Ország: Kanada
Nyelv: angol
Forrás: Health Canada
TRANEXAMIC ACID
STERIMAX INC
B02AA02
TRANEXAMIC ACID
500MG
TABLET
TRANEXAMIC ACID 500MG
ORAL
10
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0114760001; AHFS:
APPROVED
2013-01-31
Tranexamic Acid Tablets (Tranexamic Acid Tablets) Page 1 of 24 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TRANEXAMIC ACID TABLETS (Tranexamic Acid Tablets) Tablet, 500 mg, Oral Mfr. Std Antifibrinolytic Agent Submission Control No.: 260438 SteriMax Inc. 2770 Portland Drive Oakville, ON L6H 6R4 Date of Initial Authorization: December 3, 2015 Date of Revision: July 5, 2022 Tranexamic Acid Tablets (Tranexamic Acid Tablets) Page 2 of 24 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 07/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 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 4.5 Missed Dose ................................................................................................. Olvassa el a teljes dokumentumot