ENTROPHEN 325MG TABLETS TABLET (DELAYED-RELEASE)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
16-11-2021
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Aktiv ingrediens:
ACETYLSALICYLIC ACID
Tilgjengelig fra:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC-kode:
N02BA01
INN (International Name):
ACETYLSALICYLIC ACID
Dosering :
325MG
Legemiddelform:
TABLET (DELAYED-RELEASE)
Sammensetning:
ACETYLSALICYLIC ACID 325MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
OTC
Terapeutisk område:
SALICYLATES
Produkt oppsummering:
Active ingredient group (AIG) number: 0101169001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2002-03-08
Preparatomtale
PRODUCT MONOGRAPH
ENTROPHEN
® 325 MG CAPLETS
Acetylsalicylic
Acid Delayed-release Tablets USP
325 mg
ENTROPHEN
® 325 MG TABLETS
Acetylsalicylic
Acid Delayed-release Tablets USP
325 mg
ENTROPHEN
®
Acetylsalicylic
Acid Delayed-release Tablets USP
81 mg
ENTROPHEN
® CHEWABLE
Acetylsalicylic
Acid Tablets USP
81 mg
Analgesic, anti-inflammatory,
antipyretic and
Platelet aggregation inhibitor
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Quebec H4P 2T4
DATE OF REVISION:
November 16, 2021
www.pendopharm.com
SUBMISSION CONTROL NUMBER: 255502 & 255545
®
Registered trademark of Pharmascience Inc.
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................5
WARNINGS AND PRECAUTIONS
.............................................................................5
ADVERSE
REACTIONS..............................................................................................8
DRUG INTERACTIONS
..............................................................................................8
DOSAGE AND ADMINISTRATION
.........................................................................
11
OVERDOSAGE
.........................................................................................................
12
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
13
STORAGE AND STABILITY
....................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
................................................................... 14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 15
PART II : SCIENTIFIC INFOR
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