gadoterate meglumine
Drug Details
- Generic Name
- gadoterate meglumine
- Brand Names
- DOTAREM, Gadoterate Meglumine, CLARISCAN, gadoterate meglumine
- Application Number
- NDA204781
- Sponsor
- Guerbet LLC
- NDC Codes
- 14
- Dosage Forms
- INJECTION, INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- GADOTERATE MEGLUMINE
Indications and Usage
1 INDICATIONS AND USAGE Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated: for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. ( 1 )