natgillin/translations-raw huggingface dataset:
In general terms, as for the benefits, other risks are expected to be the same as for the reference product and have not been evaluated by the CVMP.
Na splošno je mogoče pričakovati, da bodo druga tveganja, tako kot koristi, enaka kot pri referenčnem zdravilu, zato jih odbor CVMP ni ovrednotil.
However, it is apparent that, for all compartments, RQs will be exceeded either immediately (sediment) or eventually (soil, ground-, and surface waters), and these risks must be addressed.
Vendar pa je očitno, da bodo količniki tveganja za vse dele okolja preseženi bodisi takoj (sedimenti) ali sčasoma (tla ter podzemne in površinske vode), zato je ta tveganja treba ustrezno zmanjšati.
Usually piglets and sows are kept on the same farm allowing treated piglet manure to be diluted.
Običajno so prašički in svinje na isti kmetiji, kar omogoča redčenje gnoja zdravljenih prašičkov.
8), where validation is concerned with substantiating claims on the applicability of predictions with reference to the intended use or purpose.
8), kjer je validacija povezana z dokazovanjem trditev o uporabnosti napovedi glede na predvideno uporabo ali namen, je treba uporabiti pragmatičen pristop.
The predicted no effect concentrations (PNECs) reported in the European Union Risk Assessment Report (EU RAR) on zinc (2010)
Predvidene koncentracije brez učinka (PNEC), navedene v poročilu Evropske unije o oceni tveganja (EU RAR) za cink (2010)
Similar regulations concerning the control of open watercourses from exposure to nutrients are adhered to in line with Good Agricultural Practice.
Podobni predpisi v zvezi z zaščito odprtih vodotokov pred izpostavljenostjo hranilom naj bi se že upoštevali v skladu z dobro kmetijsko prakso.
The amended Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Spremenjeni povzetek glavnih značilnosti zdravila in navodilo za uporabo referenčne države članice sta opredeljena v Prilogi III.
Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment
Izpostavljenost: kopičenje, biološka uporabnost in modelni izračun koncentracij cinka v okolju
Although Good Agricultural Practice varies amongst Member States and is followed on a voluntary basis, a similar RMM for Gutal may be practical and appropriate.
Čeprav se dobra kmetijska praksa med državami članicami razlikuje in je njeno izvajanje prostovoljno, bi podoben ukrep za zmanjšanje tveganja lahko bil praktičen in primeren tudi za zdravilo Gutal.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe zdravila in imetnikov dovoljenja za promet/predlagateljev
1 are considered reliable and, hence, are suitable for use in the risk characterisation of Gutal.
1, so bile ocenjene kot zanesljive in zato primerne za uporabo pri opredelitvi tveganja, povezanega z zdravilom Gutal.
Zinc is very toxic to aquatic organisms, but can affect growth, survival and reproduction in both aquatic and terrestrial plants and animals.
Cink je zelo toksičen za vodne organizme in lahko vpliva na rast, preživetje in reprodukcijo vodnih in kopenskih rastlin in živali.
For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Kar zadeva sedimentne sisteme, je od izpeljave (EU RAR, 2010) predvidene okoljske koncentracije (PEC) za sedimente prišlo do pomembnih sprememb v načinu določanja koncentracij v sedimentih.
The IDMM also considers several soil compartments and the fluxes between these and aquatic compartments.
Prav tako model IDMM upošteva več delov tal ter pretok snovi med njimi in vodnim okoljem.
5.3 Environmental properties
5.3 Okoljske lastnosti
A pragmatic approach should be taken when considering the validation of environmental mechanistic models (e.g. IDMM and FOCUS
Pri obravnavanju validacije modelov za ocenjevanje mehanizmov okolja (npr. IDMM in FOCUS
By their nature, models are an incomplete representation of the system under investigation but that is not to say that they cannot be very useful and widely implemented.
Modeli zaradi svojih lastnosti pomanjkljivo prikazujejo proučevani sistem, vendar zaradi tega ni mogoče trditi, da niso zelo uporabni in primerni za široko uporabo.
, except in instances where they may not be line with common agricultural practice in a particular Member State, for example, in Member States where manure trading is common and, hence, the farmer may not be the person spreading the manure, or in instances where the effect of the RMM has not been definitively demonstrated (e.g. buffer zones).
, razen v primerih, ko niso skladni z običajno kmetijsko prakso v določeni državi članici, na primer v državah članicah, kjer je pogosto trgovanje z gnojem, zaradi česar kmet ni nujno oseba, ki trosi gnoj, in v primerih, ko vpliv ukrepov za zmanjšanje tveganja ni bil nedvoumno dokazan (npr. varovalni pasovi).
The information provided indicates that there are errors and these are more pronounced for the sediment compartment and at low loadings.
Predloženi podatki kažejo, da so prisotne napake, ki so bolj izražene pri sedimentih in pri majhnih obremenitvah.
Therefore, it will only be a matter of time before any PNECs are exceeded in these compartments.
Zato je samo še vprašanje časa, kdaj bodo v teh delih okolja presežene vrednosti PNEC.
At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Trenutno ni jasno, kateri naj bi bil razumen najslabši možni scenarij izpostavljenosti glede na količino nanesenega gnoja.
Despite the data gap, it may be accepted that such a measure would, most likely, reduce run-off of zinc to watercourses.
Kljub pomanjkanju podatkov je mogoče zaključiti, da bi takšen ukrep zelo verjetno zmanjšal odtekanje cinka v vodotoke.
However, since the data search for the EU RAR (2010) was completed more data have become available (e.g. those used in establishing the UK Environmental Quality Standard
Vendar so po koncu zbiranja podatkov za poročilo EU RAR (2010) postali na voljo dodatni podatki (npr. podatki, ki so jih v Združenem kraljestvu uporabili za
No matter which model and application rates are used, a risk to the environment is calculated with only the time needed to arrive at this risk varying.
Ne glede na to, kateri model in odmerki se uporabijo, je pri izračunu tveganja za okolje samo vprašanje časa, kdaj se bo to tveganje spremenilo.
Therefore, the CVMP recommended the granting of the marketing authorisations for the veterinary medicinal products referred to in Annex I with amendments to the Summary of Product Characteristics and package leaflet of the reference Member State.
Odbor CVMP je zato priporočil odobritev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, navedenimi v Prilogi I, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface water.
Vendar pa je bilo ugotovljeno, da je opredelitev tveganja za sedimente veliko bolj negotova kot za tla in površinske vode.
In major pig breeding regions stringent rules and controls on manure application are in place, although it is realised that this advice is followed on a voluntary basis and Good Agricultural Practice may vary throughout the Member States.
Na območjih, kjer poteka obsežna prašičereja, veljajo strožja pravila in nadzor nad uporabo gnojil, vendar je upoštevanje teh priporočil prostovoljno, dobra kmetijska praksa pa se med državami članicami razlikuje.
Manure containing zinc should not be spread on the same area of land in successive years to avoid accumulation of zinc which may cause adverse effects in the environment.
Gnoj, ki vsebuje cink, ne razvažati na iste površine v zaporednih letih, da se izognete zbiranju cinka, ki lahko povzroči škodljive vplive na okolje.
The proposed RMMs fulfil the criteria laid out in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6
Predlagani ukrepi za zmanjšanje tveganja izpolnjujejo merila iz smernic CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicam VICH GL6
A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Ključen dejavnik pri ocenjevanju tveganja za okolje, povezanega s kovinami, je določitev njihove biološke uporabnosti.
During the CMD(v) procedure Belgium concluded that a marketing authorisation for Gutal can be granted provided that RMMs are included in the product information.
Med postopkom skupine CMD(v) je Belgija zaključila, da se dovoljenje za promet z zdravilom Gutal lahko odobri pod pogojem, da se v informacije o zdravilu vključijo ukrepi za zmanjšanje tveganja.
Although the PEC values for each compartment cannot be verified because the IDMM is not provided, overall they appear fairly conservative since a reasonable worst case exposure scenario is considered, i.e. continual application of undiluted manure until 2060.
Čeprav vseh vrednosti PEC za posamezne dele okolja ni mogoče preveriti, ker model IDMM ni bil na voljo, se zdijo precej konzervativne, saj je bil upoštevan razumen najslabši možni scenarij izpostavljenosti, tj. stalno nanašanje nerazredčenega gnoja do leta 2060.
As zinc is a metal, general assumptions that are usually made about degradation are not applicable, therefore, once critical concentrations are exceeded, the risk will be difficult to remediate.
Ker cink spada med kovine, običajne splošne predpostavke o degradaciji zanj ne veljajo, zato bo tveganje, ko bodo kritične koncentracije enkrat presežene, težko obvladati.
Although this RMM would most likely reduce the risk for all compartments, a risk for surface water and, particularly, sediment may remain.
Čeprav bi s tem ukrepom za zmanjšanje tveganja zelo verjetno zmanjšali tveganje za vse dele okolja, bi lahko bilo tveganje za površinske vode in še zlasti sedimente še vedno prisotno.
When spreading manure from treated animals, the maximum total zinc load as defined in the national or local regulations has to be strictly respected.
Pri širjenju gnoja zdravljenih živali je treba strogo upoštevati največjo obremenitev cinka, določeno v nacionalnih ali lokalnih predpisih.
A risk was identified from 2020 for two of 15 surface water scenarios (acidic, sandy soils) and for all 15 sediment scenarios.
Tveganje od leta 2020 je bilo ugotovljeno za dva od 15 scenarijev za površinske vode (kisla, peščena tla) in za vseh 15 scenarijev za sedimente.
• This referral was raised due to concerns regarding the environmental risk assessment.
• ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi z oceno tveganja za okolje.
Zinc is very toxic to aquatic organisms and is persistent in soils and sediments.
Cink je zelo toksičen za vodne organizme in vztraja v tleh in sedimentih.
Zinc binds strongly to AVS and becomes non-bioavailable, which would allow for making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)
Cink se močno veže na AVS in postane biološko neuporaben, kar bi omogočilo popravek ocene izpostavljenosti za biološko uporabnost kovin v sedimentnih sistemih (ECHA 2014)
When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, and at least a minimum buffer zone of 3 m applied, because the manure contains zinc which may cause adverse effects in the aquatic environment.
Pri razvozu gnoja zdravljenih živali je treba strogo upoštevati minimalno razdaljo do površinskih voda, kot je določena v nacionalnih in lokalnih predpisih, ter vsaj minimalni zaščitni pas 3 m, saj gnoj vsebuje cink, ki lahko škodljivo vpliva na vodne organizme.
Do not contaminate surface waters or ditches with the product or used containers.
Površinskih vod ali jarkov ne onesnažite z zdravilom ali uporabljeno posodo.
Overall, it is apparent that the long-term, continual use of zinc-containing veterinary medicinal products will result in a gradual net input of zinc to the environment.
Na splošno je očitno, da bo dolgotrajna stalna uporaba zdravil za uporabo v veterinarski medicini, ki vsebujejo cink, povzročila postopen čisti vnos cinka v okolje.
Hence, where an excess of AVS exists and zinc sulfides are formed, the PNEC may be exceeded considerably before any adverse effects are observed.
Kjer so torej prisotne presežne količine AVS in se tvorijo cinkovi sulfidi, je lahko PNEC znatno presežena, preden je mogoče opaziti kakršne koli škodljive učinke.
Nonetheless, for each compartment, risks have been identified for some scenarios at each application rate investigated.
Vseeno pa so bila za vsak del okolja pri določenih scenarijih ugotovljena tveganja pri vsakem proučevanem odmerku.
At a site-specific level, PNEC bioavailability corrections in sediment as a result of AVS/SEM content in sediment, can be made if the necessary data are available; however, such data are scarce.
Kar zadeva posamezna območja, so za sedimente popravki vrednosti PNEC za biološko uporabnost na osnovi vsebnosti AVS/SEM v sedimentu mogoči, če so na voljo potrebni podatki - vendar pa je tovrstnih podatkov zelo malo.
At the time of the zinc EU RAR (2010) there were too few effects or exposure data to be able to account for the effect of these two parameters (AVS/SEM) on zinc bioavailability in sediments.
V času priprave poročila EU RAR za cink (2010) je bilo na voljo premalo podatkov o učinkih oziroma izpostavljenosti, da bi lahko upoštevali vpliv teh dveh parametrov (AVS/SEM) na biološko uporabnost cinka v sedimentih.
The most important factors in determining bioavailability (and, hence, ecotoxicity) in soils are soil type and the time between the addition of zinc to soil and toxicity testing (‘ageing').
Najpomembnejša dejavnika, ki določata biološko uporabnost (in s tem tudi strupenost za okolje) v tleh, sta vrsta tal in čas med vnosom cinka v tla ter preskusom strupenosti („staranje“).
The bioavailability of zinc, and therefore the environmental risk, varies between soil types and environmental conditions (e.g. dissolved organic carbon, calcium and pH).
Biološka razpoložljivost cinka in tako okoljsko tveganje se razlikuje med vrstami prsti in okoljskimi pogoji (npr. raztopljen organski ogljik, kalcij in pH).
Therefore, while soils and surface waters can both be corrected for bioavailability, a correction has not been possible for the calculation of the sediment PECs in this environmental risk assessment.
Medtem ko je torej tla in površinske vode mogoče popraviti za biološko uporabnost, takšen popravek v tej oceni tveganja za okolje ni mogoč za izračun vrednosti PEC za sedimente.
To assess the risk for each compartment following extended application of manure to land, PECs and PNEC values for each FOCUS scenario were compared at three time points (years: 2020, 2040, 2060), using two application rates: a worst case application rate (7 kg zinc ha a-1
Tveganje za posamezen del okolja po obširnem nanosu gnoja na zemljo so ocenili tako, da so primerjali vrednosti PEC in PNEC za vsak scenarij v modelu FOCUS ob treh časovnih točkah (leta: 2020, 2040, 2060), pri čemer so uporabili dva odmerka: odmerek cinka v najslabšem možnem primeru (7 kg ha
3, a user-friendly version of the Biotic Ligand Model, a model that is used to predict the bioavailable metals for different aquatic species (algae, Daphnia and fish) and has been used and well reported in a large number of peer-reviewed studies for zinc, and the data used in the EU RAR for zinc (2010).
3, uporabniku prijazne različice biotskega ligandskega modela, ki se uporablja za napoved biološko uporabnih kovin za različne vodne vrste (alge, vodne bolhe in ribe) in ki so ga uporabili in natančno dokumentirali v velikem številu strokovno pregledanih študij o cinku, ter s pomočjo podatkov, uporabljenih v poročilu EU RAR za cink (2010).
Even where manure storage is combined, piglet manure would account for 40% or less of the mixture.
Tudi tam, kjer kombinirano shranjujejo različne vrste gnoja, bi gnoj prašičkov predstavljal največ 40 % mešanice.
The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)
Vrednosti PNEC za določeno območje so bile za zdravilo Gutal izračunane z Excelovim orodjem za izračun vrednosti PNEC za tla (ki ga je razvilo podjetje Arche Consulting)
Additionally, as the model was not made available to the CVMP, the relevance of the default input parameters could not be assessed and the model could not be run using data on specific application rates for zinc.
Poleg tega zaradi dejstva, da model ni bil na voljo odboru CVMP, ni bilo mogoče oceniti primernosti privzetih vhodnih parametrov niti ni bilo mogoče uporabiti modela z uporabo podatkov o odmerkih, specifičnih za cink.
The proposed indication for Gutal is for the prevention of postweaning diarrhoea in piglets.
Predlagana indikacija za zdravilo Gutal je preprečevanje driske pri prašičkih po odstavitvi.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
In order to limit nutrient loss and eutrophication, Good Agricultural Practice recommends manure should not be spread on vulnerable soils (acidic, freely draining, sandy soils).
Da bi omejili izgubo hranil in evtrofikacijo, naj se v skladu z dobro kmetijsko prakso gnoj ne bi trosil po ranljivih tleh (kislih, dobro propustnih, peščenih tleh).
A risk was identified for all FOCUS sediment scenarios, at both loading rates and at each time point.
Tveganje je bilo ugotovljeno pri vseh scenarijih za sedimente v modelu FOCUS pri obeh stopnjah obremenitve in ob vseh časovnih točkah.
Although the endpoint data from one study was not of sufficient quality to be used in calculation of the generic PNEC value from which the site-specific PNECs are derived, it is accepted that the omission of the effects data from this single study would not significantly alter the calculated PNEC.
Čeprav podatki o končnih točkah iz ene od študij niso bili dovolj kakovostni, da bi jih lahko uporabili pri izračunu generične vrednosti PNEC, iz katere so izpeljane vrednosti PNEC za določena območja, je bilo ocenjeno, da izločitev podatkov o učinkih iz te študije ne bi pomembno spremenila izračunane vrednosti PNEC.
The final RMM proposed is to apply local or national rules for the minimum distance from open water at which manure should be spread.
Zadnji predlagani ukrep za zmanjšanje tveganja pa je uvedba lokalnih in nacionalnih pravil o najmanjši razdalji od odprtih voda, na kateri se lahko trosi gnoj.
Studies have shown zinc oxide to be beneficial in piglets at risk of developing mild to moderate diarrhoea.
Študije so pokazale, da je cinkov oksid koristen pri prašičkih, pri katerih obstaja tveganje za pojav blage do zmerne driske.
The bioavailability of zinc, and therefore the environmental risk, varies between soil types.
Biološka razpoložljivost cinka in tako okoljskega tveganja se razlikuje glede na vrsto tal.
In order to better indicate the risks posed at application rates considered particularly relevant by the use of Gutal of 8.2 kg zinc ha y-1
Da bi bolje prikazali tveganja, povezana z odmerki, ki veljajo za posebej relevantne pri uporabi zdravila Gutal in znašajo 8,2 kg cinka ha y-1
Risks were identified during the decentralised procedure by Belgium, France and the Netherlands who considered that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures (RMMs) proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement to all pig farms.
Med decentraliziranim postopkom so Belgija, Francija in Nizozemska prepoznale določena tveganja in menile, da bi odobritev dovoljenja za promet z zdravilom Gutal lahko pomenila resno tveganje za okolje in da ukrepi za zmanjšanje tveganja, predlagani za obvladovanje tveganja, niso zadostni, da bi lahko obvladali ali preprečili stalno kopičenje cinka, poleg tega pa jih ne bi mogli izvajati na vseh prašičjih farmah.
Although limited data were available, results show zinc concentrations are predicted accurately in soils but less so in surface waters and sediment.
Čeprav so bili na voljo omejeni podatki, so rezultati pokazali, da je model pravilno napovedal koncentracije cinka v tleh, manj točno pa koncentracije v površinskih vodah in sedimentih.
The CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of a marketing authorisations provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc, are added to the product information.
Odbor CVMP je zaključil, da zadržki, ki sta jih izpostavili Francija in Nizozemska, ne bi smeli preprečiti odobritve dovoljenj za promet z zdravilom pod pogojem, da se v informacije o zdravilu vključijo priporočeni ukrepi za zmanjšanje tveganja, ki naj bi zmanjšali kopičenje cinka.
Supporting field studies on zinc accumulation in soils are scarce, and the available data may be considered equivocal or of limited reliability because, for example, they may not reflect the pattern of application of manure expected following the use of zinc oxide in pig breeding or soil types representative of the whole of Europe.
Podpornih terenskih študij o kopičenju cinka v tleh je zelo malo, razpoložljivi podatki pa so dvoumni ali ne povsem zanesljivi, saj med drugim ne odražajo pričakovanega vzorca nanašanja gnoja po uporabi cinkovega oksida v prašičereji in vrst tal, reprezentativnih za celotno Evropo.
For instance, soils contaminated over an extended period of time show reduced toxicity compared to freshly spiked soils.
Na primer: tla, ki so kontaminirana že dlje časa, so manj strupena kot tla, ki so bila pravkar kontaminirana z zdravilom.
Moreover, validation of the IDMM has been performed by the comparison of model predictions against published monitoring data for zinc applications.
Opravljena je bila tudi validacija modela IDMM s primerjavo napovedi modela z objavljenimi podatki o spremljanju uporabe cinka.
Though limited, the validation data for the IDMM is sufficient to give confidence that the model can be used to achieve an ample, pragmatic assessment of the exposure of zinc to the environment.
Podatki o validaciji modela IDMM so omejeni, vendar zadostni, da je mogoče potrditi, da se model lahko uporabi za pridobitev obsežne pragmatične ocene izpostavljenosti okolja cinku.
The product should not be used on farms where mixing of manure from treated animals with manure of non-treated animals is not possible.
Zdravila ne uporabljati na kmetijah, kjer ni možno mešanje gnoja zdravljenih živali z gnojem nezdravljenih živali.
The Metal Bioavailability Assessment Tool is based on the outputs from the zinc Biotic Ligand Models and the dataset used in the derivation of the Environmental Quality Standard for zinc, and only requires input data for water pH, dissolved organic carbon and dissolved calcium concentration, but does not take into account the presence of other ions that could affect zinc speciation and, hence, bioavailability.
Orodje za oceno biološke uporabnosti kovin temelji na izhodnih podatkih biotskih ligandskih modelov za cink in naboru podatkov, uporabljenih za izpeljavo okoljskega standarda kakovosti za cink, ter zahteva samo vhodne podatke za pH vode, raztopljeni organski ogljik in koncentracijo raztopljenega kalcija, ne upošteva pa prisotnosti drugih ionov, ki bi lahko vplivali na speciacijo cinka ter s tem na njegovo biološko uporabnost.