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Omniscan Generic Name & Formulations
Legal Class
Rx
General Description
Gadodiamide 287mg/mL; soln for IV inj; preservative-free.
Pharmacological Class
Gadolinium-based contrast agent.
How Supplied
Vials (5mL, 10mL, 15mL, 20mL)—10; Prefilled syringes (10mL, 15mL, 20mL)—10; Prefill Plus needle-free system (15mL, 20mL)—10 (prefilled syringe + sodium chloride 0.9% inj flush syringe)
Manufacturer
Omniscan Indications
Indications
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.
Omniscan Dosage and Administration
Adults and Children
<2yrs: not established. Give as a bolus IV inj, followed by 5mL normal saline flush to ensure complete injection. ≥2yrs: CNS: 0.2mL/kg (0.1mmol/kg). Kidney: 0.1mL/kg (0.05mmol/kg). Intrathoracic (noncardiac), intra-abdominal, pelvic cavities: 0.2mL/kg (0.1mmol/kg).
Omniscan Contraindications
Contraindications
Chronic, severe kidney disease (GFR <30mL/min/1.73m2). Acute kidney injury.
Omniscan Boxed Warnings
Boxed Warning
Not for intrathecal use. Nephrogenic systemic fibrosis (NSF).
Omniscan Warnings/Precautions
Warnings/Precautions
Not for intrathecal use; may cause convulsions, coma, sensory and motor neurologic deficits. Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury (see Contraindications). Screen for renal dysfunction. Do not exceed recommended dose and allow sufficient time for drug elimination before re-administration. Have emergency resuscitative equipment available. History of asthma or other allergic disorders. Monitor for signs/symptoms of hypersensitivity reactions during and up to several hrs after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Renal impairment: use lowest effective dose. Avoid extravasation. Interpreting Omniscan MRI scans without a companion non-contrast MRI. Elderly. Pregnancy. Nursing mothers.
Omniscan Pharmacokinetics
See Literature
Omniscan Interactions
Interactions
Interferes with serum calcium measurements with some colorimetric methods.
Omniscan Adverse Reactions
Adverse Reactions
Nausea, headache, dizziness; cardiac failure, arrhythmia, MI, hypersensitivity reactions.
Omniscan Clinical Trials
See Literature
Omniscan Note
Not Applicable
Omniscan Patient Counseling
See Literature
