Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
TRANEXAMIC ACID
PFIZER CANADA ULC
B02AA02
TRANEXAMIC ACID
100MG
SOLUTION
TRANEXAMIC ACID 100MG
INTRAVENOUS
10X10ML
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0114760002; AHFS:
APPROVED
2001-08-07
_CYKLOKAPRON (Tranexamic acid) _ _Page 1 of 24_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CYKLOKAPRON ® Tranexamic acid Tablet, 500 mg, Oral and Solution, 100 mg/mL, Intravenous House Standard Antifibrinolytic agent Pfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec, H9J 2M5 ® Pfizer Health AB Pfizer Canada ULC, Licensee Pfizer Canada ULC 2021 Date of Initial Authorization: DEC 05, 1995 Date of Revision: NOV 25, 2021 Submission Control Number: 254356 _ _ _CYKLOKAPRON (Tranexamic acid) _ _Page 2 of 24_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 11/2021 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 11/2021 7 WARNINGS AND PRECAUTIONS 11/2021 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 4.3 Reconstitution ...................... Aqra d-dokument sħiħ