Target species
Pigs (for fattening).
Indications for use
For the treatment and metaphylaxis of swine respiratory disease caused by Pasteurella multocida susceptible to florfenicol in infected herds. The presence of the disease in the herd must be established before the product is used.
Contraindications
Do not administer to boars intended for breeding.
Do not use in case of hypersensitivity to the active substance or any of the excipients.
Special warnings for each target species
Animals showing a decreased appetite and/or a poor general condition should be treated by the parenteral route.
Special precautions for use
SSpecial precautions for safe use in the target species:
The veterinary medicinal product should be used in conjunction with susceptibility testing and take into account official and local policy relating to the use of antimicrobials.
This veterinary medicinal product is intended for the manufacturing of solid medicated feed and cannot be used as it is; the incorporation rate of the veterinary medicinal product in feed cannot be lower than 5 kg/ton.
This veterinary medicinal product contains ground limestone, which can lead to a decrease in food consumption and to a phosphorus calcium imbalance in feed intake. Care should therefore be taken to consider the calcium content of the final medicated feed.
Treatment should not exceed 5 days.
In a field clinical study, within a week after the administration of the last dose, the incidence of pigs presenting either mild depression and/or mild dyspnea and/or pyrexia (40 °C) was approx. 20 % in the initially severely ill animals.
Operator warnings
Skin sensitisation may occur.
Avoid skin contact.
People with known hypersensitivity to florfenicol or any of the excipients should avoid contact with the veterinary medicinal product. Handle this veterinary medicinal product with care to avoid exposure during incorporation of the veterinary medicinal product into feed and administration of feed to animals, taking all recommended precautions.
Wear either a disposable half-mask respirator conforming to European standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143, chemically resistant gloves, protective coveralls and goggles while incorporating the veterinary medicinal product into feed.
Wear gloves and do not smoke, eat, or drink when handling the veterinary medicinal product or medicated feed.
Wash hands thoroughly with soap and water after use of the veterinary medicinal product or medicated feed.
Rinse thoroughly with water in case of exposure.
If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Manure from treated swine must be stored for a minimum of one month before being spread and incorporated in fields.
Adverse reactions
Pigs (for fattening):
Common (1 to 10 animals / 100 animals treated): | Diarrhoea1, Perianal inflammation1, Rectal prolapse1 |
Undetermined frequency (cannot be estimated from available data) | Hypercalcaemia1 |
1These effects are transient, resolving on cessation 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 the package leaflet for respective contact details.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation.
Interactions
None known.
Amounts to be administered and administration route
Oral use.
Dosage:
10 mg of florfenicol per kg body weight (equivalent to 250 mg veterinary medicinal product) per day administered for 5 consecutive days.
Administration:
For a daily feed intake of 50 g/kg body weight, this dosage corresponds to a rate of incorporation of 5 kg of the veterinary medicinal product per ton of feed, i.e. 200 ppm of florfenicol.
The rate of incorporation of the veterinary medicinal product in the feed may be increased in order to achieve the required dosage on an mg/kg body weight basis and to take into account the actual feed intake. Thus, the inclusion level may need adjusting as follows to give the correct dose.
The maximum rate of incorporation is 12.5 kg/ton (500 ppm of florfenicol); higher rates of inclusion may lead to poor palatability and decreased food consumption.
Under no circumstances should the incorporation rate of the veterinary medicinal product be below 5 kg/ton of feed.
In all cases the recommended dose of 10 mg of florfenicol per kg of body weight per day, for 5 consecutive days has to be respected.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The required dose should be measured by suitably calibrated weighing equipment.
A horizontal ribbon mixer should be used to incorporate the veterinary medicinal product into the feeding stuff. It is recommended that the veterinary medicinal product is added to the mixer containing the feeding stuff ingredients and mixed thoroughly to produce a homogeneous medicated feeding stuff. Medicated feed may also then be pelleted. Pelleting conditions include a pre-conditioning step with steam and then the mixture is passed through a pelleter or extruder under normal conditions.
Overdose
In the event of overdose, a reduction in food and water consumption, together with a decrease in bodyweight may be observed. There may be an increase in refused feed and an increase in serum calcium.
Withdrawal periods
Meat and offal: 14 days.