Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Calcium folinate
AS Kalceks
V03AF03
Calcium folinate
Solution for injection/infusion
calcium folinate
Not marketed
2023-12-07
PACKAGE LEAFLET: INFORMATION FOR THE USER FOLINIC ACID (AS CALCIUM FOLINATE) 10 MG/ML SOLUTION FOR INJECTION/INFUSION folinic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 (as calcium folinate) is and what it is used for 2. What you need to know before you are given Folinic acid (as calcium folinate) 3. How Folinic acid (as calcium folinate) is given 4. Possible side effects 5. How to store Folinic acid (as calcium folinate) 6. Contents of the pack and other information 1. WHAT FOLINIC ACID (AS CALCIUM FOLINATE) IS AND WHAT IT IS USED FOR Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion contains the active substance folinic acid as calcium folinate hydrate (further referred to as calcium folinate). Calcium folinate is a calcium salt of folinic acid. It belongs to a group of medicines called ‘detoxifying agents’. This medicine is used to: reduce the harmful effects and treat overdose of certain anticancer medicines such as methotrexate and other folic acid antagonists in adults and children. This procedure is known as “calcium folinate rescue”; treat cancer in combination with fluorouracil (an anticancer medicine). Fluorouracil works better when given with calcium folinate. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FOLINIC ACID (AS CALCIUM FOLINATE) YOU SHOULD NOT BE GIVEN FOLINIC ACID (AS CALCIUM FOLINATE) − if you are allergic to calcium folinate or any of the other ingredients of this medicine (listed in section 6); − if you have a type of anaemia (not enough red blood cells) caused by lack of vitamin B 12 . If you are not sure if any of the above applies to you, talk to your d Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 11 December 2023 CRN00DDN1 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains calcium folinate hydrate equivalent to 10 mg folinic acid. Each ml of solution contains calcium folinate hydrate equivalent to 10 mg folinic acid. Each vial with 5 ml solution contains calcium folinate hydrate equivalent to 50 mg folinic acid. Each vial with 10 ml solution contains calcium folinate hydrate equivalent to 100 mg folinic acid. Each vial with 20 ml solution contains calcium folinate hydrate equivalent to 200 mg folinic acid. Each vial with 30 ml solution contains calcium folinate hydrate equivalent to 300 mg folinic acid. Each vial with 50 ml solution contains calcium folinate hydrate equivalent to 500 mg folinic acid. Each vial with 100 ml solution contains calcium folinate hydrate equivalent to 1000 mg folinic acid. Excipient with known effect Each ml of solution contains 3.15 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion (injection/infusion). Clear, colourless or yellowish solution free from visible particles. pH between 6.5 and 8.5 Osmolality 260‑310 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 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 do Διαβάστε το πλήρες έγγραφο