1. Tradename of the veterinary medicinal product: Amoxicillin 150.
International nonproprietary name: amoxicillin.
2. Amoxicillin 150 is an oily, white to light yellow suspended mixture. The bundle of the suspension that may form during storage disappears when shaking. Shelf-life of the medicinal product under specified conditions is 4 years from the date of manufacture, after first opening – 28 days. The use of the Amoxicillin 150 after the expiration date is prohibited.
3. Amoxicillin 150 is available in 50, 100 and 250 ml capacity glass vials sealed with rubber stoppers and rolled 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 °C to 25 °C.
5. Amoxicillin 150 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 Amoxicillin 150 is available without veterinary prescription.
8. Pharmaceutical form: suspension for injection.
1 ml of Amoxicillin 150 contains 150 mg of amoxicillin trihydrate as an active substance, and excipients – up to 1 ml.
9. Amoxicillin 150 is an antibacterial medicinal product of the group of semisynthetic penicillins.
Amoxicillin trihydrate, which is part of the drug, is a semisynthetic penicillin antibiotic and has a broad spectrum of antimicrobial action; is active against most Gram-positive and Gram-negative microorganisms, including Actynomyces spp., Bacillus anthracis, Clostridium spp., Corynebacterium spp., Erysipelothrix rhusiopathiae, Listeria monocytogenes, Staphylococcus spp., Escherichia coli, Haemophilus spp., Pasteurella spp., Salmonella spp ., Streptococcus spp, Actinobacillus spp., Proteus mirabilis, Leptospira spp. The mechanism of action of the antibiotic is a violation of mucopeptide synthesis, a component of the cell wall of microorganisms by inhibiting enzymes of transpeptidase and carboxypeptidase, which leads to disruption of osmotic balance and bacterial cell destruction. After parenteral administration of the drug the maximum concentration in serum amoxicillin trihydrate is attained after 1-2 hours and held at therapeutic levels for 48 hours. The antibiotic is derived from the organism with urine and feces primarily in unmodified form.
By the degree of its effect on the body, Amoxicillin 150 is classified as a moderately hazardous substance (hazard class 3 as per GOST 12.1.007).
10. Amoxicillin 150 is used for the treatment of cattle, sheep, goats, swine with infectious diseases of the gastrointestinal tract, respiratory tract, urinary tract, joints, soft tissue and skin, necrobacteriosis, umbilical infection, atrophic rhinitis, metritis-mastitis-agalactia syndrome and other primary and secondary infections of bacterial etiology, pathogens which are sensitive to amoxicillin.
11. Contraindications include individual sensitivity of animals to penicillin antibiotics.
12. The drug is administered to cattle, sheep, goats and swine intramuscularly or subcutaneously at a dose of 1 ml per 10 kg of animal weight. If necessary, the drug may be administered repeatedly in 48 hours. Before applying, the suspension shall be carefully shaken.
The maximum amount of injection of Amoxicillin 150 in one place should not exceed 20 ml for cattle, 10 ml for swine, 5 ml for sheep, goats, calves.
13. Overdose of the medicinal product results in depression, disturbance of gastrointestinal function, swelling at the injection site.
14. No specific actions were reported at the first use and discontinuance of the drug.
15. 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.
16. No adverse reactions were observed at the administration of Amoxicillin 150 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.
17. Mixing Amoxicillin 150 with other drugs in the same syringe is prohibited.
18. The slaughter of animals for meat is allowed no earlier than 28 days after the last administration of Amoxicillin 150. 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.
19. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Amoxicillin 150. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.
20. People with hypersensitivity to the drug components should avoid direct contact with Amoxicillin 150. 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).
21. Use of the empty vials of Amoxicillin 150 for domestic purposes is prohibited; they must be disposed of along with household waste.
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