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Contra-indications, warnings, etc
Do not use in cases of resistance to other fluoroquinolones (cross-resistance).
Do not use in cases of hypersensitivity to the active substance, to any other quinolone or to any of the excipients.
Special precautions for use in animals
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 prevelance of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Operator warnings
People with known hypersensitivity to (fluoro)quinolones should avoid using this product.
In case of contact with skin or eyes, rinse with plenty of water.
Accidental self-injection can induce a slight irritation.
In case of accidental self-injection, seek medical advice and show the label to the doctor.
Wash hands after use.
Adverse Reactions (frequency and seriousness)
Intramuscular or subcutaneous injections are well tolerated although in very rare cases transitory inflammatory lesions can occur at the injection site.
The frequency of adverse reactions is defined using the following convention:
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy and lactation
May be used in pregnant and lactating cows and sows.
Overdosage may cause acute signs in the form of neurological disorders which should be treated symptomatically.
No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.
Withdrawal periods
Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 36 hours from the last treatment.
Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 6 days from the last treatment. Pigs may be slaughtered for human consumption only after 4 days from the last treatment.