MultiHance (Page 7 of 7)

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued 04/2018COEB403
MEDICATION GUIDE MULTIHANCE® (məl-tē-han(t)s) (gadobenate dimeglumine) Injection for intravenous use
What is MULTIHANCE?
  • MULTIHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA). MULTIHANCE, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
  • An MRI exam with a GBCA, including MULTIHANCE, helps your doctor to see problems better than an MRI exam without a GBCA.
  • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.
What is the most important information I should know about MULTIHANCE?
  • MULTIHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
  • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
  • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
  • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
  • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
  • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive MULTIHANCE.
Do not receive MULTIHANCE if you have had a severe allergic reaction to GBCAs including gadobenate dimeglumine, or any of the ingredients in MULTIHANCE.
Before receiving MULTIHANCE, tell your healthcare provider about all your medical conditions, including if you:
  • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
  • are pregnant or plan to become pregnant. It is not known if MULTIHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as MULTIHANCE is received during pregnancy
  • have kidney problems, diabetes, or high blood pressure.
  • have had an allergic reaction to dyes (contrast agents) including GBCAs
What are the possible side effects of MULTIHANCE?
  • See “What is the most important information I should know about MULTIHANCE?”
  • Allergic reactions. MULTIHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.
The most common side effects of MULTIHANCE include: nausea, headache, feeling hot, or burning at the injection site. These are not all the possible side effects of MULTIHANCE.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of MULTIHANCE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about MULTIHANCE that is written for health professionals.
What are the ingredients in MULTIHANCE?Active ingredient: gadobenate dimeglumineInactive ingredients: water Manufactured by: BIPSO GmbH-78224 Singen (Germany)Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831US Patent No. 4,916,246For more information, go to www.imaging.bracco.com or call 1-800-257-5181.

MultiHance® Injection 15 mLNDC 0270–5164–14

multihance-carton
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multihance-15-ml-vial-label
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MULTIHANCE gadobenate dimeglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0270-5164
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
gadobenate dimeglumine (GADOLINIUM CATION (3+)) gadobenate dimeglumine 529 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0270-5164-12 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (0270-5164-12)
2 NDC:0270-5164-13 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
2 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (0270-5164-13)
3 NDC:0270-5164-14 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
3 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (0270-5164-14)
4 NDC:0270-5164-15 5 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
4 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (0270-5164-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021357 11/23/2004
Labeler — BRACCO DIAGNOSTICS INC (849234661)
Registrant — BRACCO DIAGNOSTICS INC (849234661)
Establishment
Name Address ID/FEI Operations
BRACCO IMAGING SPA 434384007 API MANUFACTURE (0270-5164)
Establishment
Name Address ID/FEI Operations
BIPSO GmbH 342104149 MANUFACTURE (0270-5164), ANALYSIS (0270-5164)
Establishment
Name Address ID/FEI Operations
Labor LS SE & Co. KG 314929072 ANALYSIS (0270-5164)
Establishment
Name Address ID/FEI Operations
PATHEON ITALIA SPA 434078638 MANUFACTURE (0270-5164), ANALYSIS (0270-5164)
Establishment
Name Address ID/FEI Operations
BioChem Labor für biologishe und chemische Analytik GmbH 318354230 ANALYSIS (0270-5164)

Revised: 10/2020 BRACCO DIAGNOSTICS INC

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