CYKLOKAPRON 500 MG TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TRANEXAMIC ACID

可用日期:

PFIZER CANADA ULC

ATC代码:

B02AA02

INN（国际名称）:

TRANEXAMIC ACID

剂量:

500MG

药物剂型:

TABLET

组成:

TRANEXAMIC ACID 500MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

HEMOSTATICS

產品總結:

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

授权状态:

APPROVED

授权日期:

2001-08-07

产品特点

_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
......................