1 ml of the solution for injection contains:

Florfenicol 450 mg

N-methylpyrrolidone 350 mg

For the full list of excipients, see section “Pharmaceutical particulars”.

Clear, colourless to yellow solution for injection

Cattle.

Metaphylactic 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 metaphylactic treatment.

Do not use in adult bulls intended for breeding purposes.

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

None.

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.

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.

Laboratory studies in rabbits and rats with the excipient N-methylpyrrolidone have shown evidence of foetotoxic 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.

The veterinary medicinal product may cause hypersensitivity (allergy) in some people. People with known hypersensitivity to florfenicol should avoid contact with the veterinary medicinal product.

Cattle:

1 After injection of the product at the maximum recommended volume of 10 ml per injection site.

2 Transient.

3 Lasting for some days.

4 Lasting up to 61 days after subcutaneous and up to 24 days after intramuscular injection.

5 Seen at necropsy and lasting for 37 days after intramuscular injection.

6 Quick and complete recovery upon termination of treatment.

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 “Contact details” of the package leaflet.

The safety of the veterinary medicinal product has not been established in cattle

during pregnancy, lactation or in animals intended for breeding. Studies in laboratory

animals have not revealed any evidence of embryo- or foetotoxic potential for

florfenicol. Laboratory studies in rabbits and rats with the excipient N-

methylpyrrolidone have shown evidence of foetotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Do not use in adult bulls intended for breeding (see section “Contraindications”).

None known.

Subcutaneous use: 40 mg/kg body weight (4 ml/45 kg) to be administered once only.

Intramuscular use: 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.

No data available

Meat and offal:

Subcutaneous use (at 40 mg/kg body weight, once): 64 days.

Intramuscular use (at 20 mg/kg body weight, twice): 37 days.

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

ATCvet code: QJ01BA90

Antibacterials for systemic use

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 and time-dependent. 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 demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following breakpoints have been determined for florfenicol in bovine respiratory disease: susceptible: ≤2 µg/ml, intermediate: 4 µg/ml, resistant: ≥8 µg/ml.

Resistance to florfenicol is mainly mediated by an efflux system due to specific (flo-R) or multidrug transporters (AcrAB-TolC). The genes corresponding to these mechanisms are coded on mobile genetic elements such as plasmids, transposons or genes cassettes.

Surveillance data of the susceptibility of target field isolates from cattle collected between 1995 and 2009 across Europe show a constant activity of florfenicol with no finding of resistant isolates. In the recent literature, one resistant isolate of P. multocida was reported from a calf in Germany in 2007 harbouring a plasmid mediated flo-R. No co-resistance to other antibiotic families was observed. Cross-resistance with chloramphenicol can occur.

Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium and co-resistance with the third-generation cephalosporins has been observed in respiratory and digestive Escherichia Coli. This has not been observed for the target pathogens.

After parenteral application florfenicol is mainly excreted via urine and to a small extent via faeces, mainly as parent compound but also followed by florfenicol amine and florfenicol oxamic acid.

The administration of the product by the subcutaneous route at the recommended dose of 40 mg/kg maintained efficacious plasma levels of florfenicol in cattle above the MIC90 of 0.5 µg/ml and 1.0 µg/ml for 90.7 hours and 33.8 hours, respectively. Maximum mean serum concentration (Cmax) of 1.8 µg/ml occurred 7 hours (Tmax) after dosing.

The administration of the product by the intramuscular route at the recommended dose of 20 mg/kg maintained efficacious plasma levels of florfenicol in cattle above the MIC90 of 0.5 µg/ml and 1.0 µg/ml for 48.7 hours and 30.3 hours, respectively. Maximum mean serum concentration (Cmax) of 3.0 µg/ml occurred 6 hours (Tmax) after dosing.

N-methylpyrrolidone

Diethylene glycol monoethyl ether

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

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

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

Keep the vial in the outer carton in order to protect from light.

Colourless type II glass multiple dose vials, sealed with bromobutyl rubber stoppers secured with aluminium overseal.

Pack sizes:

1 vial of 50 ml in a cardboard box

1 vial of 100 ml in a cardboard box

1 vial of 250 ml in a cardboard box

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

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

UK(GB): Vm 01708/5096

UK(NI): Vm 01708/3026

03 October 2008

January 2025.

For animal treatment only. Keep out of the sight and reach of children.