TEVA-APIXABAN TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

APIXABAN

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

B01AF02

INN (Међународно име):

APIXABAN

Дозирање:

5MG

Фармацеутски облик:

TABLET

Састав:

APIXABAN 5MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Резиме производа:

Active ingredient group (AIG) number: 0153051002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2022-09-20

Карактеристике производа

_ _
_Teva-Apixaban Tablets _
_Page 1 of 81_
PRODUCT MONOGRAPH
Pr
TEVA-APIXABAN
Apixaban tablets
2.5 mg and 5 mg
Teva Standard
Anticoagulant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Approval:
January 21, 2019
Date of Revision:
September 16, 2022
Submission Control No: 266721
_ _
_Teva-Apixaban Tablets _
_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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................40
SPECIAL HANDLING INSTRUCTIONS
.......................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..........................................................................41
CLINICAL TRIALS
.........................