Generic Name and Formulations:
Gadobutrol 604.72mg/mL (1mmol/mL); soln for IV inj; preservative-free.
Indications for GADAVIST:
For use with MRI: in adults and children (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the CNS; or, to assess the presence and extent of malignant breast disease.
Adults and Children:
Give 0.1mL/kg (0.1mmol/kg) IV at a rate of 2mL/second, followed by a saline flush (to ensure complete injection).
Increased risk of nephrogenic systemic fibrosis among patients with renal impairment (eg, >60yrs, diabetes mellitus, chronic hypertension). Chronic, severe kidney disease (GFR <30mL/min/1.73m2). Acute kidney injury. Screen for renal impairment and other conditions. Do not exceed recommended dose; allow sufficient period of time for elimination prior to re-administration. History of reaction to contrast media, asthma and/or allergic disorders. Have resuscitative equipment available. Monitor for signs/symptoms of hypersensitivity reactions. Avoid extravasation. Gadavist MRI may overestimate extent of malignancy in the diseased breast up to 50% of patients. Elderly. Pregnancy (Cat.C). Nursing mothers.
Paramagnetic contrast agent (Gadolinium-based).
Do not mix with other drugs.
Headache, nausea, dizziness; nephrogenic systemic fibrosis, hypersensitivity reactions.
Single-dose vials (2mL)—15; (7.5mL, 10mL, 15mL)—20; Single-use prefilled syringes (7.5mL, 10mL, 15mL)—5
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