ACCEL-ENTECAVIR TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

Disponible des:

ACCEL PHARMA INC

Codi ATC:

J05AF10

Designació comuna 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:

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-08-16

Fitxa tècnica

_Accel-Entecavir _
_Page 1 of 40 _
PRODUCT MONOGRAPH
Pr
ACCEL-ENTECAVIR
Entecavir Tablets
0.5 mg
Antiviral
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
DATE OF REVISION:
June 21, 2019
Control No. 227796
_Accel-Entecavir _
_Page 2 of 40 _
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
..............................................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................................
10
OVERDOSAGE
...........................................................................................................................................
11
STORAGE AND STABILITY
....................................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................................
17
PART II: SCIENTIFIC INFORMATION
...........................................................................................................
18
PHARMACEUTICAL INFORMATION
................................................................................