PRADAXA CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

可用日期:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC代码:

B01AE07

INN（国际名称）:

DABIGATRAN ETEXILATE

剂量:

150MG

药物剂型:

CAPSULE

组成:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

给药途径:

ORAL

每包单位数:

10/30/60

处方类型:

Prescription

治疗领域:

DIRECT THROMBIN INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2010-10-26

产品特点

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