Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Folinic acid
Fresenius Kabi Deutschland GmbH
V03AF; V03AF03
Folinic acid
10 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Detoxifying agents for antineoplastic treatment; calcium folinate
Marketed
2016-01-22
1 M0xxxxx/00 IE V001/IE 221222222222 221222222222 221222222222 221222222222 221222222222 221222222222 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Folinic acid is and what it is used for 2. What you need to know before you take Folinic acid 3. How to take Folinic acid 4. Possible side effects 5. How to store Folinic acid 6. Contents of the pack and other information 1. WHAT FOLINIC ACID IS AND WHAT IT IS USED FOR Folinic acid (as calcium folinate) 10 mg/ml solution for injection or infusion contains Folinic acid, which is one of a group of medicine called detoxifying agents. It is a calcium salt of folinic acid, which is related to the vitamin folic acid. Folinic acid is used to: - reduce the harmful effects and treat overdose of certain types of anti-cancer medicines for instance methotrexate and other folic acid antagonists. This is known as “calcium folinate rescue”. - treat cancer in combination with 5-fluorouracil (an anti-cancer medicine). 5-fluorouracil works better when it is given together with Folinic acid. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLINIC ACID DO NOT TAKE FOLINIC ACID - if you are allergic to Folinic acid or any of the other ingredients of this medicine (listed in section 6). - if you suffer from anaemia (not enough red blood cells) caused by a lack of vitamin B 12 , such as: • pernicious anaemia (your immune systems fights your red blood cells) • megaloblastic anaemia (your red blood cells are larger than normal) You should not be given Folinic acid together with certain anticancer drugs if you are pregnant or breastfeeding (your doctor will know which these are). WARNINGS AND PRECAUTIONS Talk to your doctor or nur Lestu allt skjalið
Health Products Regulatory Authority 01 December 2023 CRN009KDL Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Folinic acid (as calcium folinate) 10mg/ml solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 10 mg of folinic acid provided as calcium folinate. Each 5, 10, 20, 35, 50, 100 ml vial contains 50, 100, 200, 350, 500 and 1000 mg of folinic acid respectively (provided as calcium folinate). Excipient with known effect: 3.14 mg/ml to 3.20 mg/ml (0.14 mmol/ml) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion Clear, yellowish solution, free from visible particles. pH: 6.5 – 8.5 Osmolality: 225-325 mOsmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcium folinate 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 cytotoxic therapy, this procedure is commonly known as “Calcium Folinate Rescue”. - 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 refer to the applied intermediate or high dose methotrexate protocol for posology and method of administration of calcium folinate. The following guidelines Lestu allt skjalið