Target species
Cattle, sheep, goats and pigs.
Indications for use, for each target species
Cattle
Treatment of infections of the respiratory tract caused by strains of Mannheimia haemolytica, Pasteurella multocida and Mycoplasma spp.
Treatment of acute severe mastitis caused by strains of Escherichia coli.
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 in cattle less than 2 years old.
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 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 urinary tract caused by strains of Escherichia coli.
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by strains of Escherichia coli and Klebsiella spp.
Treatment of infections of the alimentary tract caused by strains of Escherichia coli.
Treatment of septicaemia caused by strains of Escherichia coli.
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 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.
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.
The veterinary medicinal product should only be used in individual animals The feeding of waste milk containing residues of enrofloxacin to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
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.
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 with 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 product.
Adverse events
Cattle, sheep, goats and pigs.
Rare (1 to 10 animals / 10,000 animals treated): | Injection site inflammation1 |
Very rare (<1 animal / 10,000 animal treated, including isolated reports): | Excitation Circulatory shock2 Digestive tract disorder (e.g. diarrhoea)3 Anaphylaxis Ataxia, Seizure, Tremor |
1In pigs, after intramuscular administration. May persist up to 28 days after injection.
2In cattle, after intravenous administration.
3Mild 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
Pregnancy and Lactation:
Cattle:
The safety of the veterinary medicinal product has been established in pregnant cows during the 1st quarter of pregnancy. The veterinary medicinal product can be used in pregnant cows during the 1st quarter of pregnancy.
The use of the veterinary medicinal product in cows during the 3 last quarters of pregnancy should be based on a benefit-risk assessment by the responsible veterinarian.
Can be used during lactation.
Sheep and goats:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.
Pigs:
The safety of the veterinary medicinal product has not been established during pregnancy. Use only according to the benefit-risk assessment by the responsible veterinarian.
Can be used during lactation.
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.
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.
Cattle
5 mg of enrofloxacin/kg 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 veterinary medicinal product can be administered by slow intravenous or subcutaneous administration.
Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.
The second dose may be administered by the subcutaneous route. In this case, the withdrawal period following subcutaneous injection applies.
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/20 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/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 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.
Symptoms or 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.
In cattle, sheep and goat, overdose has not been documented.
In accidental overdose there is no antidote and treatment should be symptomatic.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance Not applicable.
Withdrawal periods
Cattle:
Meat and offal:-
s.c.: 12 days
i.v.: 5 days.
Milk:-
s.c.: 4 days
i.v.: 3 days.
Sheep:
Meat and offal: 4 days.
Milk: 72 hours.
Goats:
Meat and offal: 6 days.
Milk: 96 hours.
Pigs:
Meat and offal: 13 days.