TRANEXAMIC ACID INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

TRANEXAMIC ACID

から入手可能:

AURO PHARMA INC

ATCコード:

B02AA02

INN（国際名）:

TRANEXAMIC ACID

投薬量:

100MG

医薬品形態:

SOLUTION

構図:

TRANEXAMIC ACID 100MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

HEMOSTATICS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2019-01-18

製品の特徴

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