TEVA-DABIGATRAN CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

B01AE07

INN (Mezinárodní Name):

DABIGATRAN ETEXILATE

Dávkování:

150MG

Léková forma:

CAPSULE

Složení:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 150MG

Podání:

ORAL

Jednotky v balení:

60

Druh předpisu:

Prescription

Terapeutické oblasti:

DIRECT THROMBIN INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2018-02-19

Charakteristika produktu

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
............