TRANEXAMIC ACID TABLETS

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRANEXAMIC ACID

제공처:

STERIMAX INC

ATC 코드:

B02AA02

INN (국제 이름):

TRANEXAMIC ACID

복용량:

500MG

약제 형태:

TABLET

구성:

TRANEXAMIC ACID 500MG

관리 경로:

ORAL

패키지 단위:

10

처방전 유형:

Prescription

치료 영역:

HEMOSTATICS

제품 요약:

Active ingredient group (AIG) number: 0114760001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-01-31

제품 특성 요약

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
.................................................................................................