Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
caspofungin (as acetate)
Merck Sharp & Dohme B.V.
J02AX04
caspofungin
Antimycotics for systemic use
Candidiasis; Aspergillosis
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 seven 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.
Revision: 32
Authorised
2001-10-23
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CANCIDAS 50 mg p owder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion 2. QUALITAT IVE AND QUAN TITATIVE COMPOSITION CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial conta ins 50 mg caspofungin (as acetate). CANCIDAS 70 mg powder for concentrate fo r solution for infusion Each vial contains 70 mg caspofungin (as acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate fo r s olution for infusion. Before reconstitution, the powder is a white to off-white- compact, powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of invasive candidiasis in adult or paediatric patients. • Treatment of invasive aspergillos is in adult or paediatric patients who are refractory to or intolerant of am photericin B, lipid formulations of amphotericin B and/or itr aconazole. Refract oriness 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 therap y for presumed fungal infections (such as Candida or Aspergillus) i n febrile, neutrop aenic adult or paediatric patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Caspofungin should be in itiated by a physician experienced in the management of invasive fu ngal infections. Posology Adult patients A single 70 mg loading dose sh ould be admi nistered 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 (se e Inst ructions for Use in Paediatric Patients, Mosteller 1 Formula). For all indications, Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CANCIDAS 50 mg p owder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion 2. QUALITAT IVE AND QUAN TITATIVE COMPOSITION CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial conta ins 50 mg caspofungin (as acetate). CANCIDAS 70 mg powder for concentrate fo r solution for infusion Each vial contains 70 mg caspofungin (as acetate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate fo r s olution for infusion. Before reconstitution, the powder is a white to off-white- compact, powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of invasive candidiasis in adult or paediatric patients. • Treatment of invasive aspergillos is in adult or paediatric patients who are refractory to or intolerant of am photericin B, lipid formulations of amphotericin B and/or itr aconazole. Refract oriness 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 therap y for presumed fungal infections (such as Candida or Aspergillus) i n febrile, neutrop aenic adult or paediatric patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Caspofungin should be in itiated by a physician experienced in the management of invasive fu ngal infections. Posology Adult patients A single 70 mg loading dose sh ould be admi nistered 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 (se e Inst ructions for Use in Paediatric Patients, Mosteller 1 Formula). For all indications, Прочетете целия документ