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

baxter healthcare pty ltd - fluconazole, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium chloride; water for injections - fluconazole-baxter intravenous infusion should be used only when fluconazole cannot be administered orally: 1. 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 treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). 3. treatment of oropharyngeal and oesophageal candidiasis in patients with aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (hiv) infection. 5. vaginal candidiasis, when topical therapy has failed. 6. 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 infections. until such data are available, amphotericin b remains the drug of choice.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - fluconazole - oral capsule - 50mg

Israel - English - Ministry of Health

david margalit & co.ltd - fluconazole - solution for infusion - fluconazole 200 mg / 100 ml - fluconazole - fluconazole is indicated in the following fungal infections.fluconazole is indicated in adults for the treatment of:• cryptococcal meningitis.• coccidioidomycosis. invasive candidiasis.• mucosal candidiasis (including oropharyngeal candidiasis, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis).• chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene topical treatment are insufficient.fluconazole is indicated in adults for the prophylaxis of:• relapse of cryptococcal meningitis in patients with high risk of recurrence.• relapse of oropharyngeal or oesophageal candidiasis in patients infected with hiv who are at high risk of experiencing relapse.• prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving haematopoetic stem cell transplantation).fluconazole is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence.therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.consideration should be given to official guidance on the appropriate use of antifungals.

Israel - English - Ministry of Health

mbi pharma ltd., israel - fluconazole - solution for infusion - fluconazole 2 mg / 1 ml - fluconazole - fluconazole is indicated in the following fungal infections (see section 5.1). fluconazole is indicated in adults for the treatment of:• cryptococcal meningitis (see section 4.4).• coccidioidomycosis (see section 4.4).• invasive candidiasis.• mucosal candidiasis (including oropharyngeal candidiasis, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis).• chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.fluconazole is indicated in adults for the prophylaxis of:• relapse of cryptococcal meningitis in patients with high risk of recurrence.• relapse of oropharyngeal or oesophageal candidiasis in patients infected with hiv who are at high risk of experiencing relapse.• prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving haematopoetic stem cell transplantation (see section 5.1)).fluconazole is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.consideration should be given to official guidance on the appropriate use of antifungals.

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

aspen pharmacare australia pty ltd - fluconazole, quantity: 400 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - fluconazole injection is indicated for the following conditions but should be used only when fluconazole cannot be administered orally: 1. 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 treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). 3. treatment of oropharyngeal and oesophageal candidiasis in patients with aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (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 fluconazole 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.

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

aspen pharmacare australia pty ltd - fluconazole, quantity: 100 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - fluconazole injection is indicated for the following conditions but should be used only when fluconazole cannot be administered orally: 1. 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 treatment of the acute phase of cryptococcal meningitis. 2. maintenance therapy to prevent relapse of cryptococcal meningitis in patients with acquired immune deficiency syndrome (aids). 3. treatment of oropharyngeal and oesophageal candidiasis in patients with aids and other immunosuppressed patients. 4. secondary prophylaxis of oropharyngeal candidiasis in patients with human immunodeficiency virus (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 fluconazole 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - fluconazole 150mg; clotrimazole 10 mg/g; clotrimazole 10 mg/g; fluconazole 150mg - combination - active: fluconazole 150mg clotrimazole 10 mg/g excipient: benzyl alcohol cetostearyl alcohol cetyl palmitate octyldodecanol polysorbate 60 purified water sorbitan stearate active: clotrimazole 10 mg/g excipient: benzyl alcohol cetostearyl alcohol cetyl palmitate octyldodecanol polysorbate 60 purified water sorbitan stearate active: fluconazole 150mg - canesten fluconazole capsule & clotrimazole cream duo is indicated for vaginal candidiasis. the cream can also be used for relief of external itching/irritation and the management candida vulvovaginitis or infection of the peri-anal area.

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - fluconazole 2 mg/ml (polymorph form iii) - solution for infusion - 2 mg/ml - active: fluconazole 2 mg/ml (polymorph form iii) excipient: sodium chloride water for injection - · cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). normal hosts, and patients with aids, organ transplants or other causes of immunosuppression may be treated. fluconazole injection usp can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with aids.

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

sun pharma anz 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; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (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.

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

sun pharma anz pty ltd - fluconazole, quantity: 100 mg - capsule, hard - excipient ingredients: titanium dioxide; patent blue v; sodium lauryl sulfate; maize starch; magnesium stearate; lactose monohydrate; colloidal anhydrous silica; erythrosine; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ozole (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.