Dotagita 0.5 Mmol/Ml Solution For Injection
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Dotagita 0.5 mmol/ml solution for injection
Gadoteric acid
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dotagita is and what it is used for
2. What you need to know before you use Dotagita
3. How you will be given Dotagita
4. Possible side effects
5. How to store Dotagita
6. Contents of the pack and other information
What Dotagita is and what it is used for
Dotagita is a diagnostic agent. It belongs to the group of contrast agents used for magnetic resonance imaging (MRI).
Dotagita is used to enhance the contrast of the images obtained during MRI examinations. This contrast enhancement improves the visualisation and delineation of:
• defects (lesions) in brain, spinal cord and adjacent tissue;
• whole body defects (lesions) including lesions in liver, kidneys, pancreas, pelvis, lungs, heart, breast and musculoskeletal system;
• defects (lesions) and narrowing (stenosis) in arteries, except in coronary arteries.
This medicine is for diagnostic use only.
What you need to know before you use Dotagita
The information in this section should be read carefully. The information given should be taken into consideration by you and your doctor or radiologist before you are given Dotagita.
You should not be given Dotagita:
• if you are allergic (hypersensitive) to gadoteric acid, to meglumine or to any medicinal products containing gadolinium (like other contrast agents used for MRI) or to any of the other ingredients contained in this medicine mentioned in section 6.
Warnings and precautions
Talk to your doctor or radiologist 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 allergies (such as seafood allergy, urticaria, hay fever)
• you are taking a beta blocker (a medicine used against high blood pressure, heart problems and other conditions; such as metoprolol)
• your kidneys do not work properly
• you have recently had, or soon expect to have, a liver transplant
• you have a disease affecting your heart or blood vessels
• you have had convulsions or you are being treated for epilepsy.
In all these cases, your doctor or radiologist will assess the benefit to risk ratio and decide whether you should be given Dotagita. If you are given Dotagita, your doctor or radiologist will take the precautions necessary and the administration of Dotagita will be carefully monitored.
Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before making the decision to use Dotagita, 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, Dotagita will only be used in these patients aftercareful consideration by the doctor.
Remove all metallic objects that you wear before the examination. Inform yourdoctor if you have:
• a pacemaker
• a vascularclip
• an infusion pump
• a nerve stimulator
• a cochlear implant (implant in the innerear)
• any suspected metallic foreign bodies, particularly in the eye.
This is extremely important as these can result in serious problems, as magnetic resonance imaging devices use very strong magnetic fields.
Other medicines and Dotagita
Tell your doctor, radiologist or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, please inform your doctor or radiologist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta blocking agents (such as metoprolol), vasoactive substances (such as doxazosin), angiotensin converting enzyme inhibitors (such as ramipril), angiontensin II receptorantagonists (such as valsartan).
Dotagita with food and drink
There are no known interactions between Dotagita and food and drinks. However, please check with your doctor, radiologist or pharmacist if it is required not to eat or drink before the examination.
Pregnancyand breast-feeding
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor, radiologist or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are or might become pregnant as Dotagita should not be used during pregnancy unless strictly necessary.
Breastfeeding
Tell your doctor if you are breastfeeding 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 Dotagita.
are working.
If too much Dotagita has been administered to you
It is highly unlikely that you will be given an overdose. You will be given Dotagita in a medical setting by a trained person. In the real case of overdose, Dotagita can be removed from the body by haemodialysis (blood cleaning).
Additional information regarding the use and handling by the medical or healthcare professional is given at the end of this leaflet.
Driving and using machines If you have any further questions on the use of this medicine, ask your
doctor or radiologist.
No data are available on the effects of Dotagita on the ability to drive.
Possible side effects
If you feel unwell after the examination, you should not drive or use machines.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Dotagita will be given by an authorised healthcare professional directly into a vein (intravenously).
During the examination, you will be under the supervision of a doctor or radiologist. A needle will be left in your vein; this will allow the doctor or radiologist to inject you with appropriate emergency medicines if necessary. If you experience an allergic reaction, the administration of Dotagita will be stopped.
Dotagita can be administered by hand or by the mean of an automatic injector. In children, the product will only be administered by hand.
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 the possible complications that can occur.
Dose
Your doctor or radiologist will determine the dose you will receive and supervise the injection.
Dose in special patient groups
The use of Dotagita 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 Dotagita 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, Dotagita will only be used in these patients aftercareful consideration by the doctor. Neonates and infants should only receive one dose of Dotagita 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 1 8 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
After the administration, you will be kept under observation for at least half an hour. Most side effects occur immediately or sometimes delayed. Some effects can occur up to seven days after Dotagita injection.
There is a small risk that you may have an allergic reaction to Dotagita. Such reactions can be severe and result in shock (case of allergic reaction that could put your life in danger).
The following symptoms may be the first signs of a shock. Inform immediately your doctor, radiologist or health professional if you feel any of them:
• swelling of the face, mouth or throat which may cause you difficulties in swallowing or breathing
• swelling of hands orfeet
• lightheadedness (hypotension)
• breathing difficulties
• whistling respiration
• coughing
• itching
• runny nose
• sneezing
• eye irritation
• hives
• skin rash
Altogether, the side effects which have been described for Dotagita are the following:
Very common side effects (may affect more than 1 in 10 people):
• headaches
• tingling sensation
Common side effects (may affect up to 1 in 10 people):
• sensation ofwarmth 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 (may affect up to 1 in 100 people):
• allergic reactions
How to store Dotagita
Rare side effects (may affect up to 1 in 1,000 people):
• unusual taste in the mouth
• hives, increased perspiration
Very rare side effects (may affect up to 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, accelerated or slow heart beat, irregular heart beat, palpitations, loworhigh blood pressure, vascular dilatation, pallor
• respiratory arrest, pulmonary oedema, breathing difficulties, feeling of tight throat, wheezing, stuffy nose, sneezing, cough, dry throat
• diarrhoea, stomach pain, increased saliva secretion
• eczema
• muscle contractures, muscle weakness, back pain
• malaise, chest pain, chest discomfort, fever, chills, 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 tissue dying off at the injection site, inflammation of a vein
• decrease in oxygen level in blood
Not known
(frequency cannot be estimated from the available data):
• nephrogenic systemic fibrosis
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 Dotagita 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 nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
This medicinal product does not require any special storage conditions. 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 vial and on the carton, after the abbreviation "Exp". The expiry date refers to the last day of that month.
Do not use this medicinal product, if you have found any visible signs of damage (for example, particles in the solution of cracks in the glass vial).
Chemical and physical in use stability has been demonstrated for 48 hours at 21 °C to 23 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless opening has taken place in controlled and validated aseptic conditions.
Contents not used in a patient during one investigation must be discarded.
Each vial is for single patient use only.
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.
Contents of the pack and other information
What Dotagita contains
• The active substance is gadoteric acid. One ml solution for injection contains 279.32 mg gadoteric acid (as meglumine salt), equivalent to 0.5 mmol.
• The other ingredients are meglumine and water for injection.
What Dotagita looks like and contents of the pack
Dotagita is a clear, colourless to pale yellow solution practically free from visible particles, for intravenous injection. Each pack contains one or 1 0 single dose vials with 1 0 ml (filled with 5 ml or 1 0 ml), and 20 ml (filled with 1 5 ml or 20 ml) or 60 ml of solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Agfa Healthcare Imaging Agents GmbH Am Coloneum 4 50829 Cologne Germany
This leaflet was last revised in 07/2014
The following information is intended for healthcare professionals only:
Posology
• Brain and spinal MRI:
In neurological examinations, the recommended dose is 0.1 mmol/kg body weight, corresponding to 0.2 ml/kg body weight. In some cases, after administration of 0.1 mmol/kg body weight to patients with brain tumours, an additional dose of 0.2 mmol/kg body corresponding to 0.4 ml/kg body weight, may improve tumour characterisation and facilitate therapeutic decision making.
• MRI of other organs and Angiography:
The recommended dose for intravenous injection is 0.1 mmol/kg (i.e. 0.2 ml/kg) to provide diagnostically adequate contrast.
• Angiography: In exceptional circumstances (e.g. failure to gain
satisfactory images of an extensive vascular territory) administration of a second consecutive injection of 0.1 mmol/kg body weight, equivalent to 0.2 ml/kg body weight may be justified. However, if the use of 2 consecutive doses of Dotagita is anticipated prior to commencing angiography, use of 0.05 mmol/kg body weight, equivalent to 0.1 ml/kg body weight for each dose may be of benefit, depending on the imaging equipment available.
• Children: The 0.1 mmol/kg body weight dose applies to all indications except angiography due to insufficient data on efficacy and safety in this indication.
• Due to immature renal function in neonates up to 4 weeks of age and in infants up to 1 year of age, Dotagita 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, Dotagita injections should not be repeated unless the interval between injections is at least 7 days.
• In neonates and infants the required dose should be administered by hand.
• Patients with renal impairment: The adult dose applies to patients with mild to moderate renal impairment
(GFR > 30 ml/min/1,73m2).
See also below "Impaired renal function".
• Patients with hepatic impairment: The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period.
Method of administration
• Dotagita is indicated for intravenous administration only. Dotagita must not be administered by subarachnoid (or epidural) injection.
• Infusion rate: 3 5 ml/min (for angiographic procedures, higher infusion rates up to 1 20 ml/min, i.e. 2 ml/sec, may be used for angiographic procedures).
• Optimal imaging: within 45 minutes after injection.
• Optimal image sequence: T1 weighted.
• Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.
• Prepare a syringe with a needle. Remove the plastic disk. After cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle. Withdraw the quantity of product required for the examination and inject it intravenously.
• Each vial is for single patient use only. Contents not used in a patient during one investigation must be discarded.
• The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used.
Impaired renal function
Prior to administration of Dotagita, 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/l .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 Dotagita, 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 Dotagita, 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, Dotagita injections should not be repeated unless the interval between injections is at least 7 days.
Haemodialysis shortly after Dotagita administration may be useful at removing Dotagita 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.
Elderly
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.
Instructions on handling
The peel off tracking label on the vials 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 are used, the name of the product, the batch number and the dose should be entered into the patient record.
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