Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
metotrexat
Teva B.V.
L04AX03
methotrexate
2,5 mg
Injektionsvätska, lösning i förfylld spruta
metotrexat 2,5 mg Aktiv substans
Receptbelagt
Förpacknings: Förfylld spruta, 4 x 1 st (med fast injektionsnål) (med automatiskt nålskydd och spritsudd); Förfylld spruta, 1 st (med fast injektionsnål) (med automatiskt nålskydd); Förfylld spruta, 1 st (med fast injektionsnål) (med spritsudd); Förfylld spruta, 1 st (med fast injektionsnål); Förfylld spruta, 4 x 1 st (med fast injektionsnål) (med automatiskt nålskydd); Förfylld spruta, 4 x 1 st (med fast injektionsnål) (med spritsudd); Förfylld spruta, 4 x 1 st (med fast injektionsnål); Förfylld spruta, 12 x 1 st (med fast injektionsnål); Förfylld spruta, 12 x 1 st (med fast injektionsnål) (med automatiskt nålskydd och spritsudd); Förfylld spruta, 12 x 1 st (med fast injektionsnål) (med automatiskt nålskydd); Förfylld spruta, 12 x 1 st (med fast injektionsnål) (med spritsudd); Förfylld spruta, 1 st (med fast injektionsnål) (med automatiskt nålskydd och spritsudd)
Godkänd
2015-11-12
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NAMAXIR 2.5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 17.5 MG, 20 MG, 22.5 MG, 25 MG, 27.5 MG AND 30 MG 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. - 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 Namaxir is and what it is used for 2. What you need to know before you use Namaxir 3. How to use Namaxir 4. Possible side effects 5. How to store Namaxir 6. Contents of the pack and other information 1. WHAT NAMAXIR IS AND WHAT IT IS USED FOR Namaxir 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 (the body’s own defence mechanism) - it has anti-inflammatory effects. Namaxir 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 membranes produ Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Namaxir 2.5 mg solution for injection in pre-filled syringe Namaxir 7.5 mg solution for injection in pre-filled syringe Namaxir 10 mg solution for injection in pre-filled syringe Namaxir 12.5 mg solution for injection in pre-filled syringe Namaxir 15 mg solution for injection in pre-filled syringe Namaxir 17.5 mg solution for injection in pre-filled syringe Namaxir 20 mg solution for injection in pre-filled syringe Namaxir 22.5 mg solution for injection in pre-filled syringe Namaxir 25 mg solution for injection in pre-filled syringe Namaxir 27.5 mg solution for injection in pre-filled syringe Namaxir 30 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Namaxir 2.5 mg:_ Each pre-filled syringe of 0.33 ml contains 2.5 mg methotrexate. _Namaxir 7.5 mg:_ Each pre-filled syringe of 0.30 ml contains 7.5 mg methotrexate. _Namaxir 10 mg: _ Each pre-filled syringe of 0.40 ml contains 10 mg methotrexate. _Namaxir 12.5 mg: _ Each pre-filled syringe of 0.31 ml contains 12.5 mg methotrexate. _Namaxir 15 mg: _ Each pre-filled syringe of 0.38 ml contains 15 mg methotrexate. _Namaxir 17.5 mg: _ Each pre-filled syringe of 0.44 ml contains 17.5 mg methotrexate. _Namaxir 20 mg: _ Each pre-filled syringe of 0.50 ml contains 20 mg methotrexate. _Namaxir 22.5 mg: _ Each pre-filled syringe of 0.56 ml contains 22.5 mg methotrexate. _Namaxir 25 mg: _ Each pre-filled syringe of 0.63 ml contains 25 mg methotrexate. _Namaxir 27.5 mg: _ Each pre-filled syringe of 0.69 ml contains 27.5 mg methotrexate. _Namaxir 30 mg: _ Each pre-filled syringe of 0.75 ml contains 30 mg methotrexate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (solution for injection). Clear, yellowish-orange solution free from visible particles. Osmolality: 280 – 320 mOsm/kg. pH: 7.0 – 9.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Namaxir is indicated for the treatment of - act Прочитать полный документ