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

A ready to use sterile aqueous solution for injection containing as active ingredient 100 mg/ml enrofloxacin, and 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.

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 infections (e.g. viral pneumonia) where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

Treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of choice.

Pigs

Diseases of the respiratory and alimentary tract 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

For subcutaneous or intravenous injection in cattle.

For intramuscular injection in pigs.

Cattle

2.5 ml per 100 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by subcutaneous injection for 3 days. This rate may be doubled (5 ml per 100 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 10 ml should be administered at any one injection site.

For E. coli mastitis: administer by slow intravenous injection.

5.0 ml per 100 kg bodyweight (5 mg enrofloxacin per kg bodyweight) daily for 2 days.

Pigs

2.5 ml per 100 kg bodyweight (2.5 mg enrofloxacin per kg bodyweight) daily by intramuscular injection for 3 days. This rate may be doubled (5 ml per 100 kg; 5 mg/kg) for 5 days for salmonellosis and complicated respiratory disease. Not more than 2.5 ml should be administered at any one injection site in store pigs or 5 ml at any one site in sows.

Use during pregnancy and lactation

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

Contra-indications, warnings, etc

Baytril 10% Solution for Injection should not be used for prophylaxis.

The safety of this product has not been established in pigs or calves when administered by the intravenous route, and use of this route of administration is not recommended in these animal groups.

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. Wherever 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 decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

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

Normal sterile precautions should be taken.

Local tissue reactions may occasionally occur at the injection site.

User safety

Baytril 10% Solution for Injection is an alkaline solution, wash any splashes from skin or 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 self injection occurs seek medical advice immediately.

Withdrawal Periods

MEAT

Cattle:

Subcutaneous Use

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

Intravenous Use

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the last treatment.

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

MILK

Subcutaneous Use

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 84 hours (i.e. 7 milkings) from the last treatment.

Intravenous Use

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be

taken from cattle after 72 hours (i.e 6 milkings) from the last treatment.

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.

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

Further information

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

Enrofloxacin is bactericidal in action with activity against a wide range of 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.

Molecular resistance to fluoroquinolones has been observed to arise from two principal sources, (i) alteration to DNA gyrase or topoisomerase IV and (ii) alterations in drug permeability of the bacterial cell. Both mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Clinical resistance is dependent on several mutations accumulating in a step-wise manner. 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 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.

After an intravenous dose of 5 mg enrofloxacin per kg body weight (bw) to lactating dairy cattle, the total systemic exposure over the dosing interval of 24 h was at 7.1 mg*h/L. In cattle serum, approximately 30% of drug exposure (2.31 mg*h/L) consisted of ciprofloxacin, the active metabolite of enrofloxacin. The drug was well distributed into the body compartments (Venro = 1.5 L/kg, Vcipro = 8.51 L/kg). Total body clearance was 0.71 L/h/kg. In milk, most of drug activity consisted of ciprofloxacin. Overall drug concentrations peaked at 4.1 mg/kg two hours after treatment. Overall drug exposure over 24 h was

22.1 mg*h/L. The actives were eliminated from milk with a mean exposure half-life of 2.8 h.