TRANEXAMIC ACID INJECTION, USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TRANEXAMIC ACID

Commercializzato da:

BAXTER CORPORATION

Codice ATC:

B02AA02

INN (Nome Internazionale):

TRANEXAMIC ACID

Dosaggio:

500MG

Forma farmaceutica:

SOLUTION

Composizione:

TRANEXAMIC ACID 500MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

HEMOSTATICS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-09-18

Scheda tecnica

_Tranexamic Acid Injection, USP (_
_tranexamic acid) _
_ _ Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Tranexamic Acid Injection, USP.
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
USP
Antifibrinolytic agent
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
Canada L5N 0C2
Date of initial
Authorization:
September 17, 2020
Date of Revision:
July 19, 2022
Submission Control Number: 261259
_Tranexamic Acid Injection, USP (_
_tranexamic acid) _Page 2 of 22
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
07/2022
7
WARNINGS AND PRECAUTIONS
07/2022
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
4.3
Reconstitution
....................................................................................