TARO-APIXABAN TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
30-12-2020
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Aktiva substanser:
APIXABAN
Tillgänglig från:
SUN PHARMA CANADA INC
ATC-kod:
B01AF02
INN (International namn):
APIXABAN
Dos:
5MG
Läkemedelsform:
TABLET
Sammansättning:
APIXABAN 5MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Produktsammanfattning:
Active ingredient group (AIG) number: 0153051002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2022-09-20
Produktens egenskaper
_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.................................................................
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