Abelcet

PATIENT INFORMATION LEAFLET

Abelcet® 5mg/ml Concentrate for Solution for Infusion

Amphotericin B Lipid Complex

This leaflet contains important information. It has been prepared to help you, the patient, and your family and friends understand why your doctor has prescribed treatment with Abelcet. Please read it carefully before you start receiving your medicine and keep it in a safe place for future reference.

Each ml of Abelcet contains 5.0mg amphotericin B complexed with phospholipids dimyristoylphosphatidylcholine (DMPC) and the sodium and ammonium salts of dimyristoylphosphatidylglycerol (DMPG), along with water and sodium chloride (common salt). Abelcet is supplied as a concentrate for solution for infusion. Each vial contains 5mg Amphotericin B per ml.

What is Abelcet used for?

Your doctor has prescribed Abelcet for you, to treat a fungal infection such as systematic candidiasis, aspergillosis, cryptococcal meningitis, disseminated cryptococcosis, fusariosis, zygomycosis, blastomycosis or coccidiomycosis. Fungi are common and are found throughout nature but do not normally cause infections. However, under certain circumstances, for instance, when the body's immune system is not working properly, a few types of fungi can infect humans.

It is important that you follow your doctor's instructions and receive all the medication prescribed for you even if you feel better.

Abelcet is not recommended if:

You are hypersensitive to amphotericin B or to any of the constituents of Abelcet.

What precautions are necessary when taking this drug?

Your doctor may need to do some extra tests while you are being treated with Abelcet, particularly if you have had previous problems with your kidneys or liver. Inform your doctor if you are pregnant or breast feeding. He will decide if this medication is suitable for you.

Does Abelcet interact with any other compounds?

Tell your doctor or pharmacist if you are taking any other prescription or non-prescription medication. Abelcet may interact other drugs such as zidovudine or cyclosporin.

Special Warnings

If you have a kidney problem, your doctor will perform a blood test at least once a week while you are receiving Abelcet. If you have a liver disease you will also be carefully monitored by your doctor.

How will I receive this medication?

Abelcet is a sterile, pyrogen-free suspension which must be diluted for intravenous infusion only. A test dose of 1 mg is given initially to see if you are sensitive to any of the ingredients.

The recommended daily dose is 5.0mg of Abelcet for every kg of your body weight, given as a single infusion. This will be given by a drip into a vein in your arm over about 2 hours.

The number of days over which you will be treated depends on many factors, but will probably be at least 14 days. The dose is the same for children, elderly people and those suffering from kidney or liver disease or if you are being treated with drugs which can affect the kidney. Special tests might be needed if you are being treated with these drugs.

What side-effects can occur?

In common with other medications for serious infections, Abelcet does have the potential to cause some side-effects. You may experience chills, fever, nausea, vomiting, rash or convulsions although this will probably only occur in the first 2 days of treatment. Your nurse or doctor may be able to arrange some simple treatment to help control these side-effects. Abelcet's active ingredient, amphotericin B, is known to cause damage to the kidneys. Abelcet has been specifically designed to reduce the potential for such kidney damage. Abelcet may also affect your liver or blood. Your doctor will check for these and other unwanted effects by carrying out appropriate tests, for example checking the level of potassium in your body. There have been reports of a blood disorder, seen as fever or chills, sore throat, ulcers in the mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises. Tell your doctor immediately if you notice these symptoms. Rarely, brain and nerve cell disorders have been reported with Abelcet use, as have heart problems, for example a faster heart rate. In some people, Abelcet may cause allergic reactions, which may occasionally be severe, leading to wheezing, shortness of breath and a change in blood pressure. Please inform your doctor of any unusual symptoms while you are receiving Abelcet.

What storage conditions are necessary?

Abelcet should be stored at 2°C - 8°C. Do not freeze. Keep vial in the outer carton. Abelcet is diluted with a dextrose solution before use. Abelcet should not be mixed with other drugs or electrolytes. Abelcet is suitable for intravenous infusion only. Abelcet should not be used after the expiry date which is indicated on the label.