ADVIL MIGRAINE EXTRA STRENGTH TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
24-08-2017

유효 성분:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

제공처:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

ATC 코드:

M01AE01

INN (국제 이름):

IBUPROFEN

복용량:

400MG

약제 형태:

TABLET

구성:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG

관리 경로:

ORAL

패키지 단위:

12/20/30/60/67/77/180

처방전 유형:

OTC

치료 영역:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0108883002; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2018-08-02

제품 특성 요약

                                _ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
MIGRAINE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.
450 – 55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Submission Control No.: 206595
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.............................................
                                
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