Broilers, broiler breeders, replacement chickens, turkeys.

Treatment of infections caused by the following bacteria susceptible to enrofloxacin:

Do not use for prophylaxis.

Do not use when resistance/cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment.

Infections caused by Streptococcus spp., because of only marginal susceptibility to enrofloxacin.

Do not use in other animals.

Do not use in case of hypersensitivity to the active substance, or to any of the excipients.

Treatment of Mycoplasma spp. infections may not eradicate the organism.

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.

Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of E. coli to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in Mycoplasma synoviae in the EU.

As enrofloxacin will be partly excreted via kidneys, elimination will be delayed in cases with kidney disorders.

Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product. Wash any splashes from skin or eyes immediately with water. Wash hands and exposed skin after use. Do not eat, drink or smoke while using the product.

After the end of treatment, the watering system should be cleaned appropriately to prevent the intake of remaining subtherapeutic doses of the drug, which may lead to resistance.

Locomotion disturbances, as a result of damage to joint cartilage, cannot be excluded in cases where fluoroquinolones are used during the growing period, particularly at higher temperatures, when consumption of medicated water is drastically increased for longer periods.

Laying birds: Do not use in replacement birds within 14 days of coming into lay.

When combined with tetracyclines and macrolide antibiotics, enrofloxacin may produce an antagonistic effect.

Resorption of enrofloxacin may be reduced, when it is combined with substances containing magnesium or aluminium.

The serum level of theophylline may increase when it is combined with enrofloxacin.

Do not combine enrofloxacin with non steroidal antiphlogistics.

Increased influx of the air (admixing CO2 from the air) into medicated drinking water may result in precipitation of enrofloxacin.

Precipitation of the salt of enrofloxacin and alkalis may occur at higher concentration of calcium and magnesium in the water system during intermediate dilution in the dosage devices.

Dosage:

10 mg enrofloxacin/kg body weight per day for 3-5 consecutive days.

Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.

The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of Enroxil should be adjusted accordingly. Taking into consideration that 10 mg enrofloxacin per kg body weight corresponds to 0.1 ml of Enroxil per kg body weight; the following calculation should be made to provide the required amount of Enroxil per litre of drinking water:

Care should be taken that the intended dose is completely ingested.

The product may be put directly into the header tank or introduced via a water proportioner pump. For the preparation of the medicated water for small groups of animals the measuring cup included with the packaging should be used. During preparation of medicated water, the product should be admixed into water and not the other way round.

Only sufficient medicated drinking water should be prepared to cover the daily requirements. Medicated water should be prepared every day, immediately prior to provision. Medication of the water supply should be continuous during the treatment period and no other source of water should be available. Medicated drinking water should be replaced every 24 hours.

Due to the low toxicity of enrofloxacin the danger of overdosing is limited. In cases of significant overdose, transient reduction of mobility and cramps may occur. Symptomatic treatment is recommended in such cases.

Chickens: Meat and offal: 7 days.

Turkeys: Meat and offal: 13 days

Not authorised for use in laying birds producing eggs for human consumption. Do not administer to layer replacement birds within 14 days of coming into lay.