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Clinical particulars
Target species
Chickens and Turkeys
Indications for use
Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
Chickens
Mycoplasma gallisepticum,
Mycoplasma synoviae
Avibacterium paragallinarum
Pasteurella multocida
Escherichia coli.
Turkey
Mycoplasma gallisepticum,
Mycoplasma synoviae,
Pasteurella multocida,
Escherichia coli.
Contra-indications
Do not use for prophylaxis.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cases of confirmed, or suspected, resistance to quinolones.
Do not use in birds producing eggs for human consumption.
Special warnings for each target species
Treatment of Mycoplasma spp infections may not eradicate the organism.
Special precautions for use in animals
Before use, header tanks should be emptied, thoroughly cleaned and then filled with a known volume of clean water before adding the required amount of the veterinary medicinal product. The resulting mixture should be stirred.
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 product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Before use, header tanks should be inspected at regular intervals for presence of dust, algae formation and sedimentation
If there is no clinical improvement within two to three days susceptibility testing should be repeated and therapy should be changed, if appropriate.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product is an alkaline solution; personal protective equipment, including impervious gloves, should be worn when handling the product.
Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions.
In the event of eye or skin contact, rinse the affected area with clean water and if irritation occurs, seek medical attention.
People with known hypersensitivity to fluoroquinolones should avoid contact with the product.
Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the product.
Adverse reactions
None
Use during pregnancy, lactation or lay
Do not use in laying birds producing eggs for human consumption.
Do not administer to layer replacement birds within 14 days of coming into lay.
Interactions
Concurrent use of enrofloxacin with other antimicrobials, tetracyclines and macrolide antibiotics, may result in antagonistic effects.
Absorption of enrofloxacin may be reduced if the product is administered together with substances containing magnesium or aluminium.
Do not combine enrofloxacin with steroidal anti-inflammatory products.
Amounts to be administered and administration route
For oral administration via the drinking water. This may be put directly into the header tanks, or via water proportioner systems.
Dosage:
10 mg of the active ingredient per kg live bodyweight per day, corresponding to 50 ml of product per 100 litres water.
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.
Medication of the water supply should be continuous during the treatment period and no other source of water should be available.
Medicated water should be made every day, immediately prior to provision. Carefully calculate the total body mass to be treated and the total daily water consumption before each treatment.
The uptake of medicated water depends on age and clinical condition of the birds, ambient temperature, and light regime. In order to obtain the correct dosage the concentration of the product should be adjusted accordingly. Taking into consideration that 10 mg enrofloxacin per kg body weight corresponds to 0.1 ml of the product per kg body weight; the following calculation should be made to provide the required amount of the product per litre of drinking water:
0.1 XAverage bodyweight of birds to be treated (kg)XNumber of birds
=ml product per litre of drinking water
Total water consumption (l) of the flock at the previous day
Care should be taken that the intended dose is completely ingested.
Use appropriate and properly calibrated dosing equipment.
Overdose
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
Chickens (meat and offal): 7 days
Turkeys (meat and offal): 13 days
Not authorised for use in laying birds producing eggs for human consumption.