Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Methotrexate
medac Gesellschaft für klinische Spezialpräparate mbH
L04AX; L04AX03
Methotrexate
50 milligram(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Other immunosuppressants; methotrexate
Not marketed
2012-10-12
pal (IE) Metoject 50 mg/ml Solution for injection, pre-filled syringe National version: 09/2023 PACKAGE LEAFLET: INFORMATION FOR THE USER METOJECT 50 MG/ML SOLUTION FOR INJECTION, 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. • 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Metoject 50 mg/ml is and what it is used for 2. What you need to know before you use Metoject 50 mg/ml 3. How to use Metoject 50 mg/ml 4. Possible side effects 5. How to store Metoject 50 mg/ml 6. Contents of the pack and other information 1. WHAT METOJECT 50 MG/ML IS AND WHAT IT IS USED FOR Metoject 50 mg/ml contains methotrexate as active substance. Methotrexate is a substance with the following properties: • it interferes with the growth of certain cells in the body that reproduce quickly. • it reduces the activity of the immune system (body’s own defence mechanism). • it has anti-inflammatory effects. Metoject 50 mg/ml is indicated for the treatment of • active rheumatoid arthritis in adult patients. • 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. Rheumatoid arthritis (RA) is a chronic collagen disease, characterised by inflammation of the synovial membranes (joint membranes). These membranes produce a fluid which acts as a lubricant for many joints. The inflammation causes thickening of the membrane and swelling of the joint. Psoriatic arthritis is a kind of arthritis wi Lugege kogu dokumenti
Health Products Regulatory Authority 04 October 2023 CRN00D8RL Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoject 50 mg/ml Solution for Injection, 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 0.30 ml contains 15 mg methotrexate. 1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate. 1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection, pre-filled syringe. Clear, yellow-brown solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metoject 50 mg/ml is indicated for the treatment of ● active rheumatoid arthritis in adult patients, ● 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IMPORTANT WARNING ABOUT THE DOSAGE OF METOJECT 50 MG/ML (METHOTREXATE) In the treatment of rheumatoid arthritis, psoriasis and psoriatic arthritis, Metoject 50 mg/ml (methotrexate) MUST ONLY BE USED ONCE A WEEK. Dosage errors in the use of Metoject 50 mg/ml (methotrexate) can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. The administration should routinely be done by healthcare professionals. If the clinical situation permits the treating physician can, in selected cases, delegate the subcutaneous administration to the patient her/himself. Patients must be educated and trained in the proper injection technique when self- Lugege kogu dokumenti