ACH-APIXABAN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

APIXABAN

Dostupné s:

ACCORD HEALTHCARE INC

ATC kód:

B01AF02

INN (Mezinárodní Name):

APIXABAN

Dávkování:

2.5MG

Léková forma:

TABLET

Složení:

APIXABAN 2.5MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-09-23

Charakteristika produktu

PRODUCT MONOGRAPH
PR
ACH-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Approval:
April 23, 2019
Date of Revision:
September 22, 2022
Submission
Control No: 264541
_Pr_
_ACH-APIXABAN Product Monograph Page 2 of 77 _
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.................................................................................24
OVERDOSAGE
.................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
................................................................32
STORAGE AND
STABILITY............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................37
PART II: SCIENTIFIC
INFORMATION................................................................................38
PHARMACEUTICAL
INFORMATION.............................................................................38
CLINICAL TRIALS
..........................