FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects of Acrescent were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Acrescent blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In addition, the company pooled and analysed the results from the different studies together.
Danish: Desuden lagde virksomheden resultaterne af de forskellige undersøgelser sammen og analyserede dem samlet.
English: What consequences does this refusal have for patients in clinical trials?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser?
English: What was Acrescent expected to be used for?
Danish: Hvad forventedes Acrescent anvendt til?
English: Therefore, the CHMP was of the opinion that the benefits of Acrescent did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Acrescent ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Acrescent is a combination treatment containing two active substances which are already authorised in the EU to treat the symptoms of Alzheimer's disease.
Danish: Acrescent er et lægemiddel, der består af en kombination af to aktive stoffer, som allerede er godkendt i EU til behandling af symptomerne på Alzheimers sygdom.
English: How is Acrescent expected to work?
Danish: Hvordan forventes Acrescent at virke?
English: The causes of Alzheimer's disease are unknown, but the associated memory loss, disorientation and behavioural symptoms are believed to be due to a disturbance of neurotransmitters in the brain.
Danish: Årsagerne til Alzheimers sygdom er ukendte, men den hukommelsessvækkelse og desorientering og de adfærdssymptomer, sygdommen medfører, menes at skyldes forstyrrelse af neurotransmittere i hjernen.
English: The company informed the CHMP that there are no patients currently included in clinical trials with Acrescent in the European Union.
Danish: Virksomheden har til CHMP oplyst, at der på nuværende tidspunkt ikke deltager nogen patienter i kliniske undersøgelser med Acrescent i EU.
English: Acrescent is a medicine that contains two active substances, memantine hydrochloride and donepezil hydrochloride.
Danish: Acrescent er et lægemiddel, der indeholder de to aktive stoffer memantinhydrochlorid og donepezilhydrochlorid.
English: However, the CHMP considered that the treatment guidelines were not consistent across European countries and the company had not provided enough evidence to support the use of a combination tablet in these patients.
Danish: CHMP hæftede sig imidlertid ved, at behandlingsretningslinjerne ikke var overensstemmende i alle europæiske lande, og at virksomheden ikke havde fremlagt tilstrækkelig dokumentation til at underbygge brugen af kombinationstabletten hos disse patienter.
English: The effectiveness of the combination treatment was assessed by comparing the patients' performance in cognitive tests and in carrying out daily living activities.
Danish: Virkningen af den kombinerede behandling blev vurderet ved sammenligning af patienternes præstationer i hjernefunktionstest og hvad angår dagligdags aktiviteter.
English: It presented the results of seven main studies, including patients (or a subset of patients) who received memantine and donepezil together.
Danish: Virksomheden fremlagde resultaterne af syv hovedundersøgelser, herunder med patienter (eller undergrupper af patienter), der fik memantin og donepezil sammen.
English: Acetylcholine levels are lower in people suffering from dementia in Alzheimer's disease.
Danish: Indholdet af acetylkolin er lavere hos personer med demens ved Alzheimers sygdom.
English: The combination of memantine and donepezil is used in some European countries to treat patients with moderate to moderately severe Alzheimer's disease.
Danish: Kombinationen af memantin og donepezil anvendes i visse europæiske lande til behandling af patienter med moderat til moderat svær Alzheimers sygdom.
English: One main study involved 404 patients with moderate to severe Alzheimer's disease who were already taking donepezil.
Danish: Den ene hovedundersøgelse omfattede 404 patienter med moderat til svær Alzheimers sygdom, som i forvejen fik donepezil.
English: On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Acrescent, intended for the treatment of moderate to moderately severe Alzheimer's disease in patients who are already taking memantine and donepezil.
Danish: Den 18. oktober 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Acrescent, der er bestemt til behandling af moderat til moderat svær Alzheimers sygdom hos patienter, som i forvejen får memantin og donepezil.
English: The company also presented information intended to show the use of memantine and donepezil in combination to treat Alzheimer's disease across the European Union, including the available guidelines for treating Alzheimer's disease in different European countries.
Danish: Virksomheden fremlagde også oplysninger til dokumentation af kombineret anvendelse af memantin og donepezil til behandling af Alzheimers sygdom i EU, herunder eksisterende retningslinjer for behandling af Alzheimers sygdom i forskellige europæiske lande.
English: Acrescent was expected to be used to treat moderate to moderately severe Alzheimer's disease, in patients who are already taking a daily dose of 20 mg memantine and 10 mg donepezil.
Danish: Acrescent forventedes anvendt til behandling af moderat til moderat svær Alzheimers sygdom hos patienter, der i forvejen får en daglig dosis på 20 mg memantin og 10 mg donepezil.
English: The effects of adding memantine to donepezil was compared with adding placebo for six months of treatment.
Danish: Virkningerne af memantin som tillægsbehandling til donepezil blev sammenlignet med virkningerne af placebo som tillægsbehandling i seks måneder.
English: Donepezil works by blocking the action of an enzyme which normally breaks down a neurotransmitter called acetylcholine.
Danish: Donepezil virker ved at blokere virkningen af et enzym, der normalt nedbryder neurotransmitteren acetylkolin.
English: The Committee was concerned that the studies presented by the company had negative results except for one main study, in which patients already taking donepezil performed better in cognitive tests and in daily living activities when memantine was added to donepezil treatment.
Danish: Udvalget var betænkeligt ved, at de af virksomheden fremlagte undersøgelser viste negative resultater bortset fra én hovedundersøgelse, hvor de patienter, der i forvejen fik donepezil, fik bedre præstationer i hjernefunktionstest og hvad angår dagligdags aktiviteter, når memantin blev anvendt som tillægsbehandling til donepezil.
English: By slowing down the breakdown of acetylcholine, donepezil helps to reduce the symptoms of Alzheimer's disease.
Danish: Ved at bremse nedbrydningen af acetylkolin mindsker donepezil symptomerne på Alzheimers sygdom.
English: The Committee also noted that a published study did not show a significant improvement in patients taking the combination treatment when compared with memantine alone.
Danish: Udvalget bemærkede desuden, at en offentliggjort undersøgelse ikke viste væsentlig bedring hos patienter, der fik kombinationsbehandlingen, i forhold til behandling med memantin alene.
English: The CHMP considered that the additional analyses provided by the company did not satisfy these concerns.
Danish: CHMP fandt ikke, at disse betænkeligheder blev imødekommet af de supplerende analyser, der var fremlagt af virksomheden.
English: However, due to the study design it did not demonstrate a clear benefit of the combination treatment, since it did not include a control arm for patients treated with memantine alone.
Danish: Som følge af sin tilrettelæggelse viste undersøgelsen imidlertid ikke en klar fordel af kombinationsbehandlingen, da der ikke var en kontrolgruppe med patienter, som fik memantin alene.
English: What is Acrescent?
Danish: Hvad er Acrescent?
English: Memantine works by blocking types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Danish: Memantin virker ved at blokere en bestemt type receptorer (NMDA-receptorer), som neurotransmitteren glutamat normalt bindes til.
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease, and over-activity of the NMDA receptors can result in cell damage or death.
Danish: Den hukommelsessvækkelse, der ses ved Alzheimers sygdom, er blevet sat i forbindelse med ændringer i signaloverførslen via glutamat i hjernen og med overaktivitet af NMDA-receptorerne, der kan medføre, at cellerne beskadiges eller dør.
English: It is authorised to treat patients with moderate to severe forms of Alzheimer's disease.
Danish: Det er godkendt til behandling af patienter med moderat til svær Alzheimers sygdom.
English: It is authorised to treat patients with mild to moderately severe forms of Alzheimer's disease.
Danish: Det er godkendt til behandling af patienter med let til moderat svær Alzheimers sygdom.
English: By blocking NMDA receptors, memantine helps to reduce the symptoms of Alzheimer's disease.
Danish: Memantin blokerer NMDA-receptorerne og mindsker derved symptomerne på Alzheimers sygdom.
English: This summary was last updated in September 2015.
Danish: Dette sammendrag blev sidst ajourført i september 2015.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zulvac SBV on 6 February 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zulvac SBV den 6. februar 2015.
English: This will help protect them against the disease.
Danish: Derved opnås bedre beskyttelse af dyrene mod sygdommen.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Danish: Vaccinen indeholder desuden "adjuvanser" (aluminiumhydroxid og saponin), der forstærker immunreaktionen.
English: The full EPAR for Zulvac SBV can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zulvac SBV findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The withdrawal period for meat from cattle and sheep treated with Zulvac SBV is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra kvæg og får, der behandles med Zulvac SBV, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The effectiveness of Zulvac SBV has been investigated in laboratory studies in cattle and sheep.
Danish: Effektiviteten af Zulvac SBV er testet i laboratorieundersøgelser hos kvæg og får.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zulvac SBV's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Zulvac SBV opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Zulvac SBV.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zulvac SBV.
English: Schmallenberg virus is transmitted by midges and causes stillbirths and birth defects in cattle and sheep.
Danish: Schmallenberg-virus overføres gennem mitter og medfører dødfødsel og fødselsdefekter hos kvæg og får.
English: In the future if the animals are exposed to Schmallenberg virus, the immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene senere udsættes for Schmallenberg-virus, vil immunsystemet hurtigere kunne producere antistoffer.
English: Schmallenberg virus vaccine (inactivated)
Danish: Schmallenberg-virusvaccine (inaktiveret)
English: The animals were vaccinated according to the vaccination schedule and were then exposed to the Schmallenberg virus.
Danish: Dyrene blev vaccineret i henhold til vaccinationsplanen og blev belastet med Schmallenberg-virus.
English: Zulvac SBV is a vaccine.
Danish: Zulvac SBV er en vaccine.
English: Zulvac SBV is a veterinary vaccine used to protect cattle and sheep from 3.5 months of age against Schmallenberg virus by reducing viraemia (presence of virus in the blood).
Danish: Zulvac SBV er en veterinær vaccine til beskyttelse af kvæg og får fra 3,5-månedsalderen mod Schmallenberg-virus ved at reducere tilstedeværelse af virus i blodet (viræmi).
English: When it is given to cattle or sheep, the animals' immune system recognises the virus as foreign and makes antibodies against it.
Danish: Når vaccinen gives til kvæg eller får, registrerer dyrenes immunsystem virusset som "fremmed" og reagerer ved at danne antistoffer imod det.
English: Zulvac SBV contains Schmallenberg virus that has been inactivated so that it cannot cause disease.
Danish: Zulvac SBV indeholder Schmallenberg-virus, der er inaktiveret, så det ikke kan forårsage sygdom.
English: In cattle protection starts two weeks after vaccination and lasts 12 months.
Danish: Hos kvæg begynder beskyttelsen to uger efter vaccinationen og varer 12 måneder.
English: Other information about Zulvac SBV:
Danish: Andre oplysninger om Zulvac SBV:
English: Zulvac SBV contains the active substance inactivated (killed) Schmallenberg virus strain BH80/11-4.
Danish: Zulvac SBV indeholder inaktiveret (dræbt) Schmallenberg-virus, stamme BH80/11-4, som aktivt stof.
English: It is not intended to provide practical advice on how to use Zulvac SBV.
Danish: Det er ikke en praktisk vejledning i, hvordan Zulvac SBV bør anvendes.
English: In sheep protection starts three weeks after vaccination and lasts six months.
Danish: Hos får begynder beskyttelsen tre uger efter vaccinationen og varer seks måneder.
English: Zulvac SBV is available as a suspension for injection and can only be obtained with a prescription.
Danish: Zulvac SBV fås som injektionsvæske, suspension, og udleveres kun på recept.
English: In pregnant ewes vaccination reduced viraemia and infection of the embryo.
Danish: Vaccination af drægtige får mindskede viræmi og overførsel af smitte til fosteret.
English: What is Zulvac SBV and what is it used for?
Danish: Hvad er Zulvac SBV, og hvad anvendes det til?
English: In sheep more than one in ten animals may have an increase in body temperature of up to 1.5 °C during the 24 hours after vaccination.
Danish: Hos får kan der hos mere end ét ud af ti dyr forekomme en stigning i kropstemperaturen på op til 1,5 °C de første 24 timer efter vaccinationen.
English: For booster vaccination in cattle two injections of 2 ml should be given three weeks apart every 12 months.
Danish: Som booster-vaccination til kvæg gives to injektioner a 2 ml med tre ugers mellemrum hver 12. måned.
English: What are the risks associated with Zulvac SBV?
Danish: Hvilken risiko er der forbundet med Zulvac SBV?
English: More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, and swellings less than 2 cm in diameter may last for at least 47 days.
Danish: Mere end ét ud af ti dyr kan på injektionsstedet få hævelse eller knuder på op til 8 cm i diameter under huden, og hævelse på under 2 cm i diameter kan vedvare i mindst 47 dage.
English: More than one in ten animals may show swellings or lumps of up to 8 cm in diameter under the skin at the injection site, which may last for at least 97 days as granules less than 0.5 cm in diameter.
Danish: Mere end ét ud af ti dyr kan på injektionsstedet få hævelse eller knuder under huden på op til 8 cm i diameter, som kan vedvare i mindst 97 dage som knuder under 0,5 cm i diameter.
English: Why is Zulvac SBV approved?
Danish: Hvorfor er Zulvac SBV blevet godkendt?
English: In cattle, an increase in body temperature of up to 1.5°C during the 48 hours after vaccination and the appearance of small lumps of up to 0.7 cm in diameter at the vaccination site that resolve within 10 days are very common (seen in more than 1 animal in 10).
Danish: Hos kvæg forekommer der meget ofte en stigning i kropstemperaturen på op til 1,5 °C i de første 48 timer efter vaccinationen, og på vaccinationsstedet små knuder på op til 0,7 cm i diameter, der svinder i løbet af 10 dage (forekommer hos mere end 1 ud af 10 dyr).
English: For more information about treatment with Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Zulvac SBV, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: In pregnant ewes more than one in ten animals may have an increase in body temperature of up to 0.8 °C during 4 hours after vaccination.
Danish: Hos drægtige får kan der hos mere end ét ud af ti dyr forekomme en stigning i kropstemperaturen på op til 0,8 °C i de første 4 timer efter vaccinationen.
English: The main measure of effectiveness was absence of viraemia following exposure to the virus.The studies showed that Zulvac SBV protects cattle two weeks and sheep three weeks after vaccination.
Danish: Undersøgelserne viste, at Zulvac SBV beskytter kvæg to uger og får tre uger efter vaccination.
English: For practical information about using Zulvac SBV, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Zulvac SBV, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The vaccine is given to cattle as two injections of 2 ml into the neck muscle three weeks apart and to sheep as a single injection of 1 ml under the skin behind the elbow.
Danish: Til får gives vaccinen som én injektion (1 ml) under huden bag albuen.
English: For female sheep vaccination should be at least two weeks before breeding to reduce viraemia (virus in the blood) and infection of the embryo during the first trimester of pregnancy.
Danish: Dette er for at nedsætte virusindholdet i blodet (viræmi) og overførsel af smitte til fostret i de første tre måneder af drægtighedsperioden.
English: How is Zulvac SBV used?
Danish: Hvordan anvendes Zulvac SBV?
English: What benefits of Zulvac SBV have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zulvac SBV?
English: How does Zulvac SBV work?
Danish: Hvordan virker Zulvac SBV?
English: For booster vaccination in non-breeding sheep a single injection of 1 ml should be given every six months whilst in female breeding sheep a single injection of 1 ml should be given at least two weeks before breeding.
Danish: Hunfår, der er avlsdyr, skal have én injektion (1 ml) mindst to uger før bedækning.
English: 27 January 2011
Danish: 27. januar 2011
English: They are available in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and the United Kingdom.
Danish: De er tilgængelige i Østrig, Belgien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Luxembourg, Nederlandene, Polen, Portugal, Slovakiet, Spanien, Sverige og Det Forende Kongerige.
English: The European Commission issued a decision on 27 January 2011.
Danish: EU-kommissionen traf en afgørelse den 27. januar 2011.
English: After re-examination, the Committee confirmed these recommendations on 18 November 2010.
Danish: Efter revurdering bekræftede udvalget disse anbefalinger den 18. november 2010.
English: Indications restricted following review procedure under Article 31 of Directive 2001/83/EC as amended
Danish: Indikationer begrænset efter vurderingsprocedure i henhold til artikel 31 i Europa-Parlamentets og Rådets direktiv 2001/83/EF som ændret
English: The Committee recommended that these indications be removed from the product information.
Danish: Udvalget anbefalede, at disse indikationer blev fjernet fra produktinformationen.
English: The CHMP confirmed the above conclusions after re-examining its opinion.
Danish: CHMP bekræftede ovennævnte konklusioner efter revurdering af sin udtalelse.
English: What is modafinil?
Danish: Hvad er modafinil?
English: The full changes made to the information to doctors and patients are detailed here.
Danish: De komplette ændringer af informationen til læger og patienter er beskrevet her.
English: Medicines containing modafinil were first marketed in Europe in 1992.
Danish: Lægemidler indeholdende modafinil blev første gang markedsført i 1992.
English: Questions and answers on the review of medicines containing modafinil
Danish: Spørgsmål og svar vedrørende vurdering af lægemidler indeholdende modafinil
English: What are the recommendations for prescribers and patients?
Danish: Hvad er anbefalingerne til de ordinerende læger og patienterne?
English: Why was modafinil reviewed?
Danish: Hvorfor blev modafinil vurderet?
English: A group of experts on clinical neurosciences was also convened to provide advice.
Danish: En gruppe af eksperter i klinisk neurovidenskab blev også kaldt i samråd.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Danish: • Hvis patienterne har spørgsmål, skal de tale med deres læge eller apoteket.
English: However, the data from the trials in other disorders did not provide strong evidence to support the use of the product.
Danish: Data fra undersøgelserne af andre lidelser gav imidlertid ikke stærk evidens, der kunne understøtte brugen af produktet.
English: • There is no need for patients to stop treatment with modafinil immediately, but patients who wish to stop can do so at any time.
Danish: • Patienterne behøver ikke straks at stoppe behandlingen med modafinil, men patienter, som ønsker at stoppe, kan til enhver tid gøre dette.
English: Modafinil is used to promote wakefulness (help people stay awake).
Danish: Modafinil bruges til at fremme vågenhed (hjælpe mennesker med at holde sig vågne).
English: Which data has the CHMP reviewed?
Danish: Hvilke data har CHMP vurderet?
English: Excessive sleepiness can also happen with no known causes (idiopathic hypersomnia).
Danish: Overdreven søvnighed kan også forekomme uden nogen kendte årsager (idiopatisk hypersomni).
English: The European Medicines Agency has completed a review of the safety and effectiveness of modafinil.
Danish: Det Europæiske Lægemiddelagentur (EMA) har afsluttet en vurdering af sikkerheden og virkningen af modafinil.
English: What are the conclusions of the CHMP?
Danish: Hvad er CHMP's konklusioner?
English: They are available under the following invented names: Modasomil, Modiodal, Provigil and Vigil, and as generic medicines.
Danish: De fås under følgende særnavne: Modasomil, Modiodal, Provigil og Vigil, og som generiske lægemidler.
English: This led to an update of the product information for modafinil-containing medicines across Europe to strengthen the warnings about these risks.
Danish: Dette førte til en opdatering af produktinformationen for lægemidler indeholdende modafinil i hele Europa for at styrke advarslerne om disse risici.