Clear light yellow to yellow solution for injection. 1ml of solution for injection contains 300mg florfenical and following excipients; Dimethyl sulfoxide Propylene glycol and Macrogol 400.

Diseases caused by florfenicol susceptible bacteria.    

Treatment and metaphylaxis of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, where the presence of the disease in the herd has been established.

IM route: 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart.

SC route: 40 mg/kg bodyweight (2 ml/15 kg) to be administered once only using a 16 gauge needle.

SC route: 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.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid under dosing.

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.

Do not use in adult bulls intended for breeding purposes.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in case of resistance to the active substance.

Swab septum before removing each dose. Use a dry, sterile syringe and needle.

The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and may decrease the effectiveness of treatment with other amfenicols, due to the potential for cross resistance.

Care should be taken to avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not use the product in known cases of sensitivity to propylene glycol.

None.

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.

On very rare occasions, anaphylactic reactions have been reported.

None known.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Meat & Offal:

by IM (at 20 mg/kg bodyweight, twice): 30 days

by SC (at 40 mg/kg bodyweight, once): 44 days

Not authorised for use in animals producing milk for human consumption.

This veterinary medicinal product does not require any special storage conditions.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate container: 28 days

Type I amber glass bottle containing 100ml or 250ml solution for injection with bromobutyl rubber stopper and aluminium seal, in a cardboard box.

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Antibacterials for systemic use, Amphenicols,

ATCvet code: QJ01BA90

Florfenicol is a synthetic broad spectrum antibiotic effective against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

Florfenicol is considered to be a bacteriostatic agent, but in vitro studies of florfenicol demonstrated bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

Acquired resistance to florfenicol is mediated by efflux pump resistance associated with a floR gene. Such resistance has been identified in the target pathogens Pasteurella multocida and Mannhemia haemolytica. Cross resistance with chloramphenicol can occur. Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium. Co-resistance with the third-generation cephalosporins has been observed in respiratory and digestive Escherichia coli.

Intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels in cattle for 48 hours. Maximum mean plasma concentration (Cmax) of 3.86 μg/ml occurs at 5 hours (Tmax), after dosing. The mean plasma concentration 24 hours after dosing was 1.56 μg/ml. The harmonic mean elimination half life was 18.8 hours.

After subcutaneous administration of the recommended dose of 40 mg florfenicol/kg b.w., maximum plasma concentration (Cmax) of approximately 3.5 μg/ml occurs approximately 7.0 hours (Tmax) after dosing. The mean plasma concentration 24 hours after dosing is approximately 2 μg/ml.

Vm 01656/4026