Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Busulfan
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
MYLERAN ® _busulfan_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MYLERAN tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MYLERAN tablets against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MYLERAN IS USED FOR MYLERAN contains busulfan as the active ingredient. It belongs to a group of medicines called cytotoxics. MYLERAN is used to treat certain blood disorders. It works by reducing the amount of certain types of blood cells in your body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MYLERAN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MYLERAN IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • busulphan • any of the tablet ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin. DO NOT TAKE MYLERAN IF YOU ARE PLANNING TO BECOME PREGNANT OR FATHER A CHILD UNLESS YOU AND YOUR DOCTOR HAVE DISCUSSED THE RISKS AND BENEFITS INVOLVED. MYLERAN may harm eggs and sperm. Reliable contraceptive methods must be taken to avoid pregnancy whilst you or your partner is taking this medicine. DO NOT TAKE MYLERAN IF YOU ARE PREGNANT UNLESS YOU AND YOUR DOCTOR HAVE DISCUSSED THE RISKS AND BENEFITS INVOLVED. It may affect your developing baby if you take it during pregnancy. DO NOT TAKE THIS MEDICINE WHILST BREAST FEEDING. DO NOT TAKE I Les hele dokumentet
PRODUCT INFORMATION MYLERAN TABLETS NAME OF THE DRUG: The chemical name for busulfan is 1,4-butanediol dimethanesulfonate, it has a molecular weight of 246.29, it's molecular formula is C 6 H 14 O 6 S 2 , CAS No.: 55-98-1 and the chemical structure is: Myleran tablets contain 2 mg busulfan. DESCRIPTION: Busulfan is a white, crystalline powder. It is very slightly soluble in water and ethanol (96%), freely soluble in acetone, in acetonitrile and in chloroform. It has a melting point of 115-118°C. Each Myleran tablet also contains anhydrous lactose, pregelatinised maize starch, magnesium stearate, hypromellose, titanium dioxide and glycerol triacetate. ACTIONS: Myleran in small daily doses of 4 mg, administered orally, depresses both normal and abnormal myeloid tissue. It is this property which has proved to be of value in the treatment of a proportion of cases of chronic myelogenous leukaemia. The drug is more selective than nitrogen mustard or the folic acid antagonists in its effect on the myeloid cells and may be somewhat safer in use; certain patients have received daily doses of 4 mg for as long as a year. In such doses, although it depresses myelopoiesis, it has little effect upon the lymphocytes and platelets, and side effects are absent. Larger doses, however, depress the platelet count and cause haemorrhagic symptoms, and there is a danger of causing an irreversible depression of the bone marrow which may not become obvious for 4 to 6 months. These effects show the necessity for careful haematological control. The most favourable effects, seen in some cases of chronic myelogenous leukaemia, are rise in the haemoglobin levels, a selective reduction or even disappearance of immature myeloid cells from the blood, a reduction in the cellularity of the bone marrow, a diminution in the size of the enlarged spleen, and pronounced subjective improvement. INDICAT Les hele dokumentet