PHL-FLUCONAZOLE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUCONAZOLE

Commercializzato da:

PHARMEL INC

Codice ATC:

J02AC01

INN (Nome Internazionale):

FLUCONAZOLE

Dosaggio:

150MG

Forma farmaceutica:

CAPSULE

Composizione:

FLUCONAZOLE 150MG

Via di somministrazione:

ORAL

Confezione:

1

Tipo di ricetta:

OTC

Area terapeutica:

AZOLES

Dettagli prodotto:

Active ingredient group (AIG) number: 0122529004; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2007-08-01

Scheda tecnica

PRODUCT MONOGRAPH
PR
PHL-FLUCONAZOLE
(Fluconazole)
C
Tablets 100 mg
C
Capsules 150 mg
ANTIFUNGAL AGENT
PHARMEL INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
May 1, 2007
Montreal, Quebec
H4P 2T4
CONTROL NO. 113587
Page 2 of 47
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
..........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
......................................................................................
16
OVERDOSAGE
........................................................................................................................
19
STORAGE
AND
STABILITY
..................................................................................................
21
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION..................................................................................
23
C
LINICAL
T
RIALS
........................................................................................................................
23
DETAILED
PHARMACOLOGY
.............................................................................................
25