Enrofloxacin 5.0 mg per ml

Benzyl Alcohol 14.0 mg per ml

For the full list of excipients, see Pharmaceutical Particulars section

Oral solution

Clear aqueous solution

Piglets

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.

Should not be used for prophylaxis.

None known

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.

Enrofloxacin may cause hypersensitivity (allergic reactions). People with known hypersensitivity to fluoroquinolones (e.g., enrofloxacin or ciprofloxacin) should avoid any contact with the product.

The product may be irritating to skin and eyes.

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.

None.

Slight and transient digestive tract disorders may occur in very rare cases.

Not applicable – this product is only indicated for piglets

Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines, chloramphenicol). The simultaneous application of substances containing Aluminium or Magnesium can impair the absorption of Enrofloxacin.

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

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

Piglets: Meat: 10 days

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

ATC Vet Code: QJ01MA90

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.

Potassium hydroxide

Benzyl alcohol

Hypromellose

Water purified

None known.

Shelf-life of the veterinary medicinal product as packaged for sale: 30 months

Shelf-life after first opening the container: Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Do not store above 25˚C.

Container Material: High density polyethylene bottles.

Container Closure: Polypropylene screw cap.

Container Colour: White.

Container Volumes: 100 ml.

Dosing Device: Polypropylene/polyethylene/stainless steel pump dispensing 1ml

Secondary pack: Carton

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

N/A

Vm 00879/4124

11 November 1993

September 2023