PRADAXA CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Available from:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC code:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE

Dosage:

110MG

Pharmaceutical form:

CAPSULE

Composition:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Administration route:

ORAL

Units in package:

30/60

Prescription type:

Prescription

Therapeutic area:

DIRECT THROMBIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152467002; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-06-10

Summary of Product characteristics

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