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MAGNEVIST INJECTION

Active substance(s): DIMEGLUMINE GADOPENTETATE

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PATIENT LEAFLET: INFORMATION FOR THE USER
MAGNEVIST®
dimeglumine gadopentetate

Read all of this leaflet carefully before you are given this medicine.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask the doctor giving you
Magnevist (the radiologist) or the hospital/MRI-centre staff.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, radiologist or the hospital/MRIcentre staff.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Magnevist is and what it is used for
Before you are given Magnevist
How you will be given Magnevist
Possible side effects
How to store Magnevist
Further information

1. What Magnevist is and what it is used for
Magnevist is used together with a technique called Magnetic Resonance Imaging
(MRI) to create artificial contrast or enhancement to help make an MRI scan of the
area of your body that your doctor wants to investigate clearer.
MRI is a modern scanning technique which produces very high quality pictures of
various parts of your body without using X-rays. The use of MRI can provide a quick,
early and accurate diagnosis.
The scanner uses a strong magnetic field and radiowaves to measure the magnetic
properties of body tissues. Using a computer, this information is converted into a
black and white picture which can help your doctor see and investigate the
differences between normal and abnormal tissue.
Sometimes MRI is used in areas where it cannot produce a clear black and white
picture. This is when Magnevist is used. Magnevist produces a clearer image and
allows the doctor to see the area of interest better. Sometimes several scans will be
taken before Magnevist is injected and then further scans taken after the injection.
This medicine is for diagnostic use only.

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2. Before you are given Magnevist
Do not use Magnevist if:


you are, or suspect you are allergic (hypersensitive) to any of the ingredients
of Magnevist (see Section 6: Further Information)



you suffer from severe kidney problems, or if you are a patient who is about
to have or has recently had a liver transplant,,as use of Magnevist in
patients with these conditions has been associated with a disease called
Nephrogenic Systemic Fibrosis (NSF). NSF is a disease involving thickening
of the skin and connective tissues. NSF may result in severe joint immobility,
muscle weakness or may affect the normal working of internal organs which
may potentially be life threatening



you have a heart pacemaker or if there are any implants or clips containing
iron inside your body. (This is not because of an interaction with Magnevist
but because if you have any of these, you should not be placed in a strong
magnetic field)



the patient is a newborn baby up to 4 weeks of age.

Take special care with Magnevist
Your doctor will need to take special care when giving you Magnevist if:


you have a history of allergy (e.g. hay fever, hives), asthma, or have had a
reaction to another type of contrast media. This is because you may be more
likely to have an allergic reaction



you suffer from heart or blood circulation problems. This is because in the
rare event that you have an allergic reaction, it is more likely to be serious or
fatal



you have epilepsy or have ever had fits, seizures or a mass in or around your
brain. Fits or seizures have occurred rarely in patients with similar conditions.
Tell the radiographer or MRI-centre staff so that they will be prepared to deal
with any problems that occur



your kidneys do not work properly. Magnevist should only be given after
careful consideration if you have kidney problems



you have recently had, or soon expect to have, a liver transplant



the patient is an infant under 1 year of age. As kidney function is immature in
infants up to 1 year of age, Magnevist will only be used in infants after careful
consideration by the doctor.

Before you receive Magnevist, you must tell the radiographer or MRI-centre staff if
any of these apply to you. You will also need to have a blood test to check how well
your kidneys are working.
If you have any blood tests after your MRI scan, tell your doctor you have been
given Magnevist. This is because some tests for iron levels in the blood may be
affected for up to 24 hours after Magnevist has been given.

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Taking or using other medicines
Please tell the radiologist or MRI-centre staff if you are taking or have recently taken
any other medicines, including medicines obtained without prescription. This is
particularly important if you are taking:


beta blockers (drugs used to treat heart problems or blood pressure). This is
because in the rare event that you have an allergic reaction, you may need to
be given different medicines than normal to treat the reaction.

Using with food and drink
MRI contrast media like Magnevist can make you feel sick or actually be sick.
Therefore, you may be asked not to eat anything for 2 hours before the examination.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are or might become pregnant as
Magnevist should not be used during pregnancy unless strictly necessary.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breastfeeding should be discontinued for at least 24 hours after you receive Magnevist.

3. How you will be given Magnevist
You will be asked to lie down on the MRI scanning bed and then Magnevist will be
injected into a vein. The MRI staff will observe you for at least 30 minutes after the
injection just in case you have any side effects.
The dose of Magnevist varies depending on your weight and how much the image of
the area needs to be made clearer. Typically 0.2ml Magnevist per kilogram body
weight is used, but this may be increased in adults to 0.4ml or even 0.6ml per
kilogram body weight and in children (over 2 years) to 0.4ml per kilogram body
weight. The doctor will decide how much Magnevist is needed for your investigation.
Scanning may start immediately after Magnevist injection but may take place later
depending on your examination (usually up to 45 minutes).
You should not be given Magnevist if you suffer from severe kidney problems or if
you are a patient who is about to have or has recently had a liver transplant.
Magnevist should also not be used in newborn babies up to the age of 4 weeks.
If you have moderate kidney problems, you should only receive one dose of
Magnevist during a scan and you should not receive a second injection for at least 7
days.
As kidney function is immature in infants up to 1 year of age, infants should only
receive one dose of Magnevist during a scan and should not receive a second
injection for at least 7 days.
It is not necessary to adjust your dose if you are 65 years of age or older but you will
have a blood test to check how well your kidneys are working.

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If you receive more Magnevist than you should
Overdosing is unlikely. If it does happen the doctor will treat any symptoms that
follow and may need to use a kidney dialysis machine to remove Magnevist. There
is no evidence to suggest that this will prevent the development of NSF (see section
4 Possible side effects) and should not be used as treatment for the condition.

4. Possible side effects
Like all medicines, Magnevist can cause side effects, although not everybody gets
them.
Side effects you may get after being given a contrast medium like Magnevist are
usually mild to moderate and do not last long.
However, as with similar contrast media, severe and life-threatening reactions, as
well as deaths, have been reported.
If you notice:
• itching of the skin, rash, wheals on the skin (urticaria)
• difficulty breathing, gagging, feeling of suffocation
• swelling of the face, neck or body
• itchy or watery eyes, tickling in the throat or nose, hoarseness, coughing or
sneezing
• headache, dizziness, feeling faint
• feeling particularly hot or cold, sweating
• paleness or reddening of the skin
• chest pain, cramp, tremor
• feeling sick
Tell the radiologist or MRI staff immediately as these may be the first signs of
allergic reaction or shock. Your investigation will need to be stopped, and you may
need further treatment.
Apart from the symptoms listed above, these are the possible side effects of
Magnevist, starting with the more common ones:
Uncommon
up to 10 in every 1000 people are likely to get these
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feeling sick

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being sick

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changes in the way things taste

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dizziness

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headache

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feeling hot or cold

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sensations or reactions at the injection site (such as warm or cold
feelings, swelling, numbness and tingling or pain)

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Rare
up to 10 in every 10,000 people are likely to get these
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reddening or warming of the face or skin; burning sensations; numbness
and tingling; fever

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fast or irregular heart beat; chest pain; swollen or red veins

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disorientation

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fits or seizures; general weakness; tiredness or generally feeling unwell

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conjunctivitis

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wheezing; coughing; sneezing; irritation, pain or discomfort in the throat

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stomach pain or discomfort; diarrhoea; dry mouth; pains or numbness and
tingling in the mouth; toothache; thirst

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pain in the hands/feet; swelling of the hands, feet or face

Other side effects (frequency unknown)
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Nephrogenic Systemic Fibrosis (which causes hardening of the skin and
may affect also soft tissue and internal organs)

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sensations or reactions at the injection site (such as inflammation, pain,
change in skin colour, death of skin tissue (necrosis), bruising)

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changes in body temperature; chills; sweating

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high or low blood pressure; fast or slow heartbeat; sudden stopping of the
heart (cardiac arrest)

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confusion; agitation; problems with speech or hearing

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sleepiness; fainting; coma

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pain in the eyes or ears; watery eyes; problems with eyesight or sense of
smell

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runny nose; difficulty breathing; increase or decrease in breathing rate;
stopped breathing (respiratory arrest); blue lips or skin; watery mouth

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an inability to control the passage of urine (incontinence) and an urgent
need to pass urine; kidney failure in patients who already have kidney
problems

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fluid in the lungs; swelling in the voice box and throat; spasm of the
muscles around the voice box causing choking

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back or joint pain; swelling of various parts of the body or mucous
membranes (e.g. inside nose or mouth)

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changes in levels of iron, liver enzymes and bilirubin in the blood and
serum creatinine. These may be detected in blood tests.

Delayed reactions can occur rarely, if you are concerned you should contact your
doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, either while Magnevist is being given or for about a week afterwards, please
tell your doctor or the radiologist or the MRI-centre staff.

5. How to store Magnevist
Keep out of the reach and sight of children.
Do not use Magnevist after the expiry date which is stated on the label. The expiry
date refers to the last day of that month.
Protect from light.

6. Further Information
What Magnevist contains
The active substance is dimeglumine gadopentetate.
1 ml Magnevist contains 469.01 mg of the dimeglumine salt of gadopentetic acid.
The other ingredients are meglumine, pentetic acid and water for injections.
What Magnevist looks like and contents of the pack
Magnevist is a solution for injection available in 5ml, 10ml, 15ml, 20ml vials and also
in packs of five of 10ml, 15ml, or 20ml pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA

Manufacturer:

Bayer Schering Pharma AG
Berlin
Germany
.

This leaflet was last approved in TBC
Magnevist is a registered trademark of Bayer Schering Pharma AG (formerly
Schering AG).

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To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:

0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
MAGNEVIST® vials
MAGNEVIST® prefilled syringes

Reference number
00010/0542
00010/0543

This is a service provided by the Royal National Institute of the Blind.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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