Страна: Канада
мова: англійська
Джерело: Health Canada
TRANEXAMIC ACID
OMEGA LABORATORIES LIMITED
B02AA02
TRANEXAMIC ACID
100MG
SOLUTION
TRANEXAMIC ACID 100MG
INTRAVENOUS
(10X) 5/10/50ML
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0114760002; AHFS:
MARKETED
2013-03-27
Pr TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 1 of 25 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TRANEXAMIC ACID INJECTION Tranexamic acid injection Solution, 100 mg / mL, Intravenous Omega Standard Antifibrinolytic agent Omega Laboratories Limited Date of Initial Authorization: 11 177, Hamon March 27, 2013 Montreal, H3M 3E4 Date of Revision: Québec, Canada September 14, 2023 Submission Control Number: 274335 Pr TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 2 of 25 RECENT MAJOR LABEL CHANGES 1 INDICATIONS , 1.1 Pediatrics , 1.2 Geriatrics 09/2023 2 CONTRAINDICATIONS 09/2023 4 DOSAGE AND ADMINISTRATION , 4.4 Administration 09/2023 7 WARNINGS AND PRECAUTIONS , 7.1 Special Populations , 7.1.1 Pregnant Women , 7.1.2 Breast-feeding 09/2023 7 WARNINGS AND PRECAUTIONS , Cardiovascular , Endocrine and Metabolism Reproductive Health: Female and Male Potential 10/2021 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 ................................................................. Прочитайте повний документ