देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
OXALIPLATIN
VITAMED PHARMACEUTICAL INDUSTRIES LTD
L01XA03
CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN 5 MG / 1 ML
I.V
Required
GENEPHARM S.A., GREECE
OXALIPLATIN
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 tumour. - Treatment of metastatic colorectal cancer.Oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first line treatment of patients with metastatic pancreatic adenocarcinoma (based on NCCN guidelines, version 2.2014).
2018-11-05
This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved in NOVEMBER 2018 1. NAME OF THE MEDICINAL PRODUCT PLATINOX-V concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml concentrate for solution for infusion contains 5 mg oxaliplatin. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless solution. 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 tumour. • Treatment of metastatic colorectal cancer. Oxaliplatin in combination with leucovorin, irinotecan and 5-fluorouracil is indicated for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (based on NCCN guidelines, version 2.2014). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ FOR ADULTS ONLY The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m 2 intravenously, repeated every two weeks for 12 cycles (6 months). The recommended dose for oxaliplatin in treatment of metastatic colorectal cancer is 85 mg/m 2 intravenously, repeated every 2 weeks until disease progression or unacceptable toxicity. The recommended dose of oxaliplatin for the treatment of metastatic pancreatic adenocarcinoma is 85 mg/ m 2 given as a 2-hour intravenous infusion, immediately followed by leucovorin (400 mg/ m 2 , 2-hour intravenous infusion) with the addition after 30 minutes of irinotecan (180 mg/ m 2 , 90-minute intravenous infusion through a Y-connector) and immediately followed by 5-fluorouracil (400 mg/m 2 intravenous bolus followed by 2,400 mg/ m 2 continuous intravenous infusion for 46 hours), in 2-week cycles up to 6 months. Dosage given should be adjusted according to tolerability (see section 4.4). OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES – I.E. 5-FLUOROURACI पूरा दस्तावेज़ पढ़ें