Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN HYDROCHLORIDE
Niche Generics Limited
750 Milligram
Film Coated Tablet
2005-10-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BioFloxcin 750 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 750mg ciprofloxacin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Oval, white film-coated tablet with a scoreline on both sides. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin is a synthetic, 4-quinolone derivative with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ciprofloxacin is indicated for the treatment of single infections or mixed infections caused by two or more susceptible organisms. It may be used for infections caused by organisms resistant to other antibiotics, including aminoglycosides, penicillins and cephalosporins. The extensive tissue penetration of ciprofloxacin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables ciprofloxacin to be used alone (pending sensitivity results) or in combination with an aminoglycoside or with beta-lactam antibiotics, for instance when severe neutropenia is present, or with an antibiotic active against anaerobes where the presence of _Bacteroides fragilis _is suspected. Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria: RESPIRATORY TRACT INFECTIONS: e.g. lobar and bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema. Ciprofloxacin is not recommended as first line therapy for the treatment of pneumococcal pneumonia (see Section 4.4, Warnings and Precautions section). In circumstances where a physician considers it appropriate to use cipro Lees het volledige document