CYKLOKAPRON 500 MG TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TRANEXAMIC ACID

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

B02AA02

INN (Kansainvälinen yleisnimi):

TRANEXAMIC ACID

Annos:

500MG

Lääkemuoto:

TABLET

Koostumus:

TRANEXAMIC ACID 500MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HEMOSTATICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2001-08-07

Valmisteyhteenveto

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