Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TIAMULIN HYDROGEN FUMARATE
PAHANG PHARMACY SDN. BHD.
TIAMULIN HYDROGEN FUMARATE
1 L; 5 L
Biovet Joint Stock Company
® VETMULIN 125 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS STATEMENT OF ACTIVE SUBSTANCE: Each gram contains Tiamulin hydrogen fumarate 125.0 mg (equivalent to tiamulin 101.2 mg) PRODUCT DESCRIPTION: ® Vetmulin 125 mg/ml Solution for use in drinking water for pigs and chickens represents a clear, colourless to slightly yellow liquid. 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 a high level of in vitro activity against porcine and avian _ Mycoplasma species_ as well as gram-positive aerobes (streptococci and staphylococci), anaerobes (clostridia), gram-negative anaerobes (_Brachyspira _ _hyodysenteriae, Brachyspira pilosicoli_), and gram-negative aerobes (_Pasteurella _ _multocida_). Tiamulin has been shown to act at the 70S ribosome level and the primary binding sites are on the 50S subunit. It appears to inhibit microbial protein production by producing biochemically inactive initiation complexes, which prevent elongation of the polypeptide chain. In European isolates of _Brachyspira hyodysenteriae_ collected between 1990 and 2012 the minimum inhibitory concentration (MICs) ranged from ≤0.016 µg/ml to >16 µg/ml, with MIC50 of ≤0.063 µg/ml to 4 µg/ml and MIC90 of ≤0.016 µg/ml to >16 µg/ml. In European isolates of _ Brachyspira _ _pilosicoli_ the MICs ranged from (citation from 2006-2008-2012) ≤0.008-64 µg/ml, with MIC50s of ≤0.062 µg/ml up to 0.125 µg/ml and MIC90s of 0.25 µg/ml up to 8 µg/ml. Susceptibility testing of _Lawsonia _ _intracellularis_ is challenging since this is an obligate intracellular organism. The tiamulin MIC data determined for the available EU _ Lawsonia _ strains were (citation from 2017) all below the estimated ileal tiamulin contents of 0.63 μg/ml. In European isolates tiamulin was highly a c t i v e a g a i n s t _ M y c o p l a s m a _ _hyopneumoniae_, with MIC50 of 0.016 µg Přečtěte si celý dokument