Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Oxaliplatin
Fresenius Kabi Oncology Plc
L01XA; L01XA03
Oxaliplatin
5 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Platinum compounds; oxaliplatin
Marketed
2009-07-24
00235 OXALIPLATIN RTU PACK INSERT-GBR+IRE-BORDON-PL 187270016 - 592X300 \\fre-kp-fp01\PDD-Artworks\Europe\Oxaliplatin\RTU\IRL+UK\PL 187270016\Bordon\2017 NOV\Masters\00235 Oxaliplatin RTU Pack Insert-GBR+IRE-Bordon-PL 187270016 - 592x300.indd Black Font Size: 9 Pt. Date: 28 Novemer 2018 Version: 05 Final Packaging Site: Bordon Mfg. Site: Baddi-2 Font: Times New Roman Dimension: 592x300 mm Folding Size: 60x33 mm _(Outline of folding size for indication purpose only, _ _it should be removed before final printing.)_ Form No.: SOP/PDD/014-02 Rev. 00 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 an anti-cancer drug and 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 anti-cancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA). 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). • if you are breastfeeding • if you already have a reduced numbe Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxaliplatin 5mg/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 (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 withknowledge of the medicinal product 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 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). 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. Dosage 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 glucose 5% sol Prečítajte si celý dokument