Gadovist 1 mmol/ml solution for injection in pre-filled syringe / pre-filled cartridge
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Gadovist 1 mmol/ml solution for injection in pre-filled syringe / pre-filled cartridge
Gadobutrol
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, the person administering Gadovist (the radiologist), or hospital or imaging center staff where the MRI (magnetic resonance imaging) will be performed.
- If you experience any adverse effects, consult your doctor or radiologist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Gadovist is and what it is used for
- What you need to know before using Gadovist
- How to use Gadovist
- Possible side effects
- How to store Gadovist
- Contents of the pack and other information
1. What Gadovist is and what it is used for
Gadovist is a contrast agent for magnetic resonance imaging (MRI) used in the diagnosis of the brain, spinal cord, and blood vessels. Gadovist may also help your doctor determine the type of abnormalities (benign or malignant) known or suspected in the liver and kidneys.
Gadovist may also be used in MRI for abnormalities in other parts of the body. It enhances the visualization of abnormal structures or lesions and helps differentiate between healthy and diseased tissue.
It is indicated in adults and children of all ages (including full-term neonates).
How Gadovist works
MRI is an imaging diagnostic method that uses the behavior of water molecules in normal and abnormal tissues. This is performed using a complex system of magnets and radio waves. Computers record the activity and convert it into images.
Gadovist is administered by injection into your vein. This medicine is for diagnostic use only and will be given to you only by a healthcare professional experienced in the clinical practice of MRI.
2. What you need to know before using Gadovist
Do not use Gadovist if you
- are allergic to gadobutrol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor before using Gadovist if you
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have or have had an allergy (for example, hay fever, hives) or asthma
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have previously experienced a reaction to any contrast agent
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have severely impaired kidney function
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have brain disorders involving seizures (fits) or other nervous system diseases
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have a pacemaker or any implant or clip containing iron in your body.
Your doctor will decide whether or not the planned examination can be performed.
- Allergic-type reactions or other types of reactions causing heart problems, difficulty breathing, or skin reactions may occur after using Gadovist. Severe reactions are possible. Most of these reactions occur within half an hour after administration of Gadovist. Therefore, you will be monitored after treatment. Delayed reactions (after hours or days) have been observed (see section 4).
Kidneys/Liver
Inform your doctor if
- your kidneys are not functioning properly
- you have recently undergone, or are about to undergo, a liver transplant.
Your doctor may decide to perform a blood test to check your kidney function before deciding to use Gadovist, especially if you are 65 years of age or older.
Newborns and infants
Due to the immaturity of renal function in newborns up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful medical assessment.
Other medicines and Gadovist
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
- Pregnancy
Gadobutrol may cross the placenta. It is unknown whether it affects the fetus. You must inform your doctor if you think you are pregnant or could be pregnant, as Gadovist should not be used during pregnancy unless considered absolutely necessary.
- Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will assess whether you should continue or interrupt breastfeeding for 24 hours after administration of Gadovist.
Gadovist contains sodium
This medicine contains less than 23 mg of sodium per dose (based on the average amount administered to a 70 kg person); this is essentially "sodium-free".
3. How to use Gadovist
Gadovist is administered by a healthcare professional through a small needle into a vein. Your MRI scan may begin immediately afterward.
After the injection, you will remain under observation for at least 30 minutes.
Recommended dosage
The usual dose appropriate for you will depend on your body weight and the region being examined by MRI:
In adults, a single injection of 0.1 millilitres of Gadovist per kg of body weight is recommended (this means that for a person weighing 70 kg, the dose would be 7 millilitres). However, an additional injection of up to 0.2 millilitres per kg of body weight may be given within 30 minutes after the first injection. A total dose of up to 0.3 millilitres of Gadovist per kg of body weight may be administered (this means that for a person weighing 70 kg, the dose would be 21 millilitres) for imaging of the central nervous system (CNS) and contrast-enhanced magnetic resonance angiography (MRA). A minimum dose of 0.075 millilitres of Gadovist per kg of body weight (this means that for a person weighing 70 kg, the dose would be 5.25 millilitres) may be used for CNS imaging.
Additional information on the administration and handling of Gadovist is provided at the end of the leaflet.
Dosage in special populations
The use of Gadovist is not recommended in patients with severe renal impairment or in patients who have recently undergone or are about to undergo a liver transplant. However, if use is required, only one dose of Gadovist should be administered during a single examination, and a second injection should not be given until at least 7 days have passed.
Use in neonates, infants, children, and adolescents
The recommended dose in children of all ages (including term neonates) is a single injection of 0.1 millilitres of Gadovist per kilogram of body weight for all indications (see section 1).
Due to the immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful medical evaluation. Neonates and infants should receive only one dose of Gadovist per examination, and a second injection should not be administered until at least 7 days have passed.
Elderly patients
If you are 65 years of age or older, no dose adjustment is necessary, but a blood test may be performed to check that your kidneys are functioning properly.
If you use more Gadovist than you should
An overdose is unlikely. If it occurs, the doctor will treat all symptoms and may use dialysis to remove Gadovist from your body. There is no evidence that haemodialysis is suitable for preventing the development of nephrogenic systemic fibrosis (NSF; see section 4), and therefore it should not be used to treat this disease. In some cases, your heart will be monitored.
In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone 91 562 04 20).
If you have any further questions about the use of this medicine, ask your doctor or radiologist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them. Most of these reactions occur within the first half hour after administration of Gadovist. Delayed or other types of allergic-type reactions have been observed in rare cases, occurring from several hours to several days after receiving Gadovist. If this happens to you, inform your doctor or radiologist immediately.
The most serious adverse effects (which have been fatal or life-threatening in some cases) are:
- cardiac arrest (cardiac arrest), a severe lung disease (acute respiratory distress syndrome) / fluid in the lungs (pulmonary edema), and severe allergic reactions (anaphylactoid) (including respiratory arrest and shock).
Additionally, in some cases the following adverse effects have been observed, which have been life-threatening or fatal:
- difficulty breathing (dyspnea), loss of consciousness, severe allergic reactions, severe drop in blood pressure that may lead to collapse, respiratory arrest, fluid in the lungs, swelling of the mouth and throat, and low blood pressure.
In rare cases:
- allergic-type reactions (hypersensitivity and anaphylaxis) may occur, including severe reactions (shock) that may require immediate medical intervention.
If you notice:
- swelling of the face, lips, tongue, or throat
- coughing and sneezing
- difficulty breathing
- itching
- nasal congestion
- hives (rash similar to nettle rash)
inform the MRI department staff immediately. These may be the first signs that a serious reaction is occurring. Your examination may be stopped and you may require further treatment.
The most frequently observed adverse effects (may affect 5 or more out of 1,000 people) are:
- headache, feeling of discomfort (nausea), and dizziness.
Most adverse effects are mild to moderate.
Listed below are possible adverse effects observed in clinical trials before approval of Gadovist, categorized by their frequency:
Frequent: may affect up to 1 in 10 people
- headache
- feeling of discomfort (nausea)
Uncommon: may affect up to 1 in 100 people
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allergic-type reaction, for example:
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low blood pressure
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urticaria
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facial swelling
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swelling (edema) of the eyelids
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flushing
The frequency of the following allergic reactions is unknown:
- severe allergic reaction (anaphylactoid shock)
- severe drop in blood pressure that may lead to collapse (shock)
- respiratory arrest
- difficulty breathing (bronchospasm)
- blue lips
- swelling of the mouth and throat
- swelling of the throat
- increase in blood pressure
- chest pain
- swelling of the face, throat, mouth, lips and/or tongue (angioedema)
- conjunctivitis
- increased sweating
- cough
- sneezing
- burning sensation
- pallor (pale skin)
- dizziness, taste disturbance, numbness, and tingling
- difficulty breathing (dyspnea)
- vomiting
- redness of the skin (erythema)
- itching (pruritus, including generalized pruritus)
- rash (including generalized rash, flat red spots (macular rash), small raised localized lesions (papular rash), itchy rash (pruritic rash))
- various types of injection site reactions (e.g., extravasation into adjacent tissue, burning, cold sensation, warmth, redness, rash, pain, or bruising)
- sensation of warmth
Rare: may affect up to 1 in 1,000 people
- fainting
- seizure
- altered sense of smell
- rapid heartbeat
- palpitations
- dry mouth
- general malaise
- feeling of cold
Additional adverse effects reported after approval of Gadovist, with unknown frequency (frequency cannot be estimated from available data):
- cardiac arrest (cardiac arrest)
- a severe lung disease (acute respiratory distress syndrome)
- fluid in the lungs (pulmonary edema)
- cases of nephrogenic systemic fibrosis – NSF (which causes hardening of the skin and may also affect soft tissues and internal organs) have been reported.
After administration of Gadovist, changes in renal function test results (e.g., increases in serum creatinine) have been observed.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or radiologist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gadovist
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after EXP. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.
Chemical, physical, and microbiological stability in use has been demonstrated for a period of 24 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately after opening.
This medicine is a clear solution, colourless to pale yellow. Do not use this medicine if you notice a marked change in colour, or the presence of particles, or if the container appears damaged.
Medicines must not be disposed of via wastewater or household waste. Healthcare professionals will dispose of this medicine when it is no longer needed. This helps protect the environment.
6. Contents of the pack and other information
Composition of Gadovist
The active substance is gadobutrol.
1 ml of injectable solution contains 604.72 mg of gadobutrol (equivalent to 1 mmol of gadobutrol containing 157.25 mg of gadolinium).
1 pre-filled syringe with 5.0 ml contains 3,023.6 mg of gadobutrol.
1 pre-filled syringe with 7.5 ml contains 4,535.4 mg of gadobutrol.
1 pre-filled syringe with 10 ml contains 6,047.2 mg of gadobutrol.
1 pre-filled syringe with 15 ml contains 9,070.8 mg of gadobutrol.
1 pre-filled syringe with 20 ml contains 12,094.4 mg of gadobutrol.
1 pre-filled cartridge with 15 ml contains 9,070.8 mg of gadobutrol.
1 pre-filled cartridge with 20 ml contains 12,094.4 mg of gadobutrol.
1 pre-filled cartridge with 30 ml contains 18,141.6 mg of gadobutrol.
The other components are sodocalcobutrol (see end of section 2), trometamol, hydrochloric acid 1N, and water for injections.
Appearance of the product and contents of the pack
Gadovist is a clear, colourless to pale yellow injectable solution.
Pack contents are:
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1 or 5 pre-filled syringes containing 5, 7.5 and 10 ml of injectable solution (in a 10 ml glass or plastic syringe).
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1 or 5 pre-filled syringes containing 15 ml of injectable solution (in a 17 ml glass syringe or a 20 ml plastic syringe).
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1 or 5 pre-filled syringes containing 20 ml of injectable solution (in a 20 ml glass or plastic syringe).
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1 or 5 pre-filled cartridges containing 15, 20 and 30 ml of injectable solution (in a 65 ml cartridge).
Hospital packs:
- 5 pre-filled syringes containing 5, 7.5, 10, 15, 20 ml of injectable solution
- 5 pre-filled cartridges containing 15, 20, 30 ml of injectable solution
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Germany | Gadovist 1.0 mmol/ml solution for injection in pre-filled syringe/cartridge |
Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, Greece, Italy, Luxembourg, Norway, Portugal, Sweden | Gadovist |
Croatia | Gadovist 1.0 mmol/ml solution for injection in pre-filled syringe/cartridge |
France | GADOVIST 1.0 mmol/ml, solution for injection in pre-filled syringe |
Iceland | Gadovist 1.0 mmol/ml solution for injection in pre-filled syringe/cartridge |
Ireland | Gadovist 1.0 mmol/ml solution for injection in prefilled syringe Gadovist 1.0 mmol/ml solution for injection in prefilled cartridge |
Netherlands | Gadovist 1.0 mmol/ml, solution for injection in prefilled syringe/cartridge |
Slovenia | Gadovist 1.0 mmol/ml solution for injection in pre-filled syringe/cartridge |
Slovakia | Gadovist 1.0 mmol/ml |
Spain | Gadovist 1 mmol/ml solution for injection in pre-filled syringe/cartridge |
Malta | Gadovist 1.0 mmol/ml solution for injection pre-filled syringe/cartridge |
Date of the most recent review of this leaflet: 07/2025.
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)
This information is intended for healthcare professionals only:
- Renal impairment
Before administering Gadovist, it is recommended to assess all patients for potential renal dysfunction through laboratory tests.
Cases of nephrogenic systemic fibrosis (NSF) have been reported following the use of some gadolinium-based contrast agents in patients with severe acute or chronic renal impairment (GFR or glomerular filtration rate < 30 mL/min/1.73 m²). Patients undergoing liver transplantation are at particular risk, as the incidence of renal failure is high in this group. Since NSF may occur with Gadovist, it should only be used in patients with severe renal impairment and in patients during the perioperative period of liver transplantation after careful assessment of the risk/benefit ratio and only if the diagnostic information is essential and cannot be obtained by non-contrast MRI. If Gadovist use is necessary, the dose must not exceed 0.1 mmol/kg body weight. No more than one dose should be administered during a single examination. Due to the lack of data on repeated administration, Gadovist should not be readministered unless at least 7 days have elapsed between injections.
Since renal elimination of Gadovist may be reduced in elderly patients, it is especially important to evaluate patients aged 65 years and older for potential renal dysfunction.
Hemodialysis shortly after Gadovist administration may be helpful for eliminating Gadovist from the body. There is no evidence supporting the initiation of hemodialysis for the prevention or treatment of NSF in patients not already undergoing hemodialysis.
- Pregnancy and Lactation
Gadovist must not be used during pregnancy unless the woman's clinical condition requires treatment with Gadovist.
The decision to continue or interrupt breastfeeding 24 hours after administration of Gadovist will be at the discretion of the physician and the breastfeeding mother.
- Hypersensitivity reactions
As with other intravenous contrast media, Gadovist may be associated with hypersensitivity/anaphylactoid reactions or other idiosyncratic reactions characterized by cardiovascular, respiratory, or cutaneous manifestations, including severe reactions such as shock. In general, patients with cardiovascular disease are more susceptible to serious or even fatal consequences from severe hypersensitivity reactions.
The risk of hypersensitivity reactions may be increased in the following cases:
- previous reaction to contrast media
- history of bronchial asthma
- history of allergic disorders
In patients with a predisposition to allergic reactions, the decision to use Gadovist should be made only after careful assessment of the benefit-risk ratio.
Most of these reactions occur within 30 minutes after administration. Therefore, patient monitoring after administration is recommended.
Appropriate medication for the treatment of hypersensitivity reactions must be available, and emergency measures should be prepared.
In rare cases, delayed reactions (occurring hours or several days later) have been observed.
- Seizure disorders
As with other gadolinium-containing contrast agents, special caution should be taken in patients with a low seizure threshold.
- Overdose
In the case of accidental overdose, cardiovascular monitoring (including ECG) and monitoring of renal function are recommended as precautionary measures.
In cases of overdose in patients with renal impairment, Gadovist can be removed by hemodialysis. Approximately 98% of the contrast agent is eliminated from the body after 3 hemodialysis sessions. However, there is no evidence that hemodialysis is adequate for the prevention of nephrogenic systemic fibrosis (NSF).
- Before injection
This medicinal product is for single use only.
This medicine is a clear, colorless to pale yellow solution. The solution should be inspected visually before use.
Gadovist must not be used if significant discoloration, particulate matter is present, or if the container is damaged.
- Instructions for use
Pre-filled syringes
Gadovist is ready for use.
The pre-filled syringe should be prepared for injection immediately before administration.
The tip cap must be removed from the pre-filled syringe immediately before use.
Glass syringe only:
MANUAL INJECTION
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Plastic syringe only:
MANUAL INJECTION | INJECTION WITH INJECTOR |
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Prefilled Cartridges
The administration of contrast media must be performed by qualified personnel using appropriate procedures and equipment.
The administration of contrast media must be carried out using a sterile technique.
The contrast medium must be administered using a MEDRAD Spectris® type injector.
Instructions provided by the manufacturers of the devices used must be followed.
Any unused contrast medium remaining after an examination must be discarded according to local regulations.
Stability after first opening of the container
Any unused injectable solution must be discarded after use. Chemical, physical, and microbiological stability during use has been demonstrated for 24 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
The detachable label from the prefilled syringes/prefilled cartridges must be affixed to the patient's medical record to allow accurate documentation of the gadolinium-based contrast agent used. The administered dose should also be recorded. In cases where electronic patient records are used, the product name, batch number, and administered dose must be entered into the system.
Dosage
The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose must be calculated according to the patient's body weight and must not exceed the recommended dose per kilogram of body weight specified in this section.
- Adults
CNS Indications
The recommended dose in adults is 0.1 mmol per kilogram of body weight (mmol/kg b.w.), equivalent to 0.1 mL/kg b.w. of the 1.0 M solution.
If there is a persistent, clinically justified suspicion of a lesion despite unremarkable MRI findings, or when obtaining more precise information may influence patient management, an additional dose of up to 0.2 mL/kg b.w. may be administered within 30 minutes following the first injection. A dose of 0.075 mmol of gadobutrol per kg of body weight (equivalent to 0.075 mL of Gadovist per kg of body weight) may be administered as a minimum for CNS imaging.
Whole-body MRI (excluding MRA)
In general, administration of 0.1 mL of Gadovist per kg of body weight is sufficient to address the clinical question.
Contrast-enhanced Magnetic Resonance Angiography (MRA)
Single field-of-view (FOV) imaging: 7.5 mL for body weights below 75 kg; 10 mL for body weights equal to or greater than 75 kg (equivalent to 0.1–0.15 mmol/kg b.w.).
Multiple field-of-view (FOV) imaging: 15 mL for body weights below 75 kg; 20 mL for body weights equal to or greater than 75 kg (equivalent to 0.2–0.3 mmol/kg b.w.).
- Pediatric Population
The recommended dose in children of all ages (including term neonates) is 0.1 mmol of gadobutrol per kilogram of body weight (equivalent to 0.1 mL of Gadovist per kilogram of body weight) for all indications (see section 1).
Due to the immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age, Gadovist should only be used in these patients after careful consideration and at a dose not exceeding 0.1 mmol/kg body weight. No more than one dose should be administered during a single examination. Due to lack of data on repeated administration, Gadovist should not be readministered unless an interval of at least 7 days has elapsed between doses.
Imaging
The required dose is administered intravenously as a bolus injection. Contrast-enhanced MRI may begin immediately after administration (shortly after injection, depending on the pulse sequences used and the study protocol).
Optimal signal enhancement is observed during the first arterial pass for contrast-enhanced MRA and over a period of approximately 15 minutes after Gadovist injection for central nervous system (CNS) indications (timing depends on the type of lesion/tissue).
T1-weighted imaging sequences are particularly suitable for contrast-enhanced examinations.
Additional information on the use of Gadovist is provided in section 3 of the Summary of Product Characteristics.