ENTERIC COATED DAILY LOW DOSE ASA 81 MG TABLET (DELAYED-RELEASE)
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
23-03-2022
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Ingredient activ:
ACETYLSALICYLIC ACID
Disponibil de la:
VITA HEALTH PRODUCTS INC
Codul ATC:
B01AC06
INN (nume internaţional):
ACETYLSALICYLIC ACID
Dozare:
81MG
Forma farmaceutică:
TABLET (DELAYED-RELEASE)
Compoziție:
ACETYLSALICYLIC ACID 81MG
Calea de administrare:
ORAL
Unități în pachet:
30/120/180/300
Tip de prescriptie medicala:
OTC
Zonă Terapeutică:
SALICYLATES
Rezumat produs:
Active ingredient group (AIG) number: 0101169013; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2011-02-17
Caracteristicilor produsului
ASA 81 mg Page 1 of 46
PRODUCT MONOGRAPH
ASA 81 MG
Acetylsalicylic Acid Delayed Release Tablets
81 mg
USP
Platelet aggregation inhibitor
Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, MB
Canada R2J 3W2
Control Number: 261087
Date of Preparation:
February 3, 2011
Date of Revision :
March 23, 2022
ASA 81 mg Page 2 of 46
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
.....................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.....................................................................................
14
CLINICAL TRIALS
..............
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