Generic Name and Formulations:
Gadoterate meglumine 0.5mmol/mL (376.9mg/mL); soln for IV inj.
Indications for DOTAREM:
For use in MRI to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity in brain (intracranial), spine and associated tissues.
Adults and Children:
0.1mmol/kg (0.2mL/kg) given as an IV bolus at a rate of 2mL/sec (adults) or 1–2mL/sec (neonates/children), followed by a normal saline flush (to ensure complete injection). Weight based dosing: see full labeling.
Increased risk of nephrogenic systemic fibrosis in patients with chronic, severe renal impairment (GFR<30mL/min/1.73m2) or acute kidney injury. Screen for acute kidney injury and other conditions that may reduce renal function. Patients at risk for chronically reduced renal function (eg, >60yrs, diabetes mellitus, chronic hypertension), estimate the GFR by lab testing. Use lowest dose necessary. Do not exceed recommended dose; allow sufficient period of time for elimination prior to re-administration. History of a reaction to contrast media, bronchial asthma and/or allergic disorders. Monitor for signs/symptoms of hypersensitivity reactions. Have resuscitative equipment available. Avoid extravasation. Pregnancy. Nursing mothers.
Paramagnetic contrast agent (Gadolinium-based).
Nausea, headache, inj site pain, inj site coldness, rash; acute kidney injury, hypersensitivity reactions.
Single-dose vials (5mL, 10mL, 15mL, 20mL)—10; Pre-filled syringes (10mL, 15mL, 20mL)—5
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