Contrast Media Product Portfolio

Contrast Media Product Portfolio

50ml & 100ml

50ml & 100ml

10ml & 20ml

30ml & 100ml

Gadopentetate Dimeglumine Injection

TM

Iohexol Contrast Agent

Iohexol Contrast Agent

Core ValuesAs an organization we are driven by a desire to Improve human life at an affordable cost,Achieve scientific excellence and innovation,Operate with highest standards of ethical integrity.Provide superior quality & employ a diverse workforce that values collaboration.

We specialize in Design & Development of minimally Invasive Therapeutic Devices.We have in-house R&D facility combined with industry's most sort after work force.Our marketing team thrives to become a market leader by providing minimally invasive devices with superior product quality.

Nano Science for Innovative Therapies

CapabilitiesManufacturingQuality Control & Quality AssuranceRegulatoryResearch & DevelopmentPre-Clinical & ClinicalMarketing

Excelscan 350Excelscan 300PARAMETERS

300

0.67

11.8

6.3

1.345

50ml, 100ml

350

0.84

20.4

10.4

1.404

50ml, 100ml

Iohexol Contrast AgentIohexol Contrast Agent

ES 350050

ES 350100

350mg - 50ml

350mg - 100ml

ES 300050

ES 300100

300mg - 50ml

300mg - 100ml

Bronchospasm, angioneurotic ocedema and cardiovascular collapse may occur but these are rare. Acute pulmonary oedema may result from administration of any hyperosmolar agent to patients with poor cardiac function. Contrast agents may induce a variety of cardiac dysrhythmias, in particular, they may reduce the threshold for ventricular fibrillation. After myelography, headache is common and nausea, vomiting and dizziness are most frequent adverse reactions. Good hydration of the patient must be encouraged both before and after exami.

Indications :

Lumbar, thoracic, cervical & total columnar myelography, CNS & CT scanning, Angiography, Peripheral venography, Excretion urography, Antegrade and retrograde pyelograph, Contrats enhancement of CT scans, Direct cholangiography, Splenopostgraphy, Hysterosalpingogrophy, Arthrography, Gastrointestinal studies.

Dosage :

Depends on the type and technique of investigation but usually ranges from 5-250 ml.

Contraindications :

Previous adverse reaction to lohexol or other iodinated radiological contrast agents, allergy to other drugs, asthma and atopy, poor cardiac function, impaired renal function, myeloma and waldenstrom’s macroglobulinemia, sickle cell disease, suspected cerebral infarct, phaeochromocytoma, pregnancy, a history of epilepsy if use in the subarachnoid space is contemplated.

Special Precautions :

Severe cardiovascular disease, renal impairment, myelomatosis, phaeochromocytoma, sickle cell disease, poor general health, chronic alcoholism, multiple sclerosis, bronchial asthma, diabetes, epilepsy, dehydration, elderly, pregnancy, lactation, children, neonates.

Iohexol Contrast AgentIohexol Contrast Agent

Adult Paediatric*

Adult Paediatric*

Adult Paediatric*

A Paramagnetic Contrast Medium for use in MRI

# Excluding Heart* Paediatric : 2 Years of age and older offers broadest range of adult & paediatric indications (CNS, HEAD, NECK & BODY) of any MRI contrast agent

10 ml & 20 mlGadopentetate Dimeglumine Injection

TM

Concentration

pH

Viscosity (mPa*)s)@37ºC

Viscosity (mPa*)s)@20ºC

Osmolality (mOsm/g H2O) 37ºC

469 mg / ml

6.5 - 8.0

2.9

4.9

1.96

Composition

10 ml & 20 ml

ADVERSE REACTIONS

Cardiovascular : Hypotension, vasodilation, pallor, phlebitis, nonspecific ECG changes, substemal pain, angina.

GNS: headache, dizziness, agitation, paresthesia, tinnitus, visula field defect, convulsions, hyperesthesia.

Gastrointestinal : nausea, vomiting, gastrointestinal distress, stomach pain, thirst, increased salivation, taste abnormality.

Respiratory : dry mouth, throat irritation, rhinorrhea, wheezing, sneezing, laryngismus, cough, dyspnea/apnea.

Cutaneous / Mucous Membranes : rash, sweating, urticaria, pruritus.

Miscellaneous : injection site discomfort (coldness, burning, warmth, pain), toothache, generalized wealkness, fever,

localized edema, tiredness, anaphylactoid reactions (characterized by cardiovascular, respiratory and cutaneous symptoms),

conjunctivitis.

Each ml injection contains 469 mg (0.5 mol/l) gadopentetc acid dimeglumine salt in aqueous solution.

COMPOSITION

INDICATIONSBrain Lesions MRI

is indicated in adults and children 2 years of age and older to provide contrast enhancement during magnetic

resonance imaging (MRI) of intracranial lesions with abnormal vascularity or those supected of causing an abnormality in

the bold-brain barrier. enhanced MRI helps in the diagnosis and characterization of neoplastic disease,

acoustic neuroma, subacute infarction, inflammatory disease, certain vascular abnormalities and certain demyelinating

abnormalities (e.g., multiple sclerosis). is used in magnetic resonance (MR) studies to help differntiate changes

that occur secondary to brain tumor resection (e.g., encephalomalacia, gliosis) or to postoperative irradiation or chemotherapy

(e.g., edema, is chemia, demyelination, necrosis) from changes that represent residual or recurrent tumors to accurately

assess treatment results. MRI with is particularly useful in patients with normal unenchanted studies who have

central nervous system (CNS) symptoms, in patients with CNS tumors that are difficult to separate from surrounding edema

and in patients who have undergone surgery to differentiate recurrence of the lesions from postoperative changes. In

patients with suspected meningitis, enhanced MRI may be particularly useful in defining the active inflammatory

process of the meninges and focal lesions.

is indicated in adults to improve lwsion contrast during MR body imaging (excluding the heart) in the evaluation of

suspected hepatic lesions, endornetrial or cervical carcinomas or pelvic masses, breast lesions (suspected or known), and

musculoskeletal lesions. MRI of the breast is also used in patients with postoperative scarring and silicon implants to exclude

or demonstrate

Whole Body MRI

is indicated in adults and children 2 years of age and older to provid contrast enhancement and facilitate visualization

of lesions in the spine and associated tissues. provides enhanced contrast of epidural abscesses, which makes it

possible to differentiate them from adjacent compressed thecal sac. lt facilitates the diagnosis of disk space infection and

osteomyelitis. lt helps localize portions of paraspinal masses most likely to yield a positive percutaneous biopsy and it helps distinguish active spinal infections from those that have responded adequately to antibiotic therapy.

Spinal Lesions MRI

MRI with may be useful in differentiating postoperative epidural fibrosis (scar tissue) from recurrent disk herniation

in patients with symptoms of failed back surgery syndrome to avoid unnecessary and possibly damaging reoperation if scar

tissue is the cause.

coronary artery reperfusion after thrombolysis.

Cardiac MRI

enhanced MRI is used in the evaluation of patients with great vessel disease (e.g., aortic aneurysm,

aortic dissection, congenital abnormalities, vena cava obstrugtion): in patients with ischemic cardiac disease to examine

the heart for regions of wall thinning and intracardiac thrombus to assess chamber size, myocardial mass, wall motion,

and wall thickening and to detect regions of acute infarction; and in patients with congenital heart disease to evaluate

malrotations of the heart and for post-surgery assessment.Also, enhanced MRI helps in the assessment of

To ensure complete injection of the contrast medium the injection should be followed by a 5m 1 normal saline flush If strong clinical suspicion of an intracranial or intraspinal lesion persists despite a normal MRI scan the diagnostic yield oft the examination may be giving another injection of equivalent. to the original total dose within 30 minutes and performing MRI again.

General instructionsDOSAGE AND ADMINISTRATION :

1. Patient should be on fast for at least 2 hrs before the examination.2. The drug is given as bolus injection and can be followed by contrast enhanced MRI3. should not be drawn into the syringe until immediately before use. Any unused portion must be discarded on completion of the procedure.

4. The patient should be in supine position while administering the injection and should be kept under supine position for at least half an hour after the injection. 5. Do not use the solution if it is discoloured or particulate matter is present.

6. The imaging procedure should be completed within 1 hour since optimal contrast is generally observed in cranial investigations within 27 minutes following injection of and in spinal investigations during the early post administration phase (10 to 30 minutes). The following dosage guidelines apply to dults and children (above 2 years). 7. Recommended Dose: 0.2 ml / kg b.w. (0.1 mmol / kg. b.w.).8. Route of Administration : IV. (into a large vein, if possible).9. Rate of Administration : 10 ml / minute or as a bolus injection at 10 ml / i 5 seconds.10. Maximum Toatal Dose : 20 ml.

PRECAUTIONS

General

is to be administered strictly by i.v. injection. It will cause tissue irritation and pain if administered

extravascularly or if it leaks interstitially.

A sweet taste may be experienced briefly by patients receiving a bolus injection of iv. Pregnancy / Reproduction

Pregnancy.

Adequate and well-controlled studies in humans have not been done. Although there if no evidence that the magnetic

and electric fields associated with MRI have an effect on human development, in vitro studies and theoretical predictions

raise concern regarding the risk of exposure to MR to the developing. embryo and foetus. More studies are needed to

establish the safety of MRI in pregnant patients.

Studies in rats with at doses 2.5 times and in rabbits at doses 7.5 & 12.5 times the human dose have shown that

this agent causes slight ret ardation in development.

Breast-feeding

Problems in humans have not been documented. Since is distributed in small amounts into breast milk,

temporary discontinuation of breast-feeding should be considered for at least 24 hours following its administration.

CONTRAINDICATIONS :

Store at controlled room temperature 20°C to 30°C. Do not freez e. Protect from direct sunlight, Inspect container for particulate matter before use. Discard unused portion.

STORAGE :

1. should not be administered to patients with known or suspected hypersensitivity to Gadopentetate Dimeglumine.2. Renal failure3. Sickle cell anaemia.

Systemic consequences of overdose with have not been reported.

OVERDOSAGE :

Available Packing Information:

Gadopentetate Dimeglumine Injection

TM

Presentation

10

20

TM

TM

Gives Quality Contrast

High Fluidity

Enters easily through narrowest passages of G. I. Tract

Well tolerated by tissues

Patient is not endangered even in case of Intestinal obstruction,

Pyloric stenosis or due to leakage of contrast medium

Primarily Indicated in, - Computerised Tomography for abdomen

- Visualization of G. I. Tract

30ml & 100ml

FlavouredFlavouredFlavoured

Flavou

red

Flavou

red

Flavou

red

30ml & 100ml

Amber glass bottle of 30 ml & 100 ml

Presentation :

Therapy of meconium ileus :

Rectal administration :

For adult patients the contrast medium should be diluted with 3-4 times its volume of water. In general, unlike a barium sulphate enema, not more than 500 ml of this dilute OscanD solution is required.

In the presence of uncomplicated meconium ileus advantage is taken of the high osmotic pressure of OscanD: the surrounding tissue is forced to release considerable amounts of fluid, which then flows into the gut and dissolves the hardened meconium.

Contra-indications :

Further indications :

Indications :

Composition :OscanD OscanD contains Sodium Diatrizoate. 1ml contains Sodium Diatrizoate 417.0 mg in aqueous solution plus flavoring abd a wetting agent (Iodine Content 249.64 mg/ml).

OscanD is indicated in cases where the use of barium is not suitable specially for the threatening perforations (peptic ulcers, diverticulum), suspected partial or complete stenosis acute haemorrhage, other acute conditions for which are likely to require surgery, after resection of the stomach or intestine (danger of perforation or leak), megacolon, visualisation of a foreign body or tumour before endoscopy, visualisation of a gastrointestinal fistula before endoscopy.

Early diagnosis of a radiologically undetectable perforation or anastomatic defect in the oesophagus. The treatment of uncomplicated meconium ileus, Computerised tomography in the abdominal region.

Manifest hyperthyroidism. Not to be administered to patients who are hypersensitive to iodine. Pregnancy and lactation, as safety has not been established.

Dosage & Directions of use-Computerised tomography (CT) :

The examination can be made after the administration of 600 ml of diluted OscanD solution (30 ml / 600 ml water) and 200 ml each administered to patient at OscanD 1.5 hr. 1 hr and 30 min. before start of procedure or 30 ml, 40 ml diluted to OscanD1 L with water and administered orally prior to start of procedure.

Benefits :Use of offers many benefits compared to Barium sulphate. Patient endangered OscanDeven in case of intestinal obstruction or pyloric stenosis or due to leakage of contrast media due to perforations. Even if enters peritoneal cavity, the same is removed OscanD easily by suction and does pose any problem during surgery. Fluidity of is OscanD useful in cases of partial stenosis as contrast enters easily through narrowest passages and render the visible. Unlike barium it dose not convert partial block into complrte block. Site oft haemorrhage can be easily visualized with is well OscanD. OscanD tolerated by the tissues and hence it is a ideal contrast medium for visualization of gastrointestinal fistulas.

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For Further Information Please Write to :

NANO THERAPEUTICS PVT. LTD.Plot No. D-54/2, Hojiwala Industrial Estate, Road No. 23, Near Gate No. 3, Sachin Palsana Highway, Sachin, Surat-394 230, Gujarat, India.Tel: +91-261- 6450898, 6450853Fax: +91-261- 2392444info@nano-therapeutics.netSales@nano-therapeutics.netwww.nano-therapeutics.net

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