Posology : מינונים

4.2       Posology and method of administration
Adults
The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient.

The recommended daily dosage is as follows:

500 mg IV every 8 hours in the treatment of pneumonia, UTI, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections.

1 g IV every 8 hours in the treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicemia.

In cystic fibrosis, doses up to 2 g every 8 hours have been used; most patients have been treated with 2 g every 8 hours.

In meningitis the recommended dosage is 2 g every 8 hours.

When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 1g every 8 hours in adults (maximum approved dose is 6g daily given in 3 divided doses) and a dose of at least 20mg/kg every 8 hours in children (maximum approved dose is 120mg/kg/ daily given in 3 divided doses) are recommended.

Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.
There are limited safety data available to support the administration of a 2g bolus dose in adults as an intravenous bolus injection



Dosage Schedule for Adults with Impaired Renal Function

Dosage should be reduced in patients with creatinine clearance less than 51 mL/min, as scheduled below.

Table 1

Creatinine Clearance       Dose (based on “unit” dose range    Frequency (mL/min)                   of 500 mg, 1 g, 2 g)
26-50                      one unit dose                       every 12 hours
10-25                      one-half unit dose                  every 12 hours <10                        one-half unit dose                  every 24 hours 

Meropenem is cleared by haemodialysis and haemofiltration; if continued treatment with Meropenem/ANFARM is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations.
There is no experience with the use of Meropenem/ANFARM in patients under peritoneal dialysis.

Dosage in Adults with Hepatic Insufficiency
No dosage adjustment is necessary in patients with hepatic insufficiency (see Section 4.4).

Elderly Patients
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min.

Children
For children over 3 months and up to 12 years of age the recommended dose is 10 to 20 mg/kg every 8 hours depending on type and severity of infection, susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, adult dosage should be used. In meningitis and cystic fibrosis the recommended dose is 40 mg/kg every 8 hours.
There is no experience in children with renal impairment.

Method of Administration
Meropenem/ANFARM IV can be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes using the specific available presentations. There is limited safety data available to support the administration of a 40mg/kg bolus dose (in children). There is limited safety data available to support the administration of a 2g bolus dose (in adults).

Meropenem/ANFARM IV to be used for bolus intravenous injection should be constituted with sterile Water for Injections (5 mL per 250 mg meropenem). This provides an approximate concentration of 50 mg/mL. Constituted solutions are clear, and colourless or pale yellow.

Meropenem/ANFARM IV for intravenous infusion may be constituted with compatible infusion fluids (50 to 200 ml) (see Sections 6.2 and 6.3 6.6).
Meropenem/ANFARM should not be mixed with or physically added to solutions containing other drugs.Solutions of Meropenem/ANFARM should not be frozen.