Cattle.

For therapeutic treatment of bovine respiratory disease (BRD) due to Histophilus somni, Mannheimia haemolytica, Pasteurella multocida and Mycoplasma bovis associated with pyrexia.

Do not use in adult bulls intended for breeding. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substances or to any of the excipients.

There is no bacterial eradication of Mycoplasma bovis. Clinical efficacy against M. bovis has only been demonstrated in mixed infections.

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

Not for use for prophylaxis or metaphylaxis.

Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity. In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old.

The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product. Dose dependent maternotoxic and foetotoxic effects have been observed after oral administration of meloxicam to pregnant rats. Therefore, the veterinary medicinal product should not be administered by pregnant women.

Cattle:

Very common (>1 animal / 10 animals treated):	Injection site swelling, injection site induration, injection site warmth, injection site pain*
Undetermined frequency (cannot be estimated from the available data):	Immediate pain upon injection**

* Usually resolve without treatment within 5 to 15 days but could persist up to 49 days.

** Pain at injection site is of moderate severity and manifested as head or neck movement.

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 the national competent authority via the national reporting system. See also the last section ‘Contact details’ of the package leaflet.

The safety of the veterinary medicinal product has not been established in breeding, pregnant and lactating animals. Use only according to the benefit-risk assessment by the responsible veterinarian.

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

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Subcutaneous use.

A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam/ kg bodyweight (i.e. 1 ml/10 kg bodyweight).

The single dose volume should not exceed 15 ml per injection site. The injection should only be given in the neck area.

To ensure a correct dosage, bodyweight should be determined as accurately as possible. For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times. Otherwise, the use of a multiple-dose syringe is recommended.

In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated, as well as a single administration of 3 times (3x) the recommended dose. Repeated weekly administration of overdoses (3x and 5x the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea. Repeated weekly administration of a 3x dose was fatal in 1 out of 8 calves after the third administration. Repeated weekly administration of a 5x dose was fatal in 7 out of 8 calves after the third administration. The extent of these adverse effects was dose-dependent. Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).

Meat and offal: 56 days.

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