Biofenicol 500

Oral Powder for Veterinary Use

Pharmacotherapeutic Group: Systemic antibacterial agent

Active Ingredient: Florfenicol (500 mg per 1 g of powder)

Excipients: Lactose (500 mg per 1 g of powder)

Target Species: Poultry (broilers, ducks, geese), pigs, fish

Description: White or yellowish powder

Packaging: 500 g of powder in a white polyethylene container

Pharmacological Properties

Florfenicol is a synthetic antibiotic, a derivative of thiamphenicol, with a broader spectrum of activity. Unlike chloramphenicol, it contains a p-methylsulfonyl group instead of a p-nitro group. Florfenicol exhibits high sensitivity against gram-positive (e.g., Corynebacterium pyogenes, Streptococcus spp., Staphylococcus spp., Clostridium spp.) and gram-negative bacteria (e.g., E. coli, Salmonella spp., Pasteurella haemolytica, P. multocida, Haemophilus somnus, Actinobacillus pleuropneumoniae). Its bactericidal and bacteriostatic effects are based on the inhibition of protein synthesis in bacterial ribosomes. Florfenicol is rapidly and effectively absorbed in the gastrointestinal tract and distributed to all organs and tissues. Therapeutic concentrations are maintained for 24 hours after administration. The antibiotic is primarily excreted in the urine (97%), with the remainder excreted in feces.

Indications

Biofenicol 500 is used for the prevention and treatment of gastrointestinal and respiratory infections in poultry (broilers, ducks, geese) and pigs, including colisepticemia and sacculitis, caused by microorganisms sensitive to florfenicol (e.g., Actinobacillus spp., Pasteurella spp., Salmonella spp., Streptococcus spp.).

The product is also used to treat infectious diseases in freshwater, brackish, and marine fish (e.g., trout, salmon, carp, sea bass), such as furunculosis (Aeromonas salmonicida), vibriosis (Vibrio anguillarum), yersiniosis (Yersinia ruckeri), bacterial hemorrhagic septicemia (Aeromonas hydrophila), columnaris disease (Flexibacter columnaris), streptococcal infections, winter disease (Pseudomonas anguilliseptica), edwardsiellosis (Edwardsiella ictaluri, Edwardsiella tarda), pasteurellosis (Photobacterium damsela subsp. piscicida), and marine flavobacteriosis (Tenacibaculum maritimum).

Dosage and Administration

Poultry (broilers, ducks, geese):

• Pharmacological dose: 20 mg/kg body weight orally with drinking water for 3–5 days.

• Practical dose: 100 g per 400 liters of drinking water for 3–5 days.

Pigs:

• Pharmacological dose: 5–10 mg/kg body weight orally with drinking water or feed for 5–7 days.

• Practical dose: 1 g per 40–80 kg body weight with drinking water or feed for 5–7 days.

Fish:

• Pharmacological dose: 10 mg/kg body weight orally with feed for 10 days.

• Practical dose: 0.02 g per kg body weight with feed for 10 days.

Preparation of Medicated Feed for Fish:

• Mix the pre-weighed product in a mixer, spraying with 1% oil during mixing. Continue mixing for 2–5 minutes until a homogeneous mass is obtained. Fish should be fasted for 12–24 hours before administration. The amount of feed and product varies depending on water temperature and fish size.

Note: During treatment, only medicated water or feed should be used. Prepare fresh medicated solutions daily.

Contraindications

• Do not use in animals with blood-forming organ, liver, or kidney diseases.

• Do not use in animals with hypersensitivity to florfenicol.

• Do not use during pregnancy.

• Do not use in combination with thiamphenicol, chloramphenicol, penicillins, cephalosporins, fluoroquinolones, or sulfonamides due to the risk of toxicosis.

• Do not use in fish at water temperatures below 5°C.

Side Effects

• No side effects observed at recommended doses.

• Temporary reduction in feed and water intake, and softening of feces or diarrhea may occur during treatment.

• In pigs, diarrhea, perianal and rectal erythema/swelling, and rectal prolapse may occur; these effects are transient.

Incompatibilities

• Incompatible with preparations containing Mg²⁺, Al³⁺, or Ca²⁺ ions, as they bind to florfenicol and inhibit its absorption.

• Do not mix with other products in medicated water.

Overdose

• Administration of up to 60 mg/kg body weight in drinking water for 7 days does not cause adverse effects. Use the product at the recommended dose.

Special Precautions

• Do not exceed the recommended dose during treatment.

• In case of accidental exposure, seek medical advice.

• Avoid contact with the product; wash hands after use.

Withdrawal Period

• Poultry meat, offal, and eggs: 6 days after the last administration.

• Pig meat and offal: 14 days after the last administration.

• Fish: 16 days after the last administration (water temperature 5–10°C) or 8 days (water temperature above 10°C).

Note: Meat from animals slaughtered before the end of the withdrawal period may be used for feeding carnivorous animals.

Storage Conditions

• Store in a dry, cool place protected from light at room temperature (15–25°C).

Shelf Life: 2 years

Manufacturer: Biotecsi LLC, Georgia