Dotarem 0.5 mmol/mL Intravenous Injection, 20 mL Single-Dose Vial, 10 Vials/Pack

DOTAREM — 376.9 mg/mL, Injection, 10 × 20 mL vial in 1 package

DOTAREM (gadoterate meglumine) is a injection for intravenous use. DOTAREM 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. Supplied as 10 × 20 mL vial in 1 package; NDC 67684-2001-3; manufacturer Guerbet LLC. Rx only. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)]. Pre-filled syringes must not be frozen. Frozen syringes should be discarded.

• Active ingredient or product type: GADOTERATE MEGLUMINE
• Strength/concentration: 376.9 mg/mL
• Dosage form and route: Injection, Intravenous
• Exact package presentation: 10 × 20 mL vial in 1 package
• NDC/item number: 67684-2001-3
• Manufacturer/labeler: Guerbet LLC
• Storage/handling: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)]. Pre-filled syringes must not be frozen. Frozen syringes should be discarded.
• Status: Rx only

Important safety information: Hypersensitivity Reactions: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.