APO-ENTECAVIR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ENTECAVIR

Disponible depuis:

APOTEX INC

Code ATC:

J05AF10

DCI (Dénomination commune internationale):

ENTECAVIR

Dosage:

0.5MG

forme pharmaceutique:

TABLET

Composition:

ENTECAVIR 0.5MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDES AND NUCLEOTIDES

Descriptif du produit:

Active ingredient group (AIG) number: 0151648001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2012-11-23

Résumé des caractéristiques du produit

_APO-ENTECAVIR (Entecavir Tablets) _
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PRODUCT MONOGRAPH
PR
APO-ENTECAVIR
Entecavir Tablets
Tablets 0.5 mg
USP
Antiviral
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Preparation:
November 23, 2012
Date of Revision:
January 11, 2023
Submission Control Number: 271047
_APO-ENTECAVIR (Entecavir Tablets) _
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_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
.........................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................................
3
CONTRAINDICATIONS..................................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................................
3
ADVERSE REACTIONS
..................................................................................................................
7
DRUG INTERACTIONS
................................................................................................................
11
DOSAGE AND ADMINISTRATION
...............................................................................................
12
OVERDOSAGE
............................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.................................................................................
13
STORAGE AND STABILITY
..........................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 20
PART II: SCIENTIFIC INFORMATION
......................................................................................
22
PHARMAC