Country: Malta
Language: English
Source: Medicines Authority
OXALIPLATIN
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
L01XA03
OXALIPLATIN 5 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
OXALIPLATIN 5 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2006-09-28
Page 1 of 12 PACKAGE LEAFLET: INFORMATION FOR THE USER ELOXATIN 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 any further questions, ask your doctor, your pharmacist or nurse. • If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What ELOXATIN is and what it is used for 2. What you need to know before you use ELOXATIN 3. How to use ELOXATIN 4. Possible side effects 5. How to store ELOXATIN 6. Contents of the pack and other information 1. WHAT ELOXATIN IS AND WHAT IT IS USED FOR The active ingredient of ELOXATIN is oxaliplatin.. ELOXATIN is used to treat cancer of the large bowel (treatment of stage III colon cancer after complete resection of primary tumour, metastatic cancer of colon and rectum). ELOXATIN is used in combination with other anticancer medicines called 5 fluorouracil and folinic acid. ELOXATIN is an antineoplastic or anticancer drug and contains platinum. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ELOXATIN DO NOT USE ELOXATIN IF: • You are allergic tothis medicine. • You are breast-feeding. • You already have a reduced number of blood cells. • You already have tingling and numbness in the fingers and/or toes, and have difficulty performing delicate tasks, such as buttoning clothes. • You have severe kidney problems. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking ELOXATIN • If you have ever suffered an allergic reaction to platinum-containing medicines such as carboplatin, cisplatin. Allergic reactions can occur during any oxaliplatin infusion. • If you have moderate or mild kidney problems, Page 2 of 12 • 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 abnormal electrical signal calle Read the complete document
Page 1 of 25 1. NAME OF THE MEDICINAL PRODUCT Eloxatin 5 mg/ml concentrate for solution for infusion / Foxantal 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 40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless liquid 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 (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 medicinal products used, in conditions that guarantee the integrity of the medicinal _ _ 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. Page 2 of 25 Posology FOR ADULTS ONLY The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m² 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 until disease progression or unacceptable toxicity. Dose given should be adjusted according to tolerability (see section 4.4). OXALIPLATIN SHOULD ALWAYS BE ADMINISTERED BEFORE FLUOROPYRIMIDINES, I.E. 5 FLUOROURACIL (5 FU). Oxaliplatin is administered as a 2- to Read the complete document