FrancophonIA/ELRC3.0 huggingface dataset:
English: Omeprazole is a widely-used treatment for indigestion and acid reflux that acts by reducing the amount of acid the stomach makes.
Danish: Omeprazol anvendes i vidt omfang mod fordøjelsesbesvær og gastroøsofagal refluksygdom og virker ved at reducere syreindholdet i maven.
English: This summary was last updated in April 2013.
Danish: Dette sammendrag blev sidst ajourført i april 2013.
English: There may also be a local reaction at the injection site, such as swelling (generally lasting less than a week) or ‘nodules' (hardening under the skin) that may last for more than 6 or 7 weeks.
Danish: Der kan også opstå en lokal reaktion på injektionsstedet, såsom hævelse (der generelt varer under en uge) eller "noduli" (hårdhed under huden), som kan vare i mere end seks eller syv uger.
English: It is available as a suspension for injection.
Danish: Det fås som en suspension til injektion.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: The vaccine is given to animals as an injection under the skin.
Danish: Vaccinen gives til dyr ved injektion under huden.
English: Protection starts 25 days after the last injection and lasts for at least a year.
Danish: Beskyttelsen begynder at virke 25 dage efter den sidste injektion og holder et år.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Ovis on 15 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ZULVAC 8 Ovis den 15. januar 2010.
English: The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Danish: Det Europæiske Lægemiddelagentur (EMA) gennemgik de i henhold til en aftalt tidsplan fremsendte supplerende oplysninger om vaccinens kvalitet, sikkerhed og virkning.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Danish: Vaccinen indeholder også "adjuvanser" (aluminiumhydroxid og saponin), som giver en bedre immunrespons.
English: ZULVAC 8 Ovis was initially authorised under ‘exceptional circumstances'.
Danish: ZULVAC 8 Ovis blev oprindeligt godkendt under "særlige omstændigheder".
English: The first injection is given from one and a half months of age and the second injection is given three weeks later.
Danish: Den første injektion gives, når dyret er halvanden måned gammelt, og den anden injektion gives tre uger senere.
English: Sheep may show a temporary increase in body temperature, no more than 1.2°C, in the 24 hours after vaccination.
Danish: Der kan forekomme en forbigående stigning i fårenes kropstemperatur på højst 1,2 °C inden for 24 timer efter vaccinationen.
English: The withdrawal period for ZULVAC 8 Ovis for meat and milk is zero days.
Danish: Tilbageholdelsestiden for ZULVAC 8 Ovis for kød og mælk er nul dage.
English: The virus exists in several forms (serotypes) throughout the world; the type used in ZULVAC 8 Ovis is serotype 8.
Danish: Virusset findes i forskellige former (serotyper) rundt omkring i verden, og den type, der anvendes i ZULVAC 8 Ovis, er serotype 8.
English: This will help them to protect against the disease.
Danish: Derved er dyrene bedre beskyttet mod sygdommen.
English: Inactivated vaccine against Bluetongue disease virus, serotype 8
Danish: Inaktiveret vaccine mod bluetongue-virus, serotype 8
English: The studies also showed that the vaccine can be used in pregnant sheep.
Danish: Det fremgik også af undersøgelserne, at vaccinen kan anvendes til drægtige får.
English: In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene efterfølgende udsættes for bluetongue-vira, vil immunsystemet hurtigere kunne danne antistoffer mod dem.
English: The safety of the vaccine was studied in laboratory safety studies carried out with ZULVAC 8 Ovis in sheep.
Danish: Vaccinens sikkerhed blev undersøgt i laboratoriesikkerhedsundersøgelser, som blev gennemført med ZULVAC 8 Ovis hos får.
English: The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as preliminary results from a study in sheep investigating how long the immunity produced by the vaccine lasted after vaccination.
Danish: Virksomheden fremlagde også resultater fra en række undersøgelser med andre vacciner indeholdende andre serotyper af bluetongue-virus samt foreløbige resultater fra en undersøgelse af får, hvor man så på immunitetens varighed efter vaccination.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Ovis to convert to a normal status.
Danish: I 2013 konkluderede CVMP, at de forelagte oplysninger var tilstrækkelige for at kunne omdanne godkendelsen af ZULVAC 8 Ovis til en normal godkendelse.
English: When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når fårene vaccineres, opfatter immunsystemet viraene som "fremmede" og producerer antistoffer mod dem.
English: Results from a series of laboratory safety trials performed with vaccines of similar composition but containing different serotypes of the virus were also presented.
Danish: Der blev desuden fremlagt resultater fra en række laboratoriesikkerhedsundersøgelser, der blev gennemført med en vaccine af tilsvarende sammensætning, men med forskellige serotyper.
English: The studies showed that the vaccine is safe for sheep and that it prevents viraemia in animals from one and a half months of age that are infected with bluetongue virus serotype 8.
Danish: Det fremgik af undersøgelserne, at vaccinen er sikker for får, og at den forebygger viræmi hos dyr i alderen halvanden måned og derover, som er smittet med bluetongue-virus, serotype 8.
English: ZULVAC 8 Ovis is a vaccine.
Danish: ZULVAC 8 Ovis er en vaccine.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ZULVAC 8 Ovis exceed the risks in the prevention of viraemia caused by the bluetongue virus serotype 8 in sheep from one and a half months of age.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved ZULVAC 8 Ovis opvejer risiciene ved forebyggelse af viræmi forårsaget af bluetongue-virus, serotype 8, hos får i alderen halvanden måned og derover.
English: The vaccine is used to prevent viraemia (the presence of the virus in the blood) in sheep from one and a half months of age.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) hos får i alderen halvanden måned og derover.
English: ZULVAC 8 Ovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: ZULVAC 8 Ovis indeholder bluetongue-vira, som er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: The effectiveness of the vaccine in preventing viraemia in sheep was studied in a laboratory trial using the vaccine in sheep from one month of age.
Danish: Vaccinens virkning til forebyggelse af viræmi hos får blev undersøgt i en laboratorieundersøgelse, hvor vaccinen blev brugt til får i alderen en måned og derover.
English: This means that it was not possible to obtain complete information about ZULVAC 8 Ovis at the time of the initial authorisation.
Danish: Det betyder, at det på tidspunktet for den oprindelige godkendelse ikke var muligt at indhente fyldestgørende oplysninger om ZULVAC 8 Ovis.
English: ZULVAC 8 Ovis is a vaccine that contains inactivated (killed) bluetongue serotype 8 virus as the active substance.
Danish: ZULVAC 8 Ovis er en vaccine, der indeholder inaktiveret (dræbt) bluetongue-virus, serotype 8, som aktivt stof.
English: ZULVAC 8 Ovis is used in sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: ZULVAC 8 Ovis anvendes til får som beskyttelse mod sygdommen bluetongue, en infektion forårsaget af bluetongue-virus, der overføres gennem mitter.
English: Other information about ZULVAC 8 Ovis:
Danish: Andre oplysninger om ZULVAC 8 Ovis:
English: What is the risk associated with ZULVAC 8 Ovis?
Danish: Hvilken risiko er der forbundet med ZULVAC 8 Ovis?
English: Why has ZULVAC 8 Ovis been approved?
Danish: Hvorfor blev ZULVAC 8 Ovis godkendt?
English: What is ZULVAC 8 Ovis?
Danish: Hvad er ZULVAC 8 Ovis?
English: How has ZULVAC 8 Ovis been studied?
Danish: Hvordan blev ZULVAC 8 Ovis undersøgt?
English: What is ZULVAC 8 Ovis used for?
Danish: Hvad anvendes ZULVAC 8 Ovis til?
English: How does ZULVAC 8 Ovis work?
Danish: Hvordan virker ZULVAC 8 Ovis?
English: What benefit has ZULVAC 8 Ovis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ZULVAC 8 Ovis?
English: The specific recommendations of the CHMP are as follows:
Danish: CHMP's specifikke anbefalinger er som følger:
English: Information for patients and for healthcare professionals
Danish: Information til patienter og sundhedspersoner
English: • Patients should continue to take their medicines as prescribed.
Danish: • Patienterne bør fortsat tage deres medicin som foreskrevet.
English: Its suspension is therefore not expected to have any impact on patients in the EU.
Danish: Suspenderingen af det forventes derfor ikke at få nogen virkning for patienter i EU.
English: So far no alternative studies from other sources have been provided.
Danish: Indtil videre er der ikke blevet tilvejebragt alternative undersøgelser fra andre kilder.
English: EMA recommends suspension of one medicine
Danish: EMA anbefaler suspendering af et lægemiddel
English: More about the medicines
Danish: Mere om lægemidlerne
English: As a result, a medicine is being suspended.
Danish: Som følge heraf bliver et lægemiddel suspenderet.
English: Other riluzole-containing medicines remain available.
Danish: Andre riluzolholdige lægemidler er fortsat tilgængelige.
English: The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.
Danish: Konklusionerne sår tvivl om det kvalitetsstyringssystem, der er indført på produktionsstedet, og dermed om pålideligheden af dataene fra de undersøgelser af bioækvivalensen, der blev udført mellem marts 2013 og marts 2015.
English: EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP).
Danish: EMA vil fortsat arbejde tæt sammen med de nationale myndigheder og internationale partnere for at sikre, at undersøgelser, der underbygger markedsføringstilladelser i EU, udføres efter de højeste standarder, og at de pågældende firmaer fuldt ud opfylder alle aspekter af god klinisk praksis (GCP).
English: It also included ongoing marketing authorisation applications for medicines which use study data from the site.
Danish: Den omfattede også igangværende ansøgninger om markedsføringstilladelse for lægemidler, der benytter data fra produktionsstedet.
English: The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af Alkem blev indledt den 1. april 2016 på anmodning af den tyske lægemiddelstyrelse (BfArM) i medfør af artikel 31 i direktiv 2001/83/EF.
English: Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources.
Danish: Derfor anbefalede udvalget, at lægemidler, der er blevet godkendt, eller som evalueres på grundlag af disse undersøgelser, suspenderes eller nægtes tilladelse, medmindre der er alternative data til rådighed fra andre kilder.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, der vedtog en endelig, juridisk bindende afgørelse med gyldighed i alle EU-medlemsstaterne den 8. september 2016.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Humanmedicinske Lægemidler (CHMP), der er ansvarligt for alle spørgsmål vedrørende humanmedicinske lægemidler, og som vedtog agenturets udtalelse.
English: The CHMP's recommendations concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Danish: CHMP's anbefalinger vedrørende disse lægemidler blev sendt til Europa-Kommissionen, der vedtog en juridisk bindende afgørelse med gyldighed i hele EU.
English: The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad410208 India.
Danish: Gennemgangen omfattede lægemidler, der var godkendt efter de nationale procedurer i de enkelte EUmedlemsstater, hvis ansøgninger om markedsføringstilladelse indeholdt data fra undersøgelser udført af Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, District Raigad - 410208, Indien.
English: • The medicine being suspended, Riluzole Alkem, contains riluzole and is not yet on the market in the EU.
Danish: • Det lægemiddel, der suspenderes, Riluzole Alkem, indeholder riluzol og er endnu ikke på markedet i EU.
English: The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site.
Danish: Anbefalingerne lå i forlængelse af en fælles rutineinspektion, der blev foretaget af den tyske og nederlandske lægemiddelstyrelse i marts 2015, og som afslørede, at der var givet vildledende data i forbindelse med gennemførelsen af to forskellige forsøg, som blev udført i 2013 og 2014 på produktionsstedet i Taloja.
English: • Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.
Danish: • Riluzole Alkem, et lægemiddel til behandling af amyotrofisk lateralsklerose (ALS), der endnu ikke er blevet markedsført i EU, bør nu suspenderes.
English: On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU.
Danish: Den 23. juni 2016 anbefalede Det Europæiske Lægemiddelagentur (EMA) at suspendere et lægemiddel (Riluzole Alkem), der var genstand for undersøgelser på Alkem Laboratories Ltd's produktionssted i Taloja, Indien, og har anmodet firmaer om at fremlægge nye data vedrørende et andet lægemiddel, inden det kan godkendes i EU.
English: 8 September 2016 EMA/633777/2016 Rev. 1
Danish: 8. september 2016 EMA/632642/2016
English: • Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided.
Danish: • Cefuroxime Ingen Pharma, der for øjeblikket er genstand for evaluering af de nationale myndigheder, kan fortsat komme i betragtning til godkendelse, da der er blevet tilvejebragt undersøgelser fra andre kilder.
English: • Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance.
Danish: • Cefuroxime Alkem og Cefuroxime Krka (antibiotika) kan forblive på markedet i EU, da der er blevet tilvejebragt alternative undersøgelser, som dokumenterer et positivt benefit/risk-forhold.
English: EMA's Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU.
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) bemærkede, at selv om der ikke er bevis for skadelighed eller manglende effektivitet forbundet med Alkem Laboratories Ltd's gennemførelse af undersøgelserne, kan undersøgelserne ikke accepteres i ansøgninger om markedsføringstilladelse i EU.
English: • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd.
Danish: • Der er ingen beviser for skadelighed eller manglende effektivitet forbundet med nogen af de lægemidler, der er undersøgt af Alkem Laboratories Ltd.
English: • Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed.
Danish: • Det er blevet konstateret, at visse undersøgelser, som er udført på Alkem Laboratories Ltd's produktionssted, var behæftet med fejl.
English: • Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd.
Danish: • Ibuprofen Orion, et smertestillende middel, der er genstand for evaluering af de nationale myndigheder, kan ikke godkendes på grundlag af de undersøgelser, som Alkem Laboratories Ltd har udført.
English: Medicines under evaluation cannot be granted authorisation on the basis of these studies; further data would have to be provided to support authorisation.
Danish: Der kan ikke meddeles tilladelse til lægemidler, der er genstand for evaluering, på grundlag af disse undersøgelser.
English: The European Commission issued a decision on 28 September 2017.
Danish: Europa-Kommissionen traf en beslutning den 28. september 2017.
English: What are the conclusions of the CVMP?
Danish: Hvilke konklusioner traf CVMP?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 September 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)
Danish: Resultatet af en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/124)
English: Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Danish: I fortsættelse heraf indledte Frankrig den 1. september 2016 en procedure i henhold til artikel 35 i direktiv 2001/82/EF for ovennævnte lægemidler til dyr.
English: Which data has the CVMP reviewed?
Danish: Hvilke data gennemgik CHMP?
English: The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml.
Danish: Veterinærlægemidlerne Zanil og relaterede navne og generiske produkter deraf er orale suspensioner, der indeholder 34 mg oxyclozanid pr. ml.
English: The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.
Danish: CVMP anbefalede, at betingelserne i markedsføringstilladelserne for ovennævnte lægemidler til dyr ændres, og at produktinformationen ændres i overensstemmelse dermed.
English: France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days.
Danish: Frankrig bemærkede, at der i EU for Zanil og relaterede navne og generiske produkter deraf er godkendt forskellige tilbageholdelsestider for kvæg, får og geder, f.eks. kød og indmad fra kvæg fra 10 dage til 28 dage; mælk fra kvæg fra nul timer til 108 timer; fårekød og -indmad fra 14 dage til 28 dage; fåremælk fra "må ikke anvendes til får, der producerer mælk til menneskeligt konsum" til 7 dage; gedekød og -indmad 14 dage og gedemælk nul dage.
English: Questions and answers on Zanil and associated names, and generic products thereof EMA/586006/2017
Danish: Spørgsmål og svar vedrørende Zanil og relaterede navne og generiske produkter deraf EMA/707677/2017
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Danish: Indehaverne af markedsføringstilladelse indsendte interne data og henvisninger til videnskabelige oplysninger om restkoncentrationer.
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Danish: Oxyclozanid er et ormemiddel (et anthelmintikum) med salicylanilid, der anvendes til behandling af angreb af ikter (fasciolose) hos kvæg, får og geder samt til at udskille led af bændelorm (Moniezia spp) med æg.
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats.
Danish: CVMP blev anmodet om at gennemgå alle foreliggende restkoncentrationsdata og anbefale tilbageholdelsestider for mælk, kød og indmad fra behandlede kvæg, får og geder.
English: On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof.
Danish: Den 13. juli 2017 foretog Det Europæiske Lægemiddelagentur (agenturet) en vurdering af forbrugersikkerheden af tilbageholdelsestiderne for kød, mælk og indmad fra kvæg, får og geder for Zanil og relaterede navne og generiske produkter deraf.
English: Why were Zanil and associated names, and generic products thereof reviewed?
Danish: Hvorfor blev Zanil og relaterede navne og generiske produkter deraf vurderet igen?
English: Questions and answers on Zanil and associated names, and generic products thereof
Danish: Spørgsmål og svar vedrørende Zanil og relaterede navne og generiske produkter deraf
English: What are Zanil and associated names, and generic products thereof?
Danish: Hvad er Zanil og relaterede navne og generiske produkter deraf?
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety.
Danish: Efter at have vurderet de foreliggende oplysninger konkluderede CVMP, at det overordnede benefit/risk-forhold for Zanil og relaterede navne og generiske produkter deraf er positivt, og vedtog, at tilbageholdelsestiderne (kød, mælk og indmad) for kvæg, får og geder bør ændres af hensyn til forbrugernes sikkerhed.