PRADAXA CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

제공처:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC 코드:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE

복용량:

150MG

약제 형태:

CAPSULE

구성:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

관리 경로:

ORAL

패키지 단위:

10/30/60

처방전 유형:

Prescription

치료 영역:

DIRECT THROMBIN INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2010-10-26

제품 특성 요약

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