PATIENT INFORMATION LEAFLET. DOTAREM mg/ml, solution for injection (Gadoteric acid)

Transcription

1 PATIENT INFORMATION LEAFLET DOTAREM mg/ml, solution for injection (Gadoteric acid) Read all 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 further questions, please ask the doctor or the health professional that is giving you Dotarem. - If you get any side effects, talk to your doctor or health professional. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet: 1. What Dotarem is and what it is used for 2. What you need to know before you are given Dotarem 3. How you will be given Dotarem 4. Possible side effects 5. How to store Dotarem is stored 6. Contents of the pack and other information 1. What Dotarem is and what is it used for Dotarem is a diagnostic agent used in adults and children. Dotarem belongs to a class of products called contrast agents. It is used to help diagnosis in MRI (magnetic resonance imaging) examination. It will help to improve the visualisation of parts of your body. This medicine is for diagnostic use only. 2. What you need to know before you are given Dotarem You must not be given Dotarem if you have: a pacemaker fitted a clip fitted onto a blood vessel infusion pumps nerve stimulators cochlear implants (implants in the inner ear) any suspected metallic foreign bodies, particularly in the eye. This is important as these can result in serious problems, as MRI machines use very strong magnetic fields. Warnings and precaution Talk to your doctor or health professional: If you have ever received a contrast medium before and had an allergic reaction (for example redness, rashes, itching) If you have asthma If you have history of allergy (such as seafood allergy, urticaria, hay fever)

2 If your kidneys do not work properly If you have recently had, or soon expect to have, a liver transplant If you are being treated with beta blocking drugs. These are used to treat high blood pressure or chest pain (angina). If you suffer from epilepsy or have had fits in the past. Like all MRI contrast agents and regardless of the route of administration and the dose, there is a risk of side effects, usually minor but which may go as far as to endanger life. The possible serious reactions may occur within an hour and the minor reactions may occur up to 7 days after administration. They are unforeseeable but the risk of occurrence is increased if you have already had a reaction when administered an MRI contrast agent previously (see section 4 Possible side effects ). If this is the case, you should inform the radiologist who will perform the injection. Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use Dotarem, especially if you are 65 years of age or older. Neonates and infants As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Dotarem will only be used in these patients after careful consideration by the doctor. 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 as Dotarem 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 Dotarem. Using other medicines: Please tell your doctor or health professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 3. How you will be given Dotarem Dotarem will always be given to you by a trained health professional. It is injected into your veins just before the MRI examination. Make sure you do exactly as they tell you. If you are not sure of anything, ask this person. If you go to another hospital or see other specialists, let them know what medicines you have been taking or given.

3 Dosage in special patient groups The use of Dotarem 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 Dotarem during a scan and you should not receive a second injection for at least 7 days. Neonates, infants, children and adolescents As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Dotarem will only be used in these patients after careful consideration by the doctor. Children should only receive one dose of Dotarem during a scan and should not receive a second injection for at least 7 days. Use for angiography is not recommended in children less than 18 years of age. 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 are given more Dotarem than you should: As you will be administered the injection in hospital by a trained person, it is highly unlikely that you will be given an overdose. If you think a child or anyone else has accidentally taken any of this treatment, let the hospital casualty department or hospital staff know immediately what has happened. 4. Possible side effects There is a small risk (rare) that you may have an allergic reaction to Dotarem. Such reactions can be severe and can result in shock in exceptional cases (very rare case of allergic reaction that could put your life in danger). Any of the symptoms listed below may be the first signs of shock. Immediately inform your doctor or health professional if you have any of these symptoms. Swelling of the face, mouth, hands, feet or throat which may cause you difficulty in swallowing or breathing Fainting Breathing difficulties, coughing, wheezing, sneezing, runny nose, eye irritation, eye swelling Urticaria (hives), itching, reddening of the skin, skin rash Like all medicines, Dotarem can cause side effects, although not everybody gets them. Most side effects occur within half an hour of injection. However, some of these reactions can occur up to several days after Dotarem injection. These are usually mild to moderate and transient The side effects most commonly observed during administration of Dotarem are nausea, vomiting, itchiness, and allergic reactions (usually affecting the skin). Most side effects occur during injection or during the first hour after the injection. Some side effects can occur several days after the injection of Dotarem.

4 Very common side effects (probably affecting more than 1 in 10 people) Sensation of warmth or cold and/or pain around the injection site Tingling sensation Headache Common side effects (probably affecting up to 1 in 10 people) Nausea (feeling sick) Vomiting (being sick) Redness of the skin and itching Very rare side effects (probably affecting fewer than 1 in 10,000 people) Chest pain Back pain Feeling unwell Fever Increase in sweating Coldness Becoming very pale Fainting Abdominal pain Eczema Dizziness Convulsions (fits) Tremor Tiredness (fatigue) Sleepiness Muscle cramps Muscle weakness Injection of Dotarem into small veins can cause local reddening and swelling around the site of injection. If Dotarem is accidentally injected outside the vein, local pain can occur. Superficial local inflammation have been reported in rare cases. This is most probably related to the injection technique. There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs) most of which were in patients who received Dotarem together with other gadolinium-containing contrast agents. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via : IMB Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: Fax:

5 Website: By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Dotarem Keep this medicine out of the sight and reach of children Since Dotarem is being given to you by a trained professional, it is extremely unlikely that you will be expected to look after it. However, if you do have to, follow these instructions: Keep out of the reach and sight of children Do not use Dotarem after the expiry date which is stated on the vial or the prefilled syringe and on the carton, after the abbreviation Exp. The expiry date refers to the last day of the month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.> There are no special precautions for storage for the vials. The pre-filled syringe must not be frozen. Single use only. Discard any unused contents. 6. Contents of the pack and other information What Dotarem contains The active substance is gadoteric acid. Each 1 ml of Dotarem solution for injection contains mg of gadoteric acid, equivalent to 0.5 mmol/ml. The other ingredients are meglumine and water for injections. What Dotarem looks like and contents of the pack Dotarem solution for injection is a clear, colourless or slightly yellow solution. Each Dotarem pack contains one vial of 5 ml, 10 ml, 15 ml or 20 ml, or one pre-filled syringe of 10 ml, 15 ml or 20 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Guerbet BP Roissy CdG Cedex FRANCE Tel.: brigitte.gayet@guerbet-group.com This medicinal product is authorised in the Member States of the EEA under the following name: Dotarem This leaflet was last revised in March 2014

6 THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: The dosage may vary depending on the type of examination, the age, weight and general condition of the patient and the technique used. As a guideline, the recommended dosages are as follows: Indications Encephalic and spinal MRI Recommended dosage General : 0.1 mmol/kg body weight i.e. 0.2 ml/kg Adults Pediatric population (0-18 years) If a strong clinical suspicion of a lesion persists: a further injection of 0.2 mmol/kg, i.e. 0.4 ml/kg, within 30 minutes may be justified. The recommended and maximum dose of Dotarem is 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Whole body MRI Adults 0.1 mmol/kg body weight, i.e. 0.2 ml/kg Pediatric population (0-18 years) The recommended and maximum dose of Dotarem is 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Angiography Adults A second injection of 0.1 mmol/kg body weight, i.e. 0.2 ml/kg may be justified for certain regions. Prior to administration of Dotarem, 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 m 2 ). 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 Dotarem, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it is necessary to use Dotarem, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of

7 information on repeated administration, Dotarem injections should not be repeated unless the interval between injections is at least 7 days. Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Dotarem should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotarem injections should not be repeated unless the interval between injections is at least 7 days. As the renal clearance of gadoteric acid may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction. Haemodialysis shortly after Dotarem administration may be useful at removing Dotarem 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. Dotarem should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteric acid. Continuing or discontinuing breast feeding for a period of 24 hours after administration of Dotarem, should be at the discretion of the doctor and lactating mother. The peel-off tracking label on the vials or 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. For single use only. Discard any unused content. Please consult the Summary of Product Characteristics for full prescribing information.