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Contra-indications, warnings, etc
Do not use for prophylaxis.
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
Do not use in animals with seizures.
Do not use in growing horses because of possible deleterious damage on articular cartilage.
Adverse reactions
Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Special Precautions for use in animals
Do not exceed the recommended dosage.
Repeat injections should be made at different sites.
The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups.
Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.
In cattle, 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.
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
Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Overdose
Do not exceed the recommended dose.
In accidental overdose (lethargy, anorexia) there is no antidote and treatment should be symptomatic.
No signs of over dosage were observed in pigs following administration of the product at five times the recommended therapeutic dose.
User warnings
The product is an alkaline solution. Wash any splashes from skin and eyes immediately with water.
Do not eat, drink or smoke whilst using the product. Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves.
Care should be taken to avoid accidental self-injection. If accidental injection occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal period
Cattle:
Following intravenous injection:
Meat and offal: 5 days.
Milk: 3 days.
Following subcutaneous injection:
Meat and offal: 12 days.
Milk: 4 days.
Pigs:
Meat and offal: 13 days.