מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
vinorelbine tartrate
Hospira Australia Pty Ltd
Registered
DBL ™ Vinorelbine Injection Concentrate Page 1 DBL ™ VINORELBINE INJECTION CONCENTRATE Vinorelbine _(vi-NOR-el-been)_ CONSUMER MEDICINE INFORMATION_ _ _Date of dispensing _ _Consumer name _ _pharmacy name _ _Consumer address _ _pharmacy address_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL ™ Vinorelbine Injection Concentrate (vinorelbine). 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 being given vinorelbine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET._ _ You may need to read it again. WHAT DBL ™ VINORELBINE INJECTION CONCENTRATE IS USED FOR This medicine is used to treat: • advanced breast cancer • non-small cell lung cancer. This medicine belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. _ _ It works by stopping cancer cells from growing and multiplying. It may be used alone or in combination with other medicines to treat cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU . Your doctor may have prescribed it for another reason. This medicine is not addictive. _ _ It is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine for children. BEFORE YOU ARE GIVEN DBL ™ VINORELBINE INJECTION CONCENTRATE _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN DBL ™ VINORELBINE INJECTION CONCENTRATE IF YOU HAVE AN ALLERGY TO: • any medicine containing vinorelbine • any other similar medicines, such as vinblastine, vincristine or vindesine. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts o קרא את המסמך השלם
Product Information - Australia Version 4.0 Page 1 DBL™ VINORELBINE INJ ECTION CONCENTRATE NAME OF THE MEDICINE Vinorelbine Tartrate CAS No: 125317-39-7 The chemical structure of vinorelbine tartrate is shown below: DESCRIPTION Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumour activity. The chemical name is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-( _R_ *, _R_ *)-2,3 dihydroxybutanedioate (1:2)(salt)]. Vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula C 45 H 54 N 4 O 8 .2C 4 H 6 O 6 and molecular weight of 1079.12. The aqueous solubility is > 1000 mg/mL in distilled water. DBL™ Vinorelbine Injection Concentrate is a clear colourless to pale yellow solution containing 10 mg vinorelbine per mL (present as 13.85 mg of vinorelbine tartrate), in water for injections. The pH of DBL™ Vinorelbine Injection Concentrate is approximately 3.0 to 4.0. PHARMACOLOGY Vinorelbine is a cytostatic antineoplastic drug. It is a semi-synthetic member of the vinca alkaloid family that interferes with microtubule assembly. The vinca alkaloids are structurally similar compounds comprised of two multiringed units, vindoline and catharanthine. Unlike other vinca alkaloids, the catharanthine unit is the site of structural modification for vinorelbine. The antitumour activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. In intact tectal plates from mouse embryos, vinorelbine, vincristine, and vinblastine inhibited mitotic microtubule formation at the same concentration (2 micromolar), including a blockade of cells at metaphase. Vincristine produced depolymerisation of axonal tubules at 5 micromolar, but vinblastine and vinorelbine did not have this effect until concentrations of 30 micromolar and 40 micromolar respectively. These data suggest relative selectivity of vinorelbine for mitotic microtubules. Vinorelbine has an active metabolite, 17 deacetylvinorelbine, low levels o קרא את המסמך השלם