Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
CEFUROXIME
Glob Limited
500 Milligram
Tablets
2011-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Glob Limited 500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 601.44 mg cefuroxime axetil equivalent to 500 mg cefuroxime. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, capsule shaped tablets with ‘A34’ debossed on one side and plain on the other side. The size is 20.0 mm X 8.5 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Glob Limited is indicated for the treatment of the following mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime: • upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis • acute bacterial bronchitis, acute exacerbations of chronic bronchitis • lower uncomplicated urinary tract infections: cystitis • skin and soft tissue infections: furunculosis, pyoderma and impetigo • treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and children above 12 years of age. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: oral This medicinal product is available in three strengths: 125 mg, 250 mg and 500 mg The usual duration of therapy is 7 days (ranging from 5 to 10 days). For treatment of pharyngotonsillitis caused by _Streptococcus pyogenes _a therapy duration of at least 10 days is indicated. The duration of treatment of early Lyme disease should be 20 days. In order to achieve optimum absorption cefuroxime Glob Limited tablets should be taken shortly after meals. The dosage depends on the severity of the infection. For severe infections Przeczytaj cały dokument