TEVA-DABIGATRAN CAPSULE

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

มีจำหน่ายจาก:

TEVA CANADA LIMITED

รหัส ATC:

B01AE07

INN (ชื่อสากล):

DABIGATRAN ETEXILATE

ปริมาณ:

75MG

แบบฟอร์มเภสัชกรรม:

CAPSULE

องค์ประกอบ:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

DIRECT THROMBIN INHIBITORS

สรุปสินค้า:

Active ingredient group (AIG) number: 0152467001; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2018-02-19

สรุปลักษณะสินค้า

1
PRODUCT MONOGRAPH
PR
TEVA-DABIGATRAN
Dabigatran Etexilate
Capsule
s
Capsules 75 mg and 150 mg Dabigatran Etexilate,
(as Dabigatran Etexilate Me
silate)
Anticoagulant
Teva Canada Limited.
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Date of Preparation
APRIL 26, 2017
Control Number:
184807
2
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.....................................................................................................
21
DOSAGE AND ADMINISTRATION
................................................................................
27
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 34
STORAGE AND STABILITY
............................................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 38
PART II: SCIENTIFIC INFORMATION
....................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
40
CLINICAL
TRIALS.............................................................................................................
42
DETAILED PHARMACOLOGY
............