PRADAXA CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Sẵn có từ:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Mã ATC:

B01AE07

INN (Tên quốc tế):

DABIGATRAN ETEXILATE

Liều dùng:

150MG

Dạng dược phẩm:

CAPSULE

Thành phần:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

10/30/60

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DIRECT THROMBIN INHIBITORS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-10-26

Đặc tính sản phẩm

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