ANTIBIOTIC

Florfenidem 10%

100 mg florfenicol /ml | oral solution for pigs and poultry

Formula

1 ml Florfenidem 10% contains:

Florfenicol 100 mg

Excipients (N-methyl-2-pyrrolidone, Propylene glycol, Polyethylene glycol (PEG300) qs.ad. 1 ml

Target species

Pigs and poultry.

Indications

In pigs: for treatment of respiratory and digestive infections pro- duced by susceptible bacteria: Pasteurella multocida, Pasteurella haemolitica, Actinobacillus pleuropneumoniae, Bordetella bronchi- septica, Salmonella spp., Escherichia coli, Haemophilus parasuis, Staphylococus spp., Streptococus suis, Corynebacterium pyogenes, Shigella spp., Klebsiella pneumoniae, Micoplasma spp.

In poultry: for treatment of respiratory and digestive bacterial infec- tions produced by susceptible bacteria: Pasteurella multocida, Borde- tella bronchiseptica, Salmonella spp., Escherichia coli, Haemophilus paragalinarum, Staphylococus spp., Streptococus spp., Ornithobacte- rium rhinotracheale and Corynebacterium pyogenes.

Administration

The product is administered via drinking water in pigs and poultry as following:
In pigs: the product is administered via drinking water in dosage of 10 mg florfenicol/kg body weight/day (b.w.) for 5-7 days:

0, 1 ml Florfenidem 10% / kg bodyn weight/ day

In poultry: 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.

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

Do not administer in animals with known hypersensitivity at am- phenicols. Do not administer to pregnant sows or in lactation period and breeding boars.

Side effects

Local (digestive) and systemic reactions are infrequently and tran- sient, mainly in animals susceptible to phenicols or treated with flo- rfenicol 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 bellow (15 – 25°C), 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 direc- tions: 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 ad- ministered once in 12 hours. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing

Withdrawal period

For pig meat: 1 day from the last administration. For poultry meat: 2 days from the last administration. Not permitted for use in laying bird producing eggs for human consumption.

Special warnings

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To pre- vent 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 flor- fenicol 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 dif- ficulties, need immediate medical attention. Whenever possible, the treatments should be based on susceptibility testing of the bacteria isolated from the animal. If this isn’t possible, the treatment should be done as per official and local antimicrobial policies.

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 prod- ucts 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, and 20 l.
Not all pack sizes may be marketed.