ENTECAVIR TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

Disponible desde:

STRIDES PHARMA CANADA INC

Código ATC:

J05AF10

Designación común internacional (DCI):

ENTECAVIR

Dosis:

0.5MG

formulario farmacéutico:

TABLET

Composición:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

NUCLEOSIDES AND NUCLEOTIDES

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-04-13

Ficha técnica

PRODUCT MONOGRAPH
Pr
ENTECAVIR TABLETS
Entecavir Tablets
0.5 mg
Antiviral
Strides Pharma Canada Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 22, 2022
Varennes, QC
J3X 1P7
Submission Control No.: 266151
_2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................................................3
SUMMARY PRODUCT INFORMATION
.................................................................................................3
INDICATIONS AND CLINICAL USE
.......................................................................................................3
CONTRAINDICATIONS
......................................................................................................................3
WARNINGS AND
PRECAUTIONS.........................................................................................................4
ADVERSE REACTIONS
.......................................................................................................................8
DRUG INTERACTIONS
....................................................................................................................
12
DOSAGE AND
ADMINISTRATION......................................................................................................
13
OVERDOSAGE
...............................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................................
14
STORAGE AND
STABILITY................................................................................................................
24
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................................................
24
PART II: SCIENTIFIC INFORMATION
.................................................................................................
25
PHARMACEUTICAL
INFORMATION...................................................................