PHL-FLUCONAZOLE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-05-2007
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Active ingredient:
FLUCONAZOLE
Available from:
PHARMEL INC
ATC code:
J02AC01
INN (International Name):
FLUCONAZOLE
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
FLUCONAZOLE 150MG
Administration route:
ORAL
Units in package:
1
Prescription type:
OTC
Therapeutic area:
AZOLES
Product summary:
Active ingredient group (AIG) number: 0122529004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2007-08-01
Summary of Product characteristics
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
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