TRANEXAMIC ACID INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRANEXAMIC ACID

Διαθέσιμο από:

AURO PHARMA INC

Φαρμακολογική κατηγορία (ATC):

B02AA02

INN (Διεθνής Όνομα):

TRANEXAMIC ACID

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

TRANEXAMIC ACID 100MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HEMOSTATICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-01-18

Αρχείο Π.Χ.Π.

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
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
January 15, 2019
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
July 06, 2017
Date of Revision:
January 03, 2023
Submission Control Number: 266686
Page 2 of 26
_PRODUCT MONOGRAPH _
_TRANEXAMIC ACID INJECTION _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
01/2023
7 WARNINGS AND PRECAUTIONS
01/2023
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
..............................................................................................................
4
1.2 Geriatrics
..............................................................................................................
4
2 CONTRAINDICATIONS
.........................................................................................................
4
4 DOSAGE AND
ADMINISTRATION.........................................................................................
4
4.1 Dosing Considerations
...........................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................ 5
4.3 Reconstitution
......................................................................................................
5
4.4 Administration