FrancophonIA/ELRC3.0 huggingface dataset:
English: Individuals who develop vesicular rash after receiving the vaccine should cover the vesicles until they heal to minimize the risk of possible transmission of vaccine virus through open vesicles.
Danish: Personer, som udvikler vesikulært udslæt efter at have fået vaccinen, skal tildække vesiklerne, indtil de er helet for at minimere risikoen for mulig overførsel af vaccinevirus gennem åbne vesikler.
English: Vaccination with Ervebo does not eliminate the necessity of standard precautions when caring for patients with known or suspected Ebola disease.
Danish: Vaccination med Ervebo fjerner ikke nødvendigheden af standardforholdsregler ved pleje af patienter med kendt eller mistænkt ebola-sygdom.
English: Immune globulin (IG), blood or plasma transfusions should not be given concomitantly with Ervebo.
Danish: Der må ikke gives blod- eller plasmatransfusioner med immunglobulin (IG) samtidig med Ervebo.
English: CI = Confidence interval; GMT = Geometric mean titer; PRNT = Plaque Reduction Neutralization Test *Protocol 011 from Month 9-12
Danish: CI = Konfidensinterval; GMT = Geometrisk middeltiter; PRNT = Neutraliserende plaquereduktionsprøve *Protokol 011 fra måned 9-12
English: When in close contact (within 1 metre) of patients with Ebola Virus Disease, healthcare workers should wear face protection (a face shield or a medical mask and goggles), a clean, non-sterile long-sleeved gown, and gloves (sterile gloves for some procedures).
Danish: Sundhedspersonale, der er i tæt kontakt (inden for 1 meter) med patienter med ebola-virussygdom, skal anvende ansigtsværn (ansigtsvisir eller en medicinsk ansigtsmaske og beskyttelsesbriller), en ren, ikke-steril langærmet kittel og handsker (sterile handsker ved nogle indgreb).
English: Over 93.8% of vaccine recipients met seroresponse criteria defined as a ≥2-fold increase from baseline and ≥200 EU/mL at any time post-vaccination by GPELISA and over 80.4% of subjects met seroresponse criteria defined as a ≥4-fold increase from baseline at any time post-vaccination by PRNT.
Danish: Over 93,8% af vaccinemodtagerne opfyldte kriterierne for serorespons, defineret som en stigning på ≥ 2 gange i forhold til baseline og ≥ 200 EU/ml på et vilkårligt tidspunkt efter vaccinationen ved GP-ELISA og over 80,4% af forsøgspersonerne opfyldte kriterierne for serorespons defineret som en stigning på ≥ 4 gange i forhold til baseline på et vilkårligt tidspunkt efter vaccinationen ved PRNT.
English: Tell your healthcare worker if you get any of the side effects listed above.
Danish: Kontakt sundhedspersonalet, hvis du får en eller flere af ovenstående bivirkninger.
English: In 6 out of 18 subjects tested, the vaccine virus was detected in rashes (described as dermatitis, vesicles or cutaneous vasculitis lesions) suggesting a virally mediated process post-vaccination.
Danish: Hos 6 uf af 18 testede forsøgspersoner blev der fundet vaccinevirus i udslæt (beskrevet som dermatitis, vesikler eller kutane vaskulitis læsioner), hvilket tyder på en virusmedieret proces efter vaccination.
English: Protocol 012 was a Phase 3 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of three consistency lots and a high dose lot (approximately five times higher than the dose in consistency lots and dose used in other Phase 2/3 trials) of Ervebo compared to normal saline placebo.
Danish: Protokol 012 var et randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie, der vurderede sikkerheden og immunogeniciteten af tre consistency lots og et højdosis-lot (ca. fem gange højere end dosis i consistency lots og den dosis, der anvendtes i andre fase 2/3-studier) af Ervebo sammenlignet med placebo i form af normal saltvandsopløsning.
English: As a precautionary measure, it is preferable to avoid the use of Ervebo in individuals with known immunocompromised conditions or receiving immunosuppressive therapy, including the following conditions:
Danish: Som en sikkerhedsforanstaltning anbefales det at undgå brugen af Ervebo hos personer med sygdomme, der vides at svække immunsystemet, eller hos personer i immunsuppressiv behandling, herunder følgende:
English: In this trial, 8,673 adult subjects were enrolled and 8,651 with valid consents randomized to immediate (within 7 days of enrolment) or deferred (18 to 24 weeks after enrolment) vaccination with Ervebo.
Danish: I dette studie blev 8.673 voksne forsøgspersoner inkluderet, og 8.651 med validt samtykke blev randomiseret til øjeblikkelig (inden for 7 dage efter inklusion) eller udskudt (1824 uger efter inklusion) vaccination med Ervebo.
English: • Ervebo is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Danish: • Ervebo opbevares nedfrosset ved -80 °C til -60 °C og skal tages ud af fryseren og optøs i mindre end 4 timer, indtil der ikke er synlig is.
English: Transmission of vaccine virus through close personal contact is accepted as a theoretical possibility.
Danish: Overførsel af vaccinevirus ved tæt personkontakt anses for at være en teoretisk mulighed.
English: This is because you could pass the vaccine to them through your body fluids.
Danish: Dette skyldes, at du kan overføre vaccinen til dem gennem dine kropsvæsker.
English: • Pain, swelling, or redness at the injection site.
Danish: • Smerter, hævelse eller rødme på injektionsstedet.
English: • Use of PPE (to block splashes or other contact with infected materials)
Danish: • Anvendelse af personligt beskyttelsesudstyr (til beskyttelse mod stænk/sprøjt eller anden kontakt med inficeret materiale)
English: • Use soap and water when hands are soiled with dirt, blood, or other body fluids.
Danish: • Brug sæbe og vand, når hænderne er synligt beskidte med jord, blod eller andre kropsvæsker.
English: One dose (1 mL): Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live attenuated) ≥72 million pfu
Danish: En dosis (1 ml): Ebola-Zaire-vaccine (rVSVΔG-ZEBOV-GP, levende, svækket) ≥ 72 millioner pfu
English: • someone who has a weak immune system.
Danish: • en person, der har et svagt immunsystem.
English: 30938 Burgwedel Germany
Danish: 30938 Burgwedel Tyskland
English: • Ervebo is a colourless to slightly brownish-yellow liquid.
Danish: • Ervebo er en farveløs til let brungul væske.
English: Rash was characterized in a variety of ways including generalized rash (2.3%), vesicular rash (0.5%), dermatitis (0.3%), or cutaneous vasculitis (0.01%) in clinical trials.
Danish: Udslæt blev beskrevet på en række forskellige måder, herunder generaliseret udslæt (2,3%), vesikulært udslæt (0,5%), dermatitis (0,3%) eller kutan vaskulitis (0,01%) i kliniske studier.
English: What you need to know before you receive Ervebo
Danish: Det skal du vide, før du får Ervebo
English: No studies on the effects of Ervebo on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af Ervebos virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: The most common injection-site adverse reactions were injection-site pain (70.3%), swelling (16.7%) and erythema (13.7%).
Danish: De hyppigste bivirkninger på injektionsstedet var smerter (70,3%), hævelse (16,7%) og erytem (13,7%).
English: Healthcare workers caring for patients with suspected or confirmed Ebola virus should apply extra infection control measures to prevent contact with the patient's blood and body fluids and contaminated surfaces or materials such as clothing and bedding.
Danish: Sundhedspersonale, der plejer patienter med mistænkt eller bekræftet ebolavirus, skal anvende ekstra foranstaltninger til infektionsbekæmpelse for at undgå kontakt med patientens blod og kropsvæsker samt kontaminerede overflader eller kontamineret materiale såsom tøj eller sengetøj.
English: The Full Analysis Set population was the primary population for the immunogenicity analyses in Protocols 009 and 011 and consists of all vaccinated subjects with serology data and had a serum sample collected within an acceptable day range.
Danish: Fuldt analysesæt-populationen var den primære population til immunogenicitetsanalyserne i protokol 009 og 011 og består af alle vaccinerede forsøgspersoner med serologiske data, som fik udtaget en serumprøve inden for et acceptabelt tidsrum.
English: • The vaccine is stored frozen at -80°C to -60°C and should be removed from the freezer and thawed in less than 4 hours until no visible ice is present.
Danish: • Vaccinen opbevares nedfrosset ved -80 °C til -60 °C og skal tages ud af fryseren og optøs i mindre end 4 timer, indtil der ikke er synlig is.
English: Close monitoring is recommended following vaccination for the early signs of anaphylaxis or anaphylactoid reactions.
Danish: Efter vaccinationen anbefales grundig overvågning for tidlige tegn på anafylaksi eller anafylaktoide reaktioner.
English: Animal studies in female rats do not indicate harmful effects (see section 5.3).
Danish: Dyreforsøg med hunrotter indikerer ikke skadelige virkninger (se pkt.
English: Protocol 009 Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) was a Phase 2 randomized, double-blind, placebo-controlled trial which evaluated the safety and immunogenicity of Ebola vaccine candidates including Ervebo.
Danish: Protokol 009, Partnership for Research on Ebola Vaccines in Liberia (PREVAIL), var et randomiseret, dobbeltblindet, placebokontrolleret fase 2-studie, der vurderede sikkerheden og immunogeniciteten af ebola-vaccinekandidater, herunder Ervebo.
English: Have a weak immune system
Danish: Har et svækket immunsystem
English: Vaccine administrators should counsel vaccinees to continue to protect themselves with the following measures:
Danish: Den person, der giver vaccinen, skal råde vaccinemodtagerne til fortsat at beskytte sig med følgende forholdsregler:
English: Anaphylaxis was reported very rarely (0.006%) in clinical trials.
Danish: Anafylaksi blev rapporteret med hyppigheden “Meget sjælden” (0,006%) i kliniske studier.
English: Dispose of contaminated bandages following institutional guidelines or WHO healthcare waste management policy.
Danish: De kontaminerede bandager skal bortskaffes i henhold til institutionens retningslinjer eller WHO's politik for håndtering af medicinsk affald.
English: Ervebo administered to female rats had no effects on development or behaviour of the offspring.
Danish: Ervebo givet til hunrotter viste ingen indvirkning på udviklingen eller adfærden hos afkommet.
English: Of those 9,096 subjects, 4,160 received Ervebo (2,119 subjects were vaccinated in the immediate arm and 2,041 subjects were vaccinated in the delayed arm).
Danish: Af disse 9.096 forsøgspersoner fik 4.160 Ervebo (2.119 forsøgspersoner blev vaccineret i armen med øjeblikkelig vaccination, og 2.041 forsøgspersoner blev vaccineret i armen med forsinket vaccination).
English: Do not receive Ervebo if you:
Danish: Du må ikke få Ervebo, hvis du
English: Ervebo should be administered by a trained healthcare worker.
Danish: Ervebo skal administreres af en sundhedsperson, der er oplært heri.
English: This is because of a possibility that you could pass on the virus in the vaccine to the animals.
Danish: Dette skyldes, at der er en risiko for, at du kan overføre vaccinevirus til husdyr.
English: Ervebo administered to female rats had no effects on mating performance, fertility, or embryonic/foetal development.
Danish: Ervebo givet til hunrotter viste ingen indvirkning på parring, fertilitet eller den embryonale/føtale udvikling.
English: The Per-Protocol Immunogenicity Population was the primary population for the immunogenicity analyses in Protocol 012 and includes all subjects who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample at one or more timepoints collected within an acceptable day range.
Danish: Per-protokol-immunogenicitetspopulationen var den primære population til immunogenicitetsanalyserne i protokol 012 og inkluderer alle forsøgspersoner, som overholdt protokollen, blev vaccineret, var seronegative på dag 1, og som fik udtaget en serumprøve på et eller flere tidspunkter inden for et acceptabelt tidsrum.
English: Transmission
Danish: Overførsel
English: Protocol 011 named Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a Phase 2/3 randomized open-label trial which evaluated safety and immunogenicity of Ervebo in adults ≥18 years of age working in healthcare facilities or on frontline activities related to the Ebola response in Sierra Leone.
Danish: Protokol 011 med titlen Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) var et randomiseret, åbent fase 2/3-studie, der vurderede Ervebos sikkerhed og immunogenicitet hos voksne ≥ 18 år, der arbejdede i sundhedsfaciliteter eller med frontlinjeaktiviteter relateret til ebola-responsen i Sierra Leone.
English: In clinical trials with reports of arthritis, the median onsets were between 10 and 12 days (range from 0 to 25 days).
Danish: I kliniske studier med rapportering om artritis var median indtræden mellem 10 og 12 dage (interval: fra 0 til 25 dage).
English: The MAH should develop and introduce an active substance in-process control for total protein with appropriate acceptance.
Danish: Indehaveren af markedsføringstilladelsen skal udvikle og introducere en inprocess kontrol for lægemiddelstoffet for totalprotein med passende acceptkriterier.
English: The safety, immunogenicity and efficacy of Ervebo in children aged 1 to 17 years have not yet been established (see sections 4.8 and 5.1).
Danish: Ervebos sikkerhed, immunogenicitet og virkning hos børn i alderen 1-17 år er endnu ikke klarlagt (se pkt.
English: Plan to donate blood • Do not donate blood for at least 6 weeks after you receive this vaccine.
Danish: Planlægger at donere blod • Du må ikke donere blod i mindst 6 uger efter at have fået denne vaccine.
English: • Ervebo should not be mixed in the same syringe with any other vaccines or medicinal products.
Danish: • Ervebo må ikke blandes med andre vacciner eller lægemidler i samme sprøjte.
English: Protocol 012 Combined Consistency Lots Group
Danish: Combined Consistency Lotsgruppen
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: What Ervebo contains
Danish: Ervebo indeholder:
English: A decision must be made whether to discontinue breast-feeding or to abstain from Ervebo taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Ervebo skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Have a bleeding disorder or bruise easily
Danish: Har en blødningssygdom eller let får blå mærker
English: In this trial, 9,096 subjects ≥18 years of age who were considered CCCs of an index case with laboratory-confirmed EVD were randomized to immediate (4,539 subjects in 51 clusters) or 21 days delayed (4,557 subjects in 47 clusters) vaccination with Ervebo.
Danish: I dette studie blev 9.096 forsøgspersoner ≥ 18 år, som blev betragtet som kontakter og kontakter til kontakter til et indekstilfælde med laboratoriebekræftet EVD, randomiseret til øjeblikkelig vaccination (4.539 forsøgspersoner i 51 klynger) eller vaccination med 21 dages forsinkelse (4.557 forsøgspersoner i 47 klynger) med Ervebo.
English: If you get any side effects, talk to your healthcare worker.
Danish: Hvis du oplever bivirkninger, bør du tale med sundhedspersonalet.
English: Transmission of vaccine virus through close contact with livestock is accepted as a theoretical possibility.
Danish: Overførsel af vaccinevirus ved tæt kontakt med husdyr anses for at være en teoretisk mulighed.
English: Discard the vaccine if particulates are present.
Danish: Kassér vaccinen, hvis den indeholder partikler.
English: Arthralgia was generally reported in the first few days following vaccination, was mild to moderate in intensity, and resolved within one week after onset.
Danish: Artralgi blev generelt rapporteret i de første par dage efter vaccinationen, var let til moderat i sværhedsgrad og gik over inden for 1 uge efter indtræden.
English: • Pregnant or breast-feeding women (see section 4.6),
Danish: • Gravide eller ammende kvinder (se pkt.
English: In different trials, rash was reported with median onsets of 7.5 to 10.5 days (range from 0 to 47 days).
Danish: I andre studier blev udslæt rapporteret med median indtræden på 7,5 til 10,5 dage (interval: fra 0 til 47 dage).
English: The MAH should provide additional qualification data for the critical reagent used in the identity test (quality control release test for AS and FP).
Danish: Indehaveren af markedsføringstilladelsen skal tilvejebringe yderligere kvalifikationsdata for det kritiske reagensmiddel, der anvendes i identitetstesten (QC frigivelsestest for lægemiddelstoffet og færdigvaren).
English: Additional side effects in children and adolescents The vaccine has been studied in a small number of children and adolescents who were 6 to 17 years of age.
Danish: Vaccinen er blevet undersøgt hos et mindre antal børn og unge i alderen 6-17 år.
English: Immunization of subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus Disease (EVD).
Danish: Immunisering af personer med vaccinen medfører immunrespons og beskyttelse mod Zaire-ebolavirussygdom (EVD).
English: Vaccine administrators should counsel vaccinees to continue to protect themselves with adequate measures.
Danish: Den person, der giver vaccinen, skal råde vaccinemodtagerne til fortsat at beskytte sig med passende forholdsregler.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ.
English: • Store and transport frozen at -80°C to -60°C.
Danish: • Opbevares og transporteres nedfrosset ved -80 °C til -60 °C.
English: • Ervebo should be administered intramuscularly.
Danish: • Ervebo skal administreres intramuskulært.
English: Upon removal from the freezer, the product should be marked with both the date that it was taken out of the freezer and also a new discard date (in place of the labelled expiry date).
Danish: Når vaccinen tages ud af fryseren, skal den både markeres med datoen for, hvornår den er taget ud af fryseren og også en ny kasseringsdato (i stedet for den påtrykte udløbsdato).
English: The MAH should complete master cell banks (MCB)/working cell bank (WCB) qualification to include also tests for specified viruses.
Danish: Indehaveren af markedsføringstilladelsen skal udfylde MCB/WCBkvalificeringen, således at den også indeholder tests for specificerede vira.
English: Protocol 010 (Ring vaccination study) was a Phase 3 open-label cluster-randomized trial of ring vaccination (vaccinating contacts and contacts of contacts [CCCs] of index Ebola cases) which evaluated efficacy and safety of Ervebo in Guinea.
Danish: Protokol 010 (studie med ringvaccination) var et åbent, randomiseret fase 3-klyngestudie med ringvaccination (vaccination af kontakter og kontakter til kontakter til indekstilfælde af ebola), der vurderede Ervebos virkning og sikkerhed i Guinea.
English: This product contains GMO.
Danish: Dette produkt indeholder GMO.
English: SOLUTION FOR INJECTION IN VIAL - PACK OF 10
Danish: INJEKTIONSVÆSKE, OPLØSNING I HÆTTEGLAS - PAKNING MED 10
English: The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
Danish: Vaccinen må ikke blandes med andre vacciner eller lægemidler i samme sprøjte.
English: • generalized itching, redness, flushing or itchy bumps on the skin.
Danish: • udbredt kløe, rødmen, blussen eller kløende knopper på huden.
English: • Withdraw the entire content of the vaccine from the vial using a sterile needle and syringe.
Danish: • Træk hele indholdet af vaccinen op af hætteglasset med en steril kanyle og sprøjte.
English: • Upon removal from the freezer, the product should be marked with both the date that it was taken out of the freezer and also a new discard date (in place of the labelled expiry date).
Danish: • Når vaccinen tages ud af fryseren, skal den både markeres med datoen for, hvornår den er taget ud af fryseren og også en ny kasseringsdato (i stedet for den påtrykte udløbsdato).
English: Summary of Geometric Mean Titers for the GP-ELISA from Protocols 009, 011 and 012 Clinical Trials
Danish: Oversigt over geometriske middeltitre for GP-ELISA fra protokol 009, 011 og 012 kliniske studier
English: However, as a precaution, vaccinees should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical risk of spread of the vaccine virus.
Danish: For en sikkerheds skyld bør vaccinerede personer dog forsøge at undgå at husdyr eksponeres for blod og kropsvæsker i mindst 6 uger efter vaccinationen for at undgå den teoretiske risiko for spredning af vaccinevirus.
English: • Ervebo is given to protect you from getting Ebola virus disease caused by the Zaire Ebola virus,
Danish: • Ervebo gives for at beskytte dig mod ebola forårsaget af Zaire-ebolavirus, som er en type ebolavirus.
English: Store and transport frozen at -80°C to -60°C.
Danish: Opbevares og transporteres nedfrosset ved -80 °C til -60 °C.
English: • Fever,
Danish: • Feber
English: Ervebo should be administered by the intramuscular (IM) route.
Danish: Ervebo skal administreres intramuskulært (i.m.).
English: • Contact with bats, apes and monkeys or with blood, fluids and raw meat prepared from these animals (bushmeat) or meat from an unknown source.
Danish: • Kontakt med flagermus og menneskeaber og aber eller blod, væsker og råt kød tilberedt fra disse dyr (”bushmeat”) eller kød fra en ukendt kilde.
English: Ask your healthcare worker how to throw away medicines you no longer use.
Danish: • Spørg sundhedspersonalet, hvordan du skal bortskaffe medicinrester.
English: Vaccine virus might be present in biological fluids such as blood, urine, saliva, semen, vaginal fluids, aqueous humor, breast milk, faeces, sweat, amniotic fluid, and placenta.
Danish: Vaccinevirus kan forekomme i biologiske væsker såsom blod, urin, spyt, sæd, vaginalvæsker, kammervæske, brystmælk, fæces, sved, fostervand og placenta.
English: Baseline seropositivity, gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers, and other factors may impact the immune response to vaccine, which results in a higher immune response in Protocol 012.
Danish: Seropositivitet ved baseline, gammabestråling af prøver for at reducere risikoen for vildtype ebolavirusinfektion hos laboratoriepersonale, og andre faktorer kan påvirke immunresponset på vaccinen,
English: A progress report has to be included in the annual renewal application.
Danish: Den årlige ansøgning om fornyelse af markedsføringstilladelsen skal indeholde en statusrapport.
English: Abdominal pain Nausea
Danish: Abdominalsmerter Kvalme
English: • Safe burial practices
Danish: • Sikker begravelsespraksis
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Ervebo på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: • You can catch Ebola from blood and body fluids like urine, stools, saliva, vomit, sweat, breast milk, semen and vaginal fluids of people who are infected with Ebola virus.
Danish: • Du kan få ebola fra blod eller kropsvæsker såsom urin, afføring, spyt, opkast, sved, brystmælk og sæd og vaginalvæsker fra personer, som er inficerede med ebola-virus.
English: Arthritis
Danish: Artritis
English: As a precautionary measure, it is preferable to avoid the use of Ervebo during pregnancy.
Danish: For en sikkerheds skyld bør Ervebo undgås under graviditeten.