Country: Malta
Language: English
Source: Medicines Authority
CALCIUM FOLINATE
Fresenius Kabi Deutschland GmbH Else-Kroener Strasse 1, Bad Homburg v.d.H. 61352, Germany
V03AF03
CALCIUM FOLINATE 10.8 mg/ml
SOLUTION FOR INFUSION OR INJECTION
CALCIUM FOLINATE 10.8 mg/ml
POM
ALL OTHER THERAPEUTIC PRODUCTS
Authorised
2016-02-26
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER CALCIUM FOLINATE 10 MG/ML, SOLUTION FOR INJECTION OR INFUSION Folinic 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 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 Calcium Folinate is and what it is used for 2. What you need to know before you take Calcium Folinate 3. How to take Calcium Folinate 4. Possible side effects 5. How to store Calcium Folinate 6. Contents of the pack and other information 1. WHAT CALCIUM FOLINATE IS AND WHAT IT IS USED FOR Calcium Folinate 10 mg/ml, Solution for Injection or Infusion contains calcium folinate, 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. Calcium Folinate 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 Calcium Folinate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCIUM FOLINATE DO NOT TAKE CALCIUM FOLINATE - if you are allergic to calcium folinate 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 Calcium Folinate together with certain anticancer drugs if you are pregnant or breast-feeding (your doctor will know which thes Read the complete document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Calcium Folinate 10 mg/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% Page 2 of 11 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 may serve as an illustration for a calcium folinate rescue Read the complete document