PRADAXA CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Tilgængelig fra:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-kode:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE

Dosering:

110MG

Lægemiddelform:

CAPSULE

Sammensætning:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/60

Recept type:

Prescription

Terapeutisk område:

DIRECT THROMBIN INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2008-06-10

Produktets egenskaber

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