PRADAXA CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Предлага се от:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

АТС код:

B01AE07

INN (Международно Name):

DABIGATRAN ETEXILATE

дозиране:

150MG

Лекарствена форма:

CAPSULE

Композиция:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Начин на приложение:

ORAL

Броя в опаковка:

10/30/60

Вид предписание :

Prescription

Терапевтична област:

DIRECT THROMBIN INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2010-10-26

Данни за 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
.......................................................