TEVA-APIXABAN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

APIXABAN

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

B01AF02

INN (nemzetközi neve):

APIXABAN

Adagolás:

2.5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

APIXABAN 2.5MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0153051001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2022-09-20

Termékjellemzők

_ _
_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
.........................