ORNITIL ® (oral solution)

An oily solution ranging in colour from yellow to yellowish-brown, with a characteristic odour of its constituent components; a slight sediment is permissible.

1 ml of the product contains the following active substances:

- levofloxacin — 150,0 mg

- colistin sulfate — 1,200,000 IU

Excipients: lactic acid, purified water.

ATC vet classification code QJ01 — antibacterial veterinary medicinal products for systemic use. QJ01RA95 — Polymyxins, combinations with other antimicrobial agents.

ORNITIL is a combination product containing levofloxacin and colistin sulfate. As a result of the synergistic action of the active substances, the efficacy of the product is significantly greater than that of its individual components.

Levofloxacin is an antibiotic of the fluoroquinolone group, the levorotatory isomer of ofloxacin, active against gram-negative (E. coli, Enterobacter spp., Klebsiella spp., Proteus spp., Serratia spp., Campylobacter spp., Pseudomonas aeruginosa, Yersinia spp., Vibrio spp., Aeromonas spp., Haemophilus spp., Brucella spp., Chlamydia trachomatis, Legionella pneumophila, Moraxella catarrhalis, Campylobacter spp., Salmonella spp., Shigella spp., Mycoplasma spp.) and gram-positive (Staphylococcus spp. (including penicillinase-producing and methicillin-resistant strains), Streptococcus spp., Mycobacterium spp., Peptostreptococcus spp.) microorganisms.

The mechanism of action of levofloxacin consists in inhibition of bacterial DNA gyrase (topoisomerase II), thereby arresting the process of DNA supercoiling and synthesis, and inducing metabolic changes in the cytoplasm, cell wall, and membranes. Levofloxacin is a representative of the new generation of fluoroquinolones and overcomes microbial resistance to earlier-generation fluoroquinolones, including enrofloxacin.

Colistin is an antibiotic of the polymyxin group. It exerts a bactericidal effect against gram-negative bacteria (E. coli, Salmonella spp., Pseudomonas spp.). The mechanism of action of colistin consists in disruption of the cytoplasmic membrane of microorganisms. It interacts with phospholipids, destroying the structure of the cell membrane. The permeability of the bacterial membrane changes immediately upon contact with colistin. Colistin binds phospholipid A of cell membranes, neutralising the action of bacterial endotoxin.

Levofloxacin is rapidly and almost completely absorbed following oral administration. Feed has little effect on the rate and extent of absorption. The bioavailability of levofloxacin after oral administration is up to 99–100%. Cmax in blood plasma is reached 1–2 hours after administration. Approximately 30–40% of the orally administered dose of levofloxacin is bound to plasma proteins. The half-life of levofloxacin is 6–8 hours. The substance is practically not metabolised in the body. Levofloxacin is excreted predominantly unchanged in the urine (approximately 87% of the dose within 48 hours), with minor amounts excreted in the faeces. Less than 5% is detected in the urine as metabolites (desmethyl, nitrogen oxide).

Colistin is absorbed in small amounts from the gastrointestinal tract and therefore acts effectively in diseases of the digestive system. Unlike the low concentrations of colistin found in blood serum and tissues, high and constant concentrations are consistently present throughout the various sections of the gastrointestinal tract. The highest concentrations are observed in the large intestine and caecum. In the blood serum of pigeons, colistin is detectable at low concentrations 6 hours after oral administration via drinking water. In dogs, colistin is practically not absorbed from the gastrointestinal tract and does not accumulate in organs or tissues. Colistin is excreted primarily via the faeces.

Treatment of dogs suffering from septicaemia, arthritis, polyarthritis, meningitis, mastitis, dermatitis, secondary infections associated with viral diseases, as well as diseases of the respiratory tract (tonsillitis, tracheitis, pneumonia, bronchitis, rhinitis, sinusitis, bronchopneumonia), gastrointestinal tract (gastritis, enteritis, peritonitis), and urogenital system (nephritis, pyelitis, pyelonephritis, urethritis, metritis, urocystitis), caused by microorganisms susceptible to levofloxacin and colistin.

Treatment of pigeons suffering from septicaemia, secondary infections associated with viral diseases, as well as diseases of the respiratory and gastrointestinal tracts, caused by microorganisms susceptible to levofloxacin and colistin.

Pigeons — via drinking water: 0,5 ml of the product per 1 litre of drinking water, equivalent to 75 mg levofloxacin and 600,000 IU colistin sulfate per 1 litre of drinking water.

Dogs — via drinking water or liquid feed: 0,25 ml of the product per 10 kg of body weight (equivalent to 3,75 mg levofloxacin and 30,000 IU colistin sulfate per 1 kg of body weight).

Course of treatment: 3–5 days.

Before use, the ampoule or vial must be thoroughly shaken.

During the treatment period, pigeons must receive only water containing the product. A fresh solution must be prepared daily in a volume calculated for consumption within one day.

In dogs, the product may be administered directly into the mouth using a syringe with a small amount of drinking water.

Do not use when resistant strains of the causative agent have been identified.

Hypersensitivity to levofloxacin or colistin.

Do not use in animals with impaired renal or hepatic function.

Do not use concomitantly with tetracyclines, macrolides, lincosamides, chloramphenicol, or non-steroidal anti-inflammatory drugs.

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

Do not use in small-breed dogs under 8 months of age, or in large-breed dogs under 18 months of age, due to the adverse effects on articular cartilage development.

Do not use in pregnant animals.

Do not use in food-producing animals.

At the recommended doses, no adverse reactions are observed. In isolated cases, allergic reactions may occur (skin rash, pruritus, and oedema).

Use of this product must be discontinued if resistance of the causative agent to levofloxacin and colistin is detected; microbiological confirmation of diagnosis and bacterial susceptibility testing should be performed prior to prescribing the product.

It should be noted that colistin is used in human medicine for the treatment of infections caused by multidrug-resistant microorganisms. Use of veterinary medicinal products in a manner inconsistent with the instructions provided in this summary of product characteristics may increase the number of bacteria resistant to colistin and reduce the efficacy of treatment with other antimicrobial agents due to the presence of cross-resistance.

Do not use concomitantly with tetracycline-group products, chloramphenicol, lincosamides, or macrolides.

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

Do not use concomitantly with products containing Mg²⁺, Al³⁺, or Ca²⁺ cations, as these bind levofloxacin and impair its absorption.

When used concomitantly with theophylline (aminophylline), levofloxacin may increase its plasma concentration.

Concomitant use with aminoglycosides, third-generation cephalosporins, and broad-spectrum penicillins may produce a synergistic effect against certain bacteria (particularly Pseudomonas aeruginosa and other Enterobacteriaceae).

The product is not recommended to be mixed with other medicinal products.

Ampoules of neutral glass grades NS-1, NS-2, USP-1 of 0.5 ml and 1 ml.

Vials of neutral glass grades NS-1, NS-2, USP-1 of 2, 5, 10, 20, 50, 100, and 200 ml.

Secondary packaging: cardboard box.

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

2 years.

After first withdrawal from the vial, the product must be used within 14 days, under storage conditions in a dark place at a temperature between 4 °C and 8 °C.