Gadovist 1 mmol/mL injection – gadobutrol contrast agent for MRI

Gadovist contains gadobutrol, a gadolinium-based paramagnetic contrast agent that is injected into a vein before or during magnetic resonance imaging (MRI). The contrast makes diseased parts of the body easier to see and helps distinguish healthy from abnormal tissue.

In Serbia it is authorised as Gadovist®, 1 mmol/mL, solution for injection in a pre-filled syringe (glass or plastic, 5 x 7.5 mL), and in 30 mL glass vials. It is intended for diagnostic use only and is given only by a healthcare professional experienced in MRI.

What is Gadovist used for and how is it given during MRI?

Key facts about the medicine

What is Gadovist used for?

According to the leaflet and the Summary of Product Characteristics, Gadovist is used in adults and children of all ages (including full-term newborns) for:

• contrast enhancement in MRI of the head (brain) and spine;
• MRI of the liver or kidneys when focal lesions are suspected or confirmed, to assess whether they are benign or malignant;
• magnetic resonance angiography (imaging of blood vessels);
• MRI of abnormalities in other parts of the body.

It is used only when diagnostic information is essential and cannot be obtained with unenhanced MRI.

How is it given and dosed?

A healthcare professional gives the medicine as an injection into a vein, and imaging can start immediately. The dose depends on body weight and the region being imaged:

• In people aged 65 and over no dose adjustment is needed, but kidney function may be checked before use.
• Solution not used for one examination is discarded.

Special patient groups

• Newborns (up to 4 weeks) and infants (up to 1 year): because of immature kidney function the medicine is given only after careful assessment by the doctor.
• Elderly: checking kidney function before use is recommended.
• Severe kidney impairment and the period around liver transplantation: use only when essential, because of the risk of nephrogenic systemic fibrosis.

Contraindications – when the medicine must not be used

You must not receive Gadovist if you are allergic to gadobutrol or any of the excipients.

Warnings and precautions

Tell your doctor before the scan if:

• you have or have had an allergy (e.g. hay fever, hives) or asthma;
• you have previously reacted to a contrast agent;
• you have kidney disease or have had, or are expecting, a liver transplant;
• you have epilepsy or another nervous system disease;
• you have a pacemaker, implants or clips containing iron.

According to the Summary of Product Characteristics, gadobutrol must not be given into the spinal canal (intrathecally), and redness and swelling are possible when injected into small veins. Patients with cardiovascular disease are at higher risk of serious hypersensitivity reactions.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take, including those without prescription. No specific interactions with food and drink are described for Gadovist.

Pregnancy and breast-feeding

• Pregnancy: gadobutrol can cross the placenta; it is not used in pregnancy unless absolutely necessary – tell your doctor if you are or might be pregnant.
• Breast-feeding: the doctor decides whether you continue breast-feeding or stop for 24 hours after administration.

Driving and using machines

Gadovist has no influence on the ability to drive and use machines. It contains less than 1 mmol (23 mg) of sodium per dose.

Possible side effects

The most serious, rare side effects are cardiac arrest, acute respiratory distress syndrome, fluid in the lungs and serious allergy-like reactions (including stopping breathing and shock). Tell the staff immediately if you notice swelling of the face, lips, tongue or throat, coughing and sneezing, difficulty breathing, itching, runny nose or hives.

• common (up to 1 in 10): headache, nausea;
• uncommon (up to 1 in 100): allergy-like reactions (low blood pressure, hives, swelling of the face and eyelids, facial flushing), dizziness, taste disturbance, numbness and tingling, shortness of breath, vomiting, skin redness and itching, rash, injection site reactions, feeling hot;
• rare (up to 1 in 1,000): fainting, convulsions, smell disturbance, fast heartbeat and palpitations, dry mouth, general discomfort, feeling cold;
• frequency not known: cardiac arrest, acute respiratory distress syndrome, pulmonary oedema, nephrogenic systemic fibrosis (hardening of the skin that may also affect internal organs); increased blood creatinine has also been observed.

Delayed reactions, from several hours to several days after administration, have rarely been seen – tell your doctor or radiologist immediately if this happens.

Overdose, missed dose and stopping treatment

• Overdose: unlikely; if it happens, the doctor treats the symptoms and may use dialysis to remove the medicine, while checking heart function. Dialysis has not been shown to prevent nephrogenic systemic fibrosis.
• Missed dose and stopping: not applicable – the medicine is given once during the examination.

Related information

There is no further internal content for this hospital medicine. Please ask your doctor or radiologist about the examination.

Composition, pack and manufacturer

• Active substance: gadobutrol – 604.72 mg per mL (1 mmol/mL).
• Excipients: calcobutrol sodium, trometamol, hydrochloric acid, water for injections.
• Pack: carton with 5 pre-filled syringes (type I glass or cycloolefin polymer) of 7.5 mL; carton with 10 glass vials of 30 mL.
• Marketing authorisation holder: Bayer d.o.o. Beograd, Omladinskih brigada 88b, Belgrade. Manufacturers: Bayer AG, Berlin, Germany; Bayer farmacevtska družba d.o.o., Ljubljana, Slovenia.

Storage

• No special storage conditions are required.
• Solution not used for one examination is discarded; an opened syringe is stable for 24 hours at 20–25 °C but should be used immediately.
• Keep out of the sight and reach of children.

Frequently asked questions

Is Gadovist safe in kidney disease?

In severe kidney impairment and in patients before or after liver transplantation use is not recommended unless essential – then only one dose is given, and the next not before 7 days, because of the risk of nephrogenic systemic fibrosis.

How long do I stay at the facility after the injection?

According to the leaflet, the patient is observed for at least 30 minutes after the injection, because most reactions occur within this period.

May I breast-feed after an examination with Gadovist?

The doctor will decide whether you should continue breast-feeding or stop for 24 hours after administration.

Can I drive after the examination?

Gadovist has no influence on the ability to drive and use machines. If you feel unwell or dizzy after the examination, wait until the symptoms pass.

Sources

• ALIMS – Summary of Product Characteristics, Gadovist® 1 mmol/mL solution for injection in pre-filled syringe (SmPC, Serbian)
• ALIMS – Package leaflet, Gadovist® 1 mmol/mL pre-filled syringe (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Gadovist® 1 mmol/mL solution for injection, vial (SmPC, Serbian)
• ALIMS – Package leaflet, Gadovist® 1 mmol/mL, vial (PIL, Serbian)

Sources checked on: 25 October 2026.