| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Oral Solution |
| Active Ingredient | : | Tilmicosin phosphate |
| Target Animal | : | Calf, Chicken, Turkey |
| Package Form | : | In 480 ml glass bottles |
COMPOSITION
It is a brownish yellow colored solution containing Tilmicosin phosphate equivalent to 250 mg Tilmicosin per ml.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Tilmicosin is a semisynthetic antibiotic belonging to the macrolide group and alters protein synthesis. It has a bacteriostatic effect but also shows a high intensity bactericidal effect. Its action is directed mainly against Gram (+) microorganisms, some Gram (-) microorganisms and mycoplasmas of bovine, sheep, swine and avian origin. Its spectrum mainly includes the following bacteria;
Calf: Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and M. dispar.
Turkey and chicken: Mycoplasma gallisepticum and Mycoplasma synoviae
Evidence suggests that macrolides work synergistically with the host immune system. Macrolides increase phagocytosis of bacteria.
There is cross-resistance between tilmicosin and other macrolides and lincomycin.
Macrolides act by binding alternately to the 50S ribosomal subunit. Bacterial growth is inhibited by induction of cleavage of peptidyl transfer RNA from the ribosome during the elongation phase.
Ribosomal methylase encoded by the Erm gene can reduce resistance to macrolides by altering the ribosomal binding site. The gene encoding the efflux mechanism, mef, also confers a moderate degree of resistance. Resistance is also mediated by efflux pumps. These pumps are governed chromosomally by genes known as acrAB genes.
Resistance in Pseudomonas species, Gram-negative bacteria, Enterococci and Staphylococci is caused by chromosomal changes in permeability and drug uptake.
Pharmacokinetics Properties
After administration as directed in chickens, turkeys and calves, tilmicosin is rapidly absorbed and transported to non-serum sites with low pH. This results in low serum concentrations but reaches levels detectable in lung tissues 6 hours after the start of treatment. In turkeys and chickens, tilmicosin can also be detected in the air sacs.
When given orally to calves, it reaches detectable levels in the lungs after 6 hours and maintains a therapeutic dose for up to 60 hours after the last dose.
AREA OF USE/INDICATIONS
It is used for treatment and prevention of respiratory system infections caused by Mycoplasma gallisepticum, Mycoplasma synovia in broiler chicken and turkeys.
It is used for treatment and prevention of respiratory system infections caused by Mannheima haemolytica, Pasteurella multocida, Mycoplasma bovis and Mycoplasma dispar in calves.
USAGE AND DOSAGE
It is administered only orally. It should be mixed with water or milk before use.
It should be mixed with drinking water for broiler chicken and turkey, mixed with milk for calves.
Broiler chickens: 15 – 20 mg/kg body weight/day (6 – 8 ml product for 100 kg body weight) for 3 days.
Turkeys: 10 – 27 mg/kg body weight/day (4 – 11 ml product for 100 kg body weight) for 3 days.
Calves: 12.5 mg/kg body weight (1 ml product for 20 kg body weight) twice a day for 3-5 days.
Medicated water should prepared every 24 hours. If there is no change in disease symptoms within 3 - 5 days, the diagnosis should be re-evaluated and treatment changed. The weight of the animals should be calculated as accurately as possible to avoid underdosing. The uptake of medicated water by animals may vary according to clinical condition, age, sex and ambient temperature. Therefore, the concentration of the medicated water may need to be adjusted to ensure the correct dose. The use of appropriately calibrated weight measuring equipment is recommended. Ensure that all animals to be treated have easy access to medicated water sources. Medicated water should be the only source of water for animals during treatment
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
It should be properly diluted before use.
As a result of the disease, changes in the intake of medicated water may occur. This should be monitored continuously and the medicated water should be reconstituted if the dose administered is not sufficient for the required intake. If the medicated water intake is insufficient, alternative treatments, preferably parenteral, may be required.
Use of this product other than as directed may result in the development of tilmicosin-resistant bacteria and may reduce the effectiveness of treatments with tilmicosin or related substances.
This product should be used in accordance with official, national and regional antimicrobial policies and the results of susceptibility testing.
Not for injection.
Use during pregnancy and lactation: Fertility has not been studied in animals intended for breeding.
ADVERSE EFFECTS
Decrease in water intake has been observed very rarely.
DRUG INTERACTIONS
Cross-resistance has been observed between tilmicosin and other macrolides and lincosamides. Tilmicosin may reduce the antibacterial activity of betalactam antibiotics. Do not use together with bacteriostatic antibacterials.
Do not mix with other medicinal products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Broiler chickens treated with 375 mg /liter for 5 days did not show overdose symptoms, broiler chickens treated with 75 mg /liter for 10 days showed softening of feces.
Turkeys treated with 375 mg /liter for 3 days did not show overdose symptoms, turkeys treated with 75 mg/liter for 6 days did not show overdose symptoms.
In calves, 5 times the recommended dose given twice daily during the treatment period did not cause overdose symptoms except for a slight decrease in milk intake.
WITHDRAWAL PERIODS
Meat: 12 days for broiler chicken, 19 days for turkey, 42 days for calves.
It is not used in chicken and turkey from which egg is obtained for human consumption. It should not be used in the 14-day period before the start of laying.
CONTRAINDICATIONS
Prevent horses and other equides animals from accessing medicated water containing tilmicosin and do not use in these species.
Do not use in animals known to be sensitive to tilmicosin or excipients.
Do not use in cases where resistance to tilmicosin has been detected
GENERAL WARNINGS
Consult a veterinarian before use and if any unexpected effects are observed. Keep out of reach of children and away from foodstuffs.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
People sensitive to tilmicosin should avoid contact with the product. Skin contact with the product may cause sensitization and irritation. In some cases, hypersensitivity reactions may be serious. Therefore, avoid skin and eye contact. Wear protective clothing and gloves during handling/preparation of the product, do not consume anything, do not smoke. In case of skin or eye contact, rinse the area with plenty of water. If irritation persists or if accidentally ingested by mouth, seek immediate medical treatment and call the National Poison Center because of potentially serious problems with the heart. (Tel. No.: 114; Cemal Gürsel Cad. No: 18 Sıhhiye/ANKARA; [email protected]).
STORAGE CONDITIONS AND SHELF LIFE
Before and after opening, the product should be stored in the original packages, protected from light, below 25°C, without refrigeration or freezing. The shelf life is 2 years. After opening, it should be used within 90 days.
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
Unused veterinary medicinal product or waste materials resulting from the use of this product should be disposed of as medical waste according to the relevant legislation. Injection of
tilmicosin may be lethal for dogs, horses, pigs, monkeys and goats. In dogs, it causes tachycardia and decreased contractility
COMMERCIAL PRESENTATION FORM
480 ml amber colored glass bottle with cardboard box.
PLACE AND CONDITIONS OF SALE
It is sold in pharmacies and veterinary clinics with a veterinarian's prescription. (VHP)
APPROVAL DATE OF LEAFLET: 04.03.2025
MARKETING AUTHORIZATION DATE AND NO: 08.10.2007 – 028/0101
NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER
VİLSAN Veteriner İlaçları Ticaret ve Sanayi A.Ş.
Balıkhisar Mah. Balıkhisar Köy içi Küme Evleri No: 765A Akyurt/Ankara – Türkiye
MANUFACTURER COMPANY
VİLSAN Veteriner İlaçları Ticaret ve Sanayi A.Ş.
Balıkhisar Mah. Balıkhisar Köy içi Küme Evleri No: 765A Akyurt/Ankara – Türkiye
Made in Turkiye
