PRADAXA CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Disponible desde:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Código ATC:

B01AE07

Designación común internacional (DCI):

DABIGATRAN ETEXILATE

Dosis:

150MG

formulario farmacéutico:

CAPSULE

Composición:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Vía de administración:

ORAL

Unidades en paquete:

10/30/60

tipo de receta:

Prescription

Área terapéutica:

DIRECT THROMBIN INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-10-26

Ficha técnica

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