ARAVA

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

LEFLUNOMIDE

제공처:

AVENTIS PHARMA - Indonesia

INN (International Name):

LEFLUNOMIDE

복용량:

20 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 1 BOTOL @ 30 TABLET SALUT SELAPUT

Manufactured by:

SANOFI-WINTHROP, FRANCE

승인 날짜:

2018-07-23

제품 특성 요약

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