FLUKAS 100 MG BT 1

FLUKAS is indicated in the following fungal infections (see section 5.1).

FLUKAS 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, esophageal candidiasis, candiduria, and chronic mucocutaneous candidiasis.
• Chronic atrophic oral candidiasis (denture sore mouth) when local therapy is inadequate or inappropriate.

FLUKAS is indicated in adults for the prophylaxis of :

• Recurrence of cryptococcal meningitis in patients at high risk of recurrence.
• Recurrence of oropharyngeal or esophageal candidiasis in patients infected with HIV who are at high risk of recurrence.
• Candida infections in patients with prolonged neutropenia (such as patients with malignant hematological tumors treated with chemotherapy or patients receiving hematopoietic stem cell transplantation) (see section 5.1).

FLUKAS is indicated in full-term newborns, infants, children, and adolescents aged 0 to 17 years for the treatment of mucosal candidiasis (oropharyngeal, esophageal), invasive candidiasis, cryptococcal meningitis, and prophylaxis of Candida infections in immunocompromised patients. FLUKAS may be used as maintenance therapy to prevent recurrence of cryptococcal meningitis in children at high risk of relapse (see section 4.4).

Treatment may be initiated before the results of cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

Official recommendations for appropriate use of antifungals should be considered.