Levofloxacin-Novopharm solution for infusion 5 mg/ml bottle 100 ml No. 1




Levofloxacin-Novopharm solution for infusion is indicated for infections caused by sensitive microorganisms:
acute bacterial rhinosinusitis; exacerbation of chronic obstructive pulmonary disease, including bronchitis; community-acquired pneumonia; complicated skin and soft tissue infections; uncomplicated cystitis; acute pyelonephritis and complicated urinary tract infections; chronic bacterial prostatitis; pulmonary anthrax: post-exposure prophylaxis and treatment.Composition
Active ingredient: levofloxacin hemihydrate;
1 ml of levofloxacin hemihydrate equivalent to levofloxacin 5 mg;
Excipients: sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injections.
Contraindication
Hypersensitivity to levofloxacin, other quinolones, or any component of the drug.Adverse reactions from tendons after previous use of quinolones.
Epilepsy. Age under 18 years. Pregnancy and breastfeeding.Method of application
The drug is administered intravenously slowly 1 or 2 times a day. The dosage depends on the type and severity of the infection, as well as the sensitivity of the possible pathogen to the drug. Treatment with levofloxacin after the first use of its intravenous form can be completed by using the oral form, provided that such treatment is acceptable for the individual patient. Given the bioequivalence of parenteral and oral dosage forms, the same dose can be used.
Application features
Pregnant women
The drug is contraindicated during pregnancy or breastfeeding. If pregnancy is diagnosed during treatment, the doctor should be informed.
Children
The use of the drug is contraindicated in children (under 18 years of age), as damage to articular cartilage cannot be ruled out.
Drivers
Patients who drive vehicles, work with machines and mechanisms should take into account possible adverse reactions from the nervous system (dizziness, drowsiness, confusion, visual and hearing impairment, movement disorders, including while walking).
Overdose
The most important expected symptoms of overdose concern the central nervous system (dizziness, impaired consciousness and convulsions); gastrointestinal reactions such as nausea and erosion of the mucous membranes. When using doses exceeding therapeutic, there is a prolongation of the QT interval. In case of overdose, careful monitoring of the patient, including ECG, is necessary.
Side effects
Infections and infestations. Uncommon: fungal infections, including Candida infections. Resistance of pathogenic microorganisms. Psychiatric disorders. Common: insomnia. Uncommon: anxiety, confusion, nervousness. Nervous system disorders. Common: headache, dizziness. Vascular disorders. Common: phlebitis (only for intravenous forms of administration). Hepatobiliary disorders. Common: increased activity of liver enzymes (ALT/AST, alkaline phosphatase, GGT). General disorders and administration site conditions. Common: infusion site reaction (pain, redness).Interaction
Clinical pharmacology studies have demonstrated that no clinically significant effect on the pharmacokinetics of levofloxacin was caused when levofloxacin was used together with the following drugs: calcium carbonate, digoxin, glibenclamide, ranitidine.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
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