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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00010/0590.
Dotagraf 0.5 mmol/ml solution for injection
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Dotagraf 0.5 mmol/ml
Solution for injection
Gadoteric acid
1. What Dotagraf is and what it is used for
2. What you need to know before Dotagraf is used
3. How Dotagraf is used
4. Possible side effects
5. How to store Dotagraf
6. Contents of the pack and other information
Dotagraf is a contrast agent that contains gadoteric acid. It is for diagnostic use only.
Dotagraf is used to enhance the contrast of the images obtained in examinations with Magnetic Resonance Imaging (MRI). This contrast enhancement improves the visualisation and delineation in:
Adult and paediatric population (0-18 years)
Adult population
Inform your doctor or radiologist if the following applies to you:
In all these cases, your doctor or radiologist will assess the benefit-to-risk ratio and decide whether you should be given Dotagraf. If you are given Dotagraf, your doctor or radiologist will take the precautions necessary and the administration of Dotagraf 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 Dotagraf, especially if you are 65 years of age or older.
As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Dotagraf will only be used in these patients after careful consideration by the doctor.
Remove all metallic objects you may wear before the examination. Inform your doctor or radiologist if you have:
This is important as these can result in serious problems, as magnetic resonance imaging devices use very strong magnetic fields.
Tell your doctor or radiologist if you are taking, have recently taken or might take any other medicines. In particular, please inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart and blood pressure disorders such as beta-blocking agents, vasoactive substances, angiotensin-converting enzyme inhibitors, angiontensin II receptor antagonists.
There are no known interactions between Dotagraf 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or radiologist for advice before taking this medicine.
Pregnancy
Dotagraf should not be used during pregnancy unless strictly necessary.
Breast-feeding
Your doctor or radiologist will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive Dotagraf.
No data are available on the effects of Dotagraf on the ability to drive. If you feel unwell after the examination, you should not drive or use machines.
Dotagraf will be administered to you by intravenous injection.
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 drugs if necessary. If you experience an allergic reaction, the administration of Dotagraf will be stopped.
Dotagraf can be administered by hand or by the mean of an automatic injector. In neonates and infants, 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.
Your doctor or radiologist will determine the dose you will receive and supervise the injection.
The use of Dotagraf 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 Dotagraf 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, Dotagraf will only be used in these patients after careful consideration by the doctor. Neonates and infants should only receive one dose of Dotagraf 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.
It is highly unlikely that you will be given an overdose. You will be given Dotagraf in a medical setting by a trained person. In the real case of overdose, Dotagraf 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.
If you have any further questions on the use of this medicine, ask your doctor or radiologist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 Dotagraf injection.
There is a small risk that you may have an allergic reaction to Dotagraf. 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:
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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 Dotagraf 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.
If you get any side effects, talk to your radiologist, pharmacist, doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special precaution for storage.
Chemical and physical in-use stability has been demonstrated 72 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless opening has taken place in controlled and validated aseptic conditions.
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.
Dotagraf is a clear, colourless to yellow solution for intravenous injection.
The Dotagraf pack contains one or ten vials with 10, 15 and 20 ml of solution for injection.
Not all pack sizes may be marketed.
This leaflet was last revised in July 2020.
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