PHL-FLUCONAZOLE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
01-05-2007
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Verzend verzoek.
Verzend verzoek.
Werkstoffen:
FLUCONAZOLE
Beschikbaar vanaf:
PHARMEL INC
ATC-code:
J02AC01
INN (Algemene Internationale Benaming):
FLUCONAZOLE
Dosering:
100MG
farmaceutische vorm:
TABLET
Samenstelling:
FLUCONAZOLE 100MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
AZOLES
Product samenvatting:
Active ingredient group (AIG) number: 0122529002; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2017-09-12
Productkenmerken
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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