Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
OXALIPLATIN
1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany
L01XA03
OXALIPLATIN 5 mg/ml
POWDER FOR SOLUTION FOR INFUSION
OXALIPLATIN 5 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2008-01-29
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER OXALIPLATIN EBEWE 5 MG/ML POWDER FOR SOLUTION FOR INFUSION oxaliplatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Oxaliplatin Ebewe is and what it is used for 2. What you need to know before you are given Oxaliplatin Ebewe 3. How Oxaliplatin Ebewe is given 4. Possible side effects 5 How to store Oxaliplatin Ebewe 6. Contents of the pack and other information 1. WHAT OXALIPLATIN EBEWE IS AND WHAT IT IS USED FOR Oxaliplatin Ebewe is an anticancer medicine and contains the active substance oxaliplatin Oxaliplatin Ebewe is used for treating bowel cancer after it has been removed by surgery or when it has already spread. Oxaliplatin Ebewe is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OXALIPLATIN EBEWE YOU SHOULD NOT BE GIVEN OXALIPLATIN EBEWE: • if you are ALLERGIC to oxaliplatin if you are BREAST-FEEDING • if you already have a REDUCED NUMBER OF BLOOD CELLS • if you already have TINGLING AND NUMBNESS IN THE FINGERS AND/OR TOES , and have DIFFICULTY PERFORMING DELICATE TASKS , such as buttoning clothes • if you have SEVERE KIDNEY PROBLEMS WARNINGS AND PRECAUTIONS Talk to your doctor before you are given Oxaliplatin Ebewe • If you have ever SUFFERED AN ALLERGIC REACTION TO PLATINUM-CONTAINING MEDICINES such as CARBOPLATIN, CISPLATIN. ALLERGIC REACTIONS CAN OCCURE DURING ANY OXALIPLATIN INFUSION. • If you have mild or MODERATE KIDNEY PROBLEMS • If you have any liver problems or abnormal liver function test results during your treatment. • If you have or had heart disorders such as an Baca dokumen lengkap
Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxaliplatin Ebewe 5mg/ml powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with lyophilised powder contains 50mg, 100mg or 150mg of oxaliplatin. One vial of 50mg: Each vial contains 50 mg oxaliplatin for reconstitution in 10 ml of solvent. One vial of 100mg: Each vial contains 100 mg oxaliplatin for reconstitution in 20 ml of solvent. One vial of 150mg: Each vial contains 150 mg oxaliplatin for reconstitution in 30 ml of solvent. 1ml of reconstituted solution for infusion contains 5mg of oxaliplatin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white compact powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Oxaliplatin “Ebewe” in combination with 5-fluorouracil (5 FU) and folinic acid (FA) is indicated for: - adjuvant treatment of stage III (Dukes 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 medicines used, under conditions that guarantee integrity of the medicinal product, protection of the environment and in particular protection of the personnel handling the medicinal products, according to hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area (see section 6.6 for detailed information). Page 2 of 23 Posology FOR ADULTS ONLY The recommended dose of oxaliplatin used in adjuvant treatment is 85mg/m 2 body surface area, administered intravenously every 2 weeks for 12 cycles (6 months). The recommended dose of oxaliplatin for the treatment of metastatic colorectal cancer is 85 mg/m 2 body surface area, administered intravenously every 2 weeks until disease progression or unacceptable toxicity. Dosage given sh Baca dokumen lengkap