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.
Special Precautions for use in animals
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.
Adverse reactions
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.
Use during pregnancy and lactation
There is no restriction on the use of this product during pregnancy and lactation.
Interactions
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.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Overdose
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.
User warnings
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.
Withdrawal period(s)
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.