CANCIDAS 50 mg powder for concentrate for solution for infusion

Each vial contains 50 mg caspofungin (as acetate).

Excipients: Each 50 mg vial contains 35.7 mg of sucrose.

For a full list of excipients, see section 6.1.

Powder for concentrate for solution for infusion.

Before reconstitution, the powder is a white to off-white-compact, powder.

• 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.

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 Instruct