Target species
Cattle (calves), sheep, goats, pigs, dogs and cats.
Indications for use, specifying the target species
Calves
Treatment of infections of the respiratory tract caused by strains of Mannheimia haemolytica, Pasteurella multocida, and Mycoplasma spp.
Treatment of infections of the alimentary tract caused by strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Treatment of acute mycoplasma-associated arthritis due to strains of Mycoplasma bovis
Sheep
Treatment of infections of the alimentary tract caused by strains of Escherichia coli.
Treatment of septicaemia caused by strains of Escherichia coli.
Treatment of mastitis caused by strains of Staphylococcus aureus and Escherichia coli.
Goats
Treatment of infections of the respiratory tract caused by strains of Mannheimia haemolytica and Pasteurella multocida.
Treatment of infections of the alimentary tract caused by strains of Escherichia coli.
Treatment of septicaemia caused by strains of Escherichia coli.
Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
Pigs
Treatment of infections of the respiratory tract caused by strains of Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma spp.
Treatment of infections of the alimentary tract caused by strains of Escherichia coli.
Treatment of septicaemia caused by 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 strains of Staphylococcus spp., Escherichia coli, Bordetella spp., Klebsiella spp., Pasteurella spp., Proteus spp. and Pseudomonas spp.
Cats
Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by strains of Staphylococcus spp., Escherichia coli, Bordetella spp., Proteus spp., and Pseudomonas spp.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to other fluoroquinolones or to any of the excipients.
Do not use in animals with central nervous system-associated seizure disorders.
Do not use in the presence of existing disorders of cartilage development or musculoskeletal damage around functionally significant or weight-bearing joints.
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.
Do not use in growing horses because of possible deleterious damage on articular cartilage.
Special warnings
Cross-resistance has been shown between enrofloxacin and other (fluoro)quinolones in target pathogens, e.g. Escherichia coli. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to fluoroquinolones because its effectiveness may be reduced.
A high resistance rate of Pseudomonas spp. to enrofloxacin (up to 99%) has been reported in dogs in Europe. Enrofloxacin should only be used for treatment of infections caused by this pathogen following susceptibility testing.
Special precautions for use
Special precautions for safe use in the target species
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Veterinary medicinal product should only be used in individual animals
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.
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. For cats weighing less than 5 kg, the dosage of 25 mg/ml is more appropriate to avoid risk of overdosage (see Overdose section).
Degenerative changes of articular cartilage were observed in calves treated orally with 30 mg enrofloxacin/kg body weight during 14 days.
The use of enrofloxacin in growing lambs at the recommended dose for 15 days caused histological changes in the articular cartilage, not associated to clinical signs.
Not for use for prophylaxis.
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 veterinary medicinal product.
The product may be irritating 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 veterinary medicinal product.
Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:Not applicable.
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 veterinary medicinal product.
Adverse events
Cattle (calves), sheep, goats, pigs, dogs and cats.
Rare (1 to 10 animals / 10,000 animals treated): | Injection site inflammation1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction (e.g. oedema)2,3 Excitation Digestive tract disorders (e.g. diarrhoea)4 Anaphylaxis Ataxia, Seizure, Tremor |
1In pigs, after intramuscular administration of the product. May persist up to 28 days after injection.
2In dogs, moderate and transient.
3In calves, transient may be observed up to 14 days.
4 Mild and transient.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
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.
Pregnancy and lactation:
Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
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 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.
Administration routes and dosage
Intravenous (i.v., subcutaneous (s.c.)or intramuscular (i.m) 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..
Calves
5 mg of enrofloxacin/kg 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 veterinary medicinal product can be administered by slow intravenous or subcutaneous administration.
Not more than 10 ml should be administered at one subcutaneous injection site.
Sheep and goats
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for 3 days.
Not more than 6 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 product information of the tablet product.
Symptoms of overdose (and where applicable, emergency procedures, and antidotes
In cases of accidental overdoses 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, cattle, sheep and goats, overdose has not been documented.
In accidental overdose there is no antidote and treatment should be symptomatic.
Withdrawal periods
Calves:
Meat and offal:
s.c.: 12 days
i.v.: 5 days.
Milk:
Not authorised for use in animals producing milk for human consumption.
Sheep:
Meat and offal: 4 days.
Milk: 3 days.
Goats:
Meat and offal: 6 days.
Milk: 4 days.
Pigs:
Meat and offal: 13 days.