Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CIPROFLOXACIN LACTATE
Pfizer Healthcare Ireland
2 Mg/Ml
Solution for Infusion
2012-03-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ciprofloxacin Pfizer 2 mg/ml Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each presentation of Ciprofloxacin Pfizer 2 mg/ml infusion contains the following: CIPROFLOXACIN PFIZER 100 MG/50 ML SOLUTION FOR INFUSION 1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate. Each 50 ml vial contains 100 mg ciprofloxacin (as ciprofloxacin lactate). Excipient: Each 50 ml contains 7.7 mmol (177 mg) sodium. CIPROFLOXACIN PFIZER 200 MG/100 ML SOLUTION FOR INFUSION 1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate. Each 100 ml bottle contains 200 mg ciprofloxacin (as ciprofloxacin lactate). Excipient: Each 100 ml contains 15.4 mmol (354 mg) sodium. CIPROFLOXACIN PFIZER 400 MG/200 ML SOLUTION FOR INFUSION 1 ml of solution for infusion contains 2 mg ciprofloxacin as 2.544 mg ciprofloxacin lactate. Each 200 ml bottle contains 400 mg ciprofloxacin (as ciprofloxacin lactate). Excipient: Each 200 ml contains 30.8 mmol (708 mg) sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion (IV). Clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin Pfizer 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 Read the complete document