Land: Canada
Taal: Engels
Bron: Health Canada
TRANEXAMIC ACID
AURO PHARMA INC
B02AA02
TRANEXAMIC ACID
100MG
SOLUTION
TRANEXAMIC ACID 100MG
INTRAVENOUS
100
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0114760002; AHFS:
APPROVED
2019-01-18
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 Lees het volledige document