TEVA-DABIGATRAN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

B01AE07

INN (Kansainvälinen yleisnimi):

DABIGATRAN ETEXILATE

Annos:

75MG

Lääkemuoto:

CAPSULE

Koostumus:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

DIRECT THROMBIN INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-02-19

Valmisteyhteenveto

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