APO-ENTECAVIR TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ENTECAVIR

Prieinama:

APOTEX INC

ATC kodas:

J05AF10

INN (Tarptautinis Pavadinimas):

ENTECAVIR

Dozė:

0.5MG

Vaisto forma:

TABLET

Sudėtis:

ENTECAVIR 0.5MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30

Recepto tipas:

Prescription

Gydymo sritis:

NUCLEOSIDES AND NUCLEOTIDES

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2012-11-23

Prekės savybės

_APO-ENTECAVIR (Entecavir Tablets) _
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_Page 1 of 52_
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