TEVA-APIXABAN TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

APIXABAN

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

B01AF02

INN (Isem Internazzjonali):

APIXABAN

Dożaġġ:

2.5MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

APIXABAN 2.5MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-09-20

Karatteristiċi tal-prodott

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