Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
methotrexate
Orion Corporation / Orion Pharma
L04AX03
methotrexate
10mg
tablets
(15) in plastic container, (25) in plastic container, (50) in plastic container, (16/4x4/) in blister, (30/3x10/) in blister
Prescription
Registered
2023-03-10
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trexan 2.5 mg tablets Trexan 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trexan 2.5 mg tablets: Each tablet contains methotrexate disodium equivalent to 2.5 mg methotrexate (anhydrous). Excipient with known effect: 77.8 mg lactose (as lactose monohydrate). Trexan 10 mg tablets: Each tablet contains methotrexate disodium equivalent to 10 mg methotrexate (anhydrous). Excipient with known effect: 311.2 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Trexan 2.5 mg tablets: Yellow, round, uncoated, flat tablet, scored and engraved with ORN 57 on one side, diameter 6 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Trexan 10 mg tablets: Yellow, capsule-shaped, convex, uncoated tablet, engraved with ORN 59 on one side and score on other side, length of 14 mm and width of 6 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - _Antirheumatic:_ Active rheumatoid arthritis in adult patients - _Antipsoriatic:_ 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 - _Cytostatic_: Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. IMPORTANT WARNING WITH REFERENCE TO THE DOSING OF TREXAN (METHOTREXATE): In the treatment of rheumatic diseases, psoriasis or severe psoriatic arthritis, Trexan (methotrexate) MUST ONLY BE TAKEN ONCE A WEEK. Dosage errors in the use of Trexan (methotrexate) can result in serious adverse reactions, including death. Please read this section of t Đọc toàn bộ tài liệu