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PACKAGE LEAFLET: INFORMATION FOR THE USER

Omniscan 0.5 mmol/ml solution for injection, pre-filled syringe

Gadodiamide

Read all of this leaflet carefully before you are given Omniscan.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1. What Omniscan is and what it is used for

2. Before you are given Omniscan

3. How to use Omniscan

4. Possible side effects

This medicine is for diagnostic use only.

Omniscan is a contrast medium which is used in Magnetic Resonance Imaging (MRI) examinations of the brain or spine, and for whole body examinations like the head and neck region, the thoracic cavity including the heart, extremities (arms and legs), organs in the abdominal cavity (prostate, urinary bladder, pancreas and liver), kidney, female breast, musculosceletal system and blood vessels.

Omniscan can help some medical conditions to be seen more clearly. This helps the doctor to find and examine these conditions more easily, and can improve the information needed to make a diagnosis.

Do not use Omniscan

- if you are allergic (hypersensitive) to gadodiamide or any of the other ingredients of Omniscan.

You should not be given Omniscan 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, as use of Omniscan 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.

Omniscan should also not be given to newborn babies up to age of 4 weeks.

Take special care with Omniscan

- if you have a heart pacemaker or any implants containing iron in your body

- if you have previously experienced a severe reaction after receiving contrast media

- if you have or have had any allergies (e.g. allergies to seafood, hay fever, nettle rash), asthma or other

allergic respiratory disorders.

- if you suffer from heart diseases or disorders of the central nervous system

(epilepsy or brain lesions).

- if you suffer from moderate kidney problems.

If any of the above mentioned conditions are applicable to you, you should inform your doctor.

Tell your doctor if:

- your kidneys do not work properly

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

Before you receive Omniscan, you will need to have a blood test to check how well your kidneys are working.

Omniscan should not be used in newborn babies up to the age of 4 weeks. As kidney function is immature in infants up to 1 year of age, Omniscan will only be used in infants after careful consideration by the doctor.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you are having blood samples taken on the same day and within 12-24 hours after Omniscan injection. Omniscan interferes with some of the methods commonly used for measuring content of electrolytes (e.g. iron and calcium) in blood.

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 Omniscan should not be used during pregnancy unless strictly necessary.

Breast-feeding

Tellyour doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding should be discontinued for at least 24 hours after you receive Omniscan.

Driving and using machines

Driving should be avoided since nausea may occur after the investigation.

Important information about some of the ingredients of Omniscan

This product contains sodium. To be taken into consideration if you are on a low sodium diet.

Dosage and administration

Omniscan will be injected into one of your veins usually as a single injection before or during your MRI examination. Occasionally a second injection may be of additional diagnostic value.

The amount injected will depend upon your weight and what part of the body you are having examined. The usual dose is 0.2 ml/kg body weight or occasionally up to 0.6 ml/kg body weight. Even if you weigh more than 100 kg you will normally not receive more than 20 ml or for some conditions up to 60 ml.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Dosage in special patient groups

You should not be given Omniscan 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. Omniscan 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 Omniscan 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 Omniscan 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omniscan can cause side effects, although not everybody gets them.

Common (more than one of 100 but less than one of 10 experiences the side effect):

Transient discomfort in the form of a sensation or warmth, coolness or local pressure in connection with injection. Transient sensation of pain at the injection site. Headache, nausea.

Uncommon (more than one of 1,000 but less than one of 100 experiences the side effect):

Allergy-like skin and mucous membrane reactions, hypersensitivity. Dizziness. Tingling sensations. A transient change in your sense of taste. Vomiting. Diarrhoea. Flushing. Itching.

Rare (more than one of 10,000 but less than one of 1,000 experiences the side effect):

A transient change in your sense of smell. Cramps. Drowsiness. Difficulty in breathing. Pain in the joints. Trembling. Anxiety. Visual disturbances. Chest pain. Acute renal failure. Coughing. Rash and hives. Swelling, including face swelling. Fever. Shivering.

Unknown frequency:

There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).

Anaphylactic/anaphylactoid reactions. Rapid pulse. Sneezing. Irritation in the throat. Severe difficulty in breathing.

You should see your doctor immediately if you experience symptoms of angioedema, such as:

• difficulty in swallowing

• hives and difficulties in breathing.

Most of the allergic reactions occur within half an hour after injection. In rare cases side effects may occur after hours or days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE OMNISCAN

Keep out of the reach and sight of children.

Do not use Omniscan after the expiry date which is stated on the label.

Store pre-filled syringe in the outer carton in order to protect from light.

Do not freeze.

Do not use Omniscan if you notice severe discoloration, the occurrence of particulate matter or a defective container

Chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6. FURTHER INFORMATION

What Omniscan contains

1 ml contains 287 mg of gadodiamide, equivalent to 0.5 mmol.
10 ml contains 2.87 g of gadodiamide, equivalent to 5.0 mmol.
15 ml contains 4.31 g of gadodiamide, equivalent to 7.5 mmol.
20 ml contains 5.74 g of gadodiamide, equivalent to 10.0 mmol.

What Omniscan looks like and contents of the pack

Omniscan is a solution for injection. The product is a clear, colourless to slightly yellow, aqueous solution.

Omniscan is supplied as:

10 ml, 15 ml and 20 ml pre-filled syringes, with bromo-butyl or styrene-butadiene rubber plungers that do not contain latex.

Pack sizes of 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen

NO-0401 OSLO, Norway

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Omniscan 0,5 mmol/ml Injektionslösung

Ireland: Omniscan 0.5 mmol/ml Solution for Injection

Norway: Omniscan 0.5 mmol/ml Injeksjonsvaeske

Sweden: Omniscan 0.5 mmol/ml Injektionsvätska

This leaflet was last approved in 2010-11-25

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The following information is intended for medical or healthcare professionals only:

Each pre-filled syringe of contrast medium is intended for single use. Any unused portion must be discarded. The diameter of the pre-filled syringe is too large to allow for accurate measurements of small volumes. The syringe should not be used for volumes below 5 ml.

Prior to administration of Omniscan, all patients should be screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Omniscan and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m²). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. Therefore Omniscan must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period.

Omniscan should also not be given to newborn babies up to the age of 4 weeks.

The risk for development of NSF in patients with moderate renal impairment (GFR 30–59 ml/min/1.73 m²) is unknown, therefore, Omniscan should be only used after careful risk-benefit evaluation in patients with moderate renal impairment at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Omniscan injections should not be repeated unless the interval between injections is at least 7 days.

Due to immature renal function in infants up to 1 year of age, Omniscan should only be used in these patients after careful consideration at a dose not exceeding 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Omniscan injections should not be repeated unless the interval between injections is at least 7 days. Omniscan should not be given to newborn babies up to age of 4 weeks.

As the renal clearance of gadodiamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.

Haemodialysis shortly after Omniscan administration may be useful at removing Omniscan from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

Omniscan should not be used during pregnancy unless the clinical condition of the woman requires use of gadodiamide.

Breast-feeding should be discontinued for at least 24 hours after the administration of Omniscan.

The peel-off tracking label on the syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded.