English: 9.2 MICROBIOLOGICAL SAFETY STUDIES --------------------------------------------------------------------------------------3 9.2.1 Veterinary Antimicrobial Products ----------------------------------------------------------------------------------3 9.2.2 Sectional Reports-------------------------------------------------------------------------------------------------------3 9.2.2.1 Information about the Antimicrobial ------------------------------------------------------------------------------------------ 3 9.2.2.2 Activity Spectrum of the Antimicrobial -------------------------------------------------------------------------------------- 3 9.2.2.3 Administration of the Antimicrobial ------------------------------------------------------------------------------------------ 3 9.2.2.4 Antimicrobial Resistance Studies---------------------------------------------------------------------------------------------- 3 9.2.2.4.1 Resistance Mechanism----------------------------------------------------------------------------------------------------- 3 9.2.2.4.2 Transfer of Antimicrobial Resistance Genes --------------------------------------------------------------------------- 3 9.2.2.4.3 Cross-resistance------------------------------------------------------------------------------------------------------------- 3 9.2.2.4.4 Co-resistance ---------------------------------------------------------------------------------------------------------------- 3 9.2.2.4.5 Resistance Development -------------------------------------------------------------------------------------------------- 3 9.2.2.5 Effect on the Animal Gut Microflora------------------------------------------------------------------------------------------ 3 9.2.2.6 Effect on Human Gut Microflora ---------------------------------------------------------------------------------------------- 3 9.2.2.7 Impact on Human Medicine ---------------------------------------------------------------------------------------------------- 3 9.2.2.8 Pharmacokinetics ---------------------------------------------------------------------------------------------------------------- 3 9.2.2.9 Historical Information ----------------------------------------------------------------------------------------------------------- 3 9.2.2.10 Combination Antimicrobial Products---------------------------------------------------------------------------------------- 3 9.2.2.11 Post-approval Monitoring ----------------------------------------------------------------------------------------------------- 3 9.2.2.12 Global Harmonization --------------------------------------------------------------------------------------------------------- 3
French: 9.2 ÉTUDES D’INNOCUITÉ MICROBIOLOGIQUE -----------------------------------------------------------------------------104 9.2.1 Produits antimicrobiens vétérinaires -----------------------------------------------------------------------------104 9.2.2 Rapports de section -------------------------------------------------------------------------------------------------105 9.2.2.1 Renseignements sur le produit antimicrobien ----------------------------------------------------------------------------- 105 9.2.2.2 Spectre d’activité des antimicrobiens -------------------------------------------------------------------------------------- 105 9.2.2.3 Administration des antimicrobiens ----------------------------------------------------------------------------------------- 106 9.2.2.4 Études de résistance aux antimicrobiens----------------------------------------------------------------------------------- 106 9.2.2.4.1 Mécanisme de résistance ----------------------------------------------------------------------------------------------- 106 9.2.2.4.2 Transfert des gènes de résistance aux antimicrobiens -------------------------------------------------------------- 107 9.2.2.4.3 Résistance croisée ------------------------------------------------------------------------------------------------------- 107 9.2.2.4.4 Corésistance -------------------------------------------------------------------------------------------------------------- 107 9.2.2.4.5 Développement de la résistance --------------------------------------------------------------------------------------- 107 9.2.2.5 Effet sur la microflore intestinale des animaux --------------------------------------------------------------------------- 108 9.2.2.6 Effet sur la microflore intestinale humaine -------------------------------------------------------------------------------- 108 9.2.2.7 Impact sur la médecine humaine-------------------------------------------------------------------------------------------- 109 9.2.2.8 Pharmacocinétique------------------------------------------------------------------------------------------------------------ 109 9.2.2.9 Renseignements historiques ------------------------------------------------------------------------------------------------- 110 9.2.2.10 Combinaison de produits antimicrobiens--------------------------------------------------------------------------------- 110 9.2.2.11 Surveillance après l’autorisation ------------------------------------------------------------------------------------------ 110 9.2.2.12 Harmonisation mondiale---------------------------------------------------------------------------------------------------- 110