Active ingredients:

Name of the medicinal product
Itrafungex 100 mg Capsules

2. Qualitative and quantitative composition
Each capsule contains itraconazole 100 mg.
For excipients, see 6.1.

3. Pharmaceutical form
Hard gelatin capsule

Therapeutic indications

1. Vulvovaginal candidosis.
2. Pityriasis versicolor.
3. Dermatophytoses caused by organisms susceptible to itraconazole (Trichophyton spp., Microsporum spp., Epidermophyton floccosum) e.g. tinea pedis, tinea cruris, tinea corporis, tinea manuum.
4. Oropharyngeal candidosis.
5. Onychomycosis caused by dermatophytes and/or yeasts.
6. The treatment of histoplasmosis.
7. Itrafungex is indicated in the following systemic fungal conditions when first-line systemic antifungal therapy is inappropriate or has proved ineffective. This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

• Treatment of aspergillosis and candidosis
• Treatment of cryptococcosis (including cryptococcal meningitis): in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system.
• Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection.

Itrafungex is also indicated in the prevention of fungal infection during prolonged neutropenia when standard therapy is considered inappropriate.