FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the bottle tightly closed.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Hold beholderen tæt lukket.
English: Elderly
Danish: Litaun
English: Glucosamine
Danish: Danmerk
English: Bottle
Danish: Cyper
English: BEFORE YOU TAKE GLUCOMED
Danish: HVAD DU SKAL GØRE FØR DU BEGYNDER AT TAGE GLUCOMED
English: What Glucomed is and what it is used for Before you take Glucomed How to take Glucomed Possible side effects
Danish: Hvad er Glucomed og hvad det anvendes til 2.
English: PACKAGE LEAFLET
Danish: Indholdsfortegnelse:
English: 6 (3 x 2) pre-filled syringes (multipack)
Danish: 6 (3 x 2) fyldte injektionssprøjter (multipakning)
English: 9 and GL
Danish: 9 og GL
English: Member State (EU/EEA)
Danish: Medlemsst at (EU/EEA)
English: There is some uncertainty associated with the scale of this risk.
Danish: Der er en vis usikkerhed forbundet med omfanget af denne risiko.
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain as concerned Member States.
Danish: Ansøgningen om markedsføringstilladelse blev indgivet med Det Forenede Kongerige som referencemedlemsstat og med Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien og Spanien som berørte medlemsstater.
English: The risk to the environment can be reduced by adhering to the following measures.
Danish: Risikoen for miljøet kan reduceres ved at overholde følgende foranstaltninger.
English: Add the following text in the relevant sections of the product information:
Danish: Tilføj følgende tekst i de relevante afsnit i produktinformationen:
English: Pharmaceutical form
Danish: Farmaceutisk form
English: 8), where validation is concerned with substantiating claims on the applicability of predictions with reference to the intended use or purpose.
Danish: 8), hvor valideringen drejer sig om at underbygge påstande om beregningernes anvendelighed med hensyn til den påtænkte anvendelse eller det påtænkte formål.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Danish: Liste med navne, farmaceutiske former, styrker af de veterinære lægemiddelprodukters, dyrearter, indgivelsesvej, ansøger i medlemsstaterne
English: Since the issues raised by France and the Netherlands remained unresolved, the Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 30 September 2014 under Article 33(4) of Directive 2001/82/EC.
Danish: Eftersom de spørgsmål, som Frankrig og Nederlandene rejste, fortsat var uafklarede, kunne de berørte medlemsstater ikke nå til enighed om lægemidlet, og sagen blev derfor henvist til CVMP den 30. september 2014 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: The bioavailable fraction of zinc in soils is small (<1%).
Danish: Den biotilgængelige andel af zink i jord er ringe (<1 %).
English: Similar regulations concerning the control of open watercourses from exposure to nutrients are adhered to in line with Good Agricultural Practice.
Danish: Lignende regler vedrørende kontrol af åbne vandløb fra eksponering til næringsstoffer følges i overensstemmelse med god landbrugspraksis.
English: Other precautions regarding impact on the environment
Danish: Andre forholdsregler vedrørende indvirkning på miljøet
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er opnået under koordinationsgruppens procedure med følgende ændringer:
English: 4.5 Special precautions for use
Danish: 4.5 Særlige forsigtighedsregler ved anvendelse
English: However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface water.
Danish: Det bemærkes dog, at usikkerheden i forbindelse med risikokarakteriseringen for sediment er betydeligt større end for jord og overfladevand.
English: The level of accumulation and time dependency for the different environmental compartments were evaluated.
Danish: Akkumulationsniveauet og den tidsmæssige afhængighed for de forskellige delmiljøer blev evalueret.
English: However, it is apparent that, for all compartments, RQs will be exceeded either immediately (sediment) or eventually (soil, ground-, and surface waters), and these risks must be addressed.
Danish: Det er dog klart, at RQ'er for alle delmiljøer vil blive overskredet enten straks (sediment) eller senere (jord, grund- og overfladevand), og disse risici skal tages i betragtning.
English: Having considered the above, it can be accepted that the PNECs proposed by the applicant can be used for the characterisation of risks (calculation of risk quotients).
Danish: Under hensyntagen til ovenstående kan det accepteres, at de PNEC'er, som ansøgeren har foreslået, kan anvendes til karakteriseringen af risici (beregning af risikokvotienter).
English: The applicant provided the robust summaries of the additional peer-reviewed studies used in the effect assessment that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Danish: Ansøgeren fremskaffede solide sammendrag af de yderligere fagfællebedømte undersøgelser, der blev anvendt i effektvurderingen, og som ikke indgik i EU RAR (2010), herunder en konklusion vedrørende pålideligheden og gyldigheden af de enkelte undersøgelser.
English: The CVMP was asked to give its opinion on the concerns raised by France and the Netherlands and to conclude on the benefit-risk balance for Gutal.
Danish: CVMP blev anmodet om at afgive udtalelse om de betænkeligheder, som Frankrig og Nederlandene havde givet udtryk for, og om at drage en konklusion om risk/benefit-forholdet for Gutal.
English: Do not contaminate surface waters or ditches with the product or used containers.
Danish: Undgå at forurene overfladevand eller grøfter med produktet eller brugte beholdere.
English: By their nature, models are an incomplete representation of the system under investigation but that is not to say that they cannot be very useful and widely implemented.
Danish: Modeller er af natur ufuldstændige gengivelser af det undersøgte system, men det betyder ikke, at de ikke kan være nyttige og implementeres over en bred kam.
English: This supportive data suggests a buffer zone of 3 m or more could reduce the run-off by 3 to 5-fold.
Danish: Disse supplerende data viser, at en stødpudezone på 3 m eller derover kan reducere afløbet med tre til fem gange.
English: A pragmatic approach should be taken when considering the validation of environmental mechanistic models (e.g. IDMM and FOCUS
Danish: Der bør anlægges en pragmatisk tilgang ved overvejelser om validering af miljømæssige mekaniske modeller (f.eks. IDMM og FOCUS
English: Therefore, it will only be a matter of time before any PNECs are exceeded in these compartments.
Danish: Det er derfor kun et spørgsmål om tid, før PNEC'erne overskrides i disse delmiljøer.
English: 1 are considered reliable and, hence, are suitable for use in the risk characterisation of Gutal.
Danish: 1 anses for at være pålidelig og dermed passende at anvende i risikokarakteriseringen af Gutal.
English: Zinc oxide is included in veterinary medicinal products currently authorised in several EU Member States for use in pigs.
Danish: Zinkoxid indgår i veterinærlægemidler, som flere EUmedlemsstater i dag har godkendt til brug til svin.
English: 5.3 Environmental properties
Danish: 5.3 Miljømæssige egenskaber
English: Gutal contains zinc oxide as an active substance.
Danish: Gutal indeholder zinkoxid som et aktivt stof.
English: In general terms, as for the benefits, other risks are expected to be the same as for the reference product and have not been evaluated by the CVMP.
Danish: Med hensyn til fordele gælder det, at andre risici ventes at være de samme som for referencelægemidlet, og disse er ikke blevet vurderet af CVMP.
English: Toxicity will depend on environmental conditions and habitat types.
Danish: Toksicitet afhænger af miljøforhold og naturtyper.
English: Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment
Danish: Eksponering: akkumulering, biotilgængelighed og modelberegning af zinkkoncentrationer i miljøet
English: When spreading manure from treated animals, the maximum total zinc load as defined in the national or local regulations has to be strictly respected.
Danish: Ved spredning af gødning fra behandlede dyr skal den maksimale samlede zinkbelastning, som defineret i de nationale eller lokale regler, overholdes strengt.
English: The information provided indicates that there are errors and these are more pronounced for the sediment compartment and at low loadings.
Danish: Oplysningerne tyder på, at der er fejl, og disse er mere udtalte for delmiljøet for sediment og ved lavere belastninger.
English: Despite the data gap, it may be accepted that such a measure would, most likely, reduce run-off of zinc to watercourses.
Danish: Trods manglende data kan det accepteres, at en sådan foranstaltning sandsynligvis ville reducere afløbet af zink til vandløb.
English: Although Good Agricultural Practice varies amongst Member States and is followed on a voluntary basis, a similar RMM for Gutal may be practical and appropriate.
Danish: Selv om god landbrugspraksis er forskellig fra medlemsstat til medlemsstat, og det er frivilligt at følge den, kan en lignende risikobegrænsningsforanstaltning for Gutal være både praktisk og hensigtsmæssig.
English: Overall, it is apparent that the long-term, continual use of zinc-containing veterinary medicinal products will result in a gradual net input of zinc to the environment.
Danish: Generelt fremgår det tydeligt, at langsigtet kontinuerlig anvendelse af veterinærlægemidler, der indeholder zink, vil medføre et gradvist nettoinput af zink til miljøet.
English: Zinc is very toxic to aquatic organisms, but can affect growth, survival and reproduction in both aquatic and terrestrial plants and animals.
Danish: Zink er meget giftig for organismer, der lever i vand, men kan påvirke væksten, overlevelse og reproduktion i både akvatiske og terrestriske planter og dyr.
English: 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.
Danish: Mens jord og overfladevand begge kan korrigeres for biotilgængelighed, er det således ikke muligt at foretage korrektioner i beregningen af sediment-PEC'er i denne miljørisikovurdering.
English: • This referral was raised due to concerns regarding the environmental risk assessment.
Danish: • Denne henvisning blev indledt på grund af betænkeligheder vedrørende miljørisikovurderingen.
English: EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Danish: EKSTREMT FARLIGT FOR FISK OG VANDLEVENDE ORGANISMER.
English: Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Danish: Der er således fastsat en "ældningsfaktor" på 3, som anvendes til at beregne de stedsspecifikke PNEC'er.
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: Til sedimentsystemer er der, siden den beregnede miljøkoncentration (PEC) for sediment blev udledt (EU RAR, 2010), sket store ændringer i den måde, som sedimentkoncentrationer bestemmes på.
English: Undiluted manure from treated piglets should not be applied to land.
Danish: Ufortyndet gylle fra behandlede grise bør ikke anvendes på land.
English: In major pig breeding regions stringent rules and controls on manure application are in place, although it is realised that this advice is followed on a voluntary basis and Good Agricultural Practice may vary throughout the Member States.
Danish: I store svineopdrætsregioner er der indført strenge regler og kontrol med anvendelse af gødning, om end det forstås, at det er frivilligt at følge disse råd, og at god landbrugspraksis kan være forskellig fra medlemsstat til medlemsstat.
English: The IDMM also considers several soil compartments and the fluxes between these and aquatic compartments.
Danish: IDMM medtager endvidere flere delmiljøer for jord og strømmen mellem disse og de akvatiske delmiljøer.
English: For instance, soils contaminated over an extended period of time show reduced toxicity compared to freshly spiked soils.
Danish: Jord, der forurenes over en længere tidsperiode, viser f.eks. reduceret toksicitet sammenlignet med jord, hvor det lige er tilført.
English: 6, and was used to refine the risk assessment for Gutal as it is considered appropriate as it can be used for inorganic substances.
Danish: 6, som blev anvendt til at forbedre risikovurderingen af Gutal, da den anses for at være hensigtsmæssig, idet den kan anvendes til uorganiske stoffer.
English: Although limited data were available, results show zinc concentrations are predicted accurately in soils but less so in surface waters and sediment.
Danish: Selv om der kun var begrænsede data til rådighed, viser resultaterne, at zinkkoncentrationerne beregnes nøjagtigt i jord, men mindre nøjagtigt i overfladevand og sediment.
English: Studies have shown zinc oxide to be beneficial in piglets at risk of developing mild to moderate diarrhoea.
Danish: Undersøgelser har vist, at zinkoxid har en gavnlig virkning på smågrise, der har en risiko for at udvikle mild til moderat diarré.
English: At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Danish: Det er i øjeblikket uvist, hvad der udgør et rimeligt værst tænkeligt eksponeringsscenarie for doseringen af gødning.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY
Danish: SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE VETERINÆRLÆGEMIDLER ELLER AFFALD, HVIS NOGEN
English: However, since the data search for the EU RAR (2010) was completed more data have become available (e.g. those used in establishing the UK Environmental Quality Standard
Danish: Efter afslutningen af datasøgning til EU RAR (2010) er der imidlertid fremkommet yderligere tilgængelige data (f.eks. dem, der blev anvendt til udarbejdelsen af Det Forenede Kongeriges
English: The proposed RMMs fulfil the criteria laid out in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6
Danish: De foreslåede risikobegrænsningsforanstaltninger opfylder kriterierne i CVMP-retningslinjerne om miljøkonsekvensanalyser af veterinærlægemidler til støtte for VICH-retningslinje GL6
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Danish: 6.6 Særlige forholdsregler ved bortskaffelse af ubrugte lægemidler eller affald, der stammer fra brugen af sådanne produkter
English: The proposed indication for Gutal is for the prevention of postweaning diarrhoea in piglets.
Danish: Den foreslåede indikation for Gutal er forebyggelse af diarré hos fravænnede smågrise.
English: As zinc is a metal, general assumptions that are usually made about degradation are not applicable, therefore, once critical concentrations are exceeded, the risk will be difficult to remediate.
Danish: Da zink er et metal, kan de generelle antagelser, der normalt gøres omkring nedbrydning, ikke anvendes, og når de kritiske koncentrationer først overskrides, er det derfor vanskeligt at afhjælpe risikoen.
English: Given that the VICH and CVMP guidelines on the Phase II environmental risk assessment of veterinary medicinal products are not primarily developed for inorganic molecules, many of the assumptions and exposure models described in the guidelines are unsuitable for a substance such as zinc.
Danish: Da VICH- og CVMP-retningslinjerne om fase II-miljørisikovurdering af veterinærlægemidler ikke primært er udarbejdet for uorganiske molekyler, er mange af antagelserne og eksponeringsmodellerne, som er beskrevet i retningslinjerne, uhensigtsmæssige for et stof som zink.
English: Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal') contains zinc oxide as an active substance.
Danish: Gutal 1000 g/kg premix til foderlægemiddel til smågrise (i det følgende benævnt "Gutal") indeholder zinkoxid som aktivt stof.
English: Thus, a model used by EFSA for estimating the environmental exposure from the use of zinc oxide as feed additive, the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010)
Danish: Således en model anvendt af EFSA til at anslå den miljømæssige eksponering fra brug af zinkoxid som tilsætningsstof til foder, den intermediære dynamiske model for metal (Intermediate Dynamic Model for Metal) (IDMM) af Monteiro et al. (2010)
English: Firstly, that undiluted manure from treated piglets should be diluted before being applied to land (so that the treated manure comprises 40% or less of the total mixture).
Danish: For det første at ufortyndet gødning fra behandlede smågrise bør fortyndes, inden den anvendes på jord (så den behandlede gødning udgør 40 % eller mindre af den samlede blanding).
English: Even where manure storage is combined, piglet manure would account for 40% or less of the mixture.
Danish: Selv hvor gødningen opbevares sammen, vil gødningen fra smågrise udgøre 40 % eller mindre af blandingen.
English: However, this measure would slow down the accumulation of zinc and, hence, reduce the risk for each environmental compartment.
Danish: Denne foranstaltning vil dog sænke akkumuleringen af zink og dermed reducere risikoen for de enkelte delmiljøer.
English: The predicted no effect concentrations (PNECs) reported in the European Union Risk Assessment Report (EU RAR) on zinc (2010)
Danish: Den beregnede nuleffektkoncentration (PNEC), som fremgår af EU's risikovurderingsrapport (EU RAR) om zink (2010)
English: For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Danish: For hvert delmiljø (jord, vand og sediment) afhænger zinks biotilgængelighed af forskellige biotiske og abiotiske faktorer.
English: The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)
Danish: Beregningen af stedsspecifikke PNEC'er for Gutal blev udført ved hjælp af et Excel-værktøj til beregning af jords PNEC (udviklet af Arche Consulting)
English: No matter which model and application rates are used, a risk to the environment is calculated with only the time needed to arrive at this risk varying.
Danish: Uanset hvilken model og hvilken dosering, der anvendes, beregnes der en risiko for miljøet, idet risikoen kun varierer med den tidsmæssige faktor.
English: A risk was identified for all FOCUS sediment scenarios, at both loading rates and at each time point.
Danish: Der blev identificeret en risiko for alle FOCUSsedimentscenarier ved begge belastninger og på alle tidspunkter.
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Danish: Ændringer i de relevante afsnit af produktresuméet og indlægssedlen
English: Usually piglets and sows are kept on the same farm allowing treated piglet manure to be diluted.
Danish: Smågrise og søer holdes normalt på samme landbrug, hvilket gør det muligt at fortynde gødning fra behandlede smågrise.
English: The CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of a marketing authorisations provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc, are added to the product information.
Danish: CVMP konkluderede, at de betænkeligheder, som Frankrig og Nederlandene har givet udtryk for, ikke er til hinder for, at der kan gives markedsføringstilladelse, forudsat at de anbefalede risikobegrænsningsforanstaltninger, som ventes at reducere akkumuleringen af zink, føjes til produktoplysningerne.
English: This referral was raised due to concerns regarding the environmental risk assessment.
Danish: Denne henvisning blev indledt på grund af betænkeligheder vedrørende miljørisikovurderingen.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Danish: Disse spørgsmål forblev uafklarede, hvorfor der blev indledt en indbringelse i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF, til CMD(v) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til dyr).
English: The amended Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Danish: Referencemedlemsstatens ændrede produktresumé og indlægsseddel er anført i bilag III.
English: During the CMD(v) procedure Belgium concluded that a marketing authorisation for Gutal can be granted provided that RMMs are included in the product information.
Danish: Under CMD(v)-proceduren konkluderede Belgien, at der kunne gives markedsføringstilladelse til Gutal, forudsat at produktoplysningerne indeholdt risikobegrænsningsforanstaltninger.
English: At the time of the zinc EU RAR (2010) there were too few effects or exposure data to be able to account for the effect of these two parameters (AVS/SEM) on zinc bioavailability in sediments.
Danish: Da EU RAR (2010) om zink blev udarbejdet, var der for få effekt- eller eksponeringsdata til at kunne redegøre for effekten af disse to parametre (AVS/SEM) på zinks biotilgængelighed i sedimenter.
English: The bioavailability of zinc, and therefore the environmental risk, varies between soil types.
Danish: Zinks biotilgængelighed, og dermed miljørisikoen, varierer mellem jordtyper.
English: The product should not be used on farms where mixing of manure from treated animals with manure of non-treated animals is not possible.
Danish: Produktet bør ikke anvendes på bedrifter, hvor blanding af gødning fra behandlede dyr med gødning af ikkebehandlede dyr ikke er mulig.
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: Selv om PEC-værdierne for de enkelte delmiljøer ikke kan verificeres, da IDMM ikke er stillet til rådighed, fremstår de generelt ret konservative, eftersom det værst tænkelige eksponeringsscenarie overvejes, dvs. kontinuerlig anvendelse af ufortyndet gødning frem til 2060.
English: In order to limit nutrient loss and eutrophication, Good Agricultural Practice recommends manure should not be spread on vulnerable soils (acidic, freely draining, sandy soils).
Danish: For at begrænse tabet af næringsstoffer og eutrofikation, anbefales det i overensstemmelse med god landbrugspraksis, at gødning ikke bør spredes på sårbar jord (sur, frit drænet sandjord).
English: For two of the FOCUS scenarios (acidic, sandy soils) the risk quotients (RQs) are >1 for both loading rates at all time points.
Danish: For to af FOCUS-scenarierne (sur sandjord) er risikokvotienterne (RQ) >1 for begge belastninger på alle tidspunkter.