Multihance

Patient Information Leaflet: User Information

MultiHance, 529 mg/ml (0.5mmol/ml), solution for intravenous injection
Gadobenic acid dimeglumine

Please read carefully the contents of this leaflet before using the product, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is MultiHance and what is it used for
• 2. Important information before using 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 is MultiHance and what is it used for

MultiHance is a special contrast agent that contains a rare earth element called gadolinium
and its action is to improve the quality of liver imaging during magnetic resonance imaging (MRI) examinations.
This makes it easier for doctors to detect any abnormalities in the patient's liver.
The product is for diagnostic use only.
MultiHance is approved for use in children over 2 years of age.

2. Important information before using MultiHance

MultiHance should only be used in a hospital or clinic with appropriate equipment
and staff trained in the management of allergic reactions.

Accumulation in the body

MultiHance works because it contains a metal called gadolinium. Studies have shown that small amounts
of gadolinium can accumulate in the body, including in the brain. No adverse effects related to gadolinium accumulation in the brain have been observed.

When not to use MultiHance

• If the patient is allergic to gadobenic acid dimeglumine or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced an allergic reaction (hypersensitivity reaction) such as a rash, itching, hives, or difficulty breathing after receiving any special dye or contrast agent for MRI.

The patient should inform their doctor if any of the points in this paragraph apply to them.

Children

MultiHance is not recommended for use in children under 2 years of age.

Warnings and precautions

The patient should inform their doctor before using MultiHance if:

• they have heart problems or high blood pressure,
• they have had seizures or brain damage,
• they have a pacemaker or any metal objects in their body, such as clips, screws, or plates, that could interfere with the MRI magnet,
• their kidneys do not work properly,
• they have recently had or are about to have a liver transplant.

The doctor may decide to perform a blood test to check kidney function before deciding to use MultiHance, especially in people over 65 years of age.

MultiHance and other medicines

The patient should tell their doctor about all medicines they are taking, or have recently taken, and about any medicines they plan to take.
There are no reports of interactions between MultiHance and other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before using this medicine.
Pregnancy
Gadobenic acid may pass through the placenta. It is not known if this has any effect on the baby.
Women who think they are pregnant or may be pregnant should tell their doctor, as MultiHance should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Women who are breastfeeding or plan to breastfeed should tell their doctor. The doctor will discuss with the patient whether they should continue breastfeeding or stop breastfeeding for 24 hours after receiving MultiHance.

Driving and using machines

There is no information available on the effects of MultiHance on driving or using tools or machines. The patient should ask their doctor if they can drive and use machines and tools safely.

Important information about some ingredients of MultiHance

During storage, small amounts of benzyl alcohol (a derivative of alcohol) may be released into the MultiHance solution.

The patient should inform their doctor if they are allergic (hypersensitive) to benzyl alcohol.

3. How to use MultiHance

MultiHance is injected into a vein, usually in the arm, just before the MRI examination. The amount of solution injected into the vein depends on the patient's body weight.
The recommended dose is:

MRI of the liver:

0.1 ml per kilogram of body weight.
The injection of MultiHance will be performed by medical staff supervising the imaging examination, who will ensure that the needle is properly placed. If the patient experiences pain or a burning sensation, they should inform the medical staff.

The patient should stay in the hospital for one hour after the injection of MultiHance.

Dosing in special patient groups Kidney problems

MultiHance should not be used in patients with severe kidney disease, or in patients who have recently had or are about to have a liver transplant.
If the use of MultiHance is necessary, the patient should receive only one dose of MultiHance during the examination and should not receive a second injection for at least 7 days.
Elderly patients
There is no need to adjust the dose in patients over 65 years of age, but a blood test should be performed to check kidney function.
If the patient has any further questions or concerns about the use of this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, MultiHance can cause side effects, although not everybody gets them.
Most side effects related to MultiHance were mild and short-lived, and resolved without lasting effects. However, serious and life-threatening reactions have been reported, sometimes leading to death.

There have been reports of nephrogenic systemic fibrosis (a disease related to skin hardening, which can also affect soft tissues and internal organs) in patients who received MultiHance in combination with other gadolinium-containing medicines.
If the patient notices any side effects after receiving MultiHance, they should immediately inform the medical staff supervising the imaging examination.
If the patient has any questions not covered in this leaflet, they should consult the medical staff supervising the imaging examination.

If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store MultiHance

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
• Store in a temperature below 25°C. Do not freeze. Protect from light.
• MultiHance should be administered immediately after drawing into a syringe.
• Do not use this product if the container or closure is visibly damaged, or if the solution is discolored or contains particles.
• Medicines should not be disposed of via wastewater or household waste. The hospital pharmacist will dispose of unused medicine and waste. This will help protect the environment.

6. Contents of the pack and other information

What MultiHance contains

• The active substance is gadobenic acid. 1 ml of the solution for injection contains: gadobenic acid 334 mg (0.5 mmol) as gadobenate dimeglumine (529 mg)
• The excipient is water for injections.

What MultiHance looks like and contents of the pack

MultiHance is a clear and colorless or slightly yellowish sterile aqueous solution for intravenous injection.
MultiHance is supplied to hospitals in glass vials for single use containing 5 ml, 10 ml, 15 ml, or 20 ml of solution.
Not all pack sizes may be marketed.

Marketing authorization holder

Bracco Imaging Deutschland GmbH
Max-Stromeyer-Strasse 116
D-78467 Konstanz, Germany
For further information, please contact the representative of the marketing authorization holder:
Bracco Imaging Polska Sp. z o.o.
ul. Domaniewska 39 A
02-672 Warsaw

Manufacturer

Patheon Italia S.p.A.
2° Trav. SX Via Morolense 5
03013 Ferentino, Italy
Bracco Imaging S.p.A.
via Ribes, 5
10010 Colleretto Giacosa (TO)
Italy

Date of last revision of the leaflet: 05/2024

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Information intended for healthcare professionals only:
Method of administration
The medicinal product MultiHance should be drawn into a syringe immediately before use and should not be diluted. Unused medicinal product should be discarded. It should not be used for examinations of other patients.
To minimize the potential risk of extravasation of the medicinal product MultiHance, it should be checked that the intravenous needle or cannula is properly inserted into the vein.
The medicinal product should be administered intravenously as a bolus injection or slow injection (10 ml/min.), without dilution.
MRA: The medicinal product should be administered intravenously as a bolus, manually or using an automatic injector.
After administration of the medicinal product, the cannula or needle should be flushed with a physiological saline solution.
Image acquisition after administration of the contrast agent:

Before administration of the medicinal product MultiHance, it is recommended that all patients undergo an assessment of kidney function, including laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with the use of some gadolinium-containing medicinal products in patients with acute or chronic severe kidney disease (GFR <30 ml min 1.73 m). patients who have undergone liver transplantation are particularly at risk, as the risk of acute kidney injury in this patient group is high. due to possibility nsf during use multihance, medicinal product should be avoided with severe disease and recently or about undergo transplantation, unless diagnostic information essential not available for mri examination without contrast enhancement. if multihance cannot avoided, dose exceed 0.05 mmol kg body weight. lack data on repeated administrations, injections repeated, intervals between least 7 days.
Since the renal clearance of gadobenate dimeglumine may be reduced in elderly patients, it is particularly important to monitor patients aged 65 and over for kidney problems.
Hemodialysis immediately after administration of MultiHance may facilitate its removal from the body. There is no evidence to justify the initiation of hemodialysis to prevent or treat NSF in patients who are not already undergoing hemodialysis.
MultiHance should not be used during pregnancy, unless the clinical condition of the woman requires the use of gadobenate dimeglumine.
The doctor and the breastfeeding mother should decide whether to continue breastfeeding or stop breastfeeding for 24 hours after administration of MultiHance.
The torn vial label should be attached to the patient's card to allow proper registration of the administered gadolinium-containing medicinal product. The dose should also be recorded. If an electronic patient card is used, the name of the medicinal product, batch number, and dose should be entered into the patient's electronic record.