Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluconazole
Genus Pharmaceuticals Ltd
J02AC01
Fluconazole
10mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5030451004086
OBJECT 1 FLUCONAZOLE 50MG/5ML POWDER FOR ORAL SUSPENSION Summary of Product Characteristics Updated 18-Apr-2017 | Genus Pharmaceuticals 1. Name of the medicinal product Fluconazole 50mg/5ml Powder for Oral Suspension 2. Qualitative and quantitative composition Each 5ml of oral suspension contains 50mg of fluconazole For a full list of excipients see section 6.1. 3. Pharmaceutical form Powder for oral suspension. The powder is almost white. A whitish suspension is obtained after its reconstitution with water. 4. Clinical particulars 4.1 Therapeutic indications Fluconazole is indicated in the treatment of mycoses caused by Candida, Cryptococcus and other susceptible yeast, in particular: 1. Mucosal candidiasis: These include oropharyngeal candidiasis, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis and chronic atrophic oral candidiasis (denture sore mouth). Both normal hosts and immunocompromised patients may be treated. 2 Systemic candidiasis (including disseminated deep infections and peritonitis). 3. Acute cryptococcal meningitis in adults, including patients with AIDS, transplanted patients or other patients with other causes of immunosuppression. 4. Genital candidiasis. Acute or recurrent vaginal candidiasis. Candida balanitis. The treatment of partners who present with symptomatic genital candidiasis should be considered. 5. Prevention of fungal infections in patients predisposed to such infections as a result of chemotherapy or radiotherapy, including bone transplant patients. 6. Dermatomycosis, including infections such as Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor. Fluconazole is not indicated for nail infections and tinea capitis. Use in children Fluconazole should not be used for tinea capitis. Consideration should be given to official guidance on the appropriate use of antimycotic agents. Before initiating treatment, samples should be taken for microbiological analysis and the suitability of the therapy should be subsequently confirmed (see s Lire le document complet