Krajina: Švédsko
Jazyk: švédčina
Zdroj: Läkemedelsverket (Medical Products Agency)
metotrexat
Difa Cooper S.p.A.
L04AX03
methotrexate
20 mg
Injektionsvätska, lösning i förfylld spruta
metotrexat 20 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 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 Prečítajte si celý dokument