FrancophonIA/ELRC3.0 huggingface dataset:
English: Instructions on the handling of the vaccine before administration
Danish: Instruktioner vedrørende håndtering af vaccinen før administration
English: This exemption is subject to annual review and in any case ceases to be valid on 31 July 2022.
Danish: Denne dispensation er underlagt en årlig vurdering og ophører under alle omstændigheder 31. juli 2022.
English: While in an area affected by Ebola, it is important to avoid the following:
Danish: Ved ophold i et område, der er berørt af ebola, er det vigtigt at undgå følgende:
English: Frequencies are reported as:
Danish: Hyppigheder rapporteres som:
English: One dose (1 mL) contains:
Danish: En dosis (1 ml) indeholder:
English: Laboratory workers are also at risk.
Danish: Laboratoriepersonale er også i risikogruppen.
English: • Safe sex
Danish: • Sikker sex
English: Have had allergic reactions to vaccines or medicines
Danish: Har haft allergiske reaktioner over for vacciner eller lægemidler
English: If you plan to receive blood or blood products
Danish: Hvis du planlægger at få blod eller blodprodukter
English: • Ebola is not spread through the air, water or food.
Danish: • Ebola spredes ikke via luft, vand eller mad.
English: Uncertainties remain as to the level, duration and type of protection given the methodological limitations and the exceptional circumstances experienced during the trial.
Danish: Der er stadig usikkerhed omkring niveauet, varigheden og typen af beskyttelse i betragtning af de metodologiske begrænsninger og de usædvanlige omstændigheder, der blev oplevet under studiet.
English: • you have HIV infection or AIDS,
Danish: • du har hiv eller aids.
English: Your healthcare worker might need to do another test.
Danish: Sundhedspersonalet skal måske udføre en anden test.
English: Have a fever (high temperature)
Danish: Har feber (forhøjet temperatur)
English: As there are limitations to available data, including the small number of cases, caution should be exercised in drawing conclusions.
Danish: Eftersom der er begrænsninger i de foreliggende data, herunder det lave antal tilfælde, skal der udvises forsigtighed med at drage konklusioner.
English: This does not mean that you have Ebola.
Danish: Det betyder ikke, at du har ebola.
English: Joint pain and swelling may last for weeks or months in some people.
Danish: Ledsmerter og -hævelse kan vare i uger eller måneder hos nogle personer.
English: • Ebola is a serious disease caused by a virus.
Danish: • Ebola er en alvorlig sygdom forårsaget af en virus.
English: Pregnancy should be avoided for 2 months following vaccination.
Danish: Graviditet bør undgås i 2 måneder efter vaccinationen.
English: pfu= plaque-forming units
Danish: pfu= plaquedannende enheder
English: Both may present compelling needs that should be considered before vaccination of the mother.
Danish: Begge kan have afgørende behov, som skal tages i betragtning før vaccination af moderen.
English: If you or your child is under 18 years old, talk to your healthcare worker.
Danish: Hvis du eller dit barn er under 18 år, skal du tale med sundhedspersonalet.
English: All subjects received a single dose of vaccine.
Danish: Alle forsøgspersoner fik en enkelt dosis af vaccinen.
English: The reasons for differences in arthritis reporting across trials are not known but may be due to differences in study populations or outcome reporting.
Danish: Årsagerne til forskelle i rapportering af artritis på tværs af studier kendes ikke, men kan skyldes forskelle i studiepopulationer eller rapportering af udfald.
English: The use of other Ebola control measures should therefore not be interrupted.
Danish: Derfor må anvendelsen af andre kontrolforanstaltninger for ebola ikke afbrydes.
English: You should not receive Ervebo if any of the above apply to you.
Danish: Du må ikke få Ervebo, hvis noget af ovenstående gælder for dig.
English: • Avoid contact with blood and body fluids
Danish: • Undgå kontakt med blod og kropsvæsker
English: 29 May 2020
Danish: 29. maj 2020
English: Impact to serological testing
Danish: Indvirkning på serologisk testning
English: Get medical care right away if you have symptoms of an allergic reaction, which may include:
Danish: Søg straks lægehjælp, hvis du får symptomer på en allergisk reaktion, som kan omfatte:
English: The clinical relevance of the immunogenicity data is currently not known.
Danish: Den kliniske relevans af immunogenicitetsdata er ikke kendt på nuværende tidspunkt.
English: No cases of overdose have been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering.
English: The use of Ervebo should be in accordance with official recommendations.
Danish: Ervebo skal anvendes i henhold til de officielle anbefalinger.
English: The vaccination may have to be delayed until your fever is gone.
Danish: Vaccinationen skal måske udskydes, indtil feberen er væk.
English: It is also not known if it can pass to your baby through your breast milk.
Danish: Det er også ukendt, om det kan overføres til dit barn via modermælken.
English: Lack of reliable data on background rates of pregnancy and neonatal outcomes in the affected regions also makes a contextual assessment of the data challenging.
Danish: Manglen på pålidelige data vedrørende baggrundsrater for graviditet og neonatale udfald i de berørte områder gør det også vanskeligt at foretage en kontekstuel vurdering af data.
English: You should follow safe sex practices until you know the virus is gone from the semen.
Danish: Du skal følge sikker sex-praksis, indtil du ved, at virussen er forsvundet fra sæden.
English: Vaccine virus RNA was mainly detected from Day 1 to Day 7.
Danish: Vaccinevirus-RNA blev hovedsageligt påvist fra dag 1 til dag 7.
English: • Ervebo is a vaccine for adults who are 18 years of age and older.
Danish: • Ervebo er en vaccine til voksne i alderen 18 år og derover.
English: There is no need to use antimicrobial soaps for washing hands.
Danish: Det er ikke nødvendigt at anvende antimikrobielle sæber ved håndvask.
English: • Do not become pregnant for 2 months after you receive Ervebo.
Danish: • Du må ikke blive gravid i 2 måneder efter at have fået Ervebo.
English: A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded.
Danish: En risiko for nyfødte/spædbørn, der ammes af vaccinerede mødre, kan ikke udelukkes.
English: No immune correlates of protection have been defined to date.
Danish: Ingen immunkorrelater for beskyttelse er hidtil defineret.
English: If you get Ebola, it can kill you.
Danish: Hvis du får ebola, kan du dø.
English: Do not receive this vaccine at the same time that you get blood or blood products.
Danish: Du må ikke få denne vaccine samtidig med, at du får blod eller blodprodukter.
English: This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of Ervebo in pregnant women, or women who became pregnant after receiving the vaccine.
Danish: Der er begrænsede data (mindre end 300 graviditetsudfald) fra anvendelse af Ervebo til gravide kvinder eller kvinder, som blev gravide efter de havde fået vaccinen.
English: Protocol 009
Danish: Protokol 009
English: Immunocompromised individuals
Danish: Immunkompromitterede personer
English: If your immune system is weak (which means your body is less able to fight off diseases), you might not be able to receive Ervebo.
Danish: Hvis dit immunsystem er svækket (hvilket betyder, at kroppen har sværere ved at bekæmpe sygdomme), kan du måske ikke få Ervebo.
English: The median durations reported were between 6 to 18 days.
Danish: Median varighed blev rapporteret til at være mellem 6 og 18 dage.
English: However, infectious virus was detected at Day 1 and persistent infectious virus was not detected at any subsequent timepoints measured (Days 56, 84 and 112).
Danish: Infektiøs virus blev dog påvist ved dag 1, og vedvarende infektiøs virus blev ikke påvist på noget efterfølgende målt tidspunkt (dag 56, 84 og 112).
English: A total of 1,197 healthy subjects 18 to 65 years of age were enrolled in the US, Canada, and Spain.
Danish: I alt blev 1.197 raske forsøgspersoner i alderen 1865 år inkluderet i USA, Canada og Spanien.
English: This vaccine contains a trace amount of rice protein.
Danish: Denne vaccine indeholder spor af risprotein.
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du vaccineres, da den indeholder vigtige oplysninger.
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); Ikke almindelig (≥ 1/1.000 til < 1/100); Sjælden (≥ 1/10.000 til < 1/1.000); Meget sjælden (< 1/10.000); Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your healthcare worker may recommend that you receive this vaccine in an emergency involving the spread of Ebola virus disease.
Danish: Sundhedspersonalet kan anbefale dig at få denne vaccine i en nødsituation, der involverer spredning af ebola.
English: High-risk individuals include:
Danish: Personer i højrisikogruppen omfatter:
English: The presence of a minor infection should not result in deferral of vaccination.
Danish: Tilstedeværelse af en mindre infektion bør ikke resultere i en udsættelse af vaccination.
English: Placebo Group
Danish: Placebogruppen
English: A CD4+ T-lymphocyte count threshold for use in asymptomatic HIV-positive individuals has not been established.
Danish: Der er ikke fastsat en tærskel for CD4+ T-lymfocyttal til brug hos asymptomatiske hiv-positive personer.
English: • Current immunosuppressive therapy, including high doses of corticosteroid.
Danish: • Aktuel immunsupprimerende behandling, herunder høje doser af kortikosteroid.
English: • Contact with semen from a man who had Ebola.
Danish: • Kontakt med sæd fra en mand, som har haft ebola.
English: Implementation of EU based batch control arrangements, including the necessary variations to the terms of the marketing authorisation, has to be completed by the 31 July 2022 at the latest, in line with the agreed plan for this transfer of testing.
Danish: Implementering af EU-baseret batchkontrol, herunder de nødvendige variationer til markedsføringstilladelsen, skal senest være afsluttet 31. juli 2022, hvilket er i overensstemmelse med den aftalte plan for overførsel af testningen.
English: No adverse events of infections were observed in Phase 1/2 trials.
Danish: Ingen bivirkninger involverende infektioner blev observeret i fase 1/2-studier.
English: In view of the declared Public Health Emergency of International Concern and in order to ensure early supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control testing conducted in the registered site(s) that are located in a third country.
Danish: Set i lyset af den deklarerede folkesundhedsmæssige krisesituation af international betydning og for at sikre hurtig levering er dette lægemiddel underlagt en tidsbegrænset dispensation, der gør det muligt at stole på batchkontroltestning udført på den/de registrerede lokation(er) i et tredieland.
English: Tell your healthcare worker that you have received Ervebo.
Danish: Fortæl sundhedspersonalet, at du har fået Ervebo.
English: Are in contact with farm animals
Danish: Er i kontakt med husdyr (landbrugsdyr)
English: It reduces the number of germs on the hands and so reduces their spread from person to person.
Danish: Det sænker antallet af smittekim på hænderne og begrænser risikoen for spredning fra person til person.
English: • are allergic to Ervebo, rice, or any of the other ingredients of this vaccine (listed in section 6).
Danish: • er allergisk over for Ervebo, ris eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: Continue to follow your healthcare worker's recommendations to protect yourself from Ebola infection after you get this vaccine.
Danish: Fortsæt med at følge sundhedspersonalets anbefalinger med hensyn til at beskytte dig selv imod ebolainfektion efter, at du har fået denne vaccine.
English: You might have a weak immune system if:
Danish: Du har måske et svækket immunsystem, hvis:
English: An ERA was conducted to determine the potential impact of this vaccine on human health and the environment.
Danish: Der blev udført en miljørisikovurdering for at fastslå den potentielle indvirkning af vaccinen på menneskers helbred og miljøet.
English: • Funeral or burial rituals that require handling the body of someone who died from Ebola.
Danish: • Deltagelse i begravelse eller begravelsesritualer, der kræver håndtering af liget af en person, som er død af ebola.
English: Washing your hands correctly is the most effective way to prevent the spread of dangerous germs, like Ebola virus.
Danish: Korrekt håndvask er den mest effektive måde at forhindre spredning af farlige smittekim såsom ebolavirus.
English: Although the clinical relevance of the GPELISA GMT as well as seroresponse is currently not known, based on available data it is expected that vaccine efficacy would apply to subjects from Guinea, Liberia, Sierra Leone, the United States, Canada, Europe, or other parts of the world.
Danish: Selvom den kliniske relevans af GP-ELISA GMT såvel som serorespons ikke er kendt på nuværende tidspunkt, kan det, på basis af foreliggende data, forventes at vaccinens virkning vil gælde for personer fra Guinea, Liberia, Sierra Leone, USA, Canada, Europa eller andre dele af verdenen.
English: To avoid unintended exposure to livestock, ensure medical waste and other cleaning materials do not come in contact with livestock.
Danish: For at undgå utilsigtet eksponering af husdyr må medicinsk affald og andre rengøringsmaterialer ikke komme i kontakt med husdyr.
English: If you do get the vaccine and have a weak immune system, the vaccine may not work as well as in people with a normal immune system.
Danish: Hvis du får vaccinen og har et svagt immunsystem, virker vaccinen måske ikke så godt som hos personer med et normalt immunsystem.
English: Vaccination of contacts of Ebola cases should occur as soon as possible (see section 5.1).
Danish: Vaccination af kontakter til ebolatilfælde skal ske så hurtigt som muligt (se pkt.
English: Do not thaw the vial in a refrigerator as it is not guaranteed that the vial will thaw in less than 4 hours.
Danish: Hætteglasset må ikke optøs i køleskab, da det ikke kan garanteres, at hætteglasset vil blive optøet på mindre end 4 timer.
English: There are no data on fertility effects in humans.
Danish: Der foreligger ingen data om indvirkningen på fertilitet hos mennesker.
English: • Do not use this vaccine if you notice particles in the liquid.
Danish: • Brug ikke vaccinen, hvis du bemærker partikler i væsken.
English: Therefore, diagnostic testing for Ebola should target non-GP sections of the Ebola virus.
Danish: Derfor skal den diagnostiske testning for ebola være rettet mod ikke-GP-sektioner af ebolavirusset.
English: In certain circumstances, where alternatives to breastfeeding are limited, the immediate need and health benefits to the infant should be taken into consideration and balanced with the mother's need for Ervebo.
Danish: I visse tilfælde, hvor der er begrænsede alternativer til amning, skal det øjeblikkelige behov og de sundhedsmæssige fordele for spædbarnet tages i betragtning og afbalanceres med moderens behov for Ervebo.
English: Protection against filovirus disease
Danish: Beskyttelse mod sygdom forårsaget af filovirus
English: People catch Ebola from people or animals who are infected with Ebola or who died from Ebola.
Danish: Personer får ebola fra andre personer eller dyr, som er inficerede med ebola, eller som er døde af ebola.
English: Testing for Ebola after you receive Ervebo
Danish: Testning for ebola efter du har fået Ervebo
English: Your healthcare worker will talk to you and then together you can decide if you should receive this vaccine.
Danish: Sundhedspersonalet vil tale med dig, og I kan herefter sammen beslutte, om du skal have vaccinen.
English: This trial compared Ervebo to normal saline placebo in 1,000 adults ≥18 years of age in Liberia.
Danish: Dette studie sammenlignede Ervebo med placebo i form af normal saltvandsopløsning hos 1.000 voksne ≥ 18 år i Liberia.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Danish: Som ved alle injicerbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: Nevertheless considering the severity of EVD, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.
Danish: I betragtning af alvorsgraden af EVD skal vaccination dog ikke tilbageholdes, når der er en klar risiko for eksponering for ebolainfektion.
English: No studies have looked at how other medicines or vaccines and Ervebo might interact with each other.
Danish: Ingen studier har undersøgt, hvordan anden medicin eller vacciner og Ervebo kan påvirke hinandens virkning.
English: It is given as a single injection (dose of 1 mL) in the top of your arm or the outside of your thigh.
Danish: Det gives som en enkelt injektion (dosis på 1 ml) i den øverste del af armen eller på ydersiden af låret.
English: Randomization was stopped after an interim analysis with a p=0.0036 that did not meet the prespecified alpha level of 0.0027.
Danish: Randomisering blev stoppet efter en interimanalyse med p=0,0036, som ikke nåede det præspecificerede alfaniveau på 0,0027.
English: Ervebo might not work as well if you get blood or blood products 3 months before or up to 1 month after vaccination.
Danish: Ervebo virker muligvis ikke så godt, hvis du får blod eller blodprodukter 3 måneder før eller op til 1 måned efter vaccinationen.
English: If feasible, the waste liquid from eye washes should be collected and decontaminated before discarding into the drain.
Danish: Hvis det er muligt, skal affaldsvæske fra vask af øjne opsamles og dekontamineres, før det hældes i afløbet.
English: Tell your healthcare worker if in the 6 weeks after you receive Ervebo you might be in close contact with or in the same household as:
Danish: Fortæl det altid til sundhedspersonalet, hvis du i de første 6 uger efter at have fået Ervebo muligvis vil være i tæt kontakt med eller i samme husstand som:
English: • Safe injection practices
Danish: • Sikker injektionspraksis
English: Based on limited shedding in adults, the results of a toxicity study in non-human primates, and lack of horizontal transmission in pigs, the overall risk of Ervebo to human health and the environment is considered negligible.
Danish: På baggrund af begrænset udskillelse hos voksne, resultaterne af et toksicitetsstudie med ikke-humane primater og manglende horisontal overførsel hos grise anses den samlede risiko ved Ervebo for menneskers helbred og miljøet at være ubetydelig.
English: • A minor infection such as a cold should not be a problem but talk to your healthcare worker before receiving Ervebo.
Danish: • En mindre infektion, som f.eks. en forkølelse, bør ikke være et problem, men tal med sundhedspersonalet, inden du får Ervebo.
English: Vaccination should be postponed in subjects experiencing moderate or severe febrile illness.
Danish: Vaccination skal udsættes hos personer, der oplever moderat eller svær febersygdom.
English: An immunogenicity sub-study included 508 subjects who were vaccinated and provided samples for the assessment of immunogenicity.
Danish: Et immunogenicitets-understudie inkluderede 508 forsøgspersoner, der blev vaccinerede og leverede prøver til vurdering af immunogenicitet.
English: EU/1/19/1392/001 - pack of 10
Danish: EU/1/19/1392/001 - pakning med 10
English: Individuals 18 years of age or older: one dose (1 mL) (see section 5.1).
Danish: Personer i alderen 18 år eller derover: En dosis (1 ml) (se pkt.
English: Like all vaccines, Ervebo can cause side effects, although not everybody gets them.
Danish: Ervebo kan som alle andre vacciner give bivirkninger, men ikke alle får bivirkninger.
English: Safety and efficacy of Ervebo have not been assessed in immunocompromised individuals.
Danish: Ervebos sikkerhed og virkning er ikke vurderet hos immunkompromitterede personer.
English: Date of first authorisation: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}
English: In some people joint pain and swelling may come back after initially going away.
Danish: Hos nogle kan ledsmerter og -hævelse vende tilbage efter først at være forsvundet.
English: Intramuscular use Read the package leaflet before use.
Danish: Intramuskulær anvendelse Læs indlægssedlen inden brug.
English: It is unknown whether concurrent administration of antiviral medication including interferons could impact vaccine virus replication and efficacy.
Danish: Det er ukendt, om samtidig administration af antiviral medicin, herunder interferoner, kan påvirke replikation og virkning af vaccinevirus.
English: Month 1
Danish: Måned 1
English: In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in lymphoid organs up to 112 days post-vaccination.
Danish: I et biodistributionsstudie med ikke-humane primater blev vaccine-RNA påvist i lymfoide organer op til 112 dage efter vaccinationen.
English: Are in contact with vulnerable individuals
Danish: Er i kontakt med højrisikopersoner
English: Vaccination with Ervebo may not result in protection in all vaccinees.
Danish: Vaccination med Ervebo vil muligvis ikke yde beskyttelse hos alle vaccinemodtagere.
English: Clinical efficacy of Ervebo was assessed in Protocol 010.
Danish: Ervebos kliniske virkning blev vurderet i protokol 010.
English: • Immunocompromised individuals and individuals receiving immunosuppressive therapy (see section above),
Danish: • Immunkompromitterede personer og personer i immunsuppressiv behandling (se punktet ovenfor)
English: Certain white blood cell counts can decrease below normal after vaccination but this decrease has not resulted in illness and the counts return to normal.
Danish: Antallet af visse hvide blodlegemer kan falde til under det normale niveau efter vaccinationen, men er ikke forbundet med sygdom og vender tilbage til det normale igen.
English: Clinical immunogenicity
Danish: Klinisk immunogenicitet
English: Efficacy in children has not been assessed.
Danish: Virkningen hos børn er ikke undersøgt.
English: • Tell your healthcare worker if you have a problem with bleeding or you bruise easily.
Danish: • Fortæl sundhedspersonalet, hvis du har et problem med blødning eller let får blå mærker.
English: Ervebo is given by a healthcare worker.
Danish: Ervebo gives af sundhedspersonalet.
English: Protocol 011
Danish: Protokol 011
English: Ervebo contains sodium
Danish: Ervebo indeholder natrium
English: Efficacy data was obtained in Protocol 010 in Guinea and immunogenicity data was obtained in Protocol 009 in Liberia, Protocol 011 in Sierra Leone, and Protocol 012 in the United States, Canada, and Europe.
Danish: Virkningsdata blev indhentet i protokol 010 i Guinea, og immunogenicitetsdata blev indhentet i protokol 009 i Liberia, protokol 011 i Sierra Leone og protokol 012 i USA, Canada og Europa.