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
Hospital-acquired pneumonia,            2 g ceftolozane /      Every 8 hours  1 hour          8-14 days including ventilator-associated         1 g tazobactam pneumonia***
*Creatinine clearance estimated using Cockcroft-Gault formula.
**To be used in combination with metronidazole when anaerobic pathogens are suspected.
***To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.

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 > 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). Patients with end stage renal disease on haemodialysis were excluded from clinical trials. The dosage for end stage renal disease on haemodialysis was derived from PK PD modeling analysis.

Table 2: Recommended intravenous dose regimens for Zerbaxa in patients with creatinine clearance* ≤ 50 mL/min
Estimated                                                         Hospital-acquired pneumonia, including Complicated intra-abdominal infections,
creatinine                                                        ventilator-associated pneumonia** complicated urinary tract infections, and clearance acute pyelonephritis**
(mL/min)*
500 mg ceftolozane / 250 mg tazobactam          1 g ceftolozane / 0.5 g tazobactam 30 to 50 intravenously every 8 hours                     intravenously every 8 hours 250 mg ceftolozane / 125 mg tazobactam          500 mg ceftolozane / 250 mg tazobactam
15 to 29 intravenously every 8 hours                     intravenously every 8 hours A single loading dose of 500 mg ceftolozane      Patients with end stage renal disease on / 250 mg tazobactam followed after 8 hours      haemodialysis were excluded from clinical by a 100 mg ceftolozane / 50 mg tazobactam      trials. There are currently no dosing End stage renal   maintenance dose administered every             recommendations for patients with end disease on        8 hours for the remainder of the treatment      stage renal disease.
haemodialysis     period (on haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
*Creatinine clearance 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
Zerbaxa is not indicated for children and adolescents under 18 years old.

Method of administration
Zerbaxa is to be administered by intravenous infusion over a 1 hour period for all doses.

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.