Assign to adults for the treatment of infections caused by microorganisms sensitive to the drug: community-acquired pneumonia; complicated skin and soft tissue infections; (For the above-mentioned infections, Levofloxacin should only be used when the use of other antibacterial agents that are usually recommended for the initial treatment of these infections is impractical or impossible); pyelonephritis, complicated urinary tract infections; chronic bacterial prostatitis.
Levofloxacin Qualitative and quantitative composition
Each 50 ml vial (5 mg/ml solution) contains 250 mg of levofloxacin as levofloxacin hemihydrate.
Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as levofloxacin hemihydrate.
Excipients with known effect:
50 ml of solution for infusion contain 7.7 mmol (177 mg) sodium
100 ml of solution for infusion contain 15.4 mmol (354 mg) sodium.
For the full list of excipients, see section 6.1
Solution for infusion
Clear greenish-yellow isotonic solution
Ibigen solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
In complicated skin and soft tissue infections Levofloxacin Ibigen should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Acute pyelonephritis and complicated urinary tract infections (see section 4.4)
• Chronic bacterial prostatitis
• Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin Ibigen after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC of an appropriate oral presentation and as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Levofloxacin Ibigen solution for infusion must not be used:
• in patients hypersensitive to levofloxacin or any other quinolone or to any of the excipients listed in section 6.1
• in patients with epilepsy
• in patients with history of tendon disorders related to fluoroquinolone administration
• in children or growing adolescents
• during pregnancy
• in breast-feeding women