Target species
Cattle & pigs.
Indications for use, specifying the target species
In cattle: Indicated in the treatment of respiratory infections caused by susceptible strains of organisms. It is also indicated in the treatment of acute E. coli mastitis.
In pigs: Indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms.
Contra-indications
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 warnings for each target species
None
Special precautions for use
i. 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 prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals.
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, lactation or lay
May be used in pregnant and lactating cows and sows.
Interaction with other medicinal products and other forms of interaction
None
Amounts to be administered and administration route
The recommended dosage is 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular, subcutaneous or intravenous routes in cattle and by intramuscular route in pigs.
Treatment durations are 3 days in pigs and 3 to 5 days in cattle.
In order to reduce the risk of particulate contamination of the product, it is recommended that a draw-off needle be used to reduce the number of times the septum is punctured.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosage may cause acute signs in the form of neurological disorders which would have to 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 period(s)
| Meat | Milk |
Cattle | 6 days | 36 hours |
Pigs | 4 days | |