FrancophonIA/ELRC3.0 huggingface dataset:
English: However, differences between the 2500 ppm and the 4000 ppm groups were not observed in this respect.
Croatian: Međutim, razlike između skupina koje su primale 2500 ppm i 4000 ppm nisu opažene.
English: Pre-Assessment of Environmental Impact of Zinc and Copper Used in Animal
Croatian: Pre-Assessment of Environmental Impact of Zinc and Copper Used in Animal Nutrition.
English: No studies were submitted to support the treatment indication.
Croatian: Nisu dostavljena ispitivanja koja bi poduprla indikaciju za liječenje.
English: For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Croatian: U svakom dijelu okoliša (tlo, voda i sediment) bioraspoloživost cinka ovisi o raznim biotičkim i abiotičkim čimbenicima.
English: However, the CVMP was not able to establish the validity of the PNEC values reported as the Arche Soil PNEC calculator and the set of relevant input parameters was not made available to the CVMP during the initial assessment.
Croatian: Međutim, CVMP nije mogao ustanoviti valjanost vrijednosti PNEC-a jer Arche Soil PNEC kalkulator i skup relevantnih ulaznih parametara nisu bili dostupnu CVMP-u tijekom inicijalne procjene.
English: However, the potential reduction in antimicrobial use secondary to zinc oxide use is not considered to qualify as an 'additional benefit' in this case.
Croatian: Međutim, ne smatra se da se potencijalno smanjenje upotrebe antimikrobnih sredstava zbog primjene cinkova oksida može ocijeniti kao „dodatna korist” u ovom slučaju.
English: Therefore, the continued beneficial effect of zinc oxide after cessation of treatment remains unclear.
Croatian: Stoga, nastavljeni korisni učinak cinkova oksida nakon prestanka liječenja ostaje nejasan.
English: The results indicate that for both clay and sandy soils a risk is identified using added-risk approach, with PEC values being above the PNECsoil of 26 mg/kg.
Croatian: Rezultati pokazuju da i za glinena i pjeskovita tla postoji rizik primjenom pristupa dodanog rizika, s tim da su vrijednosti PEC-a iznad PNECtlo od 26 mg/kg.
English: For instance, soils contaminated over an extended period of time show reduced toxicity compared to freshly spiked soils.
Croatian: Primjerice, tlo koje je kontaminirano tijekom duljeg razdoblja pokazuje manju toksičnost nego svježe kontaminirano tlo kojem je dodana veća količina toksičnosti.
English: The CVMP acknowledges that LA-MRSA is a rare cause of infection in pigs, but an emerging public health concern due to the high carrier status in pigs and the transference of MRSA to food products and in-contact humans (e.g. pig farmers, veterinarians, slaughter house employees).
Croatian: CVMP prihvaća da je LA-MRSA rijedak uzrok infekcije u svinja, ali postaje sve veći razlog za zabrinutost za zdravlje ljudi zbog statusa visokog prijenosa u svinja i prijenosa MRSA-e u prehrambene proizvode te kontakta s ljudima (npr. farmeri u kontaktu sa svinjama, veterinari, zaposlenici klaonica).
English: The CVMP also notes that other sources of zinc in the environment will also contribute to the yearly increase of zinc oxide to agricultural land.
Croatian: CVMP također napominje da će drugi izvori cinka u okolišu također pridonijeti godišnjem povećanju cinkova oksida na poljoprivrednim površinama.
English: Thus, it seems that the indication should be limited to the prevention of unspecific diarrhoea of post-weaning i.e. induced by the practice of weaning in certain conditions of breeding.
Croatian: Dakle, izgleda da indikacija treba biti ograničena na sprječavanje nespecifičnog proljeva nakon prestanka sisanja, tj. izazvanog praksom odvikavanja od sisanja u određenim uvjetima uzgoja.
English: Re-examination procedure
Croatian: Postupak ponovne ocjene
English: The CVMP cannot support the claim by the marketing authorisation holder stating that determining the environmental risks should be based on consideration of the conditions in Germany only, as the products are nationally authorised in this Member State only.
Croatian: CVMP ne može poduprijeti tvrdnju nositelja odobrenja za stavljanje u promet prema kojoj se određivanje rizika za okoliš treba temeljiti na razmatranju uvjeta samo u Njemačkoj, jer su proizvodi odobreni nacionalnim postupkom samo u toj državi članici.
English: If high amounts of zinc were administered for only one week, no differences were observed between treatments, while administration of high levels of zinc during two or three weeks significantly reduced the number of days with diarrhoea per piglet.
Croatian: Ako su velike količine cinka primjenjivane samo jedan tjedan, između liječenja nisu opažene razlike, dok je primjena velikih količina cinka tijekom dva ili tri tjedna značajno smanjila broj dana s proljevom po prasetu.
English: However, the only authorised indications are for the treatment and control of diarrhoea in piglets.
Croatian: Međutim, jedine odobrene indikacije odnose se na liječenje i kontrolu proljeva u prasadi.
English: Assessment of potential benefits associated with the use of zinc oxide in food producing animals
Croatian: Procjena potencijalnih koristi povezanih s upotrebom cinkova oksida u životinja od kojih se proizvodi hrana
English: No clinical data was identified to support the claimed indication ‘prevention and treatment of various types of diarrhoea occurring at the weaning'.
Croatian: Nisu navedeni ni klinički podatci koji bi potkrijepili traženu indikaciju „sprječavanje i liječenje različitih tipova proljeva koji nastaju nakon prestanka sisanja”.
English: No study was conducted with the combination in the proposed indication and thus the clinical benefit of the association was not demonstrated.
Croatian: Budući da nije provedeno nijedno ispitivanje kombinacije za predloženu indikaciju, klinička korist nije bila dokazana.
English: Vetoquinol Biowet Sp. z o. o. ul.
Croatian: Vetoquinol Biowet Sp. z o. o. ul. Kosynierów Gdyńskich
English: Potential additional exposure concentrations, e.g., from feed additives containing zinc or other industrial sources, have not been taken into account for this environmental risk assessment.
Croatian: Potencijalne dodatne koncentracije izlaganja, npr. od dodataka hrani koji sadrže cink ili drugih industrijskih izvora, nisu bili uzeti u obzir za ovu procjenu rizika za okoliš.
English: Therefore, it will only be a matter of time before any PNECs are exceeded in these compartments.
Croatian: Stoga je samo pitanje vremena kada će vrijednosti PNEC-ova biti premašene i u tim dijelovima okoliša.
English: 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.
Croatian: U vrijeme EU RAR-a za cink (2010.) bilo je premalo podataka o učincima ili izlaganju da bi se moglo objasniti učinke tih dvaju parametara (AVS/SEM) na bioraspoloživost u sedimentima.
English: 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.
Croatian: Međutim, očito je da će za sve dijelove okoliša koeficijenti rizika biti prekoračeni ili odmah (sediment) ili naposljetku (tlo, podzemne i površinske vode), a ti se rizici moraju rješavati.
English: 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').
Croatian: Najvažniji čimbenici u određivanju bioraspoloživosti u tlu (te stoga ekotoksičnosti) jesu tip tla i vrijeme između dodavanja cinka u tlo i testiranja toksičnosti („starenja”).
English: The Committee considered that colistin mono-product alone would be sufficient to reduce clinical diarrhoea, when used for seven days in close connection to weaning, where E. coli diarrhoea is the primary cause of diarrhoea.
Croatian: Odbor je smatrao da bi proizvod samo s kolistinom bio dovoljan za smanjenje kliničkog proljeva ako se upotrebljava sedam dana, i usko je povezan s odvikavanjem od sisanja, gdje je E. coli primarni uzrok proljeva.
English: Scarce data have been presented on the potential effect of using zinc oxide in the reduction of use of antibiotics and therefore no conclusions can be made in this regard.
Croatian: Predočeno je malo podataka o potencijalnom učinku upotrebe cinkova oksida za smanjenje primjene antibiotika, pa se u tom smislu ne može donijeti zaključak.
English: The CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005)11 indicates: ‘Any fixed combination product can only be justified, if such a combination offers an advantage over their active substances, when used as single substance products.
Croatian: Smjernice CVMP-a o farmaceutskim proizvoda s fiksnom kombinacijom (EMEA/CVMP/83804/2005)11 navode: „Svaki lijek s fiksnom kombinacijom može biti opravdan samo ako takva kombinacija nudi prednost u odnosu na djelatne tvari kada se upotrebljavaju pojedinačno, kao lijekovi s jednom djelatnom tvari.
English: The CVMP agrees that this study cannot be used, on its own, as proof that environmental risks exist from the use of zinc oxide in pig production.
Croatian: CVMP se slaže da se to ispitivanje, samo za sebe, ne može upotrijebiti kao dokaz da postoje rizici za okoliš od primjene cinkova oksida u proizvodnji svinja.
English: The marketing authorisation holder's justification of the combination is based on the addition of the two effects: bactericidal activity of colistin and unspecific protective effect of zinc oxide during the post-weaning period.
Croatian: Opravdanje nositelja odobrenja za stavljanje u promet za tu kombinaciju temelji se na zbrajanju dvaju učinaka: baktericidne aktivnosti kolistina i nespecifičnog zaštitnog učinka cinkova oksida tijekom razdoblja poslije prestanka sisanja.
English: Although limited data were available, results show zinc concentrations are predicted accurately in soils but less so in surface waters and sediment.
Croatian: Iako su dostupni ograničeni podatci, rezultati pokazuju da su koncentracije cinka točno predviđene u tlu, no to nije slučaj u površinskim vodama i sedimentu.
English: All data provided for zinc oxide only refer to a prevention claim.
Croatian: Svi podatci prikazani za cinkov oksid odnose se samo na pitanje prevencije.
English: Indeed, there are examples that some EU Member States already monitor veterinary medicinal products containing zinc oxide consumption (e.g., Denmark, Czech Republic), as well as zinc soil concentrations (e.g., Denmark).
Croatian: Postoje primjeri da neke države članice EU-a već prate potrošnju veterinarskomedicinskih lijekova koji sadrže cinkov oksid (npr. Danska, Češka), a također i koncentracije cinka u tlu (npr. Danska).
English: • The absence of a multicentre field study conducted through Europe according to GCP to test the efficacy of such products in various field conditions does not permit to define the indication more precise than ‘post-weaning diarrhoea', neither to conclude on the efficacy of the products in situations where specific pathogen(s) is (are) involved nor in situations other than e.g. weaning piglets at 3-4 weeks of age.
Croatian: • Nedostatak multicentričnih terenskih ispitivanja provedenih diljem Europe prema dobroj kliničkoj praksi kako bi se ispitala djelotvornost takvih proizvoda u različitim terenskim uvjetima, ne dopušta definiranje preciznijih indikacija od „proljev nakon prestanka sisanja”, ni zaključak o djelotvornosti proizvoda u situacijama koje uključuju jedan ili više specifičnih patogena, ni u situacijama osim npr. prasadi odviknute od sisanja u dobi od 3-4 tjedna.
English: It appears that zinc oxide administered at high doses may co-select for antimicrobial resistance, a phenomenon shown in vivo for LA-MRSA ST398.
Croatian: Čini se da cinkov oksid primijenjen u visokim dozama može ko-selektirati za antimikrobnu rezistenciju, pojava koja je in vivo pokazana za LA-MRSA ST398.
English: If current practices remain unchanged in the near future, the continual application of manure from treated animals will result in risks (defined by RQ values >1) being established in 4 of 19 soil scenarios, 5 of 15 surface water scenarios and each of the 15 sediment scenarios by 2060.
Croatian: Ako sadašnje prakse ostanu nepromijenjene u bližoj budućnosti, nastavak primjene gnojiva od liječenih životinja rezultirat će do 2060. rizicima za okoliš (definirani RQ vrijednostima > 1) koji je utvrđen u 4 od 19 scenarija tla, 5 od 15 scenarija površinskih voda i u svakom od 15 scenarija sedimenta.
English: A reduction in the use of antimicrobials to treat post-weaning diarrhoea in piglets is likely to reduce the selective pressure for antimicrobial resistance development.
Croatian: Smanjenje upotrebe antimikrobnih sredstava za liječenje proljeva u prasadi nakon prestanka sisanja, vjerojatno bi smanjilo selektivni pritisak za razvoj antimikrobne rezistencije.
English: 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.
Croatian: PEC ne mogu provjeriti za svaki dio okoliša jer nisu navedene vrijednosti modela IDMM, one se sveukupno gledano čine prilično konzervativnima, jer se razmatrao razumno najgori mogući scenarij, tj. neprekidna primjena nerazrijeđenog gnojiva do 2060.
English: • Based on the studies provided, the efficacy of high content of zinc oxide in feed was shown in weaned piglets aged 3-4 weeks old in particular breeding conditions (intensive breeding, housing in building, grouping in pens with piglets of different litters/origins, premature separation with the sow, abrupt feeding transition from milk to cereal based feed).
Croatian: • Na temelju prikazanih ispitivanja, djelotvornost visokog sadržaja cinkova oksida u hrani pokazala se u prasadi odviknute od sisanja stare 3-4 tjedna u posebnim uvjetima uzgoja (intenzivni uzgoj, držanje u zgradi, grupiranje u oborima prasadi različitih legla/porijekla, prerano odvajanje od krmače, nagli prijelaz u hranjenju s mlijeka na hranu od žitarica).
English: United Kingdom SCA NuTec (Provimi Ltd) Eastern Avenue
Croatian: SCA NuTec (Provimi Ltd) Eastern Avenue Lichfield
English: Huvepharma's scientific grounds for re-examination focused on risks for the environment.
Croatian: Znanstveni razlozi tvrtke Huvepharma za ponovnu procjenu usmjereni su na rizike za okoliš.
English: Czech Republic Trouw Nutrition Biofaktory s.r.o.
Croatian: Trouw Nutrition Biofaktory s.r.o.
English: However, the marketing authorisation holders argue that additional risk mitigation measures could be considered to reduce or limit emission of zinc oxide to the environment from the use of pig manure, but did not propose any additional risk mitigation measures.
Croatian: Međutim, nositelji odobrenja za stavljanje u promet tvrde da se dodatne mjere za smanjenje rizika mogu smatrati načinom da se smanje ili ograniče emisije cinkova oksida u okoliš od upotrebe svinjskog gnoja, ali ne predlažu nikakve dodatne mjere za smanjenje rizika.
English: Nevertheless, the CVMP would like to note that although these assessments are not considered further, the outcome of two of them also indicate a risk (PEC/PNEC≥1) for the only compartments assessed (soil and surface waters).For the other two, no Phase II data were provided.
Croatian: Ipak, CVMP napominje da iako se te procjene neće dalje razmatrati, rezultat dviju procjena ukazuje i na rizik (PEC/PNEC≥1) za jedina dva procijenjena dijela okoliša (tlo i površinske vode).
English: These application rates were chosen as they were the ones reported in the Monteiro et al. (2010) study for feed additives containing zinc oxide and do not represent a worst case scenario for veterinary medicinal products containing zinc oxide which would be in the range of 8 kg ha-1 a-1.
Croatian: Te stope primjene izabrane su jer su to stope opisane u ispitivanju koje su Monteiro et al. (2010.) proveli za dodatke hrani koji sadrže cinkov oksid i ne predstavljaju najgori scenarij za veterinarsko-medicinske proizvode koji sadrže cinkov oksid, u kojem bi raspon bio od 8 kg ha-1 a-1.
English: Report no. 778 - link
Croatian: 778 - link
English: The combination of a conservative PNEC (not accounting for bioavailability) and PEC may result in an overestimate of the risk due to zinc in sediments.
Croatian: Kombinacija konzervativnog PNEC-a (ne objašnjava bioraspoloživost) i PEC-a može rezultirati precjenjivanjem rizika zbog cinka u sedimentima.
English: The exposure assessment should ideally have addressed this and considered a realistic worst-case situation with respect to the respective receiving environmental compartments.
Croatian: U zamisli, procjene izloženosti trebale su se time baviti i razmotriti realno najgori slučaj s obzirom na dijelove okoliša koji su u pitanju.
English: Not all marketing authorisation holders submitted the information that was required to validate the suitability of these additional studies for PNEC refinements.
Croatian: Među nositeljima odobrenja za stavljanje u promet neki nisu dostavili informacije koje su bile potrebne kako bi se validirala prikladnost tih dodatnih ispitivanja za poboljšanje PNEC-a.
English: In the terrestrial and aquatic compartments a risk (RQ >1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Croatian: U kopnenom i vodenom dijelu okoliša utvrđen je rizik (RQ > 1) u 4 od 19 scenarija, a u 5 od 15 scenarija od 2060. nadalje, i to za najgori slučaj, odnosno pri nižoj stopi primjene.
English: • the CVMP considered that based on the available data risks to the environment have been identified, due to accumulation of zinc, for all scenarios, either immediately (sediment, some soil and surface water types) or delayed (other soil types, ground-, and surface waters); the CVMP acknowledged that all predictive models have an inherent degree of uncertainty in their parameterisation, and the results generated (i.e., time estimates) are based on a limited amount of input data which is likely to influence the model output;
Croatian: • CVMP smatra da su na temelju dostupnih podataka identificirani rizici za okoliš zbog akumulacije cinka za sve scenarije, bilo neposredni (sediment, neka tla i površinske vode) ili odgođeni (drugi tipovi tla, površinske i podzemne vode); CVMP prihvaća da svi prediktivni modeli imaju inherentni stupanj nesigurnosti u parametrizaciji, pa se generirani rezultati (tj. vremenske procjene) temelje na ograničenom broju ulaznih podataka što će vjerojatno utjecati na izlazni model;
English: In the trials with only seven days of zinc oxide supplementation at the recommended dose no significant effect was shown.
Croatian: U ispitivanjima s dodavanjem cinkova oksida u preporučenoj dozi tijekom samo sedam dana, nije opažen nikakav značajan učinak.
English: Fixed combination product can only be justified, if such combination offers an advantage over their active substances, when used as single substance products.
Croatian: Lijek s fiksnom kombinacijom može biti opravdan samo ako takva kombinacija nudi prednost u odnosu na djelatne tvari primjenjivane pojedinačno u lijekovima s jednom djelatnom tvari.
English: The CVMP considers that four out of five environmental risk assessments have a number of deficiencies on their risk assessment and consequently cannot be used in support of the benefit-risk assessment.
Croatian: CVMP smatra da četiri od ukupno pet procjena rizika u okolišu imaju brojne nedostatke, pa se stoga ne mogu upotrijebiti za podršku procjene omjera koristi i rizika.
English: During the weaning period, piglets loose the benefit of passive immunity from the sow's milk and experience gastrointestinal changes that accompany the change in diet, which causes them a degree of stress and leaves them vulnerable to secondary infections.
Croatian: Za vrijeme odvikavanja od sisanja, prasad gubi potporu pasivnog imuniteta iz mlijeka krmače i prolazi gastrointestinalne promjene koje prate promjenu prehrane, što za njih predstavlja određeni stupanj stresa i čini ih osjetljivima na sekundarne infekcije.
English: Additionally, as the IDMM has been taken into consideration for the EFSA assessment of zinc exposure, it may also be considered relevant for the assessment of veterinary medicinal products in terms of environmental exposure assessment.
Croatian: Nadalje, budući da je IDMM uzet u obzir za EFSA-inu procjenu izlaganja cinku, može se smatrati relevantnim i za procjenu veterinarsko-medicinskih proizvoda u smislu procjene izlaganja okoliša.
English: The clinical relevance of zinc oxide in reducing the level of E. coli diarrhoea for these heavier pigs is unknown.
Croatian: Klinička važnost cinkova oksida za smanjenje razine proljeva prouzročenog E. coli za takve teže svinje nije poznata.
English: Hence, where an excess of AVS exists and zinc sulfides are formed, the PNEC may be exceeded considerably before any adverse effects are observed.
Croatian: Stoga, kada postoji prekomjeran AVS i dolazi do stvaranja cinkovih sulfida, PNEC može biti znatno premašen prije nego što se uoče štetni učinci.
English: The Committee therefore considered that it is not justified to associate an antimicrobial substance (by definition, only appropriate for infectious diseases involving target pathogen(s) and for treatment and metaphylaxis) to zinc oxide because it is not specific-pathogen targeted and has not demonstrated efficacy for treatment.
Croatian: Stoga je Odbor smatrao da nije opravdano povezati antimikrobne tvari (koje su, prema definiciji, prikladne samo protiv zaraznih bolesti koje uključuju jedan ili više ciljanih patogena te za liječenje i metafilaksu) i cinkov oksid, jer on nije ciljan posebno za patogene i u liječenju nije dokazao djelotvornost.
English: The available data did not include a multicentre GCP field study conducted in several geographical arears Europe and on animals representing the range of various husbandry practices.
Croatian: Dostupni podatci nisu uključili multicentrično terensko ispitivanje koje je prema dobroj kliničkoj praksi provedeno u nekoliko geografskih područja Europe te na životinjama koje predstavljaju raspon različitih stočnih praksi.
English: For two of the FOCUS scenarios (acidic, sandy soils) the RQs are >1 for both loading rates at all time points.
Croatian: U dva scenarija FOCUS-a (kisela, pjeskovita tla), koeficijenti rizika (RQ) bili su >1 za obje stope opterećenja u svim vremenskim točkama.
English: Higher yields were described in animals treated with 3000 ppm zinc in the first 21 days after weaning than in control animals, but the animals treated with zinc showed signs of toxicity in the three following weeks.
Croatian: Rezultati opisani u životinja liječenih s 3000 ppm cinka prvih 21 dana poslije prestanka sisanja, bili su bolji nego u kontrolnih životinja, ali su životinje liječene cinkom u sljedeća tri tjedna pokazale znakove toksičnosti.
English: Concerning sediment PECs specifically, accumulation factors are not considered (e.g. deposition, re-suspension, and burial of zinc), it is assumed that suspended sediments are representative of the deposited sediment, and no account is made for acid volatile sulfide levels.
Croatian: Što se tiče PEC-ova posebno za sediment, faktori akumulacije nisu uzeti u obzir (npr. taloženje, ponovna suspenzija i zakapanje cinka), pretpostavlja se da su suspendirani sedimenti reprezentativni za deponirani sediment, a u obzir nisu uzete koncentracije kiselih hlapivih sulfida.
English: A target animal safety study was performed at the recommended dose (100 mg/kg bw per day during 14 days) and no significant side effects have been observed.
Croatian: Ispitivanje ciljano na sigurnost životinja provedeno je pri preporučenoj dozi (100 mg/kg tjelesne težine na dan tijekom 14 dana) i nisu opažene značajne nuspojave.