A clear light yellow solution for injection containing 100mg enrofloxacin per ml and 30mg n-butanol per ml.

Treatment of bacterial infections caused by strains susceptible to enrofloxacin.

Cattle:

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma
bovis in cattle less than 2 years old.

Pigs

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp. and Actinobacillus pleuropneumoniae.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of Escherichia coli and Klebsiella spp.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

Intravenous, subcutaneous or intramuscular use.

Repeated injections should be made at different injection sites.

Cattle:

5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days.
The product can be administered by slow intravenous or subcutaneous administration.
Not more than 10 ml should be administered at one subcutaneous injection site.

Pigs:

2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1.0 ml/20 kg bw, once daily by intramuscular injection for 3 days.
In pigs, the injection should be made in the neck at the ear base.
Not more than 3 ml should be administered at one intramuscular injection site.

Do not use for prophylaxis.

Do not use when resistance / cross resistance to (Fluoro)quinolones is known to occur. Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients

Do not use in animals with seizures.

Do not use in growing horses because of possible deleterious damage on articular cartilage.

Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Do not exceed the recommended dosage.

Repeat injections should be made at different sites.

The safety of the 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.

Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

In cattle, gastrointestinal disturbances may occasionally occur.

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.

Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg bw during 14 days.

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

Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Do not exceed the recommended dose.

In accidental overdose (lethargy, anorexia) there is no antidote and treatment should be symptomatic.

No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.

The product is an alkaline solution. Wash any splashes from skin and eyes immediately with water.

Do not eat, drink or smoke whilst using the product. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.

Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician.

Cattle:

Following intravenous injection:

Meat and offal: 5 days.
Milk: 3 days.

Following subcutaneous injection:

Meat and offal: 12 days.
Milk: 4 days.

Pigs:

Meat and offal: 13 days.

Keep out of the reach and sight of children. Do not store above 25°C.

Do not use after the expiry date stated on the carton and vial after “EXP”. Shelf-life after first broaching the vial: 28 days

After first opening the immediate packaging: Do not store above 25°C.

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label.

Pack sizes: 100ml and 250ml. Not all pack sizes may be marketed.