Multihance 0.5m Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRACCD
MultiHance, 0.5 M solution for injection
Gadobenate dimeglumine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- 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 you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
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 brain/spine, arteries and other body areas during MRI scans. It helps your doctor to identify any abnormalities of your brain/spine, arteries or other parts of your body.
This medicine is for diagnostic use only.
MultiHance is approved for use in children above two years of age.
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
• 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 taking any 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.
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.
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 body weight.
The recommended dose is:
MRI of brain/spine: 0.2 ml per kilogram of body weight MRI of arteries: 0.2 ml per kilogram of body weight
MRI of the liver, the kidney, urinary tract or adrenal glands: 0.1 ml per
kilogram of body weight
MRI of the breast, heart or other body areas: 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. However, severe and life-threatening reactions sometimes leading to death have been reported.
|
Possible side effects | |
|
Common: (More than 1 out of 100 persons and less than 1 out of 10 persons) |
- Headache - Nausea - Local reactions where the injection was given such as: pain, burning, coldness or warmth feeling, redness, itching or discomfort at the injection site |
|
Uncommon: (More than 1 out of 1,000 persons and less than 1 out of 100 pe rsons) |
- Dizziness, reduced sensitivity to touch/pain/or other stimuli, tingling, changes in taste - Changes in blood pressure, and in heart rate or rhythm, flushing - Vomiting, diarrhoea, abdominal pain - Itching, skin rash, urticaria (hives), sweating - Pain in the chest, feeling hot, fever - Abnormal laboratory tests, such as: - abnormal electrocardiogram (a test that monitors changes in your heart beat) - changes in liver function tests - abnormal blood and urine tests |
|
Rare: (More than 1 out of 10,000 persons and less than 1 out of 1,000 persons) |
- Serious allergic reaction which causes difficulties in breathing or dizziness - Fainting, tremor, convulsion, strange smell - Abnormal vision - Insufficient blood supply to the heart, slow heart beats - Shortness of breath, wheezing, tightness of the throat, swelling and irritation inside the nose, cough - Dry mouth, excessive salivation - Swollen face - Pain in in muscles - Incontinence of stool - Feeling weak, chills, malaise - Change in laboratory tests |
- Serious allergic shock
- Loss of consciousness
- Eyes inflammation
- Cardiac arrest, blue discolouration of the skin and mucous membranes
- Difficulties or suspension of breathing, swelling of the throat, lack of oxygen, difficulties in breathing or wheezing, fluid in the lungs (pulmonary oedema)
- Swelling inside the mouth
- Serious allergic reaction which causes swelling of the face or throat
- Swelling at the site of injection
- Inflammation of the veins due to blood clots
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 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.
• 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
1 ml of solution for injection contains: gadobenic acid 334 mg (0.5 mmol) as gadobenate dimeglumine (529 mg).
- The other ingredient (excipient) is water for injection.
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.
MultiHance is also supplied as kits including the administration devices (15 and 20 mL vial, syringe for magnetic resonance automatic injector ((65 mL syringe (polyethelene terephthalate/polycarbonate), 115 mL syringe (polyethelene terephthalate/polycarbonate), connector (PVC/polycarbonate/polypropylene/ silicone), 2 spikes (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)
Manufacturers
Patheon Italia S.p.A., 2° Trav. SX Via Morolense 5, 03013 Ferentino (FR) (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)
This leaflet was last revised in September 2016
The following information is intended for medical or healthcare professionals only:
Method of administration
MultiHance should be drawn up into the syringe immediately before use and should not be diluted. Any unused product should be discarded and not be used for other MRI examinations.
To minimise the potential risks of soft tissue extravasation of MultiHance, it is important to ensure that the i.v. needle or cannula is correctly inserted into a vein.
The product should be administered intravenously either as a bolus or slow injection (10 mL/min.), see table for post-contrast imaging acquisition.
The injection should be followed by a flush of sodium chloride 9 mg/ml (0.9%) solution for injection.
Post-contrast imaging acquisition:
|
Liver |
Dynamic imaging: |
Immediately following bolus injection. |
|
Delayed imaging: |
between 40 and 120 minutes following the injection, depending on the individual imaging needs. | |
|
Brain and Spine |
up to 60 minutes after the administration. | |
|
MRA |
immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection <2 mL of the agent should be used to calculate the appropriate scan delay. | |
|
Breast |
A T1-weighted, gradient-echo sequence with a time resolution of 2 minutes or less should be acquired before contrast injection and repeated several times over a period of 5 to 8 min after a rapid intravenous contrast bolus injection. | |
|
Other body areas |
T1-weighted sequences to be acquired as either dynamic or static delayed imaging. | |
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, MR-angiography breast MRI or whole body MRI and should not exceed 0.05 mmol/kg body weight when used for MR of the liver, kidneys, urinary tract or adrenal glands. More than one dose should not be used during a scan except for MR cardiac perfusion imaging where two separate doses of 0.05 mmol/kg body weight can be administered in the course of a single examination. 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.
If electronic patient records are used, the name of the product, the b
batch number and the dose should be entered into the patient record. 1
O