País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CEFALEXIN
Glaxo Laboratories Limited
250 mg/5 MG/5ml
Granules for Oral Suspension
1983-11-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceporex Granules for Oral Suspension 250 mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, each 5ml contains Cephalexin .equivalent to 250mg Cephalexin (anhydrous). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension Pale orange granules with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceporex is indicated in the management of moderate and serious infections due to micro-organisms sensitive to this anti-infective, for example beta-haemolytic Streptococci, Staphylococci, _Proteus mirabilis _etc. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Many infections in adults will respond to oral dosage of 1 gram to 2 grams per day in divided doses; however, for most infections, the following simple scheme will be found satisfactory: _Adults and children over 12 years: _500mg t.d.s. (three times daily). To aid compliance, especially in ambulatory patients, the daily dosage may be given in two equal doses, e.g. 1g twice daily in adult with urinary tract infections. The following additional information should also be considered: For severe or deep-seated infections, especially when less sensitive organisms are involved, the dosage should be increased to 1g t.d.s. or 1.5g q.d.s. (four times daily). For prophylaxis of recurrent urinary tract infections in adults, a dose of 125mg each night is recommended and may be continued for several months (the 125mg/5ml suspension is suitable for this purpose). Children: Ideally, dosage should be calculated on a body-weight basis, particularly in infants. The following dosage recommendations for children are derived from a normal dosage of 25 to 60mg/kg/day. For chronic, severe or deep- seated infections, t Llegiu el document complet