ELIQUIS TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

APIXABAN

Saadav alates:

BRISTOL-MYERS SQUIBB CANADA

ATC kood:

B01AF02

INN (Rahvusvaheline Nimetus):

APIXABAN

Annus:

2.5MG

Ravimvorm:

TABLET

Koostis:

APIXABAN 2.5MG

Manustamisviis:

ORAL

Ühikuid pakis:

10/20/60/100

Retsepti tüüp:

Prescription

Terapeutiline ala:

Direct Factor Xa Inhibitors

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2011-12-16

Toote omadused

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_ELIQUIS (apixaban) Product Monograph _
_Page 1 of 83_
PRODUCT MONOGRAPH
Pr
ELIQUIS
®
apixaban tablets
2.5 mg and 5 mg
Anticoagulant
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Bristol-Myers Squibb Canada Co.
Montreal, Canada H4S 0A4
www.bmscanada.ca
Date of Initial Approval:
13 December 2011
Date of Revision:
07 October 2019
Registered trademark of Bristol-Myers Squibb Company used under
license by Bristol-Myers
Squibb Canada Co.
Submission Control No: 229267
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_ELIQUIS (apixaban) Product Monograph _
_Page 2 of 83_
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
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
39
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 39
PART II: SCIENTIFIC INFORMATION
..............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
........................................................