Enrofloxacin 25.0 mg per ml

Benzyl Alcohol 14.0 mg per ml

For a full list of excipients, see section Pharmaceutical particulars

Oral solution.

Calves

Exotic Animals (small mammals, reptiles and avian 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.

The product should not be used for prophylaxis.

Exotic Animals: Consult the Technical Services Department of Elanco prior to use.

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.

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.

None.

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.

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.

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.

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.

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.

Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.

Calves: Meat: 8 days

Not for use in poultry (chickens and turkeys). Not for use in exotic animals or birds intended for human consumption.

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.

ATC Vet Code: QJ01MA90

Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials - they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double stranded helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.

The pharmacokinetics of enrofloxacin are such that both oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.

Potassium hydroxide

Benzyl alcohol

Hypromellose

Water purified

None known.

Unopened Container: 3 years.

Broached Container: Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Diluted Product: Any medicated liquid remaining 24 hours after preparation must be discarded.

Do not store above 25oC. Store in a dry place

Container Material: High density polyethylene bottles

Container Closure: Polypropylene screw cap

Container Colour: White

Container Volumes: 100 ml, 500ml, 1 litre (some may not currently be marketed)

Any unused product or waste material should be disposed of in accordance with national requirements.

N/A

Vm 00879/4117

11 November 1993

September 2023

Baytril 2.5% Oral Solution for small mammals, reptiles and exotic birds. The dose rates given are for guidance only.

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.

When dosing with small quantities of liquid, a larger amount of gavage solution can be prepared to ensure accuracy.

Small mammals 5 mg/kg bw (0.2 ml/kg) Twice daily for 7 days

Reptile 5 mg/kg bw (0.2 ml/kg) Dose interval 24 - 48 hours for 6 days

* For animals less than 100 g add 0.2 ml Baytril to 0.8 ml water. From this 1 ml solution, dose using the table below:

Exotic birds (excludes chickens and turkeys) 10 mg/kg bw (0.4 ml/kg) Twice daily for 7 days

* For exotic birds less than 100 g add 0.2 ml Baytril to 0.8 ml water. From this 1 ml solution, dose using the table below: