A clear light yellow solution for injection containing 50mg enrofloxacin per ml and 30mg n-butanol per ml.

Calves:

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.

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 septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.

Dogs:

Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteus spp.

Cats:

Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of, e.g.: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteus spp.

Intravenous, subcutaneous or intramuscular use.
Repeated injections should be made at different injection sites.

Calves:

5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/10 kg bw, once daily for 3-5 days.
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 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/10 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 ml/10 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.

Dogs and Cats:

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for up to 5 days.
Treatment may be initiated with injectable product and maintained with enrofloxacin tablets. Duration of treatment should be based on the duration of treatment approved for the appropriate indication in the SPC of the tablet product.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

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.

Dogs under 1 year of age should not be treated with Enrofloxacin 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 Enrofloxacin until they are 18 months of age because of their longer growth period.
Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

Do not use in cats less than 8 weeks of age.

Do not use for prophylaxis.

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

Do not exceed the recommended dosage.
Repeat injections should be made at different sites.
Retinotoxic effects including blindness can occur in cats when the recommended dose is exceeded.
Occasionally skin reactions have been seen after administration to kennelled greyhounds.
Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.
In cattle and dogs, 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.

During the period of rapid growth, enrofloxacin may affect articular cartilage.
Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.
In cattle and dogs, gastrointestinal disturbances may occasionally occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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.

Combination of enrofloxacin with cloramphenicol, macrolide antibiotics or tetracyclines may produce antagonistic effects.

Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.
Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions. The decrease in drug clearances as a result of co-administration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. Thus, in dogs, the co-administration of enrofloxacin and flunixin increased the AUC and the elimination half-life of flunixin and increased the elimination half-life and reduced the Cmax of enrofloxacin.

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

In dogs and cats, lack of appetite and nausea may occur following overdose.

Overdose may result in CNS and renal dysfunction. In dogs, 10-fold over dosage results in neurological symptoms such as ataxia, tremor, nystagmus or convulsions. These symptoms are reversible on cessation of treatment.
No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.
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.

In accidental overdose, there is no antidote and treatment should be symptomatic.

The product is an alkaline solution. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves. 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.

Calves:

Following intravenous injection: Meat and offal: 5 days.
Following subcutaneous injection: Meat and offal: 12 days.
Not authorised for use in animals producing milk for human consumption.

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.

Dispose of any unused product or empty containers in accordance with guidance from your local waste regulation authority.

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