Description

Clear yellow solution.

Composition

1 ml of the drug contains the following active ingredients:

enrofloxacin – 100 mg,

trimethoprim – 50 mg.

Excipients: benzyl alcohol, lactic acid, disodium edetate, potassium hydroxide, purified water.

Pharmacological properties

ATCvet classification code QJ01 – Antibacterial veterinary drugs for systemic use. QJ01RA96 – Quinolones, combinations with other antimicrobials.

Enrofloxacin is a broad-spectrum bactericidal antibiotic from the fluoroquinolone group. The drug has antimicrobial action against gram-positive (Staphylococcus spp., Streptococcus spp., Clostridium spp., Listeria monocytogenes, Corynebacterium spp.) and gram-negative (Pseudomonas spp., E. coli, Haemophilus spp., Salmonella spp., Klebsiella spp., Proteus spp., Pasteurella spp., etc.) bacteria, and also acts against Mycoplasmas (Mycoplasma spp.) and Chlamydia (Chlamydia spp.). The mechanism of action is through the inhibition of bacterial DNA gyrase, which disrupts bacterial DNA replication.

Trimethoprim is a broad-spectrum antimicrobial agent of the diaminopyrimidine group. The drug has a bacteriostatic effect against gram-positive (Staphylococcus spp.; Streptococcus spp.) and gram-negative (Escherichia coli, Klebsiella spp., Salmonella spp.; Pasteurella spp.; Enterobacter spp.; Proteus spp.; Shigella spp.; Haemophilus spp.; Chlamydia spp.) microorganisms, and also acts against Toxoplasma gondii. The mechanism of action involves inhibiting bacterial dihydrofolate reductase.

Enrofloxacin after oral administration is quickly absorbed from the digestive tract and is well distributed in all tissues and body fluids. After 60–120 minutes, the maximum concentration of enrofloxacin in the blood is reached. The presence of food in the stomach does not affect the degree of its absorption.

Enrofloxacin has a protein binding rate of 24±2%. The highest concentrations of enrofloxacin are found in the bile, kidneys, liver, lungs, and reproductive organs. It is mainly excreted through the kidneys, with metabolites being eliminated in urine and feces. The half-life of enrofloxacin is approximately 24 hours.

Trimethoprim is quickly absorbed from the digestive tract after oral administration and is well distributed throughout various tissues and body fluids. Typically, trimethoprim concentrations in tissues are higher than in the blood. Significant levels of trimethoprim are found in the lungs, kidneys, and liver. Trimethoprim serum concentrations reach their peak 1.5 hours after oral administration. The average half-life of the drug is approximately 2.5 hours. Trimethoprim is primarily excreted through the kidneys, with urine concentrations several times higher than those in the blood. In poultry, trimethoprim has a volume of distribution of 2.2 L/kg, with a bioavailability of 80%. Its half-life in poultry ranges from 1 to 2 hours.

Indications for use

Treatment of broilers for E. coli infection, salmonellosis, necrotic enteritis, streptococcosis, hemophilia, and mycoplasmosis caused by microorganisms sensitive to enrofloxacin and trimethoprim.

Route of administration and dosage

Administer the drug orally with drinking water at a dose of 0.5-1 mL of the drug per 1 L of drinking water (this dosage corresponds to 10 mg of enrofloxacin and 5 mg of trimethoprim per kilogram of body weight). The treatment is carried out around the clock for 3 to 5 days.

When preparing the stock solution, the drug must be added to water.

Medicated water should be the sole source of drinking water throughout the entire treatment period!

When using the group administration method, the precise daily dosage of the drug should be calculated based on the recommended dose, the number of animals to be treated, and their body weight, using the following formula:

Contraindications

Hypersensitivity to enrofloxacin, trimethoprim, or any excipients.

Do not use in laying hens whose eggs are intended for human consumption, or in replacement young chicks, less than two weeks before they start laying eggs.

Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs), macrolide antibiotics, tetracycline, or chloramphenicol.

Avoid prophylactic use, or if enrofloxacin-resistant strains of the pathogen are detected.

Precautions

Side effects

No side effects have been observed when using the drug in recommended doses.

Special precautions for use

Since the approval of enrofloxacin, a component of the drug, for use in poultry, there has been a significant decrease in E. coli's susceptibility to fluoroquinolones, along with the emergence of resistant strains. Additionally, cases of Mycoplasma synoviae resistance to fluoroquinolones have been reported within the European Union. Given the potential for microorganisms to develop resistance to enrofloxacin and trimethoprim, the use of these drugs should be guided by sensitivity testing of the microorganisms responsible for the disease against the active ingredients.

Medication interactions and other forms of interactions

Avoid using this drug alongside non-steroidal anti-inflammatory drugs (NSAIDs), bacteriostatic antibiotics such as macrolides, tetracyclines, and chloramphenicol. Additionally, do not combine it with medications that contain aluminum, magnesium, iron, or calcium, as well as unsaturated fatty acids and polyphosphates.

Withdrawal period

Slaughtering poultry for meat is allowed 11 days after the last drug administration. Any meat obtained before this deadline must be disposed of or fed to non-productive animals, depending on the veterinarian's assessment.

Release form

Glass bottles of 10 ml; polymer bottles of 1000 ml.

Storage

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

Shelf life

The shelf life of this drug is 2 years.

The shelf life after first opening the bottle is 14 days when stored in a dark place at a temperature of 5 to 25°C.

After dilution with water, the drug must be used within 24 hours.

Dispensing rules

A prescription is recommended.

For veterinary use only!