PRADAXA CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

متاح من:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC رمز:

B01AE07

INN (الاسم الدولي):

DABIGATRAN ETEXILATE

جرعة:

110MG

الشكل الصيدلاني:

CAPSULE

تركيب:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/60

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

DIRECT THROMBIN INHIBITORS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2008-06-10

خصائص المنتج

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