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PACKAGE LEAFLET: INFORMATION FOR THE USER

MultiHance 529 mg/ml

solution for injection in pre-filled syringe

Gadobenate dimeglumine

What is in this leaflet:

1.    What MultiHance is and what it is used for

2.    What you need to know before you use MultiHance

3.    How to use MultiHance

4.    Possible side effects

5.    How to store MultiHance

6.    Contents of the pack and other information

1. What MultiHance is and what it is used for

MultiHance is a special dye (or contrast agent) which contains the rare earth metal gadolinium and improves images of the liver, brain/spine and breast during magnetic resonance imaging (MRI) scans. It helps your doctor to identify any abnormalities of your liver, brain/spine and breast.

This medicine is for diagnostic use only.

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

2. What you need to know before you use MultiHance

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.

Do not use MultiHance

•    If you are allergic to gadobenate dimeglumine or any of the other ingredients of this medicine (listed in section 6)

•    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

Children

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

Warnings and precautions

Talk to your doctor before using MultiHance 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

•    if you are allergic ( hypersensitive ) to benzyl alcohol, because small quantities of benzyl alcohol (a derivative of alcohol) can be released in the MultiHance solution during storage

•    your kidneys do not work properly

•    you have recently had, or soon expect to have, a liver transplant.

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.

Other medicines and MultiHance

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

Tell your doctor if you are taking or have recently taken any other medicines.

Pregnancy and breast-feeding

Ask your doctor for advice before being given this medicine.

Pregnancy

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

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.

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.

3. How to use MultiHance

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

The recommended dose is:

MRI of the liver: 0.1 ml per kilogram of body weight MRI of brain/spine: 0.2 ml per kilogram of body weight MRI of the breast: 0.2 ml per kilogram of body weight

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.

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

Dosage in special patient groups

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.

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.

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

4. Possible side effects

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.

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.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

-    for UK via the Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard

-    for Ireland via HPRA Pharmacovigilance - Earlsfort Terrace -IRL - Dublin 2 Tel: +353 1 6764971 - Fax: +353 1 6762517 -Website: www.hpra.ie -e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store MultiHance

•    Keep out of the sight and reach of children.

•    Do not use this medicine 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 after opening.

•    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.

•    Do not throw away any medicines via wastewater or household waste. The hospital pharmacist will dispose any unused product or waste material. These measures will help to protect the environment.

6.    Contents of the pack and other information

What MultiHance contains

-    The active substance is gadobenic acid as gadobenate dimeglumine.

-    The other ingredient (excipient) is water for injection.

What MultiHance looks like and contents of the pack

MultiHance is an aqueous solution for injection in pre-filled single dose syringe (clear, colourless to slightly yellow colour).

MultiHance is supplied in pre-filled syringes containing 10 ml, 15 ml, or 20 ml of solution for injection.

MultiHance is also supplied in kits with administration devices:

-    15 and 20 mL pre-filled syringe, 20 mL syringe (polypropylene), connector with 3-way stopcock (polycarbonate), spike (ABS/polypropylene), 20 G secured catheter

-    15 and 20 mL pre-filled syringe, syringe for magnetic resonance automatic injector ((115 mL syringe (polyethelene terephthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/silicone), spike (ABS)), 20 G secured catheter.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bracco Imaging spa via Egidio Folli 50 20134 Milano (Italy)

Manufacturer

Bracco Imaging spa Via Ribes 5

Colleretto Giacosa (TO)

Ivrea (Italy)

This leaflet was last revised in March 2015

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

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 m²). 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 breast MRI, 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.

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.

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.

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

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.

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

If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.

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