Kefloril 300mg/ml Solution for injection for cattle and pigs
Contra-indications, warnings, etc
Do not administer to boars and adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
Swab the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.
Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure.
Care should be taken to avoid accidental self-injection.
In case of accidental self injection, seek medical advice and show the label to the doctor.
Do not use the product in known cases of sensitivity to propylene glycol and polyethylene glycols.
Avoid direct contact with skin, eyes or mouth.
In case of accidental spillage of the solution onto skin, wash off immediately with soap and water.
In case of accidental contact with eyes, rinse immediately with plenty of water.
Adverse reactions (frequency and seriousness)
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/ oedema which may affect 50% of the animals. These effects can be observed for one week.
Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.
A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
Administration of the product by the intramuscular route may cause swelling at the injection site which may persist for 14 days. Inflammation at the injection site may persist up to 32 days after administration.
Administration of the product by the subcutaneous route may cause swelling and inflammation at the injection site which may persist at least for 41 days.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol.
Swine: the safety of the product in sows during pregnancy and lactation has not been demonstrated. Use of the product during pregnancy and lactation is therefore not recommended.
Cattle: the effect of florfenicol on bovine reproductive performance and pregnancy has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed.
After administration of 5 times the recommended dose or more vomiting has also been noted.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Meat and offal: 18 days
Meat and offal: by IM (at 20 mg/kg bodyweight, twice): 30 days
by SC (at 40 mg/kg bodyweight, once): 44 days
Milk: Not permitted for use in lactating animals producing milk for human consumption.