PRADAXA CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

MAH:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC_code:

B01AE07

INN:

DABIGATRAN ETEXILATE

dosage:

150MG

pharmaceutical_form:

CAPSULE

composition:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

administration_route:

ORAL

units_in_package:

10/30/60

prescription_type:

Prescription

therapeutic_area:

DIRECT THROMBIN INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0152467003; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-10-26

SPC

_PRADAXA Product Monograph _
_ _
_Page 1 of 69_
_ _
PRODUCT MONOGRAPH
PR
PRADAXA
®
Dabigatran Etexilate Capsules
Capsules 75 mg, 110 mg and 150 mg Dabigatran Etexilate, (as Dabigatran
Etexilate Mesilate)
Anticoagulant
Boehringer Ingelheim Canada Ltd.
5180 South Service Road
Burlington, ON L7L 5H4
BICL 0266 22 and 23
DATE OF REVISION:
March 23, 2020
CONTROL NO.234514
_PRADAXA Product Monograph _
_ _
_Page 2 of 69_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................35
STORAGE AND STABILITY
..........................................................................................40
SPECIAL HANDLING INSTRUCTIONS
.......................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
...............................................................................42
PHARMACEUTICAL INFORMATION
.......................................................