País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Oxaliplatin
Fresenius Kabi Deutschland GmbH
L01XA; L01XA03
Oxaliplatin
5 milligram(s)/millilitre
Concentrate for solution for infusion
Platinum compounds; oxaliplatin
Marketed
2009-07-24
PACKAGE LEAFLET: INFORMATION FOR THE USER OXALIPLATIN 5 MG/ML CONCENTRATE 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, pharmacist or nurse. - If you get any side effects, talk to your 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 Oxaliplatin is and what it is used for 2. What you need to know before you use Oxaliplatin 3. How to use Oxaliplatin 4. Possible side effects 5. How to store Oxaliplatin 6. Contents of the pack and other information 1. WHAT OXALIPLATIN IS AND WHAT IT IS USED FOR The active ingredient of oxaliplatin concentrate for solution for infusion is oxaliplatin. Oxaliplatin 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). Oxaliplatin is used in combination with other anticancer medicines called 5-fluorouracil and folinic acid. Oxaliplatin is an antineoplastic or anticancer drug and contains platinum. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OXALIPLATIN DO NOT USE OXALIPLATIN IF : • You are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6). • 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 or nurse before using Oxaliplatin • 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 mild or moderate kidney problems • if you hav Leia o documento completo
Health Products Regulatory Authority 11 October 2022 CRN00CXXM Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxaliplatin 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 a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless solution, free from visible particles. 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 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. Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of 5% glucose solution to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m 2 . Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used. Special Leia o documento completo