TRANEXAMIC ACID INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TRANEXAMIC ACID

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

B02AA02

INN (nume internaţional):

TRANEXAMIC ACID

Dozare:

100MG

Forma farmaceutică:

SOLUTION

Compoziție:

TRANEXAMIC ACID 100MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HEMOSTATICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-03-17

Caracteristicilor produsului

_ Tranexamic Acid Injection (tranexamic acid) _Page 1 of 24
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
House Standard
Antifibrinolytic agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville Quebec
J4B 5H3, Canada
Date of Initial Authorization:
March 16, 2020
Date of Revision:
November 28, 2022
Submission Control Number: 265633
_ Tranexamic Acid Injection (tranexamic acid) _Page 2 of 24
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2022
7 WARNINGS AND PRECAUTIONS
11/2022
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.......................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.3
Reconstitution
.................