Gadopentetate Dimeglumine label

Gadopentetate Dimeglumine

Gadopentetate Dimeglumine Recall

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Central Nervous System

Gadopentetate dimeglumine 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. Gadopentetate dimeglumine Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.

Extracranial/Extraspinal Tissues

Gadopentetate dimeglumine 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

Gadopentetate dimeglumine 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).

History

There is currently no drug history available for this drug.

Other Information

Gadopentetate dimeglumineInjection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). Gadopentetate dimeglumine Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.

Gadopentetate dimeglumine 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:

Magnevist Structural Formula

Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Gadopentetate dimeglumine Injection contains no antimicrobial preservative.

Gadopentetate dimeglumine 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

Gadopentetate dimeglumine Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/kg water. Gadopentetate dimeglumine Injection is hypertonic under conditions of use.

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Gadopentetate Dimeglumine Manufacturers

Alvogen, Inc
No Recall
Gadopentetate Dimeglumine | Alvogen, Inc
The recommended dosage of Gadopentetate dimeglumine 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 Gadopentetate dimeglumine 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 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 Gadopentetate dimeglumine Injection.
As with other gadolinium contrast agents, Gadopentetate dimeglumine 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.
Pharmacy Bulk Package Preparation: NOT FOR DIRECT INFUSION
The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.
a) The transfer of Gadopentetate dimeglumine 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 Gadopentetate dimeglumine Injection must be discarded 24 hours after the initial puncture of the bulk package.
IV tubing and syringes used to administer Gadopentetate dimeglumine 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 materials.
Alvogen, Inc
No Recall
Gadopentetate Dimeglumine | Alvogen, Inc
The recommended dosage of Gadopentetate dimeglumine 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 Gadopentetate dimeglumine 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 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 Gadopentetate dimeglumine Injection.
As with other gadolinium contrast agents, Gadopentetate dimeglumine 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.