TYLOCYCLINVET ® (powder for oral use)

Powder from light yellow to dark yellow in colour.

1 g of the product contains the active substances:

- doxycycline hyclate — 100,0 mg;

- tylosin tartrate — 100,0 mg.

Excipients: citric acid, sorbitol.

ATC vet classification code QJ01 - antibacterial veterinary medicinal products for systemic use. QJ01RA90 - Tetracyclines, combinations with other antimicrobial agents.

TYLOCYCLINVET is a combination product containing doxycycline and tylosin.

Doxycycline is a bacteriostatic antibiotic belonging to the tetracycline group. It acts on bacterial ribosomes, inhibiting protein synthesis. It is characterised by a broad spectrum of antimicrobial activity against Gram-positive (Staphylococcus spp., Diplococcus pneumoniae, Streptococcus spp., Pneumococcus spp., Bacillus anthracis, Clostridium tetani, Clostridium perfringens, Listeria monocytogenes, Actinomyces spp.) and Gram-negative (Haemophilus influenzae, E. coli, Enterobacter spp., Klebsiella spp., Salmonella spp., Shigella spp., Yersinia spp.) bacteria, as well as mycoplasmas (Mycoplasma spp.), rickettsiae (Rickettsia spp.) and chlamydiae (Chlamydia spp.).

Tylosin is a macrolide antibiotic active against gram-negative (Neisseria spp., Bacteroides nodosus, Moraxella bovis, Pasteurella spp., Spirochaetes spp.) and gram-positive (Staphylococcus spp., Streptococcus spp., Diplococcus spp., Corynebacterium spp., Clostridium spp., Erysipelothrix rhusiopathiae) microorganisms. Mycoplasmas (Mycoplasma gallisepticum, M. hyopneumoniae, M. synoviae, M. meleagridis, M. agalactiae, M. bovigenitalium), as well as chlamydiae (Chlamydia spp.) and rickettsiae (Rickettsia spp.) are particularly susceptible to tylosin.

The mechanism of action of tylosin consists in blocking protein synthesis in the bacterial cell by forming a complex with the 50S ribosomal subunits.

Following oral administration, doxycycline is well absorbed from the gastrointestinal tract. It is widely distributed in the tissues and fluids of the body. Half of the administered dose is absorbed within 50 minutes. When doxycycline is administered together with feed, the presence of feed in the intestine reduces the bioavailability of doxycycline by 20%. Elimination half-life in cattle is 4.3–9.7 hours, 6.7 hours in pigs, 3.6 hours in sheep and 4.8 hours in chickens. Doxycycline penetrates virtually all organs and tissues; however, the highest levels are observed in the lungs, liver, bile, reproductive organs and kidneys. Doxycycline is detected in cerebrospinal fluid at low concentrations, but its concentration does not reach therapeutic levels. Peak doxycycline concentration in the blood of animals is reached within 2–4 hours, and the therapeutic concentration is maintained for 18–24 hours. Doxycycline is eliminated from the body primarily via bile.

Peak tylosin concentration in the blood serum of animals is observed one hour after oral administration. The therapeutic concentration is maintained in the body for 10 to 12 hours. Tylosin penetrates virtually all organs and tissues; however, the highest levels are observed in the lungs, liver, mammary glands and kidneys. It is eliminated from the body unchanged, primarily via bile and, partially, via urine and milk.

Calves aged 4 to 8 weeks, pigs: treatment of animals with septicaemia, as well as diseases of the respiratory tract (bronchopneumonia, enzootic pneumonia, atrophic rhinitis), gastrointestinal tract (colibacillosis, salmonellosis), caused by microorganisms susceptible to doxycycline and tylosin.

Poultry (chickens, broiler chickens): treatment of birds with colibacillosis, salmonellosis, chlamydiosis, septicaemia, as well as respiratory tract diseases caused by microorganisms susceptible to doxycycline and tylosin.

- pigs - 1 g of the product (equivalent to 100 mg doxycycline hyclate and 100 mg tylosin tartrate) per 1 L of drinking water daily for 3–5 days, or 1 g per 10 kg body weight (corresponding to 10 mg doxycycline hyclate and 10 mg tylosin tartrate per 1 kg body weight of the animal);

- calves aged 4 to 8 weeks - 1 g of the product (equivalent to 100 mg doxycycline hyclate and 100 mg tylosin tartrate) per 10 kg body weight once daily for 3–5 days.

- poultry (chickens, broiler chickens) - 1 g of the product (equivalent to 100 mg doxycycline hyclate and 100 mg tylosin tartrate) per 1 L of drinking water daily for 3–5 days.

Depending on the severity of the disease, the initial dose may be doubled at the discretion of the veterinarian.

Skipping a scheduled dose should be avoided, as this may lead to a reduction in therapeutic efficacy.

Hypersensitivity to doxycycline and tylosin or to any of the excipients.

Do not use in laying hens producing eggs for human consumption, or in ruminants with functional rumen.

Do not administer to animals with impaired hepatic or renal function.

Do not administer concurrently with penicillins, cephalosporins, quinolones or lincomycin, as this reduces the antibacterial effect.

Do not use concurrently with non-steroidal anti-inflammatory drugs.

Do not use in animals for prophylactic purposes or in cases of direct or cross-resistance of microorganisms.

In rare cases (in animals sensitive to tetracyclines and tylosin), allergic reactions may occur (skin rash, pruritus and oedema). If these occur, administration of the product should be discontinued and desensitisation therapy initiated.

In young animals, the product may cause discolouration of bones and teeth to yellow, brown or grey.

High doses and prolonged use may retard bone growth.

The product may cause photosensitisation and a hepatotoxic effect.

The recommendations stated in the package insert must be strictly observed. Animals undergoing treatment should not be kept in direct sunlight.

Prior to administration of the product, it is recommended to perform a susceptibility test of microorganisms isolated from diseased animals to doxycycline and tylosin.

The product is not recommended for use in pregnant animals due to the possibility of teratogenic effects, delayed development of skeletal tissues in the embryo and discolouration of deciduous teeth.

The product should only be used following a benefit/risk assessment by a veterinarian.

When used concomitantly with products containing divalent and trivalent cations such as Mg²⁺, Al³⁺, Ca²⁺, Zn²⁺, Bi²⁺, Fe³⁺, these may bind to doxycycline and impair its absorption. Absorption of doxycycline may be reduced when used concomitantly with antacids or kaolin. When used concomitantly with anticoagulants, dose adjustment of the latter is required, as the product suppresses plasma prothrombin activity.

Slaughter of poultry for meat is permitted 7 days, pigs - 8 days, calves - 14 days after the last administration of the product. Meat obtained before the specified withdrawal period shall be disposed of or fed to non-productive animals, subject to the conclusion of a veterinarian.

Polyethylene film or other polymer film pouches of 1, 2, 10, 50, 100, 500 g and 1 kg. Polymer containers of 100, 500 g and 1 kg.

Store in a dry, dark place, out of reach of children, at a temperature of 5 to 25 °C.

2 years.

Shelf life after first opening the immediate packaging - 28 days.

Shelf life after dilution in drinking water according to directions - 24 hours.

Shelf life after incorporation into medicated feed - 36 hours.