Concentrate for oral solution. Clear slightly yellow solution.

Mode of action: Two enzymes essential in DNA replication and transcription, DNA gyrase and topoisomerase IV, have been identified as the molecular targets of fluoroquinolones. Target inhibition is caused by non-covalent binding of fluoroquinolone molecules to these enzymes. Replication forks and translational complexes cannot proceed beyond such enzyme-DNA-fluoroquinolone complexes, and inhibition of DNA and mRNA synthesis triggers events resulting in a rapid, drug concentration-dependent killing of pathogenic bacteria. The mode of action of enrofloxacin is bactericidal and bactericidal activity is concentration dependent.

Antibacterial spectrum: Enrofloxacin is active against many Gram-negative bacteria such as Escherichia coli, Klebsiella spp., Actinobacillus pleuropneumoniae, Pasteurella spp. (e.g. Pasteurella multocida), Bordetella spp., Proteus spp., Pseudomonas spp., against Gram-positive bacteria such as Staphylococcus spp. (e.g. Staphylococcus aureus) and against Mycoplasma spp. at the recommended therapeutic doses.

Types and mechanisms of resistance: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.

The pharmacokinetics of enrofloxacin are such that both oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.

Benzyl alcohol (E-1519)

Potassium hydroxide (for pH adjustment)

Hydroxyethylcellulose

Caramel aroma

Water, purified

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

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

Shelf life after dilution according to directions: Use immediately

Keep the bottle tightly closed. Any remaining diluted solution should be discarded immediately after use.

10 ml, 30 ml, and 50 ml amber type III glass bottles closed with tamper-evident HDPE/LDPE screw caps with ring and colourless LDPE syringe insert in a carton box containing 10 ml, 30 ml and 50 ml respectively. A 1 ml dosing syringe is supplied with each 10 ml bottle, a 5 ml dosing syringe is supplied with each 30 and 50 ml bottle.

Each bottle is packed in an individual carton.

Pack size:

1 x 10 ml, 10 x (1 x 10 ml).

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.