Florfenicol 40 mg/g.
Each gram of product contains:
Florfenicol (active substance): 40 mg
Pigs (fattening pigs).
Pigs (fattening): for treatment and metaphylaxis of Swine Respiratory Disease associated with Mycoplasma spp. Pasteurella multocida, Actinobacillus pleuropneumoniae, Haemophillus parasuis, Streptococcus suis, Salmonella choleraesuis, Bordetella bronchiseptica and other bacteria florfenicol-susceptible.
To be administered orally, in feed, in dose of 10 mg of florfenicol per kg body weight (bw) (equivalent to 250 mg Florfenidem premix/kg bw) per day administered for 5 consecutive days.
In order to obtain the appropriate dosage (depending on the dose of florfenicol/kg body weight and the average daily feed intake), the inclusion rate of the premix may be increased.
The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorization Holder.
- Side effects
- Correct administration
- Withdrawal period
- Other information
Do not administer to boars intended for breeding purposes.
Do not use in the case of known hypersensitivity to the active substance or to any of the excipients.
Commonly observed adverse effects are diarrhoea perianal inflammation and rectal eversion. These effects are transient, resolving on 10 days after cessation of treatment.
Special precautions for storage
Keep away from reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening of primary package: 28 days.
Shelf life after incorporation into meal or pelleted feed: 3 months.
Do not use after expiry date which is stated on the label.
Advice on correct administration
This product must be incorporated by feed manufacturers under specialist supervision. 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 (not more than 85oC).
Meat and offal: 16 days.
Use of the product should be based on susceptibility testing of the bacteria isolated from animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions may increase the prevalence of bacteria resistant to florfenicol and may decrease the effectiveness of treatment with other amphenicols due to the potential for cross resistance.
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 5kg/ton. Treatment should not exceed 5 days.
Skin sensitisation may occur. Avoid skin contact. Do not handle this product in case of known sensitization 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. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice and show the package leaflet or label to the physician. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.
The safety of the product during pregnancy and lactation has not been studied in sows. Use of the product during pregnancy and lactation is therefore not recommended.
In the event of overdose, a reduction in food and water consumption, together with a decrease in bodyweight may be observed, diarrhoea perianal inflammation and rectal eversion. There may be an increase in refused feed. These signs are transient and disappear within 14 days of cessation of treatment.
Special precautions for the disposal of unused product or waste materials
For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Bags 100g, 500g, 1kg, 5kg or 10 kg premix.
Not all pack sizes may be marketed.