Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
METHOTREXATE
DIPA PHARMALAB INTERSAINS - Indonesia
METHOTREXATE
50 MG
LARUTAN INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0.15 ML
ONCOTEC PHARMA PRODUKTION GMBH - Federal Republic of Germany
2020-08-06
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 Baca dokumen lengkapnya