Do not use in adult bulls intended for breeding purposes.

Do not use in animals suffering from hepatic and renal diseases.

Do not use if there is a risk of gastrointestinal bleeding or in cases where there is evidence of altered haemostasis.

Do not use in animals suffering from cardiac diseases.

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

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Official and local antimicrobial policies should be taken into account when the product is used.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol.

Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

Repeated daily dosing has been associated with abomasal erosions in the pre-ruminant calf. The product should be used with caution in this age group.

The safety of the product has not been tested in calves of 3 weeks of age or less.

Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.

Care should be taken to avoid accidental self-injection.

People with known hypersensitivity to propylene glycol and polyethylene glycols should avoid contact with the veterinary medicinal product.

Wash hands after use.

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

Cattle:

2these reactions may be fatal.

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 the package leaflet for respective contact details.

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

Subcutaneous use.

40 mg/kg florfenicol and 2.2 mg/kg flunixin (2 ml/15 kg body weight) to be administered by a single injection. To ensure a correct dosage, body weight should be determined as accurately as possible. The dose volume given at any one injection site should not exceed 10 ml.

It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment 48 hours after injection. The anti-inflammatory component of the veterinary medicinal product, flunixin, may mask a poor bacteriological response to florfenicol in the first 24 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

The injection should only be given in the neck.

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

Meat and offal: 46 days.

Milk: Not authorised for use in animals producing milk for human consumption. Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months of expected parturition.