Comhlíonann an tsubstaint ghníomhach sin na coinníollacha a leagtar síos i bpointe 5.2.1 d’Iarscríbhinn II a ghabhann le Rialachán (CE) Uimh. 1107/2009 toisc nár léirigh sí, ar leibhéal tréithchineáil, il-fhrithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha a úsáidtear in íocshláinte an duine nó in íocshláinte tréidliachta.
That active substance fulfils the conditions set in point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 because, at strain level, it has not demonstrated multiple resistance to anti-microbials used in human or veterinary medicine.
#2512094
Le pointe 5.2.1 d’Iarscríbhinn II a ghabhann le Rialachán (CE) Uimh. 1107/2009 leagtar amach na critéir lena measfar substaintí gníomhacha ar miocrorgánaigh iad mar shubstaintí gníomhacha íseal-riosca agus faoi láthair tagraíonn an pointe sin don il-fhrithsheasmhacht in aghaidh frithmhiocróbach a d’fhéadfadh teacht chun cinn.
Point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 sets out the criteria for considering active substances that are micro-organisms as low-risk active substances and currently refers to the possible occurrence of multiple resistance to antimicrobials.
#2512097
Mar sin féin, leis an il-fhrithsheasmhacht in aghaidh roinnt frithmhiocróbach a d’fhéadfadh teacht chun cinn mar a leagtar amach faoi láthair i bpointe 5.2.1 maidir leis an líon roghanna cóireála éifeachtacha bunaithe ar fhrithmhiocróbaigh atá ar fáil.
However, the possible occurrence of multiple resistance to some antimicrobials as currently outlined in point 5.2.1 does not clarify the number of effective treatment options based on antimicrobials which are available.