Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
mitozantrone hydrochloride
Pfizer Australia Pty Ltd
Registered
MITOZANTRONE INJECTION (MY-TOE-ZAN-TRONE) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mitozantrone Injection. 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 Injection against the benefits it 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 INJECTION IS USED FOR Mitozantrone (My-toe-ZAN-trone) 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 INJECTION HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Mitozantrone Injection will be given to you only by specially trained personnel in a hospital environment. Mitozantrone Injection is not recommended for use in children as there is not enough information on its effects in children. BEFORE YOU ARE GIVEN MITOZANTRONE INJECTION _WHEN IT MUST NOT BE USED_ YOU MUST NOT BE GIVEN MITOZANTRONE INJECTION IF YOU HAVE AN ALLERGY TO: • mitozantrone • any of the ingredients listed at the end of this leaf Belgenin tamamını okuyun
Version: pfpmitoi10817 Supersedes: pfpmitoi11209 Page 1 of 11 PRODUCT INFORMATION MITOZANTRONE ® INJECTION (MITOZANTRONE HYDROCHLORIDE) NAME OF THE MEDICINE Mitozantrone (as 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. The structural formula is represented below. O O NH NH OH OH N HO HO N H H ,2HCl Molecular formula: C 22 H 30 Cl 2 N 4 O 6 Molecular weight: 517.4 CAS No: 70476-82-3 Mitozantrone Injection is a sterile, deep blue, aqueous, isotonic solution containing Mitozantrone Hydrochloride USP equivalent to 10mg, 20mg, 25mg and 30mg mitozantrone, Sodium Chloride BP, Disodium Edetate BP, Acetic Acid and Sodium Acetate in Water for Injections BP. PHARMACOLOGY PHARMACODYNAMICS CLASS OF DRUG: Antineoplastic. MODE OF ACTION: Mitozantrone is a potent cytotoxic synthetic anthracenedione. Although its mechanism of action has not been fully determined, Mitozantrone is a DNA-reactive agent. It has a cytocidal effect on proliferating and nonproliferating cultured human cells. _In vitro_ studies suggest that Mitozantrone is not cell cycle phase specific. In animals, the principal toxic effects of Mitozantrone 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 hemorrhage 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, doxorubicin was studied simultaneously at equileucopenic doses as a positive control for anthracycline induced cardiomyopathy. Dogs given Mitozantrone and untreated control dogs showed slight dilatation of the sarcoplasmic reticulum which Version: pfpmitoi10817 Supersedes: pfpmitoi11209 Page 2 of 11 regressed over time. In monkeys, clinical s Belgenin tamamını okuyun