Target species
Cattle and pigs.
Indications for use, specifying the target species
Cattle:
Treatment of respiratory tract infections due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.
Pigs:
Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Contraindications
Do not use in adult bulls or boars intended for breeding purposes.
Do not administer in cases of hypersensitivity to the active ingredient or any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Wipe the stopper before removing each dose. Use a dry, sterile needle and syringe.
Do not use in piglets of less than 2 kg.
Under field conditions, approximately 30% of treated pigs presented with pyrexia (40°C) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose.
Use of 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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the florfenicol and may decrease the effectiveness of treatment with other antimicrobials, due to the potential for cross-resistance. Particular attention should be paid to improving farming practices to avoid any stress condition (improving management practices and by cleaning and disinfection).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken when handling the product to avoid accidental self-injection. In case of accidental self-injection, seek medical advice, and show the package leaflet or the label to the physician.
People with known hypersensitivity to the components of the formulation should avoid contact with the product.
Wash hands after handling the product.
Adverse reactions (frequency and seriousness)
Cattle:
A decrease in food consumption and transient softening of the faeces may occur during the treatment period. Treated animals recover quickly and completely upon termination of treatment.
Administration of the product by the intramuscular route may cause inflammatory lesions at the injection site which may persist for up to 28 days.
Pigs:
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals. These effects may be observed for up to one week.
Administration of the product by the intramuscular route may cause inflammatory lesions at injection site which disappear within 28 days.
Use during pregnancy, lactation or lay
Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic potential for florfenicol. However, the safety of florfenicol on bovine and porcine reproductive performance and pregnancy has not been assessed. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Intramuscular use.
The injection should be given in the neck.
Cattle:
20 mg florfenicol per kg bodyweight, i.e. 1 ml of solution per 15 kg bodyweight, twice 48 hours apart.
Pigs:
15 mg florfenicol per kg bodyweight, i.e. 1 ml of solution per 20 kg bodyweight, twice 48 hours apart.
The dose volume given at any one injection site should not exceed 10 ml in cattle and 3 ml in pigs.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In swine after intramuscular 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.
Withdrawal period(s)
Cattle:
Meat and offal: 37 days
Milk: Not permitted for use in lactating animals producing milk for human consumption.
Pigs:
Meat and offal: 18 days