Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
LEVOFOLINIC ACID SODIUM HYDROXIDE
Medac Gesellschaft fur Klinische Spezialpraparate
LEVOFOLINIC ACID SODIUM HYDROXIDE
50 Micromol
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-11-08
pal (IE) Levofolinic acid medac 50 mg/ml Date of common version: 06.03.2013, National version: 06.03.2013 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFOLINIC ACID MEDAC 50 MG/ML SOLUTION FOR INJECTION OR INFUSION (Levofolinic acid) 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. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Levofolinic acid medac 50 mg/ml is and what it is used for 2. What you need to know before you use Levofolinic acid medac 50 mg/ml 3. How to use Levofolinic acid medac 50 mg/ml 4. Possible side effects 5. How to store Levofolinic acid medac 50 mg/ml 6. Contents of the pack and other information 1. WHAT LEVOFOLINIC ACID MEDAC 50 MG/ML IS AND WHAT IT IS USED FOR USE OF LEVOFOLINIC ACID MEDAC 50 MG/ML IN COMBINATION WITH METHOTREXATE Levofolinic acid medac 50 mg/ml Solution for injection or infusion belongs to the group of drug products called antidotes. These are substances which are used during cancer therapy (cytostatic therapy) to counteract the toxicity of cytostatics. Levofolinic acid medac 50 mg/ml is used in cancer therapy in adults and children to diminish the toxicity and counteract the action of substances such as methotrexate which inhibit the action of endogenous folic acid (so called folic acid antagonists). An Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofolinic acid medac 50 mg/ml Solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 54.65 mg disodium levofolinate equivalent to 50 mg levofolinic acid. Each 1 ml vial contains 54.65 mg disodium levofolinate equivalent to 50 mg levofolinic acid. Each 4 ml vial contains 218.6 mg disodium levofolinate equivalent to 200 mg levofolinic acid. Each 9 ml vial contains 491.85 mg disodium levofolinate equivalent to 450 mg levofolinic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion Slightly yellow, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Disodium levofolinate is indicated - to diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in adults and children; - in combination with 5-fluorouracil in cytotoxic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofolinic acid medac 50 mg/ml Solution for injection or infusion is administered intravenously, either undiluted by injection or by infusion after dilution (for dilution see section 6.6). DISODIUM LEVOFOLINATE SHOULD NOT BE ADMINISTERED INTRATHECALLY. DISODIUM LEVOFOLINATE IN COMBINATION WITH 5-FLUOROURACIL IN CYTOTOXIC THERAPY The combined use of disodium levofolinate and fluorouracil is reserved for physicians experienced in the combination of folinates with 5-fluorouracil in cytotoxic therapy. Different regimes and different dosages are used, without any dosage having been proven to be the optimal one. The following regimes have been used in adults and elderly in the treatment of advanced or metastatic colorectal cancer and are given as examples. There ar Soma hati kamili