gadoteridol
gadoteridol is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including ProHance. Available dosage forms: injection, solution, powder.
Drug Details
- Generic Name
- gadoteridol
- Brand Names
- ProHance
- Application Number
- NDA021489
- Sponsor
- Bracco Diagnostics Inc
- NDC Codes
- 3
- Dosage Forms
- INJECTION, SOLUTION, POWDER
- Routes
- INTRAVENOUS
- Active Ingredients
- GADOTERIDOL
Indications and Usage
1 INDICATIONS AND USAGE ProHance Multipack is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracranial/Extraspinal Tissues ProHance is indicated for MRI in adults to visualize lesions in the head and neck.