Levofloxacin solution for infusions 500 mg/100 ml. 100 ml. №1

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.

Posology

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.