PRADAXA CAPSULE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Pieejams no:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATĶ kods:

B01AE07

SNN (starptautisko nepatentēto nosaukumu):

DABIGATRAN ETEXILATE

Deva:

110MG

Zāļu forma:

CAPSULE

Kompozīcija:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/60

Receptes veids:

Prescription

Ārstniecības joma:

DIRECT THROMBIN INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2008-06-10

Produkta apraksts

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