Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sulfachloropyridazine Sodium; Trimethoprim
Thye Pharma Sdn. Bhd
Sulfachloropyridazine Sodium; Trimethoprim
150 gm; 500 gm; 1 kg
Thye Pharma Sdn. Bhd
Veterinary Package Insert TP-KSM 125/625 MG/G WATER SOLUBLE POWDER PRODUCT DESCRIPTION Beige to light brown colour powder, which contains 625mg of sulfachloropyridazine sodium (580.2mg of sulfachloropyridazine) and 125mg of trimethoprim per gram in sachet. PHARMACODYNAMICS & PHARMACOKINETICS The antibacterial activity of veterinary drug is based on a double sequential inhibition of microbial synthesis of tetrahydrofolic acid. Trimethoprim is an antibacterial derivative of diaminopyrimidine with bactericidal and synergistic activity with sulfonamides. Sulfachloropyridazine is an antibacterial sulfonamide that acts by preventing bacterial growth. The combination of the two active substances has a synergistic effect, which influences the dosage (reduction of the doses of the active substances) and the bactericidal effect in a positive manner and broadens the spectrum of activity. Moreover, the appearance of bacterial resistance is slowed down. In chickens the veterinary medicinal product, administered at a dose of 200 mg / kg body weight, is active against respiratory and septic infections by wild-type _E. coli_ and against septic infections by _P._ _multocida_ and _S. aureus_. Resistance develops slowly through transferable elements and results from a chromosomal mutation as a result of one or more of the mechanisms described below: - permeability barrier and / or active efflux; - insensitive natural target enzymes; - adjustable modifications of the target enzyme; - mutational or recombination modifications of the target enzyme; - resistance acquired by target enzymes resistant to the veterinary drug. The pharmacokinetic parameters in chickens following a single administration of the veterinary medicinal product at the recommended daily dose are summarized in the table below, as well as steady state plasma concentrations (Css) by continuous medication in drinking water. Significantly higher plasma levels are achieved with sulfachloropyridazine. Trimethoprim Sulfachloropyridazine C max (µg/ml) 0,52 18,65 AUC 24h ( Прочетете целия документ