PRADAXA CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Commercializzato da:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Codice ATC:

B01AE07

INN (Nome Internazionale):

DABIGATRAN ETEXILATE

Dosaggio:

110MG

Forma farmaceutica:

CAPSULE

Composizione:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Via di somministrazione:

ORAL

Confezione:

30/60

Tipo di ricetta:

Prescription

Area terapeutica:

DIRECT THROMBIN INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2008-06-10

Scheda tecnica

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