Patient Medication Information: uses, side effects, how to take - Ambelvist
Serious warnings and precautions box
What AMBELVIST is used for:
AMBELVIST is a contrast agent for magnetic resonance imaging (MRI) of the body including the brain and spine. It is used in adults and in children of all ages.
How AMBELVIST works:
MRI is a form of medical diagnostic imaging that creates detailed images of the organs and tissues inside your body. AMBELVIST makes certain areas appear brighter in your MRI. This helps your healthcare professional see any issues.
| Gadolinium-based contrast agents (such as AMBELVIST) increase the risk of getting a rare and severe disease called Nephrogenic Systemic Fibrosis (NSF) in patients with: |
- Chronic, severe kidney disease, or
- Acute kidney injury.
In NSF, the skin becomes thickened, coarse and hard, which makes bending of the joints difficult. NSF may spread to other parts of the body such as your muscles and organs and even cause death. Your healthcare professional will screen you for kidney problems before you are given AMBELVIST. They will avoid giving AMBELVIST to you if you have certain kidney problems unless it is absolutely necessary. They will make sure to give you the right dose and will wait longer before giving you AMBELVIST again. See also “Other warnings you should know about”, further below, for more information. Not for Intrathecal Use If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as AMBELVIST can cause serious life-threatening side effects such as:
AMBELVIST is for intravenous (IV) use only. |
The ingredients in AMBELVIST are:
Medicinal ingredient: gadoquatrane
Non-medicinal ingredients: calcobutrol, hydrochloric acid, sodium chloride, trometamol and water for injection.
AMBELVIST comes in the following dosage forms:
Solution; 257.9 mg / mL (0.1 mmol / mL) gadoquatrane.
Do not use AMBELVIST if:
- You are allergic to gadoquatrane or to any of the other ingredients in AMBELVIST.
- You are allergic to any part of the AMBELVIST container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive AMBELVIST. Talk about any health conditions or problems you may have, including if you:
- Have had an allergic reaction to contrast agent in the past.
- Have or have had an allergy such as hay fever in the past .
- Have or have had asthma in the past.
- Have or have had a brain condition with seizures in the past.
- Have kidney problems. Your healthcare professional may take blood tests to decide if you should be given AMBELVIST.
- Have had a liver transplant in the last few months, or soon will have one .
Other warnings you should know about:
Accumulation of Gadolinium in the Brain
Gadolinium which is in AMBELVIST may accumulate (build-up) in the brain after multiple administrations. It is not known how this may affect the brain. Your healthcare professional will carefully consider whether to use repeat doses of AMBELVIST and will use the lowest dose necessary.
Nephrogenic Systemic Fibrosis
Receiving AMBELVIST may cause Nephrogenic Systemic Fibrosis (NSF). This is a rare condition which has only been observed so far in patients with kidney problems. NSF causes the skin to become thickened, coarse and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.
Your healthcare professional will screen you for kidney problems before you are given AMBELVIST. Tell your healthcare professional before you receive AMBELVIST if you know you have any kidney problems. You must get immediate medical help if you get any symptom of NSF after you receive AMBELVIST. These include: skin changes including hardening, thickening, burning, itching, scaling, darkening and tightening of the skin, red or dark patches on the skin, stiffness in the joints with trouble moving, pain in the hip bones or ribs, severe pain, muscle weakness. Also tell your healthcare professional if you have ever had symptoms of NSF after receiving MRI in the past.
Your healthcare professional will monitor your health after administering AMBELVIST.
Your healthcare professional will make sure that AMBELVIST has been removed from your body before you receive a second injection of AMBELVIST.
AMBELVIST can be removed from the body by dialysis. If you are currently on dialysis, your healthcare professional will decide when you should receive your next dialysis.
Serious Allergic Reaction
AMBELVIST can cause a serious allergic reaction. Patients who have had an allergic reaction to a contrast media agent in the past are at a greater risk. Most reactions occur within 30 minutes after receiving AMBELVIST. However, they can also happen within hours or days after receiving AMBELVIST. Your healthcare professional will monitor you for a period of time after you have received AMBELVIST. See also Serious side effects and what to do about them, further below, for symptoms and what to do if you experience them.
Pregnancy
Tell your healthcare professional before you receive AMBELVIST if you are pregnant, think you are pregnant or are planning to have a baby. It is not known if AMBELVIST may harm your unborn baby. Your healthcare professional will decide with you whether you should receive AMBELVIST.
Breastfeeding
Before you receive AMBELVIST tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if AMBELVIST passes into breast milk.
Your healthcare professional will decide if you should stop breastfeeding for 24 hours after you receive AMBELVIST and will discuss this with you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take AMBELVIST:
- AMBELVIST will be given to you by a healthcare professional.
- It will be infused directly into your vein.
- It will be given to you before your MRI procedure.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Your healthcare professional will decide how much AMBELVIST you will receive. The dose you receive will be based on your weight. The usual dose of AMBELVIST is 0.1 mL per 1 kg body weight.
Overdose:
| If you think you, or a person you are caring for, have been given too much AMBELVIST, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
Possible side effects from using AMBELVIST:
These are not all the possible side effects you may have when taking AMBELVIST. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Pain, redness, bruising, coldness or swelling where AMBELVIST was injected into your body
- Headache
- Dizziness, tingling or numbness
- Fever, feeling hot, cold or very warm
- Redness of the skin, itching
- Feeling sick to your stomach, throwing up, stomach discomfort or stomach pain
- Joint pain, pain or discomfort in an arm or leg, nose pain
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
| Serious allergic reaction: swelling of the face, lips, tongue, eyes or throat, difficulty breathing, blueness in the lips, coughing, sneezing, runny nose, feeling lightheaded, chest pain, rash or hives, and redness or paleness in the skin. This can sometimes be fatal. | ✓ | ||
| Unknown | |||
| Nephrogenic Systemic Fibrosis (NSF) (a severe disease where skin becomes thickened, coarse and hard): skin changes including hardening, thickening, burning, itching, scaling, darkening, hardening and tightening of the skin, red or dark patches on the skin, stiffness in the joints with trouble moving, pain in the hip bones or ribs, severe pain, muscle weakness, effects on the normal working of internal organs which may potentially be life threatening. | ✓ | ||
| Acute kidney injury (sudden and severe kidney problems): urinating less often than usual, fatigue, nausea or vomiting, itchiness or rashes, swelling in legs or feet, puffiness in the face or hands, weight gain, confusion. | ✓ | ||
| Seizure (sudden change in brain activity): shaking or jerking uncontrollably, loss of awareness or consciousness, confusion, collapse. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
AMBELVIST should be stored at temperatures between 15°C to 30°C. Do not freeze.
After the vial or bottle has been opened, AMBELVIST is stable for 24 hours at 20°C to 25°C and must then be discarded.
Keep out of reach and sight of children.
If you want more information about AMBELVIST:
Bayer Inc.
2920 Matheson Blvd East
Mississauga, Ontario
L4W 5R6
Canada
Date of Authorization: 2026-07-29
© 2026, Bayer Inc.
® TM see www.bayer.ca/tm-mc.
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website (http://www.bayer.ca) or by calling Bayer Medical Information at 1-800-265-7382 or emailing canada.medinfo@bayer.com.