Country: Канада
Језик: Енглески
Извор: Health Canada
FLUCONAZOLE
TEVA CANADA LIMITED
J02AC01
FLUCONAZOLE
2MG
SOLUTION
FLUCONAZOLE 2MG
INTRAVENOUS
100/200ML
Prescription
AZOLES
Active ingredient group (AIG) number: 0122529003; AHFS:
CANCELLED POST MARKET
2017-09-15
PRODUCT MONOGRAPH PR TEVA-FLUCONAZOLE Fluconazole Tablets Teva Standard 50mg and 100 mg PR FLUCONAZOLE INJECTION Solution for Intravenous Infusion 2 mg/mL (100 mL vial; and 100 mL and 200 mL Cryovac bags) Antifungal Agent Teva Canada Limited DATE OF REVISION: 30 Novopharm Court June 2, 2017 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com SUBMISSION CONTROL: 205383 2 PRODUCT MONOGRAPH PR TEVA-FLUCONAZOLE Fluconazole Tablets 50 and 100 mg Pr FLUCONAZOLE INJECTION Solution for Intravenous Infusion 2 mg/mL (100 mL vial; and 100 mL and 200 mL Cryovac bags) THERAPEUTIC CLASSIFICATION Antifungal ACTION AND CLINICAL PHARMACOLOGY Fluconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14-α- demethylation. Mammalian cell demethylation is much less sensitive to fluconazole inhibition. The subsequent loss of normal sterols correlates with the accumulation of 14-α-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole. A randomized, blinded, two-period, two-treatment, crossover bioequivalence study of TEVA- FLUCONAZOLE 100 mg tablets (Teva Canada Ltd.) and DIFLUCAN ® (Fluconazole) 100 mg tablets (Pfizer Canada, Canada) administered as a single 2 x 100 mg dose was conducted in healthy male subjects (n=16) under fasting conditions. The results from the measured data are summarized in the table below. 3 TABLE 1 _Fluconazole _ _(2 x 100 mg) _ _From measured data _ _ _ _Geometric Mean _ _ _ _ _ _ _ _ _ _Arithmetic Mean (CV %)_ _Parameter_ _ Test_ _*_ _ Reference_ _†_ _% Ratio of _ _Geometric Means_ _90% Confidence _ _Interval_ _AUC_ _T_ _ _ _(mcg_ _hr/mL) _ 192.65 193.84 (11.25) 185.88 186.59 (8.70) 103.64 100.27-107.12 _AUC_ _0-72_ _ _ _(mcg_ _hr/mL) _ 151.14 151.85 (10.08) 145.44 145.83 (7.44) 103.92 100.51-107.44 _AUC_ _I_ _ _ _(mcg_ _hr/mL) _ 202.17 203.50 (11.61) 195.70 196.37 (8.35) 103.31 99.89-106.84 _C_ _max_ _ _ _(mcg/mL) _ 4.34 4.38 (12.47) 4.32 4.39 (17.65) 100.49 95.52-105.71 _T_ _max_ _§_ _ _ _(h) _ 1.31 (71.44) 1.86 (79.77) _T_ _1/2_ _ Прочитајте комплетан документ