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Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance, to other (fluoro)quinolones or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (due to the potential for cross resistance).
Use of fluoroquinolones should be based on susceptibility testing and take into account official and local antimicrobial use policies. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions which have responded poorly to other classes of antimicrobials. Efficacy against gram positive strains has not been established.
For fluoroquinolones as a class, over-dosage at multiples of the recommended dose has been shown to induce erosion of articular cartilage. Care should be taken to dose accurately and the veterinary medicinal product should be used with caution in animals with joint disease or cartilage growth disorders.
Use of the veterinary medicinal product deviating from the instructions given above may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
1 In sensitive animals, immediate or delayed.
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 also ‘Contact details’ of the package leaflet.
At doses of three times the therapeutic dose (18 mg/kg bw), erythema of the nasal and ocular mucosae was induced and food intake was reduced. At even higher doses and prolonged exposure, there was damage to the cartilage in the joints and some animals displayed paresis, ataxia or nystagmus.
Studies in laboratory animals have shown adverse effects on reproduction. At high doses in rats (100 to 200 mg/kg/day), increase in foetal delayed ossification and in dilation of the cerebral ventricles were observed. Dams given high doses produced fewer live pups per litter and pup weight and survival were adversely affected. The safety of the product has not been established during pregnancy in cows.
The safety of the veterinary medicinal product has not been established during pregnancy in cows nor assessed in breeding bulls.
Withdrawal period
Meat and offal: 8 days.
Milk: 4 days.
Operator warnings
People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product.
Care should be taken to avoid accidental self-injection as it can induce a slight irritation. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
In case of contact with skin or eyes rinse with plenty of water.
Wash hands after use. Do not eat, drink or smoke during application.