APO-IBUPROFEN CAPLET TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
19-10-2020
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유효 성분:
IBUPROFEN
제공처:
APOTEX INC
ATC 코드:
M01AE01
INN (국제 이름):
IBUPROFEN
복용량:
400MG
약제 형태:
TABLET
구성:
IBUPROFEN 400MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
OTC
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0108883002; AHFS:
승인 상태:
APPROVED
승인 날짜:
2019-07-05
제품 특성 요약
Page 1 of 41
0
PRODUCT MONOGRAPH
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 200 MG
APO
-IBUPROFEN CAPLET
IBUPROFEN TABLETS USP, 200 MG
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 300 MG
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 400 MG
APO
-IBUPROFEN CAPLET
IBUPROFEN TABLETS USP, 400 MG
NON-STEROIDAL ANTI-INFLAMMATORY DRUG
ANALGESIC, ANTIPYRETIC AGENT
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9 OCTOBER 19, 2020
Submission Control No:
240021
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL
USE............................................................................................
4
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
5
ADVERSE REACTIONS
...............................................................................................................
11
DRUG INTERACTIONS
................................................................................................................
14
DOSAGE AND ADMINISTRATION
............................................................................................
16
OVERDOSAGE
..............................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
18
STORAGE AND STABILITY
.......................................................................................................
19
SPECIAL HANDLING
INSTRUCTIONS……………………………………………………......19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................
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