FrancophonIA/ELRC3.0 huggingface dataset:
English: When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Danish: Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvar) skabe sin egen beskyttelse (antistoffer) mod sygdommen.
English: • Supportive data in adults a)
Danish: • Understøttende data hos voksne a) Krydsreaktivitet
English: Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Danish: Fortæl det til din læge, hvis du er gravid, tror du er gravid eller planlægger at blive gravid.
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Hvis du er usikker, så tal med din læge eller sygeplejersken, inden du får denne vaccine.
English: Animals were monitored for 16-17 days after challenge to allow for a comprehensive assessment of disease progression, including the time of onset of symptoms, mortality, or subsequent recovery.
Danish: Dyrene blev monitoreret i 16-17 dage efter challenge for at tillade omfattende vurdering af sygdomsprogression, herunder tidspunkt for symptomdebut, mortalitet eller efterfølgende helbredelse.
English: • Available data in paediatric populations
Danish: • Foreliggende data fra pædiatriske populationer
English: b) Long term booster immune memory
Danish: b) Langsigtet booster-immunhukommelse
English: Via Fiorentina, 1 - 53100 Siena
Danish: Via Fiorentina, 1 - 53100 Siena Italien
English: Control animals received adjuvant alone.
Danish: Kontroldyr fik kun adjuvans.
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/05 was also tested.
Danish: Virkning mod challenge med den heterologe virus A/Indonesia/5/05 blev også testet.
English: Trial on different vaccination schedules:
Danish: c) Studier vedrørende forskellige vaccinationsprogrammer:
English: The symptoms of pandemic flu are similar to those of an ordinary flu but may be more severe.
Danish: Den pandemiske influenzas symptomer er de samme som ved almindelig influenza, men kan være mere alvorlige.
English: * In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
Danish: * I mangel af CHMP-immunogenicitetskriterier for børn, blev de CHMP-immunogenicitetskriterier, der anvendes til at evaluere sæsoninfluenzavacciner hos voksne, anvendt på de serologiske data opnået efter vaccination af børn.
English: In the clinical trials with the vaccine, most side effects were mild in nature and short term.
Danish: I lægemiddelstudier med vaccinen var de fleste bivirkninger milde og kortvarige.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemisk situation vil den hyppighed, hvormed periodiske sikkerhedsopdateringsrapporter skal indsendes i henhold til artikel 24 i forordning (EF) nr. 726/2004, ikke være tilstrækkelig til sikkerhedsovervågning af en pandemisk vaccine, for hvilken der forventes høje eksponeringsniveauer inden for et kort tidsrum.
English: There were 3678 subjects 18-60 years of age, 264 subjects 61-70 years of age, and 41 subjects greater than 70 years of age.
Danish: Der var 3678 forsøgspersoner i alderen 18-60 år, 264 forsøgspersoner i alderen 61-70 år og 41 forsøgspersoner over 70 år.
English: H5N1 influenza vaccine
Danish: H5N1 influenzavaccine
English: This leaflet was last approved in {MM/YYYY}
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}.
English: Immunogenicity was assessed in a subset (n=197) of study population.
Danish: Immunogeniciteten blev vurderet hos en subgruppe (N=197) af forsøgspopulationen.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10) Ikke almindelig (1/1.000 til <1/100) Sjælden (1/10.000 til <1/1.000) Meget sjælden (<1/10.000)
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Danish: Herudover er bivirkningerne i listen nedenfor set i dagene eller ugerne efter vaccination med vacciner, som gives rutinemæssigt hvert år for at forebygge influenza.
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Danish: Immunrespons på vaccination målt ved MN-assay er på linje med resultater opnået med SRH.
English: It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Danish: Den er beregnet til at blive givet før eller under den næste influenzapandemi for at forebygge influenza forårsaget af virus af typen H5N1.
English: Palpitation, tachycardia.
Danish: Hjerte Palpitation, takykardi.
English: Immune response against A/Vietnam/1194/2004 (H5N1):
Danish: Immunrespons på A/Vietnam/1194/2004 (H5N1):
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Read all of this leaflet carefully before you start receive this vaccine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få medicinen.
English: The sideeffects are generally similar to those related to the seasonal flu vaccine.
Danish: Bivirkningerne ligner generelt dem, der ses i forbindelse med vaccinen mod sæsoninfluenza.
English: Local
Danish: Lokale
English: Compared to the adjuvant control group, lung damage was reduced in vaccinated groups.
Danish: Sammenlignet med adjuvans-kontrolgruppen var lungeskaderne mindre hos de vaccinerede grupper.
English: MN results yielded a GMR against A/turkey/Turkey/05 ranging from 1.59 to 2.95.
Danish: MN-resultaterne gav en GMR mod A/turkey/Turkey/05 i området fra 1,59 til 2,95.
English: Viral shedding and viral titers in lungs were also reduced, suggesting that vaccination may reduce the risk of viral transmission.
Danish: Viral shedding og virustiter i lungerne var også mindre, hvilket tyder på, at vaccination kan mindske risikoen for virusoverførsel.
English: Tell your doctor if you are breast-feeding and follow his advice.
Danish: Fortæl det til din læge, hvis du ammer, og følg hans råd.
English: MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Danish: MNresultater viste i lighed med SRH-resultater et stærkt immunrespons efter gennemførelse af primingvaccinationsserien hos en population af ældre forsøgspersoner.
English: In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Danish: Derfor skal indehaveren af markedsføringstilladelsen, så snart pandemien erklæres, og den præpandemiske vaccine anvendes, indsende hyppigere, forenklede periodiske sikkerhedsopdateringsrapporter i det format og efter den tidsplan, der er defineret i "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), og eventuelle efterfølgende opdateringer.
English: Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against the A/Indonesia/5/05 virus.
Danish: To doser vaccine beskyttede 92 % af dyrene, og en enkelt dosis vaccine beskyttede 50 % af dyrene mod A/Indonesia/5/05-virussen.
English: This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) per 0,5 ml dosis, dvs. at den i det væsentlige er natrium- og kaliumfrit.
English: Any unused vaccine and waste material should be disposed of in compliance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf bør destrueres i henhold til lokale retningslinjer.
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 en influenzavaccination kan der forekomme falsk positive serologiske resultater opnået ved ELISA-metoden for antistof mod human immundefektvirus-1 (HIV-1), hepatitis C-virus og især HTLV-1.
English: Reactogenicity after a third dose, administered 12 months following the first dose, was higher than after both first and second dose.
Danish: Reaktogeniciteten efter en tredje dosis administreret 12 måneder efter den første dosis var højere end efter både første og anden dosis.
English: In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine containing either 3.75 or 7.5 micrograms of antigen was administered.
Danish: I et lignende studie blev intranasal challenge udskudt til ca. 4 måneder efter administration af den anden dosis vaccine indeholdende enten 3,75 eller 7,5 mikrogram antigen.
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: Et beskyttende respons kan ikke med sikkerhed fremkaldes hos alle vaccinerede (se pkt.
English: Persistence of antibodies after primary vaccination in this population was assessed by HI, SRH, and MN assays.
Danish: Persistens af antistoffer efter primær vaccination i denne population blev vurderet med HI-, SRH- og MN-assays.
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Danish: I en pandemisk situation kan det dog være hensigtsmæssigt at give dig vaccinen under forudsætning af, at der er adgang til passende, akut medicinsk behandling, hvis det skulle blive nødvendigt i tilfælde af en allergisk reaktion.
English: Adverse reactions from clinical trial in children (6 months to 17 years old) (Study V87P6)
Danish: Bivirkninger fra kliniske studier hos børn (6 måneder til 17 år gamle) (Studie V87P6)
English: A study in rabbits did not indicate reproductive or developmental toxicity (see section 5.3).
Danish: Et studie med kaniner viste ingen reproduktions- eller udviklingstoksicitet (se pkt.
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 forventelige lokale reaktion, og træthed og hovedpine var de mest almindeligt rapporterede forventelige systemiske reaktioner.
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Danish: Feber ≥ 38 °C (≥ 40 °C) Enhver anden utilsigtet hændelse
English: Vaccination protected animals from lethal challenge even when HI antibody titers were low or undetectable.
Danish: Vaccination beskyttede dyrene mod letal challenge, selv når HI-antistoftitrene var lave eller ikke kunne detekteres.
English: In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Danish: Derudover vil de ressourcer, som er nødvendige for en dybtgående evaluering af periodiske sikkerhedsopdateringsrapporter i det format, der er defineret i bind 9a af The Rules Governing Medicinal Product in the European Union, måske ikke være tilstrækkelige under en pandemi til hurtig at kunne identificere et nyt sikkerhedsproblem.
English: The side effects listed below have occurred in the days or weeks after vaccination with Focetria H1N1v vaccine.
Danish: Nedenstående bivirkninger er forekommet i dagene og ugerne efter vaccination med Focetria H1N1vvaccine.
English: Very limited data in subjects with co-morbidities, including immunocompromised subjects are available for this H5N1 vaccine.
Danish: Der foreligger meget begrænsede data for forsøgspersoner med co-morbiditet, herunder immunkompromitterede forsøgspersoner, for denne H5N1-vaccine.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), and exudative erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
Danish: Vaskulitis (betændelse i blodkarrene, hvilket kan forårsage hududslæt, ledsmerter og nyreproblemer), og ekssudativ erythema multiforme (en slags allergisk hudreaktion, der forekommer som respons på lægemidler, infektioner eller sygdomme).
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode J07BB02.
English: There is limited experience in the elderly
Danish: Erfaringerne hos ældre er begrænsede.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SYGEPLEJERSKEN, da det kan være, at vaccination ikke anbefales, eller at den skal udskydes.
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section
Danish: Der er observeret en vis krydsbeskyttelse mod beslægtede varianter af H5N1-virus i kliniske studier (se pkt.
English: SRH antibody response against an homologous H5N1 Vietnam strain at day 43 reached all CHMP criteria for all 3 strains.
Danish: SRH-antistofrespons mod en homolog H5N1 Vietnam-stamme opfyldte på dag 43 alle CHMP-kriterier for alle 3 stammer.
English: MARKETING AUTHORISATION NUMBER EU/1/10/657/001 1 prefilled syringe EU/1/10/657/002 10 prefilled syringes
Danish: EU/1/10/657/001 1 forfyldt injektionssprøjte EU/1/10/657/002 10 forfyldte injektionssprøjter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/657/001-002
Danish: EU/1/10/657/001-002
English: Animals were challenged by the intranasal route on day 42 with a lethal dose of A/Vietnam/1203/04 virus.
Danish: Dyrene blev inficeret intranasalt på dag 42 med en letal dosis A/Vietnam/1203/04-virus.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breast-feeding.
Danish: Din læge må vurdere fordelene og de mulige risici ved at give dig vaccinen, hvis du er gravid eller ammer.
English: Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Danish: I sammenligning med antistofniveauer dag 43 efter gennemførelse af det primære vaccinationsprogram var antistofniveauerne ved dag 202 reduceret med 1/5 til 1/2 i forhold til de tidligere niveauer.
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Danish: Immunsystemet Vasculitis med forbigående nyrepåvirkning og ekssudativ erythema multiforme.
English: Use in children There is limited experience in children between 6 months and 17 years of age.
Danish: Brug til børn Erfaringerne hos børn i alderen 6 måneder til 17 år er begrænsede.
English: Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Danish: Allergiske reaktioner, muligvis med åndenød, hivende vejrtrækning, hævelse af svælget eller førende til et farligt fald i blodtrykket, som kan føre til shock, hvis det ikke behandles.
English: Loc. Bellaria - 53018 Rosia Sovicille (SI), Italy.
Danish: Loc. Bellaria - 53018 Rosia Sovicille (SI), Italien.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen er forpligtet til at foretage de undersøgelser og supplerende pharmacovigilance-aktiviteter, som er beskrevet i pharmacovigilance-planen (ifølge aftalen i risikostyringsprogrammets (RMP) version 3, Modul 1.8.2 i markedsføringsansøgningen), og enhver efterfølgende opdatering af RMP, som er godkendt af CHMP.
English: EXPIRY DATE EXP.:
Danish: EXP.:
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
Danish: De mulige bivirkninger er opstillet efter hyppighed nedenfor: meget almindelig (forekommer hos 1 bruger ud af 10) almindelig (forekommer hos 1 til 10 brugere ud af 100) ikke almindelig (forekommer hos 1 til 10 brugere ud af 1.000) sjælden (forekommer hos 1 til 10 brugere ud af 10.000) meget sjælden (forekommer hos færre end 1 bruger ud af 10.000)
English: A slight increase in reactions in adults was reported when a booster dose is administered 18 months after the initial dosing series.
Danish: En let øget bivirkningsfrekvens hos voksne blev inberettet, når en boosterdosis blev administreret 18 måneder efter den første dosis-serie.
English: Sodium chloride
Danish: Natriumchlorid Kaliumchlorid
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Danish: Fortæl venligst din læge hvis du har blødningsproblemer eller nemt får blå mærker.
English: % SP (95% CI) Day 43
Danish: % SP (95 % CI) dag 43
English: Nervous system disorders Very common: headache Rare: convulsions
Danish: Nervesystemet Meget almindelig: hovedpine Sjælden: kramper
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Children (3-<9 years)
Danish: Feber ≥ 38 °C (≥ 40 °C) Enhver anden utilsigtet hændelse Børn (3-<9 år)
English: General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying.
Danish: Hyppigt rapporterede bivirkninger for aldersgruppen 6 til 35 måneder var rødme på injektionsstedet, muskelsmerter, irritabilitet og usædvanlig gråd.
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Danish: * dyrket i æg ** udtrykt som mikrogram hæmagglutinin.
English: Uncommon: Flu like symptoms.
Danish: Ikke almindelig: Influenzalignende symptomer.
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Danish: De øvrige indholdsstoffer er: natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat, natriumcitrat, citronsyre og vand til injektioner.
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) were administered three weeks apart to 156 healthy adults.
Danish: To vaccinedoser indeholdende H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/dosis adjuveret) blev administreret med tre ugers mellemrum til 156 raske voksne.
English: Groups of 8 ferrets received one (day 21) or two (days 0 and 21) doses of vaccine containing 3.75 or 7.5 micrograms of antigen.
Danish: Grupper på 8 fritter fik en (dag 21) eller to (dag 0 og 21) doser vaccine indeholdende 3,75 eller 7,5 mikrogram antigen.
English: In toddlers erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Danish: Hos småbørn var rødme og ømhed de mest almindeligt rapporterede forventelige lokale reaktioner, mens irritabilitet og usædvanlig gråd var de mest almindeligt rapporterede forventelige systemiske reaktioner.
English: Some heterologous immune response against A/H5N1/turkey/Turkey/05 (NIBRG23; clade2.2) and A/H5N1/Indonesia (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
Danish: Der kunne detekteres et vist heterologt immunrespons mod A/H5N1/turkey/Turkey/05 (NIBRG23; clade 2.2) og A/H5N1/Indonesia (clade 2.1) efter både anden og tredje vaccination, hvilket tyder på, at clade 1-vaccine udviser krydsreaktivitet mod clade 2-stammer.
English: Preliminary data from spontaneously reported events and ongoing post-marketing studies (pregnancy registry and prospective interventional study) do not suggest direct or indirect harmful effects on influenza vaccines adjuvanted with MF59 with respect to pregnancy, fertility, embryonic/foetal development, parturition, or post natal development.
Danish: Præliminære data fra spontant indberettede hændelser og igangværende post-markedsføringsstudier (graviditetsregister og prospektivt, interventionsstudier) antyder ingen direkte eller indirekte skadevirkninger af vacciner adjuveret med MF59 med hensyn til graviditet, fertilitet, embryonal/føtal udvikling, fødsel eller udvikling efter fødslen.
English: Adverse reactions from clinical trials in adults (18 years old and above).
Danish: Bivirkninger fra kliniske studier med voksne (18 år og derover).
English: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Danish: A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)
English: If any of these side effects occur, please tell your doctor or nurse immediately.
Danish: Hvis du får en af disse bivirkninger, skal du straks fortælle det til din læge eller på apoteket.
English: Low blood platelet count which can result in bleeding or bruising.
Danish: Blodplademangel, som kan medføre blødning eller blå mærker.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Danish: Neurologiske lidelser som encephalomyelitis (betændelse i centralnervesystemet) og en slags lammelse, som kaldes Guillain-Barrés syndrom.
English: Vaccination protected animals from lethal challenge with virus homologous and heterologous to the vaccine.
Danish: Vaccination beskyttede dyrene mod letal challenge med vira, der var homologe og heterologe med vaccinen.
English: The vaccine contains per 0.5ml 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg
Danish: Vaccinen indeholder pr. 0,5 ml 9,75 mg squalen, 1,175 mg polysorbat og 1,175 mg sorbitantrioleat.
English: Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue.
Danish: Smerte, hårdhed på injektionsstedet, rødme på injektionsstedet, hævelse på injektionsstedet eller smerte på injektionsstedet, muskelsmerter, hovedpine, svedtendens, træthed.
English: 5.2 Pharmacokinetic properties Not applicable.
Danish: 5.2 Farmakokinetiske egenskaber