TRANEXAMIC ACID TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRANEXAMIC ACID

Available from:

STERIMAX INC

ATC code:

B02AA02

INN (International Name):

TRANEXAMIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

TRANEXAMIC ACID 500MG

Administration route:

ORAL

Units in package:

10

Prescription type:

Prescription

Therapeutic area:

HEMOSTATICS

Product summary:

Active ingredient group (AIG) number: 0114760001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-01-31

Summary of Product characteristics

Tranexamic Acid Tablets (Tranexamic Acid Tablets)
Page 1 of 24
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID TABLETS
(Tranexamic Acid Tablets)
Tablet, 500 mg, Oral
Mfr. Std
Antifibrinolytic Agent
Submission Control No.: 260438
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Date of Initial Authorization:
December 3, 2015
Date of Revision:
July 5, 2022
Tranexamic Acid Tablets (Tranexamic Acid Tablets)
Page 2 of 24
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
TABLE OF CONTENTS
......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics...................................................................................................................
4
2
CONTRAINDICATIONS......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.............................................................
5
4.5
Missed Dose
.................................................................................................