Country: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLORFENICOL
Hipra Malaysia Sdn Bhd
FLORFENICOL
100.00 mcg/mL; 250.00 mcg/mL; 50 ml; 100 ml
Laboratorios Hipra, S.A.
705096-03.1 02-19 SELECTAN 300 mg/ml, solution for injection for cattle and swine COMPOSITION PER ML: Florfenicol 300 mg Excipient q.s.ad 1 ml A slightly yellowish and clear solution. Florfenicol is a systemic 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, in vitro studies of florfenicol demonstrate bactericidal activity against _Mannheimia _ _haemolytica, _ _Pasteurella _ _multocida, Actinobacillus pleuropneumoniae,_ and _Histophilus somni. _ In vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in cattle (including _ Pasteurella multocida, Mannheimia haemolytica, Histophilus _ _somni_ and _Arcanobacterium _ _pyogenes_) and in pigs (including _Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_). In cattle, intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels for 48 hours. Maximum mean serum concentration (C max ) of 2.55 μg/ml occurs at 4.7 hours (T max ) after dosing. The mean serum concentration 24 hours after dosing was 1.4 μg/ml. The harmonic mean elimination half life was 26.2 hours. In pigs, after initial intramuscular administration of florfenicol, maximum serum concentrations of between 1.9 and 3.1 μg/ml are reached after 2.2 hours and the concentrations deplete with a terminal mean half-life of 35.5 hours. After a second intramuscular administration, maximum serum concentrations of between 2.0 and 8.1 μg/ml are reached after 1.7 hours. Florfenicol concentrations achieved in lung tissue reflect plasma concentrations, with a lung: plasma concentration ratio of approximately 1. After administration to pigs by intramuscular route, florfenicol is rapidly excreted, primarily in urine. The florfenicol is extensively metabolised. INDICATIONS: Diseases caused by florfenicol susceptible bacteria: Cat Aqra d-dokument sħiħ