PACKAGE LEAFLET: INFORMATION FOR THE USER

Steripet 250 MBq/ml solution for injection

Fludeoxyglucose (¹⁸F)

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

•    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 or nurse.

In this leaflet:

1.    What Steripet is and what it is used for

2.    Before you are given Steripet

3.    How Steripet is given

4.    Possible side effects

5.    How to store Steripet

6.    Further information

1. What Steripet is and what it is used for

This medicine is used for diagnostic use only. It is used only to help identify illness.

Steripet is a 'radio-pharmaceutical' medicine. It is given before a scan and helps a special

camera see inside a part of your body.

•    It contains an active ingredient called 'fludeoxyglucose'.

•    Once injected it can be seen from outside your body by a special camera used in the scan.

•    The scan can help your doctor to detect or show changes in tumours in many parts of the body such as the brain, head and neck, thyroid, lungs, breast, pancreas, colon and rectum, ovaries, oesophagus, skin, liver and bones.

•    The scan can help your doctor see how well the heart is working, or see damage to the heart after a heart attack.

•    Some other people who have epilepsy or a similar illness are given this medicine to see affected areas of the brain.

Your doctor or nurse will explain which part of your body will be scanned.

2. Before you are given Steripet

You should not be given Steripet:

• If you are allergic (hypersensitive) to the active ingredient or any other ingredient. (Listed in Section 6).

Do not take Steripet if the above applies to you. If you are not sure talk to your doctor or

nurse.

Take special care with Steripet

Check with your doctor or nurse before having Steripet:

•    If you have diabetes or increased levels of sugar in your blood.

•    If you are pregnant or think you might be pregnant.

•    If you are on a low sodium diet.

•    If you are having or have ever had radiotherapy or chemotherapy, because they may affect the results of your test with Steripet.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because some medicines can affect the way Steripet works.

Before your scan tell your doctor or nurse if you are taking any of the types of medicine below. This is because they may affect the results of your scan:

•    Corticosteroids, such as prednisolone, deaxamethasone or hydrocortisone.

•    Catecholamines such as adrenaline, noradrenaline or dopamine.

•    Medicines used in the treatment of epilepsy, such as valproate, carbamazepine, phenytoin or phenobarbital.

•    Glucose and insulin.

•    Colony stimulating factors.

If you are not sure if any of the above apply to you, speak to your doctor or nurse before having Steripet.

Having Steripet with food and drink

In the time leading up to your scan:

•    You should avoid drinking liquids containing a type of sugar called glucose.

•    You will be given unlimited amounts of water or other liquids that do not contain glucose.

•    You will have to stop eating for a period of time (at least 4 hours) before you have the injection.

Ask your doctor or nurse if you have any questions.

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant or think you may be pregnant. Your doctor will only use this product if he considers that the benefit outweighs the risk.

Do not breast-feed if you are given Steripet. This is because small amounts of radioactivity may pass into the mother's milk. If you are breast-feeding, your doctor may wait until you have finished breast-feeding before using Steripet. If it is not possible to wait your doctor may ask you to:

•    stop breast-feeding for 12 hours, and

•    use formula feed for your child, and

•    express (remove) breast milk and throw away the milk.

Your doctor will let you know when you can start breast-feeding again.

Driving and using machines

Ask your doctor if you can drive or use machines after you have been given Steripet.

Test you may have before being given Steripet

•    The amount of glucose in your blood may be checked before you are given Steripet.

Ask your doctor if you have any questions.

Important information about Steripet

When Steripet is used you are exposed to 'radio-activity'.

•    Your doctor will always consider the possible risks and benefits before you are given the medicine.

•    You will be encouraged to pass water (urinate) after you have been given Steripet because this removes 'radio-activity' from your body.

•    The doctor will ask you to avoid close contact with young children for the first 12 hours following the use of Steripet.

Ask your doctor if you have any questions.

3. How Steripet is given

Steripet will be given to you by a specially trained and qualified person.

•    Steripet will always be used in a hospital or clinic.

• You may be asked to urinate after you have had your scan.

• You may be asked to relax and not read or speak. This is to reduce muscle tension before you have your scan.

•    They will tell you anything you need to know for its safe use.

Your doctor will decide on the dose that is best for you.

The usual dose is:

•    One single injection.

If you are given more Steripet than you should

Steripet is given in a hospital or clinic by a specially trained and qualified person. It is unlikely that you will be given too much.

If you have any concerns talk to your doctor or nurse.

4. Possible side effects

Like all medicines, Steripet may cause side effects although not everybody gets them. The only reported side effect with Steripet is a rash.

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

5. How to store Steripet

The product label includes the correct storage conditions and the expiry date for the batch. Hospital staff will ensure that the product is stored correctly, including at the correct temperature (below 25°C). They will also ensure that the product is disposed of correctly and not used after the expiry date stated on the label.

6. Further information

What Steripet contains

•    The active ingredient is fludeoxyglucose (¹⁸F) . Each ml of Steripet contains 250 MBq (Megabecquerel, - the unit in which radioactivity is measured,) of fludeoxyglucose at a fixed time.

•    The other ingredients are sodium dihydrogen phosphate, sodium hydroxide and water for injections.

What Steripet looks like and contents of the pack

Steripet is supplied as a single colourless glass vial containing between 1 ml and 10 ml of a solution for injection.

Marketing Authorisation Holder

GE Healthcare Limited Amersham Place Little Chalfont Buckinghamshire HP79NA United Kingdom

Manufacturers

GE Healthcare B.V. Den Dolech 2

5612 AZ

Eindhoven

The NETHERLANDS

GE Healthcare S.r.l.

C/o Joint Research Centre Unita BMS - Istituto I.H.C.P Cyclotron Building, 21020 Ispra (Varese)

ITALY

This leaflet was last approved in 03/2011.

Marketing Authorisations

PL 00221/0171

Steripet is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.