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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 injection 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.

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.

To ensure complete injection of Magnevist, administer 5-mL normal saline flush after the injection. The imaging procedure should be completed within 1 hour of injection of Magnevist injection.

Visually inspect for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.

Discard any unused portion in accordance with regulations dealing with the disposal of such materials.

DOSE AND DURATION OF MAGNEVIST INJECTION BY BODY WEIGHT

BODY WEIGHT

Total Volume, mL*

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

*Rate of Injection: 10 mL/15 seconds

DOSAGE FORMS AND STRENGTHS

Magnevist is a clear, colorless to slightly yellow solution containing 0.5 mmol gadopentetate dimeglumine/mL (equivalent to 469.01 mg/mL of gadopentetate dimeglumine) for intravenous use.

HOW SUPPLIED/STORAGE AND HANDLING

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 and Handling

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.

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