MAR-TRANEXAMIC ACID TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRANEXAMIC ACID

제공처:

MARCAN PHARMACEUTICALS INC

ATC 코드:

B02AA02

INN (국제 이름):

TRANEXAMIC ACID

복용량:

500MG

약제 형태:

TABLET

구성:

TRANEXAMIC ACID 500MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

HEMOSTATICS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2020-02-13

제품 특성 요약

_Page 1 of 21 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-TRANEXAMIC ACID
Tranexamic acid Tablets, BP
Tablet, 500 mg, Oral
BP
Anti-fibrinolytic agent
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Initial Authorization:
FEB 13, 2020
Date of Revision:
June 9, 2022
Submission Control Number: 260172
_Page 2 of 21 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2022
7 WARNINGS AND PRECAUTIONS
06/2022
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.............................................................................................................
5
5
OVERDOSAGE
.......................................................................................