MULTIHANCE 0.5M SOLUTION FOR INJECTION

Active substance: GADOBENATE DIMEGLUMINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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MultiHance, 0.5 M solution for injection

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Gadobenate dimeglumine

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Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
- This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

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In this leaflet:
1. What MultiHance is and what it is used for
2. Before you use MultiHance
3. How to use MultiHance
4. Possible side effects
5. How to store MultiHance
6. Further information

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1. WHAT MULTIHANCE IS AND WHAT IT IS USED FOR

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MultiHance is a special dye (or contrast agent) which contains the rare earth
metal gadolinium and improves images of the liver, brain/spine, breast and
arteries during MRI scans. It helps your doctor to identify any abnormalities of
your liver, brain/spine, breast or arteries.
This medicine is for diagnostic use only.

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MultiHance is approved for use in children above two years of age for
imaging of the brain and spine.

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2. BEFORE YOU USE MULTIHANCE

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MultiHance should only be given to you in a hospital or clinic where there are
equipment and medically trained staff able to deal with allergic reactions.

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Do not use MULTIHANCE
• If you are allergic (hypersensitive) to gadobenate dimeglumine
• If you have had any allergic reaction (hypersensitivity reaction) in the past
such as rash, itching, urticaria (hives) or difficulty in breathing following
injection of any special dye or contrast agent for a MRI scan.
Tell your doctor if you think any of the points in this section apply to you.

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Children
MultiHance should not be given to children under two years of age.

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Take special care with MULTIHANCE
Before treatment with MultiHance tell your doctor if:
• you suffer from a heart problem or have raised blood pressure
• you have a history of epilepsy or brain lesions
• you have a cardiac pacemaker, or you are aware of the presence in your
body of any other metallic objects such as clips, screws or plates as these
might interfere with the magnet of the MRI scanner
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant.

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Your doctor may decide to take a blood test to check how well your kidneys
are working before making the decision to use MultiHance, especially if you
are 65 years of age or older.

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Using other medicines
There are no reports of reactions between MultiHance and other medicines.

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Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

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Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.

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Pregnancy
You must tell your doctor if you think you are or might become pregnant as
MultiHance should not be used during pregnancy unless strictly necessary.

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Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Your
doctor will discuss whether you should continue breast-feeding or interrupt
breast-feeding for a period of 24 hours after you receive MultiHance.

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Driving and using machines
There is no information about the effects of MultiHance on driving, or using
tools or machines. Ask your doctor if you can drive and if it is safe for you to
use any tools or machines.

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Important information about some of the ingredients of MultiHance
Small quantities of benzyl alcohol (a derivative of alcohol) may be released
in the MultiHance solution during storage.
Please tell your doctor if you are allergic to benzyl alcohol.

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3. HOW TO USE MULTIHANCE

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MultiHance is injected into a vein, usually in your arm just before the MRI scan.
The amount in millilitre you will be injected depends on how much you weigh
in kilogram of body weight.

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The usual dose for MRI of the liver is: 0.1 ml per kilogram of body weight
The usual dose for MRI of brain/spine is: 0.2 ml per kilogram of body weight
The usual dose for MRI of the breast is: 0.2 ml per kilogram of body weight
The usual dose for MRI of arteries is: 0.2 ml per kilogram of body weight

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The medical staff supervising your scan will administer your injection of
MultiHance. They should ensure that the needle is correctly positioned: tell
them if you feel pain or a burning sensation at the site of the injection while
it is being administered.

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You should remain in the hospital environment for one hour after the time of
the injection.

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Dosage in special patient groups

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Impaired renal function
The use of MultiHance is not recommended in patients with severe kidney
problems and patients who have recently had, or soon expect to have, a
liver transplant. However if use is required you should only receive one dose
of MultiHance during a scan and you should not receive a second scan for
at least 7 days.

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Elderly
It is not necessary to adjust your dose if you are 65 years of age or older but
you may have a blood test to check how well your kidneys are working.

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If you have any further questions on the use of this product, ask your doctor.

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4. POSSIBLE SIDE EFFECTS

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Like all medicines, MultiHance can cause side effects, although not everybody
gets them.
Most of the side effects that have been reported with MultiHance have been mild
and were not prolonged, and spontaneously resolved without residual effects.

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Possible side effects
Headache
Nausea
Feeling hot
Local reactions where the injection was
given such as: swelling, pain or an unusual
sensation at the injection site

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-

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Common:
(More than 1 out of 100
persons and less than
1 out of 10 persons)

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- Changes in blood pressure, and in heart
rate or rhythm, abnormal electrocardiogram
(a test that monitors changes in your heart
beat)
- Pain in the chest
- Dry mouth, changes in taste, vomiting,
diarrhoea
- Dizziness, acute sensitivity to touch/pain/or
other stimuli, generalised numbness, tingling
- Sweating, feeling weak, chills, raised body
temperature
- Itching, skin rash, urticaria (hives)
- Fainting
- Heart burn, abdominal pain
- Pain in the back or in muscles
- Strange smell, increase in salivation
- Leakage out of the vein that can cause a
burning sensation and blistering around the
injection site
- Inflammation of nose or throat
- Swollen face and neck

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Uncommon:
(More than 1 out of 1,000
persons and less than
1 out of 100 persons)

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- Allergic reaction, which infrequently can
lead to shock, may include, besides itching,
skin rash, urticaria, fainting, swollen face
and neck and inflammation of nose or
throat, also:
Shortness of breath, throat spasm, wheezing
Inflammation of your eyes (conjunctivitis)

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Rare:
(More than 1 out of
10,000 persons and
less than 1 out of
1,000 persons)

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- Abnormal laboratory tests, such as:
- changes in liver function tests,
- reduction of haemoglobin (the oxygen
carrying component) in the blood,
- abnormal blood and urine tests, blood in
urine,
- changes in the mineral composition of
blood.

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- Tremor, convulsion
- Ringing in the ears (tinnitus),
- Incontinence of urine and stool, urgency to
urinate, difficulty in defecation
- Inflammation of the pancreas (pancreatitis)
- Fluid in the lungs (pulmonary oedema)
- Increase in fluid pressure in the brain
(intracranial hypertension)
- Loss of strength in arm, leg and sometimes
face on one side of the body (hemiparesis)

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There have been reports of nephrogenic systemic fibrosis (which causes
hardening of the skin and may affect also soft tissue and internal organs) in
patients who received MultiHance together with other gadolinium-containing
contrast agents.

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If you think you notice any side effects after receiving an injection of MultiHance,
immediately tell the medical staff supervising your scan.

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If you have any other questions not answered in this leaflet please ask the
medical staff supervising your scan.

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If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor.

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5. HOW TO STORE MULTIHANCE

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• Keep out of the reach and sight of children.
• Do not use MultiHance after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
• Do not freeze.
• MultiHance should be administered to you immediately once drawn up
into the syringe.
• Do not use MultiHance if you notice that the container and closure have
been damaged or the solution is discoloured or particulate matter is present.
• Medicines should not be disposed of via wastewater or household waste.
The hospital pharmacist will dispose any unused product or waste material.
These measures will help to protect the environment.

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6. FURTHER INFORMATION

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What MULTIHANCE contains
One mL of the 0.5 M solution contains the active substance gadobenic acid
334 mg (0.5M) as gadobenate dimeglumine (0.529 g) dissolved in water for
injection.

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What MULTIHANCE looks like and contents of the pack
MultiHance is an aqueous sterile solution (clear, colourless to slightly yellow
colour) for intravenous injection.
MultiHance is supplied to hospitals in single dose glass vials containing 5 mL,
10 mL, 15 mL, or 20 mL of solution.
Not all pack sizes may be marketed.

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Marketing Authorisation Holder
Bracco spa - via Egidio Folli 50, 20134 Milano (Italy)

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Manufacturer
Patheon Italia S.p.A. - 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR) (Italy)
Date of granting approval of latest variation: July 2013.

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The following information is intended for medical or healthcare professionals
only:

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Prior to administration of MultiHance, it is recommended that all patients are
screened for renal dysfunction by obtaining laboratory tests.

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There have been reports of nephrogenic systemic fibrosis (NSF) associated with
use of some gadolinium-containing contrast agents in patients with acute
or chronic severe renal impairment (GFR< 30ml/min /1.73 m 2). Patients
undergoing liver transplantation are at particular risk since the incidence of
acute renal failure is high in this group. As there is a possibility that NSF may
occur with MultiHance, it should therefore be avoided in patients with severe
renal impairment and in patients in the perioperative liver transplantation
period unless the diagnostic information is essential and not available with
non-contrast enhanced MRI. If use of MultiHance cannot be avoided, the
dose should not exceed 0.1 mmol/kg body weight when used for MR of the
brain and spine or MR-angiography and should not exceed 0.05 mmol/kg
body weight when used for MR of the liver. More than one dose should not be
used during a scan. Because of the lack of information on repeated
administration, MultiHance injections should not be repeated unless the
interval between injections is at least 7 days.

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As the renal clearance of MultiHance may be impaired in the elderly, it is
particularly important to screen patients aged 65 years and older for renal
dysfunction.

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Haemodialysis shortly after MultiHance administration may be useful at removing
MultiHance from the body. There is no evidence to support the initiation of
haemodialysis for prevention or treatment of NSF in patients not already
undergoing haemodialysis.

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The peel-off tracking label on the vials should be stuck onto the patient
record to enable accurate recording of the gadolinium contrast agent
used. The dose used should also be recorded.

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Continuing or discontinuing breast feeding for a period of 24 hours after
administration of MultiHance, should be at the discretion of the doctor
and lactating mother.

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MultiHance should not be used during pregnancy unless the clinical condition
of the woman requires use of gadobenate dimeglumine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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