Target species
Calves
Exotic Animals (small mammals, reptiles and avian species)
Indications for use, specifying the target species
The product is for use in calves in the treatment of infections of the alimentary and respiratory tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis and salmonellosis), where clinical experience supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
The product may also be used in exotic animals (small mammals, reptiles and avian species) for the treatment of bacterial infections of the alimentary and respiratory tracts where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Contraindications
The product should not be used for prophylaxis.
Special warnings for each target species
Exotic Animals: Consult the Technical Services Department of Elanco prior to use.
Special precautions for use
i) Special precautions for use in animals
See special warning for each target species
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.
ii) Special precautions to be taken by the person administering the medicinal product to animals
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Do not eat, drink or smoke whilst using the product.
iii) Other precautions
None.
Adverse reactions (frequency and seriousness)
On very rare occasions, mild and transient gastrointestinal disorders, such as vomiting or diarrhoea, may be observed. As a result, anorexia may occur.
In very rare cases, in exotic animals where the recommended dose has been exceeded, neurological signs (ataxia, excitation) can also occur.
During the period of rapid growth, enrofloxacin may affect articular cartilage.
Use during pregnancy, lactation or lay
In the absence of data on its use in some exotic species, caution should be used when prescribing during these periods and a careful risk/benefit assessment made.
Interaction with other medicinal products and other forms of interaction
Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines, or phenicols). The simultaneous application of substances containing aluminium or magnesium can impair the absorption of enrofloxacin.
Amount(s) to be administered and administration route
Calves
Administer via the milk, milk replacer, electrolyte solution or water. The dose rate is 2.5 mg enrofloxacin per kg bodyweight (5 ml per 50 kg) daily for 3 days. This rate may be doubled to 5 mg per kg (10 ml per 50 kg) for 5 days for salmonellosis and complicated respiratory disease.
Medicated fluids should be made up immediately prior to provision on a daily basis.
Exotic Animals
The dose rates given below are for guidance only; dosing charts can be found in the ‘Any other information’ section.
Small Mammals : 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.
Birds (excluding chickens and turkeys): 10 mg enrofloxacin per kg bodyweight (0.4 ml per kg bodyweight) orally diluted in water, twice daily 7 days.
For direct administration by gavage, dilutions of 1 part product to 4 parts water are recommended. 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. The dilution should be made on a daily basis immediately prior to provision, preferably in a glass container. The use of a 0.5 ml (100 unit) insulin syringe should be considered for the withdrawal of very small volumes of the product and to facilitate dilution prior to administration.
Medicated fluids should be made up immediately prior to provision on a daily basis.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.
Withdrawal period(s)
Calves: Meat: 8 days
Not for use in poultry (chickens and turkeys). Not for use in exotic animals or birds intended for human consumption.