TRANEXAMIC ACID INJECTION BP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

TRANEXAMIC ACID

Disponible des:

STERIMAX INC

Codi ATC:

B02AA02

Designació comuna internacional (DCI):

TRANEXAMIC ACID

Dosis:

100MG

formulario farmacéutico:

SOLUTION

Composición:

TRANEXAMIC ACID 100MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10X5ML/10X10ML/50ML

tipo de receta:

Prescription

Área terapéutica:

HEMOSTATICS

Resumen del producto:

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

Estat d'Autorització:

MARKETED

Data d'autorització:

2012-11-15

Fitxa tècnica

‘
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION BP
Tranexamic Acid Injection
Solution for Injection, 100 mg / mL, Intravenous
BP
Antifibrinolytic Agent
Submission Control No.: 262636
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Date of Initial Authorization:
MAY 24, 2012
Date of Revision:
SEP 08, 2022
_ _
_Tranexamic Acid Injection BP Page 2 of 25_ RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2022
7 WARNINGS AND PRECAUTIONS
09/2022 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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Reconstitution
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5
4.4
Administration
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