Instruction for use of Azitronit

I. General information

1. Tradename of the veterinary medicinal product: Azitronit.

International nonproprietary name: azithromycin.

2. Azitronit is a clear solution from colorless to yellow color.

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

The use of the drug Azitronit after the expiration date is prohibited.

3. Azitronit is available in 100 ml glass vials, sealed with aluminum caps and first opening control clips.

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°С to 25°С.

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

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

7. The veterinary drug Azitronit is available without veterinary prescription.

II. Сomposition

8. Pharmaceutical form: solution for injections

1 ml of Azitronit contains azithromycin 100 mg, lidocaine hydrochloride 10 mg as active substances and excipients – up to 1 ml.

III. Pharmacological properties

9. The veterinary medicinal product Azitronit is a macrolide antibiotic.

10. Azithromycin, as an active part of Azitronit – an antibiotic of macrolide group, azalides subdivision, broad-spectrum, taking bacteriocidal / bacterial growth-inhibitory effect on gram-negative (Actinobacillus lignieresi, Haemophilus spp, Moraxella spp, Bordetella spp, Campylobacter spp, Legionella pneumophila, Salmonella spp, Escherichia spp) and gram-positive bacteria (Listeria spp, Staphylococcus aureus, Staphylococcus spp, Streptococcus spp, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Erysipelothrix insidiosa) and some anaerobic bacteria (Сlostridium perfringens, Fusobacterium spp), Pasteurella (Mannheimia) haemolytica, Pasteurella multocida, Haemophilus parasuis, micoplasma (Mycoplasma pneumoniae), Chlamydia pneumoniae, spirochetes (Borrelia spp.).

Azithromycin mode of action is connected with inhibition of protein biosynthesis by bacteria ribosome (peptide bonds between amino acids and peptide chain is getting broken).

Azithromycin exerts postantibiotic effect – persistent inhibition of bacterial activity after their short-term contact with anti-infective medicinal product. The basis of the effect consists of irreversible changes in microorganism ribosome this translates to stable translocation block. Due to this general antibacterial action of the veterinary medicinal product is getting strengthened and extended, lasting for the term, required for resynthesis of new functional protein of microbial cell.

Azithromycin absorbs well and splits up in body tissues, reaching high concentration, which is in large excess over blood plasma concentration. High antimicrobial activity is achieved due to azithromycin ability to penetrate and accumulate intracellularly in leucocytes (polymorphonucleocytes and monocytes / macrophages), by which it is transported to area of inflammation, which results in antibiotic concentration 6 times higher in area of inflammation in comparison to intact tissue.

Lidocaine belongs to the local anesthetic drugs. The mechanism of local anesthetic effect is to stabilize the neuronal membrane, reducing its permeability to sodium ions, thus preventing action potential and conduction of impulses. Antagonism with calcium ions is possible. Rapidly hydrolyses in the weak alkaline medium of tissue and is valid for 60-90 min after a short latent period. The activity is reduced if inflammation (tissue acidosis) occurs. Effective in all types of local anesthesia. Dilates blood vessels. Not irritates tissue.

After intramuscular administration absorbs quickly (5-15 min), 50-80% is associated with proteins in the plasma, distributed in well-perfused organs, including kidneys, lungs, liver, heart, and penetrates into adipose tissue. Lidocaine is metabolized in the liver. About 90% of the administered dose is excreted in the form of metabolites and 10% is unchanged, the predominant route of excretion is by the kidneys.

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

IV. Administration procedure

11. Azitronit is used in cattle, sheep and swine for treatment of bacterial infection of respiratory system, gastrointestinal and genito-urinary system, and also infection of skin and soft tissues, caused by microorganism sensitive to azithromycin, for therapy of necrobacillosis, swine erysipelas, spirochetosis and mycoplasmal infections.

12. Contraindications include administration of the product to the animals with nephritic and hepatic decompensation, and also in case of hypersensibility to macrolide antibiotics.

13. The veterinary medicinal product Azitronit is administered to cattle, sheep and swine intramuscularly in a dose of 1 ml per 20 kg of body weight (5 mg of azithromycin per 1 kg of body weight) once a day during 2 days. If necessary injection should be repeated.

14. Overdose of the medicinal product results in psychic tension, sleep disturbance, disorientation, temporary hearing loop, liver enzyme increase. In this case it is necessary to stop the administration. There is no specific detoxication remedy, general supportive measures, intended to the veterinary medicinal product excretion and symptomatic therapy should by applied.

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

16. It is forbidden to administer the veterinary medicinal product to lactating females, administration to settled animals and growing stock is allowed judiciously, under the control of a veterinary physician.

17. Avoid missing prescribed dose administration as this may reduce treatment effectiveness. When a dose is missed, continue to administer the product in the same dose and according to the same schedule. It is not allowed to administer double dosage to compensate missed.

18. No adverse reactions were observed at the administration of Azitronit if administered subject to the instructions for use. Oedema may occur at the injection site, it soon cures and does not require treatment. In case of stable allergic response the veterinary medicinal product should be cancelled, antihistamine and symptomatic therapy is recommended.

19. Medicinal product interaction: tetracycline and chloramphenicol – potentize (synergism), lincosamides – reduce the effect. It is unsuitable for heparin. It increases toxicity of cardiac glycoside.

The veterinary medicinal product Azitronit should not be mixed with the other veterinary medicinal products in the same syringe.

20. The slaughter of cattle and sheep is allowed no earlier than 45 days, swine – 35 days after the last administration of Azitronit. Meat of animals, compulsorily slaughtered until the indicated period, can be used to feed fur-bearing animals.

 

V. Special precautions for use

21. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Azitronit.

22. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.

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 Azitronit for domestic purposes is prohibited; they must be disposed of along with household waste.