PRO-AAS EC TABLET (DELAYED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETYLSALICYLIC ACID

Commercializzato da:

PRO DOC LIMITEE

Codice ATC:

N02BA01

INN (Nome Internazionale):

ACETYLSALICYLIC ACID

Dosaggio:

81MG

Forma farmaceutica:

TABLET (DELAYED-RELEASE)

Composizione:

ACETYLSALICYLIC ACID 81MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

OTC

Dettagli prodotto:

Active ingredient group (AIG) number: 0101169013; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-03-31

Scheda tecnica

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
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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
.....................