Metoject

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

methotrexate (methotrexate disodium)

Διαθέσιμο από:

Medac GmbH

INN (Διεθνής Όνομα):

methotrexate (methotrexate disodium)

Δοσολογία:

10mg/ml

Φαρμακοτεχνική μορφή:

solution for injection

Τρόπος διάθεσης:

Prescription

Αρχείο Π.Χ.Π.

SPC (common) Metoject 10 mg/ml solution for injection, pre-filled
syringe; date of revision: 2014-03-31
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metoject 10 mg/ml solution for injection, pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 10 mg methotrexate (as methotrexate
disodium).
1 pre-filled syringe of 0.75 ml contains 7.5 mg methotrexate
1 pre-filled syringe of 1 ml contains 10 mg methotrexate
1 pre-filled syringe of 1.5 ml contains 15 mg methotrexate
1 pre-filled syringe of 2 ml contains 20 mg methotrexate
1 pre-filled syringe of 2.5 ml contains 25 mg methotrexate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metoject is indicated for the treatment of:

Severe, active rheumatoid arthritis in adult patients

Polyarthritic forms of severe, active juvenile idiopathic arthritis
when the response to non-
steroidal anti-inflammatory drugs (NSAIDs) has been inadequate

Severe and generalised psoriasis vulgaris, especially plaque-type, and
psoriatic arthritis in adult
patients which are unresponsive to conventional therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Metoject should only be prescribed by physicians, who are familiar
with the various characteristics of
the medicinal product and its mode of action. Metoject is injected
ONCE WEEKLY
. The patient is to be
explicitly informed about the fact of administration once weekly. It
is advisable to determine a fixed,
appropriate weekday as day of injection.
Methotrexate elimination is reduced in patients with a third
distribution space (ascites, pleural
effusions). Such patients require especially careful monitoring for
toxicity, and require dose reduction
or, in some cases, discontinuation of methotrexate administration (see
sections 5.2 and 4.4).
Dosage in adult patients with rheumatoid arthritis:
The recommended initial dose is 7.5 mg of m