Metotrexat Astron 50 mg/ml Injektionsvätska, lösning i förfylld spruta

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

metotrexat

Disponível em:

Astron Research Ltd

Código ATC:

L04AX03

DCI (Denominação Comum Internacional):

methotrexate

Dosagem:

50 mg/ml

Forma farmacêutica:

Injektionsvätska, lösning i förfylld spruta

Composição:

metotrexat 50 mg Aktiv substans

Tipo de prescrição:

Receptbelagt

Status de autorização:

Avregistrerad

Data de autorização:

2015-11-26

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE ASTRON 50 MG/ML SOLUTION FOR INJECTION IN PREFILLED
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 or
nurse.
•
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Methotrexate Astron is and what it is used for
2.
What you need to know before you use Methotrexate Astron
3.
How to use Methotrexate Astron
4.
Possible side effects
5.
How to store Methotrexate Astron
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE ASTRON IS AND WHAT IT IS USED FOR
Methotrexate Astron contains methotrexate as active substance
Methotrexate is a substance with 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
Methotrexate Astron 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 m

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexate Astron
50 mg/ml solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 50 mg methotrexate (as methotrexate
disodium).
1 pre-filled syringe of 0.15 ml contains 7.5 mg methotrexate.
1 pre-filled syringe of 0.20 ml contains 10 mg methotrexate.
1 pre-filled syringe of 0.25 ml contains 12.5 mg methotrexate.
1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate.
1 pre-filled syringe of 0.35 ml contains 17.5 mg methotrexate.
1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate.
1 pre-filled syringe of 0.45 ml contains 22.5 mg methotrexate.
1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate.
1 pre-filled syringe of 0.55 ml contains 27.5 mg methotrexate.
1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate
Excipient with known effect:
Each pre-filled syringe contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, yellow to brown solution.
pH: Between 7.0 to 9.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Methotrexate 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 either alone or in combination with
corticosteroids in adult
patients refractory or intolerant to thiopurines.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians, who are familiar
with the various
characteristics of the medicinal product and its mode of action. The
administration should
routinely be done by health professio