Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Sinclair IS Pharma Limited
FLUCONAZOLE
50 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
2012-07-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ByFluc 50mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluconazole 50 mg. Each capsule also contains lactose monohydrate 47mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules. Light blue opaque cap and white opaque body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. ByFluc 50mg Capsules is indicated for: 1. Genital candidiasis. Vaginal candidiasis, acute or recurrent. Candidal balanitis. 2. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated. 3. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection. These include infections of the peritoneum, endocardium and pulmonary and urinary tracts. Candidal infections in patients with malignancy, in intensive care units or those receiving cytotoxic or immunosuppressive therapy, may be treated. 4. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). Normal hosts and patients with acquired immune deficiency syndrome (AIDS), organ transplants or other causes of immunosuppression may be treated. ByFluc 50mg Capsules can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS. 5. Prevention of fungal infections in patients with malignancy who are predisposed to such infec Läs hela dokumentet