APO-VALGANCICLOVIR TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE)

Disponible des:

APOTEX INC

Codi ATC:

J05AB14

Designació comuna internacional (DCI):

VALGANCICLOVIR

Dosis:

450MG

formulario farmacéutico:

TABLET

Composición:

VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) 450MG

Vía de administración:

ORAL

Unidades en paquete:

60

tipo de receta:

Prescription

Área terapéutica:

NUCLEOSIDES AND NUCLEOTIDES

Resumen del producto:

Active ingredient group (AIG) number: 0147203001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-06-28

Fitxa tècnica

_APO-VALGANCICLOVIR Product Monograph_
Page 1 of 57
PRODUCT MONOGRAPH
PR
APO-VALGANCICLOVIR
Valganciclovir Tablets USP
450 mg (as valganciclovir hydrochloride)
Antiviral Agent
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
July 18, 2018
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO. 216724
_APO-VALGANCICLOVIR Product Monograph_
Page 2 of 57
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
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.......................................................................................
24
OVERDOSAGE
......................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
27
STORAGE AND STABILITY
..................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 31
PART II: SCIENTIFIC INFORMATION ...................................................................................
32
PHARMACEUTICAL INFORMATION
....