GD-TRANEXAMIC ACID TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TRANEXAMIC ACID

Disponibil de la:

GENMED A DIVISION OF PFIZER CANADA ULC

Codul ATC:

B02AA02

INN (nume internaţional):

TRANEXAMIC ACID

Dozare:

500MG

Forma farmaceutică:

TABLET

Compoziție:

TRANEXAMIC ACID 500MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HEMOSTATICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-07-26

Caracteristicilor produsului

_GD-TRANEXAMIC ACID (tranexamic acid)_
_ _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GD
*
-TRANEXAMIC ACID
Tranexamic acid tablets
Tablet, 500 mg, Oral
House Standard
Antifibrinolytic agent
GenMed, a division of Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec, H9J 2M5
Date of Initial Authorization:
JUL 26, 2013
Date of Revision:
November 23, 2022
Submission Control Number: 265002
* GD is a trademark of Pfizer Canada ULC
GenMed, a division of Pfizer Canada ULC., Licensee

Pfizer Canada Inc. 2022
_GD-TRANEXAMIC ACID (tranexamic acid)_
_ _
_Page 2 of 21_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
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...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.5
Missed Dose
..........................