FLUCONAZOLE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

FLUCONAZOLE

Disponible des:

SORRES PHARMA INC

Codi ATC:

J02AC01

Designació comuna internacional (DCI):

FLUCONAZOLE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

FLUCONAZOLE 100MG

Vía de administración:

ORAL

Unidades en paquete:

50/100

tipo de receta:

Prescription

Área terapéutica:

AZOLES

Resumen del producto:

Active ingredient group (AIG) number: 0122529002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2014-06-20

Fitxa tècnica

PRODUCT MONOGRAPH
PR
FLUCONAZOLE
(Fluconazole)
Tablets 50 &100 mg
ANTIFUNGAL AGENT
SORRES PHARMA INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
June 16, 2010
Montreal, Quebec
H4P 2T4
CONTROL NO. 139393
_ _
_FLUCONAZOLE Product Monograph _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION.................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
..........................................................................................
4
ADVERSE
REACTIONS............................................................................................................
7
DRUG
INTERACTIONS
..........................................................................................................
10
DOSAGE
AND
ADMINISTRATION
......................................................................................
14
OVERDOSAGE
........................................................................................................................
18
STORAGE
AND
STABILITY
..................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
C
LINICAL
T
RIALS
........................................................................................................................
22
DETAILED
PHARMACOLOGY
......................................................................