FrancophonIA/ELRC3.0 huggingface dataset:
English: Serological response defined as a ≥4-fold rise in antibody titer (≥1:20).
Danish: Serologisk respons defineret som en stigning i antistoffer ≥ 4-gange (≥1:20).
English: Therefore, as some viruses are excreted in human milk, the vaccine should not be used during breastfeeding.
Danish: Da nogle virus udskilles i human mælk, bør vaccinen ikke anvendes under amning.
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Danish: Denne vaccine følger WHO's anbefalinger og EU's beslutning for pandemien.
English: Number of Vietnam inactivat ed vaccine doses
Danish: Antal Vietnam inaktiverede vaccinedoser
English: 28 Days after inactivated vaccine
Danish: 28 dage efter inaktiveret vaccine
English: • if you are already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
Danish: • hvis du i forvejen tager acetylsalicylsyre (et stof, der findes i mange lægemidler til smertelindring og til at sænke feber).
English: This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Danish: Dette skyldes risikoen for Reyes syndrom, en meget sjælden, men alvorlig sygdom, der kan påvirke hjerne og lever.
English: Children less than 12 months
Danish: Børn under 12 måneder
English: Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
Danish: Administration af antivirale stoffer mod influenza indenfor to uger efter vaccination kan påvirke responset på vaccinen.
English: .......................................................................................................per 0.2 ml dose
Danish: .......................................................................................................pr. 0,2 ml dosis
English: Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Danish: De fleste indlæggelser skyldtes gastrointestinale infektioner og luftvejsinfektioner og fandt sted mere end 6 uger efter vaccinationen.
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine or placebo.
Danish: Data præsenteret for det kliniske studie D153-P504 gælder for studiedeltagere, som har fået to doser af studievaccinen eller placebo.
English: The second dose should be administered after an interval of at least 4 weeks.
Danish: Den anden dosis skal administreres efter mindst 4 uger.
English: • if the child is less than 12 months of age.
Danish: • hvis barnet er under 12 måneder.
English: However, in a pandemic situation, your doctor may recommend to give you the vaccine provided that appropriate medical treatement is immediately available in case of an allergic reaction.
Danish: Under en pandemi kan lægen imidlertid anbefale, at du får vaccinen på betingelse af, at passende medicinsk behandling er umiddelbart tilgængelig i tilfælde af en allergisk reaktion.
English: Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event or hypersensitivity event following administration of the vaccine.
Danish: Relevant medicinsk behandling og supervision skal altid være nemt tilgængeligt i tilfælde af en anafylaktisk reaktion eller overfølsomhedsreaktion efter administration af vaccinen.
English: The virus must infect and replicate in cells lining the nasopharynx of the vaccine recipient in order to induce protective immunity.
Danish: Virussen skal inficere og replikere i celler i slimhinden i nasofarynks hos de vaccinerede for at inducere beskyttende immunitet.
English: No data are available for individuals with significant clinical immunodeficiency.
Danish: Der er ingen tilgængelige data for personer med klinisk signifikant immundefekt.
English: Liverpool L24 9JW United Kingdom
Danish: Liverpool, L24 9JW Storbritannien
English: • if you are in close contact with someone with a severely weakened immune system (for example, a bone marrow transplant patient needing isolation).
Danish: • hvis du er i tæt kontakt med nogen, der har et alvorligt svækket immunsystem (for eksempel en person, der har fået en knoglemarvstransplantation, og som har behov for isolation).
English: In clinical studies with the vaccine, most side effects were mild in nature and short-term.
Danish: I kliniske studier med vaccinen var de fleste bivirkninger lette og kortvarige.
English: Prepare the applicator Remove rubber tip protector.
Danish: Klargør applikatoren Fjern beskyttelseshætten af gummi.
English: Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Danish: Anvendelse af salicylater til børn og unge bør undgås i 4 uger efter vaccinationen, medmindre det er medicinsk indiceret, da Reyes syndrom er rapporteret efter brug af salicylater under vildtype-influenzainfektion.
English: Days are counted relative to the only P/IIV dose for Groups 1-4 and after the first of 2 P/IIV doses for Group 5.
Danish: Dage tælles i forhold til P/IIV-dosen for gruppe 1-4 og efter den første af de 2 P/IIV-doser for gruppe 5.
English: All children will receive a second, follow-up dose after an interval of at least 4 weeks.
Danish: Alle børn skal have en opfølgende dosis efter mindst 4 uger.
English: Tell your doctor straightaway or seek urgent medical care if you experience any of the effects above.
Danish: Fortæl det straks til din læge eller søg akut lægehjælp, hvis du oplever noget af ovenstående.
English: It is used in children and adolescents 12 months to less than 18 years of age.
Danish: Den anvendes til børn og unge fra 12 måneder og op til 18 år.
English: In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Danish: I tilfælde hvor kontakt med svært immunkompromitterede personer ikke kan undgås, skal den potentielle risiko for transmission af virus fra influenzavaccinen vægtes i forhold til risikoen for at få og overføre vildtype-influenzavirus.
English: • If you are pregnant, think you may be pregnant, or plan to become pregnant soon, tell your doctor, nurse or pharmacist before vaccination.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, sundhedspersonalet eller apotekspersonalet til råds før vaccination.
English: Number of study participants
Danish: Antal deltagere i studiet
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, influenza levende svækket, ATC-kode: J07BB03
English: Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
Danish: Ingen Data for Gruppe 3-forsøgspersoner, der oprindeligt blev vaccineret med en H7N3 P/LAIV, er ikke vist.
English: Serum samples were available from 7 subjects in Group 3 on Day 28 and from 18 subjects in Group 5 on Day 56.
Danish: Serumprøver var tilgængelige fra 7 forsøgspersoner i gruppe 3 på dag 28 og fra 18 forsøgspersoner i gruppe 5 på dag 56.
English: HAI responses were not detected in any of the subjects after either the first or second dose of the vaccine.
Danish: HAI-respons blev ikke set hos nogen af forsøgspersonerne hverken efter den første eller den anden vaccinedosis.
English: The MAH should submit the final results of this study.
Danish: Indehaveren af markedsføringstilladelsen skal indsende de endelige resultater af dette studie.
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Danish: Den vaccinerede bør om muligt forsøge at undgå tæt kontakt med svært immunkompromitterede personer (fx knoglemarvstransplanterede patienter, hvor isolation er påkrævet) i 1-2 uger efter vaccination.
English: There are a moderate amount of data from the use of T/LAIV and the seasonal Fluenz Tetra vaccine in pregnant women.
Danish: Der er en moderat mængde data tilgængelige fra brug af T/LAIV og den sæsonbetingede Fluenz Tetra-vaccine til gravide kvinder.
English: Instructions for healthcare professionals
Danish: Instruktioner til læger og sundhedspersonale
English: Subjects with 4-fold antibody rise (percentage)
Danish: Forsøgspersoner med 4 gange antistofstigning (procentdel)
English: The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Danish: Vaccinen kan indeholde rester af følgende stoffer: æggeproteiner (fx ovalbumin) og gentamicin.
English: • Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise.
Danish: • Du må ikke give acetylsalicylsyre (et stof, der findes i mange lægemidler, der anvendes mod smerter eller til at sænke feber) til børn i 4 uger efter vaccination med Pandemisk influenzavaccine H5N1 AstraZeneca, medmindre lægen, sundhedspersonalet eller apotekspersonalet fortæller dig noget andet.
English: Check expiry date Product must be used before date on applicator label.
Danish: Kontroller udløbsdatoen Præparatet skal anvendes før datoen på applikatorens etiket.
English: Animal developmental toxicity studies conducted with T/LAIV and Fluenz Tetra do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier af udviklingstoksicitet udført med T/LAIV og Fluenz Tetra indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet.
English: USA, Europe, Asia/Oceania
Danish: USA, Europa, Asien/Oceanien
English: The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: In addition, studies conducted with AstraZeneca's 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Danish: Derudover anses studier udført med AstraZenecas2009 H1N1 pandemiske LAIV-vaccine og sæsonbetingede T/LAIV-influenzavaccine også for understøttende, da alle disse vacciner fremstilles under anvendelse af samme proces, administreres ad samme vej og primært er undersøgt hos behandlingsnaive personer.
English: Table 1 T/LAIV efficacy in placebo controlled paediatric studies
Danish: Tabel 1 Virkningen af T/LAIV i placebokontrollerede pædiatriske studier
English: Of these subjects, 319 received a second dose (256 subjects monovalent vaccine; 63 subjects placebo).
Danish: Af disse forsøgspersoner fik 319 en dosis nr. 2 (256 forsøgspersoner med monovalent vaccine; 63 forsøgspersoner med placebo).
English: Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Danish: Ikke almindelig: Overfølsomhedsreaktioner (herunder ansigtsødem, urticaria og meget sjældne anafylaktiske reaktioner)
English: T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Danish: T/LAIV har demonstreret superioritet i 3 aktivt kontrollerede studier med influenzavaccine til injektion.
English: *** fluorescent focus units
Danish: *** fluorescerende fokus-enheder (FFU)
English: Post-marketing experience with seasonal T/LAIV Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed.
Danish: Post-marketing erfaring med sæsonbetinget T/LAIV Der foreligger meget sjældne rapporter om Guillain-Barrés syndrom og forværring af symptomer på Leighs syndrom (mitokondriel encefalomyopati).
English: Of the P/LAIV-naïve subjects, only 10% had ≥4-fold rises by Day
Danish: Af de P/LAIV-naive forsøgspersoner havde kun 10 % en ≥4-gange stigning på dag 7.
English: Additional data are provided from 289 adults enrolled in studies of vaccine candidates for an additional 7 influenza subtypes and from 240 adults and 259 children enrolled in studies of the monovalent 2009 H1N1 pandemic vaccine.
Danish: Desuden foreligger data fra 289 voksne, der deltog i studier med vaccinekandidater med yderligere 7 influenza-undertyper, og fra 240 voksne og 259 børn, der deltog i studier med den monovalente 2009 H1N1-pandemiske vaccine.
English: No data are available for individuals with severe immunosuppression (see section 4.4).
Danish: Der er ingen tilgængelige data for personer med svær immunsuppression (se pkt.
English: Metabolism and nutrition disorders Very common: Decreased appetite
Danish: Metabolisme og ernæring Meget almindelig: Appetitløshed
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: Under en pandemi kan det imidlertid være relevant at give vaccinen under forudsætning af, at der er genoplivningsudstyr inden for rækkevidde, hvis det skulle blive nødvendigt.
English: Children and adolescents from 12 months to less than 18 years of age 0.2 ml (administered as 0.1 ml per nostril).
Danish: Børn og unge i alderen fra 12 måneder og op til 18 år 0,2 ml (administreret som 0,1 ml i hvert næsebor).
English: T/LAIV efficacy
Danish: Virkningen af T/LAIV
English: Due to the association of Reye's syndrome with salicylates and wild-type influenza infection, healthcare providers should assess the potential risks of administering the vaccine with the potential benefits in a pandemic situation (see section 4.5).
Danish: Da Reyes syndrom er associeret med salicylater og vildtype-influenzainfektion, bør sundhedspersonalet vurdere de potentielle risici ved administration af vaccinen i forhold til de potentielle fordele under en pandemi (se pkt.
English: FFU per 0.2 ml dose
Danish: FFU pr. 0,2 ml dosis
English: Although safety in children and adolescents with mild to moderate asthma has been established for T/LAIV, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
Danish: Selvom sikkerheden af T/LAIV er fastlagt hos børn og unge med let til moderat astma, er der kun begrænsede data for børn med andre lungesygdomme eller med kroniske kardiovaskulære, metaboliske eller nyrerelaterede sygdomme.
English: Do not use this vaccine after the expiry date which is stated on the applicator label after the letters EXP.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på pakningen efter Exp.
English: • DO NOT USE WITH A NEEDLE.
Danish: • MÅ IKKE ANVENDES MED EN KANYLE.
English: • After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Danish: • Efter administration af halvdelen af dosen i det ene næsebor skal den anden halvdel af dosen administreres i det andet næsebor umiddelbart eller kort tid derefter.
English: No deaths resulted from these events, and none of the hospitalised children required mechanical ventilation or admission to an intensive care unit.
Danish: Der var ingen dødsfald i forbindelse med disse hændelser, og respiratorbehandling eller indlæggelse på intensivafdeling var ikke nødvendig for nogen af de indlagte børn.
English: Shedding of the H5N1 vaccine virus in adults was extremely limited.
Danish: Udskillelse af H5N1-vaccinevirus hos voksne var ekstremt begrænset.
English: The safety of seasonal live attenuated influenza vaccine (LAIV) in children with severe asthma and active wheezing has not been adequately studied.
Danish: Sikkerheden ved at give sæsonbetinget levende svækket influenzavaccine (LAIV) til børn med svær astma og aktiv hvæsende vejrtrækning er ikke undersøgt tilstrækkeligt.
English: T/LAIV's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Danish: T/LAIV's effektdata i den pædiatriske population er beskrevet i 9 kontrollerede studier, der omfatter over 20.000 spædbørn og småbørn, børn og unge udført genem 7 influenzasæsoner.
English: There have been reports of administration of twice the recommended dose of the seasonal vaccine Fluenz Tetra and the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) in the post-marketing setting.
Danish: Der har været rapporter om indgivelse af det dobbelte af den anbefalede dosis af den sæsonbetingede vaccine Fluenz Tetra og den sæsonbetingede trivalente levende, intranasale influenzavaccine (T/LAIV) efter markedsføringen.
English: In a pandemic situation, healthcare providers need to assess the potential benefits, alternatives, and risks of administering the vaccine to children and adolescents with significant clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Danish: Under en pandemi skal sundhedspersonalet vurdere de potentielle fordele, alternativer og risikoen ved at administrere vaccinen til børn og unge med klinisk signifikant immundefekt på grund af sygdomme eller immunsuppressiv behandling, såsom akut og kronisk leukæmi, lymfomer, symptomatisk hiv-infektion, cellulær immundefekt og høje kortikosteroiddoser.
English: This medicine has been given “conditional approval”.
Danish: Dette lægemiddel er godkendt under ”betingede omstændigheder”.
English: P/LAIV priming dose
Danish: P/LAIVprimingdosis
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemic influenza vaccine H5N1 AstraZeneca in one or more subsets of the paediatric population in prevention of influenza infection.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Pandemisk influenzavaccine H5N1 AstraZenecai en eller flere undergrupper af den pædiatriske population til forebyggelse af influenzainfektion.
English: Overall, the safety profile of T/LAIV in a limited number of subjects with mildly to moderately nonHIV related compromised immune function, asymptomatic or mildly symptomatic HIV infection, or cancer (solid tumors and haematological malignancies) was comparable to that in healthy individuals and does not indicate any untoward effect.
Danish: Samlet set var sikkerhedsprofilen for T/LAIV hos et begrænset antal forsøgspersoner med let til moderat ikke-hiv-relateret kompromitteret immunfunktion, asymptomatisk eller let symptomatisk hiv-infektion eller cancer (solide tumorer og hæmatologiske maligniteter) sammenlignelig med sikkerhedsprofilen for raske personer og indikerede ingen problematiske virkninger.
English: In more than 300 case reports in the AstraZeneca safety database of vaccine administration in pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Danish: I mere end 300 rapporter i AstraZeneca's bivirkningsdatabase med administration af vaccine hos gravide kvinder, observeredes ingen usædvanlige mønstre af graviditetskomplikationer eller virkninger hos fostret.
English: Adult studies
Danish: Voksenstudier
English: After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Danish: Efter administration af halvdelen af dosen i det ene næsebor, skal den anden halvdel af dosen administreres i det andet næsebor umiddelbart eller kort tid derefter.
English: In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6,
Danish: I et overvågningsstudie udført af US CDC (Griffin et al, 2011) blev effektiviteten af H1N1-pandemisk LAIV-vaccinen hos børn i alderen 2 til 9 år estimeret til 81,9 % (95 % CI: 13,6-96,2).
English: Study group
Danish: Studiegruppe
English: Clinical study CIR 277 assessed whether prior recipients of pandemic live attenuated influenza H5N1 vaccines were primed or established long-lasting immunity that could be detected following the subsequent administration of an inactivated H5N1 vaccine.
Danish: I det kliniske studie CIR 277 blev det vurderet, hvorvidt tidligere modtagere af pandemisk levende svækket H5N1-influenzavacciner var primede eller havde erhvervet langvarig immunitet, der kunne påvises ved efterfølgende administration af en inaktiveret H5N1-vaccine.
English: D153-P502 Europe 6 to 35 M
Danish: D153-P502 Europa 6 til 35 mdr.
English: For the H7N9 P/LAIV, 8 of 14 individuals who received a single dose of vaccine and 13 of 16 individuals who received two doses of vaccine developed strong antibody responses; peak titers were again seen by Day 14.
Danish: For H7N9 P/LAIV udviklede 8 ud af 14 personer, som fik en enkelt vaccindosis, og 13 ud af 16 personer, som fik to vaccindoser, kraftige antistofreaktioner; maksimale titre blev igen set på dag 14.
English: 5 single-use nasal applicators (0.2 ml each)
Danish: 5 nasalapplikatorer til engangsbrug (0,2 ml hver)
English: Do not remove dose-divider clip at the other end of the applicator.
Danish: Klemmen til dosisdeling i den anden ende af applikatoren må ikke fjernes.
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (seasonal T/LAIV: n=1,114, seasonal injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
Danish: I et studie (D153-P515) med børn i alderen 6 til 17 år med astma (sæsonbetinget T/LAIV: n = 1.114, sæsonbetinget influenzavaccine til injektion: n = 1.115) var der ingen signifikante forskelle mellem behandlingsgrupperne i forekomsten af astmaeksacerbationer, gennemsnitligt peak flow, astmasymptomscore eller score for natlig opvågning.
English: Data regarding co-administration of the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) with live attenuated vaccines (measles, mumps, and rubella vaccine (MMR), varicella vaccine, and orally-administered poliovirus) are available and suggest that concomitant admininstration of Pandemic influenza vaccine H5N1 AstraZeneca with these live vaccines may be acceptable.
Danish: Data angående samtidig administration af den intranasale trivalente, levende, sæsonbetingede influenzavaccine (T/LAIV) og levende svækkede vacciner (vaccine mod mæslinger, fåresyge og røde hunde (MFR), skoldkoppevaccine og oralt indgivet poliovirus) er tilgængelige og tyder på, at samtidig administration af Pandemisk influenzavaccine H5N1 AstraZenecaog disse levende vacciner kan være acceptabel.
English: The adverse reactions reported were similar to those seen with the recommended single dose of T/LAIV and Fluenz Tetra.
Danish: De rapporterede bivirkninger var sammenlignelige med de bivirkninger, der er observeret ved den anbefalede enkeltdosis af T/LAIV og Fluenz Tetra.
English: For signs of allergic reactions, see section 4 “Possible side effects”.
Danish: For tegn på allergiske reaktioner, se punkt 4.
English: A total of 20 subjects (12 T/LAIV, 0.3%; 8 injectable influenza vaccine, 0.2%) were hospitalised in association with medically significant wheezing.
Danish: I alt 20 forsøgspersoner (12 for T/LAIV (0,3 %) og 8 for influenzavaccine til injektion (0,2 %)) blev indlagt i forbindelse med signifikant hvæsende vejrtrækning.
English: Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Danish: Reduktion i influenzasygdom bekræftet ved dyrkning i forhold til influenzavaccine til injektion.