD 1st once daily Morphine Sulphate
capsules (MXL® capsules)
Corporate Prix Galien A4 advert
We have built our business around the concept of putting known, trusted and effective molecules into innovative delivery mechanisms so that patients can benefit from reduced dosage frequency and improved dosing methods. In recent years, we have started to branch out into other areas of expertise, including oncology and respiratory medicine, with the same innovative spirit that we have applied to our analgesics business.
Code: UK/UNA-10210c. Date of preparation: October 2010.
Continuing Commitmentto deliver Innovation
Napp corporate ad BMJ (CR) whole page advert. 280 x 210mm. Type Area 248 x 186mm. 3mm Bleed. CMYK.
Napp_BMJ_CR_211010.indd 1 21/10/2010 14:25:17
Corporate A4 advert
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Brand: OxyNorm, OxyContinClient: Napp Pharmaceuticals
oxycodone logos.pdf 1 18/11/2010 16:04
oxycodone logos.pdf 1 18/11/2010 16:04
OxyContin. Whole page advert. 297 x 210mm (A4). 3mm Bleed. CMYK.
Code: UK/OXYC-12001. Date of preparation: Mar 2012.
Prolonged release oxycodone hydrochloride tablets
OxyContin
OxyNorm
Prolonged release oxycodone hydrochloride tablets
OxyContin
OxyNorm
OxyContin® tablets contain an opioid analgesic OxyContin® (oxycodone hydrochloride) 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tabletsPrescribing Information, United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing.Indications Moderate to severe pain in patients with cancer or post-operative pain. Severe pain requiring the use of a strong opioid.Dosage and administration Tablets must be swallowed whole, and not broken, chewed or crushed. Elderly and adults over 18 years: Take tablets at 12-hourly intervals. Dosage is dependent on the severity of pain and the patient’s previous history of analgesic requirements. Not intended for use as a prn analgesic. Usual starting dose for opioid naïve patients, or patients presenting with severe pain uncontrolled by weaker opioids: 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side-effects. Opioid naïve patients with mild to moderate renal and/or mild hepatic impairment may be started on 5 mg, 12-hourly and titrated to pain relief. Any dose increases should be made, where possible, in 25% – 50% increments. When transferring from morphine, the following ratio should be used as guidance: 10 mg oral oxycodone is equivalent to 20 mg oral morphine. Opioids are not firstline therapy in non malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals. Children under 18 years: Not recommended.Contra-indications Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known sensitivity to oxycodone or any of the constituents, moderate to severe hepatic impairment, severe renal impairment, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, any situation where opioids are contraindicated, pre-operative use or use during the first 24 hours post operatively, pregnancy.Precautions and warnings Hypothyroidism, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic disease, severe pulmonary
disease, debilitated patients, elderly and infirm patients, history of alcohol and/or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately. Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyContin tablets for 12 hours prior to the intervention. OxyContin 60 mg, 80 mg and 120 mg tablets should not be used in opioid naïve patients. OxyContin tablets should be used with caution following abdominal surgery, and not used until normal bowel function returns. OxyContin tablets have a similar abuse profile to other strong opioids. OxyContin tablets must be swallowed whole and not broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Concomitant use of alcohol and OxyContin tablets may increase the undesirable effects of OxyContin tablets; concomitant use should be avoided. Interactions OxyContin tablets, like other opioids, potentiate the effects of transquilisers, anaesthetics, hypnotics, antidepressants, sedatives, phenothiazines, neuroleptic drugs, other opioids, muscle relaxants and antihypertensives. Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression with hypertensive or hypotensive crisis. Inhibitors of CYP3A4 or CYP2D6 may inhibit the metabolism of oxycodone. Alcohol may enhance the pharmacodynamic effects of OxyContin tablets; concomitant use should be avoided. Pregnancy and lactation Not recommended.Side effects Common (≥ 1%): constipation, nausea, vomiting, dry mouth, anorexia, dyspepsia, abdominal pain, diarrhoea, headache, confusional state, asthenic conditions, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, thinking abnormal, somnolence, bronchospasm, dyspnoea, cough decreased, rash, pruritus, hyperhidrosis, chills.Uncommon (≤ 1%): but potentially serious: anaphylactic reaction, anaphylactoid reaction, hypersensitivity, biliary colic, cholestasis, ileus, gastritis, dysphagia, dental caries, hallucinations, depression, dysphoria, affect lability, mood altered, restlessness, agitation, euphoria, disorientation, amnesia, vision abnormal, vertigo, drug tolerance, drug dependence, drug withdrawal syndrome, paraesthesia, speech disorder, convulsions, urinary retention, ureteral spasm, libido decreased, supraventricular tachycardia, hypotension, orthostatic hypotension, respiratory depression, syncope, oedema, oedema peripheral, increased hepatic enzymes, exfoliative dermatitis, urticaria, amenorrhoea, erectile dysfunction. Overdose may produce respiratory depression, pin-point pupils, hypotension and hallucinations. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or
other psychotropic drugs. Please refer to the SmPC for a full list of side effects.Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POM.Package quantities and price 5 mg – £12.50 (28 tablets).10 mg – £24.99 (56 tablets). 15 mg – £37.41 (56 tablets).20 mg – £49.98 (56 tablets). 30 mg – £74.81 (56 tablets).40 mg – £99.98 (56 tablets). 60 mg – £149.66 (56 tablets).80 mg – £199.97 (56 tablets). 120 mg – £299.31 (56 tablets).Marketing Authorisation numberPL 16950/0097-0100, 0123, 0139-0141, 0150 Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. Tel: 01223 424444.Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact [email protected] effective January 2012 (UK/OXYC-11026).
® OxyContin and the NAPP device are Registered Trade Marks.© 2011 – 2012 Napp Pharmaceuticals Limited.European Patent (UK) 0 253 104. European Patent (UK) 0 576 643.European Patent Application No. 96102992.3
Prescribe by brand to reduce possible errors1,2
1. Department of Health. Building a safer NHS for patients: Improving medication safety. 2004.
2. Dickman A. Branded prescribing of strong opioids should be adopted as good practice. The Pharmaceutical Journal 2005; 275: 546.
3. Davies ED et al. A prevalence study of errors in opioid prescribing in a large teaching hospital. International Journal of Clinical Practice 2011; 65(9): 923-929.
A leading London teaching hospital demonstrated an error rate in the prescribing of opioids of 27%.
4% of the errors being potentially fatal.3
For prolonged release oxycodone write
OxyContin.
Adverse events should be reported. Reporting forms and information can be found at use www.mhra.gov.uk/yellowcard. Adverse events
should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
OxyContin A4 advert - follow-on stage
British Journal of Nursing. Whole page. Type: 255 x 195mm. Trim: 297 x 230mm with 3mm bleed.Outside back cover.
Help releaseyour patients fromthe pain of cancer
OxyContin® tablets contain an opioid analgesicOxyContin® (oxycodone hydrochloride) 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 120 mg prolonged release tablets.Prescribing Information, United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing.Indications Moderate to severe pain in patients with cancer or post-operative pain. Severe pain requiring the use of a strong opioid.Dosage and administration Tablets must be swallowed whole, and not broken, chewed or crushed.Elderly and adults over 18 years: Take tablets at 12-hourly intervals. Dosage is dependent on the severity of pain and the patient’s previous history of analgesic requirements. Not intended for use as a prn analgesic.Usual starting dose for opioid naïve patients, or patients
presenting with severe pain uncontrolled by weaker opioids: 10 mg, 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. Opioid naïve patients with mild to moderate renal and/or mild hepatic impairment may be started on 5 mg, 12-hourly and titrated to pain relief. Any dose increases should be made, where possible, in 25% – 50% increments. When transferring from morphine, the following ratio should be used as guidance: 10 mg oral oxycodone is equivalent to 20 mg oral morphine. Opioids are not first-line therapy in non-malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals.
Children under 18 years: Not recommended.
Contra-indications Respiratory depression, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, chronic obstructive airways disease, cor pulmonale, severe bronchial asthma, hypercarbia, known sensitivity to
oxycodone or any of the constituents, moderate to severehepatic impairment, severe renal impairment, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, any situation where opioids are contraindicated, pre-operative use or use during the first 24 hours post-operatively, pregnancy.
Precautions and warnings Hypothyroidism, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, alcoholism, delirium tremens, chronic renal and hepatic disease, severe pulmonary disease, debilitated patients, elderly and infirm patients, history of alcohol and/or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately.Prescribing Information continues inside back cover
Prolonged release oxycodone hydrochloride tablets
OxyContin
OxyNorm
NEW STRENGTHS AVAILABLETablets are not shown at actual size
5 mg 10 mg 15 mgNEW
20 mg 30 mgNEW
40 mg 60 mgNEW
80 mg 120 mgNEW
OxyContin® prolonged release analgesia – flexibility of dosing with reduced pill burden
OxyContin A4 advert
Online banner advert
Prolonged release oxycodone hydrochloride tablets
OxyContin
OxyNorm
Reduce the risk of dispensing errors:
Images are not shown to scale. Prescribing information can be found on the reverse.
prescribe by brand name
‘‘Including the brand name on the prescription and dispensing label will aid in the identification of the correct formulation to be dispensed or administered.” Department of Health1
Prolonged releasePrescribe 12-hourly
Immediate releasePrescribe 4 – 6 hourly
Prolonged releasePrescribe 12-hourly
The OxyNorm range contains an opioid analgesic Targinact tablets contain an opioid analgesic OxyContin tablets contain an opioid analgesic
5 mg 10 mg 15 mg 20 mg
30 mg 40 mg 60 mg 80 mg 120 mg 10 mg in 1 ml 5 mg/5 ml20 mg in 2 ml 50 mg in 1 ml 10 mg/ml
20 mg10 mg5 mg20 mg/10 mg 40 mg/20 mg5 mg/2.5 mg 10 mg/5 mg
For the treatment of moderate to severe pain in patients with cancer and post-operative pain. Severe pain requiring the use of a strong opioid.
For the treatment of moderate to severe pain in patients with cancer and postoperative pain, and severe pain requiring the use of a strong opioid.
For the treatment of severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.
Prescribe by brand A2 poster
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
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Oxycodone hydrochloride solution for injection or infusion
for severe cancer pain
Introducing a 50 mg/ml ampoule, addressing your dosing needs
Please consult the Summary of Product Characteristics before prescribing, particularly in relation to side-effects, precautions and contra-indications. Legal category: CD (Sch 2) POM. Further information is available on request from the Marketing Authorisation holder: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Code: UK/OXNO-10007 Date of preparation: June 2010.
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Dosing recommendations for s.c. infusionDilute in 0.9% saline, 5% dextrose or water for injections, if required. Diluted solutions should be used immediately or within 24 hours, unless diluted under controlled and validated aseptic conditions.1
Conversion ratio from oral to subcutaneous oxycodone1 = 2:1 e.g. for a patient receiving 30 mg prolonged release oxycodone tablets 12-hourly (i.e. 60 mg/day), 30 mg/day OxyNorm injection may represent a suitable starting dose.
Conversion ratio from subcutaneous morphine to subcutaneous oxycodone2 = 1:1
Conversion ratio from subcutaneous diamorphine to subcutaneous oxycodone = 1:1 (there are no available data providing direct conversion ratios between these two drugs, therefore when converting from subcutaneous diamorphine to subcutaneous oxycodone an initial 1:1 ratio is suggested, based on the recommended morphine:diamorphine equivalence listed in the BNF).3
OxyNorm injection 10 mg/ml and 50 mg/ml are solutions of oxycodone hydrochloride for injection or infusion. The 10 mg/ml solution is available in 1 ml and 2 ml ampoules. The 50 mg/ml solution is available in 1 ml ampoules.
OxyNorm injection is licensed for the treatment of moderate to severe pain in patients with cancer and post-operative pain and for severe pain requiring the use of a strong opioid.
Using OxyNorm® 10 mg/ml and 50 mg/ml injections in a syringe driver
Please note that caution is always necessary during conversions between different opioids or routes of administration. Conversion ratios can never be more than an approximate guide. Careful monitoring during conversion is mandatory to avoid both underdosing and excessive dosing. It is often appropriate to use a lower dose than the suggested equivalence above. This is particularly the case during switching at high doses, or if there has been a recent rapid escalation in dose of the first opioid.
Oxycodone hydrochloride solution for injection or infusion
OxyContin
OxyNorm
OxyContin
OxyNorm
Code: UK/OXNO-11004. Date of preparation: July 2011
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
OxyNorm® 10 mg/ml and 50 mg/ml, solution for injection or infusion Prescribing Information United Kingdom Presentation Solution for injection or infusion containing oxycodone hydrochloride 10 mg/ml or 50 mg/ml. Indications For the treatment of moderate to severe pain in patients with cancer and postoperative pain, and severe pain requiring the use of a strong opioid. Dosage and administration For subcutaneous or intravenous injection or infusion. For adults over 18 years: A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. NB. Where dilutions are recommended, use 0.9% saline, 5% dextrose or water for injections. i.v. (Bolus): Dilute as required. Administer a bolus dose of 1 - 10 mg, slowly, over 1-2 minutes not more frequently than every 4 hours. i.v. (Infusion): Dilute as required. A starting dose of 2 mg/hour is recommended. i.v. (PCA): Dilute as required. Administer bolus doses of 0.03 mg/kg with a minimum lock-out time of 5 minutes. s.c. (Bolus): use the 10 mg/ml concentration or dilute the 50 mg/ml as required. A starting dose of 5 mg is recommended, repeated at 4 hourly intervals as required. s.c. (Infusion): dilute if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients. Cancer patients transferring from oral oxycodone may require higher doses. Patients transferring between oral and parenteral oxycodone: The dose should be based on the following guide ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone and each patient is to be titrated to the appropriate dose. Elderly patients and patients with mild to moderate renal and/or mild hepatic impairment: Treat with caution, the lowest dose should be given with careful titration to pain control. Children under 18 years: Not recommended. Opioids are not first-line therapy in non-malignant pain, nor are they recommended as the only treatment. The need for continued treatment in non-malignant pain should be assessed at regular intervals. Contra-indications Respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; known hypersensitivity to oxycodone or any of the constituents or in any situation where opioids are contraindicated, moderate to severe hepatic impairment; severe renal impairment; chronic constipation; concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use; pregnancy. Precautions and warnings Hypothyroidism, respiratory depression, opioid dependent patients, raised intracranial pressure, hypotension, hypovolaemia, toxic psychosis, diseases of the biliary tract, inflammatory bowel disorders, prostatic hypertrophy,
For medical information enquiries, please contact [email protected]
OxyNorm® injection contains an opioid analgesic
adrenocortical insufficiency, acute alcoholism, delirium tremens, pancreatitis, chronic renal and hepatic disease or severe pulmonary disease, debilitated and elderly patients, history of alcohol and/or drug abuse. Do not use where there is a possibility of paralytic ileus occurring and if this is suspected or occurs during use discontinue immediately. Oxycodone has an abuse profile similar to other strong opioids. Infants born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth. Interactions As with other opioids, OxyNorm injection interacts with tranquillisers, anaesthetics, hypnotics, anti-depressants, sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives. Pregnancy and Lactation Not recommended. Side-effects Common side-effects seen during therapy are constipation, nausea, vomiting, dry mouth, anorexia, dyspepsia, abdominal pain, diarrhoea, headache, confusional state, asthenia, faintness, dizziness, sedation, anxiety, abnormal dreams, nervousness, insomnia, thinking disturbances, somnolence, twitching, orthostatic hypotension, bronchospasm, dyspnoea, decreased cough reflex, rash, pruritus, hyperhidrosis, chills. Some side-effects which are uncommon but could be serious are biliary colic, ileus, gastritis, hallucinations, hypertonia, depression, drug withdrawal syndrome, paraesthesia, convulsions, urinary retention, ureteral spasm, libido decreased, supraventricular tachycardia, hypotension, syncope, oedema, increased hepatic enzymes, respiratory depression, exfoliative dermatitis, hypersensitivity, anaphylactic and anaphylactoid reaction. Please refer to the SPC for further details of other uncommon side-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms. Legal category CD (Sch2) POMPackage quantities and price10 mg/ml 1 ml ampoule - £8.00 (5 ampoules) 2 ml ampoule - £16.00 (5 ampoules) 50 mg/ml 1 ml ampoule - £70.10 (5 ampoules)Marketing Authorisation number PL 16950/0128 PL 16950/0155Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UKTel: 01223 424444 Member of the Napp Pharmaceutical GroupFurther information is available from Napp Pharmaceuticals Limited.Date of preparation May 2011.® OxyNorm, NAPP and the NAPP device (logo) are Registered Trade Marks.© 2009 Napp Pharmaceuticals Limited.
References:1. Summary of Product Characteristics. OxyNorm® 10 mg/ml, solution for injection or infusion. September 2008.
Summary of Product Characteristics. OxyNorm® 50 mg/ml, solution for injection or infusion. Jan 2009.2. Twycross R and Wilcock A. Palliative Care Formulary, Third Edition. 2008. Page 471.3. British National Formulary. Edition 61, March 2011. Page 24.4. Gardiner PR. Compatibility of an injectable oxycodone formulation with typical diluents, syringes, tubings, infusion bags and drugs for potential co-administration. Hosp Pharm 2003;10:354-61.5. Hines S, Pleasance S. Compatibility of an injectable high strength oxycodone formulation with typical diluent, syringes, infusion bags and drugs for potential co-administration. EJHP Practice 2009;15:32-8.
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Help release your patients from the pain of cancer
Prescribing information can be found on Pages 28 – 29
Prolonged release oxycodone hydrochloride tablets Immediate release oxycodone hydrochloride capsules, liquid & concentrate
Oxycodone hydrochloride solution for injection or infusion
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EARN 5.5 CPD CREDITSA practical GP resource on the appropriate use of opioids for non-malignant pain.
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EARN 5.5 CPD CREDITSA practical GP resource on the appropriate use of opioids for non-malignant pain.
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Brand: TarginactClient: Napp Pharmaceuticals
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MORE GOOD DAYS
Targinact ® is the UK’s rst and only prolonged release analgesic that combines an opioid agonist with an antagonist.Targinact ® is licensed for the treatment of severe pain.
Code: UK/TARG-XXXXX. Date of preparation: November 2010.
Adverse events should be reported. Reporting forms andinformation can be found at www.yellowcard.gov.uk.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
Targinact® tablets contain an opioid analgesicTarginact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged release tablets Prescribing Information United Kingdom Presentation Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5 mg (oxycodone hydrochloride) /2.5 mg (naloxone hydrochloride), white - 10 mg (oxycodone hydrochloride)/5 mg (naloxone hydrochloride), pink - 20 mg (oxycodone hydrochloride)/10 mg (naloxone hydrochloride) and yellow - 40 mg (oxycodone hydrochloride)/20 mg (naloxone hydrochloride).Indications Severe pain, which can be adequately managed only withopioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.Dosage and administration Adults over 18 years: Usual starting dosefor opioid naïve patients is Targinact 10 mg/5 mg, taken orally at12-hourly intervals.Targinact 5 mg/2.5 mg is intended for dosetitration when initiating opioid therapy and individual dose adjustment.The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targinact depending ontheir previous opioid experience. The maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose ofoxycodone hydrochloride. Please refer to the SmPC for further detailson dose titration.Targinact tablets must be swallowed whole and notbe broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Children under 18 years: Not recommendedContra-indications Hypersensitivity to the active substances or excipients, any situation where opioids are contra-indicated, severe
respiratory depression with hypoxia and/or hypercapnia; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment.Precautions and warnings Respiratory depression, elderly or infirm,opioid-induced paralytic ileus, severely impaired pulmonary function,hypothyroidism, adrenocortical insufficiency, toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, history of alcohol and drug abuse, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic impairment, pre-operative use or within the first 12 - 24 hours post-operatively. Not suitable for the treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers.Interactions Substances having a CNS-depressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines andanti-emetics) may enhance the CNS-depressant effect of Targinact(e.g. respiratory depression). Interaction with coumarin anti-coagulantsmay increase or decrease INR. Pregnancy and lactation Not recommended. Side-effects Common adverse drug reactions are decreased/loss of appetite, restlessness, headache, vertigo, decrease in bloodpressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes,hiccups, altered mood, decreased activity, psychomotor hyperactivity,agitation, dysuria, pruritus, skin reactions, hyperhidrosis, dizziness,drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, hallucinations, disturbance in attention, somnolence, speech disorder, convulsions,
syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please referto the SmPC for further details of other uncommon side-effects and oxycodone class-effects. Tolerance and dependence may occur. It maybe advisable to taper the dose when stopping treatment to preventwithdrawal symptoms.Legal category CD (Sch2) POM.Package quantities & price Blisters of 28 tablets 5 mg/2.5 mg - £17.56Blisters of 56 tablets 10 mg/5 mg - £35.11; 20 mg/10 mg - £70.22;40 mg/20 mg - £ 140.44Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162.Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK.Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact [email protected] of preparation March 2010.® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2009 - 2010 Napp Pharmaceuticals Limited.
When suffering from cancer, don’t let severe painbe the difference between existing and living
Better Pain Relief
Improved Quality of Life
Superior GI Tolerability
Targinact ® is the UK’s first and only prolonged release analgesic that combines an opioid agonist with an antagonist.Targinact ® is licensed for the treatment of severe pain.
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New STudy
ReSuLTS
Code: UK/TARG-10129. date of preparation: August 2010.
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
Targinact® tablets contain an opioid analgesicTarginact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg /20 mg prolonged release tablets Prescribing Information United Kingdom Presentation Film-coated, oblong, prolonged release tablets containing oxycodone hydrochloride and naloxone hydrochloride, marked OXN on one side and the oxycodone strength on the other. Colours: Blue - 5 mg (oxycodone hydrochloride) /2.5 mg (naloxone hydrochloride), white - 10 mg (oxycodone hydrochloride)/5 mg (naloxone hydrochloride), pink - 20 mg (oxycodone hydrochloride) /10 mg (naloxone hydrochloride) and yellow - 40 mg (oxycodone hydrochloride)/20 mg (naloxone hydrochloride).Indications Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut.Dosage and administration Adults over 18 years: Usual starting dose for opioid naïve patients is Targinact 10 mg/5 mg, taken orally at 12-hourly intervals.Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Patients already receiving opioids may be started on higher doses of Targinact depending on their previous opioid experience. The maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. Targinact tablets are not intended for the treatment of breakthrough pain. For the treatment of breakthrough pain, a single dose of “rescue medication” should amount to one sixth of the equivalent daily dose of oxycodone hydrochloride. Please refer to the SmPC for further details on dose titration. Targinact tablets must be swallowed whole and not be broken, chewed or crushed which leads to a rapid release and absorption of a potentially fatal dose of oxycodone.
Children under 18 years: Not recommendedContra-indications Hypersensitivity to the active substances or excipients, any situation where opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia; severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment.Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, history of alcohol and drug abuse, pancreatitis, hypotension, hypertension, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, pre-existing cardiovascular diseases, head injury (due to risk of raised intracranial pressure), epileptic disorder or predisposition to convulsions, patients taking MAO inhibitors, renal impairment, mild hepatic impairment, pre-operative use or within the first 12 - 24 hours post-operatively. Not suitable for the treatment of withdrawal symptoms. Not recommended in cancer associated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers.Interactions Substances having a CNS-depressant effect (e.g. alcohol, other opioids, sedatives, hypnotics, anti-depressants, sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance the CNS-depressant effect of Targinact (e.g. respiratory depression). Interaction with coumarin anti-coagulants may increase or decrease INR. Pregnancy and lactation Not recommended. Side-effects Common adverse drug reactions are decreased/loss of appetite, restlessness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, dizziness, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Some side-effects which are uncommon but could be serious are hypersensitivity, confusion, depression, hallucinations,
disturbance in attention, somnolence, speech disorder, convulsions, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, abdominal distension and chest pain. Please refer to the SmPC for further details of other uncommon side-effects and oxycodone class-effects. Tolerance and dependence may occur. It may be advisable to taper the dose when stopping treatment to prevent withdrawal symptoms.Legal category CD (Sch2) POM.Package quantities & price Blisters of 28 tablets 5 mg/2.5 mg - £17.56Blisters of 56 tablets 10 mg/5 mg - £35.11; 20 mg/10 mg - £70.22; 40 mg/20 mg - £ 140.44Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162.Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact [email protected] of preparation March 2010.® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2009 - 2010 Napp Pharmaceuticals Limited.
References: 1. Schutter U et al. Innovative pain therapy with afixed combination of prolonged-release oxycodone/naloxone: a large observational study under conditions of daily practice. Curr Med Res Opin 2010; 26:1377–1387.2. Napp Pharmaceuticals Limited. Data on file. Study codes: OXN9002a and OXN9002b.
Compared to previous treatment in a clinical practice study (n=7836)1,2
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Why prescribe Targinact for patients with severe back pain?
Prescribing information can be found on the final page.
Prescribing information can be found on the final page.
It is essential that the patient has the best possible management during and after his/her operation to reduce pain, gut dysfunction and immobilisation 1
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Post-op detail aidbriefing notes
Indications Severe pain, which can be adequately managed only with opioid analgesics. Naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Dosage and administrationAdults over 18 years: Usual starting dose for opioid naïve patients: 10 mg/5 mg taken orally at12-hourly intervals. Patients already receiving opioids may be started on higher doses depending on their previous opioid experience.Targinact 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment. The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements. Maximum daily dose of Targinact is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride.Targinact is not intended for the treatment of breakthrough pain. Please refer to SmPC for further details. Targinact must be swallowed whole and not be broken, chewed or crushed.Children under 18 years: Not recommended. Contra-indications Hypersensitivity to active substances or excipients, any situation where opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnoea; severe COPD, cor pulmonale, severe bronchial asthma, non-opioid induced paralytic ileus, moderate to severe hepatic impairment.Precautions and warnings Respiratory depression, elderly or infirm, opioid-induced paralytic ileus, severely impaired pulmonary function, myxoedema, hypothyroidism, adrenocortical insufficiency, toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, pancreatitis, hypo- or hyper-tension, pre-existing cardiovascular diseases, head injury, epileptic disorder, predisposition to convulsions, patients taking MAO inhibitors, history of alcohol/drug abuse, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, renal impairment, mild hepatic impairment, pre-operative use or within the first 12 - 24 hours post-operatively. Not suitable for treatment of withdrawal symptoms. Not recommended in cancerassociated with peritoneal carcinomatosis or sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Concomitant use of alcohol and Targinact may increase the undesirable effects of Targinact and should be avoided. Tolerance and dependence may occur. It may be advisable to taper dose when stopping treatment to prevent withdrawal symptoms. Interactions Substances having a CNS-depressant effect (e.g. other opioids, sedatives, hypnotics, anti-depressants,
sleeping aids, phenothiazines, neuroleptics, anti-histamines and anti-emetics) may enhance CNS-depressant effect of Targinact (e.g. respiratory depression). Alcohol may enhance the pharmacodynamic effects of Targinact; concomitant use should be avoided. Interaction with coumarin anticoagulants may increase/decrease INR. Pregnancy and lactation Not recommended. Side-effects Common: decreased/loss of appetite, restlessness, dizziness, headache, vertigo, decrease in blood pressure, abdominal pain, diarrhoea, dry mouth, constipation, flatulence, vomiting, nausea, dyspepsia, increased hepatic enzymes, hiccups, altered mood, personality change, decreased activity, psychomotor hyperactivity, agitation, dysuria, pruritus, skin reactions, hyperhidrosis, drug withdrawal syndrome, feeling hot and cold, chills, asthenic conditions. Uncommon but potentially serious: hypersensitivity, confusion, depression, euphoric mood, hallucinations, paraesthesia, speech disorder, convulsions, sedation, syncope, visual disturbances, palpitations, angina pectoris, tachycardia, increase in blood pressure, dyspnoea, respiratory depression, biliary colic, erectile dysfunction, urinary retention, peripheral oedema, tooth disorder, chest pain and injuries from accidents. Refer to SmPC for further details of other uncommon side-effects and oxycodone class-effects. Legal category CD (Sch2) POM Package quantities and price Blisters of 28 tablets 5 mg/2.5 mg - £ 17.56. Blisters of 56 tablets 10 mg/5 mg - £35.11. 20 mg/10 mg - £70.22. 40 mg/20 mg - £ 140.44 Marketing Authorisation numbers PL 16950/0157-158, PL16950/0161-162. Marketing Authorisation holder Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road,Cambridge, CB4 0GW, UK. Tel: 01223 424444. Member of the Napp Pharmaceutical Group. For medical information enquiries, please contact [email protected]. Date effective March 2012® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks. © 2011 - 2012 Napp Pharmaceuticals Limited.PI Code UK/TARG-12031. PI Approved March 2012.
Targinact® tablets contain an opioid analgesic
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
Prescribing information can be found on the back cover.Code: UK/TARG-12048. Date of preparation: April 2012.
References:
1. The British Pain Society. Opioids for persistent pain: Good practice. London: British Pain Society; 2010.2. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as
prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54.3. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief
of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-12.4. Löwenstein O, Leyendecker P, Hopp M, et al. Combined prolonged-release oxycodone and naloxone improves bowel function
in patients receiving opioids for moderate-to-severe non-malignant chronic pain: a randomised controlled trial. Expert Opin Pharmacother 2009;10:531-43.
5. Napp Pharmaceuticals Limited. Data on file. OXN3001 PAC-SYM analysis.6. Dunlop W, Uhl R, Khan I, et al. Quality of life benefits and cost impact of prolonged release oxycodone/naloxone versus prolonged
release oxycodone in patients with moderate-to-severe non-malignant pain and opioid-induced constipation: a UK cost-utility analysis. J Med Econ. 2012;15(3):564-75.
7. Scottish Intercollegiate Guidelines Network (SIGN). SIGN 106; Control of pain in adults with cancer. Edinburgh: SIGN 2001-2009; November 2008 [accessed August 2011]. Available from http://www.sign.ac.uk/pdf/SIGN106.pdf
8. Foley KM. The treatment of cancer pain. N Engl J Med 1985;313(2):84-95.9. Twycross R, Wilcock A. Palliative Care Formulary. 3rd ed. palliativedrugs.com Ltd 2007; p.269.10. Summary of product characteristics. OxyContin® tablets. May 2011.11. British National Formulary, 61st Edition, March 2011.
Targinact® ▼ (oxycodone hydrochloride/naloxone hydrochloride) 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged release tablets. Prescribing Information United Kingdom. Please read the Summary of Product Characteristics (SmPC) before prescribing.
Back pain slide kit
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Back pain detail aid briefing notes Mode of actionbookmark leave piece
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FOR INTERNAL USE ONLYFOR INTERNAL USE ONLYCode: UK/TARG-11063.
Date of preparation: November 2011.
OBJECTION HANDLER
Objection handler
Targinact stand panel. 25%: 440mm x 193mm. 3mm Bleed. CMYK.
Targinact is licensed for the treatment of severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation
by blocking the action of oxycodone at opioid receptors locally in the gut.4
Prescribing information is available on this stand.
Code: UK/TARG-11059. Date of preparation: November 2011.
References:1. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy and safety of
oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54.
2. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. Int J Clin Pract 2010;64 (6):763-74.
3. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-12.
4. Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged release tablets. Summary of Product Characteristics. Revised August 2011.
counteracts opioid-induced constipation2,3
delivers effective pain relief1,2
Targinact® tablets contain an opioid analgesic.
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444.
Targinact BPS stand panel. 1000mm x 2000mm Targinact BPS stand. CMYK. 100% to scale.
Targinact is licensed for the treatment of severe pain, which can be adequately managed only with opioid analgesics.
The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors
locally in the gut.4
counteracts opioid-induced constipation2,3
delivers effective pain relief1,2
Prescribing information is available on this stand.
Code: UK/PAIN-12019f. Date of preparation: April 2012.
Targinact® tablets contain an opioid analgesic.
Adverse events should be reported. Reporting forms and information can be found at use www.mhra.gov.uk/yellowcard Adverse events should also be reported to Napp Pharmaceuticals
Limited on 01223 424444.
References:1. Vondrackova D, Leyendecker P, Meissner W, et al. Analgesic efficacy
and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54.
2. Sandner-Kiesling A, Leyendecker P, Hopp M, et al. Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain. Int J Clin Pract 2010;64 (6):763-74.
3. Simpson K, Leyendecker P, Hopp M, et al. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24(12):3503-12.
4. Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged release tablets. Summary of Product Characteristics. Revised August 2011.
Pop up banner stand panel
Dose card leave piece
When was the last time you asked them about it?59% of patients taking opioids suffer from constipation.1
They might not tell you unless you ask.
“Part of your mind is on your pain, and another
part of your brain is taken up with constipation”
“It dominates everything I can do”
“Makes one feel isolated”“It is a constant discomfort
and makes me unhappy”
“Constantlyworrying or
upset”
“I know I have to take my pain meds but it’s awful to always feel constipated”
“Sometimes it seems to take over your life”
“Don’t feel normal” “Cannot sleep”
A4 (297 x 210mm). CMYK.
1. Napp Pharmaceuticals Limited. Constipation survey of 2,000 UK adults taking opioids. July 2012. Data on file.
Real patient quotes taken from a survey
commissioned by NappPharmaceuticals of
2,000 UK opioid treated patients.
UK/PAIN-12272. Nov 2012.
UK pain advert
DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brand: Osvaren & Venofer (Assets adapted from global material)
Client: Fresenius Medical Care
Phosphate controlin harmony
Osvaren® 435mg/235mg Prescribing Information (UK)Refer to the Summary of Product Characteristics (SPC) before prescribing.Presentation: Yellow film-coated scored oral tablets.Indications: Treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis). Dosing and Administration: Dosage Adults: 3 to 10 film-coated tablets per day, depending on the serum phosphate level. The daily dose should be subdivided according to the number of meals taken over the day (usually three a day). The recommended starting dose is three tablets daily. If necessary, the dosage may be raised to maximally 12 film-coated tablets per day. To achieve the maximum phosphate binding effect, Osvaren® should be taken only together with the meal and should not be crushed or chewed. The tablets may be broken along the score line immediately before swallowing. Because the rate and/or extent of absorption of other oral medicinal products may vary when used concurrently with this medicine no other oral medicinal products should be taken within the period 2 hours before and 3 hours after administration of this medicine. In case of a missed dose, the next dose should be taken at the normal time (no attempt should be made to make up for the missed dose). Not recommended for patients under 18. Contra-indications: Hypophosphataemia, Hypercalcaemia with or without clinical symptoms, e.g. as a result of an overdose of vitamin D, a paraneoplastic syndrome (bronchial carcinoma, breast cancer, renal cell carcinoma, plasmacytoma), bone metastases, sarcoidosis or immobilisation osteoporosis Elevated serum magnesium levels of more than 2mmol/l, and/or symptoms of hypermagnesaemia, AV-block III°, Myasthenia gravis; hypersensitivity to the active substances or to any of the excipients. Warnings and Precautions: Review diet and the kind of dialysis treatment before initiating treatment. Osvaren® should only be administered with caution (only with continuous monitoring of serum calcium, magnesium and phosphate) in case of severe hyperphosphataemia with a calcium-phosphate-product of more than 5.3mmol2/L2; if; refractory to therapy; refractory hyperkalaemia; clinical relevant bradycardia or AV-block II° with bradycardia. Continuous monitoring of serum phosphate, serum magnesium, serum calcium and the calcium-phosphate-product should be performed, particularly if used with vitamin D preparations and thiazide diuretics. High doses and long-term administration may result in hypermagnesaemia, usually asymptomatic, but in some cases systemic effects may be seen. Patients with a chronic renal insufficiency may develop hypercalcaemic episodes, especially in combination with the administration of metabolites of vitamin D. Patients should be warned of the possible symptoms of hypercalcaemia. During long-term therapy with this medicine, attention must be paid to the progression or the appearance of vascular and soft
tissue calcifications. The risk decreases by lowering the calcium-phosphate-product to <4.5mmol2/L2. In patients receiving digitalis glycosides, this medicine should only be administered under ECG control and monitoring of the serum calcium level. Increased intake of calcium salts may result in constipation. Patients should be advised to seek medical advice before taking antacids containing calcium or magnesium salts. In case of diarrhoea the dosage of this medicine should be reduced. This medicine contains sucrose. This medicine contains sodium. This has to be taken into consideration by patients on a controlled sodium diet. Pregnancy and Lactation: No experience. Balance risks with benefits. Side-effects: Gastrointestinal disorders: Common; Soft stools, gastrointestinal irritation like nausea, anorexia, sensation of fullness, belching and constipation, diarrhoea. Metabolism and nutrition disorders: Common: Hypercalcaemia either asymptomatic or symptomatic, asymptomatic hypermagnesaemia Uncommon: Moderate to severe symptomatic hypercalcaemia, symptomatic hypermagnesaemia. Very rare: Hyperkalaemia, magnesium-induced osteal mineralisation disturbances. Pack size and Basic NHS Price: Osvaren® 435mg/235mg one pack of 180 film-coated tablets £24.00. Legal Category: POM. Marketing Authorisation number: PL29386/0005. Marketing Authorisation holder: Fresenius Medical Care Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H., Germany. Date of preparation: May 2011.
References1. MIMS online, May 2012. [Accessed May 2012].2. de Francisco ALM et al. Evaluation of calcium acetate/magnesium carbonate as a
phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant. Advanced Access published on June 7, 2010; DOI: 10.1093/ndt/gfq292.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Fresenius drug safety department on 0844 5027 200.
Nunn Brook Road, Huthwaite, Sutton-in-Ashfield,
Nottinghamshire, NG17 2HUNP-0712-236. Date of preparation: July 2012.
OsvaRen JRN whole page ad. 280 x 210mm with 5mm bleed. CMYK.
• Dual phosphate binding1
•Effective reduction of serum phosphate levels2
• Good tolerability profile2
OsvaRen® delivers
…at a cost that will help you control your budget1
Press advert
Irish detail aid on iPad
6pp A5 leave piece
OSVAREN® CORE CLAIMS DOCUMENT (Claims in black were derived from refs used in UK sales aid and have been reference
checked – claims in some other colours came from elsewhere – see reference list for notes on source of claims and references and to what extent they have been verified).
Need for the product Almost 40% of haemodialysis patients and 30% of peritoneal dialysis patients may not achieve K/DOQI serum phosphorus target levels.1
IndicationTreatment of hyperphosphatemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).
Patients who may be likely to benefit• Patientswithphosphatelevelsnotcontrolledoncurrenttherapy(from sales aid)
• Patientswithhyperphosphataemiainsufficientlycontrolledbycalcium-containingphosphatebindersaloneorforwhomthereareconcernsaboutcalcificationwithcalcium-containingphosphatebinders;(positioningsubmittedto)SMC
• Patientswithraisedparathyroidhormonelevels• Patientswithlowmagnesiumlevels
Key efficacy claims• OsvaRenprovidesadualphosphate-bindingeffectfromcalciumacetateandmagnesium
carbonate2,3
• OsvaRenistheonlyphosphatebinderthatcontainsacombinationofamagnesiumsaltandacalcium salt (in the UK – checked in BNF)
OsvaRen delivers:• Effectivereductionofserumphosphoruslevels2,12
• SerumcalciumlevelsmaintainedwithinK/DOQIguidelinerange2
• Serummagnesiumlevelsmildlyelevated2,12whichmayhavepotentialbenefits4,5
• LowersserumiPTH(intactparathyroidhormone)levels2
• Goodtolerabilityprofile2,20
OsvaRendeliversphosphatecontrolinharmony
The benefits of the combination• OsvaRenprovidesadualphosphate-bindingeffectfromcalciumacetateandmagnesium
carbonateanddelivers: – Theadditionalphosphatebindingeffectofmagnesiumcarbonate3
– Reductionincalciumcontentpertabletcomparedwithpurecalciumsalts,12 basedonatheoretical argument not on a comparative dose ranging study
– Lowercalciumuptakeandreducedriskofhypercalcaemiacomparedtocalciumacetateandcalciumcarbonate20
– Mildlyelevatedserummagnesiumlevels2whichmayprovidepotentialbenefits:
– In some circumstances, preventative effect in relation to calcification20
– No evidence of symptomatic hypermagnesaemia2
– Comparableefficacytosevelamerhydrochloride(HCl)2
• OsvaRenistheonlyphosphatebinderthatcontainsacombinationofamagnesiumsaltandacalcium salt (in the UK – checked in BNF)
Core claims document
For full prescribing information refer to the Summary of Product Characteristics.Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Fresenius drug safety department on 0844 5027 200. [email protected]
Date of preparation: March 2012. NP-0312-186.
Dual phosphate binding
Effective reduction of serum phosphate levels 1
Good tolerability profile 1
OsvaRen delivers
…at a cost that will help you control your budget 2
Abbreviated Prescribing Information is available on this stand.
References:
1. de Francisco ALM et al. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant Advanced Access published on June 7, 2010; DOI: 10.1093/ndt/gfq292.
2. MIMS, January 2012.
750mm w x 1500mm h. Venofer BRS stand. CMYK. 100% scale.
Phosphate control in harmony
Exhibition panel
Date of preparation: November 2012. NP-1012-254.
Prescribing information appears on back cover.
Phosphate control
in harmony
Abbreviated Prescribing Information
Osvaren® 435mg/235mg Prescribing Information (Ireland)
Refer to the Summary of Product Characteristics (SPC) before prescribing.
References:1. MIMS Ireland, November 2012. 2. Tzanakis IP, Papadaki AN, Wei M, et al. Magnesium carbonate for phosphate control in
patients on hemodialysis. A randomized controlled trial. Int Urol Nephrol 2008; 40:193–201. 3. Osvaren Summary of
Product Characteristics, January 2011. 4. de Francisco ALM et al. Evaluation of calcium acetate/magnesium carbonate as a
phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG
study) assessing efficacy and tolerability. Nephrol Dial Transplant Advanced Access published on June 7, 2010; DOI: 10.1093/ndt/
gfq292. 5. Ishimura E, Okuno S, Kitatani K, et al. Significant association between the presence of peripheral vascular calcification
and lower serum magnesium in hemodialysis patients. Clinical Nephrology 2007; 68(4):222-227. 6. Tzanakis I, Virvidakis K, Tsomi A,
et al. Intra- and extracellular magnesium levels and atheromatosis in haemodialysis patients Magnesium Research 2004; 17(2):
102-108. 7. Hümpfner A. Stellenwert des kalziumreduzierten Phosphatbinders Kalziumacetat-Mg 2+Im Kalzium-, Phosphat- und
sHPT-Management. Nieren- und Hochdruckkrankheiten 2008 S. 6:260–78. 8. Deuber HJ. Long-term efficacy and safety of an
oral phosphate binder containing both calcium acetate and magnesium carbonate in haemodialysis patients. Nieren-und
Hochdruckkrankheiten 2004; 33(8):403–8. Nunn Brook Road, Huthwaite,
Sutton-in-Ashfield, Nottinghamshire,
NG17 2HU
• Dual phosphate binding
• Effective reduction of serum phosphate levels 4
• Good tolerability profile 4
OsvaRen delivers
…at a cost that will help you control your budget 1
Monthly cost comparison*1
Presentation: yellow film-coated scored oral tablets.
Indications: Treatment of hyperphosphataemia associated with
chronicrenal insufficiency in patients undergoing dialysis
(haemodialysis, peritoneal dialysis).
Dosing and Administration: Dosage Adults: 3 to 10 film-coated
tablets per day, depending on the serum phosphate level. The
daily dose should be subdivided according to the number of
meals taken over the day (usually three a day). The recommended
starting dose is three tablets daily. If necessary, the dosage may
be raised to maximally 12 film-coated tablets per day. To achieve
the maximum phosphate binding effect, Osvaren® should be taken
only together with the meal and should not be crushed or chewed.
The tablets may be broken along the score line immediately before
swallowing. Because the rate and/or extent of absorption of other
oral medicinal products may vary when used concurrently with
this medicine no other oral medicinal products should be taken
within the period 2 hours before and 3 hours after administration
of this medicine. In case of a missed dose, the next dose should
be taken at the normal time (no attempt should be made to make
up for the missed dose). Not recommended for patients under 18.
Contra-indications: Hypophosphataemia, hypercalcaemia with or
without clinical symptoms, e.g. as a result of an overdose of
vitamin D, a paraneoplastic syndrome (bronchial carcinoma, breast
cancer, renal cell carcinoma, plasmacytoma), bone metastases,
sarcoidosis or immobilisation osteoporosis. Elevated serum
magnesium levels of more than 2mmol/L, and/or symptoms of
hypermagnesaemia, AV-block III°, myasthenia gravis; hypersensitivity
to the active substances or to any of the excipients.
Warnings and Precautions: Review diet and the kind of dialysis
treatment before initiating treatment. Osvaren® should only be
administered with caution (only with continuous monitoring of
serum calcium, magnesium and phosphate) in case of severe
hyperphosphataemia with a calcium-phosphate-product of more than
5.3mmol2/ L2; if; refractory to therapy; refractory hyperkalaemia;
clinical relevant bradycardia or AV-block II° with bradycardia.
Continuous monitoring of serum phosphate, serum magnesium,
serum calcium and the calcium-phosphate-product should be
performed, particularly if used with vitamin D preparations and
thiazide diuretics. High doses and long-term administration
may result in hypermagnesaemia, usually asymptomatic, but in
some cases systemic effects may be seen. Patients with a
chronic renal insufficiency may develop hypercalcaemic episodes,
especially in combination with the administration of metabolites of
vitamin D. Patients should be warned of the possible symptoms
of hypercalcaemia. During long-term therapy with this medicine,
attention must be paid to the progression or the appearance of
vascular and soft tissue calcifications. The risk decreases by
lowering the calcium phosphate product to <4.5mmol2/L2. In
patients receiving digitalis glycosides, this medicine should only
be administered under ECG control and monitoring of the serum
calcium level. Increased intake of calcium salts may result in
constipation. Patients should be advised to seek medical advice
before taking antacids containing calcium or magnesium salts. In
case of diarrhoea the dosage of this medicine should be reduced.
This medicine contains sucrose. This medicine contains sodium.
This has to be taken into consideration by patients on a controlled
sodium diet.
Pregnancy and Lactation: No experience. Balance risks with
benefits. Side effects: Gastrointestinal disorders: Common; Soft stools,
gastrointestinal irritation like nausea, anorexia, sensation of
fullness, belching and constipation, diarrhoea. Metabolism and
nutrition disorders: Common: Hypercalcaemia either asymptomatic
or symptomatic, asymptomatic hypermagnesaemia. Uncommon:
Moderate to severe symptomatic hypercalcaemia, symptomatic
hypermagnesaemia. Very rare: Hyperkalaemia, magnesium-induced
osteal mineralisation disturbances.
Pack size and Basic Price: Osvaren® 435mg/235mg one pack of
180 film-coated tablets €35.45
Legal Category: POM.
Marketing Authorisation number: PA1350/4/1.
Marketing Authorisation holder: Fresenius Medical Care
Nephrologica Deutschland GmbH 61346 Bad Homburg v.d.H.,
Germany. Date of preparation: September 2012
Adverse events should be reported. Reporting forms and information can be found at
http://www.imb.ie/EN/Safety--Quality/Online-Forms.aspx
Adverse events should be reported to Fresenius drug safety department on 1800 550 166 or [email protected]
* Costs based on 28 days’ therapy.
Based on prices in MIMs Ireland, November 2012.
lanthanum carbonate
hydrate
sevelamer
20 50
300250200
150100
100
upper dose €56.24starting dose €14.06
starting dose
OsvaRen
€86.11
starting dose €112.56
upper dose €333.95
upper dose €430.57
350 400 450
© DNA Healthcare Advertising Ltd. DNA Portfolio.
Well recognised for the treatment of iron deficiency
Tried and tested anaemia management
The most frequently prescribed IV iron therapy in the UK1
Effective IV iron replacement for haemodialysis patients2,3
Optimises ESA therapy2,3
References:
1. Data on file, Nephropharm 2010.
2. Richardson D, et al. Amer J Kidney Dis 2001; 38(1):109-17.
3. Shiesser D, et al. Nephrol Dial Transplant 2006; 21:2841-2845.
For full prescribing information refer to the Summary of Product Characteristics.Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Vifor Pharma UK Ltd. Tel: +44 1276 853633.Venofer® is a registered trademark.
750mm w x 1500mm h. Venofer BRS stand. CMYK. 100% scale.
Abbreviated Prescribing Information is available on this stand.
Date of preparation: April 2012. NP-0312-187.
Exhibition panel
6pp A5 leave piece
Detail aid on iPad
Well recognised for the treatment of iron deficiency
Venofer® is the most frequently prescribed IV iron therapy in the UK 1
Tried and tested anaemia management
Prescribing information can be found on last page.Date of Preparation: September 2012. NP-0912-247.
DNA Portfolio. © DNA Healthcare Advertising Ltd.
A5 patient information booklet
A 42.5% reductionin drop attacksisn’t something...
...unless you’re the one falling
A new way forward in Lennox-Gastaut Syndrome
ABBREVIATED PRESCRIBING INFORMATIONInovelon®6(rufinamide)Please refer to the SPC before prescribing.Presentation: Film coated tablets containing 100 mg, 200 mg or 400 mg rufinamide. Indication: Adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 4 years and older.Dose and administration: Children 4 years and older: (see SmPC). For oral use - Children weighing < 30 kg not receiving valproate; Initial daily dose is 200 mg in two divided doses and may be increased by 200 mg/day increments, as frequently as every two days, up to a maximum dose of 1000 mg/day. Children weighing < 30 kg receiving valproate; Initial daily dose is 200 mg in two divided doses and may be increased by 200 mg/day after a minimum of 2 days, up to a maximum dose of 400 mg/day. Adults and children 4 years or older of m 30kg; Initial daily dose is 400 mg in two divided doses and may be increased by 400 mg/day increments, as frequently as every two days, up to a maximum of 3200 mg/day based on patient’s weight (see SPC). Inovelon should be administered twice daily with water and preferably with food in the morning and in the evening. Inovelon can be crushed and administered with half a glass of water.Elderly and patients with renal or hepatic impairment: No dosage adjustment required in elderly and renal impairment. Not recommended in severe hepatic impairment.Contra-Indications: Hypersensitivity to rufinamide, triazole derivatives or any excipients.Pregnancy: Inovelon should not be used during pregnancy unless clearly necessary. Lactation: Excretion into human breast milk unknown. Lactation should be avoided during maternal treatment with Inovelon.Warnings and Precautions: Cases of status epilepticus have been observed during clinical studies, which led to discontinuation in 20% of the cases. The benefit risk ratio of the therapy should be reassessed if patients develop new seizure types and/or experience an increased frequency of status epilepticus. Withdraw gradually to reduce possibility of seizures on withdrawal and reduce dose by approximately 25% every two days. Inovelon has been associated with dizziness, somnolence, ataxia and gait abnormalities which could increase the occurrence of accidental falls in this population, therefore patients and carers should exercise caution. Serious antiepileptic drug hypersensitivity syndrome has occurred with rufinamide, e.g. fever and rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities, haematuria. Ifthis reaction is suspected, rufinamide should be discontinued and alternative treatment started. Closely monitor patients on rufinamide with unexplained rash. Women of childbearing potential must use contraceptive measures during treatment with Inovelon. Inovelon tablets contain lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Inovelon.Drug Interactions: Rufinamide concentration may be decreased by co-administration with carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone. Significant increases in rufinamide plasma concentrations possible when co-administered with valproate. Consideration should be given to a dose reduction in patients < 30 kg who are on valproate therapy. No significant changes in rufinamide concentration when co-administered with lamotrigine, topiramate or benzodiazepines. Rufinamide has no clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate or valproate steady state concentrations. Rufinamide may decrease phenytoin clearance and increase concentrations of co-administered phenytoin, therefore reducing the dose of phenytoin should be considered. Rufinamide decreases the AUC of a combined oral contraceptive (ethinyloestradiol 35 μg and norethindrone 1 mg). Women of child-bearing potential should use an additional safe and effective contraceptive method. Rufinamide does not inhibit the activity of cytochrome P450 enzymes. Rufinamide has been shown to induce the CYP3A4 enzyme. Carefully monitor patients on drugs metabolised by the CYP3A enzyme for two weeks at start of, or after the end of treatment with Inovelon. Dose adjustments should be considered when Inovelon is co-administered with drugs with narrow therapeutic window such as warfarin and digoxin. No effects on the pharmacokinetics of olanzapine. No interaction data with alcohol.Side effects: The most common adverse reactions in clinical development program were headache, dizziness, fatigue, and somnolence. Adverse reactions associated with Inovelon in clinical studies: Very common effects (>1/10): somnolence, headache, dizziness, nausea, vomiting, fatigue. Common effects (>1/100, <1/10): pneumonia, influenza, nasopharyngitis, ear infection, sinusitis, rhinitis, anorexia, eating disorder, decreased appetite, anxiety, insomnia, status epilepticus, convulsion, coordination abnormal, nystagmus, psychomotor hyperactivity, tremor, diplopia, vision blurred, vertigo, epistaxis, abdominal pain upper, constipation, dyspepsia, diarrhoea, rash, acne, back pain, oligomenorrhoea, gait disturbance, weight decrease, head injury, contusion. Uncommon (>1/1000<1/100): hypersensitivity and hepatic enzyme increase.Legal Category: POMPresentation: Aluminium/aluminium blisters.Basic UK NHS cost: Inovelon 100 mg: packs of 10 £8.58, Inovelon 200 mg: packs of 60 £51.48, Inovelon 400 mg: packs of 60 £85.80.Basic Irish cost: Inovelon 100 mg: packs of 10 €12.68, Inovelon 200 mg: packs of 60 €76.15, Inovelon 400 mg: packs of 60 €126.91.Marketing authorisation numbers: Inovelon 100 mg: packs of 10EU/1/06/378/001, Inovelon 200 mg: packs of 60 EU/1/06/378/009, Inovelon 400 mg: packs of 60 EU/1/06/378/014.Marketing authorisation holder: Eisai Ltd.Further Information from/Marketed by: Eisai Ltd, Hammersmith International Centre, 3 Shortlands, London, W6 8EE, UKDate of preparation: July 2007
Eisai code: INO 1002. Date of preparation: August 2007.
Information about adverse event reporting can be found at www.yellowcard.gov.uk Adverse events should also be reported to Eisai Ltdon 0208 600 1400 or [email protected]
A4 advert
Detail aid slides on CD
Information about adverse event reporting can be found at www.yellowcard.gov.uk Adverse events should also be reported to Eisai Ltd. on 0208 600 1400 or [email protected]
Banner stand poster for conferences
A4 folder
Product monographRep stand panel posters
Brand: InovelonClient: Eisai
Dose card
Logo design
© DNA Healthcare Advertising Ltd. DNA Portfolio.
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Walll planner
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Detail aid
BRAND IDENTITY GUIDELINES
Brand guidelines and all templates
SmPC
Trainingmanual
Launch letter / RPC mailer
DNA Portfolio. © DNA Healthcare Advertising Ltd.
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© DNA Healthcare Advertising Ltd. DNA Portfolio.
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DNA Portfolio. © DNA Healthcare Advertising Ltd.
Brand: Linx Client: Torax Medical Inc.
Torax Medical, Inc. and the LINX Reflux Management System are trademarks of Torax Medical, Incorporated.3197 Rev 27-Jan-11 Email: [email protected]
THE TREATMENT OF
REFLUXRETHINK
COME AND
SEE US ON
STAND G2
Size is 105 x 145mm plus 3mm bleed
Linx A5 advert insert for exhibition
Email: [email protected]
WIR FREUEN
UNS AUF IHREN
BESUCH AN
UNSEREM
STAND NR 103
SIE DIE BEHANDLUNG DER
REFLUX-KRANKHEIT
ÜBERDENKEN
Torax™ Medical, Inc. und das LINX™ Reflux-Managementsystemsind Marken der Torax Medical, Inc. Dok. Nr. 3198-2.
Datum der Veröffentlichung: 11. MAI
Linx A4 German advert
PREISLISTE LINX™ REFLUX MANAGEMENT SYSTEM
Folgende Hinweise sollen es Ihnen erleichtern, das Linx™ Reflux Management System zu bestellen:
• GebenSiebittedieGrösseundAnzahlderbenötigtenImplantatean
• FaxenSieIhrenAuftragbitteanfolgendeNr.+1651-361-8910
att.BrianMower
Torax™Medical,Inc.unddasLINX™Reflux-ManagementsystemsindMarkenderToraxMedical,Inc.
Torax™ Medical, Inc.4188 Lexington Avenue NorthShoreview, Minnesota 55126, USAEmail: [email protected]
Dok.Nr.Doc.3223-2Rev1.DatumderVeröffentlichung:11.MAI.
KontaktvorOrt: GerhardLandwehr
Kontaktinfo: Email:[email protected]
Tel.:+49(0)1725431919
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4pp A5 Linx German price list
A NEW TREATMENT FOR CHRONIC REFLUX DISEASE
THE TREATMENT OF
REFLUXRETHINK
NEW
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P A L E T T E
C O L O RL O G O
B & WL O G O
R E V E R S E DL O G O W I T H
T R A N S P A R E N C Y
R E V E R S E DL O G O
PANTONE5425
44c / 15m / 7y / 22k
PANTONEBLACK (70%)
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MYRIAD ROMAN(FOR REFERNCE ONLY – DO NOT RESET)
DESIGNER: Kurt Mueller/Dan Hannon
POURUN NOUVEAU TRAITEMENT
Torax® Medical, Inc. et LINX® RefluxManagement System sont des marques commerciales de Torax Medical, Incorporated.
Doc No 3393-3 Rév 1.Date of issue: Oct 2012
Torax® Medical, Inc.4188 Lexington Avenue NorthShoreview, Minnesota 55126, États-Unis
Email: [email protected] www.toraxmedical.co.uk
LE REFLUX CHRONIQUE
A5 Linx post-consultation booklet (French)CONCLUSION This study shows that augmentation of the LES barrier using the LINX™ Reflux Management System is an effective treatment for patients with uncomplicated GERD who are dissatisfied with acid suppression therapy. It is a reversible procedure, with minimal surgical dissection and preservation of normal anatomy. Furthermore, with a short operating time and the ability to resume a normal diet the day after implantation, the LINX™ Reflux Management System is likely to offer a consistent and less variable outcome in the treatment of reflux.
Figure 1a – The LINX™ device in the closed position, 1b - the closed position showing no compression of the esophageal wall, and 1c - the LINX device in the open position.
METHODS The LINX™ device was implanted at the gastro-esophageal junction, in 44 patients in a multi-centre, prospective clinical study carried out between February 2007 and October 2008. There were 26 (59%) males and 18 (41%) females with a mean age of 42.3 years (range 19-72 years) and a BMI range from 19.0 to 38.4 (mean 25.7).
Heartburn was the primary symptom in all patients and all were taking proton-pump inhibitors at standard or double dose. Eighteen patients had no hernia and twenty-six of the 44 patients (59.1%) had a <3cm sliding hiatal hernia based on radiologic and/or endoscopic criteria.
Each patient was evaluated before surgery with a symptom questionnaire, upper gastrointestinal endoscopy, barium swallow, esophageal manometry, and 24-hour esophageal pH monitoring. The Gastro-Esophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire was administered preoperatively “off” PPI therapy before any diagnostic test. All tests were repeated post-surgery at 3, 12 and 24 months apart from esophageal manometry which was carried out at 3 and 12 months. Exclusion criteria: symptoms of dysphagia, previous upper abdominal surgery, previous endoluminal antireflux procedures, >3 cm sliding hiatal hernia, greater than grade A esophagitis, and/or the presence of histologically documented Barrett’s esophagus.
RESULTS All devices were implanted without complications with a median operative time of 40 minutes (range: 19 – 104) and all but 1 patient was discharged within 48 hours. A free diet was allowed after radiological assessment of esophageal transit on postoperative day one. The total mean GERD-HRQL symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001).
LAPAROSCOPIC SPHINCTER AUGMENTATION DEVICE ELIMINATES REFLUX SYMPTOMS AND NORMALISES ESOPHAGEAL ACID EXPOSURE: ONE AND TWO YEAR RESULTS OF A FEASIBILITY TRIALThe LINX™ Reflux Management System offers a new treatment for patients with GERD, who have incomplete symptom relief from PPI therapy. Comprising a string of interlinked titanium beads with magnetic cores, the LINX™device is implanted laparoscopically around the gastro-esophageal junction, forming a flexible ring that rests around the Lower Esophageal Sphincter (LES). The magnetic bond between adjacent beads allows a weak LES to resist gastric distension, effectively stopping reflux at its source. The beads temporarily separate to accommodate a swallowed bolus and reapproximate to augment the LES in the closed position.
The one and two year results of a feasibility trial, show the LINX™ device provides excellent relief from GERD symptoms without creating new side effects.
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24 monthsn = 20
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25.7
3 monthsn = 37
4.6
2 monthsn = 39
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1a 1b 1c
Pre- and postoperative mean total score from the GERD-HRQL questionnaire (p<.0001).
Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. The average DeMeester score was reduced from 42.3 to 9.4 after 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries and all patients preserved the ability to belch after surgery. Four patients experienced the need to vomit and were able to do so.
Percentage of patients who had their esophageal acid exposure normalised after surgery.
Bonavina, et al. (2010) Laparoscopic Sphincter Augmentation Device Eliminates Reflux Symptoms and Normalises Oesophageal Acid Exposure. Annals of Surgery 252:857-862
EMEA – 3225-1 Rev 2Date of preparation: September 2011.
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Linx A4 scientific paper
A NEW TREATMENT FORCHRONIC REFLUX DISEASE
DOMANDE FREQUENTI
D. Quando posso iniziare a mangiare normalmente? I pazienti vengono incoraggiati a riprendere una dieta normale
non appena questa viene tollerata. Ciò aiuta l’organismo ad adattarsi al sistema LINX™ di gestione del re usso.
D. Quando posso riprendere la mia normale attività sica? In genere, i pazienti sono in grado di riprendere un’attività
moderata entro qualche giorno; tuttavia, come dopo qualsiasi intervento chirurgico, è necessario consultare il medico sul trattamento postoperatorio.
D. Posso passare attraverso i controlli di sicurezza in aeroporto?
Il sistema LINX™ di gestione del reflusso non influisce sui controlli aeroportuali. A tutti i pazienti sarà comunque consegnata una scheda da esibire in caso di necessità.
D. Esiste il rischio di rigetto del sistema LINX™ di gestione del reflusso?
Il sistema LINX™ è stato studiato per ridurre al minimo i rischi di rigetto. Tutte le super ci del dispositivo a contatto con l’organismo sono fabbricate con materiali di uso frequente nei dispositivi medici e che sono risultati essere molto stabili. Tuttavia, in caso di anamnesi di tendenza al rigetto di dispositivi, è importante comunicare questa informazione al medico prima dell’impianto del sistema LINX™ di gestione del re usso.
D. Posso sottopormi a una risonanza magnetica
dopo l’impianto del sistema LINX™ di gestione del reflusso?
No. Gli esami per risonanza magnetica sono proibiti dopo l’impianto del sistema LINX™ di gestione del re usso. Questa informazione è chiaramente indicata sulla scheda dell’impianto.
D. I magneti si esauriscono? Il sistema LINX™ di gestione del re usso usa magneti
permanenti studiati per non esaurirsi.
Torax™ Medical, Inc. e LINX™ Reflux Management System sono marchi commerciali di Torax™ Medical, Incorporated.
N. doc 3218-3 Rev 1Data di emissione APR 11
CURA DEL PAZIENTENEL POSTOPERATORIO
Linx 6pp DL post-op patient leave piece (Italian)
UN NOUVEAU TRAITEMENT POUR LE REFLUX PATHOLOGIQUE CHRONIQUE
LE LINX® REFLUX MANAGEMENT SYSTEM EST-IL ADAPTÉ À MON CAS ?Ressentez-vous toujours les symptômes du reflux, malgré la prise régulière de médicaments ? Êtes-vous inquiet quant aux effets secondaires à long terme de vos médicaments ? Le LINX® Reflux Management System est peut-être une solution adaptée à votre cas. Pour plus d’informations, consultez votre médecin ou visitez notre site à l’adresse www.toraxmedical.com.
Doc. N° 3208-4 Rév. 1. Date of issue Oct 12.
Torax® Medical, Inc.4188 Lexington Avenue NorthShoreview, Minnesota 55126, États-UnisEmail: [email protected]
VOTRERECONSIDÉREZREFLUX
Actual size
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Torax® Medical, Inc. et LINX® RefluxManagement System sont des marques commerciales de Torax Medical, Incorporated.
Linx 6pp DL brochure (French)
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Brands: Novo Nordisk, Mirena (Bayer Schering) & MSDClient: Cohn & Wolfe
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To register attendance, and to set up interviews / one-to-ones, please contact Jonathan Kearneyat Cohn & Wolfe London, who will be facilitating the meeting:
Email: [email protected] Telephone: +44 20 7331 2364
MEDIA ROUNDTABLE
Caring for Women: Engage in Conversations
Monday 18th May 2009, 14.00 – 15.00North Gallery Room 4, ExCeL London
One Western Gateway, Royal Victoria Dock, London E16 1XL
Novo Nordisk FemCare AG, the European Menopause and Andropause Society (EMAS), and the British Menopause Society (BMS), are pleased to invite you to a media roundtable entitled ‘Caring for Women: Engage in Conversations’ and a satellite symposium entitled‘Vaginal atrophy: Are we lost in translation?’
The media roundtable will provide you with exclusive presentations from Professor David Barlow, President of EMAS, on the role ofEMAS in raising the issue of menopausal conditions and problems and its educational programmes for healthcare professionals in thisarea, and Dr. Tim Hillard, Chairman of BMS, on the confusion and complications around the menopause that currently exist and thechallenge of menopause management, from a UK perspective. In addition there will be an in-depth briefing on the findings from aninternational survey of women on communication issues associated with post-menopausal vaginal atrophy.
The details for both events are as follows:
Satellite Symposium: 12.15-13.45 Venue: Hall A, ExCeL London
Media Roundtable: 14.00-15.00 Venue: North Gallery Room 4, ExCeL London (North Gallery Room 4 is a short walk from Hall A)
Agenda/speakers
Introduction. Prof. Henry Burger and Prof. David Barlow
The European Menopause and Andropause Society – How we can ensure problems and solutions to menopausal issuesare shared. Prof. David Barlow
The challenges of menopause management – Experiences from the British Menopause Society. Dr. Tim Hillard
Women’s voices: International survey findings in context – Highlighting international trends and variations. Dr. Rossella Nappi
From our experience – expert viewpoints
• Italy Dr. Rossella Nappi
• United Kingdom Dr. Heather Currie
Start the conversation: Practical recommendations. Prof. Henry Burger
Open moderated Q&A with media. Media / panel
Spokespersons available for interviews/one-to-ones following the media roundtable
• Prof. David Barlow President of EMAS
• Dr. Tim Hillard Chairman of BMS
• Prof. Serge Rozenberg Secretary General & President-Elect of EMAS
• Prof. Henry Burger Jean Hailes Foundation for Women’s Health, Australia
• Dr. Rossella Nappi University of Pavia, Italy
• Dr. Heather Currie Dumfries and Galloway Royal Infirmary, United Kingdom
Light refreshments will be served prior to the media roundtable.
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DIZZINESS, DROWSINESS, FAST HEARTBEAT, FEELING JITTERY, HEADACHE, HUNGER, IRRITABILITY, SWEATING, WEAKNESS TYPE 2 DIABETES HYPOGLYCAEMIA
The Type 2 Diabetes Dilemma: Exploring Hypoglycaemia
Thursday 23rd September, 9.00am – 10.30am EASD press conference room Stockholmsmässan, Stockholm
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DIZZINESS, DROWSINESS, FAST HEARTBEAT, FEELING JITTERY, HEADACHE, HUNGER, IRRITABILITY, SWEATING, WEAKNESS TYPE 2 DIABETES HYPOGLYCAEMIA
The Type 2 Diabetes Dilemma: Exploring Hypoglycaemia
MEDIA INVITATIONEASD 2010
WHEN: Thursday 23rd September 9.00am – 10.30am
WHERE: EASD press conference room Stockholmsmässan Stockholm
The Type 2 Diabetes Dilemma:Exploring Hypoglycaemia
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