APO-DABIGATRAN CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Dostępny od:

APOTEX INC

Kod ATC:

B01AE07

INN (International Nazwa):

DABIGATRAN ETEXILATE

Dawkowanie:

110MG

Forma farmaceutyczna:

CAPSULE

Skład:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG

Droga podania:

ORAL

Sztuk w opakowaniu:

60

Typ recepty:

Prescription

Dziedzina terapeutyczna:

DIRECT THROMBIN INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0152467002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-02-19

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
APO-DABIGATRAN
DABIGATRAN ETEXILATE CAPSULES
75 MG, 110 MG AND 150 MG
DABIGATRAN ETEXILATE (AS DABIGATRAN ETEXILATE MESYLATE)
ANTICOAGULANT
APOTEX INC DATE OF REVISION:
150 SIGNET DRIVE
July 18, 2022
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 258873
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT
INFORMATION.................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS..........................................................................................4
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
......................................................................................
31
OVERDOSAGE
......................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
37
STORAGE AND STABILITY
.................................................................................................
43
SPECIAL HANDLING
INSTRUCTIONS................................................................................
43
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 43
PART II: SCIENTIFIC
INFORMATION...............................................................................45
PHARMACEUTICAL INFORMATION
..................................................................................
4