Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
oxaliplatin
Teva Pharmaceutical Works Private Limited Company
oxaliplatin
5mg/ml
concentrate for solution for infusion
Prescription
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY OXALIPLATIN - TEVA, 5 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION Version: 0028 September 2012 Replaces: 0027 July 2012 MODULE 1 ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION Page: 1 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH 1. NAME OF THE MEDICINAL PRODUCT Oxaliplatin - Teva 5 mg/ml, concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 5 mg oxaliplatin. 10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin. 20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin. Excipient: lactose monohydrate. 1 ml of concentrate for solution for infusion contains 45 mg of lactose monohydrate. 10 ml of concentrate for solution for infusion contains 450 mg of lactose monohydrate. 20 ml of concentrate for solution for infusion contains 900 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless or almost colourless solution. pH: 4.0 – 6.0 Osmolarity: 0.200 osmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for: - Adjuvant treatment of stage III (Duke’s C) colon cancer after complete resection of primary tumor. - Treatment of metastatic colorectal cancer. TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY OXALIPLATIN - TEVA, 5 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION Version: 0028 September 2012 Replaces: 0027 July 2012 MODULE 1 ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION Page: 2 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS IN ENGLISH 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicinal product used, in conditions that guarantee the integrity of Прочитать полный документ