Instruction for use of Lexoflon

I. General information

1. Tradename of the veterinary medicinal product: Lexoflon.

International nonproprietary name: levofloxacin.

2. Lexoflon is a clear greenish-yellow to yellow solution.

Shelf-life of the medicinal product under specified conditions is 2 years from the date of manufacture, after first opening – 28 days. The use of the Lexoflon after the expiration date is prohibited.

3. Lexoflon is available in 100 ml glass vials closed with rubber stoppers and sealed with aluminum caps with tamper proof clamps. Vials are packed into individual carton packages.

4. The veterinary medicinal product is stored in sealed original package, separately from food and feed, in a dry place, protected from direct sunlight, storage temperature range: 5 °C to 25 °C.

5. Lexoflon should be kept out of reach of children.

6. Unused drug shall be disposed of in accordance with the applicable legislation.

7. The veterinary medicinal product Lexoflon is available without veterinary prescription.

II. Сomposition

8. Pharmaceutical form: solution for injections.

1 ml of Lexoflon contains 150 mg of levofloxacin (in the form of hemihydrate) as an active substance, hydrochloric acid and water for injections as excipients.

III. Pharmacological properties

9. Lexoflon is an antibacterial medicinal product.

10. Levofloxacin contained in the medicinal product is a broad-spectrum antibiotic from the fluoroquinolones group providing bactericidal effect against aerobic Gram-positive microorganisms (including Enterococcus spp., Listeria monocytogenes, Staphylococcus spp. (including Staphylococcus aureus), Streptococcus spp.); aerobic Gram-negative microorganisms (including Acinetobacter spp., Campylobacter spp., Enterobacter spp., Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp., Moraxella catarrhalis β+/β-, Morganella morganii, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas spp., Salmonella spp., Serratia spp.); anaerobic microorganisms (including Bacteroides fragilis, Clostridium perfringens, Fusobacterium spp., Peptostreptococcus), as well as other microorganisms: Chlamydia pneumoniae, Chlamydia psittaci, Mycobacterium spp., Mycoplasma pneumoniae, and Ricketsia spp.

Levofloxacin’s mechanism of action involves blocking DNA-gyrase (topoisomerase II) and topoisomerase IV, disruption of supercoiling and cross-linking of deoxyribonucleic acid breaks, inhibiting deoxyribonucleic acid synthesis, profound metabolic alterations in cytoplasm, cell walls and membranes.

Levofloxacin is quickly and almost completely absorbed after parenteral administration. Bioavailability of levofloxacin is 99%, concentration in the blood serum reaches its peak in 2 hours after administration, half-life is about 7 hours. Levofloxacin easily penetrates into organs and tissues: lungs, bronchial mucosa, phlegm, genitourinary organs, polymorphonucleocytes, alveolar macrophages. It is mainly eliminated from the body by the kidneys by way of glomerular filtration or tubular secretion. Levofloxacin is mostly excreted unhanged with urine within 48 hours. In lactating animals, it is excreted in milk. A trace amount was found in feces in 72-hour period.

By the degree of its effect on the body, Lexoflon is classified as a low-hazard substance (4th hazard category according to the GOST- 12.1.007-76).

IV. Administration procedure

11. Lexoflon is used for the treatment of pigs and cattle with bacterial diseases of respiratory organs, digestive system, obstetric-gynecologic diseases like metritis and mastitis, obstetric infections of sows (metritis, mastitis, agalaxia), surgical diseases, including soft tissue infections (abscesses, phlegmons) caused by pathogens susceptible to levofloxacin, including colibacillosis, pasteurellosis, salmonellosis, staphylococcosis and mycoplasmal infections.

Lexoflon is applied for therapeutic and preventive purposes in pigs and cattle to treat bacterial infections in epidemiologically concerned farms in case of detection of diseased animals.

12. It is forbidden to use the drug in hepatic and renal failure, as well as in hypersensitivity to fluoroquinolones.

13. Lexoflon is injected to animals intramuscularly in the following dosage:

– to cattle, pigs in the dosage of 1.0 mL per 30 kg of animal body weight (5.0 of levofloxacin per 1 kg of animal body weight), daily during 3-5 days.

14. Overdose of the medicinal product results in anxiety, disorientation, loss of appetite, nausea, diarrhea; rarely: tendon damage (including tendinitis), joint and muscular pains. In this case, administration of the medical drug must be discontinued. There are no specific detoxification measures; therefore, common measures are applied aimed at drug elimination from the body, and supportive care means. In case of anaphylactic shock, it is forbidden to inject corticosteroids to animals, it is recommended to use other antihistaminic agents instead (tavegil, suprastin).

15. No specific actions were reported at the first use and discontinuance of the drug.

16. It is forbidden to apply Lexoflon in pregnant animals. It is allowed to apply the drug to youngsters and lactating animals. ??

17. Avoid missing prescribed dose administration as this may reduce the treatment effectiveness. When a dose is missed, continue to administer the product in the same dose and according to the same schedule.

18. No adverse reactions were observed at the administration of Lexoflon if administered subject to the instructions for use. In rare cases, some animals may develop swelling at the injection site, which resolves within 1-2 days.

In the case of allergic hypersensitivity to Amoxicillin, the drug use shall be terminated; antihistamines and symptomatic treatment should be prescribed.

19. It is forbidden to apply the drug simultaneously with glucocorticoids due to the increased risk of tendinitis development and/tendon tear, as well as with non-steroidal anti-inflammatory drugs, tetracyclines and macrolides due to the increased toxic effect of levofloxacin. There is an increased risk of hemorrhage during simultaneous use with vitamin K antagonists, e.g. warfarin. Considering this fact, it is necessary to control coagulation parameters. It is not recommended to use levofloxacin simultaneously with ethanol.

20. The slaughter of pigs and cattle for meat is allowed at least 9 days after the last application of the drug. . Meat from animals slaughtered before the expiry of the specified period may be used as feed to fur animals. Milk dairy animals may be used for food not earlier than 96 hours after the last injection. Milk obtained during treatment and within 96 hours after the last injection may be used after boiling in animal feed.

21. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Lexoflon. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.

22. People with hypersensitivity to the drug components should avoid direct contact with Lexoflon. If product accidentally comes in contact with mucous membranes, flush them with water. In the case of allergic reactions or accidental ingestion of the product, you should contact your medical facility (you should take the instructions for use of the product or the product label with you).

23. Use of the empty vials of Lexoflon for domestic purposes is prohibited; they must be disposed of along with household waste.