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Date: Sunday, June 26, 2022 18:23

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.29
Baytril 2.5% Oral Solution
 
Species: Cattle, Ornamental birds, Rabbits, Reptiles, Small mammals
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Enrofloxacin
Product:Baytril 2.5% Oral Solution
Product index: Baytril 2.5% Oral Solution
Cattle - meat: 8 days
Withdrawal notes: Not for use in exotic animals or birds intended for human consumption. Not for use in poultry.
Qualitative and quantitative composition
Active Constituents
Enrofloxacin 25.0 mg per ml
Relevant Constituents of the Excipients
Benzyl Alcohol 14.0 mg per ml
For a full list of excipients, see section Pharmaceutical particulars
Pharmaceutical form
Oral solution.
Clinical particulars
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)
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
None known.
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.
Pharmacological particulars
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
ATC Vet Code: QJ01MA90
Pharmacodynamic properties
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.
Pharmacokinetic properties
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.
Pharmaceutical particulars
List of excipients
Potassium hydroxide
Benzyl alcohol
Hypromellose
Water purified
Incompatibilities
None known.
Shelf-life
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.
Special precautions for storage
Do not store above 25oC. Store in a dry place
Nature and composition of immediate packaging
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)
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4117
Significant changes
Date of the first authorisation or date of renewal
11 November 1993
Date of revision of the text
October 2020
Any other information
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.
Administer In Drinking Water:
Suggested concentration of Baytril in drinking water (ppm)
Suggested concentration of Baytril 2.5% Oral Solution per litre of water (ml/litre)
Concentration to be given daily in water
Rabbit
100
4
0.4 ml / 100 ml
Guinea pig
100
4
0.4 ml / 100 ml
Golden hamster
50
2
0.2 ml / 100 ml
Gerbil
100
4
0.4 ml / 100 ml
Rat
100
4
0.4 ml / 100 ml
Mouse
75
3
0.3 ml / 100 ml
Ferret
100
4
0.4 ml / 100 ml
Exotic bird
200
8
0.8 ml / 100 ml
Reptile
50
2
0.2 ml / 100 ml
Direct administration by gavage:
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
Weight of small mammal or reptile
Volume of Baytril 2.5% Oral Solution
Amount of water to be added for dosing by gavage
100 g
0.02 ml
0.08 ml*
200 g
0.04 ml
0.16 ml
500 g
0.10 ml
0.40 ml
800 g
0.16 ml
0.64 ml
1000 g
0.20 ml
0.80 ml
* 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:
Weight of small mammal or reptile less than 100 g
Dose of diluted Baytril
20 g
0.02 ml
50 g
0.05 ml
100 g
0.1 ml
Exotic birds (excludes chickens and turkeys) 10 mg/kg bw (0.4 ml/kg) Twice daily for 7 days
Weight of exotic bird
Volume of Baytril 2.5% Oral Solution
Amount of water to be added for dosing by gavage
20 g
0.008 ml
0.032 ml*
50 g
0.02 ml
0.08 ml*
100 g
0.04 ml
0.16 ml*
500 g
0.20 ml
0.80 ml
1000 g
0.40 ml
1.60 ml
* 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:
Weight of exotic bird less than 100 g
Dose of diluted Baytril
20 g
0.04 ml
50 g
0.1 ml
100 g
0.2 ml
Legal category
Legal category: POM-V
GTIN
GTIN description:Baytril 2.5% Oral Solution (100ml)
GTIN:04007221019251