Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUCONAZOLE
PFIZER INDONESIA - Indonesia
FLUCONAZOLE
2 MG/ML
CAIRAN INJEKSI
DUS, VIAL @ 100 ML
FAREVA ROMAINVILLE
2017-08-11
Generic Name: Fluconazole Trade Name: Diflucan CDS Effective Date: January 15, 2021 Supersedes: April 16, 2020 Approved by BPOM: 2020-0061279, 2020-0066398 Page 1 of 18 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Fluconazole Trade Name: Diflucan CDS Effective Date: January 15, 2021 Supersedes: April 16, 2020 DESCRIPTION Fluconazole is a bis-triazole: 2-(2,4-difluorophenyl)-1,3-bis (1H-1,2,4-triazol-1yl)-2 propanol. It has the following structural formula: Fluconazole is a white to off-white crystalline powder which is sparingly soluble in water and saline. It has a molecular weight of 306.3. Diflucan capsules contain 50 mg and 150 mg of fluconazole and the following inactive ingredients: hard gelatin capsules (which may contain Blue 5 and other inert ingredients), lactose, corn starch, silicon dioxide, magnesium stearate and sodium lauryl sulfate. Diflucan for injection is an iso-osmotic, sterile, non-pyrogenic solution of fluconazole in a sodium chloride diluent. Each ml contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 8.6. Injection volumes of 100 ml are packaged in glass infusion vials. N N N N N N CH 2 CH 2 C F F OH DISETUJUI OLEH BPOM: 02/09/2021 ID: EREG10024112100167-169 EREG10024112100361 Generic Name: Fluconazole Trade Name: Diflucan CDS Effective Date: January 15, 2021 Supersedes: April 16, 2020 Approved by BPOM: 2020-0061279, 2020-0066398 Page 2 of 18 PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code J02AC01. Mode of Action Fluconazole, a triazole antifungal agent, is a potent and specific inhibitor of fungal sterol synthesis. Its primary mode of action is the inhibition of fungal cytochrome P-450-mediated 14-alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. The accumulation of 14-alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell membrane and may be responsible for the antifungal activity Διαβάστε το πλήρες έγγραφο