Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUCONAZOLE
Pfizer Limited
2 Mg/Ml
Solution for Infusion
1989-08-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diflucan Solution for Infusion 2 mg/ml (50mg/25ml) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml contains 2mg fluconazole (50mg/25ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion A clear, sterile, colourless solution. 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. Diflucan 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. Diflucan 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 infections as a result of cytotoxic chemotherap Read the complete document