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Further information
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Pharmacotherapeutic group: antibacterials for systemic use, macrolides. ATCvet code: QJ01FA92.
Pharmacodynamic properties
Tylvalosin is a macrolide antibiotic. Macrolides are metabolites or derivatives of metabolites of soil organisms obtained by fermentation. They interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They are generally considered bacteriostatic.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly Gram-positive organisms and mycoplasma but also some Gram-negative organisms. Tylvalosin has activity against the following mycoplasma species found in poultry: Mycoplasma gallisepticum.
The minimum inhibitory concentration of tylvalosin for M. gallisepticum ranges from 0.007 to 0.25 µg/ml. Macrolides (including tylvalosin) have been shown to have effects on the innate immune system, which may augment the direct effects of the antibiotic on the pathogen and aid the clinical situation.
Bacteria can develop resistance to antimicrobial substances. There are multiple mechanisms responsible for resistance development to macrolide compounds.
Cross-resistance within the macrolide group of antibiotics cannot be excluded. Reduced susceptibility for tylvalosin was generally noted in tylosin resistant strains.
Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of the veterinary medicinal product. Tylvalosin is widely distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal mucosa, spleen, kidney and liver.
Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells. Concentrations (up to 12 times) were achieved in the cells (intracellular), compared to the extracellular concentration. In vivo studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the respiratory and gut tissues compared to the plasma.
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
The terminal half-lives for the elimination of tylvalosin and its active metabolite 3-AT range from 1 to 1.45 hours. Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g. The active metabolite 3-AT has a mean concentration of 57.9 ng/g and 441 ng/g, respectively.
Date of first authorisation: 9 September 2004.
Date of last renewal: 9 September 2014.