gadopentetsyradimegluminate
What Magnevist is and what it is used for
Magnevist is a contrast agent used for diagnostics in magnetic resonance imaging (MRI) of various joints.
MRI is a form of medical imaging technology based on the behavior of water molecules in the normal and abnormal tissue. The technology is based on an intricate system of magnets and radio waves. Computers record the activity and transfer it to visible images.
The drug is provided as a solution for injection into joints. Magnevist is for diagnostic purposes only.
2. What you need to know before you receive Magnevist
Magnevist should not be given:
- if you are allergic to gadopentetic acid dimegluminate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, radiologist, or radiologist before receiving Magnevist if you have a pacemaker or any other implant or metal clips that contain iron in your body.
Tell your doctor about:
- you have previously reacted to contrast agents
- you have or have had allergies (eg hay fever, hives ) or asthma
If any of these apply to you, talk to your doctor, radiologist, or X-ray staff before receiving Magnevist. Your doctor will determine if the scheduled examination is possible or not.
Allergy-like reactions
Allergy-like reactions may occur after using Magnevist. Serious reactions are possible. Mild swelling of the face, lips, tongue, or throat, cough, itching, runny nose, irritated eyes, sneezing, and rash ( hives ) may be the first signs of a severe reaction.
Most of these reactions occur within 30 minutes of receiving the Magnevist. Therefore, you will be kept under observation for at least 30 minutes after injection one. Delayed reactions have been observed (after hours or days).
The use of gadolinium-based contrast agents in patients with severe kidney problems has been associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a disease that causes thickening of the skin and connective tissue.
Accumulation in the body
Magnevist works because it contains the metal gadolinium. Studies have shown that small amounts of gadolinium can remain in the body, including the brain.
This has not been seen with the small amounts used in injection into a joint.
Children
There is no experience with the use of Magnevist in children.
Other medicines and Magnevist
Tell your doctor, radiologist, or radiologist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your radiologist or radiologist for advice before taking this medicine.
Pregnancy
Magnevist should not be used during pregnancy unless necessary.
Breast-feeding
Magnevist can be used during breastfeeding as it is unlikely that the baby will be affected by the small amounts that pass into breast milk.
Driving and using machines
Limited mobility of the injected joint after use of Magnevist may affect the ability to drive.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Magnevist contains sodium
This medicine contains 67.6 mg sodium (the main ingredient in table salt/table salt) per pre-filled syringe. This corresponds to 3.38% of the highest recommended daily intake of sodium for adults.
How to get Magnevist
Magnevist is given by healthcare professionals and is injected into a joint. Your MRI scan can begin immediately after injection one. You will be kept under observation for at least 30 minutes after injection one.
The recommended dose is generally up to 20 ml Magnevist (at the knee joint up to 50 ml).
The radiologist will determine the amount of Magnevist needed for your examination.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or radiologist immediately if you experience any of the following reactions:
Allergic reactions include severe reactions. Swelling of the face, lips, tongue, or throat, cough, itching, runny nose, sneezing, and hives may be the first signs that a serious reaction is developing. (Has been reported – occurs in an unknown number of users).
Other possible side effects are listed below, depending on how common they are:
Common (may affect up to 1 in 10 people):
- injection site pain and pressure sensations in the joint
Uncommon (affects up to 1 in 100 people) :
- headache, dizziness
- nausea
Rare side effects are (may affect up to 1 in 1000 users) :
- fainting due to drop in blood pressure (vasovagal reaction)
- vomiting
Has been reported (occurs in an unknown number of users):
- skin reactions(side effect reported for contrast media but not yet specific for Magnevist 2 mmol / l).
How to store Magnevist
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the syringe label after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is gadopentetic acid dimegluminate. Each ml of solution contains 0.002 mmol gadopentetic acid dimegluminate equivalent to 0.32 mg gadolinium.
- The other ingredients are meglumine, fatty acid, sodium chloride and water for injections.
What the medicine looks like and contents of the pack
Magnevist is a clear solution, free of particles.
Pre-filled syringes: 1 x 20 ml, 5 x 20 ml
Container: Colorless glass, type I.
Rubber stopper for syringe plunger: Chlorobutyl rubber, type I.
Seal: polypropylene-chlorobutyl polycarbonate
Blister: Polyethylene terephthalate/polyethylene
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
Bayer AG
13353 Berlin
Germany