Posology : מינונים

4.2    Posology and method of administration
Posology

The recommended intravenous dose regimen for patients with creatinine clearance > 50 mL/min is shown by infection type in Table 1.


Table 1: Intravenous dose of Zerbaxa by type of infection in patients with creatinine clearance > 50 mL/min
Type of infection                     Dose                 Frequency        Infusion        Duration of time            treatment
Complicated intra-abdominal           1 g ceftolozane /    Every 8 hours 1 hour             4-14 days infection*                            0.5 g tazobactam
Complicated urinary tract infection   1 g ceftolozane /    Every 8 hours 1 hour             7 days Acute pyelonephritis                  0.5 g tazobactam
*To be used in combination with metronidazole when anaerobic pathogens are suspected.

Special populations

Elderly (≥ 65 years of age)
No dose adjustment is necessary for the elderly based on age alone (see section 5.2).
Renal impairment
In patients with mild renal impairment (estimated creatinine clearance [CrCL] > 50 mL/min), no dose adjustment is necessary, see section 5.2).

In patients with moderate or severe renal impairment, and in patients with end stage renal disease on haemodialysis, the dose should be adjusted as listed in Table 2 (see sections 5.1 and 6.6).

Table 2: Intravenous dose of ceftolozane/tazobactam in patients with creatinine clearance ≤ 50 mL/min Estimated CrCL
Recommended dose regimen for Zerbaxa (ceftolozane/tazobactam)**
(mL/min)*
30 to 50                        500 mg ceftolozane / 250 mg tazobactam intravenously every 8 hours 15 to 29                        250 mg ceftolozane / 125 mg tazobactam intravenously every 8 hours A single loading dose of 500 mg ceftolozane / 250 mg tazobactam followed after 8 hours by a 100 mg ceftolozane / 50 mg tazobactam maintenance dose End stage renal disease on administered every 8 hours for the remainder of the treatment period (on haemodialysis haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
*CrCL estimated using Cockcroft-Gault formula
**All doses of Zerbaxa are administered intravenously over 1 hour and are recommended for all indications.
The duration of treatment should follow the recommendations in Table 1.

Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of ceftolozane/tazobactam in children and adolescents below 18 years of age have not yet been established. No data are available.

Method of administration

Zerbaxa is for intravenous infusion.
The infusion time is 1 hour for 1 g / 0.5 g of Zerbaxa.
Precautions to be taken before handling or administering the product
See section 6.2 for incompatibilities.
See section 6.6 for instructions on reconstitution and dilution of the medicinal product before administration.