The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-baseddistinction agent (GBCA) indicated for endovenous use with resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and medicine patients (2 years older and older) to observe and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal property.
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The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.
Adult and pediatric patients: The recommended dose of Dotarem is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients. The dose is delivered by manual or power injection.