Target species
Pigs (fattening pigs)
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 hypersensivity 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
The product should be used in conjunction with susceptibility testing and take into account official and local policy relating to the use of antimicrobials. This premix is intended for the manufacturing of solid medicated feed and cannot be used as it is; the incorporation rate of the premix in feed cannot be lower than 5 kg/ton. This premix 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.
Do not handle this product in case of known sensitisation to active substance or any of the excipients.
Handle this product with care to avoid exposure during incorporation of premix 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 premix into feed.
Wear gloves and do not smoke, eat, or drink when handling the product or medicated feed.
Wash hands thoroughly with soap and water after use of the 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 take the package leaflet or the label with you.
Manure from treated swine must be stored for a minimum of one month before being spread and incorporated in fields.
Adverse reactions
Commonly observed adverse effects are diarrhoea perianal inflammation and rectal eversion. Increased serum calcium may also be observed. These effects are transient, resolving on cessation of treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
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
To be administered orally, in medicated feeding stuff.
Dosage: 10 mg of florfenicol per kg body weight (bw) (equivalent to 250 mg 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 premix per ton of feed, i.e. 200 ppm of florfenicol.
The rate of incorporation of the medicated premix in the feed may be increased in order to achieve the required dosage on a 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.
250mg Nuflor swine premix per kg body weight and day | x | Average pig body weight (kg) |
Average daily feed intake (kg/animal) |
| | |
= mg Nuflor swine premix per kg of feed |
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 premix 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 product into the feeding stuff. It is recommended that the 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.