FrancophonIA/ELRC3.0 huggingface dataset:
English: • This vaccine has been prescribed for you or your child only.
Danish: • Lægen har ordineret denne vaccine til dig eller dit barn personligt.
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn vaccineres, da den indeholder vigtige oplysninger.
English: Allergic including anaphylactic reactions have been reported very rarely.
Danish: Allergiske reaktioner, herunder anafylaktiske reaktioner, er meget sjældent blevet rapporteret.
English: 2.5 Long-term protection
Danish: Langtidsbeskyttelse
English: Urticaria (uncommon) was only reported in subjects 9 to 17 years of age (none in adults).
Danish: Urticaria (ikke almindelig) blev kun rapporteret hos personer i alderen fra 9 til 17 år (ingen hos voksne).
English: • ever fainted from an injection.
Danish: • nogensinde er besvimet på grund af en injektion.
English: It is used to help protect you or your child against "dengue disease" caused by dengue virus serotypes 1, 2, 3 and 4.
Danish: Den anvendes til at hjælpe med at beskytte dig eller dit barn mod "denguefeber" forårsaget af denguevirus serotyperne 1, 2, 3 og 4.
English: • If you or your child miss a scheduled injection, your doctor will decide when to give the missed injection.
Danish: • Hvis du/dit barn springer en planlagt injektion over, vil lægen beslutte, hvornår den glemte injektion skal gives.
English: Vaccination is not recommended if you live in area where dengue infections do not regularly occur and if you plan to travel to an area where dengue infections regularly occur.
Danish: Vaccination anbefales ikke, hvis du bor i et område, hvor dengueinfektioner ikke forekommer regelmæssigt, og hvis du planlægger at rejse til et område, hvor dengueinfektioner forekommer regelmæssigt.
English: The recommended size of the needle to be used is 23G or 25G.
Danish: Det anbefales, at der anvendes en 23G eller 25G kanyle.
English: What is dengue and dengue disease?
Danish: Hvad er dengue og denguefeber?
English: It is recommended to continue personal protection measures against mosquito bites after vaccination.
Danish: Det anbefales at fortsætte personlige beskyttelsesforanstaltninger mod myggestik efter vaccination.
English: Individuals who have not been previously infected by dengue virus or for whom this information is unknown
Danish: Personer, som ikke tidligere har været inficeret med denguevirus, eller for hvem denne information ikke kendes
English: CYD15: Brazil, Colombia, Honduras, Mexico, Puerto Rico.
Danish: CYD15: Brasilien, Colombia, Honduras, Mexico, Puerto Rico.
English: Dengue is not transmitted directly from personto-person.
Danish: Denguefeber overføres ikke direkte fra person til person.
English: Person-years: sum of time-at-risk (in years) for the subjects during the study period.
Danish: Personår: den samlede tid personer var udsat for risiko (i år) under studiet.
English: The virus from an infected person can spread to other people through mosquito bites for about 4 to 5 days (maximum 12 days) after the first symptoms appear.
Danish: Virussen kan sprede sig fra en smittet person til andre personer via myggestik i cirka 4 til 5 dage (højst 12 dage), efter de første symptomer viser sig.
English: Symptomatic VCD Any serotype
Danish: Symptomatisk VCD Enhver serotype
English: A neurovirulence study shows that CYD dengue vaccine is not neurotoxic.
Danish: Et neurovirulensstudie viser, at CYD denguevaccine ikke er neurotoksisk.
English: Hospitalised and/or clinically severe dengue fever in long-term safety follow-up data
Danish: c. Indlæggelse og/eller klinisk alvorlig denguefeber i langsigtet opfølgning af sikkerhedsdata
English: • low blood pressure causing dizziness or fainting
Danish: • lavt blodtryk, der forårsager svimmelhed eller besvimelse
English: Pharmacotherapeutic group: Vaccines, Viral vaccines, ATC code: J07BX/ Not Yet assigned
Danish: Farmakoterapeutisk klassifikation: Vacciner, virusvacciner, ATC-kode: J07BX/Endnu ikke tildelt
English: Dengvaxia stimulates the body's natural defences (immune system), to produces antibodies that will help protect against the viruses that cause dengue disease if the body is exposed to them in the future.
Danish: Dengvaxia stimulerer kroppens naturlige forsvarsmekanismer (immunsystem) til at producere antistoffer, som vil hjælpe med at beskytte mod viraene, som forårsager denguefeber, hvis kroppen udsættes for dem i fremtiden.
English: The GMTs levels depend on age and dengue serostatus at baseline.
Danish: GMT-niveauer afhænger af alder og dengue-serostatus ved baseline.
English: This phase includes therefore the primary endpoint observation period from 28 days after the third injection up to the end of the Active Phase.
Danish: Denne fase inkluderer derfor observationsperioden for det primære effektmål fra 28 dage efter den tredje injektion indtil slutningen af den aktive fase.
English: Systemic adverse reactions tended to be less frequent after the second and third injections of Dengvaxia as compared to the first injection.
Danish: Systemiske bivirkninger havde tendens til at være mindre hyppige efter den anden og tredje injektion af Dengvaxia sammenlignet med den første injektion.
English: Contact with disinfectants is to be avoided since they may inactivate the vaccine viruses.
Danish: Kontakt med desinfektionsmidler skal undgås, da det kan inaktivere viraene i vaccinen.
English: In particular, tell your doctor or pharmacist if you are taking any of the following:
Danish: Fortæl især lægen eller apotekspersonalet, hvis du tager nogle af følgende:
English: After reconstitution, one dose (0.5 mL) contains:
Danish: Efter rekonstitution indeholder én dosis (0,5 ml):
English: The efficacy was assessed during an Active Phase of 25 months, in which surveillance was designed to maximize the detection of all symptomatic virologically-confirmed dengue (VCD) cases regardless of the severity.
Danish: Effekt blev vurderet i en aktiv fase på 25 måneder, hvorunder overvågning blev foretaget med henblik på at maksimere detektion af alle symptomatiske virologisk bekræftede tilfælde af denguevirus (VCD) uanset sværhedsgrad.
English: This increased risk may mainly begin during the third year following the first injection.
Danish: Denne øgede risiko vil for det meste begynde i det tredje år efter den første injektion.
English: Any remaining vaccine doses should be discarded at the end of the immunization session or within 6 hours after reconstitution, whichever comes first.
Danish: Eventuelle resterende doser af vaccinen skal kasseres efter vaccinationsperioden eller inden for 6 timer efter rekonstitution, afhængigt af hvad der kommer først.
English: Non-clinical safety data revealed no special risks for humans based on a repeated-dose toxicity including assessment of local tolerance, and a developmental and reproductive toxicology program.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra toksicitet efter gentagne doser, herunder vurdering af lokal tolerance og et toksikologiprogram for udvikling og reproduktion.
English: The suspension should be visually inspected prior to administration.
Danish: Suspensionen skal inspiceres visuelt inden administration.
English: • medicines called “immunoglobulins” or blood products containing immuno globulins, such as blood or plasma.
Danish: • Lægemidler, som kaldes "immunglobuliner" eller blodprodukter, som indeholder immunglobuliner som f.eks. blod eller plasma.
English: CYD14: Indonesia, Malaysia, the Philippines, Thailand, Vietnam.
Danish: CYD14: Indonesien, Malaysia, Filippinerne, Thailand, Vietnam.
English: Serious allergic (anaphylactic) reactions
Danish: Alvorlige allergiske (anafylaktiske) reaktioner
English: Any unused product or waste material should be disposed of in accordance with local regulations.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: These figures may not be extrapolated to other regions with different seroprevalence and epidemiological situations.
Danish: Disse tal kan muligvis ikke ekstrapoleres til andre områder med særlig seroprævalens og epidemiologisk situation.
English: The marketing authorisation holder (MAH) shall submit the first PSURs for this product within 6 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: • The second injection, 6 months after the first injection.
Danish: • Den anden injektion 6 måneder efter den første injektion.
English: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile France
Danish: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Frankrig
English: Protection
Danish: Beskyttelse
English: These data are not sufficient to conclude on the absence of potential effects of Dengvaxia on pregnancy, embryo-foetal development, parturition and post-natal development.
Danish: Disse data er ikke tilstrækkelige til at konkludere, at Dengvaxia ikke har en effekt på graviditet, embryo-føtal udvikling, fødsel og postnatal udvikling.
English: The vaccine efficacy against symptomatic VCD is moderate for serotypes 1 and 2 and higher for serotypes 3 and 4 (see Table 4).
Danish: Vaccineeffekten mod symptomatisk VCD er moderat for serotype 1 og 2 og højere for serotype 3 og 4 (se Tabel 4).
English: Additional protection precautions
Danish: Yderligere sikkerhedsforanstaltninger
English: If you or your child miss an injection of Dengvaxia
Danish: Hvis du eller dit barn har glemt en injektion af Dengvaxia
English: Adverse reactions occurred within 3 days following vaccination except fever which appears within 14 days after the injection.
Danish: Bivirkninger forekom inden for 3 dage efter vaccination med undtagelse af feber, som forekom inden for 14 dage efter injektion.
English: You must continue to protect yourself against mosquito bites even after vaccination.
Danish: Du skal fortsætte med at beskytte dig selv mod myggestik, selv efter du er blevet vaccineret.
English: The active detection of symptomatic dengue cases started on the day of the first injection and lasted until each subject had been followed for at least 13 months after the third injection.
Danish: Den aktive detektion af symptomatiske denguetilfælde begyndte på dagen for den første injektion og varede, indtil alle personer var blevet fulgt i mindst 13 måneder efter den tredje injektion.
English: • The third injection, 6 months after the second injection.
Danish: • Den tredje injektion 6 måneder efter den anden injektion.
English: DHF meeting any WHO
Danish: DHF der opfylder ethvert WHO kriterium
English: • blueness of the tongue or lips
Danish: • blå tunge eller læber
English: Appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following administration of the vaccine.
Danish: Passende lægebehandling og overvågning skal altid være let tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: They can also happen very rarely after receiving any vaccine (may affect up to 1 in 10 000 people).
Danish: De kan også meget sjældent forekomme efter enhver vaccination (kan forekomme hos op til 1 ud af 10.000 personer).
English: The vaccination schedule consists of 3 injections of one reconstituted dose (0.5 mL) to be administered at 6-month intervals.
Danish: Vaccinationsprogrammet består af 3 injektioner af én rekonstitueret dosis (0,5 ml), som skal administreres med 6 måneders mellemrum.
English: Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
Danish: Tegn på en allergisk reaktion kan inkludere et kløende udslæt, åndenød og hævelse i ansigtet og på tungen.
English: For patients receiving treatment with immunoglobulins or blood products containing immunoglobulins, such as blood or plasma, it is recommended to wait for at least 6 weeks, and preferably for 3 months, following the end of treatment before administering Dengvaxia, in order to avoid neutralization of the attenuated viruses contained in the vaccine.
Danish: For patienter, som får behandling med immunglobuliner eller blodprodukter, som indeholder immunglobuliner, såsom blod eller plasma, anbefales det at vente mindst 6 uger og helst 3 måneder efter behandlingsafslutning inden administration af Dengvaxia for at undgå neutralisering af de svækkede vira i vaccinen.
English: It must not be injected into a blood vessel.
Danish: Den må ikke injiceres i et blodkar.
English: Estimates from the long-term analysis suggest the onset of increased risk was mainly during the 3rd year following the first injection.
Danish: Estimater fra den langsigtede analyse antyder, at start af den øgede risiko hovedsageligt var i det 3. år efter den første injektion.
English: Prior to launch of Dengvaxia in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Dengvaxia markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: During clinical development, immunogenicity data were collected in a total of approximately 5700 subjects 9 months to 60 years of age that received at least one injection of the vaccine.
Danish: Under den kliniske udvikling blev der indsamlet immunogenicitetsdata hos i alt cirka 5.700 personer i alderen fra 9 måneder til 60 år, som fik mindst én injektion med vaccinen.
English: After mixing (reconstitution) with the solvent provided, the product should be used immediately.
Danish: Efter blanding (rekonstitution) med det medfølgende solvens skal produktet anvendes med det samme.
English: Vaccine efficacy was demonstrated for these endpoints in CYD14 and CYD15 (see Table 4).
Danish: Vaccineeffekt blev påvist for disse effektmål i CYD14 og CYD15 (se Tabel 4).
English: Higher titres post-injection 3 are associated with a lower risk of dengue disease and higher vaccine efficacy, although an immunological correlate of protection has not been established.
Danish: Højere titre efter 3. injektion er forbundet med en lavere risiko for denguefeber og højere vaccineeffekt, omend der ikke er blevet etableret et immunologisk korrelat for beskyttelse.
English: Dengvaxia must not be mixed with any other vaccine or medicinal product.
Danish: Dengvaxia må ikke blandes med andre vacciner eller lægemidler.
English: Dengue is a viral infection which spreads through the bite of an infected Aedes mosquito.
Danish: Dengue er en virusinfektion, som spredes via stik fra smittede Aedes-myg.
English: To make sure that Dengvaxia is suitable for you or your child, it is important to tell your doctor, pharmacist or nurse if any of the points below apply to you or your child.
Danish: For at sikre at Dengvaxia er egnet til dig og dit barn, er det vigtigt at fortælle din læge, apotekspersonalet eller sundhedspersonalet, hvis nogle af nedenstående punkter gælder for dig eller dit barn.
English: Among these 5700 subjects, a total of 3104 subjects 9 to 45 years of age from endemic areas received at least one injection of Dengvaxia.
Danish: Blandt disse 5.700 personer fik i alt 3.104 personer i alderen fra 9 til 45 år fra endemiske områder mindst én injektion med Dengvaxia.
English: Before each injection, the reconstituted suspension should be gently swirled once again.
Danish: Inden hver injektion skal den rekonstituerede suspension vippes forsigtigt igen.
English: There is limited amount of data from the use of Dengvaxia in pregnant women.
Danish: Der er utilstrækkelige data for anvendelse af Dengvaxia til gravide kvinder.
English: No pharmacokinetic studies have been performed on Dengvaxia.
Danish: Der er ikke blevet udført farmakokinetiske studier med Dengvaxia.
English: Dengvaxia must be reconstituted prior to administration.
Danish: Dengvaxia skal rekonstitueres inden administration.
English: Store in the outer carton in order to protect from light.
Danish: Opbevares i den ydre karton for at beskytte mod lys.
English: As there are no data on co-administration of Dengvaxia vaccine with other vaccines for the population from 9 years and above, the concomitant use of Dengvaxia with other vaccines is not recommended.
Danish: Da der ikke foreligger data vedrørende samtidig administration af Dengvaxia vaccine med andre vacciner hos patienter på 9 år og derover, anbefales samtidig brug af Dengvaxia med andre vacciner ikke.
English: • As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of
Danish: • Som det er tilfældet med alle injicerbare vacciner, skal passende lægebehandling og overvågning altid være let tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af Dengvaxia.
English: The clinical efficacy of Dengvaxia was assessed in 3 studies: one supportive Phase IIb efficacy study (CYD23) in Thailand, and 2 pivotal large-scale Phase III efficacy studies, CYD14 in Asia (Indonesia, Malaysia, the Philippines, Thailand, Vietnam) and CYD15 in Latin America (Brazil, Colombia, Honduras, Mexico, Puerto Rico).
Danish: Den kliniske effekt af Dengvaxia blev vurderet i 3 studier: et understøttende fase IIb effektstudie (CYD23) i Thailand, 2 store, pivotale fase III hovedstudier vedrørende effekt, CYD14 i Asien (Indonesien, Malaysia, Filippinerne, Thailand, Vietnam) og CYD15 i Latinamerika (Brasilien, Colombia, Honduras, Mexico, Puerto Rico).
English: †The efficacy against hospitalised and severe VCD was not a primary objective and cut-off thresholds to define statistical significance were not pre-specified.
Danish: †Effekten mod tilfælde af VCD medførende indlæggelse og alvorlig VCD var ikke et primært formål, og cut-off værdierne for statistisk signifikans var ikke forudspecificeret.
English: • skin eruption over the whole body (rash generalized)
Danish: • hududslæt over hele kroppen (generaliseret udslæt)
English: Do not use Dengvaxia if you or your daughter are pregnant or breast-feeding.
Danish: Brug ikke Dengvaxia, hvis du eller din datter er gravid eller ammer.
English: Control group
Danish: Kontrolgruppe
English: **CCID50: 50% Cell Culture Infectious Dose.
Danish: **CCID50: 50 % infektionsdosis i cellekultur.
English: 4 serotypes.
Danish: 4 serotyper.
English: • swelling of the face or throat
Danish: • hævelse i ansigt eller hals
English: • have a weak immune system (the body's natural defences).
Danish: • hvis du eller dit barn har et svagt immunsystem (kroppens naturlige forsvarsmekanisme).
English: You should take precautions to prevent mosquito bites.
Danish: Du skal tage forholdsregler for at undgå myggestik.
English: Dengvaxia is given by your doctor or nurse as an injection under the skin (subcutaneous injection) in the upper arm.
Danish: Dengvaxia gives af lægen eller sundhedspersonalet som en injektion under huden (subkutan injektion) i overarmen.
English: * CCID50: 50% Cell Culture Infectious Dose.
Danish: * CCID50: 50 % infektionsdosis i cellekultur.
English: • A new sterile syringe and needle were not used for reconstitution or withdrawal of each of the previous doses.
Danish: • Der ikke blev anvendt en ny steril injektionssprøjte og kanyle til rekonstitution eller optrækning af hver af de tidligere doser.
English: Swirl gently until the powder is completely dissolved.
Danish: Vip forsigtigt indtil pulveret er helt opløst.
English: Path to more information on dengue and vaccination by scanning the QR code included on the outer carton with a smartphone.
Danish: Få mere information om denguefeber og vaccination ved at scanne QR-koden, der findes på yderpakningen, med en smartphone.
English: There are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, therefore vaccination of these individuals is not recommended.
Danish: Der foreligger ingen data vedrørende sikkerhed, immunogenicitet eller virkning, som understøtter vaccination af personer, der bor i ikke-endemiske områder og rejser til endemiske områder.
English: Swirl gently until the powder is dissolved.
Danish: Vip forsigtigt indtil pulveret er opløst.
English: • hardening of skin at the injection site (injection site induration).
Danish: • hård hud på injektionsstedet (forhærdning af hud på injektionsstedet).
English: Most of the side effects occurred within 3 days of having the injection of Dengvaxia.
Danish: De fleste bivirkninger forekom inden for 3 dage efter injektion med Dengvaxia.
English: The clinical efficacy of the vaccine is based on bridging of immunogenicity data (see below section 3.2).
Danish: Den kliniske effekt af vaccinen er baseret på bridging af immunogenicitetsdata (se nedenfor i pkt.
English: • sudden and serious feeling of illness or unease with drop in blood pressure causing dizziness and loss of consciousness, rapid heartbeat linked with breathing difficulty.
Danish: • pludselig og alvorlig sygdomsfornemmelse eller uro med et fald i blodtrykket, der forårsager svimmelhed og bevidsthedstab, hurtig puls forbundet med vejrtrækningsbesvær.
English: It is important that you or your child follow the instructions of your doctor, pharmacist or nurse regarding follow-up injection.
Danish: Det er vigtigt, at du/dit barn følger anvisningerne fra lægen, apotekspersonalet eller sundhedspersonalet angående en eventuel opfølgningsinjektion.
English: Cases: number of subjects with at least one symptomatic virologically-confirmed dengue episode in the considered period.
Danish: Tilfælde: antal personer med mindst én symptomatisk virologisk bekræftet dengueepisode i perioden under betragtning.
English: Efficacy in subjects 9 to 11 years of age was assessed in 1554 subjects (1032 in vaccine group and 522 in Control Group).
Danish: Effekt hos personer i alderen 9 til 11 år blev bedømt hos 1.554 personer (1.032 i vaccinegruppen og 522 i kontrolgruppen).
English: Overall, the same adverse reactions but at lower frequencies were observed in dengue seropositive subjects.
Danish: Samlet set blev de samme bivirkninger observeret hos dengue-seropositive personer, men med en lavere hyppighed.
English: Animal studies did not indicate any direct or indirect harmful effects with respect to lactation.
Danish: Dyrestudier indikerede hverken direkte eller indirekte skadelige virkninger, hvad angår amning.
English: Then, GMTs stabilize over the next 2 to 4 years and remain superior to pre-vaccination GMTs.
Danish: GMT'er stabiliseres derefter i løbet af de næste 2 til 4 år og forblev overlegen i forhold til GMT'er inden vaccination.
English: To avoid vaccination of false positives, only test methods with adequate performance in terms of specificity and cross-reactivity based on the local disease epidemiology should be used.
Danish: For at undgå falsk positive bør der kun anvendes testmetoder, der i tilstrækkelig grad kan teste for specificitet og krydsreaktivitet baseret på lokal sygdomsepidemiologi.
English: • Individuals with congenital or acquired cell-mediated immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g. 20mg or 2mg/kg of prednisone for 2 weeks or more) within 4 weeks prior to vaccination.
Danish: • Personer med medfødt eller erhvervet cellemedieret immundefektsygdom, herunder immunosuppressive behandlinger, såsom kemoterapi eller høje doser af systemiske kortikosteroider (f.eks. 20 mg eller 2 mg/kg prednison i 2 uger eller mere) inden for 4 uger før vaccination.
English: Like all medicines, Dengvaxia can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 1D
Danish: 1 dosis 1D