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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
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
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
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תאריך הכללה מקורי בסל
01/03/2001
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