PRADAXA CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Доступна з:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Код атс:

B01AE07

ІПН (Міжнародна Ім'я):

DABIGATRAN ETEXILATE

Дозування:

150MG

Фармацевтична форма:

CAPSULE

Склад:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

10/30/60

Тип рецепту:

Prescription

Терапевтична области:

DIRECT THROMBIN INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2010-10-26

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
.......................................................