Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CASPOFUNGIN
Fresenius Kabi Limited
J02AX04
CASPOFUNGIN
50 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
Other mycotics for systemic use
Authorised
2016-10-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caspofungin Xellia 50 mg Powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg caspofungin (as acetate). The concentration of the reconstituted vial is 5.2 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. The powder is a white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of invasive candidiasis in adult or paediatric patients. • Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections. Posology _Adult patients_ A single 70 mg loading dose should be administered on Day-1, followed by 50 mg daily thereafter. In patients weighing more than 80 kg, after the initial 70 mg loading dose, caspofungin 70 mg daily is recommended (see section 5.2). No dosage adjustment is necessary based on gender or race (see section 5.2). _Paediatric patients (12 months to 17 years)_ In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller 1 Formula). For all indications, a Read the complete document