TRANEXAMIC ACID TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRANEXAMIC ACID

Available from:

JAMP PHARMA CORPORATION

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:

2021-08-18

Summary of Product characteristics

Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Tranexamic Acid
Tranexamic acid Tablets, BP
Tablet, 500 mg, Oral
BP
Anti-fibrinolytic agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 266700
Date of Initial Authorization:
AUG 18, 2021
Date of Revision:
SEPT 07, 2022
Page 2 of 22
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2022
7 WARNINGS AND PRECAUTIONS
09/2022
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
............