Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
Methotrexate
Nordic Group B.V.
L04AX03
methotrexate
Antineoplastic agents,
Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid
Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), 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, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.
Revision: 9
Authorised
2016-08-17
135 B. PACKAGE LEAFLET 136 PACKAGE LEAFLET: INFORMATION FOR THE USER NORDIMET 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 17.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 22.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NORDIMET 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 Nordimet is and what it is used for 2. What you need to know before you use Nordimet 3. How to use Nordimet 4. Possible side effects 5. How to store Nordimet 6. Contents of the pack and other information 1. WHAT NORDIMET IS AND WHAT IT IS USED FOR Nordimet contains the active substance methotrexate which works by: - reducing inflammation or swelling, and - reducing the activity of the immune system (the body’s own defense mechanism). An overactive immune system has been linked to inflammatory diseases. Nordimet is a medicine used to treat a range of inflammatory diseases: - active rheumatoid arthritis in adults. Active rheumatoid arthritis is an inflammatory condition that affects the joints; - severe, active juvenile idiopathic arthritis in five or more joints (the condition is therefore called polyarthritic), in patients who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs); - a severe fo Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT Nordimet 7.5 mg solution for injection in pre-filled pen Nordimet 10 mg solution for injection in pre-filled pen Nordimet 12.5 mg solution for injection in pre-filled pen Nordimet 15 mg solution for injection in pre-filled pen Nordimet 17.5 mg solution for injection in pre-filled pen Nordimet 20 mg solution for injection in pre-filled pen Nordimet 22.5 mg solution for injection in pre-filled pen Nordimet 25 mg solution for injection in pre-filled pen Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 25 mg of methotrexate. Nordimet 7.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 7.5 mg methotrexate in 0.3 mL Nordimet 10 mg solution for injection in pre-filled pen Each pre-filled pen contains 10 mg methotrexate in 0.4 mL Nordimet 12.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 12.5 mg methotrexate in 0.5 mL Nordimet 15 mg solution for injection in pre-filled pen Each pre-filled pen contains 15 mg methotrexate in 0.6 mL Nordimet 17.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 17.5 mg methotrexate in 0.7 mL Nordimet 20 mg solution for injection in pre-filled pen Each pre-filled pen contains 20 mg methotrexate in 0.8 mL Nordimet 22.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 22.5 mg methotrexate in 0.9 mL Nordimet 25 mg solution for injection in pre-filled pen Each pre-filled pen contains 25 mg methotrexate in 1.0 mL Nordime Lire le document complet