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 5% Solution for Injection is a clear sterile light yellow solution for injection containing as active ingredient enrofloxacin 50 mg/ml with 30 mg/ml n-butyl alcohol as a preservative.

Uses

Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.

Dogs and Cats

The product is indicated in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

Cattle

Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis) and secondary bacterial infections subsequent to viral conditions (e.g. viral pneumonia) where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

Pigs

Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal origin (e.g. pasteurellosis, actinobacillosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis) and mulifactorial 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

Dogs and Cats

1 ml product per 10 kg bodyweight (5 mg enrofloxacin per kg bodyweight) by subcutaneous injection once daily for up to 5 days. Treatment may be initiated with the injection and maintained orally with Baytril Tablets.

Cattle

0.5 ml per 10 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by subcutaneous injection for 3 days. This rate may be doubled (1 ml per 10 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 10 ml should be administered at one subcutaneous injection site.

Pigs

0.5 ml per 10 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by intramuscular injection for 3 days. This rate may be doubled (1 ml per 10 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 2.5 ml should be administered at one intramuscular injection site.

Use during pregnancy and lactation

There is no restriction on the use of this product during pregnancy and lactation.

Contra-indications, warnings, etc

Dogs under 1 year of age should not be treated with Baytril as damage to the articular cartilage may occur during the period of rapid growth, specifically in large breeds of dog. As a precaution very large breeds of dog should not be treated with Baytril until they are 18 months of age because of their longer growth period. Not for use in cats less than 8 weeks of age.

Baytril 5% Injection should not be used for prophylaxis.

Cats: Retinotoxic effects including blindness can occur when the recommended dose is exceeded. In accidental overdose there is no antidote and treatment should be symptomatic.

In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15mg/kg once daily for 21 consecutive days. Doses of 30mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50mg/kg given once daily for 21 consecutive days, blindness can occur.

Dogs: Occasionally skin reactions have been seen after administration to kennelled greyhounds.

Do not exceed the recommended dosage.

Repeat injections should be made at different sites.

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.

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

Local tissue reactions may occur at the injection site. Normal sterile precautions should be taken.

Withdrawal Periods

MEAT

Cattle: Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 14 days from the last treatment.

Pigs: Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 10 days from the last treatment.

MILK

Not to be used in animals producing milk for human consumption.

User Safety: Baytril 5% Solution for Injection is an alkaline solution. Wash any splashes from skin and eyes immediately with water.

Do not eat, drink or smoke whilst using the product.

Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately.

Pharmaceutical precautions

Do not store above 25°C.

Store in a dry place.

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

Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.

Further information

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

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 in dogs and cats 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, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.