Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
CEFUROXIME AXETIL
Teva Pharma B.V.
250 Base Milligrams
Film Coated Tablet
2010-02-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefuroxime Teva 250mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 250 mg film-coated tablet contains 250 mg cefuroxime (as cefuroxime axetil) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Cefuroxime Teva 250 mg film-coated tablets: light blue coloured film-coated tablets engraved with “250” on one side and “P125” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefuroxime Teva 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 Cefuroxime Teva tablets are coated to mask their taste: they should not be chewed. 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 Teva tablets should be taken shortly after meals. The dosage depends on the severity of the infection. For severe infections parenteral forms of cefuro Aqra d-dokument sħiħ