FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently, the CVMP considers that in the light of overall data available, environmental risks identified by the continuous annual accumulation of zinc in soil from the spreading of manure in agricultural land cannot be effectively controlled through the application of the two risk mitigation measures presented above.
Croatian: Stoga CVMP smatra da u svjetlu svih dostupnih podataka, rizici za okoliš utvrđeni zbog kontinuirane godišnje akumulacije cinka u tlu uslijed nanošenja gnojiva na poljoprivredne površine, ne mogu biti učinkovito kontrolirani primjenom dviju prethodno navedenih mjera za smanjenje rizika.
English: DSM Nutritional Products and Provimi's scientific grounds for re-examination focused on efficacy of zinc oxide, risks for (co-)selection of resistance genes and risks for the environment.
Croatian: Znanstveni razlozi za ponovnu procjenu tvrtki DSM Nutritional Products i Provimi usmjereni su na djelotvornost cinkova oksida, rizika za (ko)selekciju gena rezistencije i rizika za okoliš.
English: Via Togliatti 5
Croatian: Sintofarm S.p.A. Via Togliatti 5
English: For the grounds of re-examination, the marketing authorisation holder focuses on what they believe to be inconclusive results from a recent Danish soil monitoring study (Bak et al. 2015).
Croatian: Navodeći razloge za ponovnu procjenu, nositelj odobrenja za stavljanje u promet usmjerava se na ispitivanja praćenja tla u Danskoj, za što smatra da su rezultati na temelju kojih nije moguće donijeti zaključak (Bak et al.
English: • the CVMP considered that the efficacy of veterinary medicinal products containing zinc oxide for treatment of post-weaning diarrhoea in piglets is not supported by data and cannot be demonstrated;
Croatian: • CVMP smatra da djelotvornost veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za liječenje proljeva u prasadi nakon razdoblja prestanka sisanja nije potkrijepljena podatcima i ne može se dokazati;
English: According to recently published data, zinc used in animal farming might increase the prevalence of antibiotic resistant bacteria due to co-selection for antimicrobial resistance genes.
Croatian: Prema nedavno objavljenim podatcima, cink primjenjivan na farmama životinja može povećati prevalenciju rezistencije bakterija na antibiotike zbog ko-selekcije za gene antimikrobne rezistencije.
English: Horní Počernice
Croatian: Horní Počernice Czech Republic
English: That is, notwithstanding the deficiency in the data presented it is considered that the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated.
Croatian: Drugim riječima, usprkos manjku predočenih podataka, djelotvornost veterinarskomedicinskih proizvoda koji sadrže cinkov oksid za sprječavanje proljeva u prasadi nakon razdoblja prestanka sisanja smatra se dokazanom.
English: Moreover,
Croatian: Budući da:
English: According to recently published data, zinc used in animal farming might promote the spread of antimicrobial resistance (MRSA) due to co-resistance.
Croatian: Prema novije objavljenim podatcima, cink koji se koristi na životinjskim farmama može poticati širenje antimikrobne rezistencije (MRSA) zbog korezistencije.
English: During the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure.
Croatian: Tijekom prije spomenutog arbitražnog postupka za Gutal, mogućnost da se gnojiva ne nanose na istu površinu zemlje u više uzastopnih godina kako bi se usporila akumulacija cinka, smatrala se mogućom mjerom za smanjenje rizika.
English: Even applying the risk mitigation measures above it will only be a matter of time before risks are present in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Croatian: Čak i uz primjenu prije spomenutih mjera za smanjenje rizika, bit će samo pitanje vremena kada će rizici postati prisutni u svim dijelovima okoliša, ako gnojivo od svinja liječenih veterinarsko-medicinskim proizvodom koji sadrži cinkov oksid bude nanošen na površine zemlje.
English: The above risk mitigation measures will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Croatian: Te mjere za smanjenje rizika samo će odgoditi rizike utvrđene u svim dijelovima okoliša ako se gnojivo svinja liječenih veterinarsko-medicinskim proizvodima koji sadrži cinkov oksid nanosi na površine tla.
English: • the CVMP considered that based on the available data the combination of zinc oxide, for the prevention of unspecific diarrhoea during the post-weaning period, with sulfaguanidine, for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), is not justified;
Croatian: • CVMP smatra da na temelju dostupnih podataka kombinacija cinkova oksida za sprječavanje nespecifičnog proljeva u razdoblju nakon prestanka sisanja sa sulfagvanidinom za liječenje i metafilaksu proljeva izazvanog ciljanim patogenom/patogenima nije opravdana;
English: Nevertheless there remains the potential risk of overuse of zinc oxide, as it is not possible to predict which animals will develop diarrhoea, as some cases of diarrhoea at weaning are only transitory and slight and without impact on general health of the animals.
Croatian: Ipak, ostaje potencijalni rizik od prevelike upotrebe cinkova oksida, jer nije moguće predvidjeti u kojih će se životinja razviti proljev.
English: Several published studies demonstrated during in vivo experiments or by investigating environmental isolates a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistant bacteria (LA-MRSA) or of multi-resistant bacterial clones (E. coli).
Croatian: Nekoliko objavljenih ispitivanja dokazalo je u in vivo eksperimentima ili istraživanjem izolata iz okoliša, korelaciju između visokih doza cinka dodavanih hrani i povećane prevalencije antimikrobno rezistentne bakterije (LA-MRSA) ili multirezistentnih bakterijskih klonova (E. coli).
English: Zinc oxide 1000 mg/g Oral powder
Croatian: Cinkov oksid 1000 mg/g Oralni prašak
English: This beneficial effect of zinc oxide was demonstrated at a dose of 100 mg/kg bw per day (equivalent to 2500 ppm in feed), administered during 12-14 days from weaning.
Croatian: Ovaj koristan učinak cinkova oksida dokazan je pri dozi od 100 mg/kg tjelesne težine na dan (što odgovara količini od 2500 ppm u hrani), primjenjivanoj tijekom 12 - 14 dana od prestanka sisanja.
English: In the aquatic compartment, zinc bioavailability in water has been predicted using the Metal Bioavailability Assessment Tool (United Kingdom Environment Agency)13, 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 on zinc (2010).
Croatian: U vodenom okolišu, bioraspoloživost cinka u vodi procijenjena je primjenom alata za procjenu bioraspoloživosti metala (Agencija za okoliš Ujedinjene Kraljevine)13, korisnički jednostavne verzije modela biotičkog liganda, modela koji se koristi za predikciju bioraspoloživih metala za različite vodene vrste (alge, Dafnija i riba).
English: Powder for oral administration
Croatian: Prašak za oralnu primjenu
English: The CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be controlled with risk mitigation measures.
Croatian: CVMP smatra da se rizici za okoliš utvrđeni godišnjom akumulacijom cinka u tlu zbog rasprostiranja gnojiva na poljoprivredno područje ne mogu kontrolirati mjerama za smanjenje rizika.
English: Zinc supplementation may also directly influence the antimicrobial resistance profiles of bacteria via other mechanisms based on work in E. coli (Bednortz C. et al., 2013)26.
Croatian: Međutim, povećanja prevalencije MRSA-e tijekom primjene cinkova oksida u prasadi čini se djelomično prolazno (Slifierz et al., 2015.)25. Dodavanje cinka može također izravno utjecati na profile antimikrobne rezistencije bakterije putem drugih mehanizama na temelju djelovanja E. coli (Bednortz C. et al., 2013.)26.
English: Zinc oxide 622mg/g (500 mg zinc/g)
Croatian: Cinkov oksid 622mg/g (500 mg zinc/g)
English: A total of five different environmental risk assessments on products containing zinc oxide to be administered orally to piglets for 2-6 weeks, at concentrations ranging between 2500 to 3100 ppm zinc oxide in feed were made available to the CVMP during this referral procedure.
Croatian: Tijekom ovog arbitražnog postupka, CVMP-u je bilo dostupno ukupno pet različitih procjena rizika u okolišu za proizvode koji sadrže cinkov oksid, a namijenjeni su za peroralnu primjenu u prasadi tijekom 2 - 6 tjedana u koncentracijama između 2500 i 3100 ppm cinkova oksida u hrani.
English: Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistance.
Croatian: Nekoliko objavljenih ispitivanja dokazalo je (u in vivo eksperimentima ili istraživanjem izolata iz okoliša) korelaciju između visokih doza cinka dodavanih hrani i prevalencije antimikrobne rezistencije.
English: Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a strong correlation between high doses of zinc supplementation in food and an increase in the prevalence of antimicrobial resistant bacteria.
Croatian: Nekoliko objavljenih ispitivanja dokazalo je (u in vivo eksperimentima ili istraživanjem izolata iz okoliša) čvrstu korelaciju između visokih doza cinka dodavanih hrani i povećane prevalencije antimikrobno rezistentne bakterije.
English: Zinc oxide Colistin sulfate
Croatian: Cinkov oksid Kolistin sulfat
English: No matter which model and application rates are used, a risk to the environment is predicted (RQ ≥ 1), and it will only be a matter of time before risks are present in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Croatian: Bez obzira koji je model i koje stope primjene su upotrijebljene, predviđen je rizik za okoliš (RQ ≥ 1), i ako gnojivo svinja liječenih veterinarsko-medicinskim proizvodom koji sadrži cinkov oksid bude primjenjivan na površine tla, samo je pitanje vremena kada će ti rizici postati prisutni u svim dijelovima okoliša.
English: Pulvis for oral use
Croatian: Otopina za oralnu primjenu
English: Zinc oxide 622 mg/g (500 mg zinc/g)
Croatian: Cinkov oksid 622 mg/g (500 mg zinc/g)
English: 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.
Croatian: Osim toga, kako model nije postao dostupan CVMP-u, relevantnost zadanih ulaznih parametara ne može se
English: The data presented support the use of veterinary medicinal product containing zinc oxide for prevention of post-weaning diarrhoea in piglets at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), for a duration of 14 days.
Croatian: Prikazani podatci podupiru upotrebu veterinarsko-medicinskog proizvoda koji sadrži cinkov oksid za sprječavanje proljeva u prasadi poslije prestanka sisanja u dozi od 100 mg/kg tjelesne težine na dan (ekvivalentno 2500 ppm cinka u hrani) u trajanju od 14 dana.
English: Dolgos u. 2
Croatian: Prilog II.
English: (CVMP/VICH/592/98) - link
Croatian: EMEA/V/A/108) - link
English: Zinc oxide as a sole active substance
Croatian: Cinkov oksid kao samostalna djelatna tvar
English: The data available shows a beneficial effect of zinc oxide at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), given in the feed for 12-14 days.
Croatian: Raspoloživi podatci pokazuju koristan učinak cinkova oksida u dozi od 100 mg/kg tjelesne težine na dan (što odgovara količini od 2500 ppm cinka u hrani), davan u hrani tijekom 12 do 14 dana.
English: CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005) - link
Croatian: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005) - link
English: Vilofarm A/S Søagervej 9, Sdr. Onsild DK-9500 Hobro Denmark
Croatian: Onsild DK-9500 Hobro Denmark
English: Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment It is acknowledged that due to the physico-chemical properties of zinc (non-volatile and nondegradable), continual application of manure from treated animals to land under practices of intensive pig breeding will cause a gradual increase in the topsoil zinc concentration, followed by an increase in other relevant compartments, over time.
Croatian: Potvrđeno je da će zbog fizikalno-kemijskih svojstava cinka (nehlapljiv i nerazgradiv), kontinuirana primjena gnojiva od liječenih životinja na površine s praksom intenzivnog svinjogojstva, rezultirati postupnim povećanjem koncentracije cinka u gornjem sloju tla, nakon čega će s vremenom slijediti povećanje i u drugim relevantnim dijelovima okoliša.
English: Consequently, the CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be solely controlled with the aforementioned risk mitigation measures.
Croatian: Stoga CVMP smatra da se rizici koje za okoliš predstavlja godišnja akumulacija cinka u tlu zbog rasprostiranja gnojiva na poljoprivredno područje ne može kontrolirati samo prethodno spomenutim mjerama za smanjenje rizika.
English: The Committee's conclusions on the points raised in the marketing authorisation holders' scientific grounds are given below.
Croatian: Slijede zaključci Odbora za pitanja povezana sa znanstvenim razlozima nositelja odobrenja za stavljanje u promet. aniMedica GmbH
English: Colistin and zinc oxide combination
Croatian: Kombinacija kolistina i cinkova oksida
English: The CVMP considered that the combinations of zinc oxide, recommended for the prevention of nonspecific diarrhoea during the post-weaning period, with any antimicrobial substance recommended for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), are not justified.
Croatian: CVMP smatra da kombinacije cinkova oksida preporučene za sprječavanje nespecifičnog proljeva u razdoblju nakon prestanka sisanja s bilom kojom antimikrobnom tvari preporučenom za liječenje i metafilaksu proljeva izazvanog ciljanim patogenom/patogenima nisu opravdane.
English: Treatment of post-weaning diarrhoea in piglets In the absence of data the indication ‘treatment of post-weaning diarrhoea in piglets' is not supported.
Croatian: U nedostatku podataka, indikacija „liječenje proljeva u prasadi nakon prestanka sisanja” nije potkrijepljena.
English: Trckova M, Lorencova A, Hazova K, Sramkova Zajacova Z. 2015.
Croatian: Trckova M, Lorencova A, Hazova K, Sramkova Zajacova Z. 2015. Prophylaxis of post-weaning diarrhoea in piglets by zinc oxide and sodium humate.
English: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no. EMEA/V/A/108) - link results was submitted and study methods were poorly reported (no study protocols, no raw data, no statistical analysis).
Croatian: 1 CVMP opinion on Article 33(4) referral for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (Procedure no.
English: Czech Republic MIKROP ČEBÍN a.s. Čebín 416
Croatian: MIKROP ČEBÍN a.s.
English: Regarding the potential for risk reduction when complying with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to limit direct entry to water courses, but would not affect the zinc reaching water surface by leaching and run-off processes.
Croatian: U pogledu mogućnosti smanjenja rizika ako postoji usklađenost s lokalnim ili nacionalnim pravilima za najmanju udaljenost od otvorene vode na kojoj bi gnojivo smjelo biti rasprostranjeno, CVMP smatra da bi to bilo primjenjivo samo na granice izravnog ulaženja u vodene tokove, ali ne bi utjecalo na dospijevanje cinka do površine vode kroz ispiranje i otjecanje.
English: According to recently published data, zinc used in animal farming might promote the spread of antibiotic resistance due to co-resistance.
Croatian: Prema novijim objavljenim podatcima, cink koji se koristi na farmama životinja može poticati širenje rezistencije na antibiotike zbog korezistencije.
English: MEDITEK Zn 500 mg/g premix pro medikaci krmiva
Croatian: Zn 500 mg/g premix pro medikaci krmiva
English: 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Croatian: Stoga CVMP smatra da će prethodno preporučene mjere za smanjenje rizika u okviru postupka prema članku 33. stavku 3. Direktive 2001/82 za Gutal (EMEA/V/A/108), samo odgoditi rizike utvrđene za sve dijelove okoliša ako se gnojivo svinja liječenih veterinarsko-medicinskim proizvodom koji sadrži cinkov oksid nanosi na zemlju.
English: 13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15.
Croatian: 14 Arche Consulting Soil PNEC calculator - link 15 ECHA, 2014.
English: Considering the use of these products, current EU rules and Good Agricultural Practice on manure spreading, how the target animals are kept and how manure is managed, the suggested risk mitigation measures (dilution of manure and distance to surface waters), although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were recommended for the referral procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate either the imminent and future environmental risks identified from the risk assessment, but will just delay the total zinc accumulation in the environment (i.e. the time when the PEC will exceed the PNECs).
Croatian: S obzirom na upotrebu tih proizvoda, sadašnja pravila i dobra poljoprivredna praksa za primjenu gnojiva EU-a, kako se drže ciljane životinje te kako se barata gnojivom, navedene mjere za smanjenje rizika (razrjeđenje gnojiva i udaljenost od površinskih voda), iako su u skladu sa smjernicom CVMP/VICH (CVMP/VICH/790/03) i preporučene su za postupak arbitraže prema članku 33(4) Direktive 2001/82 za Gutal (EMEA/V/A/108) kako bi se smanjila
English: • the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated;
Croatian: • CVMP smatra da je dokazana djelotvornost veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za sprječavanje proljeva u prasadi nakon razdoblja prestanka sisanja;
English: Although during the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure, and despite being in line with the criteria set out by the CVMP reflection paper on risk mitigation measures23, it may prove difficult to enact in reality; not only in instances where there may not be the possibility to apply
Croatian: Iako se tijekom prethodno spomenutog postupka arbitraže za Gutal kao moguća mjera za smanjenje rizika smatrala mogućnost da se gnojivo ne nanosi na istu površinu zemlje tijekom uzastopnih godina kako bi se usporila akumulacija cinka, te unatoč tome što je u skladu s kriterijima navedenim u mišljenju CVMP-a o mjerama za smanjenje rizika23, to se može pokazati teško provedivim u stvarnosti, ne samo u slučajevima gdje možda ne postoji mogućnost nanošenja obrađenog gnojiva na različite površine zemlje, nego i zbog trgovine gnojivom između država članica i mogućnosti da se na osjetljive tipove tla nanosi gnojivo s visokim koncentracijama cinkova oksida.
English: However, while the marketing authorisation holder claims a lower exposure and annual load from their products compared to other zinc oxide veterinary medicines, they have not submitted data supporting a quantitative risk assessment, and have not considered that, while their conclusion on a limited environmental release of zinc oxide was estimated from the use of these products on 3-4 week old piglets (7-8 kg), the claim for their products is for pigs up to 40 kg/bw, and treating heavier pigs would also increase the environmental load.
Croatian: Nadalje, nositelj odobrenja za stavljanje u promet nije uzeo u obzir da su njihovi zaključci o ograničenom ispuštanju cinkova oksida bili procijenjeni na temelju upotrebe tih proizvoda u prasadi od 3 - 4 tjedna (7 - 8 kg), dok se zahtjev povezan s njihovim proizvodima odnosi na svinje do 40 kg tjelesne težine, a liječenje težih svinja povećalo bi i opterećenje za okoliš.
English: On 1 February 2016, the Netherlands and France presented to the European Medicines Agency a referral notification in accordance with Article 35 of Directive 2001/82/EC for veterinary medicinal products containing zinc oxide to be administered orally to food producing species, due to concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide.
Croatian: Nizozemska i Francuska podnijele su Europskoj agenciji za lijekove obavijest o arbitražnom postupku u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže cinkov oksid, a namijenjeni su za peroralnu primjenu u vrsta životinja od kojih se proizvodi hrana.
English: Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching surface water and drinking water by leaching and run-off processes.
Croatian: S obzirom na mjere smanjenja rizika koje bi bile usklađene s lokalnim ili nacionalnim propisima za najmanju udaljenost od otvorene vode na kojoj bi gnojivo smjelo biti rasprostranjeno, CVMP smatra da bi to bilo primjenjivo samo za sprječavanje izravnog ulaženja u vodene tokove, ali ne bi utjecalo na ulaženje cinka u površinske vode i pitku vodu kroz procese ispiranja i otjecanja.
English: Zinc oxide Sulfaguanidin um
Croatian: Cinkov oksid Sulfagvanidin
English: 10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no. EMEA/V/A/106) - link 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link combination.
Croatian: 10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no.
English: Johansen M., Jørgensen L and Schultz M.S., 2007.
Croatian: Johansen M., Jørgensen L and Schultz M.S., 2007. Effect of zinc and organic acids on diarrhoea in the weaner period.
English: Whereas
Croatian: Stoga, u
English: Chapter R.7b:Endpoint specific guidance 16 VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I
Croatian: Chapter R.7b:Endpoint specific guidance