FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine, ATC code: J07BX02
Danish: Farmakoterapeutisk klassifikation: Vacciner, virale vacciner, ATC-kode: J07BX02
English: Over 80.1% of subjects continued to meet the seroresponse criteria for GP-ELISA and over 63.5% of vaccine recipients continued to meet seroresponse criteria for PRNT at 12 months.
Danish: Over 80,1% af forsøgspersonerne fortsatte med at opfylde kriterierne for serorespons ved GP-ELISA og over 63,5% af vaccinemodtagerne fortsatte med at opfylde kriterierne for serorespons ved PRNT i måned 12.
English: • Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Danish: • Kongenit eller hereditær immundefekt i familieanamnesen, medmindre der er vist immunkompetence hos den potentielle modtager af vaccinen.
English: Because this vaccine is based on VSV, a known pathogen in livestock (e.g. horses, cattle, pigs), the risk assessment included species that are relevant for the wild type (wt) VSV backbone of this vaccine.
Danish: Da denne vaccine er baseret på VSV, der er en kendt patogen hos husdyr (f.eks. heste, kvæg, grise), omfattede risikovurderingen arter, der er relevante for vildtype (wt) VSV-fundamentet i denne vaccine.
English: • After thawing, the vaccine should be used immediately.
Danish: • Efter optøning skal vaccinen bruges straks.
English: In the Phase 1 study with the highest rate of arthritis, 6 of 24 patients (25%) who reported arthritis after vaccination had persistent joint symptoms two years after vaccination.
Danish: I fase 1-studiet med den højeste forekomst af artritis havde 6 ud af 24 patienter (25%), som rapporterede artritis efter vaccination, vedvarende ledsymptomer to år efter vaccination.
English: Evaluation of the vaccine virus in animal milk has not been conducted.
Danish: Der er ikke foretaget en vurdering af vaccinevirus i mælk hos dyr.
English: Standard precautions, as outlined by WHO, include the following:
Danish: Standardforholdsregler i henhold til WHO inkluderer følgende:
English: Administration of immune globulins, blood or plasma transfusions administered 3 months before or up to 1 month after Ervebo administration may interfere with the expected immune response.
Danish: Blod- eller plasmatransfusioner med immunglobuliner givet 3 måneder før eller op til 1 måned efter administration af Ervebo kan interferere med det forventede immunrespons.
English: Across the Phase 1 through Phase 3 trials, 234 children and adolescents 6 to 17 years of age received a dose of Ervebo.
Danish: I fase 1- til fase 3-studierne fik 234 børn og unge i alderen 6-17 år en dosis Ervebo.
English: CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: It is unknown whether the vaccine virus is secreted in human milk.
Danish: Det er ukendt, om vaccinevirus udskilles i human mælk.
English: At the end of 14 days, the vaccine should be used or discarded.
Danish: Efter de 14 dage skal vaccinen enten bruges eller kasseres.
English: This vaccine will not protect you against the other types of Ebola virus.
Danish: Denne vaccine beskytter dig ikke mod de andre typer af ebolavirus.
English: Samples taken from humans and animals for investigation of Ebola infection should be handled by trained staff and processed in suitably equipped laboratories.
Danish: Prøvemateriale, der er udtaget fra mennesker og dyr med henblik på undersøgelse for ebolainfektion, skal håndteres af uddannet personale og behandles i laboratorier med egnet laboratorieudstyr.
English: • Because Ervebo does not contain the whole Ebola virus, it cannot give you Ebola virus disease.
Danish: • Da Ervebo ikke indeholder hele ebola-virussen, kan Ervebo ikke give dig ebola.
English: Vaccine virus RNA has been detected by PCR in the plasma of most of the adult subjects.
Danish: Vaccinevirus-RNA er påvist ved PCR i plasma fra de fleste voksne personer.
English: Tell your healthcare worker if you are taking, have recently taken or might take any other medicines or vaccines.
Danish: Fortæl altid sundhedspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin eller vacciner.
English: The need for a booster dose has not been established.
Danish: Det er ikke blevet fastslået, at der er behov for en boosterdosis.
English: Arthritis has been reported by subjects in clinical trials at a frequency that ranged from 0% in several protocols to 23.5% in one Phase 1 study.
Danish: Artritis blev rapporteret af forsøgspersoner i kliniske studier med en hyppighed, som gik fra 0% i flere protokoller til 23,5% i et fase 1-studie.
English: If you think you might have a weak immune system, ask your healthcare worker if you should receive this vaccine.
Danish: Hvis du tror, at du har et svagt immunsystem, skal du spørge sundhedspersonalet, om du skal have denne vaccine.
English: • swelling of the face, lips, tongue, or other parts of the body,
Danish: • hævelse af ansigtet, læberne, tungen eller andre kropsdele
English: The safety profile of Ervebo in children and adolescents 6 to17 years of age was generally similar to that observed in adults.
Danish: Ervebos sikkerhedsprofil hos børn og unge i alderen 6-17 år var generelt sammenlignelig med den, der blev observeret hos voksne.
English: The majority of arthritis reactions were mild to moderate in severity.
Danish: Størstedelen af bivirkningerne med artritis var lette til moderate i sværhedsgrad.
English: Overall, the side effects in children and adolescents were similar to those in adults.
Danish: Generelt var de bivirkninger, der blev set hos børn og unge, de samme som hos voksne.
English: The clinical development program included four Phase 2/3 (Protocols 009-012) clinical trials.
Danish: Det kliniske udviklingsprogram omfattede fire kliniske fase 2/3-studier (protokol 009-012).
English: Vaccine efficacy has been established in the period ≥10 to ≤31 days after vaccination, however the duration of protection is not known (see section 5.1).
Danish: Vaccinens virkning er påvist i perioden fra ≥ 10 til ≤ 31 dage efter vaccination, men varigheden af beskyttelsen er ikke kendt (se pkt.
English: Arthritis (arthritis, joint effusion, joint swelling, osteoarthritis, monoarthritis or polyarthritis) was generally reported within the first few weeks following vaccination.
Danish: Artritis (artritis, ledeffusion, hævede led, osteoartritis, monoartritis eller polyartritis) blev generelt rapporteret inden for de første par uger efter vaccinationen.
English: Do not thaw the vial in a refrigerator.
Danish: Hætteglasset må ikke optøs i køleskab.
English: • you are taking certain medicines that make your immune system weak such as immunosuppressants or corticosteroids,
Danish: • du tager visse lægemidler, der svækker dit immunsystem, som f.eks. immundæmpende midler eller kortikosteroider.
English: • you have cancer or a blood problem that makes your immune system weak,
Danish: • du har kræft eller en blodsygdom, der svækker dit immunsystem.
English: • If you have ever had an allergic reaction to a vaccine or medicine, talk to your healthcare worker before you receive this vaccine.
Danish: • Hvis du nogensinde har haft en allergisk reaktion over for en vaccine eller et lægemiddel, skal du tale med sundhedspersonalet, før du får denne vaccine.
English: • someone who may be pregnant or breast-feeding,
Danish: • en person, der kan være gravid eller ammer
English: This does not include individuals who are receiving topical, inhaled or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Danish: Dette omfatter ikke personer, som får topiske, inhalerede eller lavdosis-parenterale kortikosteroider (f.eks. profylaktisk behandling for astma eller substitutionsbehandling).
English: 30 Oct 2020
Danish: 30. oktober 2020
English: • Diseases of the blood such as leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems.
Danish: • Blodsygdomme såsom leukæmi, lymfomer af enhver type eller andre maligne neoplasmer, som påvirker det hæmatopoietiske system og lymfesystemet.
English: • If you might be in close contact with, or in the same household as someone who may be pregnant or breast-feeding during the 6 weeks after you receive Ervebo, tell your healthcare worker.
Danish: • Hvis du muligvis kommer i tæt kontakt med eller er i samme husstand som en person, der kan være gravid eller ammer, inden for 6 uger efter at du har fået Ervebo, skal du fortælle det til sundhedspersonalet.
English: • Ervebo is available in a pack of 10 vials.
Danish: • Ervebo fås i en pakning med 10 hætteglas.
English: Immunocompromised individuals may not respond as well as immunocompetent individuals to Ervebo.
Danish: Immunkompromitterede personer responderer muligvis ikke lige så godt på Ervebo som immunkompetente personer.
English: The vaccine should appear as a colourless to slightly brownish-yellow liquid with no particulates visible.
Danish: Vaccinen skal fremstå som en farveløs til let brungul væske uden synlige partikler.
English: The bandage may be removed when there is no visible fluid leakage.
Danish: Bandagen kan fjernes, når der ikke er synlige tegn på væskelækage.
English: The vaccine virus is a Genetically Modified Organism (GMO).
Danish: Vaccinevirussen er en genetisk modificeret organisme (GMO).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: • You can also catch Ebola from things that have touched the blood or body fluids of a person or animal with Ebola (like clothes or objects in direct contact).
Danish: • Du kan også få ebola fra ting, der har været i kontakt med blod eller kropsvæsker fra en person eller et dyr med ebola (såsom tøj eller genstande i direkte kontakt).
English: The final primary analysis was to assess efficacy against laboratory confirmed EVD by comparing incidence of cases occurring 10 to 31 days post-randomization for those vaccinated in the immediate vaccination rings versus incidence of cases for subjects who consented on Day 0 in the delayed vaccination rings.
Danish: Den endelige primære analyse gik ud på at vurdere virkningen over for laboratoriebekræftet EVD ved at sammenligne incidensen af tilfælde, der forekom 10 til 31 dage efter randomisering for dem, som blev vaccineret i ringene med øjeblikkelig vaccination, versus incidensen af tilfælde for forsøgspersoner, der afgav samtykke på dag 0 i ringene med forsinket vaccination.
English: The vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding or bruising may occur following an intramuscular administration in these individuals.
Danish: Vaccinen skal gives med forsigtighed til personer med trombocytopeni eller en koagulationsforstyrrelse, da blødning eller blå mærker kan forekomme efter intramuskulær administration hos disse personer.
English: Following vaccination with Ervebo, individuals may test positive for Ebola glycoprotein (GP) nucleic acids, antigens, or antibodies against Ebola GP, which are targets for certain Ebola diagnostic tests.
Danish: Efter vaccination med Ervebo kan personerne teste positive for ebola-glykoprotein (GP)-nukleinsyre, antigener eller antistoffer mod ebola-GP, der er mål for visse diagnostiske tests for ebola.
English: Standard precautions when caring for patients with known or suspected Ebola disease
Danish: Standardforholdsregler ved pleje af patienter med kendt eller mistænkt ebola-sygdom
English: See description of selected adverse reactions.
Danish: Se beskrivelse af udvalgte bivirkninger.
English: • You may test positive for Ebola virus after you receive Ervebo.
Danish: • Du kan teste positiv for ebola, efter du har fået Ervebo.
English: The MAH should provide comprehensive comparability data confirming that the commercial product manufactured at the Burgwedel site is representative of the material used in the clinical trials.
Danish: Indehaveren af markedsføringstilladelsen skal tilvejebringe udførlige sammenlignelighedsdata til påvisning af, at det kommercielle produkt, der er fremstillet på fremstillingsstedet Burgwedel, er repræsentativt for det materiale, der anvendes i de kliniske studier.
English: All healthcare workers and other ancillary providers who have been vaccinated should not alter their practices with regard to safe injection, hygiene, and personal protective equipment (PPE) after vaccination.
Danish: Alle sundhedspersoner og andre hjælpepersoner, som er blevet vaccineret, må ikke ændre praksis med hensyn til sikker injektion, hygiejne og personligt beskyttelsesudstyr (PPE) efter vaccination.
English: Shedding of vaccine virus has been detected by PCR in urine or saliva in 19 out of 299 adult subjects and in skin vesicles in 4 out of 10 adult subjects.
Danish: Udskillelse af vaccinevirus er påvist ved PCR i urin eller spyt hos 19 ud af 299 voksne personer og i hudvesikler hos 4 ud af 10 voksne personer.
English: This vaccine might not protect everyone who receives it and the length of time you are protected from Ebola by Ervebo is not known.
Danish: Denne vaccine beskytter ikke nødvendigvis alle, der får den, og det er ikke kendt, hvor lang tid Ervebo beskytter dig imod ebola.
English: Arthralgia and arthritis
Danish: Artralgi og artritis
English: • Hand washing
Danish: • Håndvask
English: No data are available for administration via the subcutaneous or intradermal routes.
Danish: Der foreligger ingen data om subkutan eller intradermal administration.
English: Table 1: Tabulated summary of adverse reactions considered related to vaccination MedDRA-System Organ Class Adverse Reactions
Danish: Tabel 1: Tabeloversigt over bivirkninger, der anses for at være forbundet med vaccinationen MedDRA-systemorganklasse Bivirkninger
English: The median duration of arthritis across clinical trials in which arthritis was reported ranged from 2 days to 81.5 days (including duration of recurrent arthritis) with a maximum of 330 days.
Danish: Den mediane varighed af artritis på tværs af kliniske studier, hvor artritis blev rapporteret, lå fra 2 dage til 81,5 dage (inklusive varighed af tilbagevendende artritis) med et maksimum på 330 dage.
English: • Basic hand hygiene
Danish: • Basal håndhygiejne
English: CI = Confidence interval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/mL); GMT = Geometric mean titer *Protocol 011 from Month 9-12
Danish: CI = Konfidensinterval; GP-ELISA = Anti-Glycoprotein Human Enzyme-Linked Immunosorbent Assay (EU/ml); GMT = Geometrisk middeltiter *Protokol 011 fra måned 9-12
English: Protocols 009 and 011 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers
Danish: I protokol 009 og 011 blev der anvendt gammabestråling af prøver for at reducere risikoen for vildtype ebola-virusinfektion hos laboratoriepersonale.
English: Women who are able to become pregnant should use an effective method of birth control.
Danish: Kvinder, som kan blive gravide, skal bruge en sikker præventionsmetode.
English: Viral shedding was observed more frequently in children and adolescents (28/39) compared to adults.
Danish: Virusudskillelse sås hyppigere hos børn og unge (28/39) end hos voksne.
English: Vaccine efficacy was 100% (unadjusted 95% CI: 63.5% to 100%; 95% CI adjusted for multiplicity: 14.4% to 100%) (0 cases in the immediate arm; 10 cases in 4 rings in the delayed arm).
Danish: Virkningen af vaccinen var 100% (ikke-justeret 95% CI: 63,5% til 100%; 95% CI (justeret for multiplicitet): 14,4% til 100%) (0 tilfælde i armen øjeblikkelig vaccination; 10 tilfælde i 4 ringe i armen med forsinket vaccination).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Ervebo might make you bleed or bruise where the vaccine is injected.
Danish: Ervebo kan medføre blødning eller give blå mærker på det sted, hvor vaccinen indsprøjtes.
English: This vaccine contains less than 1 mmol (23 mg) of sodium per dose.
Danish: Denne vaccine indeholder mindre end 1 mmol (23 mg) natrium pr. dosis.
English: Process and batch data from at least 3 representative FP batches should be provided.
Danish: Proces- og batchdata fra mindst 3 repræsentative batches af lægemiddelstoffet skal tilvejebringes.
English: As shown in Tables 2 and 3, the geometric mean titers (GMT) of GP-ELISA and PRNT increased from pre-vaccination to post-vaccination.
Danish: Som vist i tabel 2 og 3 steg de geometriske middeltitre (GMT) for GP-ELISA og PRNT i perioden fra før vaccinationen til efter vaccinationen.
English: • wheezing or trouble breathing,
Danish: • hvæsende vejrtrækning eller problemer med at trække vejret
English: The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire Ebola virus are unknown.
Danish: De relative bidrag fra den innate, humorale og cellemedierede immunitet til beskyttelse mod Zaire-ebolavirus er ukendt.
English: The preferred site is the deltoid area of the non-dominant arm or in the higher anterolateral area of the thigh.
Danish: Det foretrukne sted er deltoidområdet i den ikkedominerende arm eller i det øvre anterolaterale område af låret.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ervebo in one or more subsets of the paediatric population in prevention of Ebola disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Ervebo i en eller flere undergrupper af den pædiatriske population til forebyggelse af ebolasygdom (se pkt.
English: In a Phase 1 trial in children 6 to 17 years of age (median age = 10), non-validated ELISA and Pseudovirion Neutralization Assay (PsVNA) results at Day 28 and Day 180 post-vaccination were similar to those observed in adults in the same study (see also sections 4.4 and 4.8).
Danish: I et fase I-studie med børn i alderen 6-17 år (medianalder = 10) var ikke-validerede ELISA- og PsVNA (Pseudovirion Neutralization Assay)resultater på dag 28 og 180 efter vaccinationen sammenlignelige med dem, der blev observeret hos voksne i samme studie (se også pkt.
English: Inadvertent transmission of vaccine virus to animals and livestock is also theoretically possible, see below.
Danish: Utilsigtet overførsel af vaccinevirus til dyr og husdyr er også en teoretisk mulighed, se nedenfor.
English: • babies who are less than 1 year old,
Danish: • børn under 1 år
English: Talk to your healthcare worker before you receive Ervebo if you:
Danish: Kontakt sundhedspersonalet, før du får Ervebo, hvis du:
English: If breakage/spillage were to occur, disinfectants such as aldehydes, alcohols and detergents are proven to reduce viral infection potential after only a few minutes.
Danish: I tilfælde af brud/spild har desinficerende midler som aldehyder, alkoholer og rengøringsmidler vist sig at reducere det virale infektionspotentiale efter kun et par minutter.
English: Process and batch data from at least 3 representative AS batches should be provided.
Danish: Proces- og batchdata fra mindst 3 repræsentative batches af færdigvaren skal tilvejebringes.
English: Pregnant and breast-feeding women
Danish: Gravide og ammende kvinder
English: • Use alcohol-based hand sanitiser when hands are not dirty.
Danish: • Brug et alkoholbaseret hånddesinfektionsmiddel, når hænderne ikke et synligt beskidte.
English: • Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia, and AIDS or symptomatic HIV infection.
Danish: • Svær humoral eller cellulær (primær eller erhvervet) immundefekt som f.eks. svær kombineret immundefekt, agammaglobulinæmi og aids eller symptomatisk hiv-infektion.
English: The vaccine virus RNA was detected in a skin vesicle at 12 days post-vaccination in one of the four subjects.
Danish: Vaccinevirus-RNA blev påvist i en hudvesikel 12 dage efter vaccinationen hos en ud af fire personer.
English: • a member of your family has a weak immune system.
Danish: • en i din familie har et svagt immunsystem.
English: Ervebo has no or negligible influence on the ability to drive and use machines.
Danish: Ervebo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: For precautions regarding thawing, handling and disposal of the vaccine, see section 6.6.
Danish: 6.6 for forholdsregler vedrørende optøning, håndtering og bortskaffelse af vaccinen.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your healthcare worker for advice before you receive this vaccine.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge sundhedspersonalet til råds, før du får denne vaccine.
English: The safety of Ervebo has not been established in pregnant women.
Danish: Ervebos sikkerhed er ikke klarlagt hos gravide kvinder.
English: Thrombocytopenia and coagulation disorders
Danish: Trombocytopeni og koagulationsforstyrrelser
English: • Avoid contact with bats and non-human primates or blood, fluids and raw meat prepared from these animals (bushmeat) or meat from an unknown source.
Danish: • Undgå kontakt med flagermus og ikke-humane primater eller blod, væsker og råt kød tilberedt fra disse dyr (”bushmeat”) eller kød fra en ukendt kilde.
English: • If you have a fever (high temperature), you should talk to your healthcare worker before receiving Ervebo.
Danish: • Hvis du har feber (forhøjet temperatur), skal du tale med sundhedspersonalet, før du får Ervebo.
English: In general, these reactions were reported within 7 days after vaccination, were mild to moderate in intensity, and had short duration (less than 1 week).
Danish: Generelt blev disse bivirkninger rapporteret inden for 7 dage efter vaccinationen, de var lette til moderate i sværhedsgrad og var kortvarige (under 1 uge).
English: The vaccine will not prevent disease caused by Filoviruses other than Zaire Ebola virus.
Danish: Vaccinen forhindrer ikke sygdom forårsaget af filovirus bortset fra Zaire-ebolavirus.
English: Solution for 1 dose in a vial (type I glass) with a stopper (chlorobutyl) and a flip-off plastic cap with aluminium seal.
Danish: Opløsning til 1 dosis i et hætteglas (type I-glas) med en prop (chlorobutyl) og et flip-off plastiklåg med aluminiumsforsegling.
English: The preferred injection site is the deltoid area of the non-dominant arm or in the higher anterolateral area of the thigh.
Danish: Det foretrukne injektionssted er deltoidområdet i den ikke-dominerende arm eller i det øvre anterolaterale område af låret.
English: • Items that may have come in contact with an infected person's blood or body fluids (such as clothes, bedding, needles, and medical equipment).
Danish: • Genstande som kan have været i kontakt med en smittet persons blod eller kropsvæsker (såsom tøj, sengetøj, kanyler og medicisk udstyr).
English: • Do not use this medicine after the expiry date which is stated on the vial label and the outer carton after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasetiketten og den ydre karton efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.