PRADAXA CAPSULE

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Доступна с:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

код АТС:

B01AE07

ИНН (Международная Имя):

DABIGATRAN ETEXILATE

дозировка:

110MG

Фармацевтическая форма:

CAPSULE

состав:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/60

Тип рецепта:

Prescription

Терапевтические области:

DIRECT THROMBIN INHIBITORS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2008-06-10

Характеристики продукта

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