Patient Information Leaflet Carboplatin 10 mg/ml Concentrate For Infusion

Please read this leaflet carefully before you receive this medicine. It briefly outlines the most important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or nursing staff.

The name of your medicine is Carboplatin 10 mg/ml Concentrate for Infusion.

WHAT IS CARBOPLATIN?

Each 5 ml vial contains 50 mg of the active ingredient carboplatin.

Each 15 ml vial contains 150 mg of the active ingredient carboplatin.

Each 45 ml vial contains 450 mg of the active ingredient carboplatin.

The other ingredients are mannitol and water for injection.

The product is available in packs containing a single 5 ml, 15 ml or 45 ml vial.

The Marketing Authorisation holder and the company responsible for manufacture is Pharmachemie BV, The Netherlands, Haarlem, Holland (Teva Group logo).

WHAT IS CARBOPLATIN USED FOR ?

Carboplatin is a platinum containing compound. It is an anti-cancer agent which is used either alone or in combination with other drugs for the treatment of certain kinds of ovarium cancer and lung cancer.

Ask your doctor or nursing staff if you need additional information.

BEFORE YOU RECEIVE CARBOPLATIN

Do you have a history of severe allergic reactions to Carboplatin or any other platinum containing compounds; or to mannitol?

Are you pregnant or breast-feeding?

Do you have any kidney problems?

Do you have any bone marrow problems?

Do you have a tumour that bleeds?

Are you taking phenytoin?

Have you received cisplatin in the past?

Are you taking or being given any drugs which can cause damage to either your kidneys or inner ears e.g.aminoglycosides such asgentamicin, streptomycin or diuretics such as bumetanide, furosemide?

If the answer to any of these questions is YES, you should not receive Carboplatin before talking to your doctor or nursing staff.

Carboplatin may cause you to feel or be sick. Do not drive or operate machinery until you are sure you are not affected.

The usual adult dose is 400 mg/m² given as a single intravenous (into the vein) dose over a period of 15 to 60 minutes.

For elderly patients (over 65 years old), the dosage may need adjusting depending on your physical condition.

If you have received treatment previously or have kidney problems your dosage will be adjusted to suit you.

•    Carboplatin should only be administered by specifically qualified doctors.

•    Carboplatin will be diluted and then administered to you by the intravenous route only.

•    You will have regular tests performed to monitor your condition.

You should use an effective method of contraception during therapy. Male patients should continue to use contraception for at least six months after their therapy has ended.

If you become pregnant or suspect that you may be pregnant during therapy, you must tell your doctor immediately.

AFTER RECEIVING CARBOPLATIN

You may experience some side effects with Carboplatin. Tell your doctor if you

experience any of the following:

•    Nausea, vomiting, abdominal pain, diarrhoea, constipation or if you have a rash, fever, chill, sore throat, ulcers in your mouth or throat, itching, taste alteration, ringing in the ears or hearing loss, sight problems or hair loss.

•    Unusual bleeding or unexplained bruising, infections, anaemia (unusual tiredness or weakness), gout, kidney problems, slow reflexes, pins-and-needles and numbness.

•    Injection site reactions such as pain, redness, swelling, nettle rash and dead skin.

In addition the following have been reported:

•    Single cases of wheezing, low blood pressure, and severe allergic reaction shortly after receiving the drug.

•    Cases of abnormal liver function tests, liver problems and changes in blood chemistry.

•    Single cases of high blood pressure, heart problems, stroke and blood clots.

•    Single cases of secondary malignancies (cancerous tumour that spreads from its original location to establish secondary tumours in other parts of the body). Although it has not been established that Carboplatin was the cause of this effect.

Tell your doctor, if you have any other unusual problems.

Your doctor may give you blood or urine tests to check your blood composition, kidney or

liver function before, during and after treatment with Carboplatin.

STORING CARBOPLATIN

Do not store above 25°C. Keep the container in the outer carton.

After dilution in 0.9% NaCI solution or 5% glucose solution, storage should be restricted to

three hours at room temperature protected from light or 24 hours at 2 - 8°C when carried

out under validated aseptic conditions. The storage times relate to the commencement of drug administration.

Only use this product if it is a clear, colourless to faintly yellow solution, free from fibres and particles of foreign matter.

FURTHER INFORMATION

This leaflet only gives a brief outline of some of the more important points about Carboplatin. If you want to know more about this medicine or its effects, please ask your doctor or nursing staff.

Keep out of reach of children.

April 2005