MAR-TRANEXAMIC ACID TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRANEXAMIC ACID

Available from:

MARCAN PHARMACEUTICALS INC

ATC code:

B02AA02

INN (International Name):

TRANEXAMIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

TRANEXAMIC ACID 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

HEMOSTATICS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-02-13

Summary of Product characteristics

_Page 1 of 21 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-TRANEXAMIC ACID
Tranexamic acid Tablets, BP
Tablet, 500 mg, Oral
BP
Anti-fibrinolytic agent
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Initial Authorization:
FEB 13, 2020
Date of Revision:
June 9, 2022
Submission Control Number: 260172
_Page 2 of 21 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2022
7 WARNINGS AND PRECAUTIONS
06/2022
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.............................................................................................................
5
5
OVERDOSAGE
.......................................................................................