Magnevist

DRUG DESCRIPTION

MAGNEVIST® (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 (gadopentetate dimeglumine) Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.

MAGNEVIST (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® (gadopentetate dimeglumine) Structural Formula Illustration

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 (gadopentetate dimeglumine) Injection contains no antimicrobial preservative.

MAGNEVIST (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 at 25° C and pH7 log Pow= - 5.4

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

What are the possible side effects of gadopentetate dimeglumine (Magnevist)?

Some of the side effects of gadopentetate dimeglumine can occur up to 24 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • urinating more or less than usual, or not at all;
  • feeling light-headed, fainting;
  • skin changes...

Read All Potential Side Effects and See Pictures of Magnevist »


Magnevist Patient Information Including Side Effects

Brand Names: Magnevist

Generic Name: gadopentetate dimeglumine (Pronunciation: gad oh PEN te tate dye MEG loo meen)

  • What is gadopentetate dimeglumine (Magnevist)?
  • What are the possible side effects of gadopentetate dimeglumine (Magnevist)?
  • What is the most important information I should know about gadopentetate dimeglumine (Magnevist)?
  • What should I discuss with my health care provider before receiving gadopentetate dimeglumine (Magnevist)?
  • How is gadopentetate dimeglumine used (Magnevist)?
  • What happens if I miss a dose (Magnevist)?
  • What happens if I overdose (Magnevist)?
  • What should I avoid after receiving gadopentetate dimeglumine (Magnevist)?
  • What other drugs will affect gadopentetate dimeglumine (Magnevist)?
  • Where can I get more information?

What is gadopentetate dimeglumine (Magnevist)?

Gadopentetate dimeglumine is a contrast agent. Gadopentetate dimeglumine produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadopentetate dimeglumine is used to help diagnose certain disorders of the heart, brain, blood vessels, and spinal tissues.

Gadopentetate dimeglumine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of gadopentetate dimeglumine (Magnevist)?

Some of the side effects of gadopentetate dimeglumine can occur up to 24 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • urinating more or less than usual, or not at all;
  • feeling light-headed, fainting;
  • skin changes where the injection was given; or
  • fast, uneven heart rate.

Less serious side effects may include:

  • headache, dizziness, anxiety;
  • nausea, vomiting, loss of appetite;
  • increased thirst;
  • chills;
  • numbness or tingly feeling;
  • cold feeling, warmth, pain, or burning where the injection was given; or
  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gadopentetate dimeglumine (Magnevist)?

Gadopentetate dimeglumine can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:

  • burning, itching, swelling, and tightening or hardening of your skin;
  • muscle weakness;
  • pain or stiffness in your arms, hands, legs, or feet;
  • deep bone pain in your ribs or your hips;
  • yellow patches on the whites of your eyes; or
  • skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadopentetate dimeglumine.

Tell your doctor if you have liver disease, a seizure disorder, sickle cell or hemolytic anemia, a history of stroke or blood clots, a recent head or brain injury, asthma or allergies, or if you are on dialysis.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

Some of the side effects of gadopentetate dimeglumine can occur up to 24 hours after you have received the medication.

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