CYKLOKAPRON 500 MG TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

TRANEXAMIC ACID

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

B02AA02

INN (International Adı):

TRANEXAMIC ACID

Doz:

500MG

Farmasötik formu:

TABLET

Kompozisyon:

TRANEXAMIC ACID 500MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

HEMOSTATICS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2001-08-07

Ürün özellikleri

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