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Diseases caused by florfenicol susceptible bacteria.
Cattle:
Preventive (in herds where the diagnosis was previously confirmed) and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Pigs
Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida.
Florfenicol 300 mg/ml
Do not administer to bulls and boars intended for breeding.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in piglets of less than 2 kg.
In cattle
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 and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days. Usually, these reactions are mild and transient.
In very rare cases, anaphylactic shocks have been reported in bovines.
In pigs
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals.
Under field conditions approximately 30% of treated pigs presented with pyrexia (40ºC) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose. 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.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Cattle
For treatment
IM route: 20 mg florfenicol/kg bodyweight (1ml/15 kg bw) to be administered twice 48 hours apart.
SC route: 40 mg florfenicol/kg bodyweight (2ml/15 kg bw) to be administered once only.
For prevention
SC route: 40 mg florfenicol/kg bodyweight (2ml/15 kg bw) to be administered once only.
Pigs
15 mg florfenicol/kg bodyweight (1 ml per 20 kg bw) by intramuscular injection, twice at 48-hour intervals.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
It is recommended to treat animals in the early stages of disease and to evaluate the response to treatment within 48 hours after the second injection. If clinical signs of respiratory disease persist 48 hours after the last injection, treatment should be changed using another formulation or another antibiotic and continued until clinical signs have resolved.
Swab septum before removing each dose. Use a dry sterile needle and syringe. Do not broach the vial more than 25 times.
The injection should only be given in the neck muscle using a 16 gauge needle.
The volume administered per injection site should not exceed 10 ml in cattle and 3 ml in pigs.
Cattle (meat and offal):
30 days (after IM administration).
44 days (after SC administration).
Not permitted for use in lactating animals producing milk for human consumption.
Pigs (meat and offal): 18 days.
Do not store above 25°C.
Do not refrigerate.
Protect from frost.
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological (region, farm level) information about susceptibility of the target bacteria. Use of the product deviating from the instructions in the SPC may increase the risk of development and selection of florfenicol-resistant bacteria and decrease the effectiveness of treatment with other amphenicols due to the potential for cross-resistance.
Official, national and regional antimicrobial policies will be considered when using the product.
Special precautions to be taken by the person administering the medicinal products to animals
Do not use the product in known cases of sensitivity to active substance or excipients.
Handle this product with great care to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Direct skin contact should be avoided due to sensitization, contact dermatitis or possible hypersensitivity reactions to amphenicols that may occur. When handling the product wearing impervious gloves is recommended.
Do not eat, drink or smoke during the administration of the product.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol. However, the effect of florfenicol on target species reproductive performance, pregnancy and lactation has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
No data available.
Overdose
In cattle, 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.
In swine, 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.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Vials of 50 ml, 100 ml, 250 ml.
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