PRADAXA CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Доступно од:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

АТЦ код:

B01AE07

INN (Међународно име):

DABIGATRAN ETEXILATE

Дозирање:

110MG

Фармацеутски облик:

CAPSULE

Састав:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Пут администрације:

ORAL

Јединице у пакету:

30/60

Тип рецептора:

Prescription

Терапеутска област:

DIRECT THROMBIN INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2008-06-10

Карактеристике производа

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