APO-IBUPROFEN CAPLET TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
19-10-2020
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有効成分:
IBUPROFEN
から入手可能:
APOTEX INC
ATCコード:
M01AE01
INN（国際名）:
IBUPROFEN
投薬量:
400MG
医薬品形態:
TABLET
構図:
IBUPROFEN 400MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
OTC
治療領域:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
製品概要:
Active ingredient group (AIG) number: 0108883002; AHFS:
認証ステータス:
APPROVED
承認日:
2019-07-05
製品の特徴
Page 1 of 41
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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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