module 1 - gskpro.com file- there is no national surveillance system in place to collect and monitor...

Rotavirus Online Training Module Quiz. For Healthcare Professionals registered in Ireland

IE/ROT/0017/16a Date created Aug 2016

Module 1

Question 1:

Rotavirus (RV) is a common cause of gastroenteritis (GE) in young children and its impact on primary and secondary care is very high. What is the estimated number of GP consultations caused by RVGE annually in Ireland?

Options are:

- 1150 - 3050 - 2690 - 950

Question 2:

What is the estimated annual cost to the HSE for treating rotavirus gastroenteritis?

Options are:

- €1.5m - €3.5m - €5.5m - €10.5m

Question 3:

Which of the following are reasons explaining why the burden of rotavirus (RV) is underestimated? Choose all that apply:

Options are:

- Testing for RV is not routinely carried out - Symptoms displayed are similar to other childhood illnesses - There is no national surveillance system in place to collect and monitor data



Question 4:

If a child is sick with rotavirus gastroenteritis, what would you recommend?

Options are:

- Stop regular feeding - Prescribe antibiotics - Offer oral rehydration when needed - Admit the child to hospital as a precaution

Question 5:

Which expert bodies recommend the vaccination of infants to protect against rotavirus gastroenteritis? Choose all that apply:

Options are:

- World Health Organisation Strategic Advisory Group of Experts (WHO SAGE) - UK’s Joint committee on Vaccination and Immunisation (JCVI) - Ireland’s National Immunisation Advisory Committee (NIAC) - Germany’s Standing Committee on Vaccination at the Robert Koch Institute (STIKO) - Advisory Committee of Immunisation Practices (ACIP) in USA

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Module 2

Question 1:

Which of the following rotavirus strains is the most common one found in Europe?

Options are:

- G1P[8] - G2P[4] - G3P[8] - G4P[8] - G9P[8]



Question 2:

Which of the following are possible sources of rotavirus infection for babies? Choose all that apply:

Options are:

- Toys - Pets - Hands - Soil - Food

Question 3:

It is July and your GP surgery suddenly sees an influx of rotavirus gastroenteritis cases. Would you say this is unusual for this time of year?

Options are:

- Yes - No

Question 4:

Of the following members of a fictional family, who would you say is most likely to be infected by rotavirus gastroenteritis?

Options are:

- 32 year old mother - 8 year old son - 6 month old infant - 65 year old grandmother



Question 5:

A father brings in his 3 month old daughter to see you, with the complaint that she has been unwell the past few days. You ask him to describe her symptoms – which of the following would lead you to suspect that the baby might have rotavirus gastroenteritis? Choose all that apply:

Options are:

- Rashes on her stomach - Multiple episodes of diarrhoea a day - A high fever - Difficulty breathing - Redness around the navel - Vomiting

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Module 3

Question 1:

How many doses of Rotarix does an infant have to be administered to complete the full vaccination course?

Options:

- 1 dose - 2 doses - 3 doses - 4 doses



Question 2:

Please chose the age at which Rotarix will be administered in the immunisation calendar in Ireland

Options:

- At 2 months of age - At 6 months of age - At 10 weeks of age - At 4 months of age

Question 3:

Rotarix has been shown to provide immunity that lasts over the first two years of an infant’s life. True or false?

Options

- True - False

Question 4:

Your clinic has been informed that G2P[4] is the most prevalent rotavirus strain in Ireland this season. Will Rotarix be able to protect infants against this strain?

Options

- Yes - No

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Module 4

Question 1:

What are the most common side effects of Rotarix? Choose the following that apply:

Options

- Abdominal pain - Diarrhoea - Flatulence - Bloody stools - Irritability

Question 2:

You see the following infants in your clinic today – who should you NOT administer Rotarix to? Choose all that apply:

Options

- Infant with history of intussusception - Infant born premature and underweight - Infant born with asymptomatic HIV - Infant diagnosed with SCID - Infant who has been ill for the past 24 hours with a high fever and vomiting

Question 3:

Which of the following sentences best describe intussusception? Choose all that apply:

Options

- Ileocolic intussusception is the most common form observed in young children - Intussusception in children is most often caused by viruses - In Europe, intussusception most commonly occurs in infants who are 3-9 months of

age - Common symptoms include severe abdominal pain and swelling, vomiting, fever and

a pale appearance



Question 4:

What is the number one cause of intussusception in young children?

Options:

- Viral infection - Tumour - Recent abdominal surgery - Inflammatory bowel disease - No known cause

Question 5:

In Europe, at what age are children most likely to present with intussusception?

Options:

- child aged 1-3 months - child aged 3-9 months - child aged 9-15 months - child aged 15-24 months

Question 6:

A parent brings his/her 8 week old son for his first dose of Rotarix. The family also has a 2 year old daughter who was born with SCID. What advice could you offer the parent?

Options

- the infant boy should be fine to return to the childminder in 2-3 days - ensure the daughter does not come into contact with the son’s stools especially for at

least 7 days following vaccination - the parent should arrange for their daughter to be immunised as well, if she hasn’t

already been vaccinated

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Module 5

Question 1:

What rotavirus strain was used to develop the live attenuated vaccine Rotarix?

Options:

- G1P[8] - G2P[4] - G3P[8] - G4P[8] - G9P[8]

Question 2:

You are about to administer Rotarix. As you inspect the oral applicator, which of the following would lead you to discard the vaccine? Choose all that apply:

- An expiry date of 8th December 2017 and today’s date is 8th July 2017 - Small white particles in the solution - Colourless liquid

Question 3:

How should Rotarix be administered?

Options:

- Subcutaneously - Intravenously - Orally - Topically



Question 4:

After administering Rotarix to a young infant, he/she regurgitates most of the vaccine. What should you do?

Options:

- Explain to the parent what has happened and schedule another appointment for a replacement dose a week later

- Administer a replacement dose in the same visit - Estimate how much liquid was regurgitated and administer that amount using a new

oral applicator

Question 5:

Can Rotarix be given at the same clinic appointment as the other age-related scheduled childhood vaccines like the DTaP/IPV/HepB-Hib?

Options

- Yes - No

Question 6:

At what temperature should Rotarix be stored at in the refridgerator?

Options are:

- 20-25oC (room temperature) - 15-20oC - 9-15oC - 2-8oC - -4-2oC

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Enclosed please find answers to the multiple choice quiz

Module 1

Question 1:

Rotavirus (RV) is a common cause of gastroenteritis (GE) in young children and its impact on primary and secondary care is very high. What is the estimated number of GP consultations caused by RVGE annually in Ireland?

Options are:

- 1150 - 3050 - 2690 - 950

Correct answer is:

- 2690

Question 2:

What is the estimated annual cost to the HSE for treating rotavirus gastroenteritis?

Options are:

- €1.5m - €3.5m - €5.5m - €10.5m

Correct answer is:

- €5.5m



Question 3:

Which of the following are reasons explaining why the burden of rotavirus (RV) is underestimated? Choose all that apply:

Options are:

- Testing for RV is not routinely carried out - Symptoms displayed are similar to other childhood illnesses - There is no national surveillance system in place to collect and monitor data

Correct answer is:

- Testing for RV is not routinely carried out - Symptoms displayed are similar to other childhood illnesses

Question 4:

If a child is sick with rotavirus gastroenteritis, what would you recommend?

Options are:

- Stop regular feeding - Prescribe antibiotics - Offer oral rehydration when needed - Admit the child to hospital as a precaution -

Correct answer is:

- Offer oral rehydration when needed -

Most cases of rotavirus gastroenteritis are usually mild and treatable at home, where parents are encouraged to feed their child as normal and use an oral rehydration solution if they notice signs of dehydration. Treatment with drugs such as antibiotics is generally unnecessary and hospitalisation is required only in cases of severe dehydration.



Question 5:

Which expert bodies recommend the vaccination of infants to protect against rotavirus gastroenteritis? Choose all that apply:

Options are:

- World Health Organisation Strategic Advisory Group of Experts (WHO SAGE) - UK’s Joint committee on Vaccination and Immunisation (JCVI) - Ireland’s National Immunisation Advisory Committee (NIAC) - Germany’s Standing Committee on Vaccination at the Robert Koch Institute (STIKO) - Advisory Committee of Immunisation Practices (ACIP) in USA

Correct answers:

- World Health Organisation Strategic Advisory Group of Experts (WHO SAGE) - UK’s Joint committee on Vaccination and Immunisation (JCVI) - Ireland’s National Immunisation Advisory Committee (NIAC) - Germany’s Standing Committee on Vaccination at the Robert Koch Institute

(STIKO) - Advisory Committee of Immunisation Practices (ACIP) in USA

Module 2

Question 1:

Which of the following rotavirus strains is the most common one found in Europe?

Options are:

- G1P[8] - G2P[4] - G3P[8] - G4P[8] - G9P[8]

Correct answer is:

- G1P[8]

The majority of rotavirus gastroenteritis cases in Europe are the result of infection by the G1P[8] rotavirus strain.



Question 2:

Which of the following are possible sources of rotavirus infection for babies? Choose all that apply:

Options are:

- Toys - Pets - Hands - Soil - Food

Correct answers are:

- Toys - Hands - Food

Rotavirus is spread mainly via faecal-oral transmission. Babies may become infected when they put objects that have been contaminated with the virus into their mouths. Common objects include toys, food and their hands.

Question 3:

It is July and your GP surgery suddenly sees an influx of rotavirus gastroenteritis cases. Would you say this is unusual for this time of year?

Options are:

- Yes - No

Correct answer is:

- Yes

Rotavirus tends to be seasonal, with most cases occurring in winter or early spring (December – April/May). It would be unusual to see a peak in incidence rate in July.



Question 4:

Of the following members of a fictonal family, who would you say is most likely to be infected by rotavirus gastroenteritis?

Options are:

- 32 year old mother - 8 year old son - 6 month old infant - 65 year old grandmother

Correct answer is:

- 6 month old infant

While people of all ages can be infected by rotavirus, babies and young children aged four and under are most vulnerable to infection.

Question 5:

A father brings in his 3 month old daughter to see you, with the complaint that she has been unwell the past few days. You ask him to describe her symptoms – which of the following would lead you to suspect that the baby might have rotavirus gastroenteritis? Choose all that apply:

Options are:

- Rashes on her stomach - Multiple episodes of diarrhoea a day - A high fever - Difficulty breathing - Redness around the navel - Vomiting

Correct answers are:

- Multiple episodes of diarrhoea a day - A high fever - Vomiting

The most common symptoms experienced by children with rotavirus gastroenteritis are diarrhoea, fever and vomiting.



Module 3

Question 1:

How many doses of Rotarix does an infant have to be administered to complete the full vaccination course?

Options:

- 1 dose - 2 doses - 3 doses - 4 doses

Correct answer:

- 2 doses

The full vaccination course for Rotarix consists of 2 doses, administered a minimum of 4 weeks apart. It is important for infants to complete the immunisation series by receiving both doses

Question 2:

Please chose the age at which Rotarix will be administered in the immunisation calendar in Ireland

Options:

- At 2 months of age - At 6 months of age - At 10 weeks of age - At 4 months of age

Correct answers:

- 2 months of age - 4 months of age

The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between



doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.

Question 3:

Rotarix has been shown to provide immunity that lasts over the first two years of an infant’s life. True or false?

Options

- True - False

Correct answer:

- True

Clinical trials have shown that when infants are immunised with Rotarix, they may be protected against rotavirus gastroenteritis for up to two years post-vaccination.

Question 4:

Your clinic has been informed that G2P[4] is the most prevalent rotavirus strain in Ireland this season. Will Rotarix be able to protect infants against this strain?

Options

- Yes - No

Correct answer:

- Yes

Rotarix offers protection against a number of rotavirus strains, including G2P[4].



Module 4

Question 1:

What are the most common side effects of Rotarix? Choose the following that apply:

Options

- Abdominal pain - Diarrhoea - Flatulence - Bloody stools - Irritability

Correct answers:

- Diarrhoea - Irritability

Following immunisation children may become irritable and experience diarrhoea. Abdominal pain, flatulence and dermatitis are uncommon. Please see Rotarix prescribing information for further information on undesirable effects: http://www.medicines.ie/medicine/15020/SPC/Rotarix+oral+suspension+in+pre-filled+oral+applicator/

Question 2:

You see the following infants in your clinic today – who should you NOT administer Rotarix to? Choose all that apply:

Options

- Infant with history of intussusception - Infant born premature and underweight - Infant born with asymptomatic HIV - Infant diagnosed with SCID - Infant who has been ill for the past 24 hours with a high fever and vomiting

Correct answers:

- Infant with history of intussusception - Infant diagnosed with SCID - Infant who has been ill for the past 24 hours with a high fever and vomiting

http://www.medicines.ie/medicine/15020/SPC/Rotarix+oral+suspension+in+pre-filled+oral+applicator/�




Rotarix must not be given to infants with SCID or those with a history of intussusception. Infants who are ill on the day of vaccination should be immunised at a later date when they have fully recovered.

Question 3:

Which of the following sentences best describe intussusception? Choose all that apply:

Options

- Ileocolic intussusception is the most common form observed in young children - Intussusception in children is most often caused by viruses - In Europe, intussusception most commonly occurs in infants who are 3-9 months of

age - Common symptoms include severe abdominal pain and swelling, vomiting, fever and

a pale appearance

Correct answers:

- Ileocolic intussusception is the most common form observed in young children

- In Europe, intussusception most commonly occurs in infants who are 3-9 months of age

- Common symptoms include severe abdominal pain and swelling, vomiting, fever and a pale appearance

Most cases of intussusception observed in young children are ileocolic and of unknown origin. The age group most commonly affected in Europe is infants aged 3-9 months. Common symptoms of intussusception include severe abdominal pain, abdominal swelling, vomiting, high fever and a pale appearance.

Question 4:

What is the number one cause of intussusception in young children?

Options:

- Viral infection - Tumour - Recent abdominal surgery - Inflammatory bowel disease - No known cause

Correct answer:

- No known cause



Nearly 90% of all cases of intussception in infants are of unknown cause.

Question 5:

In Europe, at what age are children most likely to present with intussusception?

Options:

- child aged 1-3 months - child aged 3-9 months - child aged 9-15 months - child aged 15-24 months

Correct answer:

- child aged 3-9 months

In Europe, intussusception has been found to occur most frequently in infants aged 3-9 months old.

Question 6:

A parent brings his/her 8 week old son for his first dose of Rotarix. The family also has a 2 year old daughter who was born with SCID. What advice could you offer the parent?

Options

- the infant boy should be fine to return to the childminder in 2-3 days - ensure the daughter does not come into contact with the son’s stools especially for at

least 7 days following vaccination - the parent should arrange for their daughter to be immunised as well, if she hasn’t

already been vaccinated

Correct answer:

- ensure the daughter does not coming into contact with the son’s stools especially for at least 7 days following vaccination

Following immunisation, the infant boy may excrete the vaccine virus in his stools (known as viral shedding). This is a potential source of transmission and immunocompromised children (such as the infant’s sister) are especially at risk and should avoid any contact with the stools.



Module 5

Question 1:

What rotavirus strain was used to develop the live attenuated vaccine Rotarix?

Options:

- G1P[8] - G2P[4] - G3P[8] - G4P[8] - G9P[8]

Correct answer:

- G1P[8]

Rotarix is live-attenuated vaccine derived from the G1P[8] rotavirus strain.

Question 2:

You are about to administer Rotarix. As you inspect the oral applicator, which of the following would lead you to discard the vaccine? Choose all that apply:

- An expiry date of 8th December 2017 and today’s date is 8th July 2017 - Small white particles in the solution - Colourless liquid

Correct answer:

- Small white particles in the solution

Upon inspection, Rotarix should appear clear, colourless and free if visible particles. The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.



Question 3:

How should Rotarix be administered?

Options:

- Subcutaneously - Intravenously - Orally - Topically

Correct answer:

- Orally

Rotarix is for oral administration only. The vaccine cannot be given via any other routes.

Question 4:

After administering Rotarix to a young infant, he/she regurgitates most of the vaccine. What should you do?

Options:

- Explain to the parent what has happened and schedule another appointment for a replacement dose a week later

- Administer a replacement dose in the same visit - Estimate how much liquid was regurgitated and administer that amount using a new

oral applicator

Correct answer:

- Administer a replacement dose in the same visit

If the infant spits or regurgitates most of the vaccine, you may administer another dose to replace the original. This may be done immediately in the same visit.



Question 5:

Can Rotarix be given at the same clinic appointment as the other age-related scheduled childhood vaccines like the DTaP/IPV/HepB-Hib?

Options

- Yes - No

Correct answer:

- Yes

Rotarix may be co-administered with the DTaP/IPV/HepB-Hib vaccine along with a number of other paediatric vaccines. Please refer to the SPC for full prescribing details.

Question 6:

At what temperature should Rotarix be stored at in the refridgerator?

Options are:

- 20-25oC (room temperature) - 15-20oC - 9-15oC - 2-8oC - -4-2oC

Correct answer:

- 2-8oC

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REFERENCES

Module 1

• Tilson L et al. Vaccine 2011; 29: 7463-7473 • Soriano-Gabarró, et al. Pediatr Infect Dis J 2006; 25: S7–11 • Patel, et al. Pediatr Infect Dis J 2007; 26: 914–9 • Guarino et al. J Paediatr Gastroenterology and Nutrition 2008; 46: 619-621



• National Institute of Health and Clinical excellence (NICE) Clinical guideline 84, 2009. Available at https://www.nice.org.uk/guidance/cg84

• World Health Organisation (WHO) 2009 Global use of rotavirus vaccines recommended. Available at http://www.who.int/mediacentre/news/releases/2009/rotavirus_vaccines_20090605/en/ and http://www.who.int/immunization/newsroom/newsstory_rotavirus_vaccines_immunization_programmes/en/

• UK Green Book, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457263/Green_Book_Chapter_27b_v3_0.pdf

• Prevention of rotavirus gastroenteritis among infants and children, Recommendations of the ACIP. MMWR, February 6, 2009, Vol 58, #RR-02; Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm

• Statement of the German Standing Committee on Vaccination at the RKI. Recommendations of the Standing Committee on Vaccination (STIKO) at the Robert Koch Institute/Effective: August 2015, available on http://www.rki.de/EN/Content/infections/Vaccination/recommandations/34_2015_engl.pdf?__blob=publicationFile

• National immunisation guidelines for Ireland, Rotavirus chapter, available on www.immunisation.ie accessed July 2016

Module 2

• Iturriza-Gomara M and Gray J. EuroRotaNet 5th year report • Ansari SA et al. J Clin Microbiology 1988; 26(8): 1513-1518 • Ansari SA et al. Applied and Environmental Microbiology 1989; 55(12): 3113-3118 • HPSC Factsheet on rotavirus, http://www.hpsc.ie/A-Z/Gastroenteric/Rotavirus/Factsheet/ accessed July

2016 • HPSC/CIDR: Seasonal distribution of rotavirus notifications from 2012 to 2015 • National immunisation guidelines, Rotavirus Chapter,

http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter19.pdf accessed July 2016 • American Academy of Pediatrics (AAP) committee on infectious diseases. Pediatrics 2007; 119(1): 171-

181 • D’Agostino J. Clinical Pediatrics 2006; 45: 203-212 • CDC Pink Book Rotavirus Chapter, http://www.cdc.gov/vaccines/pubs/pinkbook/rota.html accessed July

2016

Module 3

• Rotarix Summary of Product Characteristics, available on http://www.medicines.ie/medicine/15020/SPC/Rotarix+oral+suspension+in+pre-filled+oral+applicator/ accessed July 2016

• National immunisation guidelines, Rotavirus Chapter, http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter19.pdf accessed July 2016

• Vesikari T et al. Lancet 2007; 370: 1757-1763 • Phua KB et al. Vaccine 2009; 27: 5936-5941 • De Vos B et al. Pediatr Infect Dis J 2009; 28: 261-266

Module 4

https://www.nice.org.uk/guidance/cg84�

http://www.who.int/mediacentre/news/releases/2009/rotavirus_vaccines_20090605/en/�

http://www.who.int/immunization/newsroom/newsstory_rotavirus_vaccines_immunization_programmes/en/�

http://www.who.int/immunization/newsroom/newsstory_rotavirus_vaccines_immunization_programmes/en/�

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457263/Green_Book_Chapter_27b_v3_0.pdf�

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457263/Green_Book_Chapter_27b_v3_0.pdf�

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm�

http://www.rki.de/EN/Content/infections/Vaccination/recommandations/34_2015_engl.pdf?__blob=publicationFile�

http://www.rki.de/EN/Content/infections/Vaccination/recommandations/34_2015_engl.pdf?__blob=publicationFile�

http://www.immunisation.ie/�

http://www.hpsc.ie/A-Z/Gastroenteric/Rotavirus/Factsheet/�

http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter19.pdf%20accessed%20July%202016�

http://www.cdc.gov/vaccines/pubs/pinkbook/rota.html�






• Great Ormond Street Hospital (GOSH) for Children NHS Foundation 2012. Intussusception. Available at http://www.gosh.nhs.uk/medical-information-0/search-medical-conditions/intussusception accessed June 2016

• Kombo LA et al. Pediatrics 2001; 108: e37

Module 5


• National immunisation guidelines, Rotavirus Chapter, http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter19.pdf accessed July 2016

Rotarix oral suspension in pre-filled oral applicator. Rotavirus vaccine live.

(Please refer to SmPC before prescribing)

Composition: Each 1.5 ml dose of oral suspension contains human rotavirus RIX4414 strain (live, attenuated* not less than 106.0 CCID50. * Produced on Vero cells. Active excipient: sucrose 1073 mg. Therapeutic indications: Active immunisation of infants aged 6 to 24 weeks for prevention of gastro-enteritis due to rotavirus infection. Use should be based on official recommendations. Posology: The vaccination consists of two 1.5 ml oral doses. The first dose may be administered from the age of 6 weeks and there should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by age of 24 weeks. It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix as there are no safety, immunogenicity or efficacy data when Rotarix is administered with another rotavirus vaccine. Method of administration: Oral use only. Contraindication: Hypersensitivity to active substance or any excipients, or to previous rotavirus vaccination. History of intussusception. Uncorrected congenital malformation of GIT that would predispose to intussusception. Severe Combined Immunodeficiency Disorder (SCID). Postpone in subjects with or suffering from diarrhoea or vomiting. Special warnings and precautions for use: Caution in infants with gastrointestinal illnesses or growth retardation. Follow-up on any symptoms of intussusception ( e.g. severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) and advise parents/guardians to promptly report such symptoms to their healthcare provider. Administer to infants with known or suspected immunodeficiency with caution and also to infants with immunodeficient close contacts e.g. patients with malignancies, or otherwise immunocomprised. Contacts of recent vaccines should wash their hand after changing child’s nappies. The potential risk of apnoea and for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation to infants born ≤ 28 weeks gestation and particularly for those with a previous history of respiratory immaturity. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this vaccine. Interactions: No clinically relevant interactions. Pregnancy & Lactation: Not intended for use in adults. Undesirable effects: The most commonly reported adverse events are diarrhoea and irritability with a frequency classified as common (≥1/100 to <1/10). Other reported events include:


http://www.gosh.nhs.uk/medical-information-0/search-medical-conditions/intussusception�





Abdominal pain, flatulence, and dermatitis (uncommon ≥1/1000 to <1/100), Intussusception (very rare <1/10, 000) and Gastoenteritis with vaccine viral shedding in infants with SCID, and Apnoea in infants ≤ 28 weeks of gestation (frequency unknown.) Legal Category: POM A. Marketing Authorisation(MA) Number: EU/1/05/330/005-8. MA Holder: GlaxoSmithKline Biologicals s.a., Rue de l’Institut 89, B-1300 Rixensart, Belgium. Further information is available from: GlaxoSmithKline (Ireland) Ltd., 12 Riverwalk, Citywest Business Campus, Dublin 24. Tel: 01 4955000. Code: IE/ROT/0002/16. Date of preparation: April 2016.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

For Healthcare Professionals registered in Ireland

Rotavirus Online Training Module

Date created August 2016

IE/ROT/0017/16a

http://www.hpra.ie/�

module 1 - gskpro.com file- there is no national surveillance system in place to collect and monitor...

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