FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Sundhedspersonalet skal derfor overveje fordele og potentielle risici ved administration af vaccinen til personer med trombocytopeni eller andre blødningsforstyrrelser, hvor intramuskulær injektion er kontraindiceret, medmindre den potentielle fordel er større end risikoen for blødning.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pumarix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine.
Danish: Det Europæiske Lægemiddelagentur har besluttet at udskyde forpligtelsen til at indsende resultater fra studier med Pumarix administreret til en eller flere undergrupper af børn med influenzainfektion forårsaget af en influenzastamme indeholdt i vaccinen eller relateret til en stamme indeholdt i vaccinen.
English: After mixing: Use within 24 hours and do not store above 30°C.
Danish: Efter sammenblanding: anvendes inden for 24 timer og må ikke opbevares over 30 °C.
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside
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 en pandemisk situation, vil en normal PSUR-cyklus og et normalt PSUR-format blive fastholdt, med specifik overvågning af AESI og mulige bivirkninger relateret til adjuvansen.
English: A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Danish: Der skal også udarbejdes et kort resume over PSUR, hvor alle problemstillinger markeres, udredningen af signalerne prioriteres (hvis der er flere hændelser), og hvor passende tidslinjer for indsendelse af en fuldstændig evalueringsrapport over signalerne angives.
English: As with all vaccines, Pumarix may not fully protect all persons who are vaccinated.
Danish: Som det også er tilfældet for andre vacciner, giver Pumarix ikke fuld beskyttelse til alle, der bliver
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Danish: Det kan være ledsaget af adskillige neurologiske tegn som f.eks. kortvarige synsforstyrrelser, paræstesier og tonisk-kloniske ekstremitetsbevægelser under opvågningen.
English: The safety and efficacy of Pumarix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Danish: Pumarix' sikkerhed og virkning hos børn under 3 år og hos børn og unge i alderen 10-17 år er ikke
English: In particular, please tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system.
Danish: Du skal især fortælle din læge eller sygeplejerske, hvis du får en behandling, som påvirker immunforsvaret (f.eks. kortikosteroid eller kemoterapi mod kræft).
English: Tell the doctor requesting these tests that you have recently been given Pumarix.
Danish: Fortæl det til den læge, som har udbedt sig disse blodprøver, at du for nyligt har fået
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each
Danish: Derfor anbefales overvågning af temperatur og febernedsættende tiltag (såsom at give paracetamol eller anden febernedsættende medicin) efter hver
English: Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Danish: Voksne i alderen 18 år og derover: Én dosis på 0,5 ml på en bestemt dag.
English: • Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand
Danish: • Smerter i ryggen eller nakken, stivhed i muskler, muskelkramper, smerter i ben eller hænder
English: The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03
Danish: Resultatet af dette heterologe forsøg indikerer en beskyttelse på 80,7 % - 100 % for alle adjuverede vaccinekandidater sammenlignet med 43 % beskyttelse for ikke-adjuverede vacciner, hvilket viser fordelen ved AS03 adjuveringen.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C).
Danish: Den blandede vaccine kan enten opbevares i køleskab (2 °C - 8 °C) eller ved stuetemperatur (25 °C - 30 °C).
English: There are currently no data available on the use of Pumarix in pregnancy.
Danish: Der er på nuværende tidspunkt ingen data fra anvendelse af Pumarix til gravide kvinder.
English: Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.
Danish: I betragtning af de foreliggende data om feber hos børn, vurderede PRAC, at ændringer i
English: Pumarix should under no circumstances be administered intravascularly.
Danish: Pumarix må under ingen omstændigheder gives intravaskulært.
English: Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years.
Danish: Desuden var feber mere udbredt hos børn i alderen 69 år end hos børn i alderen 3-5 år.
English: Pumarix may be used in lactating women.
Danish: Pumarix kan gives til ammende kvinder.
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) post
Danish: Derfor anbefales overvågning af temperatur samt febernedsættende tiltag (såsom antipyretisk medicin som vurderes klinisk nødvendig) hos små børn (f.eks. op til ca. 6 år)
English: Non-clinical data obtained with Pumarix 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 en formulering af Pumarix viser ikke nogen risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter akutte og gentagne doser, lokal tolerance, fertilitet hos kvinder, toksicitet for foster/nyfødt barn (til og med afslutningen af
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Danish: Den kliniske relevans af hæmagglutinationshæmningstiter (HI) ≥ 1:40 hos børn er ikke kendt.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR AT ANBEFALE VARIATIONEN AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN
English: Persons previously vaccinated with one or two doses of AS03-containing vaccine containing HA derived from a different clade of the same subtype
Danish: Personer, som tidligere er blevet vaccineret med en eller to doser AS03-adjuveret vaccine indeholdende HA fra en anden undergruppe af samme influenza-subtype
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Pumarix.
Danish: En mindre infektion, f.eks. forkølelse, er normalt ikke noget problem, men lægen eller sygeplejersken afgør, om du skal vaccineres med
English: Serious unexpected reactions (PTs)
Danish: Alvorlige, uventede reaktioner (foretrukne termer) 4.
English: - Report submission is no later than day 22 (i.e. the following Monday).
Danish: - Uret startes fra den første mandag efter afsendelse af den første vaccinebatch - Der indsendes rapport senest på dag 22 (dvs. den følgende mandag).
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 psykologisk reaktion over for kanylestik.
English: • SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: • SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER/TILTAG EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER
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 hududslæt, åndenød og hævelse af ansigt eller tunge.
English: The MAH shall perform the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan and requested as specific obligations.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de studier og aktiviteter, som er beskrevet i lægemiddelovervågninsplanen og påkrævet som specifikke forpligelser.
English: - All tables will be based on number of events (presented on PT level, sorted by System Organ Class
Danish: - Alle tabeller baseres på antal hændelser (med foretrukket term, opført efter organklasser (SOC)) og
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains and any safety data relevant
Danish: Dette vil inkludere data fra igangværende studier, eller evt. tilgængelige data fra aktuel brug af ”mock-up” stammen, samt andre relevante sikkerhedsdata i relation til adjuvanssystemet.
English: At day 42, the neutralising antibody responses were as follows: Immune response to A/Vietnam/1194/2004 21 days after 2
Danish: På dag 42 var det neutraliserende antistofrespons følgende: Immunrespons mod A/Vietnam/1194/2004 21 dage efter anden dosis
English: Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Pumarix indeholder thiomersal som konserveringsmiddel, og det er muligt, at du kan få en overfølsomhedsreaktion.
English: Talk to your doctor or nurse before you are given Pumarix:
Danish: Kontakt lægen eller sygeplejerske, før du får Pumarix:
English: During a pandemic situation (Phase 6 of the WHO global Influenza preparedness plan), bi-weekly "simplified PSUR" accompanied by a summary of vaccine distribution will be provided according to the cRMP guidance (Doc.
Danish: Under en pandemisk situation (WHO fase 6), skal en ”simplificeret PSUR” sammen med en opsummering af distributionen fremsendes to gange om ugen i overensstemmelse med cRMP guidance
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Danish: Sådanne situationer kræver, at oplysninger om sikkerhed, som kan have stor betydning for afvejning af fordele og ulemper ved en pandemi, indberettes hurtigt.
English: Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%.
Danish: Ti dage efter boosterdosen var seroprotektionsraten mod A/Turkey/Turkey/1/2005 og A/Indonesia/5/2005 99,2 %.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Danish: Den sammenblandede vaccine er kemisk og fysisk holdbar i op til 24 timer ved 30 °C.
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Danish: Kontrolgrupperne omfattede fritter immuniseret med hhv. adjuvans alene og ikke-adjuveret vaccine (7,5 µg HA).
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Danish: Anden vaccinedosis på 0,5 ml skal gives mindst 3 uger senere.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer før og under
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: Under en pandemisk situation er de nødvendige ressourcer muligvis ikke til stede for at dybdegående evaluering af PSUR i et format i overensstemmelse med Volume 9a (Rules Governing Medicinal product in the European Union) for en hurtig identifikation af nye sikkerhedssignaler.
English: Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Danish: Serologiske test indikerer en direkte sammenhæng mellem vaccineinduceret HI og neutraliserende antistoftitre hos dyr, som har opnået beskyttelse sammenlignet med kontrolgrupperne
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes)
Danish: Hvis den blandede vaccine opbevares i køleskab, skal vaccinen have stuetemperatur (efter minimum 15
English: However, in a pandemic situation, it may be appropriate to give the vaccine provided that facilities for resuscitation should be immediately available in case of need.
Danish: Det kan dog i en pandemisk situation skønnes nødvendig at vaccinere og genoplivningsudstyr skal da være umiddelbart inden for rækkevidde, hvis behovet skulle opstå.
English: Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine (H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose.
Danish: Kliniske data for børn under 6 år, som fik to doser af en anden pandemisk influenzavaccine (H5N1 fremstillet i Dresden, Tyskland) antyder en stigning i hyppigheden af feber (aksillær ≥ 38 °C) efter administration af den anden dosis.
English: The per-dose frequency of adverse reactions was as follows:
Danish: Hyppigheden pr. dosis af bivirkninger var følgende:
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes).
Danish: Inden emulsionen (adjuvans) og suspensionen (antigen) sammenblandes, skal de to komponenter have stuetemperatur (efter minimum 15 minutter).
English: Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports
Danish: Dødelige og/eller livstruende reaktioner - hver foretrukket term for sig, inkl.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile
Danish: Hvis den pandemiske situation tillader det, skal vaccination af patienter med svær, febril sygdom eller
English: Pumarix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Danish: Pumarix indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. den er stort set natrium- og kaliumfri.
English: • if you have problems with your immune system, since your response to the vaccine may then be
Danish: • hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat.
English: There is limited information available on the use of vaccine very similar to Pumarix (but manufactured in a different facility) to children aged from 3-9 years who received either two adult doses or two half adult doses given three weeks apart.
Danish: Der findes kun begrænset information om vaccination med en tilsvarende vaccine (fremstillet ved en anden proces) til børn i alderen fra 3-9 år, som har fået enten to voksendoser eller to halve voksendoser med 3 ugers mellemrum.
English: The suspension is a translucent to off white opalescent suspension, which may sediment slightly.
Danish: Suspensionen er en gennemskinnelig til råhvid, opaliserende suspension, som kan være let sedimenteret.
English: • Reactions where the injection was given such as bruising, a hard lump, itching, warmth
Danish: • Reaktioner hvor indsprøjtningen blev givet (f.eks. blå mærker, hårdhed, kløe, varme)
English: • Adults from 18 years onwards: you will receive two doses of Pumarix.
Danish: Voksne fra 18 år og derover: Du vil få to vaccinedoser Pumarix .
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 resultater m.h.t. antistoffer mod humant immundefekt-virus-1 (HIV-1), hepatitis C-virus og specielt HTLV-1 i serum undersøgt med ELISAmetoden.
English: Pumarix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Danish: Pumarix er til forebyggelse af pandemisk influenza hos voksne fra 18 år og derover.
English: Allergic reactions which may cause you to have dangerously low blood pressure.
Danish: Overfølsomhedsreaktioner, som kan medføre et alvorligt lavt blodtryk.
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 med nogle årtiers mellemrum, og som spreder sig hurtigt i hele verden.
English: - In Tables 1 to 5, numbers will be provided for events received during the reporting period and
Danish: - I tabel 1-5 vises antal hændelser i rapporteringsperioden og kumulativt.
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Danish: 2firdobbelt stigning af serum-neutraliserende antistof-titer 3procent af de vaccinerede, som opnåede en serum-neutraliserende antistof-titer på mindst 1:80
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Danish: Vaccinen blandes ved at trække det totale indhold af hætteglasset med adjuvans op vha. en 5 ml injektionssprøjte og tilsætte dette til hætteglasset med antigen.
English: • Allergic reactions leading to a dangerously low blood pressure.
Danish: • Overfølsomhedsreaktioner (allergiske reaktioner), som kan føre til et alvorligt lavt blodtryk.
English: Pumarix contains sodium and potassium
Danish: Pumarix indeholder natrium og kalium
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Danish: 3 boosterfaktor: forholdet mellem post-boostergeometrisk middeltiter (GMT) og præ-booster-GMT.
English: The volume of the Pumarix vial after mixing is at least 5 ml.
Danish: Efter sammenblanding af Pumarix indeholder hætteglasset mindst 5 ml.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the
Danish: Under en pandemi vil ansøgeren af markedsføringstilladelsen udføre et prospektivt kohortestudie, som beskrevet i lægemiddelovervågningsplanen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter sammenblanding indeholder 1 dosis (0,5 ml):
English: The use of Pumarix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Danish: Vaccination med Pumarix kan overvejes til gravide kvinder, hvis det skønnes nødvendigt.
English: Immune response against A/Indonesia/5/2005 (H5N1)
Danish: Immunrespons mod A/Indonesia/05/2005 (H5N1)
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Danish: Fortæl altid lægen eller sygeplejersken, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘Guillain
Danish: • Neurologiske lidelser (nervelidelser), f.eks. encephalopati (betændelse i det centrale nervesystem), neuritis (betændelse af nerver) og en form for lammelser kendt som Guillain-Barrés Syndrom
English: A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180.
Danish: En titer på 1:80 blev opnået hos 95,7 % af personerne på dag 21, samt på dag 42 og hos 85,1 % af
English: Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet have this capability.
Danish: - Et mål for den relative rapporteringsrate af signaler for hver rapporteret PT skal om muligt indsendes (f.eks. Proportional reporting ratio (PRR), Information Component (IC) eller Empirical Bayesion Geometric Mean (EBMG)); dette er ikke et påbud, idet ikke alle indehavere af en
English: GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
English: Protocol of the registry will be submitted as part of RMP, during the pandemic
Danish: Under pandemien vil en protokol over registreringen blive indsendt som en del af
English: In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Danish: Yderligere blev en gruppe med seks fritter immuniseret med vaccinekandidat, som indeholder 3,75 µg H5N1 + fuld dosis AS03 og en kontrolgruppe blev immuniseret med ikke-adjuveret vaccine (3,75 µg HA).
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Danish: Suspension: multidosishætteglas med antigen Emulsion: multidosishætteglas med adjuvans.
English: At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years
Danish: På dag 42 havde 100 % af personerne i alderen 18-60 år og 96,4 % af personerne over 60 år en titer på mindst
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Danish: Bivirkningerne nedenfor er set for en H1N1 AS03-adjuveret vaccine.
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Danish: Vaccinens evne til at yde beskyttelse mod homologe og heterologe virusstammer er vurderet præ-klinisk for A/Indonesia/05/05 (H5N1) ud fra et forsøg med fritter.
English: In adults 18 to 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (80.5%), muscle aches (37.2%), fatigue (25.2%), headache (25.1%), joint pain
Danish: Hos voksne på 18-64 år var de hyppigst rapporterede bivirkninger efter vaccination smerter på injektionsstedet (80,5 %), muskelsmerter (37,2 %), træthed (25,2 %), hovedpine (25,1 %), ledsmerter