Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
AMPHOTERICIN B
Cephalon UK Limited
AMPHOTERICIN B
5 Micromol
Suspension for Injection
Withdrawn
2013-04-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Abelcet 5mg/ml Concentrate for Suspension for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amphotericin B Liquid Complex. Each ml contains 5mg Amphotericin B. Each vial contains 20ml (100mg, 100,000IU of amphotericin B) which must be diluted before intravenous infusion. Abelcet contains 3.6 mg/ml of sodium (0.156 mmol); this represents 71.8 mg of sodium (3.12 mmol) per 20ml vial. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for suspension for Infusion Abelcet is a sterile, pyrogen free yellow suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS First-line treatment of aspergillosis Abelcet is indicated for the first-line treatment of aspergillosis in immunocompromised and immunocompetent patients. First-line treatment of systemic candidal infections Abelcet is indicated for first-line treatment of systemic candidal infections in neutropenic and non-neutropenic patients. In a randomised, comparative study against conventional amphotericin B, the two treatments were equally efficacious in terms of clinical improvement and in the eradication of fungal pathogens. However, a comparison of patients’ renal function showed that Abelcet was significantly better tolerated than conventional amphotericin B. A statistically significant delay in deterioration of renal function was observed in the Abelcet patients compared to those treated with conventional amphotericin B. First line treatment of cryptococcal meningitis Abelcet is also indicated for first line treatment of cryptococcal meningitis and systemic cryptococcosis in patients with acquired immunodeficiency syndrome (AIDS). In a comparative clinical study in AIDS patients with cryptococcal meningitis, the efficacy of Abelcet was Lees het volledige document