FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Ervebo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ervebo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Ervebo is given by a trained healthcare worker.
Danish: Ervebo indgives af en sundhedsperson.
English: What information is still awaited for Ervebo?
Danish: Hvilke oplysninger afventes der stadig for Ervebo?
English: A main study showed that Ervebo was effective in preventing Ebola virus disease in adults at risk of infection during an outbreak.
Danish: Et hovedstudie viste, at Ervebo var effektivt til at forebygge ebolavirussygdom hos voksne med risiko for infektion under et udbrud.
English: Later, when the person comes into contact with the actual virus, the immune system recognises the virus protein and is already prepared to attack the virus and so protects the person from Ebola virus disease.
Danish: Når personen senere kommer i kontakt med det egentlige virus, genkender immunsystemet virusproteinet og er allerede klar til at angribe virusset, og beskytter dermed personen mod ebolavirussygdommen.
English: Side effects reported with Ervebo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ervebo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: When a person receives the vaccine, it triggers an immune response against the virus protein.
Danish: Når en person får vaccinen, udløser det en immunrespons mod virusproteinet.
English: Ervebo must not be used in people who are hypersensitive (allergic) to rice or to any ingredients of the vaccines.
Danish: Ervebo må ikke anvendes til personer, som er overfølsomme (allergiske) over for ris eller et eller flere af indholdsstofferne i vaccinerne.
English: The vaccine only contains one protein from Zaire Ebola virus and cannot cause the disease.
Danish: Vaccinen indeholder kun et protein fra Zaire-ebolavirus og kan ikke forårsage sygdommen.
English: For the full list of side effects and restrictions of Ervebo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ervebo fremgår af indlægssedlen.
English: The study was conducted in Guinea during an Ebola outbreak and involved people who were either direct contacts or contacts of contacts of someone who had Ebola virus disease.
Danish: Studiet blev gennemført i Guinea under et ebolaudbrud og omfattede personer, der enten var i direkte kontakt med en person med ebolavirussygdom eller i kontakt med en person, der havde været i kontakt med en person med ebolavirussygdom.
English: Ervebo is effective in protecting adults from Ebola virus disease; however, the duration of this protection is currently unknown.
Danish: Ervebo er effektivt til at beskytte voksne mod ebolavirussygdom, men beskyttelsens varighed kendes stadig ikke.
English: Healthcare workers and other carers who have been vaccinated with Ervebo should also continue to apply standard precautions for safe injection and hygiene and wear personal protective equipment when caring for patients with known or suspected Ebola virus disease.
Danish: Sundhedspersoner og andet plejepersonale, der er blevet vaccineret med Ervebo, bør også fortsat træffe almindelige forholdsregler mht. sikker injektion og hygiejne og anvende personlige værnemidler, når de er i kontakt med patienter med bekræftet eller formodet ebolavirussygdom.
English: The active substance in Ervebo contains a protein found on the Ebola Zaire virus.
Danish: Det aktive stof i Ervebo indeholder et protein, der findes på Zaire-ebolavirusset.
English: Ervebo contains a virus known as vesicular stomatitis virus which has been weakened and modified to contain a protein from the Zaire Ebola virus.
Danish: Ervebo indeholder et virus, der kaldes vesikulær stomatitisvirus, som er blevet svækket og ændret til at indeholde et protein fra Zaire-ebolavirussen.
English: Ervebo is a vaccine to protect adults aged 18 years and older against Ebola virus disease caused by the Zaire Ebola virus.
Danish: Ervebo er en vaccine til beskyttelse af voksne i alderen 18 år og opefter mod ebolavirussygdom forårsaget af Zaire-ebolavirussen.
English: People vaccinated with Ervebo should continue to take precautions to protect themselves from Ebola virus disease.
Danish: Personer, der er vaccineret med Ervebo, bør fortsat træffe forholdsregler for at beskytte sig mod ebolavirussygdom.
English: Ervebo should be used in individuals at risk of infection with Ebola virus.
Danish: Ervebo bør anvendes til personer, der har risiko for at blive smittet med ebolavirus.
English: Amongst the 2,108 people who received immediate vaccination, none had Ebola virus disease between 10 days and 31 days after vaccination; amongst those whose vaccination was delayed (1429 people), 10 developed the disease within 31 days after vaccination.
Danish: Blandt dem, som blev vaccineret senere (1.429 personer), udviklede 10 sygdommen inden for 31 dage efter vaccinationen.
English: How is Ervebo used?
Danish: Hvordan anvendes Ervebo?
English: How does Ervebo work?
Danish: Hvordan virker Ervebo?
English: Side effects with Ervebo were similar to those of most vaccines; they were mild to moderate in intensity and generally lasted less than a week.
Danish: De var milde til moderate i intensitet og varede generelt i mindre end en uge.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ervebo 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 Ervebo.
English: What benefits of Ervebo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ervebo?
English: This helps to protect against the disease.
Danish: Derved bliver man bedre beskyttet mod sygdommen.
English: These usually disappear within one to two days without treatment.
Danish: Disse bivirkninger svinder uden behandling i løbet af en til to dage.
English: It contains a flu strain called A/Viet Nam/1194/2004 (H5N1).
Danish: Vaccinen indeholder en influenzastamme, der kaldes A/Viet Nam/1194/2004 (H5N1).
English: The European Commission granted a marketing authorisation valid throughout the EU for Daronrix to GlaxoSmithKline Biologicals s.a. on 21 March 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Daronrix til GlaxoSmithKline Biologicals s.a. den 21. marts 2007.
English: Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur (EMEA) vil gennemgå alle nye oplysninger, der måtte blive til rådighed, og vil ajourføre dette sammendrag, når der bliver behov for det.
English: The virus is whole, but it has been inactivated (killed) so that it does not cause disease.
Danish: Viruset er helt, men det er blevet inaktiveret (dræbt), så det ikke er sygdomsfremkaldende.
English: The effects of Daronrix were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Daronrix blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It is given by injection into the upper arm muscle.
Danish: Den gives ved injektion i overarmsmusklen.
English: If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Danish: Hvis en pandemi er brudt ud, kan det dog alligevel være hensigtsmæssigt at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed.
English: A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: Udbrud af en influenzapandemi forekommer, når der opstår en ny type (stamme) af et influenzavirus, der let smitter fra menneske til menneske, fordi mennesker er uden immunitet (beskyttelse) mod den. En pandemi kan berøre de fleste lande og regioner verden over.
English: According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastlagt af Udvalget for Humanmedicinske Lægemidler (CHMP), skal en modelvaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af de vaccinerede for at kunne anses for egnet.
English: 21 days after the second injection, 70.8% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Danish: 21 dage efter den anden injektion havde 70,8 % af de vaccinerede personer en mængde antistof, der ville beskytte dem mod H5N1.
English: This summary was last updated in 03-2007.©EMEA 2007
Danish: Dette sammendrag blev sidst ajourført i 03-2007.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Danish: Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det møder samme virus igen.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DARONRIX EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) DARONRIX EPAR - sammendrag for offentligheden
English: Daronrix is a vaccine that can only be used once a flu ‘pandemic' has been officially declared by the World Health Organization (WHO) or European Union (EU).
Danish: Daronrix er en vaccine, der kun må bruges, når udbrud af en pandemi officielt er erklæret af Verdenssundhedsorganisationen (WHO) eller af Den Europæiske Union (EU).
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the patients' blood before vaccination, on the day of the second injection (day 21), and 21 days later (day 42).
Danish: Behandlingens virkning blev hovedsagelig bedømt ved mængden af antistoffer mod influenzavirus i patienternes blod dels før vaccinationen, dels på dagen for den anden injektion (dag 21) og dels 21 dage senere (dag 42).
English: This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Danish: Det vil sige, at eftersom man ikke kender den influenzavirusstamme, der eventuelt vil forårsage en pandemi, har det ikke været muligt at skaffe fuldstændige oplysninger om den fremtidige vaccine til brug mod pandemien.
English: Daronrix has been authorised under “Exceptional Circumstances”.
Danish: Daronrix er godkendt under "særlige omstændigheder".
English: Daronrix contains small amounts of a virus called H5N1.
Danish: Daronrix indeholder små mængder af viruset H5N1.
English: The committee recommended that Daronrix be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Daronrix.
English: Daronrix would be given according to official recommendations.
Danish: Daronrix vil da blive udleveret i henhold til officielle anbefalinger.
English: Daronrix is given in two doses, at least three weeks apart.
Danish: Daronrix gives to gange med mindst tre ugers mellemrum.
English: They will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Danish: Firmaet indsamler da oplysninger om sikkerhed og virkning af den endelige vaccine, der skal bruges mod pandemien, og indsender oplysningerne til CHMP til vurdering.
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Danish: I stedet kan firmaerne fremstille en vaccine, der indeholder en influenzavirusstamme, der specielt er valgt efter, at ingen har været udsat for smitte med den, og ingen er immune.
English: Other information about Daronrix:
Danish: Andre oplysninger om Daronrix:
English: Daronrix should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein or gentamicin sulphate (an antibiotic).
Danish: Daronrix bør ikke gives til patienter, der har haft en anafylaktisk reaktion (en svær overfølsomhedsreaktion) over for nogle af vaccinens komponenter eller over for nogen af de sporstoffer, den indeholder, f.eks. æg, kyllingeprotein eller gentamicin sulfat (et antibiotikum).
English: This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Danish: Oplysningerne skal omfatte vaccinens bivirkninger og sikkerheden hos børn, gravide, meget syge patienter og personer med nedsat immunforsvar.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Danish: Vaccinen indeholder desuden et "adjuvans" (en aluminiumholdig forbindelse), der forstærker immunresponsen.
English: It is a suspension for injection that contains influenza (flu) viruses that have been inactivated (killed).
Danish: Det er en injektionsvæske, suspension, der indeholder influenzavirus, som er inaktiveret (dræbt).
English: The CHMP concluded that Daronrix's benefits outweighed its risks, and that it had shown its suitability as a mock-up vaccine in preparation for a pandemic flu outbreak.
Danish: CHMP konkluderede, at fordelene ved Daronrix opvejer risiciene, og at den er bevist at være velegnet som modelvaccine til forberedelse mod udbrud af en influenzapandemi.
English: The main study of Daronrix included 387 healthy adults and compared the ability of different doses of Daronrix, with or without the adjuvant, to trigger the production of antibodies (immunogenicity).
Danish: Hovedundersøgelsen af Daronrix omfattede 387 raske voksne personer og sammenlignede evnen af Daronrix i forskellige doser, med og uden adjuvans, til at fremkalde produktion af antistoffer (immunogenicitet).
English: The study showed that Daronrix containing 15 micrograms of haemagglutinin and the adjuvant produced an antibody response that satisfies these criteria.
Danish: Undersøgelsen viste, at Daronrix med 15 mikrogram hæmagglutinin og adjuvans bevirkede en antistofrespons, der opfylder disse kriterier.
English: The full EPAR for Daronrix can be found here.
Danish: Den fuldstændige EPAR om Daronrix findes her.
English: Daronrix is a vaccine.
Danish: Daronrix er en vaccine.
English: If Daronrix is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Danish: Hvis Daronrix bliver taget i anvendelse under en pandemi, skal det firma, der fremstiller vaccinen, løbende indsamle oplysninger om vaccinens sikkerhed, mens den bruges.
English: The most common side effects with Daronrix (seen in more than 1 in 10 people) are headache, pain and redness at the site of the injection, and fatigue (tiredness).
Danish: De hyppigste bivirkninger af Daronrix (som ses hos flere end 1 ud af 10 patienter) er hovedpine, smerte og rødme på injektionsstedet samt træthed.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Danish: Når man bliver vaccineret, opfatter immunsystemet de svækkede virus som "fremmede" og producerer antistoffer mod dem.
English: This is a special type of vaccine that can be developed to help with the management of a pandemic.
Danish: En modelvaccine er en særlig vaccinetype, der kan udvikles for at kontrollere en pandemi.
English: If a pandemic starts, the virus strain in Daronrix will be replaced by the strain causing the pandemic before the vaccine can be used.
Danish: Hvis pandemien bryder ud, skal virusstammen i Daronrix erstattes af den stamme, der er årsag til pandemien, før vaccinen kan bruges.
English: The participants received two injections of Daronrix, containing one of four different amounts of haemagglutinin (a protein found in flu viruses), with or without the adjuvant, 21 days apart.
Danish: Deltagerne fik med 21 dages mellemrum to injektioner af Daronrix, der indeholdt en af fire forskellige mængder hæmagglutinin (et protein, der findes i influenzavirus), med eller uden adjuvans.
English: What information is still awaited for Daronrix?
Danish: Hvilke oplysninger afventes der stadig for Daronrix?
English: Which measures are being taken to ensure the safe use of Daronrix?
Danish: Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Daronrix?
English: Why has Daronrix been approved?
Danish: Hvorfor blev Daronrix godkendt?
English: Daronrix is a ‘mock-up' vaccine.
Danish: Daronrix er en "modelvaccine".
English: For the full list of all side effects reported with Daronrix, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Daronrix fremgår af indlægssedlen.
English: What is the risk associated with Daronrix?
Danish: Hvilken risiko er der forbundet med Daronrix?
English: They can test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included.
Danish: Derved bliver det muligt at forudsige, hvordan mennesker vil reagere på vaccine indeholdende den influenzastamme, der er årsag til en pandemi.
English: What is Daronrix?
Danish: Hvad er Daronrix?
English: If a pandemic is declared, and if the company that makes Daronrix decides to market the vaccine, they will include the flu strain responsible in the vaccine.
Danish: Hvis der udsendes en erklæring om, at der er udbrudt en pandemi, skal det firma, der fremstiller Daronrix, tilsætte den pågældende influenzastamme til vaccinen.
English: How has Daronrix been studied?
Danish: Hvordan blev Daronrix undersøgt?
English: What is Daronrix used for?
Danish: Hvad anvendes Daronrix til?
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance.
Danish: Før pandemien bryder ud, ved ingen, hvilken influenzavirusstamme der forårsager den.
English: How is Daronrix used?
Danish: Hvordan anvendes Daronrix?
English: What benefit has Daronrix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Daronrix?
English: How does Daronrix work?
Danish: Hvordan virker Daronrix?
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Danish: Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som skal implementeres af medlemslandet
English: NovoSeven has been approved in the European Union since 1996.
Danish: NovoSeven har været godkendt i Den Europæiske Union siden 1996.
English: What is NovoSeven?
Danish: Hvad er NovoSeven?
English: The Company submitted the results of three studies, involving a total of 486 patients.
Danish: Firmaet fremlagde resultaterne af tre undersøgelser med i alt 486 patienter.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NOVOSEVEN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for NOVOSEVEN
English: The application was at Day 157 when the Company withdrew it.
Danish: Ansøgningsproceduren var ved dag 157, da firmaet trak sin ansøgning tilbage.
English: The CHMP normally takes up to 90 days (with the possibility to extend it to another 90 days) to adopt an opinion after it has received an application for a change to a marketing authorisation.
Danish: CHMP er normalt indtil 90 dage (med mulighed for forlængelse med endnu 90 dage) om at vedtage en udtalelse, efter at det har modtaget en ansøgning om ændring af en markedsføringstilladelse.
English: Following CHMP opinion, it usually takes around 6 weeks to the European Commission to update the licence.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. seks uger om at ajourføre tilladelsen.
English: The letter from the Company notifying the EMEA of the withdrawal of the application is available here.
Danish: Skrivelsen fra firmaet, hvori EMEA underrettes om tilbagetrækningen af ansøgningen, kan ses her.
English: What documentation has been presented by the Company to support the application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt for at underbygge sin ansøgning til CHMP?
English: The data submitted show that NovoSeven has an effect on the volume of the haemorrhage, but it is not clear how this effect translates into a better outcome for the patient, especially at the dose selected for this indication.
Danish: De fremlagte data viser, at NovoSeven har en effekt på hæmorrhagiens størrelse, men det er ikke klart, hvordan denne effekt udmønter sig i et bedre resultat for patienten, især ved den dosis, der er valgt til denne indikation.
English: How is NovoSeven expected to work in this indication?
Danish: Hvordan forventes NovoSeven at virke til denne indikation?
English: International Non-proprietary Name (INN): eptacog alfa (activated)
Danish: Internationalt fællesnavn (INN): eptacog alfa (aktiveret)
English: What were the reasons given by the Company to withdraw the application?
Danish: Hvilke begrundelser gav firmaet for tilbagetrækningen af ansøgningen?
English: It increases the production of thrombin, another coagulation factor, on the surface of the particles that make up blood clots (the platelets), and this helps producing a stable ‘plug' at the site of bleeding.
Danish: Det stimulerer produktionen af trombin, en anden koagulationsfaktor, på overfladen af de partikler, som udgør blodpropper (blodpladerne), og dette medvirker til at producere en stabil ‘prop' på blødningsstedet.
English: On 3 April 2006, Novo Nordisk A/S has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for NovoSeven, in the treatment of acute intracerebral haemorrhage (ICH) in adults for limiting haemorrhage growth and improving clinical outcome.
Danish: Den 3. april 2006 meddelte Novo Nordisk A/S officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at trække sin ansøgning tilbage om en ny indikation for NovoSeven til behandling af akut intracerebral hæmorrhagi (ICH) hos voksne for at reducere væksten i blodansamlingen og forbedre de kliniske resultater.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that NovoSeven could not be approved for the treatment of acute intracerebral haemorrhage.
Danish: På baggrund af gennemgangen af dataene og firmaets svar på CHMP's liste med spørgsmål på tidspunktet for tilbagetrækning af ansøgningen havde CHMP sine betænkeligheder og var af den foreløbige opfattelse, at NovoSeven ikke kunne godkendes til behandling af akut intracerebral hæmorrhagi.
English: There are no consequences for NovoSeven's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
Danish: Tilbagetrækningen har ingen konsekvenser for anvendelsen af NovoSeven til de indikationer, det allerede er godkendt til, og hvor der ikke er ændringer i kendte fordele og risici.
English: The main study was carried out in 399 patients (aged 66 on average), and compared the effectiveness of three dosages of NovoSeven to that of a placebo (dummy treatment).
Danish: Hovedundersøgelsen omfattede 399 patienter (med en gennemsnitsalder på 66), hvori effekten af tre doser NovoSeven blev sammenlignet med effekten af placebo (en uvirksomhed behandling).