Target Species
Cattle
Indications for use
Preventive and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol. The presence of the disease in the herd should be confirmed before administering preventive treatment.
Contraindications
Do not use in adult bulls intended for breeding purposes.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.
Do not use where resistance to florfenicol or other amphenicols is known to occur. Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to florfenicol and other amphenicols.
The prolonged or repeated use of the veterinary medicinal product should be avoided by improving farming management practices, cleaning and disinfection measures and eliminating any stress condition.
Operator warnings
Care should be taken to avoid accidental self-injection. In case of self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Avoid direct contact with skin, mouth and eyes. Wash hands after treatment.
Adverse Reactions
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.
Subcutaneous injection of the product at the maximum recommended volume of 10 ml per injection site may cause transient local algesia and clinically obvious swelling at the injection site. Local algesia may persist for some days. Injection site swellings decrease over time but may persist for up to 61 days.
Intramuscular injection of the product at the maximum recommended volume of 10 ml per injection site may cause transient local algesia and clinically obvious swelling at the injection site. Local algesia may persist for some days. Injection site swellings decrease over time but may persist for up to 24 days. Inflammatory lesions at the injection site (seen at necropsy) may persist for 37 days after injection.
Use during pregnancy or lactation
Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol.
However, 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.
Interactions
None known.
Amounts to be administered and administration route
SC route: 40 mg/kg body weight (4 ml/45 kg) to be administered once only.
IM route: 20 mg/kg body weight (2 ml/45 kg) to be administered twice 48 hours apart.
The injection should only be given in the neck. The dose volume given at any one injection site should not exceed 10 ml.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Swab septum before removing each dose. Use a dry, sterile needle and syringe.
For 250 ml vials, do not broach the vial more than 25 times.
Overdose
No data available
Withdrawal periods
Meat and offal:
by SC (at 40 mg/kg body weight, once): 64 days
by IM (at 20 mg/kg bodyweight, twice): 37 days Not permitted for use in lactating animals producing milk for human consumption.