Երկիր: Ինդոնեզիա
Լեզու: ինդոնեզերեն
Աղբյուրը: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEFLUNOMIDE
AVENTIS PHARMA - Indonesia
LEFLUNOMIDE
20 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL @ 30 TABLET SALUT SELAPUT
SANOFI-WINTHROP, FRANCE
2018-07-23
ARAVA ® 20 MG LEFLUNOMIDE Film-coated tablets This package insert is continually updated: please read carefully before using a new pack. In case of any question, please contact your physician or pharmacist. COMPOSITION Active ingredient: Leflunomide Each film-coated tablet ARAVA 20 mg, contains 20 mg leflunomide respectively. Excipients: tablet core: Maize starch, povidone, crospovidone, colloidal anhydrous silica, lactose monohydrate, magnesium stearate. Film-coating: talc, hypromellose, titanium dioxide, macrogol 8000, and yellow ferric oxide for ARAVA 20 mg. PHARMACOLOGICAL PROPERTIES 1. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: selective immunosuppressive agents, ATC code: L04AA13 _Human pharmacology_ Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. _Animal pharmacology_ Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase. It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties. Leflunomide exhibits the best protective effects on animal models of autoimmune diseases when administered in the early phase of the disease progression. _In vivo_, it is rapidly and almost completely metabolised to active metabolite (A771726) which is active _in vitro_, and is presumed to be responsible for the therapeutic effect. _Mode of action_ A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity. Clinical efficacy and safety _Rheumatoid arthritis_ The efficacy of Arava in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III). The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104). The treatment duration was 6 months. All Կարդացեք ամբողջական փաստաթուղթը