GD-TRANEXAMIC ACID TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TRANEXAMIC ACID

Dostępny od:

GENMED A DIVISION OF PFIZER CANADA ULC

Kod ATC:

B02AA02

INN (International Nazwa):

TRANEXAMIC ACID

Dawkowanie:

500MG

Forma farmaceutyczna:

TABLET

Skład:

TRANEXAMIC ACID 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HEMOSTATICS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2013-07-26

Charakterystyka produktu

_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
..........................