Generic Name and Formulations:
Gadodiamide 287mg/mL; soln for IV inj.
Indications for OMNISCAN:
For use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. For use in MRI to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.
CNS: 0.2mL/kg given as a bolus IV inj. Kidney: 0.1mL/kg. Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.2mL/kg.
CNS: 2–16yrs: 0.2mL/kg given as a bolus IV inj. Kidney: 0.1mL/kg. Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.2mL/kg.
Chronic, severe renal disease (GFR <30mL/min/1.73m2) or acute kidney injury.
Not for intrathecal use; may cause convulsions, coma, sensory and motor neurologic deficits. Increased risk for nephrogenic systemic fibrosis in patients with impaired elimination of gadolinium-based contrast agents (see full labeling). Screen for acute kidney injury and other conditions that reduce renal function. Acute renal failure possible in patients with renal insufficiency within 48hrs of injection; use lowest possible dose and evaluate renal function. Do not exceed recommended dose; allow sufficient period of time for elimination prior to re-administration. History of asthma/allergy disorders. Anaphylactoid reactions possible; have emergency equipment available. Monitor for hypersensitivity during and for several hours post-inj; discontinue if occurs. Pregnancy (Cat.C). Nursing mothers.
Interferes with serum calcium measurements with some colorimetric methods. May affect MRI.
Gadolinium-based contrast agent.
Nausea, headache, dizziness; cardiac failure, arrhythmia, MI, anaphylaxis (may be fatal).
Vials (5mL, 10mL, 15mL, 20mL)—10; Prefilled syringe (10mL, 15mL, 20mL)—10; Prefill Plus needle-free system (15mL, 20mL)—10 (prefilled syringe + sodium chloride 0.9% inj flush syringe)
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