Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Pinewood Laboratories Ltd,
125 MG/5ml
Powder for Oral Solution
1997-05-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucillin 125mg/5ml Powder for Oral Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains flucloxacillin 125 mg as flucloxacillin sodium. Excipients: also includes sucrose 3.1g per 5ml, sodium 0.534mmol per 5ml and trace amounts of sulphur dioxide (E220). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. A pink, pineapple-flavoured granular powder for oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is recommended for the treatment of infections due to pencillinase-producing Staphylococci and other gram-positive organisms susceptible to Flucloxacillin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: 750 mg to 1500 mg daily in divided doses. The dosage may be increased if necessary. Children: Aged over 12 years: 750 mg to 1500 mg daily in divided doses. The dosage may be increased if necessary. Aged 2 – 12 years: The usual daily dose is 50 mg/kg bodyweight in divided doses. Special Groups: In the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or extension of dose interval should be considered. Administration: Oral doses should be administered one hour before meals or on an empty stomach. 4.3 CONTRAINDICATIONS Flucloxacillin should not be given to patients with a history of hypersensitivity to -lactam antibiotics (e.g. penicillins, cephalosporins) or any of the excipients. Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated janudice/hepatic dysfunction. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/07/2008_ _CRN 2053972_ _page number: 1_ 4.4 Olvassa el a teljes dokumentumot