334 mg / ml (0.5 mmol / ml) Solution for injection
Gadobenic acid
What MultiHance is and what it is used for
MultiHance is a special dye (or contrast agent) that contains the rare earth metal gadolinium and enhances images of the liver during magnetic resonance imaging (MRI) examinations. It helps the doctor to identify abnormalities in the liver. Intended for diagnostics only.
MultiHance is approved for use in children over two years of age.
What you need to know before using MultiHance
MultiHance should only be given to you at a hospital or clinic where you have the equipment and medically trained staff who can handle allergic reactions.
Accumulation in the body
MultiHance works because it contains the metal gadolinium. Studies have shown that small amounts of gadolinium can remain in the body, including the brain. No side effects due to residual gadolinium in the brain have been seen.
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 previously had an allergic reaction ( hypersensitivity reaction ) such as a rash, itching , hives or difficulty breathing after injecting a special dye or contrast agent for MRI examination.
Tell your doctor if any of the above points apply to you.
Children
MultiHance should not be given to children under two years of age.
Warnings and cautions
Talk to your doctor before using MultiHance about:
- you suffer from heart problems or high blood pressure
- Your medical history includes epilepsy or brain damage
- you have a pacemaker , or you know that there are some other metal objects in your body such as clamps, screws or plates as these can be affected by / affect the magnet in the magnetic camera.
- your kidneys are not functioning normally.
- you have recently undergone or are soon expected to undergo a liver transplant.
Doctors may decide to take a blood test to check how your kidneys are working before deciding 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 or might take any other medicines.
Pregnancy and breastfeeding
Consult a doctor before taking any medicine.
Pregnancy
You must tell your doctor if you think you are or may become pregnant or are planning to become pregnant as MultiHance should not be used during pregnancy unless necessary.
Breast-feeding
Tell your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will discuss with you whether you should continue or discontinue breastfeeding for 24 hours after receiving MultiHance.
Driving and using machines
There is no information on how MultiHance affects the ability to drive or use tools or machines
Ask your doctor if you can drive and if it is safe for you to use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
MultiHance contains benzyl alcohol
Small amounts of benzyl alcohol can be released in the MultiHance solution during storage.
Tell your doctor if you are allergic to benzyl alcohol
How to use MultiHance
MultiHance is injected into a vein, usually in the arm, just before the MRI scan. The amount of milliliters injected depends on how much you weigh.
The recommended dose is:
Liver MRI: 0.1 ml per kg body weight
The healthcare staff, who are monitoring the examination, will give you an injection with MultiHance. They should make sure that the needle is positioned correctly: Tell them if you feel pain or have a burning sensation at the injection site while injecting the product.
You should stay in the hospital area for one hour after injection one.
Dosage in special patient groups
Impaired renal function
The use of MultiHance is not recommended for patients with severe kidney problems and for patients who have recently had or are expected to undergo a liver transplant. If use is nevertheless necessary, you should only receive a dose of MultiHance during an examination and you should not receive a second injection before at least 7 days have passed.
Older
It is not necessary to adjust the dose if you are 65 years of age or older but you may need to have a blood test to check how well your kidneys are working.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects reported with MultiHance were mild. They were transient and disappeared spontaneously with no lasting effects. However, severe and life-threatening, and sometimes fatal reactions have been reported.
| Side effect ar | |
| Common :(may affect up to 1 in 10 users) | HeadacheNausea |
| Uncommon:(may affect up to 1 in 100 users) | Dizziness, tingling sensation, taste change altered blood pressure, and pulse or heart rate, rednessVomiting, diarrhea, dry mouth itching, rash, gives the feeling of heat, fever, local reactions at the injection site such as pain, burning sensation or feeling of cold or heat, redness, itching or discomfort at the injection site Deviating laboratory tests such as abnormal ECG (a test that measures changes in your heartbeat)change in liver function test abnormal blood and urine tests |
| Rare:(may affect up to 1 in 1,000 users) | A severe allergic reaction that causes difficulty breathing or dizziness fainting, tremors, seizures, sensory disturbances decreased sensitivity to touch, pain or other irritationVisual disturbancesInsufficient blood supply to the heart, low heart rateFluid in the lungs ( pulmonary edema ), shortness of breath, wheezing, narrowed trachea, swollen and irritated inside of the nose, cough increased salivation, abdominal pain swollen face, sweatingMuscle pain chest pain, feeling of weakness, chills, feeling uncomfortable changes in laboratory tests |
| Has been reported: (occurs in an unknown number of users) | Chest pain radiating to the neck or left arm, which may be a sign of a potentially serious allergic reaction known as Kuoni’s syndrome severe allergic shockUnconsciousnessEye inflammationMyocardial infarction, blue tinting of skin and mucous membranes difficulty or inability to breathe, swelling of the throat, lack of oxygen, difficulty breathing or wheezing swelling in the mouthSevere allergic reaction that causes swelling of the face or neck swelling at the injection site, blisters at the injection site inflammation of the veins caused by blood clots |
There have been reports of nephrogenic systemic fibrosis (which causes thickening of the skin and which may also affect soft tissues and internal organs) in patients receiving MultiHance with other gadolinium-containing contrast agents.
If you think you are experiencing any side effects after the injection of MultiHance, tell the hospital staff who are monitoring your magnetic resonance imaging examination immediately.
If you have any questions that are not answered in this information, please contact the hospital staff who are monitoring your examination.
How to store MultiHance
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
- Do not freeze.
- MultiHance should be given to you immediately after it is drawn into the syringe.
- Do not use MultiHance if the container or closure is damaged or if the solution is discolored or particles are visible.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is gadobenic acid as gadobenate dimeglumine.1 ml solution for injection contains: gadobenic acid 334 mg (0.5 mmol) as gadobendimeglumine (529 mg).
- The other ingredients are water for injections.
What the medicine looks like and contents of the pack
MultiHance is a sterile aqueous solution (clear, colorless to pale yellow) for intravenous injection. MultiHance is supplied to hospitals in single-dose glass vials containing 5 ml, 10 ml, 15 ml, or 20 ml solution.
MultiHance is also available in packs containing administration equipment: (15 and 20 ml vial , syringe for automatic magnetic resonance injector) (65 ml syringe (polyethylene terephthalate / polycarbonate), 115 ml syringe (polyethylene terephthalate / polycarbonate), contact part (PVC / polycarbonate / polypropylene / silicone ), 2 spikes (ABS)), 20 G secured catheter .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorisation Holder
Bracco Imaging SpA, Via Egidio Folli 50, 20134 Milan, Italy
Manufacturer:
Pantheon Italia SpA –2 ° Trav. SX Via Morolense 5, 03013 Ferentino (FR), Italy
BIPSO GmbH, Robert-Gerwig-Strasse 4, 78224 Singen, Germany
Bracco Imaging SpA, Bioindustry Park, Via Ribes, 5, 10010 Colleretto Giacosa (TO), Italy