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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, 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 Hematopoietic 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.

Fluconazole 2 mg / mL is indicated in the following fungal infections (see section 5.1). Fluconazole 2 mg / mL 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, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis. - Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient. Fluconazole 2 mg / mL 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 Hematopoietic Stem Cell Transplantation (see section 5.1)). Fluconazole 2 mg / mL is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old : Fluconazole 2 mg / mL is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole 2 mg / mL 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.

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, 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 crytopcoccal 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 Hematopoietic 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.