FLORFENIDEM 50 premix

Medicated Premix


500 mg/g, premix for medicated feed for pigs, poultry and fish.
NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT:
SC DELOS IMPEX ’96 SRL, Str. Horia, Cloşca şi Crişan, nr. 81, Otopeni, jud. Ilfov
Tel:0372.714.433, Fax: 0372.714.460.

NAME OF THE VETERINARY MEDICINAL PRODUCT:

FLORFENIDEM 50, 500 mg/g, premix for medicated feed for pigs, poultry and fish.

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS:1 gram FLORFENIDEM 50 contains: Florfenicol 500 mg, Excipient (lactose monohydrate) qs. ad. 1 g
INDICATIONS
Poultry:for the treatment of respiratory or digestive infections, primary and secondary caused by Pasteurella multocida, Bordetella bronchiseptica, Salmonella spp., Escherichia coli, Haemophilus spp., Staphylococus spp., Streptococus spp., Ornithobacterium rhinotracheale and other microorganisms florfenicol susceptible.
Pigs:is recommended for the treatment of respiratory or digestive infections, primary and secondary caused by: Pasteurella multocida, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Salmonella spp., Escherichia coli, Haemophilus parasuis, Staphylococus spp, Streptococus suis, Mycoplasma spp. and other microorganisms florfenicol susceptible.
Fish:furunculosis, vibriosis, yersiniosis and other bacterial diseases produced by bacteria susceptible to florfenicol.

CONTRAINDICATIONS: Do not administer to animals susceptible to florfenicol. The product should not be administered to sows in gestation and lactation period and breeding boars.

ADVERSE REACTIONS: None.
TARGET SPECIES:Swine, Poultry, Fish.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Poultry:the therapeutically dosage is 20 mg florfenicol/kg body weight/day (equivalent with 40 mg Florfenidem 50/ kg body weight) administered in feed, for 3-5 consecutive days.
Pigs: the therapeutically dosage is 10 mg florfenicol (equivalent with 20 mg Florfenidem 50 / kg body weight / day) administered in feed, for 3-5 consecutive days.
Fish: Florfenidem 50 is administered mixed with feed, in dosage of 10-20 mg Florfenidem 50/kg fish/day, for 10 consecutive days.
Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of Florfenidem 50 should be calculated according to the following formula:

Florfenidem 50

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.
In some fish species, the uptake of medicated feed depends on water temperature. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.

ADVICE ON CORRECT ADMINISTRATION: The product should be well mixed with the feed to ensure a proper dispersion. During treatment, the animals should eat only medicated feed.

WITHDRAWAL PERIOD
Pigs(meat and offal): 20 days from cessation of oral medication.Poultry(meat and offal): 2 days from cessation of oral medication. Forfish meat: 180degree-daysfrom cessation of oral medication. Not authorised for use in laying birds producing eggs for human consumption.
SPECIAL PRECAUTIONS FOR STORAGE: Keep in original packaging, at temperatures below 25oC, protected from moisture and direct sunlight. Medicated feed is valid for 7 days from the date of the mixture. Shelf-life after first opening the immediate packaging: 7 days. Do not use after expiry date stated on the label. Keep away from reach and sight of children!

SPECIAL WARNINGS
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
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 gloves, eye-glasses and protective masks should be worn when handling the product. 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 with caution in pregnant or lactating animals and only after the assessment of risk/benefit ratio. In pigs, a dose 5 times higher than recommended dose could lead in some animals to a decreased feed intake, diarrhoea, perineal congestion and loss of weight. Remove medicated feed and institute the symptomatic therapy. These signs disappear after 14 days from cessation of medication.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
For the environmental protection, the veterinary medicinal product 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. During the treatment the animals should be housed throughout entire treatment period and the manure should not be used as grassland fertilizer.

OTHER INFORMATION
Presentation: bags of 10 g, 25 g, 50g, 100 g, 500 g, 1000 g, 5 kg, 10 kg, sacks of 25 kg, 50 kg. Not all pack size may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorization holder.