Posology : מינונים

4.2     Posology and method of administration
The recommended dosage and administration by infection is shown in the following table: 
Infection                                         Dosage            Frequency        Infusion Time Complicated intra-abdominal infection             500 mg           every 8 hours         1 hour Complicated UTI, including pyelonephritis         500 mg           every 8 hours         1 hour 
The usual treatment duration of doripenem therapy is 5-14 days and should be guided by the severity, site of the infection and the patient’s clinical response. Doripenem was given for up to 14 days in clinical studies and the safety of longer durations of therapy has not been established. After commencing treatment with intravenous doripenem, a switch to appropriate oral therapy to complete the treatment course is possible once clinical improvement has been established.

Dosage in paediatric patients
Doribax is not recommended for use in children below 18 years of age due to a lack of safety and efficacy data.

Dosage in patients with impaired renal function
In patients with mild renal impairment (i.e. creatinine clearance (CrCl) is 51-79 ml/min), no dosage adjustment is necessary. In patients with moderate renal impairment (CrCl 30 to <50 ml/min), the dosage of Doribax should be 250 mg every 8 hours. In patients with severe renal impairment (CrCl <30 ml/min), the dosage of Doribax should be 250 mg every 12 hours. Due to limited clinical data and an expected increased exposure of doripenem and its metabolite, Doribax should be used with caution in patients with severe renal impairment (see section 5.2).


Doribax PI_08 2008 EL
Dosage in patients on dialysis
Doribax is haemodialysable; however, there is insufficient information to make dose adjustment recommendations in patients on dialysis. Therefore, Doribax is not recommended for patients on any type of dialysis (see section 5.2).

Dosage in elderly patients (65 years of age)
No dosage adjustment is necessary in elderly patients, except in cases of moderate to severe renal insufficiency (see Dosage in patients with impaired renal function above and section 5.2).

Dosage in patients with impaired hepatic function
No dosage adjustment is necessary.

Method for administration
Doribax is to be reconstituted and then further diluted (see section 6.6) prior to administration by intravenous infusion over a period of one or four hours.