国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
CEFPODOXIME PROXETIL
Sanofi-Aventis Ireland Limited
40 Base mg/5ml
Granules for Oral Suspension
1999-07-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefodox Paediatric 40mg/5ml Granules for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted each 5ml volume contains 40mg of cefpodoxime, as cefpodoxime proxetil. Excipients: contains per 5ml: Aspartame (E951) 20mg Lactose monohydrate q.s. Sucrose 601.33mg Potassium 2.17mg Sulphites 0.72 micrograms Glucose 322.2mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension Pale yellow granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefodox is a bactericidal cephalosporin antibiotic active against _in vitro _a wide range of gram-negative and gram- positive organisms. It is indicated for the treatment of the following infections. Indications include: _Upper respiratory tract infections _caused by organisms sensitive to cefpodoxime, including acute otitis media, sinusitis, tonsillitis and pharyngitis. Cefodox should be reserved for recurrent or chronic infections. _Lower respiratory tract infection_s caused by organisms sensitive to cefpodoxime. _Upper and lower urinary tract infections _caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis. _Skin and soft tissue infections _caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, folliculitis, paronychia, carbuncles, burns and ulcers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. Adults & Elderly: Not applicable for this product. Children: The recommended mean dosage for children is 8mg/kg/day administered in two divided doses at 12 hour intervals. The following dosage regimen is proposed as a guide to prescribing: Below 6 months: 8mg/kg/day in 2 divided doses. 6 months-2 years: 5.0 ml twice daily. 3-8 years: 10.0 ml t 完全なドキュメントを読む