Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Ciprofloxacin lactate 2.653 mg/mL equivalent to Ciprofloxacin 2 mg/mL
Baxter Healthcare Ltd
Ciprofloxacin lactate 2.653 mg/mL (equivalent to Ciprofloxacin 2 mg/mL)
0.2% w/v
Solution for infusion
Active: Ciprofloxacin lactate 2.653 mg/mL equivalent to Ciprofloxacin 2 mg/mL Excipient: Hydrochloric acid Lactic acid Sodium chloride Water for injection
Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 50 mL, 50 mL
Prescription
Prescription
Mylan Laboratories Limited
Package - Contents - Shelf Life: Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 50 mL - 50 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze - Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 100 mL - 100 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze - Bottle, glass, Clear Type II colourless bottle with grey bromobutyl rubber closure 200 mL - 200 mL - 36 months from date of manufacture stored at or below 30°C protect from light. do not freeze
2006-07-13
NEW ZEALAND DATA SHEET CIPROFLOXACIN Data Sheet 14 March 2018 Page 1 of 12 Baxter Healthcare Ltd 1 CIPROFLOXACIN (0.2%w/v, solution for infusion) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient _ Ciprofloxacin lactate 2.653mg/mL (equivalent to ciprofloxacin 2mg/mL). For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. CIPROFLOXACIN 2mg/mL is a clear, colourless to slightly yellow infusion solution containing ciprofloxacin lactate equivalent to 2mg of ciprofloxacin per mL. The pH of CIPROFLOXACIN solution for infusion is 3.9 ‐ 4.5. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications _Adults _ _Uncomplicated and complicated infections caused by ciprofloxacin sensitive pathogens _ Infections of the lower respiratory tract. In the treatment of outpatients with pneumonia due to _Pneumococcus_, ciprofloxacin should not be used as a medicine of first choice. Ciprofloxacin can be regarded as a suitable treatment for pneumonias caused by _Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, _ _Branhamella, Legionella, _and_ Staphylococcus._ Infections of the kidneys and/or the efferent urinary tract. Infections of the genital organs, including adnexitis, gonorrhoea and prostatitis. Infections of the abdominal cavity (e.g. infections of the gastrointestinal tract or the biliary tract, peritonitis). Infections of the skin and soft tissue. Infections of the bones and joints. Sepsis. Inhalation anthrax (post‐exposure): To reduce the incidence or progression of disease following exposure to aerosolized _Bacillus anthracis_. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. _Children _ For the treatment of acute pulmonary exacerbation of cystic fibrosis associated with_ _ _P. aeruginosa _infection in paediatric patients aged 5 ‐ 17 years. For the indication of inhalational anthrax (post Les hele dokumentet