DOM-FLUCONAZOLE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
29-04-2008
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Aktiv ingrediens:
FLUCONAZOLE
Tilgjengelig fra:
DOMINION PHARMACAL
ATC-kode:
J02AC01
INN (International Name):
FLUCONAZOLE
Dosering :
50MG
Legemiddelform:
TABLET
Sammensetning:
FLUCONAZOLE 50MG
Administreringsrute:
ORAL
Enheter i pakken:
50/100
Resept typen:
Prescription
Terapeutisk område:
AZOLES
Produkt oppsummering:
Active ingredient group (AIG) number: 0122529001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2002-07-02
Preparatomtale
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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