PRADAXA CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

זמין מ:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

קוד ATC:

B01AE07

INN (שם בינלאומי):

DABIGATRAN ETEXILATE

כמות:

110MG

טופס פרצבטיות:

CAPSULE

הרכב:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/60

סוג מרשם:

Prescription

איזור תרפויטי:

DIRECT THROMBIN INHIBITORS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2008-06-10

מאפייני מוצר

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