APO-DABIGATRAN CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)

Boleh didapati daripada:

APOTEX INC

Kod ATC:

B01AE07

INN (Nama Antarabangsa):

DABIGATRAN ETEXILATE

Dos:

75MG

Borang farmaseutikal:

CAPSULE

Komposisi:

DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 75MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

DIRECT THROMBIN INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-02-19

Ciri produk

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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_ PAGE 2 OF 81 _
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