TEVA-FLURBIPROFEN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
14-07-2015
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유효 성분:
FLURBIPROFEN
제공처:
TEVA CANADA LIMITED
ATC 코드:
M01AE09
INN (국제 이름):
FLURBIPROFEN
복용량:
50MG
약제 형태:
TABLET
구성:
FLURBIPROFEN 50MG
관리 경로:
ORAL
패키지 단위:
100/500
처방전 유형:
Prescription
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0115998002; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2019-08-08
제품 특성 요약
PRODUCT MONOGRAPH
PR
TEVA-FLURBIPROFEN
(Flurbiprofen tablets BP)
50 mg and 100 mg Tablets
Nonsteroidal anti-inflammatory drug (NSAID)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 14, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control No.: 184835
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
...............................................................................................
16
DRUG INTERACTIONS
...............................................................................................
19
DOSAGE AND ADMINISTRATION
..........................................................................
22
OVERDOSAGE
..............................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 23
STORAGE AND
STABILITY.......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.....................................................................
27
CLINICAL TRIALS
.......................................................................................................
28
DETAILED PHARMACOLOGY
.................................................................................
30
TOXICOLOGY
..............................................................................................................
30
REFERENCES
.
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