ENTROPHEN 325MG CAPLETS TABLET (DELAYED-RELEASE)
Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
16-11-2021
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
ACETYLSALICYLIC ACID
Disponibbli minn:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
Kodiċi ATC:
N02BA01
INN (Isem Internazzjonali):
ACETYLSALICYLIC ACID
Dożaġġ:
325MG
Għamla farmaċewtika:
TABLET (DELAYED-RELEASE)
Kompożizzjoni:
ACETYLSALICYLIC ACID 325MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100
Tip ta 'preskrizzjoni:
OTC
Żona terapewtika:
SALICYLATES
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0101169001; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2002-03-08
Karatteristiċi tal-prodott
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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