País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIAMULIN HYDROGEN FUMARATE
N.S. LABORATORY SDN. BHD.
TIAMULIN HYDROGEN FUMARATE
500 gm
N.S. LABORATORY SDN. BHD.
N.S.LABORATORY SDN. BHD. T-MULIN 20, 200g/kg, Premix for medicated feeding stuff ACTIVE INGREDIENT: Each kg contains Tiamulin (as hydrogen fumarate) ------------------ 200g PRODUCT DESCRIPTION: White or almost white powder which is incorporated in animal feeding stuff DOSAGE FORM: Premix for medicated feeding stuff PHARMACODYNAMICS: Tiamulin is a bacteriostatic semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and acts at the ribosomal level to inhibit bacterial protein synthesis. Tiamulin has shown in-vitro activity against a wide range of bacteria including _Brachyspira hyodysenteriae_, _ Brachyspira pilosicoli_, _ Lawsonia intracellularis _ and _Mycoplasma_ spp. Tiamulin is bacteriostatic at therapeutic concentrations and has been shown to act at the 70S ribosome level and the primary binding site is on the 50S subunit and possibly a secondary site where the 50S and 30S subunits join. It appears to inhibit microbial protein production by producing biochemical inactive initiation complexes, which prevent elongation of the polypeptide chain. Mechanisms responsible for resistance development in _ Brachyspira_ spp to the pleuromutilin class of antibiotics are considered to be based on mutations at the ribosomal target site. Clinically relevant resistance to tiamulin requires combinations of mutations around the tiamulin binding site. Resistance to tiamulin may be associated with decreased susceptibility to other pleuromutilins. PHARMACOKINETICS: Pigs- Following oral administration, tiamulin hydrogen fumarate is rapidly absorbed from the gastrointestinal tract of pigs (85-90%) and appears in the blood within 30 minutes. 2-4 hours (t max ) after the oral administration of 10 mg tiamulin/kg BW in the form of an oral solution, a C max of 1 µg/ml was measured; an oral administration of 25 mg/kg gave a C max of 1.82 µg/ml. There is very good distribution in the tissues with accumulation in lungs and in the colon. 30-50% of tiamulin is bound to serum proteins. Tiamulin is rapidly metabolised Leia o documento completo