Posology : מינונים

4.2         Posology and method of administration
Posology
The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP.

Table 1     Dosage in adults with normal renal function, creatinine clearance (CrCL) > 50 mL/min
Indications                                        Posology         Infusion time (mg/infusion) (minutes)/Frequency


Complicated skin and soft tissue infections (cSSTI)     600 mg
60/every 12 hours
Community-acquired pneumonia (CAP)


Table 2      Dosage in paediatric patients with normal renal function, creatinine clearance (CrCL) > 50 mL/min*

Indications                      Age group                         Posology            Infusion time (mg/infusion)       (minutes)/Frequency
Adolescents aged from 12 to < 18 years with                600 mg              60/every 12 hours bodyweight ≥ 33 kg
Complicated skin and soft        Adolescents aged from tissue infections (cSSTI)        12 years to < 18 years            12 mg/kg to a bodyweight < 33 kg and            maximum of          60/every 8 hours children ≥ 2 years to             400 mg
Community-acquired               < 12 years pneumonia (CAP)                  Infants ≥ 2 months to
8 mg/kg             60/every 8 hours
< 2 years a

* Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.

Special populations

Elderly patients (> 65 years)

No dosage adjustment is required for the elderly with creatinine clearance values > 50 mL/min (see section 5.2).

Renal impairment
The dose should be adjusted when creatinine clearance (CrCL) is ≤ 50 mL/min, as shown in Tables 3 and 4 (see sections 4.9 and 5.2). The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP.
Table 3 Dosage in adults with impaired renal function, creatinine clearance (CrCL) ≤ 50 mL/min
Indications                    Creatinine clearance Posology                 Infusion time (mL/min)a               (mg/infusion)         (minutes)/Frequency
Standard dose
> 30 to ≤ 50            400 mg
Complicated skin and soft tissue infections(cSSTI)       ≥ 15 to ≤ 30            300 mg

ESRD, including            200 mg haemodialysisb

60/every 12 hours


Community-acquired pneumonia (CAP) a
Calculated using the Cockcroft-Gault formula for adults. Dose is based on CrCL. CrCL should be closely monitored and the dose adjusted according to changing renal function.
b
Ceftaroline is haemodialyzable; thus Zinforo should be administered after haemodialysis on haemodialysis days.

Dose recommendations for children and adolescents are based on pharmacokinetic (PK) modelling.

There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to < 18 years with bodyweight < 33 kg and in children aged from 2 to 12 years with End-stage renal disease (ESRD).

There is insufficient information to recommend dosage adjustments in children aged from 2 months to < 2 years with moderate or severe renal impairment or ESRD

Table 4   Dosage in paediatric patients with impaired renal function, creatinine clearance (CrCL) ≤ 50 mL/min
Indications        Age group            Creatinine        Posology          Infusion time clearance         (mg/infusion) (minutes)/Frequency
(mL/min)a

Standard dose                                   > 30 to ≤ 50        400 mg Adolescents aged
≥ 15 to ≤ 30        300 mg from 12 to
ESRD,                                  60/every 12 hours
< 18 years with
Complicated skin                                including           200 mg bodyweight ≥ 33 kg and soft tissue                                 haemodialysisb infections (cSSTI)      Adolescents aged                            8 mg/kg to a from 12 years to        > 30 to ≤ 50        maximum of
< 18 years                                  300 mg bodyweight < 33 kg                                             60/every 8 hours Community-                                                          6 mg/kg to a and children
≥ 15 to ≤ 30        maximum of acquired                ≥ 2 years to pneumonia (CAP)                                                     200 mg < 12 years a
Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m2). Dose is based on CrCL.
CrCL should be closely monitored and the dose adjusted according to changing renal function.
b
Ceftaroline is haemodialyzable; thus Zinforo should be administered after haemodialysis on haemodialysis days.
Hepatic impairment
No dosage adjustment is considered necessary in patients with hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of Zinforo in children below the age of 2 months have not yet been established.
No data are available

Method of administration
Zinforo is administered by intravenous infusion over 60 minutes for all infusion volumes (50 mL, 100 mL or 250 mL) (see section 6.6).

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.