Dotarem Solution For Injection
PIL DOTA PFS UK.qxp_210 X 297 mm - PMS 286 18/09/2014 10:45 Pagel
PIL DOTA PFS UK.qxp_210 X 297 mm - PMS 286 18/09/2014 10:45 Pagel
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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOTAREM 0.5 mmol/ml Solution for injection
Gadoteric acid
What is 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
6. Contents of the pack and other information
1. WHAT DOTAREM IS AND WHAT IS IT USED FOR 1 2
Other medicines and Dotarem
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
There are no known interactions between Dotarem and other medicines.
Please inform your doctor or pharmacist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blockers.
Dotarem with food and drink
There are no known interactions between Dotarem and food and drink. However, please check with your doctor or pharmacist if it is required not to eat or drink before the examination.
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 breastfeeding for a period of 24 hours after you receive Dotarem.
Driving and using machines
Dotarem is unlikely to affect your ability to drive or use machines. If you feel unwell after the examination, like nausea (feeling sick), you should not drive or use machines.
3. HOW YOU WILL BE GIVEN DOTAREM
Dotarem will be administered to you by intravenous injection.
During the examination, you will be under the supervision of a doctor. A plastic needle will be left in your vein; this will allow the doctor to inject you with appropriate emergency drugs if necessary. If you experience an allergic reaction, the administration of Dotarem will be stopped.
The procedure will be carried out in a hospital, clinic or private practice. The attending staff know what precautions have to be taken for the examination. They are also aware of any possible complications that can occur.
Dosage
Your doctor will determine the dose you will receive and supervise the injection.
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 in 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 too much Dotarem has been administered to you
It is highly unlikely that you will be given an overdose. You will be given Dotarem in a medical setting by a trained person. In a real case of overdose, Dotarem can be removed from the body by haemodialysis (blood cleaning).
If you have any further questions on the use of this product ask your doctor
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects occur during the injection or within the first hour following administration. Some effects can occur up to several days after Dotarem injection.
Side effects of Dotarem are generally mild to moderate and are temporary.
There is a small risk (rare) that you may have an allergic reaction to Dotarem. Such reactions can be severe and exceptionally result in shock (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 them.
• swelling of the face, mouth ot throat which may cause you difficulties in swallowing or breathing
• hypotension (low blood pressure)
• breathing difficulties
• whistling breathing
• coughing
• itching
• runny nose
• sneezing
• eye irritation
• urticaria (patches of red skin, severely itching)
Altogether, the side effects which have been described for Dotarem are the following:
Very common side effects (probably affecting more than 1 in 10 people)
• headaches
• tingling sensation
Common side effects (probably affecting up to 1 in 10 people)
• sensation of warmth or cold and/or pain at the injection site
• nausea (feeling sick)
• vomiting (being sick)
• redness of the skin, itching and rash
Uncommon side effects (probably affecting up to 1 in 100 people)
• allergic reactions
Rare side effects (probably affecting fewer than 1 in 1,000 people)
• unusual taste in the mouth
• urticaria (rash with itching and burning),increased sweating
Very rare side effects (probably affecting fewer than 1 in 10,000 people)
• agitation, anxiety
• coma, seizures, syncope (brief loss of consciousness), faintness (dizziness and feeling of imminent loss of consciousness), dizziness, disorder of smell (perception of often unpleasant odours), tremor
• conjunctivitis, red eye, blurred vision, increased tear secretion, eye swelling
• cardiac arrest, acceleration or abnormal slowing of heart beat, irregular heart beat, palpitations, hypotension or hypertension, increased diameter of blood vessels, pallor
• respiratory arrest, pulmonary oedema, breathing difficulties, feeling of tight throat, wheezing, feeling of blocked nose, sneezing, cough, feeling of dry throat
• diarrhoea, stomach pain, increased saliva secretion
• eczema, other skin reactions (e.g.: red skin)
• muscle contractures, muscle weakness, back pain
• malaise, chest pain, chest discomfort, fever, rigors, swelling of the face, fatigue, injection site discomfort, injection site reaction, injection site swelling, diffusion of the product outside of blood vessels that can lead to inflammation (redness and local pain) or necrosis (death of the cells of the skin) at the injection site, superficial phlebitis
• decrease in oxygen level in blood
Frequency unknown:
• nephrogenic systemic fibrosis
Injection of Dotarem into small veins can cause reddening and swelling around the site of injection. If Dotarem is accidently injected outside the vein, pain can occur around the site of injection.
Superficial phlebitis (blood clot in the vein which causes inflammation)has been reported in rare cases.
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. If, during the weeks following the MRI examination, you notice changes in the colour and/or thickness of your skin in any part of your body, inform the radiologist who performed the examination.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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..
The vials do not require any special storage conditions. The pre-filled syringe must not be frozen.
Do not use this medicine 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 that month.
It is unlikely that you will be asked to dispose of any left over Dotarem. If this happens ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Dotarem contains
• The active substance is gadoteric acid. One ml of solution for injection contains 279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid.
• The other ingredients are meglumine and water for injection.
What Dotarem looks like and contents of the pack
Dotarem is a clear, colourless to yellow solution for intravenous injection.
The Dotarem pack contains one vial of 5, 10, 15 or 20 ml or one pre-filled syringe of 10, 15 or 20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Guerbet
BP 57400 - 95943 Roissy CdG cedex - France
Tel.: +33 1 45 91 50 00
E-mail: brigitte.gayet@guerbet-group.com
Manufacturer:
Guerbet
16-24 rue Jean Chaptal - 93600 Aulnay-sous-Bois - France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Guerbet Laboratories Ltd.,
Avon House, 435 Stratford Road, Shirley, Solihull,
West Midlands B90 4AA
This medicinal product is authorised in the Member States of the EEA under the following name : Dotarem
This leaflet was last revised in September 2014.
The following information is intended for medical or healthcare professionals only:
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 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 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 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 in infants up to 1 year of age, Dotarem should only be used to this group of 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 Dotarem 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. If electronic patient records o are used, the name of the product, the batch number and the dose should be entered into the patient record.
Guerbet I is:
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Dotarem is a diagnostic agent used in adults and children. It belongs to the group of contrast agents used for magnetic resonance imaging (MRI).
Dotarem is used to enhance the contrast of the images obtained during MRI examinations. This contrast enhancement improves the examination of some areas of the body.
This medicine is for diagnostic use only.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOTAREM
You should read the information in this section carefully.
You and your doctor should consider this information before you are given Dotarem.
You should NOT be given DOTAREM if:
• you are allergic to the active substance or any of the other ingredients of Dotarem (listed in section 6)
• you are allergic to medicines containing gadolinium (like other contrast agents used for MRI).
Remove all metallic objects that you wear before the examination. Inform your doctor if you have:
• a pacemaker
• a vascular clip
• an infusion pump
• a nerve stimulator
• a cochlear implant (implant 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 precautions
Inform your doctor if the following applies to you:
• you have previously reacted to a contrast agent during an examination
• you have asthma
• you have a history of allergy (such as seafood allergy, hay fever, urticaria)
• you are being treated with a beta-blocker (medicine for heart and blood pressure disorders)
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant
• you have had convulsions or you are being treated for epilepsy
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.
In all these cases, your doctor will only give you Dotarem if the benefits outweigh the risks. If you are given Dotarem, your doctor will take the precautions necessary and the administration of Dotarem will be carefully monitored.
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.