Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN
Baxter Healthcare Limited
2
Solution for Injection
2008-10-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Redibag 2 mg/ml, Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg ciprofloxacin in 5 % w/v glucose monohydrate solution. Each bag with 100 ml contains 200 mg ciprofloxacin. Each bag with 200 ml contains 400 mg ciprofloxacin. Excipient: Glucose (see section 4.4) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, slightly greenish-yellow solution. pH of the solution: 3.5 to 4.6. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin Redibag 2 mg/mL 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 - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - 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_ In the above genital tract infections when thought or known to be due to _Neisseria gonorrhoeae _it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing. IRISH MEDICINES BOARD ____________________________________________________________________________ সম্পূর্ণ নথি পড়ুন