Label: information for the user

MultiHance 529 mg/ml injectable solution

Gadobenate dimeglumine

1. What is MultiHance and how it is used

2. What you need to know before starting to use MultiHance

3. How to use MultiHance

4. Possible adverse effects

5. Storage of MultiHance

6. Contents of the package and additional information

MultiHance is a special dye (or contrast agent) that contains the metal gadolinium and improves liver images in Magnetic Resonance (MR) scans. This helps your doctor to identify alterations in your liver.

This medication is solely for diagnostic use.

MultiHance is approved for use in children over 2 years old.

MultiHance should only be administered in hospitals or clinics where there are teams and medical staff trained to handle 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 the brain. No adverse effects have been observed due to gadolinium accumulation in the brain.

Do not use MultiHance

• if you are allergic to gadobenate dimeglumine or any of the other components of this medication (listed in section 6).
• if you have had anyallergic reaction (hypersensitivity reaction), such as rash, itching, urticaria, or difficulty breathing after injection of any contrast agent for MRI.

Consult your doctor if you think you fall into any of these cases.

Children

MultiHance should not be administered to children under 2 years old.

Warnings and precautions

Consult your doctor before starting to use MultiHance if:

• you have aheart problemor havehigh blood pressure
• you have a history of epilepsy or brain injuries
• you have apacemakeror any other metal object such as clips, screws, or plates in your body, as they may interfere with the MRI scanner's magnet
• your kidneys do not function correctly
• if you have recently undergone, or are about to undergo, a liver transplant.

Your doctor may decide to perform a blood test to check the proper functioning of your kidneys before deciding to use MultiHance, especially if you are 65 years old or older.

Use of MultiHance with other medications

No data on interactions of MultiHance with other medications are available.

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

Consult your doctor before using any medication.

Pregnancy:

Gadobenate crosses the placenta. It is unknown whether it affects the fetus. Inform your doctor if you are pregnant or think you may be pregnant or intend to become pregnant, as MultiHance should not be used during pregnancy unless strictly necessary.

Breastfeeding:

Inform your doctor if you are breastfeeding or about to start. Your doctor will assess whether you should continue breastfeeding or interrupt it 24 hours after MultiHance administration.

Driving and operating machines

No effects of MultiHance on driving or use of tools or machines are known. Ask your doctor if you can drive and if it is safe to use any tool or machine.

Important information about some of the components of MultiHance

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

Please inform your doctor if you are allergic to benzyl alcohol.

MultiHance is injected into a vein, usually in the arm, before the MRI examination. The amount in milliliters to be injected depends on how many kilograms you weigh.

Therecommended dose is:

MRI of the liver:0.1 ml per kilogram of body weight

The medical staff responsible for the examination will administer the MultiHance injection. Make sure they place the needle correctly: inform them if you feel pain or a burning sensation at the injection site during administration.

You should remain in the hospital for one hour after the injection administration.

Posology in special populations

Renal insufficiency

The use of MultiHance is not recommended in patients with severe kidney problems or in patients who are about to undergo or have recently undergone a liver transplant. However, if use is required, during an examination, only one dose of MultiHance should be administered, and a second injection should not be administered until at least 7 days have passed.

Advanced age patients

If you are 65 years old or older, it is not necessary to adjust the dose, but you may undergo a blood test to check the proper functioning of your kidneys.

If you use more MultiHance than you should

In case of overdose, you will be closely monitored, and symptomatic treatment will be applied.

In case of overdose, consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered.

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, MultiHance may cause side effects, although not everyone will experience them. Most side effects reported with MultiHance have been mild, non-prolonged, and have resolved spontaneously without residual effects. However, severe and potentially fatal reactions have been reported, which may lead to death.

Systemic fibrosis nephrogenica (which causes skin hardening and may also affect soft tissues and internal organs) has been reported in patients who received MultiHance in combination with other gadolinium-based contrast agents.

If you think you are experiencing any side effect after the injection of MultiHance, inform your healthcare professional immediately.

If after reading this prospectus you have any doubts, please ask your healthcare professional.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance for Human Use Medications: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not freeze.
• MultiHance must be administered immediately after loading it into the syringe.
• Do not use MultiHance if you notice that the packaging and closure have been damaged, the solution has discolored, or any other problem exists.
• Medications should not be disposed of through drains or trash. The hospital pharmacy will dispose of unused product or waste material. This helps to protect the environment.

Composition ofMultiHance

• The active ingredient is gadobenic acid in the form of dimeglumine gadobenate
• 1 ml of injectable solution contains: 334 mg of gadobenic acid (0.5 mmol) as dimeglumine gadobenate (529 mg).
• The other component (excipient) is water for injection preparations.

Appearance of the product and contents of the package

MultiHance is a sterile aqueous solution (without particles, transparent or slightly yellowish in color) 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.

MultiHance is also supplied in kits with administration devices: 15 ml and 20 ml vials, injector syringe for automatic Magnetic Resonance (MR) injector (65 ml (polyethylene terephthalate/poly carbonate) syringe, 115 ml (polyethylene terephthalate/poly carbonate) syringe, connector (PVC/poly carbonate/polypropylene/silicone), 2 tips (ABS)), safety catheter 20 G.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Bracco Imaging s.p.a.

Via Egidio Folli, 50

20134 Milan (Italy)

Manufacturer responsible:

Patheon Italia s.p.a.

2nd Trav. SX Via Morolense, 5

03013 Ferentino (Italy)

BIPSO GmbH

Robert-Gerwig-Strasse 4

78224 Singen (Germany)

Bracco Imaging S.p.A.

Bioindustry Park - Via Ribes, 5

10010 Colleretto Giacosa (TO) (Italy)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Tel: 913756230

Last review date of this leaflet: May 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for doctors or healthcare professionals.

Administration form

MultiHance must be aspirated with a syringe immediately before use and should not be diluted. The unused product should be discarded and should not be used for other MRI examinations.

To minimize the possible risk of extravasation of MultiHance in soft tissues, it is essential to check that the intravenous cannula or needle is correctly inserted into a vein.

The product should be administered intravenously in a bolus or by slow injection (10 ml/min). See table for post-contrast imaging.

After injection, a saline solution (9 mg/ml (0.9%)) should be perfused.

Post-contrast imaging:

Before administering MultiHance, it is recommended to evaluate all patients to detect possible renal dysfunction by laboratory tests.

Cases of systemic fibrosis nephrogenica (FNS) have been reported associated with the use of some gadolinium-based contrast media in patients with severe acute or chronic renal failure (TFG or glomerular filtration rate <30>2). Patients undergoing liver transplantation have a special risk since the incidence of renal failure is high in this group. Since there is a possibility that FNS may occur with MultiHance, it should be avoided in patients with severe renal failure and in patients in the perioperative period of liver transplantation unless the diagnostic information is essential and cannot be obtained by MRI without contrast.

If the use of MultiHance cannot be avoided, the dose should not exceed 0.05 mmol/kg of body weight. Due to the lack of information on repeated administration, the administration of MultiHance should not be repeated unless an interval of at least 7 days has elapsed between injections.

Since renal elimination of dimeglumine gadobenate may be reduced in elderly patients, it is especially important to evaluate patients aged 65 and over to detect possible renal dysfunction.

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

MultiHance should not be used during pregnancy unless the clinical situation of the woman requires treatment with dimeglumine gadobenate.

The continuation or interruption of breastfeeding 24 hours after administration of dimeglumine gadobenate will be at the discretion of the doctor and the breastfeeding mother.

The detachable label of the vials should be stuck to the patient's history to allow for a precise record of the gadolinium-based contrast medium used. The dose used should also be recorded. If electronic patient records are used, the name of the product, batch number, and dose should be entered in the patient's history.