GATINOL (oral solution)

Liquid from light yellow to dark yellow in colour; a slight sediment may occur.

1 ml of the product contains active substances:

- gatifloxacin – 50 mg;

- colistin sulfate – 1 200 000 IU;

- trimethoprim – 50 mg.

Excipients: lactic acid, purified water.

ATCvet code QJ01 – antibacterial veterinary medicinal products for systemic use.

GATINOL is a combination product containing three active substances. As a result of the synergistic action of the active substances, the activity of the product is significantly higher than that of its individual components.

Gatifloxacin is an antibiotic of the fluoroquinolone group with a broad spectrum of antibacterial activity against most gram-positive (Staphylococcus aureus, Streptococcus pneumoniae (including both penicillin-susceptible and penicillin-resistant strains)) and gram-negative (E. coli, Haemophilus influenzae and others) microorganisms. Its mechanism of action is associated with inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an important enzyme involved in bacterial DNA replication. Topoisomerase IV is an enzyme necessary for replication, transcription and repair of bacterial DNA, mainly in gram-positive bacteria.

Colistin is an antibiotic of the polymyxin group synthesized by the aerobic spore-forming rod Bacillus polymyxa. The mechanism of action of colistin consists in disruption of the integrity of the cytoplasmic membrane of microorganisms. It interacts with phospholipids and penetrates inside, destroying the structure of the cell membrane. Permeability of the bacterial membrane changes immediately after contact with colistin. In addition to antibacterial action, colistin binds lipid A and neutralizes the biological effect of bacterial endotoxin. Colistin is effective mainly against gram-negative microorganisms such as: E. coli, Salmonella spp., Shigella spp., Proteus spp., Pseudomonas aeruginosa, Klebsiella pneumoniae, Bordetella spp.

Trimethoprim is a broad-spectrum antimicrobial agent of the diaminopyrimidine group. Trimethoprim has antimicrobial activity against gram-positive (Staphylococcus spp., Streptococcus spp., Haemophilus spp., Chlamydia spp.) and gram-negative (E. coli, Klebsiella spp., Salmonella spp., Pasteurella spp., Enterobacter spp., Proteus spp., Shigella spp.) microorganisms, and it also acts on Toxoplasma and coccidia. The mechanism of action is associated with inhibition of bacterial dihydrofolate reductase.

After oral administration, gatifloxacin is widely distributed in the body tissues and fluids. The bioavailability of gatifloxacin is 96%. Its Cmax in the blood plasma of pigeons is reached 1–2 hours after oral administration. Binding of gatifloxacin to plasma proteins is approximately 20% and does not depend on concentration. Due to the rapid distribution of gatifloxacin, its concentration in most tissues of the pigeons’ body is higher than in blood serum. The mean half-life of gatifloxacin is 7 to 14 hours and does not depend on the dose and regimen of administration. Gatifloxacin is excreted mainly in the urine.

After oral administration, colistin is practically not absorbed from the gastrointestinal tract, therefore a high concentration of the antibiotic is created in the intestine. Colistin does not accumulate in organs and tissues. It is excreted from the body mainly unchanged with faeces, and a small amount is excreted in urine.

Trimethoprim is well absorbed from the gastrointestinal tract of parrots, canaries and pigeons after oral administration. In case of inflammation of the meninges, the concentration of the product may reach 50% of the concentration in blood serum. The maximum antibacterial concentration in the blood of pigeons is observed 3–4 hours after administration and is maintained at a therapeutic level for 24 hours. The half-life is 8–10 hours. It is metabolised in the liver and excreted mainly by the kidneys via glomerular filtration and active tubular secretion. The concentration of trimethoprim in urine is significantly higher than in blood. It is excreted from the body mainly in urine.

Treatment of pigeons, parrots and canaries suffering from chronic respiratory diseases, pseudomoniasis (Pseudomonas infections), colibacillosis, salmonellosis, staphylococcal infections, as well as diseases of the digestive tract caused by microorganisms sensitive to gatifloxacin, colistin and trimethoprim.

Administer orally at a dose of 0,5 ml of the product per 1 l of drinking water (25 mg of gatifloxacin, 600 000 IU of colistin, 25 mg of trimethoprim per 1 l of drinking water), which corresponds to 3 mg of gatifloxacin, 72 000 IU of colistin, 3 mg of trimethoprim per 1 kg of body weight. The treatment course is 3–5 days.

In severe forms of diseases and in cases of salmonellosis, the dose is increased by 50% and administered for 5–7 days.

Shake the ampoule or vial with the product before use.

During the treatment period, the birds should receive only water containing the product. Prepare a fresh solution of the product daily in a volume calculated for consumption during the day.

Hypersensitivity to the components of the product.

Do not administer to food-producing animals!

Do not administer concomitantly with tetracyclines, chloramphenicol, cyclosporine, macrolides, ampicillin, cephalosporins and aminoglycosides.

Do not administer together with non-steroidal anti-inflammatory drugs.

Do not administer concomitantly with products containing Mg2+, Al3+, Ca2+ cations.

At the recommended doses, adverse reactions are generally not observed. If adverse reactions occur (itching, muscle tremor), administration of the product should be discontinued and desensitizing therapy should be administered.

Use of this product must be discontinued when bacterial (pathogen) resistance to the active substances of the product is detected; microbiological confirmation of the diagnosis and antimicrobial susceptibility testing of the bacteria should be carried out before prescribing the product.

Not established.

The safety of the product in target bird species during the laying period has not been investigated. Therefore, the product should be used only after a benefit/risk assessment by the responsible veterinarian.

Do not administer concomitantly with tetracyclines, chloramphenicol, cyclosporine and macrolides due to the risk of toxicity.

Do not administer the product concomitantly with ampicillin, cephalosporins and aminoglycosides due to a marked decrease in the antibacterial effect of colistin.

Do not administer together with non-steroidal anti-inflammatory drugs due to an increased risk of CNS stimulation and seizures.

Do not administer concomitantly with products containing Mg2+, Al3+, Ca2+ cations, as the latter bind gatifloxacin and prevent its absorption.

It is not recommended to mix the product with other medicinal products.

Glass ampoules made of neutral glass NS-1, NS-2, USP-1 of 0,5 ml and 1 ml.

Glass vials of 10, 20, 50 and 100 ml. Secondary packaging – cardboard box.

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

After first opening of the vial, the product must be used within 7 days.

2 years from the date of manufacture.