Central Nervous System:

MAGNEVIST Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. MAGNEVIST Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

Extracranial/ Extraspinal Tissues:

MAGNEVIST is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.

Body:

MAGNEVIST Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).

The recommended dosage of MAGNEVIST Injection is 0.2 mL/kg (0.1 mmol/ kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.

Drug Handling: To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush. The imaging procedure should be completed within 1 hour of injection of MAGNEVIST Injection.

As with other gadolinium contrast agents, MAGNEVIST Injection has not been established for use in magnetic resonance angiography.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.

MAGNEVIST Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/ mL of gadopentetate dimeglumine. MAGNEVIST Injection is supplied in the following sizes:

5 mL single- dose vials, rubber stoppered, in individual cartons, Boxes of 20 NDC 50419-188-05

10 mL single- dose vials, rubber stoppered, in individual cartons, Boxes of 20 NDC 50419-188-01

10 mLpre- filled disposable syringe, Boxes of 5 NDC 50419- 188- 36

15 mL single- dose vials, rubber stoppered, in individual cartons, Boxes of 20 NDC 50419-188- 15

15 mL pre- filled disposable syringe, Boxes of 5 NDC 50419- 188- 37

20 mL single- dose vials, rubber stoppered, in individual cartons, Boxes of 20 NDC 50419-188-02

20 mL pre- filled disposable syringe, Boxes of 5 NDC 50419- 188-38

Storage

MAGNEVIST Injection should be stored at controlled room temperature, between 15-30° C (59- 86° F) and protected from light. DO NOT FREEZE. Should freezing occur in the vial MAGNEVIST Injection should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, MAGNEVIST Injection should return to a clear, colorless to slightly yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard vial.

Manufactured for: Bayer Healthcare Pharmaceuticals., Wayne, NJ 07470. Revised May 2007. FDA rev date: 9/4/2007

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