Metoject 25 mg Injektionsvätska, lösning i förfylld injektionspenna

Land: Sverige

Språk: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv ingrediens:

metotrexat

Tilgjengelig fra:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC-kode:

L04AX03

INN (International Name):

methotrexate

Dosering :

25 mg

Legemiddelform:

Injektionsvätska, lösning i förfylld injektionspenna

Sammensetning:

metotrexat 25 mg Aktiv substans

Resept typen:

Receptbelagt

Produkt oppsummering:

Förpacknings: Förfylld penna, 1 st (25 mg/0,5 ml); Förfylld penna, 24 st (25 mg/0,5 ml); Förfylld penna, 10 st (25 mg/0,5 ml); Förfylld penna, 6 st (25 mg/0,5 ml); Förfylld penna, 5 st (25 mg/0,5 ml); Förfylld penna, 4 st (25 mg/0,5 ml); Förfylld penna, 2 st (25 mg/0,5 ml); Förfylld penna, 15 st (25 mg/0,5 ml); Förfylld penna, 14 st (25 mg/0,5 ml); Förfylld penna, 12 st (25 mg/0,5 ml); Förfylld penna, 11 st (25 mg/0,5 ml)

Autorisasjon status:

Godkänd

Autorisasjon dato:

2018-01-30

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
METOJECT 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
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 Metoject is and what it is used for
2.
What you need to know before you use Metoject
3.
How to use Metoject
4.
Possible side effects
5.
How to store Metoject
6.
Contents of the pack and other information
1.
WHAT METOJECT IS AND WHAT IT IS USED FOR
Metoject is indicated for the treatment of
•
active rheumatoid arthritis in adult patients.
•
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.
RHEUMATOID ARTHRITIS
(RA)
is a chronic collagen disease, characterised by inflammation of the
synovial membranes (joint membranes). These membranes produce a fluid
which acts as a lubricant
for many joints. The inflammation causes thickening of the membrane
and swelling of the joint.
PSORIASIS
is a common chronic skin disease, characterised by red patches covered
by thick, dry,
silvery, adherent scales.
PSORIATIC ARTHRITIS
is a kind of arthritis with psoriatic lesions of the skin and nails,
especially at the
joints of fingers and toes.
Metoject modifies and slows down the progressi

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metoject 7.5 mg solution for injection in pre-filled pen
Metoject 10 mg solution for injection in pre-filled pen
Metoject 15 mg solution for injection in pre-filled pen
Metoject 20 mg solution for injection in pre-filled pen
Metoject 25 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate.
1 pre-filled pen with 0.20 ml solution contains 10 mg methotrexate.
1 pre-filled pen with 0.30 ml solution contains 15 mg methotrexate.
1 pre-filled pen with 0.40 ml solution contains 20 mg methotrexate.
1 pre-filled pen with 0.50 ml solution contains 25 mg methotrexate.
Excipients with known effect: sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
Clear, yellow-brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metoject is indicated for the treatment of

active rheumatoid arthritis in adult patients,

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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
IMPORTANT WARNING ABOUT THE DOSAGE OF METOJECT (METHOTREXATE)
In the treatment of rheumatoid arthritis, and psoriasis and psoriatic
arthritis, Metoject (methotrexate)
MUST
ONLY BE USED ONCE A WEEK
. Dosage errors in the use of Metoject (methotrexate) can result in
serious adverse
reactions, including death. Please read this section of the summary of
product characteristics very carefully.
2
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a full
understanding of the risks of methotrexate therapy. Patients must be
educated and trained in the proper
injection technique when self-administering methotrexate. The first
injection of Metoject should be
performe