ODAN-LEFLUNOMIDE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LEFLUNOMIDE

제공처:

ODAN LABORATORIES LTD

ATC 코드:

L04AA13

INN (국제 이름):

LEFLUNOMIDE

복용량:

10MG

약제 형태:

TABLET

구성:

LEFLUNOMIDE 10MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0140182001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-07-05

제품 특성 요약

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_PAGE 1 OF 70_
PRODUCT MONOGRAPH
Pr
ODAN-LEFLUNOMIDE
Leflunomide, Mfr. Std.
Film-coated Tablets 10, 20 mg
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
ODAN LABORATORIES LTD
325 STILLVIEW AVENUE
POINTE-CLAIRE, QUEBEC
H9R 2Y6
Date of Revision:
July 5, 2017
SUBMISSION CONTROL NO.: 205879
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_PAGE 2 OF 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
.....................................................................
3
CONTRAINDICATIONS
...........................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................
5
ADVERSE REACTIONS
.........................................................................................
15
DRUG INTERACTIONS
..........................................................................................
21
DOSAGE AND ADMINISTRATION
......................................................................
26
OVERDOSAGE
........................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
.................................................... 27
STORAGE AND STABILITY
.................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................... 31
PART II: SCIENTIFIC INFORMATION
................................................................................
32
PHARMACEUTICAL INFORMATION
................................................................. 32
CLINICAL TRIALS
.................................................................................................
32
DETAILED PHARMACOLOGY
.............................................................................
40
TOXICOLOGY
...............................