Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN
Niche Generics Limited
2 Mg/Ml
Solution for Infusion
2009-01-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Niche 2mg/ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for infusion contains ciprofloxacin (as lactate) equivalent to 2 mg ciprofloxacin. Each glass bottle with 50 ml solution for infusion contains 100 mg ciprofloxacin (as lactate). The sodium content is 177mg (7.7 mmol). Each glass bottle with 100 ml solution for infusion contains 200 mg ciprofloxacin (as lactate). The sodium content is 354mg (15.4 mmol). Each glass bottle with 200 ml solution for infusion contains 400 mg ciprofloxacin (as lactate). The sodium content is 708mg (30.8 mmol). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion. Clear yellowish to slightly yellow, odourless solution free from foreign bodies. The pH-value of the solution for infusion ranges from 3.9 to 4.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1) Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. ADULTS: • Lower respiratory tract infections due to Gram-negative bacteria o exacerbations of chronic obstructive pulmonary disease o broncho-pulmonary infections in cystic fibrosi or in bronchiectasis o pneumonia • Chronic suppurative otitis media • Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria • Urinary tract infections • Epididymo-orchitis including cases due to _Neisseria gonorrhoeae_ • Pelvic inflammatory disease including cases due to _Neisseria gonorrhoeae_ IRISH Přečtěte si celý dokument