Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Folinic acid
Pfizer Healthcare Ireland
V03AF; V03AF03
Folinic acid
10 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Detoxifying agents for antineoplastic treatment; calcium folinate
Not marketed
1992-08-18
Page 1 of 7 2021-0072934 PACKAGE LEAFLET: INFORMATION FOR THE USER FOLINIC ACID (AS CALCIUM FOLINATE) 10 MG/ML SOLUTION FOR INJECTION CALCIUM FOLINATE HYDRATE 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Folinic acid Solution for Injection is and what it is used for 2. What you need to know before you use Folinic acid Solution for Injection 3. How to use Folinic acid Solution for Injection 4. Possible side effects 5. How to store Folinic acid Solution for Injection 6. Contents of the pack and other information 1. WHAT FOLINIC ACID SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR Folinic acid is one of the B group of vitamins. Folinic acid Solution for Injection is used to reduce the side effects of other medicines (a group of medicines called folic acid antagonists). Examples of folic acid antagonists are: • methotrexate (a medicine often used to treat cancer) • trimetrexate (an antibiotic and anti-cancer medicine) • trimethoprim (an antibiotic) • pyrimethamine (a medicine often used to treat malaria) It may also be used to treat an overdose of these medicines. Folinic acid Solution for Injection may also be used to increase the effectiveness of the anti- cancer medicine fluorouracil. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOLINIC ACID SOLUTION FOR INJECTION FOLINIC ACID SOLUTION FOR INJECTION MUST NOT BE INJECTED INTRATHECALLY (INTO THE SPINE). DO NOT USE FOLINIC ACID SOLUTION FOR INJECTION • Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 11 August 2022 CRN00CQ7K Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Folinic Acid (as Calcium Folinate) 10mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml, 10 ml or 30 ml solution contains 10 mg/ml of folinic acid provided as calcium folinate hydrate. Each 1 mg of folinic acid is equivalent to 1.08 mg of calcium folinate hydrate. Excipients with known effect Folinic Acid 50 mg/5 ml solution for injection contains 16.74 mg of sodium in each 5 ml vial. Folinic Acid 100 mg/10 ml solution for injectioncontains 33.5 mg of sodium in each 10 ml vial. Folinic Acid 300 mg/30 ml solution for injectioncontains 100.5 mg of sodium in each 30 ml vial. For the full list of excipients, see section 6.1_._ 3 PHARMACEUTICAL FORM Solution for Injection. Clear, straw to pale yellow solution free of particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcium folinate is indicated a) 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 cytotoxic therapy, this procedure is commonly known as “Calcium Folinate Rescue”; b) in combination with 5-fluorouracil in cytotoxic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous and intramuscular administration only. In the case of intravenous administration, no more than 160 mg of calcium folinate should be injected per minute due to the calcium content of the solution. For intravenous infusion, calcium folinate may be diluted with 0.9% sodium chloride solution or 5% glucose solution before use. Refer also to sections 6.3 and 6.6. Posology _Calcium folinate rescue in methotrexate therapy:_ Since the calcium folinate rescue dosage regimen depends heavily on the posology and method of the intermediate- or high-dose methotrexate administration, the methotrexate protocol will dictate the dosage regimen of calcium folinate rescue. Therefore, it is best to r Lesen Sie das vollständige Dokument