FLORFENIDEM 10%

Oral Solution

100 mg florfenicol /ml, oral solution for pigs and poultry.

NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT: 

S.C. Delos Impex ’96 S.R.L. 81, Horia, Closca si Crisan Street, Otopeni, Ilfov District, Romania Tel./Fax +0040-372 714 433

NAME OF THE VETERINARY MEDICINAL PRODUCT: Florfenidem 10%, as florfenicol 100 mg/ml, oral solution for pigs and poultry.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Florfenidem 10% is a viscous, yellowish solution. Each ml of Florfenidem 10% contains: Florfenicol (active substance) 100 mg, Excipients ad.1 ml.

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, Micoplasma 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 rhinotrachealeand Corynebacterium pyogenes.

CONTRAINDICATIONS: Do not administer in animals with known hypersensitivity at amphenicols. Do not administer to pregnant sows or in lactation period and breeding boars.

ADVERSE REACTIONS

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.

TARGET SPECIES: Pigs and poultry.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF 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 1,5 – 2 mg florfenicol/kg body weight/day (b.w.) for 5-7 days:

in youngster pigs 1,5 ml product/ 100 kg b.w./day and

in adult pigs 2 ml/100kg b.w./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.
Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Florfenidem 10% should be calculated according to the following formula:

Florfenidem 10

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.

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

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 PRECAUTIONS FOR STORAGE

Keep away from reach and sight of children! Store in original packaging, at temperature 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 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.
SPECIAL WARNINGS

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. 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 products should be disposed of in accordance with local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

August 2011

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.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.