Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Methotrexate
medac Gesellschaft für klinische Spezialpräparate mbH
L01BA; L01BA01
Methotrexate
15 milligram(s)
Solution for injection in pre-filled pen
Product subject to prescription which may not be renewed (A)
Folic acid analogues; methotrexate
Marketed
2018-04-13
pal (IE) Metoject, solution for injection in pre-filled pen Version date: 08/2023 PACKAGE LEAFLET: INFORMATION FOR THE USER METOJECT 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN METOJECT 25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN 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 is and what it is used for 2. What you need to know before you use Metoject 3. How to use Metoject 4. Possible side effects 5. How to store Metoject 6. Contents of the pack and other information 1. WHAT METOJECT IS AND WHAT IT IS USED FOR Metoject 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. PSORIASIS is a common chronic skin disease, characterised by red patches covered by thick, dry, silvery, adherent scales. PSORIATIC ARTHRITIS is a kind of arthritis with psoriatic lesions of the skin and nails, especially Belgenin tamamını okuyun
Health Products Regulatory Authority 04 October 2023 CRN00D8RL Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Metoject 15 mg solution for injection in pre-filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate. 1 pre-filled pen with 0.20 ml solution contains 10 mg methotrexate. 1 pre-filled pen with 0.30 ml solution contains 15 mg methotrexate. 1 pre-filled pen with 0.40 ml solution contains 20 mg methotrexate. 1 pre-filled pen with 0.50 ml solution contains 25 mg methotrexate. Excipients with known effect: sodium chloride and sodium hydroxide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled pen. Clear, yellow-brown solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metoject 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 (METHOTREXATE) In the treatment of rheumatoid arthritis, and psoriasis and psoriatic arthritis, Metoject (methotrexate) must only be used once a week. Dosage errors in the use of Metoject (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. Patients must be educated and trained in the proper injection technique when self-administering methotrexate. The first injection of Metoject should be performed under direct medical supervision. Metoject is injected ONCE WEEKLY. The patient must be explicitly informed about the fact that Metoject is administered ONCE Belgenin tamamını okuyun