Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Methotrexate
Accord Healthcare Ireland Ltd.
L04AX; L04AX03
Methotrexate
50 milligram(s)/millilitre
Solution for injection in pre-filled syringe
Other immunosuppressants; methotrexate
Not marketed
2016-02-19
SE/H/1431/001/IA/045, ver 002, Dec 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOFILL 50 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE methotrexate 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Methofill is and what it is used for 2. What you need to know before you use Methofill 3. How to use Methofill 4. Possible side effects 5. How to store Methofill 6. Contents of the pack and other information 1. WHAT METHOFILL IS AND WHAT IT IS USED FOR Methofill contains methotrexate as active substance Methotrexate is a substance with following properties: • it interferes with the growth of certain cells in the body that reproduce quickly • it reduces the activity of the immune system (the body’s own defence mechanism) • it has anti-inflammatory effects Methofill is indicated for the treatment of • active rheumatoid arthritis in adult patients. • polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti- inflammatory drugs (NSAIDs) has been inadequate, • severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. • mild to moderate Crohn’s Disease in adult patients when adequate treatment with other medicines is not possible. Rheumatoid arthritis (RA) is a chronic collagen disease, characterised by inflammation of the synovial membranes (joint membranes). These membr Przeczytaj cały dokument
Health Products Regulatory Authority 12 February 2024 CRN00F3ZK Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methofill 50 mg/mL solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 50 mg methotrexate (as methotrexate disodium). 1 pre-filled syringe of 0.15 ml contains 7.5 mg methotrexate. 1 pre-filled syringe of 0.20 ml contains 10 mg methotrexate. 1 pre-filled syringe of 0.25 ml contains 12.5 mg methotrexate. 1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate. 1 pre-filled syringe of 0.35 ml contains 17.5 mg methotrexate. 1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate. 1 pre-filled syringe of 0.45 ml contains 22.5 mg methotrexate. 1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate. 1 pre-filled syringe of 0.55 ml contains 27.5 mg methotrexate. 1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate Excipient with known effect: Each pre-filled syringe contains <1 mmol sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. Clear, yellow to brown solution. pH: Between 7.0 to 9.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Methotrexate is indicated for the treatment of active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. mild to moderate Crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therap Przeczytaj cały dokument