Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Caspofungin acetate 57.8mg equivalent to 50 mg caspofungin anhydrous free base;
Merck Sharp & Dohme (New Zealand) Limited
Caspofungin acetate 57.8 mg (equivalent to 50 mg caspofungin anhydrous free base)
50mg + transfer set
Powder for infusion
Active: Caspofungin acetate 57.8mg equivalent to 50 mg caspofungin anhydrous free base Excipient: Glacial acetic acid Mannitol Sodium hydroxide Sucrose Water for injection
Vial, glass, single dose, vial 10mL with transfer set, 50 mg
Prescription
Prescription
Merck Sharp & Dohme Corp
Package - Contents - Shelf Life: Vial, glass, single dose, vial 10mL with transfer set - 50 mg - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2000-09-18
S-WPC-MK0991-IV-102016 Page 1 of 16 NEW ZEALAND DATA SHEET 1 PRODUCT NAME CANCIDAS 50 mg Powder for infusion CANCIDAS 70 mg Powder for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mL vial contains either 50 mg or 70 mg of caspofungin free base. CANCIDAS contains, as the active ingredient, caspofungin acetate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CANCIDAS is a sterile, lyophilised product for intravenous infusion. Each vial contains a solid white to off white cake. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CANCIDAS is indicated for: • Empirical therapy for presumed fungal infections in febrile, neutropaenic patients • Treatment of Invasive Candidiasis, including candidaemia, in neutropaenic and non- neutropaenic patients • Treatment of Oesophageal Candidiasis • Treatment of Oropharyngeal Candidiasis • Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE GENERAL RECOMMENDATIONS IN ADULT PATIENTS CANCIDAS should be administered in adults (≥18 years of age) by slow intravenous infusion over approximately 1 hour. Empirical Therapy A single 70 mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. Empirical therapy should be continued until resolution of neutropaenia. Patients found to have a fungal infection should be treated for a minimum of 14 days; treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved. If the 50 mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased S-WPC-MK0991-IV-102016 Page 2 of 16 to 70 mg. Although an increase in efficacy with 70 mg daily has not been demonstrated, safety data suggest that an increase in dose to 70 mg daily is well tolerated. Invasive Candidiasis A single 70-mg loading dose should be admi Izlasiet visu dokumentu