Target species
Chicken, turkey and rabbit.
Indications for use, specifying the target species
Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
Chickens
Mycoplasma gallisepticum,
Mycoplasma synoviae,
Avibacterium paragallinarum,
Pasteurella multocida,
Turkey
Mycoplasma gallisepticum,
Mycoplasma synoviae,
Pasteurella multocida,
Rabbits
For the treatment infectious diseases due to Pasteurella multocida and bacterial enteritis due to infection with E.coli.
Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the active substance of choice.
Contraindications
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.
Do not use in the case of known hypersensitivity to the active substance, other (fluoro)quinolones or to any of the excipients.
Special warnings for each target species
Treatment of Mycoplasma spp infections may not eradicate the organism.
Special precautions for use
Special precautions for use in the target species
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.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Not for use for prophylaxis.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Special precautions to be taken by the person administering the medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid contact with the veterinary medicinal product.
Avoid contact with skin and eyes.
In case of accidental spillage onto skin or eyes, rinse immediately with water, seek medical advice immediately and show the package leaflet to the physician. Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laying birds:
Do not use in laying hens producing eggs for human consumption.
Do not administer to layer replacement birds within 14 days before the start of the laying period.
Interaction with other medicinal products and other forms of interaction
In vitro,an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial agents such as macrolides or tetracyclines and phenicols. The simultaneous application of substances containing aluminium or magnesium can impair the absorption of enrofloxacin.
Amount(s) to be administered and administration route
In drinking water use.
Always make sure that the entire dose offered has been consumed. The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of enrofloxacin may need to be adjusted accordingly. The medicated water should be made up fresh each day just before it is offered to the animals. The drinking water must be medicated throughout the treatment period, and no other water source should be available.
Use only fresh pre-solutions, prepared every day before start of treatment. Pumping systems should be checked constantly to assure proper medication. Empty the water system and fill it with medicated water before starting the treatment.
The veterinary medicinal product may be put directly into the header tank or introduced via a water proportioner pump.
Chickens and turkeys:
10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.
Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Based on the recommended dose and the number and weight of animals to be treated, the exact daily quantity of the veterinary medicinal product should be calculated according to the following formula:
0.1ml of veterinary medicinal product x average body weight (kg) of animals to be treated |
average daily water intake (l/animal) |
= ml veterinary medicinal product per litre of drinking water |
Rabbits
10 mg/kg bodyweight per day for 5 consecutive days.
Based on the recommended dose and the number and weight of animals to be treated, the exact daily quantity of the veterinary medicinal product should be calculated according to the following formula:
0.1ml of veterinary medicinal product x average body weight (kg) of animals to be treated |
average daily water intake (l/animal) |
= ml veterinary medicinal product per litre of drinking water |
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse clinical symptoms were observed in chickens and turkeys treated respectively with doses up to 10 and 6 times higher than the therapy dose.
The use of fluoroquinolones during the growth phase combined with a marked and prolonged increase in the intake of drinking water, and hence active ingredient, possibly due to high temperatures, may potentially be associated with damage of the articular cartilage.
Withdrawal period(s)
Chickens: Meat and offal: 7 days.
Turkeys: Meat and offal: 13 days.
Rabbits: Meat and offal: 3 days.
Not for use in birds producing eggs for human consumption.
Do not administer to layer replacement birds within 14 days before the start of the laying period