国家: 马耳他
语言: 英文
来源: Medicines Authority
OXALIPLATIN
Actavis Group h.f. Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland
L01XA03
OXALIPLATIN 5 mg/ml
POWDER FOR SOLUTION FOR INFUSION
OXALIPLATIN 5 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2008-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OXALIPLATIN 5 MG/ML POWDER FOR SOLUTION FOR INFUSION Oxaliplatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Oxaliplatin 5mg/ml powder for solution for infusion is and what it is used for 2. What you need to know before you use Oxaliplatin 5mg/ml powder for solution for infusion 3. How to use Oxaliplatin 5mg/ml powder for solution for infusion 4. Possible side effects 5. How to store Oxaliplatin 5mg/ml powder for solution for infusion 6. Contents of the pack and other information 1. WHAT OXALIPLATIN 5MG/ML POWDER FOR SOLUTION FOR INFUSION IS AN WHAT IT IS USED FOR Oxaliplatin 5mg/ml powder for solution for infusion is used to treat metastatic (advanced) cancer of the colon (large bowel) or rectum (back passage), or as additional treatment following surgery to remove a tumour (growth) in the colon. It is used in combination with other anticancer agents, 5-fluorouracil (5-FU) and folinic acid (FA). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN 5 MG/ML POWDER FOR SOLUTION FOR INFUSION DO NOT USE OXALIPLATIN 5MG/ML POWDER FOR SOLUTION FOR INFUSION: - if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding - if you already have a reduced number of blood cells (white blood cells and/or 阅读完整的文件
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxaliplatin 5 mg/ml powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the reconstituted solution for infusion contains 5mg oxaliplatin. 50 mg vial: Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent. 100 mg vial: Each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. A white or almost white powder. 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. 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 medical product used, in conditions that guarantee the integrity of the medical product, the protection of the environment and in particular the protection of the personnel handling the medicinal products, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area. _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/m² intravenously repeated every 2 weeks. Dosage given should be adj 阅读完整的文件