DOM-FLUCONAZOLE CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
29-04-2008
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
FLUCONAZOLE
Fáanlegur frá:
DOMINION PHARMACAL
ATC númer:
J02AC01
INN (Alþjóðlegt nafn):
FLUCONAZOLE
Skammtar:
150MG
Lyfjaform:
CAPSULE
Samsetning:
FLUCONAZOLE 150MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
OTC
Lækningarsvæði:
AZOLES
Vörulýsing:
Active ingredient group (AIG) number: 0122529004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2008-05-01
Vara einkenni
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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