FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: På sit møde i december 2016 har CVMP således vurderet, at den overordnede benefit/risk-balance for veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter, er negativ, da fordelene ved zinkoxid til forebyggelse af diarré hos svin ikke opvejer risikoen for miljøet.
English: 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.
Danish: Der foreligger ingen data fra interne eller publicerede undersøgelser, der understøtter effektiviteten af zinkoxid til behandling af diarré hos smågrise efter fravænning.
English: 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.
Danish: En detaljeret risikovurdering til undersøgelse af de risici, der er forbundet med co-selektion for antibiotikaresistens ved anvendelse af zinkoxid, er ikke tilgængelig i øjeblikket.
English: Contamination of soil and water systems by heavy metals, such as zinc, is currently difficult to remedy with existing technologies.
Danish: For nuværende er det vanskeligt at rette op på tungmetalforurening, herunder zinkforurening, af jord- og vandsystemer med de eksisterende teknologier.
English: In conclusion the combination of zinc oxide and sulfaguanidine is not justified.
Danish: Det kan således konkluderes, at der ikke er belæg for at kombinere zinkoxid og sulfaguanidin.
English: For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Danish: Hvad angår sedimentsystemer, er der siden fastsættelsen af PEC-værdien for sedimenter i EU's risikovurderingsrapport (2010) sket store ændringer i den måde, som sedimentkoncentrationer bestemmes på.
English: 26 Bednorz C, Oelgeschläger K, Kinnemann B, Hartmann S, Neumann K, Pieper R, Bethe A, Semmler T, Tedin K, Schierack
Danish: 26 Bednorz C, Oelgeschläger K, Kinnemann B, Hartmann S, Neumann K, Pieper R, Bethe A, Semmler T, Tedin K, Schierack P, Wieler LH, Guenther S. 2013.
English: 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.
Danish: Under revurderingen af den omhandlede indbringelsesprocedure har CVMP derfor udelukkende forholdt sig til markedsføringstilladelsesindehavernes videnskabelige begrundelser for revurdering.
English: 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.
Danish: Rapportens overvågningsdata for jord i Danmark viser, at anvendelsen af svinegylle på jord har ført til en signifikant stigning i jordens samlede indhold af zink, navnlig i den seneste overvågningsperiode (1998-2014).
English: The Committee therefore considered that it is not justified to associate an antimicrobial substance (by definition, only appropriate for infectious diseases involving target pathogen(s) and for treatment and metaphylaxis) to zinc oxide because it is not specific-pathogen targeted and has not demonstrated efficacy for treatment.
Danish: Udvalget har derfor vurderet, at der ikke er belæg for at kombinere et antibiotikum (der pr. definition kun er egnet til behandling og metafylakse af infektionssygdomme med et eller flere målpatogener) med zinkoxid, da en sådan kombination ikke er specifikt rettet mod et målpatogen, og da det ikke er påvist, at en sådan kombination er effektiv til behandling.
English: This effect is limited to prevention of unspecific diarrhoeas occurring at post-weaning period in piglets.
Danish: Virkningen er begrænset til forebyggelse af uspecificeret diarré hos smågrise efter fravænning.
English: • 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;
Danish: • CVMP anerkender, at der er en risiko for co-selektion for resistensgener forbundet med anvendelsen af zinkoxid, men at risikoen ikke kan kvantificeres på nuværende tidspunkt.
English: And when using the bioavailability correction, then:
Danish: Og CVMP har konkluderet, at man ved brug af "korrektion for biotilgængelighed"-tilgangen når frem til følgende:
English: At an earlier time (year 2020) a risk is identified for two of 15 surface water scenarios (acidic, sandy soils) and for all 15 sediment scenarios.
Danish: For den helt nære fremtid (år 2020) er der identificeret en risiko i 2 ud af 15 scenarier for overfladevand (sur sandjord) og i 15 ud af 15 scenarier for sedimenter.
English: 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.
Danish: Men som bemærket ovenfor vil de foreslåede risikoreducerende foranstaltninger kun bremse akkumuleringen af zink i de enkelte delmiljøer og dermed blot forsinke den samlede zinkakkumulering i miljøet (dvs. det tidspunkt, hvor PEC-værdierne vil overskride PNEC-værdierne); på grund af zinks iboende egenskaber kan de ikke garantere, at de effektivt kan eliminere de nært forestående eller fremtidige miljørisici, der er identificeret i risikovurderingen.
English: The fact that LAMRSA CC398 has currently a low impact on human populations does not negate the public health concerns.
Danish: Det ophæver ikke bekymringen for folkesundheden, at LA-MRSA CC398 i øjeblikket kun påvirker humane populationer i begrænset omfang.
English: 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.
Danish: Uanset tilgang viser dataene, at hvis anvendelsen af zinkoxid som veterinærlægemiddel på svinefarme og gødskning af jord med gødning fra svin fortsætter i samme omfang som de seneste år, vil der akkumuleres zink i i jordens matrix; det vil føre til, at zinks biotilgængelige del bliver større, og dermed ende med at give højere zink-niveauer end PNEC.
English: 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.
Danish: I en undersøgelse med fravænnede smågrise (Poulsen, 1995)8 observerede man, at tilskud af store mængder zink i form af zinkoxid i 1, 2 eller 3 uger efter fravænning påvirkede forekomsten af fravænningsrelateret diarré (som et af parametrene).
English: Consequently, the CVMP considers that the environmental risk assessment provided during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108) is scientifically sound and should be used in the benefit-risk evaluation for products containing zinc oxide to be administered orally to food producing species.
Danish: CVMP har således vurderet, at den miljørisikovurdering, der er fremlagt under indbringelsesproceduren vedrørende Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82/EF, er videnskabeligt sund og bør anvendes ved vurdering af benefit/risk-balancen for produkter, der indeholder zinkoxid og skal administreres oralt til fødevareproducerende arter.
English: 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.
Danish: På grund af zinks iboende egenskaber (ikkeflygtig og ikkenedbrydelig) er det meget bekymrende, at PNEC-værdierne på et tidspunkt potentielt kan overskrides ved kontinuerlig og længerevarende gødskning af jord med gødning fra behandlede dyr, navnlig hvad angår de mest sårbare jordtyper (sur, veldrænet sandjord) og organismer i vandmiljøer.
English: The CVMP agrees that this study cannot be used, on its own, as proof that environmental risks exist from the use of zinc oxide in pig production.
Danish: CVMP anerkender, at denne undersøgelse alene ikke udgør tilstrækkelig dokumentation for, at anvendelse af zinkoxid i svineproduktion medfører miljørisici.
English: 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).
Danish: Behandlingerne bestod af baseline-foder med 100 ppm zink i form af zinkoxid eller det samme foder med tilskud af 2 400 ppm zink (i form af zinkoxid).
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.
Danish: Uanset model og dosering viser beregningerne en risiko for miljøet (RQ ≥ 1), og det vil kun være et spørgsmål om tid, før risikoen er til stede i alle delmiljøer, hvis man gødsker jord med gødning fra svin, der er behandlet med zinkoxid-holdige veterinærlægemidler.
English: 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.
Danish: Selv om der er usikkerhed forbundet med lineær ekstrapolering af IDMM-resultaterne, anses de PECværdier, der ekstrapoleres af IDMM-outputtet, for at give et rimeligt billede af miljøeksponeringen, som kan anvendes i risikokarakteriseringen af zinkoxid-holdige veterinærlægemidler til foderproducerende dyr.
English: 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.
Danish: Markedsføringstilladelsesindehaverne anerkender CVMP's vurdering af, at de foreslåede risikoreducerende foranstaltninger kun vil fortynde og ikke sænke den samlede zinkemission til miljøet, og at det derfor kun vil være et spørgsmål om tid, før risikoen er til stede i alle delmiljøer.
English: 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.
Danish: Aktuelt anbefales forskellige indikationer og doseringer, men zinkoxid anvendes primært i foder i daglige doser på 100 mg pr. kg legemsvægt i 14 dage i træk, svarende til 2 500 ppm zink i foder.
English: Evaluation and conclusions on the benefit-risk balance
Danish: Vurdering af benefit/risk-forholdet og konklusioner
English: Therefore, the continued beneficial effect of zinc oxide after cessation of treatment remains unclear.
Danish: Det er således uklart, om zinkoxid fortsat har gavnlig effekt efter behandlingsophør.
English: • A risk of zinc to soil dwelling species will on average be reached in approximately 31 years in sandy soils.
Danish: • I gennemsnit vil zink om ca. 31 år udgøre en risiko for arter, der findes i sandjord.
English: No original proprietary data or clinical trials were submitted by the marketing authorisation holders in support of the indications and dose.
Danish: Markedsføringstilladelsesindehaverne har ikke indsendt egne data eller resultater fra kliniske undersøgelser, der kan understøtte de pågældende indikationer og doseringer.
English: 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.
Danish: For at vurdere risikoen for de enkelte delmiljøer efter udbredt anvendelse af gødning på jord blev PECog PNEC-værdierne for de enkelte FOCUS21-scenarier, baseret på data for Gutal, sammenlignet på tre tidspunkter (år 2020, 2040 og 2060) ved brug af to doseringer: en dosering på 7 kg zink ha-1 a-1 og en lavere dosering på 4 kg zink ha-1 a-1.
English: The percentage of piglets with diarrhoea was significantly influenced by the administration of zinc in feed.
Danish: Der sås signifikant effekt på antallet af smågrise med diarré ved tilskud af zink i foderet.
English: • A risk of zinc to soil dwelling species will on average be reached in approximately 55 years in clay soils;
Danish: • I gennemsnit vil zink om ca. 55 år udgøre en risiko for arter, der findes i lerjord.
English: Horní Počernice
Danish: Horní Počernice Czech Republic
English: 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.
Danish: Derudover konkluderer forfatterne, at den aktuelle anvendelse af zink i svineproduktionen i Danmark kan medføre, at der udvaskes zink fra marker, som gødes med svinegylle, til vandmiljøerne i koncentrationer, der kan udgøre en risiko for akvatiske arter.
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.
Danish: På trods af manglerne i de fremlagte data vurderes det, at virkningen af zinkoxid-holdige veterinærlægemidler til forebyggelse af diarré hos fravænnede smågrise er påvist.
English: The CVMP considers that because Enteroxid products are included within the scope of this procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing zinc oxide to be administered orally to food producing species, such argument is not applicable.
Danish: CVMP mener, at denne argumentation er irrelevant, da Enteroxid-produkter er omfattet af denne procedure, jf. artikel 35 i direktiv 2001/82/EF, vedrørende veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter.
English: Advantages of the combination sulfagunidine and zinc oxide versus the use of the individual substances were not provided.
Danish: Fordelen ved en kombination af sulfagunidin og zinkoxid frem for det enkelte aktive stof hver for sig er ikke godtgjort.
English: No study was provided to demonstrate the efficacy for the treatment of post-weaning diarrhoeas in piglets.
Danish: Der er ikke udført undersøgelser til at påvise kombinationens egnethed til behandling af diarré hos smågrise efter fravænning.
English: 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.
Danish: Udvalget anerkender, at det kan være hensigtsmæssigt at overvåge forbruget af zinkoxid som veterinærlægemiddel, men vurderer, at den identificerede miljørisiko ved brug af zinkoxid som veterinærlægemiddel på nuværende tidspunkt vejer tungere end fordelene.
English: 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.
Danish: Derudover konkluderede rapportens forfattere, at den aktuelle anvendelse af zink i svineproduktionen i Danmark kan medføre, at der udvaskes zink fra marker, som gødes med svinegylle, til vandmiljøerne i koncentrationer, der kan udgøre en risiko for akvatiske arter.
English: No information was available to establish the duration of the effect after the end of zinc oxide administration.
Danish: Der foreligger ingen data til anskueliggørelse af, hvor længe virkningen varer efter endt zinkoxid-behandling.
English: 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.
Danish: Report to the European Food Safety Authority - link forbundet med brug af IDMM-modellen til beregning af miljøets eksponering for zink fra brug i veterinærlægemidler, f.eks. hvad angår indvirkningen af hydrologi, opløst organisk kulstof og metals ældning.
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.
Danish: De ovenfor omtalte risikoreducerende foranstaltninger vil kun udskyde de risici, der er identificeret for alle delmiljøerne, hvis man gødsker jord med gødning fra svin, der er behandlet med zinkoxid-holdige veterinærlægemidler.
English: However, the importance of these findings to animal and public health remains unclear due to gaps in the available knowledge.
Danish: På grund af huller i den tilgængelige viden er det dog uklart, hvilken betydning disse fund har for dyrs og menneskers sundhed.
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.
Danish: DSM Nutritional Products' og Provimis videnskabelige begrundelse for revurdering har fokus på virkningen af zinkoxid, risikoen for (co-)selektion for resistensgener og miljørisici.
English: Although the PEC values for each compartment cannot be verified because the IDMM is not provided, overall they appear fairly conservative since a reasonable worst case exposure scenario is considered, i.e. continual application of undiluted manure until 2060.
Danish: fremstår de generelt ret konservative, eftersom det værst tænkelige eksponeringsscenarie medtages, dvs. kontinuerlig anvendelse af ufortyndet gødning frem til 2060.
English: 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.
Danish: Trods fraværet af undersøgelser udført efter god klinisk praksis har CVMP ud fra de samlede tilgængelige data vurderet, at virkningen af zinkoxid-tilskud på reduktionen af diarré hos smågrise efter fravænning er tilstrækkeligt underbygget.
English: If high amounts of zinc were administered for only one week, no differences were observed between treatments, while administration of high levels of zinc during two or three weeks significantly reduced the number of days with diarrhoea per piglet.
Danish: behandlingskrævende diarré hos smågrisene, mens der ved administration af store mængder zink i to eller tre uger sås signifikant færre dage med diarré.
English: 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.
Danish: CVMP har derfor vurderet, at de PNEC-værdier, der er anført af markedsføringstilladelsesindehaveren Huvepharma, kan anvendes til risikokarakterisering af veterinærlægemidler, der indeholder zinkoxid og skal administreres oralt til fødevareproducerende dyr (beregning af risikokvotienterne (RQ'erne)).
English: 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).
Danish: CVMP kan ikke tilslutte sig markedsføringstilladelsesindehaverens argumentation om, at den oprindelige vurdering af benefit/risk-forholdet var positiv ved indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4, i direktiv 2001/82.
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).
Danish: En lang række publicerede undersøgelser har ved in vivo-test eller ved analyse af miljøisolater vist en korrelation mellem høje doser af zinktilskud i næringsmidler og prævalensen af antibiotikaresistente bakterier (LA-MRSA) eller multiresistente bakteriekloner (E. coli).
English: 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).
Danish: Markedsføringstilladelsesindehaveren påberåber sig også, at der ikke er belæg for at afvise de risikoreducerende foranstaltninger, der er foreslået under indbringelsesproceduren for Gutal (EMEA/V/A/108), jf. artikel 33, stk. 4 i direktiv 2001/82/EF.
English: 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.
Danish: CVMP anerkender, at der er en risiko for co-selektion for resistensgener forbundet med anvendelsen af zinkoxid, men at risikoen ikke kan kvantificeres på nuværende tidspunkt.
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.
Danish: I henhold til nyligt publicerede data kan anvendelse af zink i husdyrbrug øge forekomsten af antibiotikaresistente bakterier som følge af co-selektion for antibiotikaresistensgener.
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.
Danish: Den 1. februar 2016 indbragte Nederlandene og Frankrig i henhold til artikel 35 i direktiv 2001/82/EF en sag for Det Europæiske Lægemiddelagentur (EMA) vedrørende veterinærlægemidler, der indeholder zinkoxid og administreres oralt til fødevareproducerende arter.
English: However, differences between the 2500 ppm and the 4000 ppm groups were not observed in this respect.
Danish: Forskellen, hvad angår (fravær af) behandlingskrævende diarré i den gruppe, der fik 2 500 ppm, og den gruppe, der fik 4 000 ppm, blev imidlertid ikke beskrevet.