ENROFLOXVET ® 10% (solution for injection)

Solution ranging in colour from light yellow to dark yellow.

1 ml of the product contains the active substance:

- enrofloxacin – 100,0 mg

Excipients: gluconolactone, propylene glycol, acetic acid, water for injections.

ATCvet classification code QJ01 — antibacterial veterinary medicinal products for systemic use. QJ01MA90 — Enrofloxacin.

Enrofloxacin belongs to the fluoroquinolone class of antibiotics. Its mechanism of action involves inhibition of subunit A of DNA gyrase (topoisomerase II) in gram-negative bacteria, thereby blocking the supercoiling of the DNA molecule. In gram-positive bacteria, this process affects topoisomerase IV rather than topoisomerase II. Under these conditions, transcription and recombination processes in bacterial DNA are blocked.

The product exerts bactericidal activity against Gram-positive (Staphylococcus spp., Streptococcus spp., Clostridium spp., Listeria monocytogenes, Corynebacterium spp., and others) and Gram-negative (E. coli, Salmonella spp., Klebsiella spp., Proteus spp., Pasteurella spp., Bordetella spp., and others) microorganisms, and is also active against mycoplasmas (Mycoplasma gallisepticum, M. synoviae, M. hyosynoviae, M. hyopneumoniae, M. meleagridis, M. iowae).

Following parenteral administration, enrofloxacin is rapidly and completely absorbed from the injection site and distributed throughout the animal's body. Within 1–2 hours after administration, its active concentration in most tissues (lungs, liver, kidneys, skin, bones, and lymphatic system) reaches 2–3 times higher levels than in blood plasma. After subcutaneous administration, the maximum plasma concentration of enrofloxacin is maintained for 6 hours. The elimination half-life ranges from 2 to 6 hours.

After subcutaneous administration of enrofloxacin to calves at a dose of 5,0 mg/kg body weight, the maximum plasma concentration is 2,0 µg/ml, reached 1 hour after administration. Subsequent dynamics show a decline in enrofloxacin levels to 1,5 µg/ml at 8 hours, to 1,1 µg/ml at 12 hours, and to 0,35 µg/ml at 24 hours. At 36 hours post-administration, the product is no longer detectable in plasma.

Following intramuscular administration of enrofloxacin to pigs at a dose of 2,5 mg/kg body weight, the mean half-life is 12,06 ± 0,68 h, while the mean residence time in the systemic circulation is 17,15 ± 1,04 h. The maximum plasma concentration of enrofloxacin reaches 1,17 ± 0,23 µg/ml, with a time to peak concentration of 1,81 ± 0,23 h. The product is detectable in kidney and liver tissues for 10 days post-administration at concentrations ranging from 0,012 to 0,017 µg/g, while it is not detectable in other organs.

Enrofloxacin is excreted from the body primarily unchanged; it is partially metabolised to ciprofloxacin and eliminated via urine and bile.

Cattle: Treatment of colisepticaemia (caused by Escherichia coli), acute mastitis (caused by Escherichia coli), respiratory tract disease (caused by Pasteurella multocida, Mannheimia haemolytica, and Mycoplasma spp.), and gastrointestinal tract disease (caused by Escherichia coli) due to microorganisms susceptible to enrofloxacin.

Pigs: Treatment of colisepticaemia (caused by Escherichia coli), post-partum syndrome, dysgalactia, metritis–mastitis–agalactia syndrome (caused by Escherichia coli and Klebsiella spp.), respiratory tract disease (caused by Pasteurella multocida, Mycoplasma spp., and Actinobacillus pleuropneumoniae), gastrointestinal tract disease (caused by Escherichia coli), and urinary tract disease (caused by Escherichia coli) due to microorganisms susceptible to enrofloxacin.

- cattle - 5 ml of the product per 100 kg body weight (equivalent to 5 mg enrofloxacin per 1 kg body weight) once daily.

- pigs - 2,5 ml of the product per 100 kg body weight (equivalent to 2,5 mg enrofloxacin per 1 kg body weight) once daily.

Course of treatment: 3 days; for salmonellosis - 5 days.

The maximum volume per injection site must not exceed 10 ml for cattle and 2,5 ml for pigs.

Hypersensitivity to enrofloxacin or to any of the excipients.

Do not administer to animals with clinical signs of central nervous system disease, musculoskeletal disorders, or articular cartilage damage.

Do not use concurrently with tetracyclines, macrolides (erythromycin), chloramphenicol, or theophylline.

Do not use concurrently with the immunosuppressant ciclosporin or its analogues.

Do not use when strains of pathogenic bacteria resistant to quinolones have been identified.

Do not use for prophylactic purposes.

A temporary mild local inflammation at the injection site is possible; this requires no treatment and resolves by day 5–7.

In very rare cases, gastrointestinal disturbances (e.g., diarrhoea) may occur. These signs are generally mild and resolve rapidly.

Fluoroquinolones may cause arthropathy and lameness in young animals as a result of articular cartilage damage.

Use of the product should be based on susceptibility testing of the causative microorganisms to enrofloxacin.

As with other fluoroquinolones, this product should not be used for mild infections, as there is a risk of development of resistance to enrofloxacin.

If recovery does not occur within three days of the start of treatment, the antibiotic should be changed.

The safety of enrofloxacin has been demonstrated in pregnant cows during the first quarter of gestation; use during later stages of pregnancy should be based on a benefit-risk assessment by the responsible veterinarian.

The safety of the product in pigs during pregnancy has not been established; use during pregnancy should be based on a benefit-risk assessment by the responsible veterinarian.

The product may be used during lactation.

When enrofloxacin is used concurrently with products containing magnesium and aluminium, the absorption of enrofloxacin is reduced.

Slaughter of animals for meat is permitted 12 days after the last administration of the product. Consumption of milk by humans is permitted 5 days after the last administration of the product. Meat and milk obtained before the specified withdrawal period must be disposed of or fed to non-productive animals, subject to the advice of the attending veterinarian.

Type NS-1, NS-2, USP-1 (neutral glass grades per Ukrainian standard) neutral glass vials sealed with rubber stoppers under aluminium crimp caps, available in sizes of 10, 20, 50, 100, and 200 ml. Secondary packaging: cardboard carton.

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

2 years.

After first opening, the product must be used within 14 days, under storage conditions in a dark place at a temperature between 0 °C and 5 °C.