FLUCONAZOLE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
12-10-2016
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Aktiva substanser:
FLUCONAZOLE
Tillgänglig från:
SORRES PHARMA INC
ATC-kod:
J02AC01
INN (International namn):
FLUCONAZOLE
Dos:
50MG
Läkemedelsform:
TABLET
Sammansättning:
FLUCONAZOLE 50MG
Administreringssätt:
ORAL
Enheter i paketet:
50/100
Receptbelagda typ:
Prescription
Terapiområde:
AZOLES
Produktsammanfattning:
Active ingredient group (AIG) number: 0122529001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2014-06-20
Produktens egenskaper
PRODUCT MONOGRAPH
PR
FLUCONAZOLE
(Fluconazole)
Tablets 50 &100 mg
ANTIFUNGAL AGENT
SORRES PHARMA INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
June 16, 2010
Montreal, Quebec
H4P 2T4
CONTROL NO. 139393
_ _
_FLUCONAZOLE Product Monograph _
_Page 2 of 45_
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
..........................................................................................................
10
DOSAGE
AND
ADMINISTRATION
......................................................................................
14
OVERDOSAGE
........................................................................................................................
18
STORAGE
AND
STABILITY
..................................................................................................
19
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
C
LINICAL
T
RIALS
........................................................................................................................
22
DETAILED
PHARMACOLOGY
......................................................................
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