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Magnevist (Gadopentetate Dimeglumine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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).

DOSAGE AND ADMINISTRATION

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.

DOSE AND DURATION OF MAGNEVIST INJECTION BY BODY WEIGHT
BODY WEIGHT Total Volume, mL 1
lb kg
22 10 2
44 20 4
66 30 6
88 40 8
110 50 10
132 60 12
154 70 14
176 80 16
198 90 18
220 100 20
242 110 22
264 120 24
286 130 26

1 Rate of Injection: 10 mL/15 sec

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.

HOW SUPPLIED

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

5 mL single-dose vials (RFID), rubber stoppered, in individual cartons,
Boxes of 20 NDC 50419-188-40

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

10 mL single-dose vials (RFID), rubber stoppered, in individual cartons,
Boxes of 20 NDC 50419-188-42

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

10 mL pre-filled disposable syringe (RFID),
Boxes of 5 NDC 50419-188-43

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

15 mL single-dose vials (RFID), rubber stoppered, in individual cartons,
Boxes of 20 NDC 50419-188-44

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

15 mL pre-filled disposable syringe (RFID),
Boxes of 5 NDC 50419-188-45

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

20 mL single-dose vials (RFID), rubber stoppered, in individual cartons,
Boxes of 20 NDC 50419-188-46

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

20 mL pre-filled disposable syringe (RFID),
Boxes of 5 NDC 50419-188-47

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.

U. S. Patent Nos. 5,362,475; 5,560,903 and, 5,876,695 relate to this product

Manufactured for:
Bayer HealthCare Pharmaceuticals Inc
Wayne, NJ 07470

Manufactured in Germany

2009, Bayer HealthCare Pharmaceuticals Inc., All Rights Reserved.

May 22, 2009

6703002

The following are representative examples of Magnevist labeling. See the "How Supplied" section for a complete listing of all components.

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