Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Methotrexate
Accord Healthcare Ireland Ltd.
L01BA; L01BA01
Methotrexate
17.5 milligram(s)
Solution for injection in pre-filled injector
Folic acid analogues; methotrexate
Marketed
2017-08-04
SE/H/1431/001-011/IA/045, ver 001, Sep 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER METHOFILL 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 10 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 15 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 17.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 20 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 22.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 25 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 27.5 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR METHOFILL 30 MG SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR 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 • Rheumatoid arthritis (RA) in adult patients- (RA) is a chronic disease, characterised by inflammation Prečítajte si celý dokument
Health Products Regulatory Authority 11 May 2023 CRN00DGL4 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methofill 17.5 mg solution for injection in pre-filled injector 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pre-filled injector with 0.35 ml solution contains 17.5 mg methotrexate Excipient with known effect: Each pre-filled injector contains <1 mmol sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled injector. 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, who are familiar with the various characteristics of the medicinal product and its mode of action. If considered appropriate, the treating physician can, in selected cases, delegate subcutaneous administration to the patient. Patients must be educated to use the proper injection technique. The first injection of methotrexate should be performed under direct medical supervision. Methotrexate is injected ONCE WEEKLY The patient must be explicitly informed about the fact that methotrexate is administered ONCE A WEEK ONLY. It is advisable to determine an appropriate fixed day of the week for the injection. Methotrexate elimination is reduced in patients with a third distribution space (ascites, pleural effusions). Such pa Prečítajte si celý dokument