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

Use of the veterinary medicinal 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.

Cattle:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Anaphylactic reaction

Undetermined frequency (cannot be estimated from the available data)

Reduced food intake1

Loose stool1

Injection site swelling2

Injection site inflammation3

1Quick and complete recovery upon termination of treatment.

2After intramuscular administration: may persist for 14 days; after subcutaneous administration: may persist for 41 days.

3After intramuscular administration: may persist for 32 days; after subcutaneous administration: may persist for 41 days.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.

None known.

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

Special precautions for the protection of the environment:

The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.

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.

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Vm 01656/4026