FrancophonIA/ELRC3.0 huggingface dataset:
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 sæsonbestemte vacciner tyder ikke på misdannelser eller toksicitet hos fostre eller nyfødte.
English: 24-35 months4
Danish: 24-35 måneder4
English: Immune response to A/Vietnam/1194/2004
Danish: Immunrespons mod A/Vietnam/1194/2004
English: Like all medicines, Arepanrix can cause side effects, although not everybody gets them.
Danish: Arepanrix kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 3.05 (dated September 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version 3.05 (dateret 4. september 2009) i Modul 1.8.1 i ansøgningsmaterialet til markedsføringstillladelsen, er på plads og fungerer, før produktet når markedet, og så længe det markedsførte produkt bliver anvendt.
English: • Adjuvant:
Danish: • Adjuvans:
English: Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension.
Danish: Et hvidligt bundfald kan ses i hætteglasset med suspension; dette bundfald er en del af suspensionens normale fysiske udseende.
English: Tell your doctor if you have any known allergies.
Danish: Fortæl det til din læge, hvis du lider af allergi.
English: Pharmacovigilance The Applicant/MAH will support one prospective and one retrospective cohort safety study with Arepanrix, in at least 9,000 patients, in accordance with the protocols submitted with the Risk Management Plan.
Danish: Pharmacovigilance Ansøgeren/indehaveren af markedsføringstilladelsen skal udføre et prospektivt og et retrospektivt kohorte sikkerhedsforsøg med Arepanrix, med mindst 9.000 patienter i overensstemmelse med protokollen indsendt med risikohåndterinsplanen (RMP).
English: One pack of Arepanrix consists of:
Danish: En pakke Arepanrix består af:
English: anti-HA antibody
Danish: Anti-HA antistof
English: 6-9 years
Danish: 6-9 år
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: Et beskyttende immunrespons kan ikke med sikkerhed fremkaldes hos alle vaccinerede (se pkt.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Danish: Denne vaccine indeholder thiomersal (en organisk kviksølvforbindelse) som konserveringsmiddel, og det er derfor muligt, at der kan forekomme overfølsomhedsreaktioner (se pkt.
English: 3.75 micrograms**
Danish: 3,75 mikrogram**
English: Adverse reactions reported are listed according to the following frequency:
Danish: De rapporterede bivirkninger er opstillet ud fra følgende hyppighed:
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 vaccination.
Danish: Det anbefales derfor at overvåge temperaturen og sænke feberen (f.eks kan administration af antipyretika være klinisk nødvendigt) hos yngre børn (f.eks op til ca. 6 år) efter hver vaccination.
English: Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were reported very commonly.
Danish: For børn i alderen 3-5 år er døsighed, irritabilitet og appetittab yderligere set ”meget almindeligt”.
English: There are currently no data available on the use of Arepanrix in pregnancy.
Danish: Der foreligger på nuværende tidspunkt ingen tilgængelige data om anvendelse af Arepanrix til gravide kvinder.
English: If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
Danish: Hvis den blandede vaccine opbevares i køleskab, skal vaccinen have stuetemperatur før hver udtagning.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Alle læger er opmærksomme på denne bivirkning og har akutberedskab klar til brug i sådanne tilfælde.
English: If any of these side effects occur, please tell your doctor or nurse immediately.
Danish: Hvis nogen af ovennævnte bivirkninger opstår, skal du straks fortælle det til din læge eller sygeplejerske.
English: Therefore the data indicate that Arepanrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Danish: Data indikerer derfor, at Arepanrix kan gives tre uger efter administration af ikke-adjuverede sæsoninfluenza-vacciner.
English: Children aged less than 6 months Vaccination is not currently recommended in this age group.
Danish: Børn under 6 måneder På nuværende tidspunkt anbefales det ikke at vaccinere børn i denne aldersgruppe.
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 bør derfor overvåges og feberen sænkes (f.eks. ved at give paracetamol eller anden medicin, som kan sænke feberen) efter hver vaccinedosis.
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of the AS03-containing vaccine containing HA from H1N1v alone.
Danish: Co-administration var ikke forbundet med en øget hyppighed af lokale eller systemiske reaktioner sammenlignet med administration af AS03-adjuveret vaccine, som indeholder HA fra H1N1v alene.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Danish: Der er ingen data for administration af AS03-adjuverede vacciner før eller efter administration af andre typer af influenzavacciner til præ-pandemisk eller pandemisk anvendelse.
English: These side effects may occur with Arepanrix.
Danish: Disse bivirkninger kan opstå som følge af Arepanrix.
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Danish: • Neurologiske lidelser (nervelidelser), f.eks. encephalopati (betændelse i det centrale nervesystem), neuritis (betændelse af nerver) og en form for lammelser kendt som GuillainBarrés Syndrom
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske forstyrrelser, f.eks. encefalomyelitis, neuritis og Guillain-Barré-syndrom.
English: The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: Hætteglasset skal omrystes før hver administration og inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende.
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Danish: • Overfølsomhedsreaktioner (allergiske reaktioner), som kan føre til et alvorligt blodtryksfald, der kan føre til shock, hvis det ikke bliver behandlet.
English: When Arepanrix is given for the first dose, it is recommended that Arepanrix (and not another vaccine against H1N1) be given for the complete vaccination course.
Danish: Når Arepanrix gives som første dosis, bør Arepanrix (og ikke en anden vaccine mod H1N1) også anvendes under hele vaccinationsprogrammet.
English: Dispose of in accordance with local regulations
Danish: Destrueres i henhold til lokale retningslinjer.
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinationen skal gives som intramuskulær injektion fortrinsvis i deltoideus eller i det anterolaterale lår (afhængig af muskelmassen).
English: Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance.
Danish: Hvert hætteglas skal omrystes og inspiceres visuelt for fremmede partikler (udover det hvide bundfald beskrevet ovenfor) og/eller ændringer i det fysiske udseende.
English: There are no data on co-administration of Arepanrix with other vaccines.
Danish: Der foreligger ingen data om co-administration af Arepanrix med andre vacciner.
English: • if you have a poor immune response (as for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer),
Danish: • hvis du har nedsat immunforsvar (f.eks. som følge af en behandling, som nedsætter immunforsvaret, som f.eks. behandling med kortikosteroid eller kemoterapi mod kræft).
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 tilfælde af en pandemi kan det være hensigtsmæssig at blive vaccineret alligevel, under forudsætning af at medicinsk behandling er umiddelbart tilgængelig i tilfælde af en overfølsomhedsreaktion.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf bør destrueres i henhold til lokale retningslinjer.
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 mikrogram HA).
English: Prior to administration, the two components should be mixed.
Danish: Før administration skal indholdet af de to hætteglas sammenblandes.
English: Immune system disorders Anaphylaxis, allergic reactions
Danish: Immunsystemet Anafylaksi, allergiske reaktioner
English: Psychiatric disorders Uncommon: insomnia
Danish: Psykiske forstyrrelser Ikke almindelig: insomnia
English: Immune response to A/Indonesia/5/2005 18-60 years
Danish: Immunrespons mod A/Indonesia/5/2005 18-60 år
English: Adults including the elderly and children from the age of 10 years onwards: A dose (0.5 ml) of the vaccine will be given
Danish: Voksne, inklusive ældre og børn i alderen 10 år og derover En dosis (0,5 ml) vaccine gives.
English: Before the vaccine is mixed:
Danish: Før vaccinen tilberedes:
English: After mixing: Use within 24 hours and do not store above 25°C.
Danish: Efter sammenblanding: anvendes inden for 24 timer og må ikke opbevares over 25 °C.
English: Common: nausea, diarrhoea
Danish: Almindelig: kvalme, diaré
English: It is recommended that subjects who receive a first dose of Arepanrix should complete the vaccination course with Arepanrix (see section 4.4).
Danish: Det anbefales, at personer, som får den første dosis af Arepanrix, fuldfører vaccinationsprogrammet med Arepanrix (se pkt.
English: Elderly (>60 years)
Danish: Ældre (over 60 år)
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Patienter med endogen eller iatrogen immunsuppression kan have et utilstrækkeligt antistofrespons.
English: Arepanrix should under no circumstances be administered intravascularly.
Danish: Arepanrix må under ingen omstændigheder gives intravaskulært.
English: See section 4.4 for Special warnings and special precautions for use.
Danish: 4.4 for Særlige advarsler og forsigtighedsregler vedrørende brugen.
English: 05 March 2010
Danish: 5. marts 2010
English: B-1330 Rixensart Belgium
Danish: B-1330 Rixensart Belgien
English: The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur (EMEA) vurderer regelmæssigt al ny information vedrørende Pandemrix, og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Danish: Kuldegysning Svedtendens Feber > 38 °C Feber > 39 °C Diaré
English: Rare: Neuralgia, transient thrombocytopenia.
Danish: Sjælden: Neuralgi, forbigående trombocytopeni
English: Suspension vial:
Danish: Suspension i hætteglas:
English: The MAH shall submit on a monthly basis a simplified periodic safety update report with the timelines, format and content as defined in the CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009) and any subsequent update.
Danish: Indehaveren af markedsføringstilladelsen skal på månedlig basis indsende en simplificeret bivirkningsovervågningsrapport i overensstemmelse med tidsplan, format og indhold anført i ”CHMP Recommendations for Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccines (EMEA/359381/2009)”, med efterfølgende ændringer.
English: The mixed vaccine is a whitish emulsion.
Danish: Den færdigblandede vaccine er en hvidlig emulsion.
English: • Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
Danish: • Smerter i ryggen eller nakken, stivhed i muskler, muskelkramper, smerter i ben, arme eller hænder
English: 3.75 micrograms*
Danish: 3,75 mikrogram*
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Danish: Den rekonstituerede vaccine er kemisk og fysisk holdbar i op til 24 timer ved 25 °C.
English: Areapanrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Danish: Arepanrix kan gives samtidig med en sæsoninfluenza-vaccine, som ikke indeholder adjuvans.
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)
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 hududslæt, ledsmerter og nyreproblemer)
English: Arepanrix is a vaccine against a pandemic influenza (flu).
Danish: Arepanrix er en vaccine til forebyggelse af pandemisk influenza.
English: * propagated in eggs ** haemagglutinin
Danish: * opformeret i æg ** hæmagglutinin
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN GSK Biologicals, Rixensart - Belgien
English: • Tingling or numbness of the hands or feet
Danish: • Prikken eller følelsesløshed i hænder eller fødder
English: “Possible side effects” may affect the ability to drive or use machines.
Danish: 4 (”Bivirkninger”), kan påvirke din evne til at køre bil eller anvende maskiner.
English: 04 June 2010
Danish: 4. juni 2010
English: The emulsion is a whitish homogeneous liquid.
Danish: Emulsionen er en hvidlig, homogen væske.
English: (see section 6.
Danish: (se afsnit 6 - Yderligere oplysninger).
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, stakåndethed og opsvulmet ansigt eller tunge.
English: • Clinical trials
Danish: • Kliniske forsøg
English: In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Danish: I tilfælde af observation af et af de nævnte forhold (inklusive gummipartikler fra proppen), skal vaccinen kasseres.
English: Very rare
Danish: Meget sjældne
English: You should not receive Arepanrix:
Danish: Du må ikke få Arepanrix:
English: • Low blood platelet count which can result in bleeding or bruising
Danish: • Lavt blodpladetal, som kan medføre blødninger eller blå mærker
English: 50 vials: emulsion (adjuvant)
Danish: 50 hætteglas: emulsion (adjuvans)
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 som fik hhv. antigen og adjuvans.
English: Ear and labyrinth disorders Uncommon: vertigo
Danish: Øre og labyrint Ikke almindelig: vertigo
English: Nervous system disorders Febrile convulsions
Danish: Nervesystemet Feberkramper
English: 21 days after 2nd dose
Danish: 21 dage efter første dosis
English: Children aged 6-35 months
Danish: Børn i alderen 6-35 måneder
English: This medicinal product has been authorised under a so-called “conditional approval” scheme.
Danish: Dette lægemiddel er godkendt under ”betingede omstændigheder”.
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Danish: Vaccinen bør administreres i overensstemmelse med den anbefalede dosis (se pkt.
English: Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Danish: Omvendt var kombinationen af doseringerne med H5N1-antigen, som var adjuveret med AS03, i stand til at beskytte mod mortalitet og at reducere lungvirusbelastningen og virusspredningen efter intra-trakeal belastning med en homolog vildtype H5N1-virus.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Danish: Fortæl det til din læge eller sygeplejerske, hvis du har forstyrrelser i blodets evne til at størkne eller nemt får blå mærker.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Danish: Den blandede vaccine kan enten opbevares i køleskab (2 °C - 8 °C) eller ved stuetemperatur (højst 25 °C).
English: Such situation requires rapid notification of safety information that may have the greatest implications for benefit-risk 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: Arepanrix may be used in lactating women.
Danish: Arepanrix kan gives til ammende kvinder.
English: The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly.
Danish: Følgende bivirkninger er set i kliniske forsøg med Arepanrix (H5N1) til voksne inklusive ældre.
English: The frequency of possible side effects listed below is defined using the following convention:
Danish: Forekomsten af mulige bivirkninger er anført nedenfor og er defineret på følgende måde:
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (dated January 2010) 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 forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen (RMP), som aftalt i version 4 (dateret januar 2010) af Risikohåndteringsplanen (RMP) anført i modul 1.8.2. i ansøgningen om markedføringstilladelsen, og i efterfølgende CHMP-krav til opdateringer af RMP.
English: The volume of the Arepanrix vial after mixing is at least 5 ml.
Danish: Efter rekonstitution af Arepanrix indeholder hætteglasset mindst 5 ml.
English: After mixing, the vaccine should be used within 24 hours.
Danish: Efter sammenblanding skal vaccinen anvendes inden for 24 timer.
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 svagt sedimenteret.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: Den officielle batchfrigivelse vil blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil i henhold til artikel 114 i Rådets direktiv 2001/83/EØF, med ændringer.
English: Adults aged 18-60 years:
Danish: Voksne i alderen 18-60 år:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intramuskulær anvendelse
English: Immune response to A/Indonesia/5/2005
Danish: Immunrespons mod A/Indonesia/5/2005
English: Pharmacovigilance The Applicant/MAH commits to support an effectiveness study with Arepanrix ongoing and submit the results one week after being available.
Danish: Pharmacovigilance Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til løbende at fremsende et effektforsøg med Arepanrix og indsende resultaterne en uge efter opnåelsen af disse.
English: Ferrets immunized with the non adjuvanted H5N1 influenza vaccine were not protected from death and showed similar lung viral loads and degree of viral shedding in the upper respiratory tract as those exhibited by ferrets immunized with the adjuvant alone.
Danish: De fritter, som blev immuniseret med ikke-adjuveret H5N1-influenzavaccine, var ikke beskyttet mod død og viste sammenlignelig virusbelastning i lungerne og grad af virusudskillelse i de øvre luftveje, som blev set hos de fritter, som var immuniseret med adjuvans alene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/03/2010
Danish: Dato for først MT 23/03/2010
English: Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to 11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to 35 months old).
Danish: Analyse af en undergruppe på 36 personer i alderen 6-35 måneder har vist, at 80,6 % havde en firdobbelt stigning af serum-neutraliserende antistofniveau 21 dage efter den første dosis (66,7 % hos 12 personer i alderen 6-11 måneder, 91,7 % hos 12 personer i alderen 12-23 måneder og 83,3 % hos 12 personer i alderen 24-35 måneder.
English: Shake before use
Danish: Omrystes før brug
English: The use of Arepanrix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Danish: Vaccination med Arepanrix kan overvejes til gravide kvinder, hvis det skønnes nødvendigt.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Danish: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut BE-1330 Rixensart Belgien
English: The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 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 injektionssprøjte og tilsætte dette til hætteglasset med antigen.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly.
Danish: Hver enkel vaccinedosis a 0,5 ml (hel dosis) eller 0,25 ml (halv dosis) udtages vha. en injektionssprøjte og administreres intramuskulært.