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צפורוקסים - פרזניוס 1500 מ"ג CEFUROXIME - FRESENIUS 1500 MG (CEFUROXIME AS SODIUM SALT)

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
Posology
Table 1. Adults and children ≥ 40 kg

Indication                                                 Dosage
Community acquired pneumonia and acute                         750 mg every 8 hours (intravenously exacerbations of chronic bronchitis                            or intramuscularly) Soft-tissue infections: cellulitis, erysipelas and wound infections.
Intra-abdominal infections

Sinusitis, septic arthritis                                    750 mg every 8 hours (intravenously or intramuscularly). For more severe infections, this dose should be increased to 1.5g every 8 hours i.v. The frequency of i.m. or i.v. injections can be increased to six-hourly if necessary, giving total doses of 3g to 6g daily.
Where clinically indicated, some infections respond to 750 mg )i.v or i.m( twice daily or 1.5 g (i.v or two 750 mg doses i.m into different injection sites ) twice daily


Complicated urinary tract infections, including                1.5 g every 8 hours (intravenously or pyelonephritis                                                 two 750 mg doses intramuscularly into different injection sites )


Severe infections                                              750 mg every 6 hours (intravenously) 1.5 g every 8 hours (intravenously)

Surgical     prophylaxis     for     gastrointestinal,         1.5 g with the induction of anaesthesia. This may be supplemented gynaecological surgery (including caesarean section)           with two 750 mg doses (intramuscularly) after 8 hours and 16 and orthopaedic operations                                     hours
Surgical prophylaxis for cardiovascular and                    1.5 g with induction of anaesthesia followed by 750 mg oesophageal operations                                         (intramuscularly) every 8 hours for a further 24 hours 

Table 2. Children < 40 kg
Infants and toddlers > 3               weeks      Infants (birth to 3 weeks) and children < 40 kg
Community acquired pneumonia
Complicated urinary tract infections ,including pyelonephritis            30 to100 mg/kg/day
Soft-tissue infections :cellulitis , erysipelas ( intravenously ) given as 3 or 4 divided 30     to    100      mg/kg/day and wound infections                            doses ; a dose of 60 mg/kg/day is               (intravenously) given as 2 or 3 appropriate for most infections                 divided doses (see section 5.2) Intra-abdominal infections

Sinusitis, septic arthritis                   Doses of 30 to 100 mg/kg/day given as             Doses of 30 to 100 mg/kg/day given as three or four divided doses. A dose of            two or three divided doses.
60mg/kg/day is appropriate for most infections.


Renal impairment
Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Cefuroxime -Fresenius should be reduced to compensate for its slower excretion.

Table 3. Recommended doses for Cefuroxime -Fresenius in renal impairment 
Creatinine clearance                              T1/2 (hrs)               Dose (mg) > 20 mL/min/1.73 m²                             1.7–2.6                It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily)


10-20 mL/min/1.73 m²                            4.3–6.5                750 mg twice daily 
< 10 mL/min/1.73 m²                             14.8–22.3              750 mg once daily 
Patients on haemodialysis                       3.75                   A further 750 mg dose should be given intravenously or intramuscularly at the end of each dialysis; in addition to parenteral use, cefuroxime sodium can be incorporated into the peritoneal dialysis fluid (usually
250 mg for every 2 litres of dialysis fluid)



Patients in renal failure on continuous         7.9–12.6 (CAVH)        750 mg twice daily; for low-flux haemofiltration arteriovenous haemodialysis (CAVH) or           1.6 (HF)               follow the dosage recommended under impaired renal high-flux haemofiltration (HF) in intensive                            function therapy units



Hepatic impairment
Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.

Method of administration
Cefuroxime -Fresenius should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater than 1.5 g intravenous administration should be used. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

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תאריך הכללה מקורי בסל 01/01/1995
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NEOPHARM (ISRAEL) 1996 LTD

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149 08 33470 00

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צפורוקסים - פרזניוס 1500 מ"ג

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