natgillin/translations-raw huggingface dataset:
aniMedica's scientific grounds for re-examination focused on benefits associated with the use of their products (veterinary medicinal products containing colistin sulfate and zinc oxide), risks for (co-)selection of resistance genes and risks for the environment associated with the use their products.
Znanstveni razlozi tvrtke aniMedica za ponovnu procjenu bili su usmjereni na koristi povezane s primjenom njihov proizvoda (veterinarsko-medicinski proizvodi koji sadrže kolistin sulfat i cinkov oksid), rizike od (ko-)selekcije gena rezistencije i rizike za okoliš povezane s primjenom njihovih proizvoda.
Taking into account the overall data available, despite the absence of GCP studies, the CVMP considered that the effect of zinc oxide supplementation on the reduction of post-weaning diarrhoea was considered to be sufficiently substantiated.
Uzimajući u obzir sve dostupne podatke, unatoč tomu što ne postoje ispitivanja provedena prema dobroj kliničkoj praksi, CVMP je smatrao da je učinak dodavanja cinkova oksida na smanjenje proljeva poslije prestanka sisanja dovoljno potkrijepljen.
A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Kada se procjenjuje rizik koji za okoliš predstavljaju metali, od presudne je važnosti odrediti njihovu bioraspoloživost.
No study was provided to demonstrate the efficacy for the treatment of post-weaning diarrhoeas in piglets.
Nije navedeno nijedno ispitivanje koje bi pokazalo djelotvornost za liječenje proljeva u prasadi nakon prestanka sisanja.
Risks for the environment
Rizici za okoliš
Different indications and dosages are currently recommended, but zinc oxide is mainly used in the feed at a dosage of 100 mg per kg body weight (bw) per day for 14 consecutive days, that is 2500 ppm zinc in feed.
Trenutačno se preporučuju različite indikacije i doze, ali cinkov oksid uglavnom se koristi u hrani u dozi od 100 mg po kg tjelesne težine na dan tijekom 14 uzastopnih dana, odnosno 2500 ppm cinka u hrani.
Premix for medicated feedingstuff
Premiks za ljekovitu životinjsku hranu
The authors of the report also concluded that the current use of zinc in pig production in Denmark may lead to leaching of zinc from fields fertilised with pig slurry into the water compartments, in concentrations that may pose a risk to aquatic species.
Autori izvješća također su zaključili da postojeća upotreba cinka u proizvodnji svinja u Danskoj može dovesti do ispiranja cinka iz polja gnojenih svinjskim gnojem u dijelove vode, u koncentracijama koje mogu predstavljati rizik za vodene životinjske vrste.
Actually, the use of veterinary medicinal products containing zinc oxide contributes to about 30% of the total zinc present in manure.
Zapravo, upotreba veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid pridonosi ukupnom cinku prisutnom u gnojivu za oko 30 % . Rizik koji predstavlja taj doprinos od 30 % već je identificiran u tlima Danske.
22 Bak JL, Jensen J, Larsen MM. 2015.
22 Bak JL, Jensen J, Larsen MM. 2015. Belysning af kobber- og zinkindholdet I jord.
A summary of results from a study performed by Johansen et al. in Denmark in 20072 considering the effects of zinc oxide on post weaning diarrhoea in piglets have been provided.
Jedan od sažetaka odnosio se na rezultate ispitivanja koje je proveo Johansen et al. u Danskoj 2007.2, a opisivali su učinke cinkova oksida na proljev u prasadi s proljevom nakon prestanka sisanja.
The PNEC values in this report are considered reliable and, hence, are suitable for use in the risk characterisation veterinary medicinal products containing zinc oxide administered orally to food producing animals.
U tom izvješću vrijednosti PNEC smatraju se pouzdanima pa stoga i prikladnima za karakterizaciju rizika veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid, a primjenjuju se peroralno životinjama namijenjenim za proizvodnju hrane.
No data from proprietary or published studies are available to support the efficacy of zinc oxide for the treatment of post-weaning diarrhoea in piglets.
Nema dostupnih podataka iz vlasnički zaštićenih ili objavljenih ispitivanja koji bi poduprli djelotvornost cinkova oksida za liječenje proljeva u prasadi nakon prestanka sisanja.
Zinc does not degrade in the environment, and a zinc load in the environment, once established, is difficult to remedy with existing technologies.
Cink se u okolišu ne razgrađuje, pa cink opterećuje okoliš, a kad se jednom nađe u okolišu teško ga je ukloniti postojećim tehnologijama.
Besides this, the authors concluded that the current use of zinc in pig production in Denmark may lead to leaching of zinc from fields fertilised with pig slurry into the water compartments, in concentrations that may pose a risk to aquatic species.
Osim toga, autori su zaključili da postojeća upotreba cinka u proizvodnji svinja u Danskoj može dovesti do ispiranja cinka iz polja gnojenih svinjskim gnojem u dijelove vode, i to u koncentracijama koje mogu predstavljati rizik za vodene životinjske vrste.
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.
Na razini specifične lokacije mogu se provesti korekcije bioraspoloživosti PNEC-a u sedimentu kao rezultat AVS/SEM udjela u sedimentu, no takvih je podataka malo.
Overall summary of the scientific evaluation of veterinary medicinal products containing zinc oxide to be administered orally to food producing species (see Annex I)
Cjeloviti sažetak znanstvene procjene veterinarskomedicinskih proizvoda koji sadrže cinkov oksid za peroralnu primjenu u životinjskih vrsta koje se koriste za proizvodnju hrane (vidjeti Prilog I.)
Considering the use of these products, current EU rules and Good Agricultural Practice (GAP) on manure spreading, how the target animals are kept and how manure is managed, the risk mitigation measures proposed above, although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were proposed for the referral procedure on Gutal under Article 33(4) of Directive 2001/82/EC (EMEA/V/A/108) in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate imminent and future environmental risks identified in the risk assessment, but will just delay the total zinc accumulation in the environment, (i.e. the time when PEC will exceed PNECs).
S obzirom na upotrebu tih proizvoda, sadašnja pravila i dobra poljoprivredna praksa (GAP) za nanošenje gnojiva EU-a, kako se drže ciljane životinje te kako se barata gnojivom, prethodno predložene mjere za smanjenje rizika (razrjeđenje gnojiva i udaljenost od površinskih voda), iako su u skladu sa smjernicom CVMP/VICH (CVMP/VICH/790/03) i predložene su za postupak arbitraže za Gutal prema članku 33(4) Direktive 2001/82/EZ (EMEA/V/A/108) kako bi se smanjila akumulacija cinka u svakom odjeljku, ne mogu jamčiti da se njima mogu učinkovito eliminirati neposredno postojeći i budući rizici za okoliš identificirani u procjeni rizika, nego će samo odgoditi ukupnu akumulaciju cinka u okolišu (tj. vrijeme kada će PEC premašiti PNEC-ove).
Grounds for the refusal of the marketing authorisations and for withdrawal of the existing marketing authorisations
Razlozi za odbijanje izdavanja odobrenja za stavljanje VMP-a u promet te ukidanje postojećih odobrenja
Report to the European Food Safety Authority - link 20 EFSA Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - link validation of the IDMM has been performed by the comparison of model predictions against published monitoring data for zinc applications.
20 EFSA Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - link 21 Forum for Co-ordination of Pesticide Fate Models and their Use (FOCUS) - link razine varijabilne, kada nastaju cink sulfidi PNEC-ovi mogu bit uvelike premašeni prije nego što se uoče štetni učinci.
7 Mateos GG, Garcia Jimenez M, Garcia Lorenzo M. 1998.
7 Mateos GG, Garcia Jimenez M, Garcia Lorenzo M. 1998. Composición Micromineral y Vitamínica de Correctores comerciales: Premezclas para porcino.
The Metal Bioavailability Assessment Tool requires fewer data inputs to predict zinc bioavailability in water than the Biotic Ligand Model, and can be used to calculate site-specific PNECs.
U odnosu na model biotičkog liganda, alat za procjenu bioraspoloživosti metala zahtijeva unos manjeg broja podataka za predviđanje bioraspoloživosti cinka u vodi, te se može koristiti za izračunavanje PNEC-ova specifičnih za lokaciju.
Risk mitigation measures
Mjere za smanjivanje rizika
The marketing authorisation holders' grounds for requesting a re-examination of the CVMP opinion focused on risks for (co-)selection of resistance genes and risks for the environment.
Razlozi nositelja odobrenja za stavljanje u promet zbog kojih zahtijevaju ponovnu procjenu CVMP mišljenja fokusirani su na rizike za (ko)-selekciju gena rezistencije i rizika za okoliš.
The CVMP was requested to review all available data and to evaluate the overall benefit-risk balance of the products concerned in order to determine the benefits associated with the use of zinc oxide in food producing species and also the risks for the environment and risks of (co-)selection of resistance genes.
Od CVMPa se tražila ocjena svih dostupnih podataka te procjena ukupnog omjera koristi i rizika tih veterinarskomedicinskih proizvoda, kako bi se odredile koristi povezane s upotrebom cinkova oksida u vrsta životinja od kojih se proizvodi hrana, a također i rizika za okoliš te rizika od (ko)selekcije gena rezistencije.
The study was a nonGood Clinical Practice (GCP) single-farm comparative study conducted with 3200 piglets.
To je bilo usporedno ispitivanje provedeno na 3200 praseta na jednoj farmi, ali ne prema pravilima dobre kliničke prakse (GPC).
Due to the intrinsic nature of zinc (non-volatile and nondegradable), the potential for PNECs to be eventually surpassed as a result of continual application of manure from treated animals to land over an extended period is a significant environmental concern, particularly with regard to the most vulnerable soil types (acidic, freely draining, sandy soils) and organisms of the aquatic compartments.
Zbog intrinzične prirode cinka (nehlapljiv i nerazgradiv), značajnu zabrinutost u odnosu na okoliš predstavlja činjenica da će se potencijal za PNEC-ove naposljetku premašiti kao rezultat kontinuirane primjene gnojiva liječenih životinja na površine tla tijekom duljeg razdoblja, osobito s obzirom na najosjetljivije vrste tla (kisela, pjeskovita tla koja se slobodno dreniraju) i organizme vodenih dijelova okoliša.
Zinc oxide has been authorised for several years in a number of EU Member States and experience in some of these countries suggests that zinc oxide use may be correlated with a smaller magnitude of reduction in colistin use than was previously expected, in addition, zinc used in animal farming might have a role to play in increasing the prevalence of antibiotic resistance due to co-resistance.
Cinkov oksid odobren je na nekoliko godina u brojnim članicama EU-a i iskustvo u nekim od tih zemalja upućuju na to da cinkov oksid može biti u korelaciji s manjim opsegom smanjenja u primjeni kolistina nego što se prethodno očekivalo.
Recommended duration of administration The available information supports the duration of 12 to 14 days for prevention of post-weaning diarrhoea in piglets.
Preporučeno trajanje primjene Za sprječavanje proljeva u prasadi nakon prestanka sisanja, dostupne informacije potkrepljuju trajanje primjene od 12 do 14 dana.
During the aforementioned procedure for Gutal, the possibility of not spreading 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.
Tijekom prije spomenutog postupka za Gutal, mogućnost da se gnojiva ne rasprostranjuje na istu površinu zemlje u više uzastopnih godina kako bi se usporila akumulacija cinka, smatrala se moguća mjera za smanjenje rizika.
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.
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.
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.
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.
Via Togliatti 5
Sintofarm S.p.A. Via Togliatti 5
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).
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.
• 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;
• 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;
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.
Prema nedavno objavljenim podatcima, cink primjenjivan na farmama životinja može povećati prevalenciju rezistencije bakterija na antibiotike zbog ko-selekcije za gene antimikrobne rezistencije.
Horní Počernice
Horní Počernice Czech Republic
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.
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.
Moreover,
Budući da:
According to recently published data, zinc used in animal farming might promote the spread of antimicrobial resistance (MRSA) due to co-resistance.
Prema novije objavljenim podatcima, cink koji se koristi na životinjskim farmama može poticati širenje antimikrobne rezistencije (MRSA) zbog korezistencije.
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.
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.
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.
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.
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.
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.
• 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;
• 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;
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.
Ipak, ostaje potencijalni rizik od prevelike upotrebe cinkova oksida, jer nije moguće predvidjeti u kojih će se životinja razviti proljev.
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).
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).
Zinc oxide 1000 mg/g Oral powder
Cinkov oksid 1000 mg/g Oralni prašak
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.
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.
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).
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).
Powder for oral administration
Prašak za oralnu primjenu
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.
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.
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.
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.
Zinc oxide 622mg/g (500 mg zinc/g)
Cinkov oksid 622mg/g (500 mg zinc/g)
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.
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.
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.
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.
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.
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.
Zinc oxide Colistin sulfate
Cinkov oksid Kolistin sulfat
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.
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.
Pulvis for oral use
Otopina za oralnu primjenu
Zinc oxide 622 mg/g (500 mg zinc/g)
Cinkov oksid 622 mg/g (500 mg zinc/g)
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.
Osim toga, kako model nije postao dostupan CVMP-u, relevantnost zadanih ulaznih parametara ne može se
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.
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.
Dolgos u. 2
Prilog II.
(CVMP/VICH/592/98) - link
EMEA/V/A/108) - link
Zinc oxide as a sole active substance
Cinkov oksid kao samostalna djelatna tvar
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.
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.
Vilofarm A/S Søagervej 9, Sdr. Onsild DK-9500 Hobro Denmark
Onsild DK-9500 Hobro Denmark