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Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
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.
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.
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.
History
There is currently no drug history available for this drug.
Other Information
Magnevist® (brand of gadopentetate dimeglumine) injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). Magnevist Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.
Magnevist Injection is a 0.5-mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl] glycinato (5-) ]gadolinate(2-)(2:1) with a molecular weight of 938, an empirical formula of C28H54GdN5O20, and has the following structural formula:
Each mL of Magnevist injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid, and water for injection. Magnevist injection contains no antimicrobial preservative.
Magnevist Injection has a pH of 6.5 to 8.0. Pertinent physicochemical data are noted below:
PARAMETER |
||
Osmolality (mOsmol/kg) water) |
at 37° C |
1,960 |
Viscosity (CP) |
at 20° C |
4.9 |
at 37° C |
2.9 |
|
Density (g/mL) |
at 25° C |
1.195 |
Specific Gravity |
at 25° C |
1.208 |
Octanol: H2O Coefficient |
at 25° C, pH7 log Pow = - 5.4 |
Magnevist injection has an osmolality 6.9 times that of plasma, which has an osmolality of 285 mOsmol/kg water. Magnevist injection is hypertonic under conditions of use.
Sources
Magnevist Manufacturers
-
Bayer Healthcare Pharmaceuticals Inc.
Magnevist | Bayer Healthcare Pharmaceuticals Inc.
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
-
Bayer Healthcare Pharmaceuticals Inc.
Magnevist | Bayer Healthcare Pharmaceuticals Inc.
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
Pharmacy Bulk Package Preparation: NOT FOR DIRECT INFUSION
The Pharmacy Bulk Package contains many single doses and is used with an appropriate transfer device for filling empty sterile syringes.
a. The transfer of Magnevist Injection from the Pharmacy Bulk Package must be performed in an aseptic work area, such as a laminar flow hood, using aseptic technique. b. Once the Pharmacy Bulk Package is punctured, it should not be removed from the aseptic work area during the entire 24-hour period of use. c. The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours. d. Any unused Magnevist Injection must be discarded 24 hours after the initial puncture of the bulk package.IV tubing and syringes used to administer Magnevist Injection must be discarded at the conclusion of the radiological examination.
Any unused portion must be discarded in accordance with regulations dealing with the disposal of such material.
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