Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - fluconazole, quantity: 200 mg - capsule, hard - excipient ingredients: purified water; lactose monohydrate; maize starch; patent blue v; magnesium stearate; titanium dioxide; erythrosine; gelatin; colloidal anhydrous silica; sodium lauryl sulfate - fluconazole apotex (fluconazole) capsules, given orally, are indicated for the following conditions: - treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note: data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin b in the acute phase of cryptococcal meningitis. - maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. - treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. - secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. - serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note: it remains to be shown that fluconazole is as effective as amphotericin b in the treatment of serious and life-threatening candida infecctions. until such data are available, amphotericin b remains the drug of choice. - vaginal candidiasis, when topical therapy has failed. - treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therpy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimycotics for systemic use - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 10 mg/ml - oral liquid, powder for - excipient ingredients: sucrose; citric acid; sodium citrate dihydrate; sodium benzoate; xanthan gum; colloidal anhydrous silica; titanium dioxide; flavour - indications as at 21 may 2004 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of extensive tinea corporis, extensive tinea cruris and extensive tinea pedis infections in immunocompetent patients in whom topical therapy is not a practical treatment option. usually, topical therapy should be attempted first because oral therapy has a less favourable ratio of benefits to risks (see adverse reactions). diflucan iv is indicated for the same conditions in adults and children but should be used only when diflucan cannot be administered orally.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 100 mg - capsule, hard - excipient ingredients: patent blue v; colloidal anhydrous silica; titanium dioxide; sodium lauryl sulfate; magnesium stearate; gelatin; lactose monohydrate; maize starch; erythrosine; butan-1-ol; shellac; industrial methylated spirit; dimeticone 1510; iron oxide black; lecithin; propylene glycol; isopropyl alcohol; purified water; ethanol; strong ammonia solution; potassium hydroxide - indications as at 21 june 2005 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of exten

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 50 mg - capsule, hard - excipient ingredients: patent blue v; colloidal anhydrous silica; titanium dioxide; sodium lauryl sulfate; gelatin; magnesium stearate; lactose monohydrate; maize starch; butan-1-ol; shellac; industrial methylated spirit; dimeticone 1510; iron oxide black; lecithin; propylene glycol; isopropyl alcohol; purified water; ethanol; strong ammonia solution; potassium hydroxide - indications as at 21 june 2005 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of exten

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 200 mg - capsule, hard - excipient ingredients: colloidal anhydrous silica; indigo carmine; lactose monohydrate; erythrosine; sodium lauryl sulfate; titanium dioxide; maize starch; gelatin; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; industrial methylated spirit; dimeticone 1510; lecithin - indications as at 21 may 2004 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of extens

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - indications as at 21 may 2004 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of extens

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: sodium chloride; water for injections - indications as at 21 may 2004 : diflucan, given orally, is indicated for: 1. treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin b. note : data suggest that the clinical efficacy of diflucan is lower than that of amphotericin b in the treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with aids. 3. treatment of oropharyngeal and oesophageal candidiasis in aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with hiv infection. 5. serious and life-threatening candida infections in patients who are unable to tolerate amphotericin b. note : it remains to be shown that diflucan is as effective as amphotericin b in the treatment of serious and life-threatening candida infections. until such data are available, amphotericin b remains the drug of choice. 6. vaginal candidiasis when topical therapy has failed. 7. treatment of extens

Israel - English - Ministry of Health

merck sharp & dohme israel ltd - posaconazole - suspension - posaconazole 40 mg/ml - posaconazole - posaconazole - noxafil is indicated for use in the treatment of the following fungal infections in adults : - invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products - fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b - chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole - coccidioidomycosis in patients with disease that is refractory to amphotericin b itraconazole or fluconazole or in patients who are intolerant of these medicinal products - oropharyngeal candidiasis : as first - line therapy in patients who have severe disease or are immunocompromised in whom response to topical therapy is expected to be poor. refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses

Israel - English - Ministry of Health

ofek pharma ltd, israel - posaconazole - tablets delayed release - posaconazole 100 mg - posaconazole - treatment of the following fungal infections in adults:- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b.- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patient intolerant to itraconazole.- coccidioidomycosis in patients with disease refractory to amphotericin b, itraconazole or fludonazole or in patient intolerant to these medicinal products.- zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.these are also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplatic syndrome (mds) expected to result in prolonged neutropenia who are at high-risk of developing invasive fungal infections.-hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high-risk of developing invasive fungal infections.