Target species
Cattle and sheep.
Indications for use
Cattle:
Diseases caused by florfenicol susceptible bacteria.
Metaphylactic and therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before metaphylactic treatment.
Sheep:
Treatment of ovine respiratory tract infections due to M. haemolytica and P. multocida susceptible to florfenicol.
Contraindications
Do not use in adult bulls and rams intended for breeding purposes.
Do not use in the 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.
The safety of the product has not been established in sheep younger than 7 weeks of age.
Operator warnings
People with known hypersensitivity to propylene glycol and polyethylene glycols should avoid contact with the veterinary medicinal product. In case of accidental contact with skin or eyes, rinse immediately with plenty of water.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of fetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.
Adverse reactions
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.
Intramuscular and subcutaneous administration may cause inflammatory lesions at the injection site which may persist for 14 days.
In very rare cases, anaphylactic shock has been reported in cattle.
Sheep:
A decrease in food consumption may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
Intramuscular administration may cause inflammatory lesions at the injection site which may persist up to 28 days. Typically, these are mild and transient.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established in cattle and sheep during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interactions
No data available.
Amounts to be administered and administration route
Swab septum before removing each dose. Use a dry sterile needle and syringe.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The vials should not be broached more than 20 times. User should therefore select the most appropriate vial size according to the target species to be treated.
When treating groups of animals at the same time, use of a draw-off needle in the vial stopper is recommended to avoid excess stopper broaching. The draw-off needle should be removed after treatment.
For treatment
Cattle:
Intramuscular use: 20 mg/kg bodyweight (1ml/15kg) to be administered twice 48 hours apart using a 16 gauge needle.
Subcutaneous use: 40 mg/kg bodyweight (2ml/15kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.
Sheep:
Intramuscular use: 20 mg florfenicol/kg bodyweight (1 ml/15 kg) to be administered daily for three consecutive days. The volume administered per injection site should not exceed 4 ml.
Pharmacokinetic studies showed that mean plasma concentrations remain above MIC90 (1 μg/ml) for up to 18 hours after administration of the product at the recommended treatment dose. The pre-clinical data supported the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml.
For metaphylaxis
Cattle:
Subcutaneous use: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle. The dose volume given at any one injection site should not exceed 10 ml.
The injection should only be given in the neck.
Overdose
Cattle:
No symptoms other than those described under Adverse reactions above. 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.
Sheep:
After administration of 3 times the recommended dose or more a transient reduction in feed and water consumption has been observed. Additional effects included an increased incidence of lethargy, emaciation and loose faeces. Head tilt was seen after administration of 5 times the recommended dose and was considered most likely a result of irritation at the injection site.
Withdrawal period
Meat and offal:
Cattle: IM use (20 mg/kg bodyweight, twice): 30 days.
SC use (40 mg/kg bodyweight, once): 44 days.
Sheep: 39 days.
Milk:
Not authorised for use in animals producing milk for human consumption including pregnant animals intended to produce milk for human consumption.