TRANEXAMIC ACID INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TRANEXAMIC ACID

Commercializzato da:

EUGIA PHARMA INC.

Codice ATC:

B02AA02

INN (Nome Internazionale):

TRANEXAMIC ACID

Dosaggio:

100MG

Forma farmaceutica:

SOLUTION

Composizione:

TRANEXAMIC ACID 100MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-10-04

Scheda tecnica

Page 1 of 26
_PRODUCT MONOGRAPH _
_TRANEXAMIC ACID INJECTION _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
House Standard
Antifibrinolytic agent
EUGIA PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite 402
January 15, 2019
Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
October 04, 2022
Date of Revision:
January 02, 2024
Submission Control Number: 281103
Page 2 of 26
_PRODUCT MONOGRAPH _
_TRANEXAMIC ACID INJECTION _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2024
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
1 INDICATIONS
.....................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
.................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 5
4.3 Reconstitution
...........................................................................................................