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Florfenicol 100 mg /ml.
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ANTIBIOTIC
Florfenidem 10%
Formula
Each ml of product contains:
Florfenicol (active substance) 100 mg
Target species
Pigs and chickens.
Indications
In pigs: for treatment of respiratory and digestive infections produced by susceptible bacteria: Pasteurella multocida, Pasteurella haemolitica, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Salmonella spp., Escherichia coli, Haemophilus parasuis, Staphylococus spp., Streptococus suis, Corynebacterium pyogenes, Shigella spp., Klebsiella pneumoniae, Mycoplasma spp.
In poultry: for treatment of respiratory and digestive bacterial infections produced by susceptible bacteria: Pasteurella multocida, Bordetella bronchiseptica, Salmonella spp., Escherichia coli, Haemophilus paragalinarum, Staphylococus spp., Streptococus spp., Ornithobacterium rhinotracheale and Corynebacterium pyogenes.
Administration
The product is administered via drinking water in pigs and poultry as following:
In chickens: the product is administered via drinking water in dosage of 20 mg/kg b.w.:
0.2 ml of product/kg b.w./day in birds under 4 weeks of age, and 0.4 ml of product/kg b.w./day in birds over 4 weeks of age, for 3 -5 days.
In pigs: the product is administered via drinking water in dosage of 10 mg florfenicol/kg body weight/day (corresponding with 0.1 ml Florfenidem 10%/kg b.w.) for 5 consecutive days.
The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.
For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorization Holder.
- Contraindications
- Side effects
- Storage
- Correct administration
- Withdrawal period
- Warnings
- Disposal
- Other information
Contraindications
Do not administer in animals with known hypersensitivity at florfenicol.
Do not administer to pregnant sows or in lactation period and breeding boars.
Side effects
Local (digestive) and systemic reactions are infrequently and transient, mainly in animals susceptible to phenicols or treated with florfenicol overdoses. These side effects concern the reduction of food and/or water consumption, diarrhea, peri-anal and rectal erythema/edema.
Special precautions for storage
Keep away from reach and sight of children!
Store in original packaging, at temperature below 25oC, protected from direct sunlight and freeze.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution in drinking water, according to directions: 24 hours.
Shelf-life after first opening of package: 28 days. Close tight the recipient after use.
Do not use after expiry date which is stated on the label.
Advice on correct administration
During treatment, the animals should drink only medicated water. If this is not possible the daily dosage must be divided in two and administered once in 12 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Withdrawal period
Pigs: 20 days.
Chickens: 2 days.
Not for use in birds producing or intended to produce eggs for human consumption.
Special warnings
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for florfenicol, bacteriological sampling and susceptibility testing are recommended. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given 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. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and protective masks should be worn when administering the product. The direct contact of persons with florfenicol solution should be avoided, first of all concerning eyes, skin and clothing. In case of accidental exposure, wash any splashes from eyes with water for skin exposure, wash with soap and water. Wash hands and exposed skin after use.
In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as face swelling, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.
Use during pregnancy, lactation or during the laying period
Studies performed on laboratory animals have not demonstrated teratogenic, embryotoxic or materno-toxic effects. Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian. It is not recommended to use in sows during pregnancy and lactation.
Interactions with other medicinal products or other forms of interaction
The product will not be administered simultaneously with products based on thiamphenicol or chloramphenicol.
Overdose (symptoms, emergency procedures, antidotes)
In case of overdose, intolerance phenomena may occur, especially digestive. Remove the medicated water and apply symptomatic treatment.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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
Other information
PE-HD flasks of 100 ml, 500 ml, and 1000 ml.
PE-HD cans of 5 l, 10 l.
Not all pack sizes may be marketed.
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