Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
mitozantrone hydrochloride
Novotech Australia Pty Ltd
Mitozantrone hydrochloride
Registered
CONSUMER MEDICINE INFORMATON MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mitozantrone Hydrochloride Injection Concentrate. It does not contain all 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 Mitozantrone Hydrochloride Injection Concentrate against the benefits this medicine is expected to have for you. This medicine is likely to be used while you are in hospital. IF POSSIBLE, PLEASE READ THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO YOU. If you have any concerns about taking this medicine, ask your doctor or nurse. KEEP THIS LEAFLET. You may need to read it again. WHAT MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE IS USED FOR Mitozantrone belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. It is used to treat some types of cancer, such as: • breast cancer, including breast cancer which has spread to other parts of the body • some types of leukaemia • non-Hodgkin’s lymphoma, a cancer of the lymph glands. Mitozantrone is thought to work by interfering with the growth of cancer cells, which slows their growth and destroys them. The growth of normal cells in other parts of your body may also be affected. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. Mitozantrone Hydrochloride Injection Concentrate will be given to you only by specially trained personnel in a hospital environment. 1/7 CMI v2 15/6/2010 Mitozantrone Hydrochloride Injection Concentrate is not recommended for use in children as there is not enough information on its effects in children. BEFORE YOU ARE GIVEN MITOZANTRONE HYDR Aqra d-dokument sħiħ
PRODUCT INFORMATION NAME OF THE MEDICINE MITOZANTRONE HYDROCHLORIDE INJECTION CONCENTRATE Mitozantrone hydrochloride DESCRIPTION Mitozantrone hydrochloride is a hygroscopic dark blue solid, sparingly soluble in water, slightly soluble in methanol, practically insoluble in acetone, acetonitrile or chloroform. Mitozantrone hydrochloride is a potent cytotoxic synthetic anthracenedione. Molecular formula: C 22 H 28 N 4 O 6 .2HCl Molecular weight: 517.4. CAS Number: 70476-82-3. PHARMACOLOGY Although its mechanism of action has not been fully determined, mitozantrone hydrochloride is a DNA-reactive agent. It has a cytocidal effect on proliferating and non- proliferating cultured human cells. _In vitro_ studies suggest that mitozantrone is not cell- cycle phase specific. In animals, the principal toxic effects of mitozantrone hydrochloride at doses within the human therapeutic range are reversible myelosuppression (manifested predominantly as leucopenia; erythropenia and thrombocytopenia are normally less severe) and lymphocytic depletion of the lymphoid organs. Gastrointestinal haemorrhage and congestion were noted in continuous daily dosing studies but not in the intermittent schedules to be used clinically. In dog and monkey studies with mitozantrone hydrochloride, doxorubicin was studied simultaneously at equileucopenic doses as a positive control for anthracycline-induced cardiomyopathy. Dogs given mitozantrone hydrochloride and untreated control dogs showed slight dilation of the sarcoplasmic reticulum which regressed over time. In monkeys, clinical signs of congestive heart failure were observed in animals given doxorubicin, but not mitozantrone hydrochloride. Myocyte alterations in doxorubicin- treated monkeys were characteristic of degeneration, whereas myocyte alterations in 1/11 v2 15/6/2010 monkeys treated with mitozantrone hydrochloride were suggestive of cellular regeneration and repair. In rats, there was no evidence of the progressive cardiomyopathy characteristic of anthracyclines. An analysis of cardio Aqra d-dokument sħiħ