What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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.

Package leaflet: Information for the user

Dotagraf 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 or radiologist.
  • If you get any side effects, talk to your doctor, radiologist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Dotagraf is and what it is used for

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)

  • MRI of the Central Nervous System including defects (lesions) in brain, spinal cord and adjacent tissue;
  • Whole body MRI including defects (lesions) in liver, kidneys, pancreas, pelvis, lungs, heart, breast and musculoskeletal system.

Adult population

  • MR angiography including defects (lesions) and narrowing (stenosis) in arteries, except in coronary arteries.

2. What you need to know before Dotagraf is used

You should NOT be given Dotagraf

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to medicines containing gadolinium (like other contrast agents used for magnetic resonance imaging).

Warnings and precautions

Inform 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 allergy (such as seafood allergy, urticaria, hay fever)
  • you are being treated with a beta-blocker (medicine for heart and blood pressure disorders, 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 your 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 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.

Neonates and infants

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:

  • 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 magnetic resonance imaging devices use very strong magnetic fields.

Other medicines and Dotagraf

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.

Dotagraf with food and drink

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

3. How Dotagraf is used

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.

Dosage

Your doctor or radiologist will determine the dose you will receive and supervise the injection.

Dosage in special patient groups

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.

If too much Dotagraf has been administered to you

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.

4. Possible side effects

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:

  • swelling of the face, mouth or throat which may cause you difficulties in swallowing or breathing
  • swelling of hands or feet
  • lightheadedness (low blood pressure)
  • breathing difficulties
  • whistling respiration
  • coughing
  • itching
  • runny nose
  • sneezing
  • eye irritation
  • hives
  • skin rash

Uncommon side effects (may affect up to 1 in 100 people)

  • hypersensitivity (allergic reaction)
  • headaches
  • unusual taste in the mouth
  • dizziness
  • somnolence (sleepiness)
  • sensation of tingling, warmth/burning, cold and/or pain
  • low or high blood pressure
  • nausea (feeling sick)
  • stomach pain
  • rash
  • feeling hot, feeling cold
  • asthenia (loss of energy; weakness)
  • injection site discomfort, injection site reaction, injection site coldness, injection site swelling, diffusion of the product outside of blood vessels that can lead to inflammation (redness and local pain)

Rare side effects (may affect up to 1 in 1,000 people)

  • anxiety, faintness (dizziness and feeling of imminent loss of consciousness)
  • eyelid swelling
  • palpitations
  • sneezing
  • vomiting (being sick)
  • diarrhoea
  • increased saliva secretion
  • hives, itching, sweating
  • chest pain, chills

Very rare side effects (may affect up to 1 in 10,000 people)

  • anaphylactic or anaphylactic-like reactions (a serious, potentially life-threatening allergic reaction)
  • agitation
  • coma, seizures, syncope (brief loss of consciousness), disorder of smell (perception of often unpleasant odours), tremor
  • conjunctivitis, red eye, blurred vision, increased tear secretion
  • cardiac arrest, accelerated or slow heart beat, irregular heart beat, vascular dilatation, pallor
  • respiratory arrest, pulmonary oedema, breathing difficulties, wheezing, stuffy nose, cough, dry throat, throat constriction with feeling of suffocation, respiratory spasms, throat swelling
  • eczema, redness of the skin, swelling of the lips and localized in the mouth
  • muscle cramps, muscle weakness, back pain
  • malaise, chest discomfort, fever, swelling of the face, diffusion of the product outside of blood vessels that can lead to tissue dying off at the injection site, inflammation of a vein
  • decrease in oxygen level in blood

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.

Reporting of side effects

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

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Dotagraf

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.

6. Contents of the pack and other information

What Dotagraf contains

  • The active substance is gadoteric acid. One millilitre of solution for injection contains 279.32 mg of gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).
  • The other ingredients are meglumine, 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) and water for injection.

What Dotagraf looks like and contents of the pack

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.

Marketing Authorisation Holder United Kingdom

Bayer plc
400 South Oak Way
Reading
RG2 6AD

Manufacturer

Sanochemia Pharmazeutika GmBH
Landegger Straße 7
2491 Neufeld/Leitha
Austria

This leaflet was last revised in July 2020.

007_0