natgillin/translations-raw huggingface dataset:
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Avalox solution for infusion outweigh its risks, and therefore the marketing authorisation for Avalox solution for infusion should be granted in all concerned Member States.
CHMP je na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora zaključil, da koristi zdravila Avalox raztopina za infundiranje odtehtajo z njim povezana tveganja, zato
However, the prescribing information for Avalox solution for infusion should be amended in all the Member States where it is authorised.
Vendar je treba spremeniti podatke o predpisovanju zdravila Avalox raztopina za infundiranje v vseh državah članicah, kjer je zdravilo odobreno.
What is Avalox solution for infusion?
Kaj je zdravilo Avalox raztopina za infundiranje?
This was not the case.
To se ni zgodilo.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION 1.
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA 1.
This experiment began three weeks later than the first experiment.
Ta poskus se je začel tri tedne pozneje od prvega.
Invented name Pharmaceutic al form
Izmišljeno ime Farmacevtska oblika
These PECs were considered acceptable.
Te vrednosti PKO se štejejo za sprejemljive.
As the tests were carried out 3 weeks apart it is unlikely that conditions were the same.
Ker so bili preskusi opravljeni 3 tedne narazen, ni verjetno, da so bili pogoji enaki.
Given all the problems with the study recorded above, the fact that the value approaches the maximum difference allowed is a cause for concern.
Glede na vse zgoraj opisane težave s študijo je dejstvo, da se vrednost približa največji dovoljeni razliki, zaskrbljujoče.
The reporting and analysis of the results did not follow the OECD guideline.
Poročanje in analiza rezultatov nista bila v skladu s smernico OECD.
The requirements of the VICH guidelines were not fulfilled.
Zahteve smernic VICH niso bile izpolnjene.
The decision on the acceptability of the data from these studies was of key importance to the re-examination and so both studies have been re-evaluated critically.
Za ponovni pregled je bila ključna odločitev o sprejemljivosti podatkov iz teh študij in zato sta bili obe študiji ponovno kritično ovrednoteni.
The DT50 value of 7.6 days for chicken excreta can be accepted as a realistic conservative value.
Vrednost DT50 7,6 dneva v iztrebkih piščancev se lahko sprejme za stvarno konzervativno vrednost.
Effects on Daphnia magna were determined based on data from published literature.
Učinke na organizme Daphnia magna so ugotovili na podlagi podatkov iz objavljene literature.
However, the CVMP does not agree with the approach and conclusions in respect to specific parts of the assessment and therefore the overall conclusions on the environmental risk assessment.
CVMP se ne strinja s pristopom in zaključki v posameznih delih ocene in posledično s splošnimi zaključki ocene tveganja za okolje.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REFUSAL TO GRANT NEW MARKETING AUTHORISATIONS AND FOR THE REVOCATION OF EXISTING MARKETING AUTHORISATIONS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAVRNITEV ODOBRITVE NOVIH DOVOLJENJ ZA PROMET Z ZDRAVILOM IN PREKLIC OBSTOJEČIH DOVOLJENJ ZA PROMET Z ZDRAVILOM
2.2.2 Effects on algae (cyanobacteria)
2.2.2 Učinek na alge (cianobakterije)
Some serious deficiencies with the plant study were identified.
V študiji na rastlinah so bile ugotovljene resne pomanjkljivosti.
The study is considered to suffer from a number of deviations described below.
Ugotovljeno je bilo, da ima študija številne nepravilnosti, ki so opisane spodaj.
2.2.4 Effects on fish
2.2.4 Učinek na ribe
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
There was very low nitrate production in the control soil between days 0 and 7, but this phenomenon was not observed at later time points.
V kontrolni prsti je bila med dnevoma 0 in 7 zelo majhna tvorba nitrata, vendar ta pojav v poznejših časovnih točkah ni bil prisoten.
At present a risk for the terrestrial compartment cannot be excluded.
V tem trenutku ni mogoče izključiti tveganja za kopenski del.
No detailed records of greenhouse conditions except temperature are provided in the report so it is impossible to conclude if environmental conditions were identical.
Podrobnih zapisov o pogojih v rastlinjaku razen temperature v poročilu ni, zato ni mogoče ugotoviti, ali so bili dejavniki okolja enaki.
A previously reported endpoint for Microcystis aeruginosa was not used in the assessment as it was not in line with the relevant OECD guideline 201.
Predhodno objavljena končna točka za Microcystis aeruginosa se pri vrednotenju ni uporabila, ker ni bila skladna z zadevno smernico OECD št. 201.
GROUNDS FOR REFUSAL AND REVOCATION OF THE MARKETING AUTHORISATIONS Considering that:
PODLAGA ZA ZAVRNITEV IN PREKLIC DOVOLJENJ ZA PROMET Z ZDRAVILOM Ob upoštevanju naslednjega:
• a risk for cyanobacteria cannot be excluded on the basis of the data available;
• tveganja za cianobakterije na podlagi razpoložljivih podatkov ni mogoče izključiti;
As a result it is considered that the design of the second experiment is seriously flawed as radish should have been included in this experiment.
Posledično se šteje, da ima zasnova drugega poskusa resne napake, saj bi morali v ta poskus vključiti radič.
Many of the failings described above arise from the poor reporting of the study which does not follow the requirements of the OECD guideline and may be a consequence of using a non-GLP compliant laboratory.
Veliko zgoraj opisanih napak izvira iz slabega poročila o študiji, ki ne upošteva zahtev smernice OECD in je morda posledica uporabe laboratorija, ki ni skladen z DLP.
The study does not fully comply with this criterion as the differences between 2 replicates of control soil at day 14 were above 15%.
Študija ni v celoti skladna s tem merilom, saj so razlike med 2 ponovitvama kontrolne prsti na 14. dan večje od 15 %.
1 Marketing Authorisation granted
1 Dovoljenje za promet z zdravilom odobreno.
The absence of reliable effects data for plants and microorganisms means that reducing exposure, i.e. lowering the PECsoil by restricting indications and species does not alter the potential for an unacceptable risk.
Ker zanesljivih podatkov o učinkih na rastline in mikroorganizme ni, zmanjšanje izpostavljenosti, tj. znižanje PKOprst z omejevanjem indikacij in živalskih vrst, ne spremeni možnosti nesprejemljivega tveganja.
The rate of nitrate production was not provided as required by the OECD guideline; instead the concentration of nitrate at each time point was given.
Hitrost nastajanja nitrata, ki jo zahteva smernica OECD, ni bila navedena; namesto tega je bila za vsako časovno točko podana koncentracija nitrata.
Risk mitigation measures
Ukrepi za zmanjševanje tveganja
Only for courgette was one concentration below this PEC (0.25 PEC).
Samo pri bučkah je bila ena koncentracija pod tem PKO (0,25 PKO).
After careful evaluation of all the information it is considered that due to the inadequacy of the data provided no firm conclusions can be drawn from this study.
Po skrbni oceni vseh podatkov je ugotovljeno, da zaradi nezadostnosti predloženih podatkov trdni zaključki na podlagi študije niso mogoči.
Other degradation studies in manure suggest a significant role for biodegradation, resulting in differences between sterile and non-sterile conditions, which are not observed in this particular study.
Druge študije razpadanja v gnoju kažejo bistveno vlogo biorazgradnje, kar povzroči razliko med sterilnimi in nesterilnimi pogoji, česar v omenjeni študiji niso opazili.
Without a tier II-B assessment, no further conclusions with regards to the risk for cyanobacteria can be drawn.
Brez vrednotenja v stopnji II-B nadaljnji zaključki o tveganju za cianobakterije niso mogoči.
Instead a second main experiment was begun using only two additional species, courgette and sunflower.
Namesto tega se je drugi glavni poskus začel le z dvema dodatnima vrstama: bučkami in sončnico.
The results of the study cannot be considered reliable and they cannot be used in the environmental risk assessment.
Rezultatov študije ni mogoče šteti za zanesljive in jih ni mogoče uporabiti v oceni tveganja za okolje.
A new study and several published studies were provided which investigate the degradation of tylosin in cattle, pigs and poultry manure and soil/poultry mixtures.
Predstavljene so bile nova študija in več objavljenih študij, v katerih so raziskovali razpad tilozina v gnoju goveda, prašičev in perutnine ter zmeseh prsti/gnoja perutnine.
The key omission in the report is the absence of tables for all endpoints determined in the study, for example the numbers of seeds germinating and the biomass (growth) is not reported for the control groups of any of the plants tested.
Ključna pomanjkljivost poročila so manjkajoče tabele za vse končne točke, ki so se v študiji določale, npr. število kaljenih semen ter biomasa (rast) v kontrolni prsti za katero koli izmed preskusnih rastlin.
• no conclusion on the effects on terrestrial plants can be drawn;
• zaključki o učinkih na kopenske rastline niso mogoči;
The difference in nitrate production between control and the lowest (1X) PEC at 28 days is 23% which is only just below the 25% maximum allowed by the OECD guideline.
Razlika v nastajanju nitrata med kontrolno prstjo in prstjo z najnižjo (1X) PKO je bila na 28. dan 23 %, kar je le nekoliko pod največjo vrednostjo 25 %, ki jo dovoljuje smernica OECD.
Member State Applicant/Marketing Authorisation Holder
Država članica Predlagatelj/imetni k dovoljenja za promet z zdravilom
These deviations from the OECD guideline may have contributed to the high standard deviations seen in nitrate production at each of the time points and concentrations tested.
Ti odkloni od smernice OECD so lahko prispevali k velikim standardnim odklonom pri nastajanju nitrata v vsaki časovni točki ter za vsako preskušeno koncentracijo.
The seedlings should not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants should exhibit only normal variation in growth and morphology for that particular species.
Sadike ne smejo kazati vidnih znakov fitotoksičnih učinkov (npr. kloroze, nekroze, venenja, deformacij listov in stebel), rastline pa morajo kazati samo normalne variacije rasti in morfologije, ki so značilne za posamezno vrsto.
This part of the experiment can be considered the Tier A study on three species.
Ta del poskusa lahko štejemo za študijo stopnje A na treh rastlinskih vrstah.
There were some deviations from the OECD guideline: the biomass in the test soil was lower than required at day 0; it was not clear if the soil had been stored for more than 3 months before the study was carried out; the maximum water holding capacity was not provided so it was not possible to conclude if the soil complied with the requirements for moisture content during the study.
Bilo je nekaj odklonov od smernice OECD: biomasa v preskusni prsti je bila na dan 0 manjša od zahtevane; ni bilo jasno, ali je bila prst shranjena več kot 3 mesece pred izvedbo študije; največja zmogljivost zadržanja vode ni bila navedena, zato ni bilo mogoče ugotoviti, ali je prst ustrezala zahtevam za vsebnost vlage med študijo.
The results of the study cannot be used in the environmental risk assessment.
Rezultatov študije ni mogoče uporabiti v vrednotenju tveganja za okolje.
Tier B refinement is therefore not feasible.
To pomeni, da izboljšava stopnje B ni mogoča.
The maximum predicted surface water concentration was 4.44 μg/l.
Največja napovedana koncentracija v površinskih vodah je bila 4,44 μg/l.
The risk for plants cannot be determined based on the submitted data.
Tveganja za rastline na podlagi predloženih podatkov ni mogoče določiti.
At a later date data were presented in a form that enabled the comparison of nitrate production between control and treatment soils.
Pozneje so bili podatki prikazani na način, ki omogoča primerjavo nastajanja nitrata v kontrolni in preskusni prsti.
The choice of 7264 µg/kg as the lowest PEC can be criticised as it is 1.6 times greater than the maximum PECsoil produced by use of this product, but the choice was justified in the report as a conservative approach.
Izbira koncentracije 7264 µg/kg kot najnižje PKO je lahko predmet negativne kritike, saj je 1,6-krat večja od največje vrednosti PKOprst, zabeležene pri uporabi tega zdravila, vendar v poročilu izbiro upravičijo s konzervativnim pristopom.
2.1.3 Effect on emergence and growth of plants
2.1.3 Učinek na pojav in rast rastlin
The EC50 value for 48 hour survival of Daphnia magna exposed to tylosin tartrate was 680 mg/l.
Vrednost EC50 za 48-urno preživetje organizmov Daphnia magna, izpostavljenih tilozin tartratu, je bila 680 mg/l.
A study performed to assess the effect of tylosin tartrate on the growth of the freshwater cyanobacteria Anabaena flos-aquae was provided.
Opravljena je bila študija za vrednotenje učinka tilozin tartrata na rast sladkovodnih cianobakterij Anabaena flos-aquae.
In order to follow VICH guidance when proceeding to Tier B the most sensitive species from the above experiment, i.e. radish, should have been retested together with two additional species from the same category.
Za prehod na stopnjo B po smernicah VICH je treba najobčutljivejšo vrsto iz zgornjega poskusa, tj. radič, znova preskusiti z dvema dodatnima vrstama iz iste kategorije.
Test concentrations were seen to decline over the test period and consequently it was considered justifiable to base the results on the geometric mean of the measured test concentrations.
Ugotovili so, da se preskusne koncentracije med preskusnim obdobjem znižujejo, zato so šteli za upravičeno, da se kot podlago za rezultate uporabi geometrijsko povprečje izmerjenih preskusnih koncentracij.
A new study would be necessary in order to draw a conclusion on the risk to plants.
Za ugotovitev tveganja za rastline bi bila potrebna nova študija.
• no conclusion on long term influence on nitrogen transformation by soil microbes can be drawn;
• zaključki o dolgoročnem vplivu na pretvorbo dušika z mikrobi v prsti niso mogoči;
The product is a generic of the reference product Tylan W.O and intended to be used as follows:
Je generično zdravilo na podlagi referenčnega zdravila Tylan W.O in ima naslednje indikacije:
The TWA PEC was calculated over 3 days as this corresponds to the duration of the blue-green algae (cyanobacteria) study.
Vrednost TWA PKO so izračunali za časovno obdobje 3 dni, saj to ustreza trajanju študije modrozelenih alg (cianobakterij).
In the main study the test on wheat, radish and French bean was carried out 3 weeks before the test on courgette and sunflower.
V glavni študiji je bil preskus na pšenici, radiču in navadnemu fižolu opravljen 3 tedne pred preskusom na bučkah in sončnici.
The resulting PEC/PNEC ratios are below 1 for all four target animal species, therefore it can be concluded that the risk for soil invertebrates is low.
Nastala razmerja PKO/PKBU so za vse štiri ciljne živalske vrste manjša od 1, zato lahko zaključimo, da je tveganje za nevretenčarje v prsti majhno.
In its opinion of 10 December 2008 the CVMP considered that the nitrogen transformation study provided was inadequate and that no firm conclusions could be drawn from the study and therefore the test results provided did not exclude a risk for soil microorganisms.
CVMP je v svojem mnenju z dne 10. decembra 2008 ugotovil, da je predložena študija pretvorbe dušika nezadostna in da ne omogoča trdnih zaključkov, kar pomeni, da predloženi rezultati preskusov ne izključujejo tveganja za mikroorganizme prsti.
The experiments cover the effects of tylosin at concentrations between 0 and 5000 mg/kg soil (dry weight) on collembolans, earthworms and enchytraeids but did not use standardised methods.
Poskusi obsegajo učinke tilozina pri koncentracijah od 0 do 5000 mg/kg prsti (suha masa) na skakače, deževnike in enhitreje, vendar niso bile uporabljene standardizirane metode.
Huvepharma NV provided the statistical analysis for the proposed LOECs and NOECs for the three species (courgette, radish and sunflower).
Družba Huvepharma NV je predložila statistično analizo za predlagane vrednosti LOEC in NOEC za tri vrste (bučke, radič in sončnica).
The resulting PEC/PNEC ratios are 1.16 (pigs), 2.986 (broilers), 1.47 (turkeys) and 2.13 (calves), i.e. resulting in a risk quotient (RQ) above 1 indicating a potential risk.
Nastala razmerja PKO/PKBU so 1,16 (prašiči), 2,986 (pitovni piščanci), 1,47 (purani) in 2,13 (teleta), torej je količnik tveganja (RQ) nad 1, kar kaže možno tveganje.
The PECssoil are: calves: 3199 µg/kg; pigs: 1738 μg/kg; broilers: 4435 μg/kg and turkeys 2210 μg/kg.
Vrednosti PKOprst so: teleta: 3199 µg/kg; prašiči: 1738 μg/kg; pitovni piščanci: 4435 μg/kg in purani 2210 μg/kg.
In the detailed grounds for the re-examination of the opinion Huvepharma NV argued that the data from the soil nitrification study and the plant growth study are in line with the current guidance and should be considered as conclusive.
Družba Huvepharma NV je v podrobnih podlagah za ponovni pregled mnenja dokazovala, da so podatki iz študije nitrifikacije v prsti ter študije rasti rastlin skladni s trenutnimi smernicami, zato jih je treba šteti za dokončne.
For the soil nitrification study to be valid the difference between control replicates should be less than ±15%.
Študija nitrifikacije v prsti je veljavna, če so razlike med ponovitvami kontrole manjše od ±15 %.
For the majority of climate and water body scenarios investigated, tylosin concentrations were below 0.001 µg/l.
V večini raziskanih scenarijev podnebij in vodnih teles so bile koncentracije tilozina pod 0,001 µg/l.
This would have the effect of reducing the TWA PEC from 1.77 μg/l to 0.40 μg/l, and lead to a PEC/PNEC ratio of 0.10.
Učinek tega bi bil znižanje TWA PKO z 1,77 μg/l na 0,40 μg/l, kar da razmerje PKO/PKBU 0,10.
In particular the adequacy of the data provided in respect to the effects on aquatic and terrestrial organisms (Tier A) was questioned as these data do not enable a conclusion to be drawn on the environmental risk assessment.
Največ vprašanj je bilo glede zadostnosti predloženih podatkov o učinkih na vodne in kopenske organizme (stopnja A), saj na podlagi teh podatkov ni mogoče narediti zaključkov o oceni tveganja za okolje.
Based on the information presented it is not possible to tell if two of the criteria, seedling emergence of at least 70% and mean survival of emerged control seedlings of at least 90% for the duration of the study, were met.
Na podlagi predloženih podatkov ni mogoče ugotoviti, ali sta izpolnjeni dve merili: najmanj 70-odstotna kalitev in najmanj 90-odstotno povprečno preživetje kaljenih kontrolnih sadik med trajanjem študije.
A study performed to assess the acute toxicity of tylosin tartrate to rainbow trout (Oncorhynchus mykiss) was provided.
Predložena je bila študija za vrednotenje akutne toksičnosti tilozin tartrata na šarenko (Oncorhynchus mykiss).
A study in turkey litter describes a rapid dissipation of tylosin under aerobic and sterile conditions with a half-live (DT50) of 4.9 days.
Študija nastilja puranov opisuje hitro zmanjšanje vsebnosti tilozina v aerobnih in sterilnih pogojih z razpolovno dobo (DT50) 4,9 dneva.
However, the CVMP considered that there are concerns regarding the refinements made to the PECs generated using FOCUS modelling; in particular on the use of the time weighted averages in relation to the acute cyanobacteria study and the use of a DT50 value of 19.15 days in the FOCUS models when the geometric mean DT50 presented by Huvepharma NV was 51 days.
CVMP je menil, da obstajajo zadržki glede izboljšav vrednosti PKO z modeli FOCUS, zlasti zaradi uporabe časovno uteženih povprečij v študiji akutnih učinkov na cianobakterije ter uporabe vrednosti DT50 19,15 dneva v modelih FOCUS, čeprav je geometrično povprečje DT50 po podatkih družbe Huvepharma NV 51 dni.
Even with the proposed refinement for degradation in manure, RQs higher than 1 are obtained when the effect assessment for plants is based on the EC50 with an AF of 100.
Kljub predlagani izboljšavi zaradi razpadanja v gnoju so vrednosti RQ višje od 1, če se učinki na rastline vrednotijo na podlagi EC50 z AF 100.
On the basis that the concentrations estimated using FOCUS modelling represent peak values and so overestimate the risks, Huvepharma NV calculated the time weighted average concentration (TWA PEC) and recalculated the PEC/PNEC ratio for the scenario where a risk had been indicated.
Na podlagi dejstva, da koncentracije, ocenjene z modeli FOCUS, predstavljajo najvišje vrednosti in s tem precenjujejo tveganje, so v družbi Huvepharma NV izračunali časovno uteženo povprečno koncentracijo (TWA PKO) in znova izračunali razmerje PKO/PKBU za scenarij z nakazanim tveganjem.
A comparison of the surface water concentrations obtained using the FOCUS models, with the established PNEC (4.2 μg/l) demonstrated that, for all but one of the scenarios investigated, predicted concentrations of tylosin were below the predicted no effect concentrations.
Primerjava koncentracij v površinskih vodah, dobljenih z modeli FOCUS, in ugotovljene vrednosti PKBU (4,2 μg/l) je pokazala, da so v vseh scenarijih razen enem napovedane koncentracije tilozina pod napovedanimi koncentracijami brez učinka.
Pharmasin 100% W/W Water Soluble Granules and its associated names is presented as water soluble granules containing tylosin tartrate, which is a macrolide antibiotic.
Zdravilo Pharmasin 100% W/W Water Soluble Granules in z njim povezana imena so v obliki vodotopnih zrnc, ki vsebujejo tilozin tartrat, ki je makrolidni antibiotik.
As germination (emergence) was expressed as percentage of the control in the report it is not possible to conclude that the criteria that seedling emergence is at least 70% was met.
Ker je bila kalitev (pojav) v poročilu izražena kot odstotek v primerjavi s kontrolo, ni bilo mogoče ugotoviti, ali je bilo izpolnjeno merilo kalitve najmanj 70 %.
2.1 Risk to terrestrial compartment
2.1 Tveganje za kopenski del
The study was performed in line with OECD guideline 203.
Študija je bila opravljena v skladu s smernico OECD št. 203.
The study was performed in line with OECD guideline 201.
Študija je bila opravljena v skladu s smernico OECD št. 201.
During the decentralised procedure concerns were raised that Pharmasin 100% W/W Water Soluble Granules may present a potential serious risk to public health regarding risk to algae and to terrestrial plants.
Med decentraliziranim postopkom so se pojavili zadržki, da lahko zdravilo Pharmasin 100% W/W Water Soluble Granules pomeni možno resno tveganje za javno zdravje v obliki tveganja za alge in kopenske rastline.
The first main experiment was carried out on wheat, radish and French bean.
Prvi glavni poskus je bil opravljen na pšenici, radiču in navadnem fižolu.
Anabaena flos-aquae was exposed to different concentrations of an aqueous solution of tylosin tartrate for 72 hours.
Cianobakterije Anabaena flos-aquae so za 72 ur izpostavili različnim koncentracijam vodne raztopine tilozin tartrata.
No justification for omitting to establish LOECs and NOECs for wheat and French bean was provided.
Utemeljitev opustitve določanja vrednosti LOEC in NOEC za pšenico in navadni fižol ni bila predložena.
The study was performed with concentrations of tylosin in soil of 7264 μg/kg, which was derived from the maximum PEC of tylosin in soil arising from the use of other Pharmasin products, and at 5 times, 10 times, 25 times and 125 times this maximum PEC value.
Študija je bila opravljena pri koncentraciji tilozina 7264 μg/kg v prsti, ki je bila izpeljana iz najvišje PKO tilozina v prsti kot posledice uporabe drugih zdravil Pharmasin, ter pri 5-kratni, 10-kratni, 25-kratni in 125-kratni vrednosti te najvišje PKO.