Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Fotemustine
Servier Laboratories (Australia) Pty Ltd
Medicine Registered
MUPHORAN ® _fotemustine (pronounced fo-te-mus-teen )_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about MUPHORAN. It does not contain all the available information. Reading this leaflet 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 being treated with MUPHORAN against the expected benefits for you. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST, OR ONCOLOGY NURSE. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT MUPHORAN IS The name of your medicine is MUPHORAN. The active ingredient of MUPHORAN is called fotemustine. Fotemustine is a type of chemotherapy that belongs to a group of anti-cancer agents called nitrosoureas (pronounced ni-tro-so-u- ree-as). WHAT MUPHORAN IS USED FOR YOU HAVE BEEN PRESCRIBED MUPHORAN FOR MELANOMA (ALSO KNOWN AS MALIGNANT MELANOMA). MUPHORAN is available only with a prescription - usually from an experienced cancer specialist (also known as an oncologist). WHY MUPHORAN IS USED FOR MELANOMA Melanoma is a type of skin cancer. Sometimes melanoma spreads from the skin to the lung, liver, bowel, or brain. MUPHORAN works by stopping the rapid growth of some types of cancer cells. MUPHORAN treatment can shrink and slow the growth of melanoma tumours for some patients. Other patients may not have a useful treatment response from MUPHORAN. Ask your doctor if you have any questions about why you are being treated with MUPHORAN. BEFORE YOU ARE TREATED WITH MUPHORAN There are some people who shouldn't be treated with MUPHORAN. Please read the following lists. If you think any of these situations apply to you or you have any questions, please consult your doctor, pharmacist, or oncology nurse. WHEN YOU MUST NOT BE TREATED WITH MUPHORAN • YOU ARE ALLERGIC TO FOTEMUSTINE OR ANY OTHER NITROSOUREA. Symptoms of an allergic reaction to MUPHORAN may include short Прочитајте комплетан документ
MUPHORAN ® (FOTEMUSTINE) – Product Information 1 (8) Version: 2k _MUPHORAN_ _®_ PRODUCT INFORMATION NAME OF THE MEDICINE Registered tradename: _MUPHORAN _ DESCRIPTION Chemical name: Diethyl 1-[3-(2-chloroethyl)-3-nitrosureido] ethylphosphonate RS INN (recommended): fotemustine Formulae: Structural Formula: Molecular formula: C 9 H 19 CIN 3 O 5 P Molecular weight (relative): 315.7 Physicochemical properties: Physical form: pale yellow powder Solubility: results obtained show that fotemustine, in accordance with the standards of the European pharmacopoeia is slightly soluble in water and soluble in 95% ethanol pH: 6.3 (03% aqueous solution) pKa: 10.4 for the acid group Polymorphism: an infrared spectrophotometric study carried out on several batches shows no polymorphism Partition coefficient: octanol/water of 15.7-17.9 (pH 2.1- 7.4) _ _ PHARMACOLOGY Fotemustine is a cytostatic anticancer agent of the nitrosourea family with an alkylating and carbamoylating effect with a wide spectrum of experimental antitumoral activity. PHARMACODYNAMICS Fotemustine is a cytostatic antineoplastic agent whose chemical formula includes a bioiostere of alanine (1-amino ethylphosphonic acid) in order to facilitate cellular penetration and passage across the blood-brain barrier. In animal pharmacology, its spectrum of anticancer activity is very wide and is exerted on tumours of various histological types and in various anatomical sites, particularly cerebral and visceral. MUPHORAN ® (FOTEMUSTINE) – Product Information 2 (8) Version: 2k As a result of its Прочитајте комплетан документ