natgillin/translations-raw huggingface dataset:
This Danish national monitoring study confirms the results obtained with the IDMM and CVMP guidelines that the use of veterinary medicinal products containing zinc oxide leads to a significant increase in the soil zinc concentrations (and such is ultimately reflected in water concentrations).
Dansko nacionalno ispitivanje praćenja potvrđuje rezultate dobiveni prema smjernicama IDMM-a i CVMP-a koje navode da upotreba veterinarskomedicinskih proizvoda koji sadrže cinkov oksid dovodi do značajnog porasta koncentracija cinka u tlu (a to se u konačnici odražava u koncentracijama u vodi).
In conclusion, the combination of colistin and zinc oxide for the approved indication (metaphylaxis and treatment of gastrointestinal infections caused by non-invasive E. coli sensitive to colistin) for seven days duration of administration is not justified.
Kao zaključak, kombinacija kolistina i cinkova oksida za odobrenu indikaciju (metafilaksa i liječenje gastrointestinalnih infekcija prouzročenih neinvazivnom E. coli osjetljive na kolistin) tijekom primjene od sedam dana nije opravdana.
It is believed that bioavailability of metals in sediment can be predicted by measuring the acid volatile sulphide (AVS) and the simultaneously extracted metal (SEM) contents of sediments.
Smatra se da se bioraspoloživost metala u sedimentu može predvidjeti mjerenjem kiselinskog hlapivog sulfida (engl. acid volatile sulphide, AVS) i udjela istovremeno ekstrahiranog metala (SEM-a) u sedimentu.
Other parameters affecting (lowering) zinc bioavailability in sediments are the presence of precipitated mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Drugi parametri koji utječu na (snižavanje) bioraspoloživosti cinka u sedimentima jesu prisutnost precipitiranih mineralnih faza, npr. željezovi (oksi)hidroksidi i magnezijevi oksidi, kao i udio organskih tvari u sedimentima.
Based on the totality of the data available, including the information submitted during the original assessment procedure and the detailed scientific grounds for re-examination put forward by the marketing authorisation holders, the CVMP concluded that there were not sufficient scientific grounds to revise its previous conclusions as included in its opinion of 8 December 2016, which concluded that the overall benefit-risk balance for the veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative.
Na temelju ukupnosti dostupnih podataka, uključujući informacije dostavljene tijekom postupka prvobitne procjene i iznesenih detaljnih znanstvenih razloga za ponovnu procjenu koju provodi nositelj odobrenja za stavljanje u promet, CVMP je zaključio da nema dovoljno znanstvenih razloga da se revidira njihova prijašnja odluka kako je to uključeno u njihovo mišljenje od 8. prosinca 2016., kada je zaključeno da je ukupni omjer koristi i rizika za veterinarsko-medicinske lijekove koji sadrže cinkov oksid za peroralnu primjenu u životinja namijenjenih za proizvodnju hrane negativan.
In addition, it appears that zinc oxide is useful to reduce the incidence of post-weaning diarrhoea but not to treat diarrhoea and that it is not possible to clearly identify the mechanism of action of zinc oxide and thus any specific target.
Osim toga, čini se da je cinkov oksid koristan za smanjenje pojave proljeva nakon prestanka sisanja ali ne i za liječenje proljeva, te da nije moguće jasno ustanoviti mehanizam djelovanja cinkova oksida, a time ni specifičan cilj.
The proposed indication of the combined product is for treatment, but no clinical data to support the use of zinc oxide in the treatment of diarrhoea (i.e. in presence of the disease at the initiation of zinc oxide administration - infection already confirmed in the herd) was available.
Predložena indikacija kombiniranih proizvoda je za liječenje, ali nema kliničkih podataka koji bi potkrijepili upotrebu cinkova oksida za liječenje proljeva (tj. u prisutnosti bolesti na početku primjene cinkova oksida - infekcija je već bila potvrđena u stadu).
This trend of zinc accumulation on agricultural soils from the veterinary use of zinc oxide has been recently reported by Bak et al. (2015).
Ovaj trend akumulacije cinka u poljoprivrednim tlima zbog veterinarske primjene cinkova oksida, nedavno je opisao Bak et al. (2015.).
The Committee accepts that, while there may be a benefit in monitoring the zinc oxide consumption as a veterinary medicine, a risk to the environment has been identified and, at this time, the risks are considered to outweigh the benefits for zinc oxide as a veterinary medicine.
Odbor prihvaća da, iako može biti korisno pratiti potrošnju cinkova oksida kao veterinarskog lijeka, rizik za okoliš je utvrđen, i ovoga se trenutka smatra da rizici premašuju koristi od cinkova oksida kao veterinarskog lijeka.
However, this would just delay the total zinc accumulation in the environment (i.e. the time when PEC will exceed PNECs), but given the nature of zinc risk mitigation measures cannot guarantee that they can effectively eliminate short term (2020) risks identified in the risk assessment.
Međutim, to bi samo odgodilo ukupnu akumulaciju cinka u okolišu (tj. vrijeme kada će PEC premašiti PNEC-ove), a uzimajući u obzir prirodu cinka, mjere za smanjenje rizika ne mogu jamčiti da će učinkovito eliminirati kratkoročne (2020.) rizike utvrđene u procjeni rizika.
Although this risk mitigation measure could be considered in line with the criteria set out by the CVMP reflection paper on risk mitigation measures (EMA/CVMP/ERAWP/409328/2010), the CVMP was of the view that, in practice, applying this risk mitigation measure will not be feasible where there may not be the possibility to apply treated manure on different areas of land or where there is trading of manure.
Iako se mjere za smanjenje rizika mogu uzeti u obzir u skladu sa skupom kriterija koje je u svom mišljenju o mjerama za smanjenje rizika iznio CVMP (EMA/CVMP/ERAWP/409328/2010), gledište CVMP-a bilo je da u praksi, provedba tih mjera za smanjenje rizika neće biti izvediva tamo gdje možda neće postojati mogućnost nanošenja obrađenog gnojiva na različite površine zemlje ili gdje se gnojivom trguje.
• A risk of zinc to soil dwelling species is already present in clay soil; • A risk of zinc to soil dwelling species is already present in sandy soil.
• rizik od cinka za vrste životinja koje žive u tlu već je prisutan u glinastom tlu, • rizik od cinka za vrste životinja koje žive u tlu već je prisutan u pjeskovitom tlu.
Although there were uncertainties in both PEC and PNEC calculations on environmental compartments, the overall risk assessment was viewed as conservative and as a result various risk mitigation measures were proposed, which were anticipated to reduce the accumulation of zinc in the environment.
Iako je bilo nesigurnosti i u proračunima PEC-a i PNEC-a za dijelove okoliša, procjena sveukupnog rizika smatrala se konzervativnom, pa su kao rezultat predložene različite mjere za smanjenje rizika za koje se očekivalo da će smanjiti akumulaciju cinka u okolišu.
However, the study supports the line of evidence that the use of zinc oxide as a veterinary medicinal product in pig farming will lead to a gradual accumulation in agricultural soils, which will eventually not only exceed safe concentrations of zinc in soil, but also in sediment and water systems.
Međutim, ispitivanje podupire liniju dokaza da će upotreba cinkova oksida kao veterinarsko-medicinskog proizvoda u farmskom uzgoju svinja dovesti do postupne akumulacije u poljoprivrednim tlima, što će naposljetku ne samo premašiti sigurne koncentracije cinka u tlu, nego i u sustavima sedimenta i vode.
The marketing authorisation holders presented an environmental risk assessment by: a) addressing measured soil concentrations of zinc in (Danish) soils - but not taking into consideration the contributing from the repeated (annual) load of zinc from non-aged pig slurry; and b) by combining two methods for incorporating bioavailability (the so called ‘added risk approach' together with the ‘bioavailability correction approach'), yet the combination of both is not supported by the CVMP.
Nositelji odobrenja za stavljanje u promet opisali su procjenu rizika za okoliš: a) navodeći izmjerene koncentracije cinka u tlu (Danska), ali nisu uzeli u obzir doprinos od ponavljanog (godišnjeg) opterećenja cinka od gnoja svinja koje nisu stare, te b) kombinacijom dviju metoda za uključivanje bioraspoloživosti (tzv. „pristup dodanog rizika” zajedno s „pristupom korekcije bioraspoloživosti”).
This increase in zinc concentrations in soil and consequent risks identified for selected compartments is established in this assessment only considering exposure of zinc coming from veterinary products.
Porast koncentracija cinka u tlu i posljedični rizici za odabrane dijelove okoliša, utvrđeni su u ovoj procjeni uzimajući u obzir samo izloženost cinku koji potječe iz veterinarskih proizvoda.
Scientific conclusions and grounds for the refusal of the marketing authorisation and for withdrawal of the existing marketing authorisations
Znanstveni zaključci i razlozi za odbijanje izdavanja odobrenja za stavljanje VMP-a u promet te ukidanje postojećih odobrenja
Despite these uncertainties, and in the absence of a better alternative, it is considered that the IDMM can be used to gain a reasonable assessment of the risk to the environment posed by the use of Gutal or any other zinc containing veterinary product.
Usprkos ovim nesigurnostima, te u odsutnosti bolje alternative, zaključeno je da se IDMM može koristiti kako bi se dobila razumna procjena rizika koju za okoliš predstavlja primjena Gutala ili nekog drugog veterinarskog proizvoda koji sadrži cink.
Effect assessment
Procjena učinaka
The CVMP notes that after further considerations regarding the current EU rules and Good Agricultural Practice on manure spreading, and how the target animals are kept and how manure is be managed, the initially suggested risk mitigation measures would slow down the accumulation of zinc in each compartment.
CVMP je uočio da bi nakon daljnjih razmatranja sadašnjih EU pravila i dobre poljoprivredne prakse za rasprostiranje gnojiva, kako se drže ciljane životinje i kako se postupa s gnojivom, inicijalno predložene mjere za smanjenje rizika usporile akumulaciju cinka u svakom dijelu okoliša.
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In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
U tlu, svojstva poput pH, sadržaja organskog ugljika, kapaciteta izmjene kationa i udjela gline, utvrđuju bioraspoloživost u kopnenom dijelu okoliša.
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.
Sve u svemu, očito je da će dugoročna, stalna uporaba veterinarsko-medicinskih proizvoda koji sadržavaju cink rezultirati postupnim neto unosom cinka u okoliš.
Although this is in line with the criteria set out by the CVMP reflection paper on risk mitigation measures, it might be difficult not only in instances where there may not be the possibility to apply treated manure on different areas of land, but also because of the trade on manure between EU Member States and possibility for manure containing high concentrations of zinc oxide being used in susceptible soil types.
Iako je to u skladu s kriterijima koje je CVMP naveo u svom mišljenju o mjerama za smanjenje rizika, to može biti teško ne samo u slučajevima gdje možda ne postoji mogućnost nanošenja obrađenog gnojiva na različite površine tla, nego i zbog trgovanja gnojivom između država članica EU i mogućnosti da se na nekim osjetljivim tipovima tla primjenjuje gnojivo s visokim koncentracijama cinkova oksida.
There are a number of uncertainties associated with use of the IDMM for predicting the environmental exposure of zinc from use in veterinary medicinal products, such as the effects of hydrology, dissolved organic carbon and metal aging.
Prisutan je niz nesigurnosti povezanih s primjenom IDMM-a za predviđanje izloženosti okoliša cinku primijenjenog u veterinarsko-medicinskim proizvodima, poput učinaka hidrologije, otopljenog organskog ugljika i starenja metala.
The CVMP recognises the importance of bioavailability when addressing toxicity of metals, and considers that while different models might take into consideration the bioavailable fraction of zinc oxide and conclude on a slight different timeframe for when (i.e., in which year) environmental risks are predicted to occur, none of the models support a prediction of no environmental risk from the use of zinc oxide as a veterinary medicinal product, nor that zinc in soil will not become bioavailable to soil, water or aquatic biota.
CVMP prepoznaje važnost bioraspoloživosti kada se radi o toksičnosti metala i smatra da dok različiti modeli mogu uzeti u obzir bioraspoloživu frakciju cinkova oksida i zaključiti o neznatno drugačijem vremenskom okviru za to kada se (tj. koje godine) predviđa da će se dogoditi ti rizici u okolišu, nijedan od tih modela ne podupire predviđanje da upotreba cinkova oksida kao veterinarsko-medicinskog proizvoda neće predstavljati rizik za okoliš ili da cink u tlu neće postati bioraspoloživ u tlu, vodi ili vodenoj bioti.
• A risk of zinc to soil dwelling species will on average be reached in approximately 55 years in clay soils;
• rizik od cinka za vrste životinja koje žive u tlu bit će u prosjeku dosegnut za približno 55 godina u glinastim tlima,
The czrC zinc resistance gene has been shown to occur on SCCmec of meticillin-resistant Staphylococcus aureus (MRSA) and zinc use has been shown to result in co-selection for MRSA carrying this gene (Cavaco et al., 2010)24.
Pokazalo se da se gen za rezistenciju cinku czrC javlja na SCCmec meticilin-rezistentnoj Staphylococcus aureus (MRSA), i pokazalo se da upotreba cinka rezultira koselekcijom bakterije MRSA koja nosi taj gen (Cavaco et al., 2010.)24.
Moreover the data provided only concern separate use of colistin and zinc oxide and not the clinical use of the
Štoviše, podatci su se bavili samo odvojenom upotrebom kolistina i cinkova oksida, a ne kliničkom upotrebom kombinacije.
No information was available to establish the duration of the effect after the end of zinc oxide administration.
Nema dostupnih podataka kako bi se ustanovilo trajanje učinka poslije završetka primjene cinkova oksida.
The posology of aniMedica's veterinary medicinal products (daily dose of 1 g product per 5 kg bw, equivalent to 5 mg colistin sulphate and 96 mg zinc oxide per kg bw, for 5 - 7 days), means that the concentration of zinc oxide in-feed will be 3000 ppm (approximately 2400 ppm zinc).
Doziranje veterinarsko-medicinskih proizvoda tvrtke aniMedica (dnevna doza od 1 g proizvoda na 5 kg tjelesne težine, što odgovara količini od 5 mg kolistin sulfata i 96 mg cinkova oksida po kg tjelesne težine, tijekom 5 - 7 dana), znači da će koncentracija cinkova oksida u hrani biti 3000 ppm (približno 2400 ppm cinka).
The results demonstrated that, among the piglets fed with 2500 ppm or 4000 ppm zinc, a significantly lower number of piglets required anti-diarrhoea treatment.
Rezultati su pokazali da je među prasadi hranjenoj cinkom u količini od 2500 ppm ili 4000 ppm, značajno manji broj prasadi trebao liječenje protiv proljeva.
Much of the text was focused on the health and growth benefits of zinc oxide.
Mnogo teksta fokusiralo se na zdravlje i koristi za rast od cinkova oksida.
• the CVMP acknowledged that there is a risk of co-selection for resistance associated with the use of zinc oxide, but at the present time, that risk is not quantifiable;
• CVMP prihvaća da postoji rizik od ko-selekcije za rezistenciju povezanu s primjenom cinkova oksida, ali u ovom trenutku, taj se rizik ne može kvantificirati;
The study was performed on 260 piglets from 36 litters weaned at the age of 28 days and assigned, according to initial body weight and the litter of origin, to one of six treatment groups: 0 ppm zinc, 100 ppm zinc; 200 ppm zinc; 1000 ppm zinc; 2500 ppm zinc and 4000 ppm zinc.
provedeno na 260 prasadi iz 36 legla koji su prestali sisati u dobi od 28 dana, a prema svojoj početnoj težini i leglu podijeljeni su u jednu od šest ispitivanih skupina: 0 ppm cinka, 100 ppm cinka, 200 ppm cinka, 1000 ppm cinka, 2500 ppm cinka i 4000 ppm cinka.
The data presented identify a hazard for human and animal health but, at the present time, that risk is not quantifiable.
Prikazani podatci pokazuju opasnost za zdravlje ljudi i životinja, ali se u ovom trenutku taj rizik ne može kvantificirati.
Concerning the reduction of the use of antibiotics by use of zinc oxide it is considered that the clinical data were too sparse to conclude on this potential effect.
S obzirom na mogućnost da bi se primjenom cinkova oksida smanjila primjena antibiotika, smatra se da su klinički podatci previše oskudni da bi se zaključilo o tom potencijalnom učinku.
A number of marketing authorisation holders referred to the European Union Risk Assessment Report (EU RAR) on zinc (2010)12 in their effect assessment.
U procjenama učinaka, nekoliko nositelja odobrenja za stavljanje u promet pozivalo se na Izvješće Europske unije o procjeni rizika (European Union Risk Assessment Report, EU RAR) za cink (2010.)12.
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.
Alat za procjenu bioraspoloživosti metala temelji se na izlaznim podatcima modela biotičkog liganda za cink i skupu podataka upotrijebljenih u izradi standarda kvalitete okoliša za cink, potrebni su samo ulazni podatci za pH vode, otopljeni organski ugljik i koncentraciju otopljenog kalcija, ali ne uzima u obzir prisutnost drugih iona koji mogu utjecati na specijaciju cinka i, stoga, na bioraspoloživost.
Considering the duration of the administration of high amounts of zinc in the feed of weaned piglets (between 2500 and 3000 ppm of zinc), Hollis (2000)6 advises that administration of high zinc content feed should not be prolonged for more than two weeks after weaning, and that zinc used should be in the form of zinc oxide.
Uzimajući u obzir trajanje primjene velikih količina cinka u hrani prasadi odviknute od sisanja (između 2500 i 3000 ppm cinka), Hollis (2000)6 smatra da primjena hrane s velikim količinama cinka ne smije trajati dulje od dva tjedna od prestanka sisanja te da upotrijebljeni cink treba biti u obliku cinkova oksida.
The IDMM predicts the long-term mass balance of metals, with defined inputs (e.g. veterinary medicinal products usage) and outputs (e.g. crop off-take, ageing), and concludes that zinc will accumulate in soil following continual application of treated manure with acidic sandy soils being most vulnerable as these soils have a tendency to accumulate zinc more rapidly than other type of soils and will also have a higher drainage and run-off of zinc to surface water.
Model IDMM predviđa dugoročnu ravnotežu masa metala, s definiranim unosima (npr. upotreba veterinarsko-medicinskih proizvoda) i rezultatima (npr. preuzimanje kroz usjev, starenje), i zaključuje da će se cink akumulirati u zemlji nakon kontinuirane primjene obrađenog gnojiva, pri čemu su kisela pjeskovita tla najosjetljivija, jer su ta tla sklona akumulirati cink brže od drugih tipova tla te također imaju veću stopu drenaže i istjecanja cinka u površinske vode.
Zinc oxide for weanling piglets.
8 Poulsen HD. 1995. Zinc oxide for weanling piglets.
The CVMP confirmed that, at this level, zinc oxide cannot be considered as an excipient only and that furthermore, considering the substantial amount of zinc oxide present in the aforementioned products (Enteroxid N AMV aniMedica and aniMedica Enteroxid N), the classification of the substance as an excipient or active substance is not relevant.
CVMP je potvrdio da se pri toj koncentraciji cinkov oksid ne može smatrati samo kao pomoćna tvar te da štoviše, uzimajući u obzir značajnu količinu cinkova oksida prisutnu u spomenutim proizvodima (Enteroxid N AMV aniMedica i aniMedica Enteroxid N), klasifikacija tvari kao pomoćna tvar ili djelatna tvar nije relevantna.
The conclusion of this study was that adding 2400 ppm zinc (as zinc oxide) for 14 days after weaning reduces the incidence of diarrhoea.
Zaključak ovog ispitivanja bio je da se dodavanjem 2400 ppm cinka (kao cinkov oksid) tijekom 14 dana nakon prestanka sisanja smanjuje pojavu proljeva.
The published data from Hu et al. (Hu et al., 2013a3; Hu et al., 2013b4) showed in two different nonGCP studies a statistically significant effect on faecal consistency (scored from 1 to 5) of the feed supplementation with 2250 ppm zinc in weaned piglets (aged 21 days) for 14 days, in comparison with a negative control.
Objavljeni podatci Hua et al. (Hu et al., 2013a3; Hu et al., 2013b4) pokazali su u dva različita ispitivanja, koja također nisu bila u skladu s dobrom kliničkom praksom, statistički značajan učinak na konzistenciju fecesa (bodovano od 1 do 5) kada se hrani prasadi koja je prestala sisati (u dobi od 21 dana) dodavalo 2250 ppm cinka tijekom 14 dana, u usporedbi s negativnom kontrolom.
The results of the environmental risk assessment for Gutal reflect the conclusion from EFSA on zinc i.e. there is a potential environmental concern related to the aquatic compartment (including sediment), with acidic, sandy, well-drained soils being most vulnerable to these processes.
Rezultati procjene rizika u okolišu za Gutal odražavaju zaključak EFSA-e za cink, tj. postoji potencijalna zabrinutost za okoliš s obzirom na vodeni dio okoliša (uključujući sediment), s tim da su kisela, pjeskovita, dobro isušena tla najosjetljivija na ove procese.
The zinc oxide supplementation was given for three weeks from weaning and the challenge performed four days after weaning.
Cinkov oksid kao dodatak davan je tri tjedna od prestanka sisanja, a zaraživanje je provedeno četiri dana poslije prestanka sisanja.
It should be noted that no information supporting a seven days administration of zinc oxide was available.
Treba napomenuti da nisu postojali podatci koji bi potkrijepili primjenu cinkova oksida u trajanju od sedam dana.
The degree of stress experienced during the weaning period in piglets varies with age of weaning (more stress in younger piglets) and husbandry conditions, and can influence the severity of post-weaning diarrhoea.
Stupanj stresa koji prasad doživljava za vrijeme odvikavanja od sisanja varira s njihovom starošću u trenutku odvikavanja (veći stres u mlađe prasadi) te uvjetima stočarstva, i može utjecati na težinu proljeva u razdoblju poslije sisanja.
The marketing authorisation holders, while acknowledging that there is a risk to the environment due to accumulation of zinc, are proposing to collect data on the sale and consumption of veterinary medicinal products containing zinc oxide within the ESVAC activity, as it is already done with antibiotics, as such data would help to further investigate the use and consequent environmental impact of zinc oxide when used as a veterinary medicinal product.
Prihvaćajući da postoji rizik za okoliš zbog akumulacije cinka, nositelji odobrenja za stavljanje u promet predlažu prikupljanje podataka o prodaji i potrošnji veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid unutar aktivnosti ESVAC-a, kao što je već učinjeno za antibiotike, jer bi takvi podatci pomogli daljnjem istraživanju upotrebe i posljedičnog utjecaja na okoliš cinkova oksida kada se koristi kao veterinarsko-medicinski proizvod.
A study to evaluate the effects of adding high amounts of zinc in the diets of weaned pigs (Lima et al., 1994)9 included 162 piglets from a farm with a previous history of diarrhoea due to E. coli.
Ispitivanje kojim se procjenjivao učinak dodavanja velikih količina cinka u prehranu prasadi odviknute od sisanja (Lima et al., 1994.)9 uključio je 162 praseta s farme na kojoj je prije utvrđen proljev prouzročen E. coli.