Introduction

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Company name: Bayer plc

Address: Animal Health Division

Bayer House, Strawberry Hill,

Newbury

Berkshire RG14 1JA

Telephone: 01635 563000

Fax: 01635 563622

Email: animal.health@bayerhealthcare.com

Website: www.bayer.co.uk/products/animalhealth.html

Presentation

Baytril Piglet Doser is a clear aqueous solution for oral use containing as active ingredient, 5 mg/ml enrofloxacin with 14 mg/ml benzyl alcohol as a preservative.

Uses

The product is for use in the treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), and multifactorial diseases such as atrophic rhinitis and enzootic pneumonia, where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

Dosage and administration

Dose rate is 1.5 – 5 mg enrofloxacin/kg bodyweight daily. The contents of Baytril Piglet Doser are administered orally using the dosing pump. 1 pump stroke delivers 1 ml.

For piglets up to 3 kg bodyweight – 1 ml once daily for 3 to 5 days

For piglets 3 kg up to 10 kg bodyweight – 3 ml once daily for 3 to 5 days

Contra-indications, warnings, etc

The product should not be used for prophylaxis.

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.

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

Consumer Safety

Withdrawal Period: Piglets: Meat: 10 days

User Safety

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 while using the product.

Environmental Safety

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

Pharmaceutical precautions

Do not store above 25°C.

Following withdrawal of the first dose, use the product within 28 days.

Discard unused material.

Legal category

POM-V

Packaging Quantities

White high density polyethylene bottles with polypropylene screw cap containing 100 ml.

Dosing Device: a polypropylene/polyethylene/stainless steel pump dispensing 1ml

Further information

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It 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 standard 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 oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that 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, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.