Gadopentetate Dimeglumine

Gadopentetate Dimeglumine

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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.

Gadopentetate Dimeglumine Manufacturers


  • Alvogen, Inc
    Gadopentetate Dimeglumine Injection [Alvogen, Inc]
  • Alvogen, Inc
    Gadopentetate Dimeglumine Injection [Alvogen, Inc]

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