Velos 20 mg Injektionsvätska, lösning i förfylld spruta

国家: 瑞典

语言: 瑞典文

来源: Läkemedelsverket (Medical Products Agency)

有效成分:

metotrexat

可用日期:

Difa Cooper S.p.A.

ATC代码:

L04AX03

INN（国际名称）:

methotrexate

剂量:

20 mg

药物剂型:

Injektionsvätska, lösning i förfylld spruta

组成:

metotrexat 20 mg Aktiv substans

类:

Apotek

处方类型:

Receptbelagt

治疗领域:

Metotrexat

產品總結:

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)

授权状态:

Avregistrerad

授权日期:

2015-10-02

产品特点

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