FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur (EMA) vurderer hvert år ny information og denne indlægsseddel vil om nødvendigt blive opdateret.
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske forstyrrelser, f.eks. encefalomyelitis, neuritis og Guillain-Barré-syndrom
English: Fainting can occur following, or even before, any needle injection.
Danish: Besvimelse kan opstå efter og endda før injektion med nål.
English: Clinical data in children less than 6 years of age who received two doses of pandemic preparedness or zoonotic influenza vaccine (H5N1) 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 pandemisk beredskabs- eller zoonotisk influenzavaccine (H5N1), antyder en stigning i hyppigheden af feber (aksillær ≥ 38 °C) efter administration af den anden dosis.
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: induration, hævelser, smerter og rødmen ved administrationsstedet, feber, træthed Almindelig: kuldegysninger, influenzalignende symptomer, reaktioner på administrationsstedet (f.eks. varme, kløe)
English: There are currently no data available on the use of Adjupanrix in pregnancy.
Danish: Der er på nuværende tidspunkt ingen data fra anvendelse af Adjupanrix til gravide kvinder.
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 ‘GuillainBarré Syndrome'.
Danish: • Forstyrrelser i hjerne og nerver pga. betændelse i centralnervesystemet (encefalomyelitis) eller i nerver (neuritis) eller lammelser som følge af ”Guillain-Barrés syndrom”.
English: METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Danish: ADMINISTRATIONSMETODE Blandes med antigen, suspension før brug
English: Seroprotection rate*1
Danish: Seroprotektionsrate*1
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: Det er ikke sikkert, at der opnås beskyttende immunrespons hos alle vaccinerede (se pkt.
English: - Vasculitis:
Danish: - Vaskulitis:
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Danish: Bivirkningerne nedenfor er set for H1N1-AS04-adjuveret vacciner.
English: 6 months after vaccination
Danish: 6 måneder efter vaccination
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
Danish: 3 serokonverteringsfaktor: forholdet mellem post-vaccinationsgeometrisk middeltiter (GMT) og prævaccinations-GMT.
English: • The double injections will be given in opposite arms.
Danish: • Dobbeltindsprøjtninger vil blive givet i hver sin arm.
English: • you have a bleeding problem or you bruise easily.
Danish: • hvis du har blødningsforstyrrelser eller let får blå mærker.
English: • Swollen glands in your neck, armpit or groin
Danish: • Hævede kirtler i hals, armhule eller lyske
English: • if you have problems with your immune system, since your response to the vaccine may then be poor.
Danish: • hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat
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 hele indholdet i hætteglasset med adjuvans op vha. en 5 ml injektionssprøjte og tilsætte det til hætteglasset med antigen.
English: Uncommon: insomnia
Danish: Psykiske forstyrrelser Ikke almindelig: insomni
English: At day 180, the seroprotection rate was 13%.
Danish: Seroprotektionsraten var 13 % på dag 180.
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 ses falsk positive resultater m.h.t. antistoffer mod HIV-1, hepatitis C og specielt HTLV-1 i serum undersøgt med ELISA-metoden.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: After two doses administered 6 months apart all subjects had a titre of at least 1:80.
Danish: Efter administration af to doser med 6 måneders mellemrum opnåede alle personer en titer på mindst 1:80.
English: In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Danish: Derudover havde hhv. 44,8 % og 56,1 % af personerne i de respektive dosisgrupper en firdobbelt forøgelse i serum-neutraliserende antistoftiter fra dag 0 til dag 42 og hhv. 96,6 % og 100 % havde en titer på mindst 1:80 på dag 42.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om brailleskrift
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically 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: “Possible side effects” may affect your ability to drive or use tools or machines.
Danish: Nogle af de bivirkninger, der er nævnt i afsnit 4 ”Bivirkninger”, kan påvirke din evne til at køre bil, anvende værktøj eller maskiner.
English: The seroprotection rates were 16.3% and 4.7% at months 12 and 24, respectively.
Danish: Seroprotektionsraten var henholdsvis 16,3 % og 4,7 % ved måned 12 og 24.
English: Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Danish: Hud og subkutane væv Angioødem, generaliserede hudreaktioner, urticaria
English: The percentage of subjects reaching neutralising antibody titres of >1/80 were 54.9% and 44.9% at months 12 and 24, respectively.
Danish: Andelen af personer, som havde en neutraliserende antistoftiter på > 1/80 var henholdsvis 54,9 % og 44,9 % ved måned 12 og 24.
English: Adjupanrix contains thiomersal
Danish: Adjupanrix indeholder thiomersal
English: The use of Adjupanrix may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Danish: Administration af Adjupanrix kan overvejes til gravide, hvis det skønnes nødvendigt.
English: A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
Danish: En firdobbelt stigning i serum-neutraliserende antistof mod A/Indonesia/05/2005 blev opnået hos > 90 % af personer efter to doser uafhængigt af vaccinationsprogram.
English: Adjupanrix should under no circumstances be administered intravascularly.
Danish: Adjupanrix må under ingen omstændigheder gives intravaskulært.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: Inden emulsionen (adjuvans) og suspensionen (antigen) sammenblandes, skal de to komponenter have antaget stuetemperatur (efter minimum 15 minutter); hvert hætteglas skal omrystes og inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende.
English: Day 180 N=138
Danish: dag 180 n = 138
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Danish: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgien
English: Seroconversion rates for neutralising antibodies against A/Indonesia/5/2005 were 15.7% and 12.2% for months 12 and 24, respectively.
Danish: Serokonverteringsraten for neutraliserende antistof mod A/Indonesia/5/2005 var henholdsvis 15,7 % og 12,2 % ved måned 12 og 24.
English: An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Adjupanrix 6 months or 12 months apart.
Danish: Et forlænget doseringsinterval blev undersøgt i studie D-H5N1-012, i hvilket en gruppe personer i alderen 18-60 år modtog to doser af Adjupanrix med 6 måneders eller 12 måneders interval.
English: For further information, see sections 4.4, 4.8 and 5.1.
Danish: 4.4, 4.8 og 5.1.
English: If a double dose is given, the injections should be given into opposite limbs preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinationen skal gives som intramuskulær injektion fortrinsvis i deltoideus eller anterolateralt i låret (afhængigt af muskelmassen).
English: This can cause bleeding or bruising
Danish: Dette kan medføre blødninger eller blå mærker.
English: Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Danish: Adjupanrix indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. det er i det væsentlige natrium- og kaliumfri.
English: The suspension is a colourless light opalescent liquid.
Danish: Suspensionen er en farveløs, lys, opaliserende væske.
English: Induration Pain
Danish: Induration Smerter
English: At day 42, the anti-HA antibody responses were as follows:
Danish: På dag 42 var anti-HAantistofresponset følgende:
English: 12 months after vaccination
Danish: 12 måneder efter vaccination
English: Adjupanrix may be used in lactating women.
Danish: Adjupanrix kan administreres til ammende kvinder.
English: How Adjupanrix works
Danish: Hvordan Adjupanrix virker
English: Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Danish: Hver enkel vaccinedosis a 0,5 ml udtages vha. en 1 ml injektionssprøjte og administreres intramuskulært.
English: Anaphylaxis, allergic reactions
Danish: Immunsystemet Anafylaksi, allergiske reaktioner
English: It is recommended to equip the syringe with a needle gauge not larger than 23G.
Danish: Det anbefales at bruge en kanylestørrelse, der ikke er større end 23-G.
English: A difference in the frequency of local and general solicited adverse reactions between half adult and adult doses was observed after each dose.
Danish: Der blev set en forskel i hyppigheden af lokale og generelle indsamlede bivirkninger efter hver administration af hhv. halv voksendosis og fuld voksendosis.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy.
Danish: For at opnå maksimal effekt skal anden dosis på 0,5 ml gives i intervallet mindst 3 uger og indtil 12 måneder efter den initiale dosis.
English: • Pain, redness, swelling or a hard lump where the injection was given
Danish: • Smerter, rødmen, hævelse eller en hårdhed, hvor indsprøjtningen blev givet
English: What Adjupanrix is and what it is used for Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Danish: Adjupanrix er en vaccine, som anvendes til voksne i alderen fra 18 år mod influenza ved udbrud af en pandemi.
English: Adjupanrix can still be given but your response to the vaccine may be poor.
Danish: Du kan godt få Adjupanrix, men virkningen af vaccinen kan være nedsat.
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Danish: Efter to doser givet med 21 dages eller 6 måneders mellemrum havde 96,0 % af personerne en firdobbelt stigning i serum-neutraliserende antistoftiter, og 98-100 % af personerne havde en titer på mindst 1:80.
English: The volume of the Adjupanrix vial after mixing is at least 5 ml.
Danish: Efter rekonstitution af Adjupanrix indeholder hætteglasset mindst 5 ml.
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Danish: Fritterne blev vaccineret på dag 0 og 21 og eksponeret intra-trachealt på dag 49 med en letal dosis H5N1/A/Vietnam/1194/04 eller heterolog H5N1/A/Indonesia/5/05.
English: METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Danish: ADMINISTRATIONSMETODE Blandes med adjuvans, emulsion, før brug
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Danish: Vaccinen skal administreres i overensstemmelse med den anbefalede dosis (se pkt.
English: The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
Danish: Den anden vaccination skal gives mindst tre uger og indtil 12 måneder efter den første vaccination.
English: Talk to your doctor or nurse before you are given Adjupanrix
Danish: Kontakt lægen eller sygeplejersken før du får Adjupanrix:
English: In each experiment, four groups of six ferrets were immunised intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
Danish: I hvert forsøg blev fire grupper med hver 6 fritter vaccineret intramuskulært med en AS03-adjuvansvaccine indeholdende HA fra H5N1/A/Vietnam/1194/04 (NIBRG-14).
English: Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Danish: Til voksne i alderen fra 18 år og derover: en dosis på 0,5 ml gives i.m.
English: If any of the side effects below occur, please tell your doctor or nurse immediately:
Danish: Hvis du får nogle af nedennævnte bivirkninger, skal du straks fortælle det til din læge eller sygeplejersken:
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis samtidig administration med andre vacciner påtænkes, skal det ske i forskellige ekstremiteter.
English: Vistor hf. Sími: +354 535 7000
Danish: Sími: +354 535 7000
English: • From 80 years onwards: you may receive two double injections of Adjupanrix.
Danish: • Fra 80 år og opefter: Du vil muligvi få to dobbeltvaccinationer af Adjupanrix.
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: Brug af anden medicin sammen med Adjupanrix Fortæl det altid til lægen eller sygeplejersken, hvis du bruger anden medicin eller har gjort det for nylig, eller hvis du for nylig er blevet vaccineret med en anden vaccine.
English: The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Danish: Der blev hverken ved administration af halv eller fuld voksendosis set en øget reaktogenicitet efter anden dosis, bortset fra hyppigheden af almene symptomer, som var højere efter anden dosis, især for hyppigheden af feber hos børn < 6 år.
English: Against A/Vietnam 21 days after boosting with A/Vietnam N=46
Danish: Mod A/Vietnam 21 dage efter boosterdosis A/Vietnam n= 46
English: Seropositivity rate2
Danish: Seropositivitetsrate2
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Danish: Suspension: flerdosis-hætteglas indeholdende antigen, Emulsion: flerdosis-hætteglas indeholdende adjuvans.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Danish: Mod A/Indonesia 21 dage efter boosterdosis A/Indonesia n= 49
English: This means that for scientific reasons it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for denne vaccine af videnskabelige årsager.
English: After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Danish: Efter tilberedning af vaccinen: Efter sammenblandingen, skal den færdige vaccine indsprøjtes inden for 24 timer og må ikke opbevares over 25 °C.
English: • Warmth, itching or bruising where the injection was given
Danish: • Varme, kløe eller blåt mærke ved det sted, hvor indsprøjtningen blev givet
English: Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03.
Danish: Nedennævnte bivirkninger er vurderet i kliniske studier med ca. 5.000 personer på 18 år og derover, som fik vaccine indeholdende mindst 3,75 mikrogram HA/AS03.
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Danish: Seroprotektionsraten var 92 % mod A/Indonesia 21 dage efter boostervaccination og 69,2 % på dag 180.
English: This can cause skin rashes, joint pain and kidney problems
Danish: Dette kan medføre hudrødme, ledsmerter og nyreproblemer.
English: In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Danish: Ved observation af et af de nævnte forhold (inklusive gummipartikler fra proppen) skal vaccinen kasseres.
English: Seroprotection rate1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 At day 42, and after 6, 12 and 24 months the neutralising antibody responses were as follows: Serum neutralising antibody
Danish: 1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40 På dag 42, og efter 6, 12, og 24 måneder var det neutraliserende antistofrespons følgende: Serumneutraliserende antistof
English: Adjupanrix contains sodium and potassium
Danish: Adjupanrix indeholder natrium og kalium
English: Excipient with known effect The vaccine contains 5 micrograms thiomersal (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Vaccinen indeholder 5 mikrogram thiomersal (se pkt.
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Danish: Knogler, led, muskler og bindevæv Meget almindelig: artralgi, myalgi
English: In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses.
Danish: Børn i alderen 3-9 år har i et klinisk studie fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml).
English: Although an adequate immune response was achieved at day 42 following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), a higher response was observed following two administrations of a double dose of vaccine.
Danish: Selvom et tilstrækkeligt immunrespons blev opnået på dag 42 efter to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1), blev der opnået et højere respons efter administration af to dobbeltdoser vaccine.
English: A 4-fold increase in serum neutralising antibody titres was observed in 79.2% of subjects twenty-one days after the first dose, 95.8% twenty-one days after the second dose and 87.5% six months after the second dose.
Danish: En firdobbelt stigning i serum-neutraliserende antistoftiter blev set hos 79,2 % af personerne 21 dage efter første dosis, hos 95,8 % af personerne 21 dage efter anden dosis og hos 87,5 % af personerne seks måneder efter anden dosis.
English: • Generalised skin reactions including urticaria (hives)
Danish: • Reaktioner i huden, som f.eks. nældefeber (udslæt).
English: Tell your doctor if you have any known allergies.
Danish: Fortæl din læge, hvis du ved, at du er overfølsom over for andre ting.
English: • Increased sweating, shivering, flu-like symptoms
Danish: • Øget svedtendens, kuldegysninger, influenzalignende symptomer
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Danish: Snæver SMQ ”Anafylaktisk reaktion” og snæver SMQ
English: GMT1 Seroconversion rate2
Danish: GMT1 Serokonverteringsrate2
English: A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose.
Danish: En firdobbelt stigning i serum-neutraliserende antistoftiter mod A/Vietnam blev opnået hos 49 % af personerne 21 dage efter første dosis, hos 67,3 % af personerne 21 dage efter anden dosis og hos 44,9 % af personerne 6 måneder efter anden dosis.
English: • If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet.
Danish: • Kontakt lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
Danish: Seroprotektionsraten, boosterserokonverteringsraten og boosterfaktoren mod A/Indonesia/5/2005 var henholdsvis 100 %, 99,7 % og 123,8, 21 dage efter boostervaccination.
English: Month N=35
Danish: måned n = 35
English: The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows:
Danish: Seroprotektionsraten 6, 12, 24 og 36 måneder efter første dosis var følgende:
English: Month 6 N=48
Danish: måned 6 n = 48
English: 2.5 ml per vial.
Danish: 2,5 ml pr. hætteglas.
English: In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
Danish: Krydsreaktionsimmunrespons imod A/Indonesia/05/2005 blev ligeledes observeret i dette studie.
English: The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Danish: Den færdigblandede vaccine er en hvidlig til gullig, homogen, mælkeagtig emulsion.
English: *propagated in eggs **expressed in microgram haemagglutinin
Danish: * opformeret i æg ** mikrogram hæmagglutinin
English: There are no data on co-administration of Adjupanrix with other vaccines.
Danish: Der foreligger ingen data om samtidig admnistration af Adjupanrix og andre vacciner.
English: The suspension and emulsion vials once mixed form a multidose container.
Danish: Når suspension og emulsion fra hætteglassene sammenblandes, fremkommer en multidosisbeholder.
English: No post-marketing surveillance data are available following Adjupanrix administration.
Danish: Der findes ingen data fra overvågning efter markedsføring for Adjupanrix.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret
English: Month 6 N=40
Danish: måned 6 n = 40
English: Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection rate following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Danish: Meget begrænsede data for seronegative personer > 80 år (n = 5) viste, at ingen personer opnåede serobeskyttelse efter administration af to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1).
English: Adjupanrix consists of two containers:
Danish: Adjupanrix består af to hætteglas:
English: Double dose (N=131)
Danish: dobbeltdosis (n = 131)
English: Immune response against A/Vietnam/1194/2004 (H5N1):
Danish: Immunrespons mod A/Vietnam/1194/2004 (H5N1):