Velos 17,5 mg Injektionsvätska, lösning i förfylld spruta

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

metotrexat

זמין מ:

Difa Cooper S.p.A.

קוד ATC:

L04AX03

INN (שם בינלאומי):

methotrexate

כמות:

17,5 mg

טופס פרצבטיות:

Injektionsvätska, lösning i förfylld spruta

הרכב:

metotrexat 17,5 mg Aktiv substans

סיווג:

Apotek

סוג מרשם:

Receptbelagt

איזור תרפויטי:

Metotrexat

leaflet_short:

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)

מצב אישור:

Avregistrerad

תאריך אישור:

2015-10-02

מאפייני מוצר

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