TARO-APIXABAN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

APIXABAN

Dostupno od:

SUN PHARMA CANADA INC

ATC koda:

B01AF02

INN (International ime):

APIXABAN

Doziranje:

2.5MG

Farmaceutski oblik:

TABLET

Sastav:

APIXABAN 2.5MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2022-09-20

Svojstava lijeka

_TARO-APIXABAN (Apixaban Tablets) Product Monograph_
_Page 1 of 79_
PRODUCT MONOGRAPH
PR
TARO-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
ANTICOAGULANT
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1.
Date of Preparation: December 30, 2020
Submission Control No.: 229728
_TARO-APIXABAN (Apixaban Tablets) Product Monograph_
_Page 2 of 79_
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
..............................................................................................
10
DRUG INTERACTIONS
..............................................................................................
19
DOSAGE AND
ADMINISTRATION............................................................................
23
OVERDOSAGE............................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 31
STORAGE AND
STABILITY.......................................................................................
36
SPECIAL HANDLING
INSTRUCTIONS......................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 37
PART II: SCIENTIFIC INFORMATION
............................................................................38
PHARMACEUTICAL INFORMATION
.......................................................................
38
CLINICAL
TRIALS.................................................................