ENTERIC COATED ASA DAILY LOW DOSE TABLET (DELAYED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ACETYLSALICYLIC ACID

Saatavilla:

PHARMASCIENCE INC

ATC-koodi:

B01AC06

INN (Kansainvälinen yleisnimi):

ACETYLSALICYLIC ACID

Annos:

81MG

Lääkemuoto:

TABLET (DELAYED-RELEASE)

Koostumus:

ACETYLSALICYLIC ACID 81MG

Antoreitti:

ORAL

Kpl paketissa:

7/30/120/150/180/255/300/360/365/500/1000

Prescription tyyppi:

OTC

Terapeuttinen alue:

SALICYLATES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2017-10-21

Valmisteyhteenveto

PRODUCT MONOGRAPH
ENTERIC COATED ASA DAILY LOW DOSE
Acetylsalicylic Acid Delayed-release Tablets, USP
81 mg
Analgesic, anti-inflammatory, antipyretic and
Platelet aggregation inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
DATE OF REVISION:
March 08, 2017
SUBMISSION CONTROL NUMBER: 199017
_ENTERIC COATED ASA DAILY LOW DOSE Product Monograph _
_Page 2 of 38_
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
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II : SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................1