Patient leaflet - Vistadot 0.5 mmol/ml solution for injection
1. What Vistadot is and what is it used for
Vistadot is a diagnostic agent used in adults and children. It belongs to the group of contrast agents used for magnetic resonance imaging (MRI).
Vistadot 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.
2. What you need to know before you are given Vistadot
You should NOT be given Vistadot
- if you are allergic to gadoteric acid 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 MRI).
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 Vistadot. If you are given Vistadot, your doctor or radiologist will take the precautions necessary and the administration of Vistadot 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 Vistadot, 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, Vistadot will only be used in these patients after careful consideration by the doctor.
Remove all metallic objects that you 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 MRI machines use very strong magnetic fields.
Other medicines and Vistadot
Tell your doctor or radiologist if you are taking or 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-blockers agents, vasoactive substances, angiotensin-converting enzyme inhibitors, angiontensin II receptor antagonists.
Vistadot with food and drink
There are no known interactions between Vistadot and food and drink. However, please check with your doctor or radiologist 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
Vistadot 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 Vistadot.
Driving and using machines
No data are available on the effects of Vistadot on the ability to drive. If you feel unwell after the examination, you should not drive or use machines.
3. How Vistadot is used
Vistadot 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 Vistadot will be stopped.
Vistadot 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 any 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 Vistadot 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 Vistadot during a scan and you should not receive a second injection for at least 7 days.
Use in 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, Vistadot will only be used in these patients after careful consideration by the doctor. Children should only receive one dose of Vistadot 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 Vistadot has been administered to you
It is highly unlikely that you will be given an overdose. You will be given Vistadot in a medical setting by a trained person. In a real case of overdose, Vistadot 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 Vistadot injection.
There is a small risk that you may have an allergic reaction to Vistadot. 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 shock. Inform immediately your doctor or radiologist 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 (hypotension)
- 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
- headaches
- unusual taste in the mouth
- dizziness
- somnolence
- sensation of tingling, warmth, cold and/or pain
- low or high blood pressure
- nausea (feeling sick)
- stomach pain
- rash
- feeling hot, feeling cold
- asthenia
- 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).
The following information is intended for medical or healthcare professionals only:
Please refer to the Summary of Product Characteristics for details on the method of administration and full prescribing information.
Prior to administration of Vistadot, 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 Vistadot, 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 Vistadot, 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, Vistadot 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, Vistadot 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, Vistadot injections should not be repeated unless the interval between injections is at least 7 days.
WIP URN: XXXX -070425-PIL-02 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
- 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 heartbeat, irregular heartbeat, 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 in the mouth
- muscle contractures, 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 gadoteric acid 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 radiologist. 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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vistadot
Keep this medicine out of the sight and reach of children.
The medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the vial and on the carton, after “Exp”. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration (such as particles in solution or fissures in the vial).
6. Contents of the pack and other information
What Vistadot 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 (as meglumine salt).
- The other ingredients are meglumine and water for injection.
What Vistadot looks like and contents of the pack
Vistadot is a clear, colourless to pale yellow solution for intravenous injection.
The Vistadot pack contains one or ten glass vial(s) of 5 ml, 10 ml, 15 ml, 20 ml, 60 ml or 100 ml solution for injection sealed with a stopper of bromobutyl rubber, with a cap of aluminium and plastic.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Euro-link Pharma Ltd.,
110 Butterfield,
Great Marlings,
Luton, Bedfordshire,
LU2 8DL, UK
Manufacturer:
Ascenders Consulting Services Limited,
110 Butterfield,
Great Marlings,
Luton, Bedfordshire,
LU2 8DL, UK
This leaflet was last revised in April 2025
As the renal clearance of Vistadot may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Haemodialysis shortly after Vistadot administration may be useful at removing Vistadot 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.
Vistadot 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 Vistadot, 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 are used, the name of the product, the batch number and the dose should be entered into the patient record.
WIP URN: XXXX -070425-PIL-02