Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLORFENICOL
Thye Pharma Sdn. Bhd
FLORFENICOL
1l kg
Thye Pharma Sdn. Bhd
Veterinary Package Insert TP-Flor 200 SOL Florfenicol 200mg/ml Solution PRODUCT DESCRIPTION Light yellow to yellow colour liquid, which contains florfenicol 200mg in 1ml of solution (20% in w/v). PHARMACODYNAMICS & PHARMACOKINETICS Florfenicol is a synthetic broad spectrum antibiotic active against many gram-negative and gram- positive bacteria isolated from domestic animals. It acts by inhibiting bacterial protein synthesis. In vivo activity has been demonstrated against bacterial pathogens commonly associated with swine respiratory disease, including Actinobacillus pleuropneumoniae and Pasteurella multocida. In vitro activity has been demonstrated against Salmonella spp and Streptococcus suis and in vitro activity against Mycoplasma hyopneumoniae and Mycoplasma hyorrhinis has been detected. However, the clinical significance of this activity in swine is not known. _For Swine: _ Florfenicol was detectable in the serum of all animals through 12 hours after gavage. After gavage of florfenicol on the fifth day, the maximum serum florfenicol concentrations were between 2.78 µg/mL and 7.34 µg/mL and the median terminal half life was 2.0 hours. The extent of bioavailability ranged from 24% to 97%. _For Chicken: _ After the first oral gavage administration of florfenicol of 42 mg/kg bw/day for 3 days to broiler chicken, the highest concentration of florfenicol in serum (12200 µg/l) was measured after 30 minutes and then declined to reach 810 µg/l, 8 hours later. Florfenicol could not be detected in the serum, 60 hours after the last administration. During a continuous treatment for broiler chicken with florfenicol in drinking water at a daily dose of 26 mg/kg bw for 18 hours for 3 days, the estimated mean serum concentration of florfenicol was 711 µg/l. No florfenicol was detected in the serum, 72 hours after the terminal dose. INDICATION _Broiler Chickens: _The product is indicated in broiler chickens for the treatment and control of air sacculitis associated with E. coli susceptible to florfenicol. _Swine: _The Прочетете целия документ