Zevtera 500 mg powder for concentrate for solution for infusion. Each vial contains 500 mg of ceftobiprole (as 666.6 mg ceftobiprole medocaril sodium). After reconstitution, each mL of concentrate contains 50 mg ceftobiprole (as 66.7 mg of ceftobiprole medocaril sodium).
- Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP)
- Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate use of antibacterial agents. The recommended dose of Zevtera is 500mg administered as a 2-hour intravenous infusion every 8 hours. For CAP, a switch to an appropriate oral antibiotic may be considered after completion of at least 3 days of intravenous ceftobiprole medocaril sodium treatment, depending on the patient's clinical response.No dose adjustment is necessary in elderly patients, except in cases of moderate to severe renal impairment (see below and section 5.2).
In patients with mild renal impairment (i.e., creatinine clearance [CLCR] 50 to 80 mL/min), no dosage adjustment is necessary. In patients with moderate renal impairment (CLCR 30 to <50mL/min), the recommended dose of Zevtera is 500mg administered every 12 hours as a 2-hour intravenous infusion. In patients with severe renal impairment (CLCR <30mL/min), the recommended dose of Zevtera is 250mg administered every 12 hours as a 2-hour intravenous infusion. Due to limited clinical data and an expected increased exposure of Zevtera and its metabolite, Zevtera should be used with caution in patients with severe renal impairment.