Pet rabbits, rodents, ornamental birds and reptiles.

Treatment of infections of the digestive and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.

Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.

Treatment of infections of the digestive and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.

The product should not be used for prophylaxis.

Do not use in case of confirmed or suspected resistance to quinolones, since a high degree or cross resistance between enrofloxacin and other quinolones exists.

Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the excipients.

Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.

None.

Official and local antimicrobial policies should be taken into account when the product is used.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

This product may cause allergic reactions in those that are sensitive.

People with known hypersensitivity to (fluoro)quinolones should avoid contact with the product.

The product is an alkaline solution and may cause irritation if it comes into contact with the skin or eyes.

Wear impermeable gloves when administering the product.

Rinse any splashes from skin or eyes immediately with water.

Wash hands and exposed skin after use.

Do not smoke, eat or drink when handling the product.

During the period of rapid growth, enrofloxacin may affect articular cartilage.

In the absence of data on its use in some of the target species, caution should be used when prescribing during these periods and a careful risk/benefit assessment made.

None known.

For administration by gavage or in drinking water.

Owing to physiological and pharmacokinetic differences between the wide range of species for which this product is indicated, the dose rates below are for guidance only. Depending upon the species of animal and the infection to be treated, alternative doses may be appropriate using an evidence-based approach. However, any change in dosing regimen should be based on a benefit:risk assessment by the responsible veterinarian, as tolerance at higher doses has not been investigated.

Pet rabbits and rodents:5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight) orally diluted in water, twice daily for 7 days.

Reptiles:5 mg enrofloxacin per kg bodyweight (0.2 ml per kg bodyweight) orally diluted in water, at 24-48 hour intervals for 6 days.

Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems. Metabolism of substances and activity of the immune system are, thus, critically dependant on the body temperature. Therefore, the veterinarian must be aware of correct temperature requirements of the respective reptile species and the hydration status of the individual patient. Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of the veterinary medicinal product. Therefore, the recommendations made here can only be used as a starting point for individual dose setting.

Ornamental birds:10 mg enrofloxacin per kg bodyweight (0.4 ml per kg bodyweight), orally diluted in water, twice daily for 7 days.

The undiluted veterinary medicinal product is strongly alkaline and, therefore, to avoid caustic effects, it is essential to dilute the product with at least 4 parts water prior to administration. In the case of smaller animals (weighing less than 500 g), it may be appropriate to dilute 0.1 ml of the neat product with >4 parts water and administer a proportion of the total volume.

If the product is to be given via the drinking water, concentrations of between 50 and 200 ppm should be considered as suitable working dilutions; concentrations in excess of 250 ppm should be avoided as precipitation may occur.

Medicated fluids should be made up immediately prior to provision on a daily basis.

20 ml bottle: A 3 ml syringe is provided with the 20 ml bottle for withdrawal of the product and facilitation of dilution prior to administration. This syringe has graduations of 0.1 ml. It is recommended to draw up a minimum of 0.1 ml of product prior to dilution since it is not possible to accurately measure volumes that are lower than this.

100 ml bottle: A 10 ml syringe is provided with the 100 ml bottle for withdrawal of the product and facilitation of dilution prior to administration. This syringe has graduations of 0.2 ml. It is recommended to draw up a minimum of 0.2 ml of product prior to dilution since it is not possible to accurately measure volumes that are lower than this.

To withdraw product, firmly insert the syringe hub into the centre of the self-sealing syringe adaptor of the bottle and remove the required amount.

To avoid inhalation of the medication, care should be taken with restraint of the animal and administration of the product.

In cases of accidental overdose, digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur. There is no antidote and treatment should be symptomatic.

Do not use in animals producing food intended for human consumption.