1. Name of product: Flofencol 20% sol

Pharmaceutical form: Clear, colorless, and aqueous solution

Route of administration: P.O.

Qualitative and quantitative composition

Each 1L contains

1)      Florfenicol                                                        200g

2)      Excipients

1. Polyethylene glycol 200                                                           80g
2. Propylene glycol                                                                     400g
3. N-Methylpyrrolidone                                                                q.s.
4. Polyvinylpyrrolidone                                                                q.s.
5. Diethanolamine                                                                       q.s.

Pharmacological properties

1)      Pharmacodynamic properties

Florfenicol is a synthetic broad spectrum antibiotic effective against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. However, bactericidal activity has been demonstrated in-vitro against Actinobacillus pleuropneumoniae, Pasteurella multocida, Mannheimia haemolytica and Histophilus somni. In-vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in pigs, including Actinobacillus pleuropneumoniae and Pasteurella multocida

Acquired resistance to florfenicol is mediated by efflux pump resistance associated with a floR gene. Such resistance has not yet been identified in the target pathogens except for Pasteurella multocida. Cross resistance with chloramphenicol can occur. Resistance to florfenicol and other antimicrobials has been identified in the food-borne pathogen Salmonella typhimurium.

2)      Pharmacokinetic properties

For swine,

After single intramuscular administration of the recommended dose of 15mg/kg to pigs maximum mean plasma concentration (Cmax) of 2.8 μg/ml occurs at 2 hours (Tmax) after dosing.

After administration to pigs by the intramuscular route, florfenicol is rapidly excreted, primarily in urine. Florfenicol is extensively metabolised.

For chicken,

After a single iv injection(florfenicol 30 mg/kg body weight) , the kinetic disposition of florfenicol followed a 2‐compartmental open model with an

elimination half‐life of 173 min, total body clearance of 26.9 ml/kg/min and a steady state volume of distribution of 5.11 1/kg.

The highest plasma concentrations of florfenicol were 3.82 and 3.20 μg/ml following single im and oral administration, respectively. The systemic bioavailability was 96.6% and 55.3% after im and oral administration. The plasma protein binding of florfenicol was 18.5%.

 Following its administration, the highest tissue concentrations of the drug were found in the kidney bile, lung, muscle, intestine, heart, liver, spleen and plasma. Low concentrations of the drug were found in brain, bone marrow and fat. No florfenicol residues were detected in tissues and plasma after 72 h except in the bile from where it disappeared after 96 h.

Therapeutic claims and dosages

1)      Poultry : 0.5ml/L of drinking water(Florfenicol 100mg per liter) for 5 days

2)      Swine: 0.5ml/L of drinking water(Florfenicol 100mg per liter) for 5 days

Specific warning regarding the use of the product in target animals

1)      Do not administer to layer chickens

2)      Continuous administration may cause temporary inflammation to the cloaca areas

Specific warning regarding the person administrating the product to animal

1)      Follow the prescription and direction of veterinarian.     

2)      Follow designated indications and dosages

Withdrawal times

1)      Poultry : 5days

2)      Swine : 16 days

Pharmaceutical information

1)      Shelf life: 24 months from manufacturing date.

2)      Special precautions for storage :

Keep out of reach of children and approach of animal to prevent safety accident.

1)      Nature and contents of container

HDPE bottle

Manufacturer of the product

1)      Name: Korea Thumb Vet. Co., Ltd.

2)      Address : 470-15 Sunhwa-ro(Shinheung-dong), Iksan-si, Jeollabuk-do, South Korea