DOM-FLUCONAZOLE CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
29-04-2008
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Verzend verzoek.
Werkstoffen:
FLUCONAZOLE
Beschikbaar vanaf:
DOMINION PHARMACAL
ATC-code:
J02AC01
INN (Algemene Internationale Benaming):
FLUCONAZOLE
Dosering:
150MG
farmaceutische vorm:
CAPSULE
Samenstelling:
FLUCONAZOLE 150MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
OTC
Therapeutisch gebied:
AZOLES
Product samenvatting:
Active ingredient group (AIG) number: 0122529004; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2008-05-01
Productkenmerken
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
....................................................................................
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