PRO-AAS EC TABLET (DELAYED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
27-02-2023
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Aktiva substanser:
ACETYLSALICYLIC ACID
Tillgänglig från:
PRO DOC LIMITEE
ATC-kod:
N02BA01
INN (International namn):
ACETYLSALICYLIC ACID
Dos:
81MG
Läkemedelsform:
TABLET (DELAYED-RELEASE)
Sammansättning:
ACETYLSALICYLIC ACID 81MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
OTC
Produktsammanfattning:
Active ingredient group (AIG) number: 0101169013; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2023-03-31
Produktens egenskaper
PRODUCT MONOGRAPH
PRO-AAS EC
Acetylsalicylic Acid Delayed-release Tablets USP
81 mg
Analgesic, anti-inflammatory, antipyretic and
Platelet aggregation inhibitor
PRO DOC LTÉE
2925, BOUL. INDUSTRIEL
LAVAL, QUÉBEC
H7L 3W9
DATE OF REVISION:
February 27, 2023
SUBMISSION CONTROL NUMBER:
269256
PRO-AAS EC; PRO-AAS CHEWABLE
PRO-AAS EC_PM_EN.pdf
Pg. 1
Page
2
of
39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II : SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
.....................
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