TRANEXAMIC ACID INJECTION SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TRANEXAMIC ACID

Dostępny od:

OMEGA LABORATORIES LIMITED

Kod ATC:

B02AA02

INN (International Nazwa):

TRANEXAMIC ACID

Dawkowanie:

100MG

Forma farmaceutyczna:

SOLUTION

Skład:

TRANEXAMIC ACID 100MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

(10X) 5/10/50ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HEMOSTATICS

Podsumowanie produktu:

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

Status autoryzacji:

MARKETED

Data autoryzacji:

2013-03-27

Charakterystyka produktu

Pr
TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
Omega Standard
Antifibrinolytic agent
Omega Laboratories Limited Date of Initial Authorization:
11 177, Hamon March 27, 2013
Montreal, H3M 3E4 Date of Revision:
Québec, Canada September 14, 2023
Submission Control Number: 274335
Pr
TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 2 of 25
RECENT MAJOR LABEL CHANGES
1
INDICATIONS
, 1.1
Pediatrics
, 1.2
Geriatrics
09/2023
2
CONTRAINDICATIONS
09/2023
4
DOSAGE AND ADMINISTRATION
,
4.4 Administration
09/2023
7
WARNINGS AND PRECAUTIONS
,
7.1 Special Populations
,
7.1.1
Pregnant Women
,
7.1.2 Breast-feeding
09/2023
7
WARNINGS AND PRECAUTIONS
,
Cardiovascular
,
Endocrine
and
Metabolism
Reproductive
Health:
Female
and
Male
Potential
10/2021
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
.................................................................