PRADAXA CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Tilgjengelig fra:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kode:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE

Dosering :

150MG

Legemiddelform:

CAPSULE

Sammensetning:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Administreringsrute:

ORAL

Enheter i pakken:

10/30/60

Resept typen:

Prescription

Terapeutisk område:

DIRECT THROMBIN INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-10-26

Preparatomtale

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