ASA 81 MG TABLET (DELAYED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACETYLSALICYLIC ACID

Tersedia dari:

VITA HEALTH PRODUCTS INC

Kode ATC:

B01AC06

INN (Nama Internasional):

ACETYLSALICYLIC ACID

Dosis:

81MG

Bentuk farmasi:

TABLET (DELAYED-RELEASE)

Komposisi:

ACETYLSALICYLIC ACID 81MG

Rute administrasi :

ORAL

Unit dalam paket:

30/120/180/300

Jenis Resep:

OTC

Area terapi:

SALICYLATES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2011-09-23

Karakteristik produk

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