Baineann éifeachtúlacht na cóireála le gníomhaíocht líseasach na mbaictéarafagach lena dtugtar don ghníomhaíocht bhaictéiricídeach ar na baictéarafagaigh sin sainiúlacht don tréithchineál baictéarach lena mbaineann.
Efficacy of treatment is linked to the lytic activity of phages that confers bactericidal activity on those bacteriophages with specificity for the bacterial strain concerned.
Lactobacillus reuteri DSM 17938 agus Lactobacillus reuteri ATCC PTA 5289, thart ar an méid céanna den dá thréithchineál (tá íosmhéid iomlán de 1 × 108 CFU/losainn de gach tréithchineál baictéarach i ngach losainn)
Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289, approximately equal amount of each strain (total minimum amount of 1 × 108 CFU/lozenge of each bacterial strain)
Ina theannta sin, an 1 Deireadh Fómhair 2019, d’iarr an t-iarratasóir ar an gCoimisiún go gcosnófaí sonraí dílseánaigh i gcás roinnt staidéar a cuireadh isteach mar thaca leis an iarratas, eadhon na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.
On 1 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via nuclear magnetic resonance (‘NMR’) of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.
Sa tuairim eolaíoch ón Údarás, mheas sé nach bhféadfadh sé teacht ar a chuid conclúidí maidir le sábháilteacht 3-FL gan na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil micreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.
In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.
Tar éis dó tuairim eolaíoch an Údaráis a fháil, d’iarr an Coimisiún ar an iarratasóir soiléiriú breise a thabhairt maidir leis an réasúnú a cuireadh ar fáil i dtaca lena éileamh dílseánaigh ar na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (‘NMR’) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro i lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar tocsaineachta béil 3 seachtaine ar bhainbh nuabheirthe.
Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.