NU-LEFLUNOMIDE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
02-02-2012
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유효 성분:
LEFLUNOMIDE
제공처:
NU-PHARM INC
ATC 코드:
L04AK01
INN (국제 이름):
LEFLUNOMIDE
복용량:
20MG
약제 형태:
TABLET
구성:
LEFLUNOMIDE 20MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
제품 요약:
Active ingredient group (AIG) number: 0140182002; AHFS:
승인 상태:
CANCELLED (UNRETURNED ANNUAL)
승인 날짜:
2018-03-28
제품 특성 요약
Page 1 of 62
PRODUCT MONOGRAPH
Pr
NU-LEFLUNOMIDE
LEFLUNOMIDE TABLETS
HOUSE STANDARD
10 MG AND 20 MG
ANTIRHEUMATIC, IMMUNOMODULATOR AGENT
NU-PHARM INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT 2
FEBRUARY 2, 2012
VAUGHAN, ONTARIO
L4K 4N7
CONTROL #: 152701
Page 2 of 62
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
....................................................................................................................13
DRUG
INTERACTIONS.....................................................................................................................18
DOSAGE AND
ADMINISTRATION.................................................................................................21
OVERDOSAGE
...................................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................23
STORAGE AND
STABILITY.............................................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................26
PART II: SCIENTIFIC INFORMATION
...........................................................................................27
PHARMACEUTICAL
INFORMATION....................................................................................
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