Dogs, cats, pigs (piglets), rabbits, rodents, reptiles and ornamental birds.

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.

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: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp. and Proteus spp.

Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of: Pasteurella multocida, Mycoplasma spp., 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.

Treatment of infections of the alimentary and respiratory tracts caused by enrofloxacin susceptible strains of: Escherichia coli, Pasteurella multocida and Staphylococcus spp.

Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.

Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice.

Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients.

Do not use in animals that are epileptic or suffer from seizures since enrofloxacin may cause CNS stimulation.

Do not use in young dogs during their growth, i.e. in small breeds of dogs less than 8 months of age, in big breeds of dogs less than 12 months of age, in giant breeds of dogs less than 18 months of age.

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

None.

i) Special precautions for use in animals

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 including use deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to enrofloxacin and may decrease the effectiveness of treatment with all fluoroquinolones due to the potential for cross-resistance.

Special caution should be taken when using enrofloxacin in animals with impaired renal function.

Special caution should be taken when using enrofloxacin in cats because higher doses than recommended can cause retinal damage and blindness (see Overdose section).

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

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 irritant to skin and eyes. In case of contact with skin or eyes, wash the affected area with clear running water.

Wash hands after use. Do not eat, drink or smoke whilst handling the product.

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

iii) Other precautions

In countries where feeding of fallen stock to scavenger bird populations is permitted as a conservation measure (see Commission Decision 2003/322/EC), the possible risk to hatching success should be considered before feeding carcasses of livestock recently treated with this product.

Digestive tract disorders (e.g. diarrhoea, vomiting and anorexia) may occur in very rare cases. These signs are generally mild and transient.

In very rare cases, neurological signs (seizures, tremors, ataxia, excitation) and anaphylactic reactions can also occur.

In pigs, after intramuscular administration of the product, inflammatory reactions may occur. They may persist up to 28 days after the injection.

In dogs, a moderate and transient local reaction (such as oedema) may occur.

In rabbits, reactions (from reddening to ulcerative lesions with deep loss of tissue), may occur. They may persist at least up to 17 days after the injection.

In reptiles and birds, muscle bruising may occur in very rare cases.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic effects but have shown evidence of foetotoxic effects at maternotoxic doses.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

The safety of the veterinary medicinal product has not been established during lay. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.

Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines or phenicols).

Do not use concurrently with theophylline as the elimination of theophylline may be delayed.

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 coadministration 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.

Subcutaneous or intramuscular use.

Repeated injections should be made at different injection sites.

To ensure a correct dosage, body weight (bw) should be determined as accurately as possible to avoid underdosing.

5 mg of enrofloxacin/kg bw, corresponding to 1 ml/5 kg bw, 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 product information of the tablet product.

2.5 mg of enrofloxacin/kg bw, corresponding to 1 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 of bw, corresponding to 2 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.

10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.

10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days. If necessary, depending on the severity of clinical signs, this dosage can be doubled.

Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.

Metabolism of substances and activity of the immune system are, thus, critically dependent on the body temperature. Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient. Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of Baytril 25 mg/ml solution for injection. Therefore, the recommendations made here can only be used as a starting point for individual dose setting.

5–10 mg/kg bw, corresponding to 0.2–0.4 ml/kg bw, once daily by intramuscular injection for 5 consecutive days.

An extension of the treatment interval to 48 hours may be necessary in individual cases. In complicated infections, higher dosages and longer treatment courses may be necessary. The presence of the renal portal system in reptiles means it is prudent to administer substances in the front half of the body wherever possible.

20 mg/kg bw, corresponding to 0.8 ml/kg bw, once daily by intramuscular injection for 5 to 10 consecutive days. In case of complicated infections higher doses may be necessary.

In cases of accidental overdose digestive tract disorders (e.g. vomiting, diarrhoea) and neurological disorders may occur.

In pigs, no adverse effects were reported after the administration of 5 times the recommended dose.

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

In dogs, rabbits, small rodents, reptiles and birds, overdose has not been documented.

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

Meat and offal: 13 days.

Rabbits:

Meat and offal: 6 days.

Do not use in birds intended for human consumption.