Namaxir 7,5 mg Injektionsvätska, lösning i förfylld spruta

Nchi: Uswidi

Lugha: Kiswidi

Chanzo: Läkemedelsverket (Medical Products Agency)

Viambatanisho vya kazi:

metotrexat

Inapatikana kutoka:

Teva B.V.

ATC kanuni:

L04AX03

INN (Jina la Kimataifa):

methotrexate

Kipimo:

7,5 mg

Dawa fomu:

Injektionsvätska, lösning i förfylld spruta

Tungo:

metotrexat 7,5 mg Aktiv substans

Dawa ya aina:

Receptbelagt

Bidhaa muhtasari:

Förpacknings: 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); Förfylld spruta, 4 x 1 st (med fast injektionsnål) (med automatiskt nålskydd och spritsudd)

Idhini hali ya:

Godkänd

Idhini ya tarehe:

2015-11-12

Taarifa za kipeperushi

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

Tabia za bidhaa

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