Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
McDermott Laboratories Ltd t/a Gerard Laboratories
125 Base mg/5ml
Powder for Oral Solution
1996-12-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geriflox Elixir 125 mg/5 ml Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted as directed each 5 ml of elixir contains flucloxacillin sodium equivalent to 125 mg flucloxacillin. Excipients: Sucrose 3.1 g/5 ml Sulphur dioxide (E220) 0.16 mg/5 ml For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Pink, pineapple-flavoured granular powder for reconstitution as an oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Geriflox Elixir is indicated for the treatment of infections due to penicillinase producing staphylococci and other gram- positive organisms susceptible to this anti-infective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Geriflox Elixir is administered orally. Oral forms of Flucloxacillin should be taken half to one hour before meals. _Recommended dosage schedules:_ _Adults and Children over 10 years_ 750 mg - 1500 mg daily in divided doses (i.e. 250 mg - 500 mg three times a day). This dosage may be doubled if necessary. _Children aged 2-10 years_ The usual daily dose is 50mg/kg body weight in divided doses (or half the adult dose). _Children under _2 _years:_ _A quarter of adult dose._ _The dosage may be increased if necessary._ _Special groups:_ Geriflox Elixir usage in patients with renal impairment does not required dosage reduction. In the presence of severe renal failure (creatine clearance < 10 mg/min) a reduction in dose or extension of dose interval should be considered. In high dose regimens the maximum recommended dose is 1g every 8 to 12 hours. 4.3 CONTRAINDICATIONS Geriflox Elixir should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. IRISH MEDICINES BOARD _ Prečítajte si celý dokument