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• leaflet BAYER PLC_PL 00010-0543
• leaflet MAH BRAND_PL 00010-0542
• leaflet MAH BRAND_PL 00010-0543

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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/MRI-centre staff.

In this leaflet:

1.    What Magnevist is and what it is used for

2.    Before you are given Magnevist

3.    How you will be given    Magnevist

4.    Possible side effects

5.    How to store Magnevist

6.    Further information

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.

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.

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.

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.

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

-    feeling sick

-    being sick

-    changes in the way things taste

-    dizziness

-    headache

-    feeling hot or    cold

-    sensations or    reactions at the injection site (such as warm or cold

feelings, swelling, numbness and tingling or pain)

Rare

up to 10 in every 10,000 people are likely to get these

-    reddening or warming of the face or skin; burning sensations; numbness and tingling; fever

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

-    disorientation

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

-    conjunctivitis

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

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

-    pain in the hands/feet; swelling of the hands, feet or face Other side effects (frequency unknown)

-    Nephrogenic Systemic Fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs)

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

-    changes in body temperature; chills; sweating

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

-    confusion; agitation; problems with speech or hearing

-    sleepiness; fainting; coma

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

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

-    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

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

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

- 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.

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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