TRANEXAMIC ACID TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TRANEXAMIC ACID

Tilgjengelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

B02AA02

INN (International Name):

TRANEXAMIC ACID

Dosering :

500MG

Legemiddelform:

TABLET

Sammensetning:

TRANEXAMIC ACID 500MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

HEMOSTATICS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-08-18

Preparatomtale

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