Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Medimpex France SA
150 Milligram
Capsules Hard
2003-03-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluconazole 150 mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150mg fluconazole The capsules contain lactose. For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Capsule upper part: medium blue, lower part: white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole is indicated for the treatment of the following infections when caused by fungi that are known or are likely to be fluconazole-susceptible: o Acute or recurrent vaginal candidiasis. o Mucous membrane candidiasis including oropharyngeal, oesophageal, mucocutaneous and non-invasive bronchopulmonary candidiasis and candiduria in patients with immunosuppression. o Systemic candidiasis (candidaemia, disseminated deep candidiasis, peritonitis). o Prevention of Candida infections in neutropenic patients (eg. AIDS, bone marrow transplantation). o Treatment and maintenance treatment of cryptococcal meningitis in immunosuppressed patients. o Verified fungal skin infections caused either by dermatophytes or other species (_tinea_ _corporis/cruris/pedis/versicolor_) or Candida when local treatment has failed or is considered inappropriate. Fluconazole should be used to treat _Tinea versicolor _only when the infection is resistant to first line therapy or when the patient is immunosuppressed. Consideration should be given to official guidance on the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The daily dose depends on the type and severity of the fungal infection. The treatment of infections requiring multiple dosing must be continued until clinical parameters or laboratory results show that the active fungal infection has responded. An insufficient treatment period may lead to Leggi il documento completo