FLUCONAZOLE TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
12-10-2016
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Aktivna sestavina:
FLUCONAZOLE
Dostopno od:
SORRES PHARMA INC
Koda artikla:
J02AC01
INN (mednarodno ime):
FLUCONAZOLE
Odmerek:
100MG
Farmacevtska oblika:
TABLET
Sestava:
FLUCONAZOLE 100MG
Pot uporabe:
ORAL
Enote v paketu:
50/100
Tip zastaranja:
Prescription
Terapevtsko območje:
AZOLES
Povzetek izdelek:
Active ingredient group (AIG) number: 0122529002; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2014-06-20
Lastnosti izdelka
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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