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.
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What is the
most important information I should know about MULTIHANCE?
- GBCAs like MULTIHANCE may cause serious side effects including
death, coma, encephalopathy, and seizures when it is given intrathecally
(injection given into the spinal cord). It is not known if MULTIHANCE
is safe and effective with intrathecal use. MULTIHANCE is not approved
for this use.
- 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.
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| 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
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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
dimeglumine
Inactive ingredients: water
Manufactured by: BIPSO GmbH-78224 Singen (Germany)
Manufactured
for: Bracco Diagnostics Inc., Monroe Township, NJ 08831
US Patent No. 4,916,246
For more information, go to www.imaging.bracco.com
or call 1-800-257-5181. |