TRANEXAMIC ACID INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TRANEXAMIC ACID

Disponibil de la:

EUGIA PHARMA INC.

Codul ATC:

B02AA02

INN (nume internaţional):

TRANEXAMIC ACID

Dozare:

100MG

Forma farmaceutică:

SOLUTION

Compoziție:

TRANEXAMIC ACID 100MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

Active ingredient group (AIG) number: 0114760002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-10-04

Caracteristicilor produsului

Page 1 of 26
_PRODUCT MONOGRAPH _
_TRANEXAMIC ACID INJECTION _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
House Standard
Antifibrinolytic agent
EUGIA PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite 402
January 15, 2019
Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
October 04, 2022
Date of Revision:
January 02, 2024
Submission Control Number: 281103
Page 2 of 26
_PRODUCT MONOGRAPH _
_TRANEXAMIC ACID INJECTION _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2024
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
1 INDICATIONS
.....................................................................................................................
4
1.1 Pediatrics
.....................................................................................................................
4
1.2 Geriatrics
.....................................................................................................................
4
2
CONTRAINDICATIONS........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
.......................................................................................
4
4.1 Dosing Considerations
.................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.3 Reconstitution
...........................................................................................................