DOM-FLUCONAZOLE CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

FLUCONAZOLE

MAH:

DOMINION PHARMACAL

ATC_code:

J02AC01

INN:

FLUCONAZOLE

dosage:

150MG

pharmaceutical_form:

CAPSULE

composition:

FLUCONAZOLE 150MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

OTC

therapeutic_area:

AZOLES

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2008-05-01

SPC

PRODUCT MONOGRAPH
PR
DOM-FLUCONAZOLE
(Fluconazole)
C
Tablets 50 &100 mg
C
Capsules 150 mg
ANTIFUNGAL AGENT
DOMINION PHARMACAL
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
April 22, 2008
Montreal, Quebec
H4P 2T4
CONTROL NO. 121426
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............................................................................................................
8
DRUG
INTERACTIONS
..........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
20
STORAGE
AND
STABILITY
..................................................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION..................................................................................
23
C
LINICAL
T
RIALS
........................................................................................................................
23
DETAILED
PHARMACOLOGY
....................................................................................