METOJECT

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

METHOTREXATE

Tilgængelig fra:

DIPA PHARMALAB INTERSAINS - Indonesia

INN (International Name):

METHOTREXATE

Dosering:

50 MG

Lægemiddelform:

LARUTAN INJEKSI

Enheder i pakken:

DUS, 1 PREFILLED SYRINGE @ 0.60 ML

Fremstillet af:

ONCOTEC PHARMA PRODUKTION GMBH - Federal Republic of Germany

Autorisation dato:

2020-08-22

Produktets egenskaber

1 of 13
METOJECT
Methotrexate
NAME OF THE MEDICINAL PRODUCT
Metoject 50 mg/ml solution for injection, pre-filled syringe.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml of solution contains 50 mg methotrexate.
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
PHARMACEUTICAL FORM
Solution for injection, pre-filled syringe. Clear, yellow-brown
solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Metoject is indicated for the treatment of
1.
active rheumatoid arthritis in adult patients,
2.
severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of
therapy such as phototherapy, PUVA, and retinoids.
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. Patients must be
educated to use the proper injection
technique. The first injection of Metoject should be performed under
direct medical supervision.
Metoject is injected ONCE WEEKLY.
The patient is to be explicitly informed about the fact of
administration ONCE A WEEK ONLY. 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.
Dosage in adult patients with