New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 10 mg/ml - oral solution - 10 mg/ml - active: itraconazole 10 mg/ml excipient: caramel cherry flavour 654536 cherry flavour 654595 hydrochloric acid hydroxypropyl-beta-cyclodextrin propylene glycol purified water saccharin sodium sodium hydroxide sorbitol - sporanox oral solution is indicated for the: · treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. · prophylaxis of fungal infections in neutropenic patients.

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

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - itracap is indicated for use in adults for the treatment of: ? superficial dermatomycoses not responding to topical treatment. ? fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? pityriasis versicolor not responding to any other treatment. ? vulvovaginal candidiasis not responding to topical treatment. ? oral candidiasis in immunocompromised patients. ? onychomycosis caused by dermatophytes. ? systemic mycoses: - systemic aspergillosis, histoplasmosis, sporotrichosis. - treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. - treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

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

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - itranox is indicated for use in adults for the treatment of: ? superficial dermatomycoses not responding to topical treatment. ? fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? pityriasis versicolor not responding to any other treatment. ? vulvovaginal candidiasis not responding to topical treatment. ? oral candidiasis in immunocompromised patients. ? onychomycosis caused by dermatophytes. ? systemic mycoses: - systemic aspergillosis, histoplasmosis, sporotrichosis. - treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. - treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type a; hypromellose phthalate; gelatin; brilliant blue fcf; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: sodium starch glycollate type a; titanium dioxide; brilliant blue fcf; hypromellose phthalate; silicon dioxide; magnesium stearate; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

janssen-cilag pty ltd - itraconazole, quantity: 10 mg/ml - oral liquid, solution - excipient ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; flavour - sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.

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

janssen-cilag pty ltd - itraconazole, quantity: 100 mg - capsule, hard - excipient ingredients: macrogol 20000; titanium dioxide; gelatin; hypromellose; indigo carmine; erythrosine; maize starch; sucrose - sporanox is indicated for use in adults for the treatment of: superficial dermatomycoses not responding to topical treatment. fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. pityriasis versicolor not responding to any other treatment. vulvovaginal candidiasis not responding to topical treatment. oral candidiasis in immunocompromised patients. onychomycosis caused by dermatophytes. systemic mycoses: -systemic aspergillosis, histoplasmosis, sporotrichosis. -treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. -treatment of oropharyngeal and/or oesophageal candidiasis when fist line systemic antifungal therapy is inappropriate or has proven ineffective. -treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology,

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - itraconazole -

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - capsules - see ingredients - each capsule contains itraconazole 100,0 mg