ASA 81 MG TABLET (DELAYED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ACETYLSALICYLIC ACID

Dostępny od:

VITA HEALTH PRODUCTS INC

Kod ATC:

B01AC06

INN (International Nazwa):

ACETYLSALICYLIC ACID

Dawkowanie:

81MG

Forma farmaceutyczna:

TABLET (DELAYED-RELEASE)

Skład:

ACETYLSALICYLIC ACID 81MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/120/180/300

Typ recepty:

OTC

Dziedzina terapeutyczna:

SALICYLATES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2011-09-23

Charakterystyka produktu

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