Medine.co.uk

Baytril 2.5% Oral Solution

Revised: September 2007

AN: 00739/2007

SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF THE VETERINARY MEDICINAL PRODUCT


Baytril 2.5% Oral Solution


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


2.1

Active Constituents

mg per ml





Enrofloxacin

25.0




2.2

Relevant Constituents of the Excipients






Benzyl Alcohol

14.0





For a full list of excipients, see section 6.1



3. PHARMACEUTICAL FORM


Oral solution.


4. CLINICAL PARTICULARS


4.1 Target species


Calves

Exotic Animals (small mammals, reptiles and avian species)


4.2 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.


4.3 Contraindications


The product should not be used for prophylaxis.


4.4 Special warnings for each target species


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


4.5 Special precautions for use


i) Special precautions for use in animals


See 4.4.


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.


4.6 Adverse reactions (frequency and seriousness)


During the period of rapid growth, enrofloxacin may affect articular cartilage.


4.7 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.


4.8 Interaction with other medicinal products and other forms of interaction

None known.


4.9 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. Veterinary surgeons are advised to contact the company prior to use to discuss the particulars of each individual case.


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 10 mg enrofloxacin per kg bodyweight (0.4 ml per kg

(excluding chickens bodyweight) orally diluted in water, twice daily 7 days.

and turkeys)

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.


4.10 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.


4.11 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.


5. PHARMACOLOGICAL PROPERTIES


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


ATC Vet Code: QJ01MA90


5.1 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.


5.2 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.


6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


Potassium hydroxide

Benzyl alcohol

Hypromellose

Water purified


6.2 Incompatibilities


None known.


6.3 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.


6.4 Special precautions for storage


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


6.5 Nature and composition of immediate packaging


Container Material:

High density polyethylene bottles


Container Closure:

Polypropylene screw cap


Container Colour:

White


Container Volumes:

UK: 100 ml, 500ml (1 litre not currently marketed)

Ireland: 100 ml


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.


7. MARKETING AUTHORISATION HOLDER


UK Only:

IRL Only:

Bayer plc,

Animal Health Division,

Bayer House,

Strawberry Hill,

Newbury,

Berkshire RG14 1JA

Bayer Limited,

Animal Health Division,

Chapel Lane,

Swords,

Co. Dublin


8. MARKETING AUTHORISATION NUMBER(S)


UK Only:

IRL Only:

Vm 00010/4078

VPA 10021/21/1


9. DATE OF FIRST AUTHORISATION


UK Only:

IRL Only:

11 November 1993

01 October 1988


9.1 Last Renewal of the Authorisation


UK Only:

IRL Only:

11 November 2003

01 October 2003


10. DATE OF REVISION OF THE TEXT


UK Only:

IRL Only:

21 September 2006

27 June 2006


PROHIBITION OF SALE, SUPPLY AND/OR USE


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