Nordimet
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
31-10-2019
Fachinformation
(SPC)
31-10-2019
Öffentlichen Beurteilungsberichts
(PAR)
31-10-2019
Wirkstoff:
Methotrexate
Verfügbar ab:
Nordic Group B.V.
ATC-Code:
L04AX03
INN (Internationale Bezeichnung):
methotrexate
Therapiegruppe:
Antineoplastic agents,
Therapiebereich:
Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid
Anwendungsgebiete:
Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), 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, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients.
Produktbesonderheiten:
Revision: 9
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2016-08-17
Gebrauchsinformation
135
B. PACKAGE LEAFLET
136
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORDIMET 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 12.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 17.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 22.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
NORDIMET 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 Nordimet is and what it is used for
2.
What you need to know before you use Nordimet
3.
How to use Nordimet
4.
Possible side effects
5.
How to store Nordimet
6.
Contents of the pack and other information
1.
WHAT NORDIMET IS AND WHAT IT IS USED FOR
Nordimet contains the active substance methotrexate which works by:
-
reducing inflammation or swelling, and
- reducing the activity of the immune system (the body’s own defense
mechanism). An
overactive immune system has been linked to inflammatory diseases.
Nordimet is a medicine used to treat a range of inflammatory diseases:
-
active rheumatoid arthritis in adults. Active rheumatoid arthritis is
an inflammatory condition
that affects the joints;
-
severe, active juvenile idiopathic arthritis in five or more joints
(the condition is therefore
called polyarthritic), in patients who have had an inadequate response
to nonsteroidal
anti-inflammatory drugs (NSAIDs);
-
a severe fo
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
Nordimet 7.5 mg solution for injection in pre-filled pen
Nordimet 10 mg solution for injection in pre-filled pen
Nordimet 12.5 mg solution for injection in pre-filled pen
Nordimet 15 mg solution for injection in pre-filled pen
Nordimet 17.5 mg solution for injection in pre-filled pen
Nordimet 20 mg solution for injection in pre-filled pen
Nordimet 22.5 mg solution for injection in pre-filled pen
Nordimet 25 mg solution for injection in pre-filled pen
Nordimet 7.5 mg solution for injection in pre-filled syringe
Nordimet 10 mg solution for injection in pre-filled syringe
Nordimet 12.5 mg solution for injection in pre-filled syringe
Nordimet 15 mg solution for injection in pre-filled syringe
Nordimet 17.5 mg solution for injection in pre-filled syringe
Nordimet 20 mg solution for injection in pre-filled syringe
Nordimet 22.5 mg solution for injection in pre-filled syringe
Nordimet 25 mg solution for injection in pre-filled syringe
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 25 mg of methotrexate.
Nordimet 7.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 7.5 mg methotrexate in 0.3 mL
Nordimet 10 mg solution for injection in pre-filled pen
Each pre-filled pen contains 10 mg methotrexate in 0.4 mL
Nordimet 12.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 12.5 mg methotrexate in 0.5 mL
Nordimet 15 mg solution for injection in pre-filled pen
Each pre-filled pen contains 15 mg methotrexate in 0.6 mL
Nordimet 17.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 17.5 mg methotrexate in 0.7 mL
Nordimet 20 mg solution for injection in pre-filled pen
Each pre-filled pen contains 20 mg methotrexate in 0.8 mL
Nordimet 22.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 22.5 mg methotrexate in 0.9 mL
Nordimet 25 mg solution for injection in pre-filled pen
Each pre-filled pen contains 25 mg methotrexate in 1.0 mL
Nordime
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