Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
OXALIPLATIN
Ebewe Pharma GmbH Nfg. KG Mondseestrasse 11, 4866 Unterach, Austria
L01XA03
OXALIPLATIN 5 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN 5 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2011-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OXALIPLATIN EBEWE 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Oxaliplatin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Oxaliplatin Ebewe is and what it is used for 2. Before you use Oxaliplatin Ebewe 3. How to use Oxaliplatin Ebewe 4. Possible side effects 5 How to store Oxaliplatin Ebewe 6. Further information 1. WHAT OXALIPLATIN EBEWE IS AND WHAT IT IS USED FOR The drug Oxaliplatin Ebewe is used to treat cancer. It can be used alone but more commonly it is used in combination with other anti-cancer agents. Oxaliplatin Ebewe in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is used for treating bowel cancer after is has been removed by surgery or when it has already spread. 2. BEFORE YOU USE OXALIPLATIN EBEWE DO NOT USE OXALIPLATIN EBEWE: • If you are hypersensitive (allergic) to oxaliplatin or any of the other ingredients of Oxaliplatin Ebewe (please refer to “6. Further Information” for list of ingredients) • If you are breast feeding • If your bone marrow is not producing enough blood cells • If you have numbness or tingling in your hands or feet which affects yo Perskaitykite visą dokumentą
PAGE 1 OF 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxaliplatin Ebewe 5 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml 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 40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid pH: 4.0 – 6.0 Osmolarity: 140 mOsmol/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. 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 (see section 6.6 for detailed information). Posology FOR ADULTS ONLY The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m² intravenously repeated every two weeks for Perskaitykite visą dokumentą