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מרופנם פרזניוס 500מ"ג MEROPENEM FRESENIUS 500 MG (MEROPENEM AS ANHYDROUS)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-ורידי : I.V

צורת מינון:

אבקה להמסה להזרקהאינפוזיה : POWDER FOR SOLUTION FOR INJ/INF

Posology : מינונים

4.2 Posology and method of administration

The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.
A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp.), or very severe infections.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).

Adults and Adolescents

Infection                                                       Dose to be administered every 8 hours Severe pneumonia including hospital and ventilator-             500 mg or 1 g associated pneumonia.
Broncho-pulmonary infections in cystic fibrosis                 2g
Complicated urinary tract infections                            500 mg or 1 g Complicated intra-abdominal infections                          500 mg or 1 g Intra- and post-partum infections                               500 mg or 1 g Complicated skin and soft tissue infections                     500 mg or 1 g Acute bacterial meningitis                                      2g
Management of febrile neutropenic patients                      1g


Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6).
Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.
Renal impairment
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the application of these dose adjustments for a unit dose of 2 g.

Creatinine clearance (ml/min)                   Dose                                  Frequency (based on “unit” dose range of
500 mg or 1 g or 2 g, see table above)
26-50                                one unit dose                           every 12 hours

10-25                                half of one unit dose                   every 12 hours 
<10                                  half of one unit dose                  every 24 hours 
Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.

Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Dose in elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Pediatric population
Children under 3 months of age
The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2).

Children from 3 months to 11 years of age and up to 50 kg body weight 
The recommended dose regimens are shown in the table below:

Infection                                                           Dose to be administered every 8 hours Severe pneumonia including hospital and ventilator-                 10 or 20 mg/kg associated pneumonia
Broncho-pulmonary infections in cystic fibrosis                     40 mg/kg Complicated urinary tract infections                                10 or 20 mg/kg Complicated intra-abdominal infections                              10 or 20 mg/kg Complicated skin and soft tissue infections                         10 or 20 mg/kg Acute bacterial meningitis                                          40 mg/kg Management of febrile neutropenic patients                          20 mg/kg 
Children over 50 kg body weight
The adult dose should be administered.
There is no experience in children with renal impairment.
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.

שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/03/2001
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

בעל רישום

NEOPHARM (ISRAEL) 1996 LTD

רישום

157 62 34370 00

מחיר

0 ₪

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מרופנם פרזניוס 500מ"ג

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