FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.
Danish: Co-administration var ikke forbundet med en øget hyppighed af lokale eller systemiske reaktioner sammenlignet med administration af Pandemrix alene.
English: • Severe stabbing or throbbing pain along one or more nerves
Danish: • kraftigt stikkende eller bankende smerter langs en eller flere nerver
English: These data suggest that the excessive risk tends to decline with increasing age at vaccination.
Danish: Disse data typer på, at den forøgede risiko har tendens til at blive mindre med stigende alder på vaccinationstidspunktet.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: En læge eller sygeplejerske vil give dig vaccinen i overensstemmelse med officielle anbefalinger.
English: • Short-term sleepiness following vaccination
Danish: • forbigående søvnighed efter vaccination
English: Pandemrix should be used in accordance with Official Guidance.
Danish: Pandemrix skal anvendes i overensstemmelse med officielle anbefalinger.
English: Uncommon Insomnia
Danish: Ikke almindelig Insomni
English: A minor infection such as a cold should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated with Pandemrix.
Danish: En mindre infektion, f.eks. forkølelse, bør ikke være et problem, men lægen eller sygeplejersken vil afgøre, om du kan blive vaccineret med Pandemrix.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Lægen er opmærksom på dette og har et nødberedskab klar i sådanne tilfælde.
English: Epidemiological studies relating to Pandemrix in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Danish: Epidemiologiske studier med Pandemrix i flere europæiske lande har indikeret en øget risiko for narkolepsi med eller uden katapleksi hos vaccinerede sammenlignet med ikke-vaccinerede personer.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede, sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website.
Danish: Detaljer omkring denne vurdering kan ses i CHMPs vurderingsrapport EMEA/H/C/000832/II/0079, som er offentliggjort på EMAs webside.
English: Talk to your doctor or nurse before you receive Pandemrix:
Danish: Tal med lægen eller sygeplejersken, inden du får Pandemrix:
English: Based on the evaluation of the data submitted, the CHMP considers that the above post-authorisation measures as reflected above have been fulfilled.
Danish: På baggrund af evalueringen af de indsendte data, finder CHMP, at de ovennævnte foranstaltninger efter udstedelse af markedsføringstilladelse er opfyldte.
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Danish: ANDET Opbevaring (2 °C til 8 °C), må ikke nedfryses, beskyttes mod lys
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 May 2008
Danish: Dato for første markedføringstilladelse: 20. maj 2008
English: Excessive sleepiness during the day, often at the wrong times (a long-term condition called narcolepsy), has been reported very rarely after vaccination with Pandemrix in several European countries.
Danish: Overdreven søvnighed i løbet af dagen, ofte på forkerte tidspunkter (en længerevarende tilstand kaldet narkolepsi), er i meget sjældne tilfælde blevet rapporteret efter vaccination med Pandemrix i flere europæiske lande.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenza-vacciner, ATC-kode: J07BB02.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du får Pandemrix.
English: Tell the doctor requesting these tests that you have recently been given Pandemrix.
Danish: Fortæl det til den læge, som har udbedt sig disse blodprøver, at du for nyligt har fået Pandemrix
English: The relationship between Pandemrix and narcolepsy is still under investigation.
Danish: Sammenhængen mellem Pandemrix og narkolepsi undersøges fortsat.
English: They may also happen with Pandemrix.
Danish: De kan også opstå som følge af Pandemrix.
English: However, in the case this needle size would not be available, a 21-G needle might be used.
Danish: Er denne kanylestørrelse ikke tilgængelig kan en 21-G kanyle dog også anvendes.
English: All these side effects were reported very commonly after each dose.
Danish: Alle disse bivirkninger var meget almindelige efter begge doser.
English: Antigen suspension for Pandemrix Influenza vaccine
Danish: Antigen, suspension til Pandemrix Influenzavaccine
English: Split influenza virus, inactivated, containing antigen* equivalent to:
Danish: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til:
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Danish: Data fra gravide kvinder vaccineret med forskellige inaktiverede, ikke-adjuverede sæson-vacciner tyder ikke på misdannelser eller føtal/neonatal toksicitet.
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects
Danish: Doseringsanbefalingerne tager hensyn til sikkerheds- og immunogenicitetsdata fra kliniske studier med raske personer.
English: Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
Danish: Immunisering af personer med svær, febril sygdom eller akut infektion skal udsættes.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Pandemrix but containing antigen derived from H5N1 viruses.
Danish: Der findes yderligere information fra studier udført med en anden vaccine med komposition svarende til Pandemrix, men med et antigen fra H5N1-vira.
English: Two clinical studies evaluated the immunogenicity of Pandemrix in healthy subjects aged 18-60 years.
Danish: To kliniske studier evaluerede immunogeniciteten af Pandemrix hos raske personer i alderen 18-60 år.
English: Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
Danish: Dyrestudier med Pandemrix indikerer ikke reproduktionstoksicitet (se pkt.
English: The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Danish: Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale foranstaltninger, der muliggør identifikation og sporbarhed af den A/H1N1 vaccine, som administreres til hver enkelt patient, for herved at minimere administrationsfejl og hjælpe patienter og sundhedspersonale med at indberette bivirkninger.
English: It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix.
Danish: Det bør foretrækkes at administrere ikkeadjuverede sæsoninfluenza-vacciner før eller sammen med første dosis Pandemrix.
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Danish: Kontrolgrupperne omfattede fritter vaccineret med adjuvans alene med en ikke-adjuveret vaccine (15 mikrogram HA) eller med en saltvandsopløsning indeholdende en phosphatbuffer.
English: The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.
Danish: Bivirkningerne anført nedenfor er set i kliniske studier med Pandemrix til voksne, inklusive ældre.
English: Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Danish: Børn under 6 måneder På nuværende tidspunkt anbefales det ikke at vaccinere børn i denne aldersgruppe.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen og enhver efterfølgende godkendt opdatering af RMP.
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Danish: Det er estimeret, at over 200.000 kvinder er blevet vaccineret under graviditeten.
English: There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months.
Danish: Der er ingen tilgængelige sikkerheds- og immunogenicitetsdata fra kliniske studier med Pandemrix (H1N1)v til børn under 6 måneder.
English: One pack of Pandemrix consists of:
Danish: En pakning Pandemrix består af:
English: Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).
Danish: Narkolepsi kan forekomme med eller uden pludselig muskelsvaghed, som kan forårsage fald (en tilstand kaldet katapleksi).
English: Tell your doctor if you have any known allergies.
Danish: Fortæl det til lægen, hvis du lider af allergi.
English: This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Danish: Pandemrix indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. den er i det væsentlige natrium- og kaliumfri.
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Danish: Brug ikke suspensionen og emulsionen efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before each withdrawal.
Danish: Hvis den blandede vaccine opbevares i køleskab, skal vaccinen have antaget stuetemperatur (efter minimum 15 minutter) før hver udtagning.
English: • A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden weakness (cataplexy), which may lead to falls without loss of consciousness
Danish: • en længerevarende tilstand, der resulterer i overdreven søvnighed i dagtimerne (narkolepsi) med eller uden pludselig svaghed (katapleksi), der kan medføre fald uden bevidsthedstab
English: The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Pandemrix.
Danish: Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale en måde, hvorpå patienter og sundhedspersonale vedvarende har tilgang til opdateret information om Pandemrix.
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: Du skal derfor fortælle det til lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse med en injektion.
English: Anaphylaxis, allergic reactions
Danish: Anafylaksi, allergiske reaktioner
English: It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Danish: Det anbefales, at bruge en kanylestørrelse der ikke er større end 23-G.
English: Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single dose may be sufficient.
Danish: Immunogenicitetsdata opnået tre uger efter en dosis Pandemrix (H1N1)v indikerer, at en enkelt dosis er tilstrækkelig.
English: - Phenotypic characterization of hypocretin and influenza-specific T cells after stimulation with hypocretin or influenza peptides.
Danish: - Fænotypisk karakterisering af hypocretin og influenzaspecifikke T-celler efter stimulering med hypocretin eller influenzapeptider.
English: Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Danish: Pandemrix kan gives samtidig med en sæsoninfluenza-vaccine, som ikke indeholder adjuvans.
English: neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Danish: neuritis (betændelse af nerver) og en form for lammelser kendt som Guillain-Barrés Syndrom.
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Danish: Temperaturen skal derfor overvåges og feberen sænkes (f.eks. ved at give paracetamol eller anden medicin, som kan sænke feberen) efter hver vaccinedosis.
English: It is recommended that subjects who receive a first dose of Pandemrix should complete the vaccination course with Pandemrix (see section 4.4).
Danish: Det anbefales, at personer, som får den første dosis af Pandemrix, fuldfører vaccinationsprogrammet med Pandemrix (se pkt.
English: In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Danish: Både i kontrolgruppen, som fik ikke-adjuveret vaccine, og kontrolgruppen, som blev vaccineret alene med adjuvans, døde alle dyr eller måtte aflives, fordi de var døende 3-4 dage efter påbegyndt belastning.
English: Pandemrix should under no circumstances be administered intravascularly.
Danish: Pandemrix må under ingen omstændigheder gives intravaskulært.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemrix in one or more subsets of the paediatric population in the prevention of influenza infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Pandemrix i en eller flere undergrupper af den pædiatriske population som profylakse mod influenza (se pkt.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Danish: Den kliniske relevans af hæmagglutinationshæmmingstiter (HI-titer) ≥ 1:40 hos børn er ukendt.
English: 50 vials: suspension (antigen)
Danish: 50 hætteglas: suspension (antigen)
English: Adults aged 18 years and older:
Danish: Voksne i alderen 18 år og derover:
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 nævnt i punkt 4 (”Bivirkninger”), kan påvirke din evne til at køre bil eller anvende maskiner.
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.
Danish: Der findes ingen sikkerheds-, immunogenicitets- eller effektdata, der støtter udskiftning af Pandemrix med andre (H1N1)v-vacciner.
English: The side effects listed below have happened after Pandemrix (H1N1)v came on the market:
Danish: Følgende bivirkninger er set, efter Pandemrix (H1N1)v er blevet markedsført:
English: It is not known whether the observed effects would apply to administration of nonadjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals have elapsed since administration of Pandemrix.
Danish: Det vides ikke, om denne effekt også vil kunne observeres ved administration af ikke-adjuveret sæsoninfluenza-vaccine efter en enkelt dosis Pandemrix eller ved længere tidsinterval efter administration af Pandemrix.
English: See sections 4.4, 4.8 and 5.1 for details.
Danish: 4.4, 4.8 og 5.1.
English: The volume of the Pandemrix vial after mixing is at least 5 ml.
Danish: Efter rekonstitution af Pandemrix indeholder hætteglasset mindst 5 ml.
English: Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each dose of Pandemrix.
Danish: Det anbefales derfor at overvåge temperaturen og sænke feberen (f.eks kan administration af antipyretika være klinisk nødvendigt) hos yngre børn (dvs. børn op til ca. 6 år) efter hver dosis Pandemrix.
English: Some side effects (including local redness and fever) occurred more frequently after the second dose compared to the first dose.
Danish: Nogle bivirkninger (f.eks. rødme og feber) var hyppigere efter den anden dosis end efter første dosis.
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Danish: • neurologiske lidelser (nervelidelser), f.eks. encefalopati (betændelse i det centrale nervesystem),
English: What you need to know before you receive Pandemrix
Danish: Det skal du vide, før du får Pandemrix
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 overfølsomhedsreaktion kan være kløende udslæt, åndenød og hævelse af ansigt eller tunge
English: Pandemrix contains thiomersal
Danish: Pandemrix indeholder thiomersal
English: • Tingling or numbness of the hands or feet
Danish: • prikken eller følelsesløshed i hænder eller fødder
English: Half dose
Danish: Halv dosis
English: Immune response to Pandemrix (H1N1)v
Danish: Immunrespons mod Pandemrix (H1N1)v
English: - Verify influenza-specificity of hypocretin-specific CD4 T cells from narcoleptic patients by complementary assays and verify if crossreactive CD4 T cells are found among influenza-specific CD4 T cells from healthy subjects after vaccination with Pandemrix or nonadjuvanted H1N1v vaccine.
Danish: - Verificere influenza-specificiteten af hypocretinspecifikke CD4-T-celler fra narkolepsi-patienter ved brug af komplementære analyser og verificere, om krydsreaktive CD4-T-celler findes blandt influenzaspecifikke CD4-T-celler fra raske personer efter vaccination med Pandemrix eller med en ikke-adjuveret H1N1v-vaccine.
English: • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Danish: • vaskulitis (betændelse i blodkarrerne, som kan forårsage udslæt, ledsmerter og nyreproblemer)
English: Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Danish: Erfaringer med trivalente sæsoninfluenzavacciner efter markedsføring Blod og lymfesystem Sjælden
English: Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Danish: Prækliniske data fra mock-up-vaccinen indholdende H5N1-vaccinestamme viser ikke nogen risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter akutte og gentagne doser, lokal tolerance, fertilitet hos kvinder, toksicitet for foster/nyfødt barn (til og med afslutningen af ammeperioden).
English: 10-17 years
Danish: 10-17 år
English: Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.
Danish: Pandemrix er en vaccine til forebyggelse af influenza forårsaget af A(H1N1)v-2009-virus.
English: The anti-HA antibody responses 21 days after the first and the second dose were as follows:
Danish: Anti-HA-anstistofresponset 21 dage efter første og anden dosis var følgende:
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models.
Danish: Vaccinens evne til at yde beskyttelse mod homologe og heterologe virusstammer er vurderet præklinisk ud fra et belastningsforsøg med fritter.
English: Children aged less than 6 months
Danish: Børn under 6 måneder
English: In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose.
Danish: Specielt steg hyppigheden af feber betydeligt (aksillær temperatur > 38 ºC) efter den anden dosis.
English: Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders
Danish: Rødme og kløe ved injektionsstedet, feber Ikke almindelig Induration og varme ved injektionsstedet, influenzalignende sygdom, utilpashed Erfaringer med Pandemrix (H1N1)v efter markedsføring Immunsystemet
English: The suspension is a colourless light opalescent liquid.
Danish: Suspensionen er en farveløs, let opaliserende væske.
English: In study D-Pan-H1N1-008, the neutralising antibody responses were as follows:
Danish: I studiet D-Pan-H1N1-008 var det neutraliserende antistofrespons følgende: Serumneutraliserende antistof
English: Conduct non-clinical (including mechanistic) studies in order to elucidate the role of the vaccine and its adjuvant on the association between Pandemrix and narcolepsy: - Identify T cell signature from narcoleptic patients by deep sequencing of total CD4 T cells obtained from narcolepsy patients and DQ0602-matched non-vaccinated healthy subjects and, if identified, verify if signature is found in CD4 T cells from healthy subjects after vaccination with Pandemrix or non-adjuvanted H1N1v vaccine.
Danish: Udføre non-kliniske (herunder mekanistiske) studier for at belyse rollen af vaccinen og dens adjuvans i sammenhængen mellem Pandemrix og narkolepsi: - Identificere T-celle-signaturen hos patienter med narkolepsi ved dyb sekventering af total CD4-T-celler fra narkolepsi-patienter og DQ0602-matchede ikkevaccinerede raske personer og (hvis identificeret) verificere, om signaturen er fundet i CD4-T-celler fra raske vaccinerede personer efter vaccination med Pandemrix eller med en ikke-adjuveret H1N1v- vaccine.
English: There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Danish: Der opnås et højere immunrespons efter den anden dosis a 0,25 ml givet efter et interval på tre uger.
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).
Danish: Vaccinen skal administreres i overensstemmelse med den anbefalede dosis (se punkt 3 ”Sådan bliver du behandlet med Pandemrix”).
English: Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Danish: Tolv måneder efter første dosis var seroprotektionsraten 85 % i begge aldersgrupper.
English: Pandemrix contains sodium and potassium
Danish: Pandemrix indeholder natrium og kalium
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 influenza-vaccination kan der forekomme falsk positive resultater m.h.t. antistoffer mod hiv1, hepatitis C-virus og specielt HTLV-1 i serum undersøgt med ELISA-metoden.