Tylvalosin-P

Therapeutic indications:

The drug is used for treatment of pigs and poultry (broiler chickens, laying hens, parent stock birds) in case of infectious diseases caused by microorganisms sensitive to tilvalosin.

The drug is administered to poultry in chronic respiratory diseases, ornithobacteriosis, infectious sinusitis, salpingitis, clostridiosis, necrotic enteritis, diarrhea, cholangiohepatitis and other diseases.

In pigs the drug is used in enzootic pneumonia, ileitis (proliferative enteropathy in piglets), dysentery, colitis in piglets, infectious atrophic rhinitis, mycoplasma arthritis, necrotizing enterocolitis and other diseases.

Composition of the veterinary drug:

1 g of the drug contains:

• 625 mg of tilvalosin tartrate.

Pharmacological activity:

TYLVALOSIN-P is an antibacterial drug that belongs to antibiotics of the macrolide group.

The active substance of the drug is tilvalosin. This substance has bacteriostatic effect against Gram-positive and some Gram-negative microorganisms: Staphylococcus spp, Streptococcus spp., Diplococcus spp., Corynebacterium spp., Clostridium spp., Erysipelothrix rhusiopathiae, Moraxella bovis, Klebsiella spp, Fusobacterium necrophorum, Bordetella bronchiseptica, Haemophilus spp., Pasteurella spp., Rickettsia spp., Chlamydia spp., Lawsonia intracellularis, Brachyspira hyodysenteriae. Mycoplasmas are highly sensitive to tilvalosin (Mycoplasma gallisepticum, Mycoplasma meleagridis, Mycoplasma synoviae, Mycoplasma arthritidis, Mycoplasma hyosynoviae, Mycoplasma bovis, Mycoplasma suipneumoniae, Mycoplasma hyopneumoniae and Mycoplasma hyorhinis).

Mechanism of action of tilvalosin is based on suppression of protein biosynthesis in microbial cell at the ribosomal level by inactivation of translocase enzyme. Tilvalosin shows higher antibacterial activity in comparison with other macrolides because its metabolite - 3-acetylisovaleryltilosin is also active against bacteria.

Tilvalosin is well absorbed from the gastrointestinal tract, reaching therapeutic concentration in tissues after 1-2 hours. The highest level of tilvalosin is achieved in lungs, liver, mammary gland and kidneys. Therapeutic concentration of the antibiotic in the blood after a single use is retained in the body for 24 hours. Tilvalosin is excreted from the body in the form of its metabolite 3-acetylisovaleryltilosin mainly with feces (about 70%), to a lesser extent with urine.

Dosage:

The drug is administered orally with feed or drinking water in the following daily doses:

• in pigs: 4-8 mg of the drug per 1 kg of animal body weight (equivalent to 2.5-5 mg of tilvalosin tartrate per 1 kg of animal body weight) for 5-7 days;
• in poultry (broiler chickens, laying hens, parent stock birds): 24-40 mg of the drug per 1 kg of body weight of poultry (equivalent to 15-25 mg of tilvalosin tartrate per 1 kg of body weight) during 3-5 days.

During the period of drug administration prepared solution should be the only source of drinking water for animals and poultry.

Aqueous solution of the drug shall be prepared daily in the volume required for daily consumption.

Precautions and adverse reactions:

If used in accordance with the instructions, the drug usually does not cause side effects. In rare cases (with increased individual sensitivity), animals and poultry may experience allergic reactions (dermatitis, itching, edema) and digestive disorders (vomiting, diarrhea). In this case, the use of the drug is discontinued and antihistamines and symptomatic treatment are prescribed.

Do not use the drug in pigs and poultry with increased individual sensitivity to the components of the drug, as well as with severe liver and kidney dysfunctions.

Do not use the drug in laying hens and young hens less than 2 weeks before the beginning of egg laying due to accumulation of tilvalosin in eggs.

In case of an overdose of the drug, gastrointestinal tract dysfunction and reduced feed intake may occur. In this case, the use of the drug is discontinued and symptomatic treatment is prescribed. There are no specific antidotes.

Do not use the drug simultaneously with penicillins, cephalosporins, lincosamides (clindamycin, lincomycin), amphenicols and rifampicin.

Simultaneous use with bentonite causes a decrease in the activity of the drug.

Tilvalosin has a wide spectrum of compatibility: it potentiates the effect of spiramycin, tetracycline and erythromycin; it is compatible with sulfonamides, aminoglycosides, spectinomycin and eimeriostatics.

After the first administration no peculiarities are revealed.

Avoid missing the next dose of the drug, as it may lead to the reduced therapeutic effect. If administration of the veterinary drug is missed, resume it in the same dosage and according to the same treatment scheme as soon as possible.

Do not use the drug to poultry whose eggs are used for food purposes.

Withdrawal period:

Pigs and poultry should not be slaughtered for human consumption within 3 days after the last drug treatment. Meat of animals and poultry forcibly slaughtered earlier than the specified period expires may be used for feeding carnivores.

Storage conditions:

Store in a dry, dark place at a temperature between +2°C to +25°C.

The drug should be kept out of the reach of children.

Shelf-life:

Shelf-life of the veterinary drug under appropriate storage conditions is 2 years from the date of manufacture, after the first opening of the package - 3 month. The shelf-life of the working solution is 24 hours.