देश: स्वीडन
भाषा: स्वीडिश
स्रोत: Läkemedelsverket (Medical Products Agency)
metotrexat
Difa Cooper S.p.A.
L04AX03
methotrexate
10 mg
Injektionsvätska, lösning i förfylld spruta
metotrexat 10 mg Aktiv substans
Apotek
Receptbelagt
Metotrexat
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 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)
Avregistrerad
2015-10-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VELOS 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 Velos is and what it is used for 2. What you need to know before you take Velos 3. How to use Velos 4. Possible side effects 5. How to store Velos 6. Contents of the pack and other information 1. WHAT VELOS IS AND WHAT IT IS USED FOR Velos 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. Velos 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 produce a fluid whic पूरा दस्तावेज़ पढ़ें
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Velos 2.5 mg solution for injection in pre-filled syringe Velos 7.5 mg solution for injection in pre-filled syringe Velos 10 mg solution for injection in pre-filled syringe Velos 12.5 mg solution for injection in pre-filled syringe Velos 15 mg solution for injection in pre-filled syringe Velos 17.5 mg solution for injection in pre-filled syringe Velos 20 mg solution for injection in pre-filled syringe Velos 22.5 mg solution for injection in pre-filled syringe Velos 25 mg solution for injection in pre-filled syringe Velos 27.5 mg solution for injection in pre-filled syringe Velos 30 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Velos 2.5 mg:_ Each pre-filled syringe of 0.33 ml contains 2.5 mg methotrexate. _Velos 7.5 mg:_ Each pre-filled syringe of 0.30 ml contains 7.5 mg methotrexate. _Velos 10 mg: _ Each pre-filled syringe of 0.40 ml contains 10 mg methotrexate. _ _ _Velos 12.5 mg: _ Each pre-filled syringe of 0.31 ml contains 12.5 mg methotrexate. _Velos 15 mg: _ Each pre-filled syringe of 0.38 ml contains 15 mg methotrexate. _Velos 17.5 mg: _ Each pre-filled syringe of 0.44 ml contains 17.5 mg methotrexate. _Velos 20 mg: _ Each pre-filled syringe of 0.50 ml contains 20 mg methotrexate. _Velos 22.5 mg: _ Each pre-filled syringe of 0.56 ml contains 22.5 mg methotrexate. _Velos 25 mg: _ Each pre-filled syringe of 0.63 ml contains 25 mg methotrexate. _Velos 27.5 mg: _ Each pre-filled syringe of 0.69 ml contains 27.5 mg methotrexate. _Velos 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 Velos is indicated for the treatment of - active rheumatoid arthritis in adult patients पूरा दस्तावेज़ पढ़ें