natgillin/translations-raw huggingface dataset:
Several of the publications submitted in support of the dose were not relevant since the investigations either focused on the growth benefits of zinc oxide or clinical trials combining both zinc oxide and antimicrobials.
Nekoliko publikacija dostavljenih za potkrepu doze nije bilo relevantno, jer su se istraživanja ili fokusirala na koristi cinkova oksida za rast ili na klinička ispitivanja u kojima je cinkov oksid kombiniran s antimikrobnim lijekovima.
For all compartments, risks have been identified for some scenarios at the application rates investigated.
Za svaki dio okoliša rizici su identificirani za neke scenarije u istraženim stopama primjene.
Advantages of the combination sulfagunidine and zinc oxide versus the use of the individual substances were not provided.
Nisu navedene ni prednosti primjene kombinacije sulfagvinidina i cinkova oksida naspram primjene pojedinačnih tvari.
In 45% of all soil samples, PNECs were already exceeded.
PNEC vrijednosti bile su već premašene u 45 % uzoraka tla.
With regard to environmental risks, the marketing authorisation holders consider that in the initial assessment the CVMP did not use the risk assessment methodology applied during the EU RAR on zinc, and argues that the developments in the scientific literature published after the EU RAR on zinc, on how to incorporate metal bioavailability in the a risk assessment, were not taken into consideration.
S obzirom na rizike za okoliš, nositelji odobrenja za stavljanje u promet smatraju da u svojoj inicijalnoj procjeni CVMP nije koristio metodologiju procjene rizika kakva je bila kod EU RAR-a za cink te navodi da dostignuća opisana u znanstvenoj literaturi objavljenoj poslije EU RAR-a za cink, te kako uključiti bioraspoloživost metala u procjenu rizika, nisu bili uzeti u obzir.
Following the CVMP opinion of 8 December 2016 on this referral procedure, several marketing authorisation holders (aniMedica GmbH, Huvepharma N.V., DSM Nutritional Products (UK) Ltd., Provimi Ltd., Andrés Pintaluba S.A., Bio Vet Aps, Calier Portugal S.A., Dunavet-B Zrt., Industrial Veterinaria S.A., Laboratorios Calier S.A., Laboratorios Support Pharma S.L., S.C. Crida Pharm S.R.L., ScanVet Animal Health A/S, Sintofarm S.p.A, Tekro, spol.
Nakon mišljenja CVMP-a od 8. prosinca 2016. o ovom arbitražnom postupku, nekoliko nositelja odobrenja za stavljanje u promet (aniMedica GmbH, Huvepharma N.V., DSM Nutritional Products (UK) Ltd., Provimi Ltd., Andrés Pintaluba S.A., Bio Vet Aps, Calier Portugal S.A., Dunavet-B Zrt., Industrial Veterinaria S.A., Laboratorios Calier S.A., Laboratorios Support Pharma S.L., S.C. Crida Pharm S.R.L., ScanVet Animal Health A/S, Sintofarm S.p.A, Tekro, spol. s r.o., Vepidan Aps, Vetlima S.A., Vetoquinol Biowet Sp. z o. o. i Vetpharma Animal Health S.L.) tražilo je preispitivanje mišljenja CVMP-a.
The CVMP concluded that when using the added risk approach, then:
Kada se koristi pristup dodanog rizika, CVMP je zaključio:
The marketing authorisation holder Huvepharma presented a pragmatic approach on their exposure assessment on Gutal and considered the results from a model used by EFSA (the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010))19 for estimating the environmental exposure from the use of zinc oxide as feed additive.
Nositelj odobrenja za stavljanje u promet, tvrtka Huvepharma, iznijela je pragmatički pristup o njihovoj procjeni izloženosti za Gutal i razmatrala rezultate modela koje je upotrijebila Europska agencija za sigurnost hrane - EFSA (Intermediate Dynamic Model for Metal (IDMM) autora Monteiro et al. (2010.))19 za procjenu izloženosti okoliša kod primjene cinkova oksida kao dodatka u hrani.
In some of the other trials, no diarrhoea was observed in the piglet groups.
U nekim drugim ispitivanjima u skupini prasadi nije opažen proljev.
Data indicates that the annual application of manure coming from farms where animals are treated with veterinary products containing zinc oxide, results in the gradual and continuous increase of zinc in soil, water and sediment systems.
Podatci pokazuju da godišnja primjena gnojiva koje dolazi s farmi gdje su životinje liječene veterinarskim proizvodima koji sadrže cinkov oksid, rezultira postupnim i kontinuiranim povećanjem cinka u tlu, vodi i sedimentu.
Based on the data on Gutal, to assess the risk for each compartment following extended application of manure to land, PECs and PNEC values for each FOCUS21 scenario were compared at three time points (years: 2020, 2040, 2060), using two application rates: application rate of 7 kg zinc ha-1 a-1 and a lower application rate of 4 kg zinc ha-1 a-1.
Na temelju podataka za Gutal, za procjenu rizika od produljene primjene gnojiva na tlo za svaki dio okoliša, PEC-ovi i vrijednosti PNEC-a za svaki scenarij FOCUS-a21 uspoređeni su u tri vremenske točke (godine: 2020., 2040., 2060.) za dvije stope primjene: stopu primjene od 7 kg cinka ha-1 a-1 i nižu stopu primjene od 4 kg cinka ha-1 a-1.
Veterinary medicinal products containing zinc oxide are used for the treatment and/or prevention and control of post-weaning diarrhoea in piglets.
Veterinarsko-medicinski proizvodi koji sadrže cinkov oksid namijenjeni su za liječenje ili sprječavanje i kontrolu proljeva u prasadi nakon prestanka sisanja.
Several marketing authorisation holders provided proprietary studies for veterinary medicinal products containing zinc oxide as single active substance.
Nekoliko nositelja odobrenja za stavljanje u promet objavilo je vlastita zaštićena ispitivanja za veterinarsko-medicinske proizvode koji sadrže cinkov oksid kao jedinu djelatnu tvar.
In this report, monitoring data in soil from Denmark showed that the use of pig slurry on soils has led to a significant increase in total soil concentrations of zinc, especially in the latest monitoring period from 1998 to 2014.
U tom ispitivanju, podatci praćenja za tla u Danskoj pokazali su da je nenošenje svinjskog gnoja na tla dovelo do značajnog porasta ukupnih koncentracija cinka u tlu, osobito u najnovijem razdoblju praćenja od 1998. do 2014.
At this time a detailed risk assessment to examine the risk(s) associated with the co-selection for antimicrobial resistance following the use of zinc oxide is not available.
U ovom trenutku, detaljna procjena rizika kojom se ispituju rizici povezani s ko-selekcijom antimikrobne rezistencije nakon primjene cinkova oksida nije dostupna.
Consequently, bioavailability was not considered for exposure calculations (establishing the PECs), thus leading to a risk assessment that did not account for the bioavailable fraction of zinc but rather for the total zinc concentrations (bioavailable and non-bioavailable).
Posljedično tomu, bioraspoloživost nije uzeta u obzir prilikom izračuna izlaganja (utvrđivanje PEC-ova), što je rezultiralo procjenom rizika koja nije uzela u obzir frakciju bioraspoloživog cinka, već ukupne koncentracije cinka (bioraspoložive i nebioraspoložive).
Consequently, the CVMP considered that the PNECs proposed by the marketing authorisation holder Huvepharma can be used for the characterisation of risks (calculation of risk quotients (RQs)) of veterinary products containing zinc oxide to be used orally in food producing animals.
Posljedično tomu, CVMP je smatrao da se PNEC-ovi koje je predložio nositelj odobrenja za stavljanje u promet, Huvepharma mogu upotrijebiti za karakterizaciju rizika (izračun kvocijenta rizika (RQ)) veterinarskih proizvoda koji sadrže cinkov oksid za peroralnu primjenu u životinja namijenjenih za proizvodnju hrane.
Tolerance
Podnošljivost
In the study from Trckova et al. (2015)5, clinical observation of weaned piglets challenged with enterotoxic E. coli demonstrated a lower diarrhoea score and diarrhoea incidence in the treated animals (fed with a diet containing 2500 ppm zinc oxide in feed) than in the control animals (untreated pigs).
U ispitivanju koje su proveli Trckova et al. (2015.)5, kliničko opažanje prasadi zaražene nakon prestanka sisanja enterotoksičnom E. coli, pokazalo je niži rezultat za proljev i incidenciju proljeva u liječenih životinja (hranjene hranom koja je sadržavala 2500 ppm cinkova oksida) nego kontrolne životinje (neliječena prasad).
However, and as noted above, the previously suggested risk mitigation measures would slow down the accumulation of zinc in each compartment, thus just delaying the total zinc accumulation in the environment (i.e. the time when PEC will exceed PNECs), but given the nature of zinc they cannot guarantee that they can effectively eliminate imminent and future environmental risks identified in the risk assessment.
Međutim, kako je već spomenuto, prethodno predložene mjere za smanjenje rizika usporile bi akumulaciju cinka u svakom dijelu okoliša čime bi se ukupna akumulacija cinka samo odgodila u okolišu (tj. vrijeme kada će PEC premašiti PNEC-ove), ali s obzirom na prirodu cinka oni ne mogu jamčiti da će djelotvorno eliminirati neposredne i buduće rizike za okoliš koji su identificirani u procjeni rizika.
Despite these uncertainties, considering the nature of the active substance, as an inorganic molecule, and the difficulties identified throughout the application procedure in terms of assessing the environmental risk for a compound ‘outside' of current CVMP/VICH guidance, it may be accepted that the estimated PEC values extrapolated from the IDMM outputs offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Unatoč tim nesigurnostima, s obzirom na prirodu djelatne tvari kao anorganske molekule, te teškoće identificirane tijekom postupka prijave u smislu procjene rizika za okoliš za spoj „izvan” aktualne smjernice CVMP-a/ VICH-a, može se prihvatiti da procijenjene PEC vrijednosti dobivene ekstrapolacijom iz izlaznih vrijednosti IDMM-a predstavljaju odraz izloženosti okoliša prikladan za karakterizaciju rizika za Gutal.
On the other hand, using the bioavailability correction approach, and considering within this approach that bioavailability is dependent on soil type and the time zinc was incorporated onto soil (i.e., zinc aging), the bioavailable fraction was for both
S druge strane, koristeći pristup korekcije bioraspoloživosti i uzimajući u obzir unutar tog pristupa da bioraspoloživost ovisi o tipu tla i vremenu koje je cink uključen u tlo (tj. starenje cinka), bioraspoloživa
In the frame of the aforementioned procedure, the Committee for Medicinal Products for Veterinary Use (CVMP) considered that there is some uncertainty associated with the calculated risks for some environmental compartments as the predicted environmental concentration (PEC) due to the use of zinc as a veterinary medicinal product could not be validated, and the predicted no effect concentration (PNEC) did not always account for zinc bioavailability (specifically for the sediment compartment).
U okviru spomenutog postupka, Odbor za veterinarsko-medicinske proizvode (CVMP) smatra da postoji određena nesigurnost povezana s izračunatim rizicima za neke dijelove okoliša, jer se za cink predviđena koncentracija u okolišu (engl. predicted environmental concentration, PEC) nastala zbog upotrebe cinka kao veterinarsko-medicinskog proizvoda ne može potvrditi, a predviđena koncentracija bez učinka (engl. predicted environmental concentration, PNEC) nije uvijek objasnila biološku raspoloživost cinka (osobito za sediment).
• the CVMP considered that based on the available data the clinical benefit of the veterinary medicinal products containing colistin sulfate and zinc oxide cannot be demonstrated;
• CVMP smatra da na temelju dostupnih podataka klinička korist veterinarsko-medicinskih proizvoda koji sadrže kolistin sulfat i cinkov oksid ne može biti dokazana;
This effect is limited to prevention of unspecific diarrhoeas occurring at post-weaning period in piglets.
Učinak je ograničen na sprječavanje nespecifičnog proljeva koji se događa u prasadi u razdoblju nakon prestanka sisanja.
As a result, the CVMP considers that the environmental risk assessment presented above for all zinc oxide mono-products is also adequate to predict environmental risks from the use of Enteroxid products in the EU.
Kao rezultat, CVMP smatra da je prethodno opisana procjena rizika za okoliš za sve proizvode koji sadrže samo cinkov oksid, također odgovarajuća za predviđanje rizika za okoliš koji nastaje od upotrebe Enteroxid proizvoda u EU.
• A risk of zinc to soil dwelling species will on average be reached in approximately 31 years in sandy soils.
• rizik od cinka za vrste životinja koje žive u tlu bit će u prosjeku dosegnut za približno 31 godinu u pjeskovitim tlima.
As a result, procedural and legal considerations are not within the remit of the CVMP; therefore during the re-examination of the present referral procedure the CVMP considered only the marketing authorisation holders' scientific grounds for reexamination.
Stoga je tijekom ponovne procjene sadašnjeg arbitražnog postupka CVMP razmatrao samo znanstvene razloge za ponovnu procjenu nositelja odobrenja za stavljanje u promet.
The Committee acknowledged that there is a risk of coselection for resistance associated with the use of zinc oxide, but at the present time, that risk is not quantifiable.
Odbor je prihvatio da postoji rizik od koselekcije za rezistenciju povezanu s primjenom cinkova oksida, ali se u ovom trenutku taj rizik ne može kvantificirati.
However, since the data search for the EU RAR (2010) was completed, more data have become available and were used by some of the
Međutim, otkako je završilo prikupljanje podataka za EU RAR (2010.), postalo je dostupno još podataka i neki nositelji odobrenja za stavljanje u promet upotrijebili su ih za određivanje (poboljšanje) PNEC-ova za relevantne dijelove okoliša.
During the above-mentioned referral procedure, a complete benefit-risk assessment was not conducted by the CVMP, and while the therapeutic benefits of Gutal were not taken into account as the product is a generic and bioequivalence with the reference product was accepted, quality, target animal safety, user safety impact on antimicrobial resistance development and residues were not assessed during the initial referral procedure, (given the scope of that referral).
Potpunu procjenu koristi i rizika u gore spomenutom arbitražnom postupku nije proveo CVMP, i dok se terapijske koristi Gutala nisu uzele u obzir jer je lijek generički, i bioekvivalencija s referentnim lijekom je bila prihvaćena, kakvoća, sigurnost ciljnih životinja, sigurnost korisnika, utjecaj na razvoj antimikrobne rezistencije te rezidui u okolišu nisu bili procijenjeni tijekom postupka arbitraže (s obzirom na opseg te arbitraže).
clay and sandy soils below the PNECsoil of 26 mg/kg (16.3 and 14.4 mg/kg for sandy and clay soils, respectively).
frakcija bila je i za glinu i za pjeskovita tla ispod vrijednosti PNECtlo od 26 mg/kg (16,3 mg/kg za pjeskovita i 14,4 mg/kg za glinasta tla).
In a study on the administration of zinc oxide in weaned piglets (Poulsen, 1995)8, the administration of high amounts of zinc as zinc oxide for a duration of 1, 2 or 3 weeks after weaning affected the incidence of post-weaning diarrhoea, among other parameters.
U ispitivanju primjene cinkova oksida u prasadi odviknute od sisanja (Poulsen, 1995.)8, primjena velikih količina cinka u obliku cinkova oksida u trajanju od 1, 2 ili 3 tjedna nakon prestanka sisanja utjecao je, između drugih parametara, na incidenciju proljeva poslije prestanka sisanja.
Treatments consisted in a baseline diet of 100 ppm zinc in the form of zinc oxide or the same diet supplemented with 2400 ppm zinc (as zinc oxide).
Liječenja su se sastojala od osnovne prehrane s 100 ppm cinka u obliku cinkova oksida ili jednake prehrane s dodatkom 2400 ppm cinka (u obliku cinkova oksida).
Therefore, exposure using application rates that are considered relevant from the use of zinc containing veterinary medicinal products are calculated from the pre-defined loading rates of the IDMM.
Stoga je izloženost na temelju stopa primjene za koje se smatra da su relevantne za primjenu veterinarsko-medicinskih proizvoda koji sadrže cink, izračunata iz prethodno definiranih stopa opterećenja modela IDMM.
Although there are uncertainties with the linear extrapolation of the IDMM results, the PEC values extrapolated from the IDMM outputs are considered to offer a ‘reasonable' reflection of the environmental exposure for use in the risk characterisation of veterinary medicinal products containing zinc oxide for use in food producing animals.
Iako postoje nesigurnosti s linearnom ekstrapolacijom rezultata IDMM-a, smatra se da PEC vrijednosti ekstrapolirane iz izlaznih podataka modela IDMM nude „razumni” odraz izlaganja okoliša za karakterizaciju rizika od veterinarsko-medicinskih proizvoda koji sadrže cinkov oksid za primjenu u životinja namijenjenih za proizvodnju hrane.
At higher dose (x3 during 28 days) significant side effects (impact on growth rate, clinical signs) have been observed.
Značajne nuspojave (utjecaj na stopu rasta, klinički znakovi) opažene su pri većoj dozi (x 3 tijekom 28 dana).
For this referral procedure, and to support the risk assessment on zinc from its oral use as a veterinary medicinal product in food producing animals, Bak et al. (2015)22 analysed for a 28 year period following application of pig slurry.
Za ovaj postupak arbitraže te kao pomoć u procjeni rizika koji predstavlja cink iz peroralne primjene veterinarsko-medicinskog proizvoda u životinja namijenjenih za proizvodnju hrane, Bak et al. (2015.)22 analizirali su rizik od cinka nakon primjene svinjskog gnoja u razdoblju od 28 godina.
• the CVMP considered that the overall benefit-risk balance for the for veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment; the CVMP has recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide to be administered orally to food producing species as referred in Annex I.
• CVMP smatra da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu vrstama životinja od kojih se proizvodi hrana negativan, jer koristi cinkova oksida za sprječavanje proljeva u prasadi ne premašuju rizike za okoliš; CVMP je preporučio da se izdavanje odobrenja za stavljanje u promet odbije te da se povuku sadašnja odobrenja za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u vrsta životinja namijenjenih za proizvodnju hrane, kako je navedeno u Prilogu I.
MEDITEK Zn 500 mg/g perorální prášek
Zn 500 mg/g perorální prášek
CALIER PORTUGAL, S.A. Centro Empresarial SintraEstoril II, Ed. C, R. Pé de Mouro
CALIER PORTUGAL, S.A. Centro Empresarial SintraEstoril II, Ed.
In 2015 following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC, for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal')1, a risk to the environment has been identified due to accumulation of zinc, in the terrestrial and aquatic compartment (including sediment), with acidic, sandy, well-drained soils being most vulnerable.
Nakon arbitražnog postupka 2015. godine (EMEA/V/A/108) prema članku 33. stavku 4. Direktive 2001/82/EZ za Gutal 1000 g/kg premiks za ljekovitu životinjsku hranu za prasad (u daljnjem tekstu ‘Gutal')1, rizik za okoliš utvrđen je zbog akumulacije cinka u kopneni i vodeni okoliš (uključujući sediment), s tim da su najosjetljivija kisela, pjeskovita, dobro isušena tla.
No original proprietary data or clinical trials were submitted by the marketing authorisation holders in support of the indications and dose.
Nositelji odobrenja za stavljanje u promet nisu dostavili vlasničke zaštićene podatke ili klinička ispitivanja kao potporu indikacija i doze.
Therefore, while soils and surface waters can both be corrected for bioavailability, a correction has not been possible for the calculation of the sediment PECs in this environmental risk assessment.
Stoga, dok se u toj procjeni rizika za okoliš može korigirati bioraspoloživost za tla i površinske vode, korekcija za izračun PEC-ova za sediment nije moguća.
Višňová 2/484
Tekro, spol. s r.o. Višňová 2/484
Andrés Pintaluba S.A., Bio Vet Aps, Calier Portugal S.A., Dunavet-B Zrt., Industrial Veterinaria S.A., Laboratorios Calier S.A., Laboratorios Support Pharma S.L., S.C. Crida Pharm S.R.L., ScanVet Animal Health A/S, Sintofarm S.p.A, Tekro, spol.
Andrés Pintaluba S.A., Bio Vet Aps, Calier Portugal S.A., Dunavet-B Zrt., Industrial Veterinaria S.A., Laboratorios Calier S.A., Laboratorios Support Pharma S.L., S.C. Crida Pharm S.R.L., ScanVet Animal Health A/S, Sintofarm S.p.A, Tekro, spol. s r.o., Vepidan Aps, Vetlima S.A., Vetoquinol Biowet Sp. z o. o. and Vetpharma Animal Health S.L.
Curative treatment of post-weaning diarrhoeas in piglets is not supported by data provided.
Kurativno liječenje proljeva nakon prestanka sisanja u prasadi nije potkrijepljeno dostavljenim podatcima.
Zinc oxide is considered to be beneficial for the prevention of post-weaning diarrhoea (i.e. reduction in the incidence of diarrhoea during the post-weaning period) in piglets.
Smatra se da je cinkov oksid koristan za sprječavanje proljeva u prasadi nakon prestanka sisanja (tj. smanjenje incidencije proljeva tijekom razdoblja nakon prestanka sisanja).
Regardless of the approach presented, data indicates that if the uses of zinc oxide as a veterinary medicinal product in pig farming, and applications of manure to land continue as they have been in the last years, zinc will continue to accumulate within the soil matrix, leading to an increase in bioavailable fraction of zinc in soils, eventually to levels higher than the PNEC.
Bez obzira na opisani pristup, podatci pokazuju da će se - ako se nastavi primjena cinkova oksida kao veterinarsko-medicinskog proizvoda u uzgoju svinja te nanošenje gnojiva na zemlju kao što je to bilo proteklih godina - cink nastaviti akumulirati unutar matriksa tla dovodeći do povećanja frakcije bioraspoloživosti cinka u tlima te konačno dovesti do razina viših od PNEC-a.
The marketing authorisation holders accept that, based on the CVMP assessment, the risk mitigation measures proposed will only dilute and not decrease the total zinc output to the environment, and thus it will only be a matter of time before risks are present in all compartments.
Na temelju procjene CVMP-a, nositelji odobrenja za stavljanje u promet prihvaćaju da će predložene mjere za smanjenje rizika samo razrijediti, a ne i smanjiti ukupni unos cinka u okoliš, pa će tako biti samo pitanje vremena kada će rizici postati prisutni u svim dijelovima okoliša.
Therefore, the CVMP, during its December 2016 meeting, considered that the overall benefit-risk balance for the veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment.
Stoga je CVMP na sastanku u prosincu 2016. smatrao da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadrže cinkov oksid za peroralnu primjenu u životinja namijenjenih za proizvodnu hrane negativan, jer koristi cinkova oksida za sprječavanje proljeva u prasadi ne premašuju rizike za okoliš.
The CVMP does not agree with the marketing authorisation holder's argument that the initial benefit-risk assessment was concluded to be positive for the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
CVMP se ne slaže s argumentom nositelja odobrenja za stavljanje u promet da je zaključeno da je inicijalna procjena koristi i rizika bila pozitivna za postupak prema članku 33. stavku 4. Direktive 2001/82 za Gutal (EMEA/V/A/108).
The marketing authorisation holder also argues the lack of justification for rejecting risk mitigation measures proposed during the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
Nositelj odobrenja za stavljanje u promet također napominje nedostatak opravdanja za odbijanje mjera za smanjenje rizika predloženih tijekom postupka prema članku 33. stavku 4. Direktive 2001/82 za Gutal (EMEA/V/A/108).