FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Danish: I tilfælde af flere resultater kan vurderingen af resultater blive prioriteret, og der skal indføres passende tidsrammer for indsendelse af en fuldstændig evalueringsrapport af resultaterne.
English: Adjuvant MF59C.1 containing: Squalene
Danish: Adjuvans MF59C.1, som indeholder: Squalen
English: The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Danish: Lægen skal informere dig om risikoen for at få kramper, især hvis du tidligere har haft epilepsi.
English: Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Danish: Foclivia indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) per dosis.
English: You should discuss with your doctor whether you should receive Foclivia.
Danish: Du skal drøfte med din læge, om du skal have Foclivia.
English: Only spontaneously reported data should be included in the PSUR.
Danish: Kun uvilkårlig rapporteret data må inkluderes i PSUR'en.
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Danish: Særlig opmærksomhed skal udvises hos personer, der lider af epilepsi, og lægen skal informere personerne (eller forældrene) om risikoen for, at der opstår kramper (se pkt.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Der kan forekomme allergiske reaktioner efter vaccinationen, som i sjældne tilfælde kan føre til shock.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Danish: - Alle tilfælde, som ikke er bekræftede af en læge, er dem, som blev indtastet i databasen inden data-lock point.
English: However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Danish: I en pandemisituation kan det imidlertid alligevel være relevant at give vaccinen under forudsætning af, at faciliteter til genoplivning er lettilgængelige, hvis behovet skulle opstå.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du får denne vaccine.
English: Immunogenicity was assessed in a subset (n=197) of the study population.
Danish: Immunogeniciteten blev vurderet hos en delgruppe (n=197) af forsøgspersonerne.
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Danish: Immunrespons på vaccination vurderet med MN-analyse stemmer overens med resultater opnået med SRH.
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Danish: I en pandemisk situation skal ressourcerne koncentreres om en betimelig og effektiv overvågning af sikkerhedsprofilen for de influenzavacciner, der anvendes under pandemien.
English: • Data in paediatric populations
Danish: • Data hos pædiatriske populationer
English: Foclivia can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Foclivia takes due account of the officially declared pandemic strain.
Danish: Foclivia må kun markedsføres, når WHO/EU officielt har erklæret, at der er en influenzapandemi, og på betingelse af at indehaveren af markedsføringstilladelsen til Foclivia tager behørigt hensyn til den officielt erklærede pandemistamme.
English: They are isolated from the surface of influenza virus particles, which are grown in fertilised hen's eggs from healthy chicken flocks and inactivated with formaldehyde.
Danish: De isoleres fra overfladen af influenzaviruspartikler, som er formeret i befrugtede hønseæg fra sunde hønsehold og inaktiveret med formaldehyd.
English: In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10.000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Danish: To store observationsstudier designet til at vurdere sikkerheden af Focetria-eksponering under graviditet viste heller ingen stigning i forekomsten af svangerskabsdiabetes, præeklampsi, abort, dødfødsel, lav fødselsvægt, præmatur fødsel, neonatale dødsfald eller kongenitale misdannelser blandt næsten 10.000 vaccinerede gravide kvinder og deres børn sammenlignet med uvaccinerede kontrolpersoner.
English: Anti-HA antibody (SRH)
Danish: Anti-HA-antistof (SRH)
English: Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
Danish: Uanset alder var reaktogeniciteten højere efter den første dosis end efter den anden vaccination.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Danish: - Rapporteurens vurderingsrapport udsendes til CHMP-medlemmerne på dag 50.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Danish: Uden for den pandemiske periode opretholdes den normale PSUR-frekvens og -format med en specifik gennemgang af AESI'er og mulige bivirkninger i forbindelse med et adjuvans.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER/TILTAG EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: First dose
Danish: Første dosis
English: - Active Substance:
Danish: - Aktivt stof:
English: Postmarketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Danish: Spontant rapporterede bivirkninger efter markedsføring og et interventionsstudie tyder hverken på direkte eller indirekte skadelige virkninger af Focetria-eksponering på graviditet.
English: - CHMP report is circulated to the vaccine manufacturer on Day 55.
Danish: - CHMP-rapporten sendes til fremstilleren af vaccinen på dag 55.
English: Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Danish: Foclivia kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig administrering af en anden vaccine er indiceret, skal immuniseringen ske på forskellige lemmer.
English: • Post-marketing surveillance
Danish: • Bivirkningsovervågning efter markedsføring
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Danish: Pandemisk influenza er en type influenza, som opstår i tidsintervaller, der varierer fra under 10 år til flere årtier.
English: Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Danish: Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode J07BB02
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Danish: Efter influenzavaccination kan ELISA-metoden give falsk positive serologiske testresultater for antistoffer mod humant immundefektvirus-1 (HIV-1), hepatitis C-virus og især HTLV-1.
English: Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Pandemiske beredskabsvacciner indeholder influenza-antigener, som er anderledes end antigenerne i de aktuelt cirkulerende influenza-vira.
English: The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Danish: Procentdelen af personer, der rapporterede lokale reaktioner, var højere i de ældre aldersklasser, hovedsagelig på grund af flere rapporter om smerte.
English: Immunogenicity results with Focetria H1N1v (Study V111_03):
Danish: Immunogenicitetsresultater med Focetria H1Nv (Studie V111_03):
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy
Danish: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italien
English: The majority of febrile convulsions occurred in paediatric subjects.
Danish: De fleste feberkramper opstod hos pædiatriske personer.
English: Pregnancy No data have been generated with Foclivia in pregnant women.
Danish: Graviditet Der er ikke genereret data fra anvendelse af Foclivia til gravide kvinder.
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Danish: Der skal gives en kort opsummering, hvori de validerede resultater og problemområder er fremhævet, mens der tages højde for informationen fra det prospektive kohortestudie beskrevet i pkt.
English: As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.
Danish: Ligesom med andre vacciner er det ikke sikkert, at Foclivia yder fuld beskyttelse til alle, der får vaccinen.
English: 7.5 micrograms**
Danish: 7,5 mikrogram**
English: Foclivia should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Danish: Foclivia bør ikke gives samtidig med andre vacciner (hvis en anden vaccination er nødvendig på samme tid, bør indsprøjtningerne gives på forskellige lemmer.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Danish: Serumprøver blev testet mod den originale H5N3 og også et antal H5N1-isolater.
English: Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations.
Danish: Sundhedspersonalet skal vurdere fordele og potentielle risici ved administration af Foclivia-vaccine til gravide kvinder og tage officielle anbefalinger med i vurderingen.
English: The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Danish: Adjuvanset indeholder også polysorbat 80 og sorbitantrioleat i en citratbuffer (natriumcitrat, citronsyre).
English: It should be noted that the adverse reactions may be intensified.
Danish: Bemærk, at bivirkningerne kan forstærkes.
English: However, in a pandemic situation, you may still be given the vaccine.
Danish: Men i en pandemisk situation vil du måske alligevel få vaccinen.
English: Tell your doctor if you have any known allergies.
Danish: Fortæl din læge, hvis du er allergisk over for noget.
English: Systemic
Danish: Systemiske
English: This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Danish: Dette bør omfatte data fra igangværende studier, eller hvis relevant fra klinisk anvendelse af pandemiske beredskabsstammer og alle sikkerhedsdata, der er relevante for adjuvanssystemet.
English: 10 x 1 dose
Danish: 10 x 1 dosis
English: Depending on and after implementation of vaccine when first pandemic will take place.
Danish: Afhængig af hvornår den første pandemi finder sted samt efter implementering af vaccinen.
English: Important information about some of the ingredients of Foclivia Foclivia contains thiomersal
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Foclivia Foclivia indeholder thiomersal
English: Fertility No fertility data are available.
Danish: Fertilitet Der er ingen tilgængelige data vedrørende fertilitet.
English: Reactogenicity after a third dose, administered 12 months after the second dose, was higher than after both first and second dose.
Danish: Reaktogeniciteten efter en tredje dosis, som blev administreret 12 måneder efter den anden dosis, var højere end efter både første og anden dosis.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Danish: Din læge skal afveje fordelene op mod de mulige risici ved at give dig vaccinen.
English: Two doses of 7.5 micrograms were administered three weeks apart and a third dose 12 months following the first dose.
Danish: Der blev administreret to doser på 7,5 mikrogram med tre ugers mellemrum og en tredje dosis 12 måneder efter den første dosis.
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Danish: Hyppigheden af bivirkninger blandt personer over 60 år var lavere end blandt de 18- til 60-årige.
English: Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Danish: Selv om Foclivia i flerdosishætteglas indeholder konserveringsmiddel, der hæmmer mikrobiel vækst, påhviler det brugeren at minimere risikoen for kontaminering af flerdosishætteglas ved hver optrækning af en dosis.
English: There is limited experience of the booster dose in the elderly population.
Danish: Erfaringerne med booster-dosen hos den ældre population er begrænsede.
English: It is essentially sodium- and potassium-free.
Danish: Det er stort set natrium- og kaliumfrit.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Danish: Dette kan være ledsaget af adskillige neurologiske tegn som f.eks. forbigående synsforstyrrelser, paræstesier og tonisk-kloniske ekstremitetsbevægelser under opvågningen.
English: Cross reactivity
Danish: Krydsreaktivitet
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Danish: * formeret i befrugtede hønseæg fra sunde hønsehold ** udtrykt i mikrogram hæmagglutinin.
English: - Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
Danish: - Med undtagelse af Tabel 1 vil alle tabeller være baseret på antal bivirkninger (fremlagt på PT-niveau og inddelt efter systemorganklasse [SOC] og højniveau-term [HLT]) og ikke på antal tilfælde.
English: Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP.
Danish: Brug ikke Foclivia efter den udløbsdato, der står på pakningen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Danish: Der bør gives en ny dosis vaccine efter et interval på mindst 3 uger.
English: The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur (EMA) vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Product-specific data can be evaluated during signal work-up.
Danish: 1 Produktspecifikke data kan medtages i vurderingen af de påviste resultater.
English: Syringes without needle are fitted with a Luer Lock system.
Danish: Sprøjter uden kanyle er udstyret med et Luer-Lock system.
English: The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Danish: Desuden blev det konstateret, at den adjuverede vaccine inducerede antistoffer, der krydsbeskyttede mod de H5N1-stammer, som blev isoleret i 2003 og 2004, som udviser antigen drift sammenlignet med de originale stammer.
English: This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Danish: Denne vaccine opfylder WHO's anbefalinger og EU's bestemmelser i forbindelse med en pandemi.
English: Some side effects listed in Section 4.
Danish: Nogle af de bivirkninger, der er nævnt i pkt.
English: Foclivia injection
Danish: Foclivia injektionsvæske
English: Foclivia contains sodium and potassium
Danish: Foclivia indeholder natrium og kalium
English: H5N1 adjuvanted vaccine
Danish: Adjuveret H5N1-vaccine
English: Foclivia is a milky-white liquid.
Danish: Foclivia er en mælkehvid væske.
English: Baseline Serostatus
Danish: Serostatus ved baseline
English: Fainting can occur following, or even before, any needle injection.
Danish: Besvimelse kan forekomme efter eller endda før enhver indsprøjtning med kanyle.
English: In children and adolescents pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Danish: Hos børn og unge var smerte den hyppigst rapporterede lokale reaktion, mens træthed og hovedpine var de hyppigst rapporterede systemiske reaktioner.
English: Adverse reactions from clinical trial in children aged 6 months to 17 years
Danish: Bivirkninger fra klinisk studie hos børn i alderen 6 måneder til 17 år
English: EU/1/09/577/001 1 prefilled syringe with needle EU/1/09/577/002 10 prefilled syringes with needle EU/1/09/577/005 1 prefilled syringe without needle EU/1/09/577/006 10 prefilled syringes without needle
Danish: EU/1/09/577/001 1 fyldt sprøjte med kanyle EU/1/09/577/002 10 fyldte sprøjter med kanyle EU/1/09/577/005 1 fyldt sprøjte uden kanyle EU/1/09/577/006 10 fyldte sprøjter uden kanyle
English: This section describes the clinical experience with the H5N1 pandemic preparedness vaccines following a two-dose administration of 7.5 microgram.
Danish: Dette afsnit beskriver den kliniske erfaring med de pandemiske H5N1-beredskabsvacciner efter administrering af to doser på 7,5 mikrogram.
English: One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
Danish: En dosis (0,5 ml) af vaccinen indeholder mindst 7,5 mikrogram hæmagglutinin af følgende anbefalede influenzavirusstamme:
English: Induration and ecchymosis were very common reactions in toddlers but were less common in infants.
Danish: Induration og ekkymose var meget almindelige reaktioner hos småbørn, men mindre almindelige hos spædbørn.
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Danish: Adjuvans: MF59C.1 olie i vand-emulsion indeholdende squalen som oliefase stabiliseret med polysorbat 80 og sorbitantrioleat i en citratbuffer (natriumcitrat, citronsyre).
English: In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints.
Danish: I visse tilfælde kan bivirkningerne også omfatte højere temperatur, ubehag (en generel følelse af utilpashed), rystelser, træthed, hovedpine, tendens til at svede, smerter i muskler og led.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Danish: Synkope (besvimelse) kan opstå efter og endda før vaccination som en psykogen reaktion på kanylestik.
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Danish: Ansøgeren skal indsamle dokumentation om klinisk sikkerhed og virkning af den pandemiske vaccine i løbet af pandemien og indsende disse oplysninger til CHMP til vurdering.
English: Adverse reactions from clinical trial in adults and elderly (above 18 years old)
Danish: Bivirkninger fra klinisk studie hos voksne og ældre (over 18 år)
English: This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Danish: I så fald skal der være umiddelbar adgang til lægebehandling i tilfælde af, at du får en allergisk reaktion.
English: There were fewer reactions after the second dose compared with the first.
Danish: Der var færre bivirkninger efter den anden dosis end efter den første.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
Danish: Ansøgeren skal udføre et prospektivt kohortestudie under pandemien som beskrevet i lægemiddelovervågningsplanen.
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Danish: Nogle af de bivirkninger, der er omtalt under punkt 4 ”Bivirkninger”, kan påvirke evnen til at køre motorkøretøj og betjene maskiner.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Danish: Tegn på en allergisk reaktion kan omfatte kløende hududslæt, stakåndethed og hævelser i ansigt eller tunge.
English: The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Foclivia i en eller flere undergrupper af den pædiatriske population til aktiv immunisering mod H5N1 deltype af Influenza A-virus.
English: MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Danish: MN-resultaterne viste i lighed med SRH-resultaterne et stærkt immunrespons efter gennemførelse af de primære vaccinationsserier hos en population af ældre forsøgspersoner.
English: A third (booster) dose of H5N1 vaccine combined with MF59C was administered 6 months onwards after the primary vaccination series.
Danish: En tredje (booster-) dosis af H5N1-vaccine kombineret med MF59C blev administreret fra og med 6 måneder efter den primære vaccinationsserie.
English: Once the needle is locked in place, remove the needle protector and administer the vaccine.
Danish: Når kanylen er låst på plads, fjernes kanylebeskytteren, og vaccinen administreres.
English: Data obtained with a pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with pandemic preparednessvaccines are relevant for the pandemic vaccines.
Danish: Data indhentet med en pandemisk beredskabsvaccine vil understøtte en vaccinationsstrategi, der sandsynligvis vil blive anvendt med den pandemiske vaccine: data vedrørende klinisk effekt og sikkerhed af pandemiske beredskabsvacciner er relevante for pandemi-vacciner.
English: Very common reactions reported in 146 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea, vomiting and change in eating habits.
Danish: Meget almindelige reaktioner rapporteret hos 146 spædbørn og småbørn i alderen 6-35 måneder: Ømhed, erytem, irritabilitet, usædvanlig gråd, søvnighed, diarré, opkastning og ændrede spisevaner.