Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CEFUROXIME SODIUM
Sandoz Ltd
250 Milligram
Pdr for Soln for Injection
2006-08-25
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime 250 mg powder for solution / suspension for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 250 mg of cefuroxime as 263 mg of cefuroxime sodium. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution / suspension for injection. White to almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime is indicated in the parenteral treatment of the following infections caused by sensitive pathogens respiratory tract infections: e.g. acute and chronic bronchitis, bacterial pneumonia o infections of the ear, nose and throat, o urinary tract infections o infections of skin and soft tissue o bone and joint infections o obstetric and gynaecological infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: By intramuscular injection, intravenous injection or infusion. Usual dosage for Adults and the Elderly: Most infections will respond to cefuroxime 750 mg three times a day. For more severe infections, the dose may be increased to 1.5 g three times a day by intravenous injection. _THE INTRAMUSCULAR METHOD OF ADMINISTRATION IS RESERVED TO EXCEPTIONAL CLINICAL SITUATIONS AND SHOULD UNDERGO A_ _RISK-BENEFIT ASSESSMENT._ _SPECIAL ADVICE FOR INTRAMUSCULAR INJECTION HAS TO BE REGARDED (SEE SECTION 6.6, SPECIAL PRECAUTIONS FOR DISPOSAL OF A_ _USED MEDICINAL PRODUCT OR WASTE DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT)._ If necessary, the frequency of administration of cefuroxime can be increased to four times a day up to total daily doses of 3 g to 6 g. IRISH MEDICINES BOARD _________________________________________ Прочитать полный документ