FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Synflorix?
Danish: Hvilke risici er der forbundet med Synflorix?
English: Based on a comparison of the immune response of Synflorix with the investigational vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.
Danish: Baseret på en sammenligning af immunresponset på Synflorix og den vaccine, der blev brugt i undersøgelsen, forventes Synflorix at give tilsvarende beskyttelse mod akut mellemørebetændelse forårsaget af S. pneumoniae.
English: Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine's benefit in preventing community acquired pneumonia.
Danish: Synflorix blev endvidere vurderet i en stor undersøgelse, der omfattede ca. 24.000 børn i alderen 616 uger, hvor der hovedsageligt blev fokuseret på vaccinens evne til at forebygge lungebetændelse erhvervet uden for hospitalet.
English: The study compared the immunogenicity of Synflorix with that of another vaccine that is authorised in the EU to protect children against S. pneumoniae infection, and which contains seven of the ten polysaccharides in Synflorix.
Danish: I undersøgelsen blev Synflorix' immunogenicitet sammenlignet med immunogeniciteten af en anden vaccine, der er godkendt i EU til beskyttelse af børn mod S. pneumoniae-infektion, og som indeholder 7 af de 10 polysakkarider i Synflorix.
English: The European Medicines Agency noted that the immune system's response to Synflorix was comparable to its response to another vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
Danish: Det Europæiske Lægemiddelagentur lagde vægt på, at immunsystemets reaktion på Synflorix svarede til immunsystemets reaktion på an anden vaccine, der allerede er godkendt i EU til beskyttelse af børn mod S. pneumoniae.
English: Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae.
Danish: Synflorix blev vurderet i en stor undersøgelse, der omfattede over 30.000 spædbørn under 7 måneder, som blev vaccineret med enten Synflorix eller en sammenligningsvaccine, der ikke virkede på S. pneumoniae.
English: For the full list of side effects with Synflorix, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Synflorix fremgår af indlægssedlen.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet bakteriedelene i vaccinen som "fremmede" og danner antistoffer mod dem. Immunsystemet vil derefter være i stand til hurtigere at danne antistoffer, når det eksponeres for den samme bakterie igen.
English: Another main study looked at whether Synflorix prevents acute otitis media.
Danish: En anden undersøgelse så nærmere på, om Synflorix forebygger akut mellemørebetændelse.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synflorix have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Synflorix.
English: It is used to protect infants and children aged between 6 weeks and 5 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Danish: Synflorix anvendes til at beskytte spædbørn og børn i alderen seks uger til fem år mod invasiv sygdom, lungebetændelse og akut mellemørebetændelse forårsaget af S. pneumoniae.
English: How is Synflorix used?
Danish: Hvordan anvendes Synflorix?
English: Synflorix was effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster dose, one case occurred among the 10,000 children given two doses of Synflorix and a booster dose and 12 cases occurred in 10,000 children given the comparator vaccine.
Danish: Synflorix var effektivt til at beskytte mod invasive sygdomme: Der blev ikke observeret nogen tilfælde blandt de 10.000 børn, der fik tre doser Synflorix og en booster.
English: What benefits of Synflorix have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Synflorix?
English: • Premature babies (born between 27 and 36 weeks gestation) are given a course of three doses with an interval of at least one month between each dose, with the first dose given at 2 months of age.
Danish: • Spædbørn, der er født for tidligt (mellem 27. og 36. svangerskabsuge), skal have et vaccinationsforløb på tre doser med mindst en måned mellem hver dosis.
English: • Children aged between 12 months and 5 years are given a course of two doses with an interval of at least 2 months between them.
Danish: • Børn på mellem 12 måneder og 5 år skal have et vaccinationsforløb på to doser med mindst to måneder mellem hver dosis.
English: How does Synflorix work?
Danish: Hvordan virker Synflorix?
English: • Infants aged between 7 and 11 months are given a course of two doses with an interval of at least one month between them.
Danish: • Spædbørn i alderen 7-11 måneder skal have et vaccinationsforløb på to doser med mindst en måned mellem hver dosis.
English: • Infants aged between 6 weeks and 6 months are given a course of three doses with an interval of at least one month between each dose, with the first dose usually given at 2 months of age.
Danish: • Spædbørn i alderen 6 uger til 6 måneder skal have et vaccinationsforløb på tre doser med mindst én måned imellem hver dosis.
English: However, these effects have only been observed during early treatment.
Danish: Denne effekt er imidlertid kun observeret ved tidlig behandling.
English: This linear extrapolation is questionable, since the processes involved are not linear.
Danish: Denne lineære ekstrapolering er tvivlsom, eftersom de involverede processer ikke er lineære.
English: Risks of (co-)selection of resistant bacteria
Danish: Risici for (co-)selektion af resistente bakterier
English: No synergy was demonstrated and the potential antagonism was not tested.
Danish: Der er ikke påvist nogen synergi, og den potentielle antagonisme er ikke testet.
English: Determination of specific conditions
Danish: Bestemmelse af specifikke forhold
English: For this 30% contribution alone a risk is already identified for Danish soils.
Danish: Alene for disse 30 % er der allerede identificeret en risiko, hvad angår dansk jord.
English: However, more studies are required to fill remaining data gaps in this area and to confirm these effects.
Danish: Men der er brug for flere undersøgelser for at udfylde datahullerne på dette område og bekræfte en sådan virkning.
English: This restricts the focus to the findings of Poulsen (1995), and Holm (1990)27.
Danish: Dermed begrænses fokus til fundene fra Poulsen (1995) og Holm (1990)27.
English: Reduction of global use of antibiotics
Danish: Reduktion af det samlede forbrug af antibiotika
English: The margin of safety can be considered as lower than 3 times the recommended dose.
Danish: Sikkerhedsmargenen vurderes at være under 3 gange den anbefalede dosis.
English: The bioavailable fraction of zinc in soils is small (<1%).
Danish: Den biotilgængelige andel af zink i jord er lille (< 1 %).
English: The CVMP has calculated PECsoils when taking into account the two approaches noted above, separately.
Danish: CVMP har beregnet PECsoil under hensyn til de to ovenfor anførte tilgange hver for sig.
English: The margin of safety for the target animals at the dose stated above is relatively small but acceptable.
Danish: Sikkerhedsmargenen for måldyrene ved den ovenfor angivne dosis er relativt lille, men acceptabel.
English: It has to be noted that the PNECs used in this study is adapted to Danish situations and may be lower (more worst-case) in other parts of Europe with different soil types.
Danish: Det skal bemærkes, at de PNEC-værdier, der benyttes i denne undersøgelse, er tilpasset danske forhold og kan være lavere (mere worst-case) i andre dele af Europa med andre jordtyper.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og indehavere af markedsføringstilladelse i medlemsstaterne
English: Powder for oral administration
Danish: Pulver til oral administration
English: CVMP overall conclusions after re-examination
Danish: CVMP's overordnede konklusion efter revurdering
English: Czech Republic MIKROP ČEBÍN a.s. Čebín 416
Danish: MIKROP ČEBÍN a.s. Čebín 416
English: Fixed combination products cannot be justified for reasons of compensating inadequate diagnosis.
Danish: Kombinationsprodukter kan ikke retfærdiggøres ved, at der skal kompenseres for utilstrækkelige diagnoser.
English: At higher dose (x3 during 28 days) significant side effects (impact on growth rate, clinical signs) have been observed.
Danish: Ved højere doser (x3 i 28 dage) er der observeret signifikante bivirkninger (indvirkning på væksten, kliniske tegn).
English: In the absence of relevant diagnostic data it was not possible to identify the pathogens involved.
Danish: I fravær af relevante diagnosticeringsdata har det ikke været muligt at identificere de involverede patogener.
English: Duration of the protective effect The duration of the protective effect was investigated only in one study (Johansen et al. (2007), in which the follow-up period was approximately 41 days.
Danish: Varigheden af den beskyttende effekt er kun vurderet i én undersøgelse (Johansen et al. 2007), hvor opfølgningsperioden var på ca. 41 dage.
English: The data presented identify a hazard for human and animal health but, at the present time, that risk is not quantifiable.
Danish: De fremlagte data identificerer en risiko for menneskers og dyrs sundhed, men for nuværende er risikoen ikke kvantificerbar.
English: Antimicrobial resistance
Danish: Antibiotikaresistens
English: Risks for the environment
Danish: Risici for miljøet
English: To manage the risks and determine adequate risk mitigation measures, the marketing authorisation holders suggest adding a number of statements on the product information regarding the mixing and/or spreading of manure to land.
Danish: For at styre risiciene og fastsætte passende risikoreducerende foranstaltninger foreslår markedsføringstilladelsesindehaverne at tilføje en række angivelser i produktinformationen, hvad angår opblanding og/eller spredning af gødning på jord.
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 sedimenter og ved lavere belastninger.
English: Much of the text was focused on the health and growth benefits of zinc oxide.
Danish: Meget af teksten har fokus på de sundheds- og vækstmæssige fordele ved zinkoxid.
English: This is not only applicable on farms where dilution of manure is not possible, but also for farms that are able to dilute manure.
Danish: Dette gælder ikke kun farme, hvor det ikke er muligt at fortynde gødningen, men også farme, hvor det er muligt at fortynde gødningen.
English: It should be noted that the CVMP is a scientific Committee and that while it operates within the framework of the Union legislation regulating veterinary medicinal products, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Danish: Det skal bemærkes, at CVMP er et videnskabeligt udvalg, som, skønt det arbejder inden for EU's lovgivningsramme for veterinærlægemidler, ikke kan indgå i en nærmere drøftelse af lovgivningens proceduremæssige og retlige aspekter.
English: A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Danish: En vigtig overvejelse i forbindelse med vurdering af metallers miljørisici er bestemmelsen af deres biotilgængelighed.
English: The CVMP concluded that when using the added risk approach, then:
Danish: CVMP har konkluderet, at man ved brug af "added risk"-tilgangen når frem til følgende:
English: Shorter or longer treatment durations were considered not supported by sufficient data.
Danish: Det vurderes, at kortere eller længere tids behandling ikke understøttes af tilstrækkelige data.
English: DSM Nutritional Products (UK) Ltd. and Provimi Ltd.
Danish: DSM Nutritional Products (UK) Ltd. og Provimi Ltd.
English: Diarrhoea was observed only during the first two weeks after weaning.
Danish: Der sås kun diarré i de første to uger efter fravænning.
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-værdierne overskrides i disse delmiljøer.
English: Environment
Danish: Miljø
English: Colistin alone is sufficiently effective for the metaphylaxis and treatment of gastrointestinal infections caused by non-invasive E. coli (see procedure EMEA/V/A/106)10.
Danish: Colistin alene er tilstrækkeligt effektivt til metafylakse og behandling af gastrointestinale infektioner forårsaget af ikke-invasiv E. coli (se procedure EMEA/V/A/106)10.
English: 101, Ap. 47 sector 6, Bucharest Romania
Danish: 2 Intrarea Vagonetului, Bl. 101, Ap. 47 sector 6, Bucharest Romania
English: However, after the cessation of zinc oxide supplementation at day 14, acids were added in the feed and consequently the effects of each component could not be evaluated during the follow-up period.
Danish: Efter ophøret med zinkoxid-tilskud på dag 14 blev der imidlertid tilsat syrer i foderet, hvorfor virkningen af hver enkelt komponent ikke kunne vurderes i opfølgningsperioden.
English: The Committee also considers that variability in soil characteristics (i.e. soil types) causes variation in zinc fate and behaviour.
Danish: Udvalget bemærker, at variabiliteten i jords (dvs. forskellige jordtypers) egenskaber medfører variationer i zinkens skæbne og opførsel.
English: The marketing authorisation holders informed the EMA that they had not received the official notification of the inclusion of their products (Pigzin and ZincoTec) in this Article 35 referral procedure.
Danish: Markedsføringstilladelsesindehaverne har informeret EMA om, at de ikke har modtaget den officielle meddelelse om, at deres produkter (Pigzin og ZincoTec) er omfattet af denne artikel 35indbringelsesprocedure.
English: Therefore the information submitted by those marketing authorisation holders at the stage of reexamination was taken into consideration in order to safeguard their rights.
Danish: Derfor er der taget hensyn til de oplysninger, som disse markedsføringstilladelsesindehavere har indsendt i forbindelse med revurderingen, for at sikre deres rettigheder.
English: For the grounds of re-examination, the marketing authorisation holder focuses on what they believe to be inconclusive results from a recent Danish soil monitoring study (Bak et al. 2015).
Danish: I forbindelse med revurderingen henviser markedsføringstilladelsesindehaveren til det, han mener er inkonklusive resultater fra en nylig dansk jordovervågningsundersøgelse (Bak et al. 2015).
English: It is still difficult at present time to define the situations in which the zinc oxide containing products will be beneficial or not beneficial.
Danish: For nuværende er det stadig vanskeligt at definere, hvornår brug af zinkoxid holdige produkter vil være gavnligt eller ikke gavnligt.
English: Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Danish: Der er derfor fastsat en "ældningsfaktor" på 3, som anvendes til at beregne de stedsspecifikke PNEC-værdier.
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 FOCUS-sedimentscenarier ved begge belastninger og på alle tidspunkter.
English: Additionally the marketing authorisation holders consider that an ad hoc expert group together EFSA could help to address the environmental risks from a broader point of view.
Danish: Derudover mener markedsføringstilladelsesindehaverne, at en ad hoc-ekspertgruppe i samarbejde med EFSA vil kunne vurdere miljørisiciene på et bredere grundlag.
English: 664 23 Čebín
Danish: 664 23 Čebín Czech Republic
English: AVS is produced by bacteria in anoxic sediments.
Danish: AVS produceres af bakterier i anoxiske sedimenter.
English: Huvepharma's scientific grounds for re-examination focused on risks for the environment.
Danish: Huvepharmas videnskabelige begrundelse for revurdering har fokus på miljørisici.
English: Nevertheless there remains the potential risk of overuse of zinc oxide, as it is not possible to predict which animals will develop diarrhoea, as some cases of diarrhoea at weaning are only transitory and slight and without impact on general health of the animals.
Danish: Men der er stadig en potentiel risiko for et overforbrug af zinkoxid, da det ikke er muligt at forudsige, hvilke dyr der vil udvikle diarré, idet nogle tilfælde af diarré ved fravænning kun er forbigående, lette og uden betydning for dyrenes generelle sundhed.
English: To conclude on this point, the marketing authorisation holders did not provide any additional data that will change the original CVMP conclusion with regard to efficacy.
Danish: Hvad angår dette punkt, har markedsføringstilladelsesindehaverne ikke fremlagt yderligere data, der vil ændre CVMP's oprindelige konklusion om virkningen.
English: However, the only authorised indications are for the treatment and control of diarrhoea in piglets.
Danish: De eneste godkendte indikationer er imidlertid behandling og kontrol af diarré hos smågrise.
English: However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface waters given that bioavailability considerations were harder to take into account.
Danish: Det bemærkes dog, at usikkerheden i forbindelse med risikokarakteriseringen for sedimenter er betydeligt større end for jord og overfladevand, da det er vanskeligere at tage hensyn til biotilgængeligheden i sedimenter.
English: For two of the FOCUS scenarios (acidic, sandy soils) the RQs are >1 for both loading rates at all time points.
Danish: For to af FOCUS-scenarierne (sur og sandet jord) er RQ > 1 for begge belastninger på alle tidspunkter.
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 sedimenter.
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 sedimenter) afhænger zinks biotilgængelighed af forskellige biotiske og abiotiske faktorer.
English: They further state that their products contribute to achieving lower antimicrobial consumption in pigs, and that the identified risks will not be mitigated by removing veterinary medicinal products containing zinc oxide from the market.
Danish: Derudover anfører de, at deres produkter bidrager til at opnå et lavere forbrug af antibiotika hos svin, og at de identificerede risici ikke vil blive reduceret ved at fjerne zinkoxid-holdige veterinærlægemidler fra markedet.
English: Given that the VICH and CVMP guidelines16,17,18 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-retningslinjerne16,17,18 for 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: A number of marketing authorisation holders referred to the European Union Risk Assessment Report (EU RAR) on zinc (2010)12 in their effect assessment.
Danish: En række markedsføringstilladelsesindehavere har henvist til EU's risikovurderingsrapport (RAR) vedrørende zink (2010)12 i deres effektvurdering.
English: The results indicate that for both clay and sandy soils a risk is identified using added-risk approach, with PEC values being above the PNECsoil of 26 mg/kg.
Danish: Resultaterne tyder på, at der for både sand- og lerjord identificeres en risiko ved brug af "added risk"-tilgangen, hvor PEC-værdierne ligger over PNECsoil på 26 mg/kg.
English: No studies were submitted to support the treatment indication.
Danish: Der blev ikke fremlagt nogen studier til understøttelse af behandlingsindikationen.
English: Not all marketing authorisation holders submitted the information that was required to validate the suitability of these additional studies for PNEC refinements.
Danish: Ikke alle markedsføringstilladelsesindehavere har fremlagt de oplysninger, der er påkrævet for at vurdere egnetheden af disse yderligere undersøgelser til præcisering af PNEC-værdierne.
English: The CVMP considers that four out of five environmental risk assessments have a number of deficiencies on their risk assessment and consequently cannot be used in support of the benefit-risk assessment.
Danish: CVMP mener, at fire ud af de fem miljørisikovurderinger udviser en række mangler i deres risikobedømmelse, og at de derfor ikke kan anvendes til støtte for fastsættelsen af benefit/riskbalancen.
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 remedy.
Danish: Da zink er et metal, gælder de almindelige antagelser om nedbrydning ikke, så når først de kritiske koncentrationer er overskredet, er det vanskeligt at imødegå risikoen.
English: In the trials with only seven days of zinc oxide supplementation at the recommended dose no significant effect was shown.
Danish: I undersøgelserne med kun 7 dages tilskud af zinkoxid i den anbefalede dosis sås ingen signifikant effekt.
English: The exposure assessment should ideally have addressed this and considered a realistic worst-case situation with respect to the respective receiving environmental compartments.
Danish: Ideelt set burde eksponeringsvurderingen have taget hensyn til dette og vurderet det værst tænkelige realistiske scenarie for de berørte delmiljøer.
English: The CVMP also notes that other sources of zinc in the environment will also contribute to the yearly increase of zinc oxide to agricultural land.
Danish: CVMP skal desuden bemærke, at andre kilder til zink i miljøet også vil bidrage til den årlige stigning af zinkoxid i landbrugsjord.
English: Therefore, in the absence of more data, it is not possible to further characterise the risk posed to both public and animal health.
Danish: Da der således ikke foreligger tilstrækkelige data, er det ikke muligt at give en nærmere karakteristik af risikoen for menneskers og dyrs sundhed.
English: Scientific conclusions and grounds for the refusal of the marketing authorisation and for withdrawal of the existing marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for afslag på ansøgning om markedsføringstilladelse og for tilbagetrækning af de eksisterende markedsføringstilladelser
English: The marketing authorisation holders' grounds for the re-examination were submitted before 6 February
Danish: Markedsføringstilladelsesindehavernes begrundelser for ønsket om revurdering er blevet forelagt den 6. februar 2017.