APO-ASA LD TABLET (DELAYED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ACETYLSALICYLIC ACID

Prieinama:

APOTEX INC

ATC kodas:

B01AC06

INN (Tarptautinis Pavadinimas):

ACETYLSALICYLIC ACID

Dozė:

81MG

Vaisto forma:

TABLET (DELAYED-RELEASE)

Sudėtis:

ACETYLSALICYLIC ACID 81MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

8/24/30/90/100/120/125/180/240/250/500

Recepto tipas:

OTC

Gydymo sritis:

SALICYLATES

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2017-02-09

Prekės savybės

_APO-ASA LD (LOW DOSE) _
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_Page 1 of 38 _
PRODUCT MONOGRAPH
APO-ASA LD (LOW DOSE)
Acetylsalicylic Acid Delayed Release Tablets, USP
81 mg
Platelet Aggregation Inhibitor
APOTEX INC.
Date of Revision
150 Signet Drive
November 09, 2022
Toronto, Ontario
M9L 1T9
Submission Control Number: 268417
_APO-ASA LD (LOW DOSE) _
_ _
_Page 2 of 38 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS.........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
7
DOSAGE AND ADMINISTRATION
.....................................................................................
9
OVERDOSAGE
......................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 10
STORAGE AND STABILITY
...............................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 12
PART II: SCIENTIFIC INFORMATION
.............................................................................
13
PHARMACEUTICAL INFORMATION
................................................................