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Omniscan

Omniscan

Manufacturer:

A. Menarini

Distributor:

Zuellig
Concise Prescribing Info
Contents
Gadodiamide
Indications/Uses
Contrast medium for cranial & spinal MRI & for general MRI of the body after IV administration. Evaluation of CAD by myocardial perfusion imaging MRI.
Dosage/Direction for Use
Adult & childn CNS 0.1 mmol/kg (equiv to 0.2 mL/kg) up to 100 kg. Above 100 kg body wt, 20 mL is usually sufficient. Adult Equivocal scans A 2nd bolus inj of 0.2 mmol/kg (equiv to 0.4 mL/kg) may be of additional diagnostic value when administered w/in 20 min of the 1st inj (0.1 mmol/kg). Suspected brain metastases 0.3 mmol/kg (equiv to 0.6 mL/kg), can be administered up to 100 kg & as a bolus IV inj. Above 100 kg body wt, 60 mL is usually sufficient. Whole body 0.1 mmol/kg (equiv to 0.2 mL/kg) or occasionally 0.3 mmol/kg (equiv to 0.6 mL/kg) up to 100 kg. Above 100 kg body wt, 20 mL or 60 mL, respectively, is usually sufficient. Angiography 0.1 mL/kg (equiv to 0.2 mL/kg). In cases of stenosis of abdominal & iliac arteries, a higher dosage of up to 0.3 mmol/kg (equiv to 0.6 mL/kg) has been shown to provide additional diagnostic information. Mammography 0.1-0.2 mmol/kg (equiv to 0.2-0.4 mL/kg). Above 100 kg body wt, 20-40 mL is usually sufficient. CAD Cardiac perfusion: 0.15 mmol/kg (equiv to 0.3 mL/kg) given as 2 separate doses of 0.075 mmol/kg (equiv to 0.15 mL/kg) administered w/in an interval of ≥10 min. Evaluation of late enhancement: 0.15 mmol/kg total dose. Childn from 6 mth Whole body 0.1 mmol/kg (equiv to 0.2 mL/kg).
Contraindications
Hypersensitivity. Severe renal impairment (GFR <30 mL/min/1.73 m2), &/or acute kidney injury. Neonates up to 4 wk.
Special Precautions
Possibility of serious, life-threatening, fatal, anaphylactoid or CV reactions or other idiosyncratic reactions especially in patients w/ known clinical hypersensitivity or history of asthma or other allergic resp disorders. Not to be used intrathecally. Screen all patients for renal dysfunction by obtaining lab tests prior to administration. Reports of nephrogenic systemic fibrosis in patients w/ chronic severe renal impairment &/or acute kidney injury. Administration should not be repeated unless the interval between inj is at least 7 days. Trace amounts of gadolinium may be retained in the brain (particularly in dentate nucleus & globus pallidus), & in other tissues. Rare reports of pathologic skin changes including gadolinium-associated plaques & post-marketing reports of adverse events involving multiple organ systems in patients w/ normal renal function. Use lowest effective dose & perform careful benefit-risk assessment before administering repeated doses. Increased likelihood of convulsions during exam in patient suffering from epilepsy or brain lesions. May interfere w/ serum Ca measurements using some colorimetric (complexometric) methods; do not use such methods for 12-24 hr after administration of Omniscan. Pregnancy & lactation. Paed patients, infants up to 1 yr.
Adverse Reactions
Hypersensitivity, including anaphylactoid reactions, anaphylactic/anaphylactoid shock; anxiety; taste alteration, headache, dizziness, convulsions, paraesthesia, tremor, somnolence, transient parosmia; visual disturbance; tachycardia; dyspnoea, coughing, bronchospasm, resp distress, throat irritation, sneezing; flushing; nausea, vomiting, diarrhea; nephrogenic systemic fibrosis, pruritus, face oedema, angioedema, urticaria, rash, skin plaque; arthralgia; acute kidney injury, increased blood creatinine (in patients w/ pre-existing severe renal insufficiency); feeling hot, inj site pain, chest pain, fever, shivering.
MIMS Class
Radiographic & Diagnostic Agents
ATC Classification
V08CA03 - gadodiamide ; Belongs to the class of paramagnetic agents used as magnetic resonance imaging contrast media.
Presentation/Packing
Form
Omniscan soln for inj 287 mg/mL
Packing/Price
10 mL x 10 × 1's;20 mL x 10 × 1's
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