FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies have evaluated the incidence of adverse reactions in more than 1,000 subjects 18 years old and above who received Pandemrix (H1N1).
Danish: Forekomst af bivirkninger er evalueret i kliniske studier med flere end 1.000 personer i alderen 18 år og derover, som fik Pandemrix (H1N1).
English: The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale en måde, hvorpå sundhedspersonalet får målrettet information, som indeholder følgende:
English: Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Danish: Tolv måneder efter første dosis var seroprotektionsraten 100 % i alle aldersgrupper og dosisgrupper.
English: Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Danish: Data indikerer således, at Pandemrix kan administreres samtidig med ikke-adjuverede sæsoninfluenzavacciner (injiceret i modsatte ekstremiteter).
English: METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Danish: ADMINISTRATIONSMETODE Blandes med antigen, suspension, før brug
English: • Swollen glands in the neck, armpit or groin
Danish: • hævede kirtler i hals, armhule eller lyske
English: The neutralising antibody responses in subjects >60 years were as follows: Serum neutralising antibody
Danish: Det neutraliserende antistofrespons hos personer over 60 år var følgende: Serumneutraliserende antistof
English: All subjects received two doses of 0.5 ml 21 days apart, except in study D-Pan H1N1-008, in which half of the subjects received only one dose of 0.5 ml.
Danish: Alle personer fik to doser a 0,5 ml med 21 dages mellemrum, med undtagelse af halvdelen af personerne i studiet D-Pan H1N1-008, som kun fik en dosis a 0,5 ml.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow 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: Prophylaxis of influenza caused by A (H1N1)v 2009 virus.
Danish: Profylakse mod influenza forårsaget af A(H1N1)v-2009-virus.
English: Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Danish: Gastrointestinale symptomer (såsom diarré, opkastning, mavesmerter, kvalme)
English: Very common Headache Uncommon Paraesthesia, dizziness
Danish: Hovedpine Ikke almindelig Paræstesi, svimmelhed
English: • Low blood platelet count which can result in bleeding or bruising
Danish: • lavt blodpladetal, som kan medføre blødninger eller blå mærker.
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Danish: Meget sjælden Neurologiske forstyrrelser såsom encefalomyelitis, neuritis og GuillainBarrés syndrom
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Seroprotection rate1
Danish: Seroprotektions rate1
English: Obligation to conduct post-authorisation measures
Danish: • Forpligtigelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: Half adult dose
Danish: Halv voksendosis
English: • Increased sweating
Danish: • øget svedtendens
English: In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
Danish: I et klinisk studie, hvor en ikke-adjuveret sæsoninfluenza-vaccine (Fluarix, som beskrevet ovenfor) blev administreret 3 uger efter anden dosis Pandemrix (de to doser blev givet med 21 dages mellemrum), sås et lavere immunrespons over for Fluarix i forhold til, hvad der blev set hos personer, som ikke havde fået Pandemrix forinden.
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 Pandemrix Fortæl det altid til lægen eller sygeplejersken, hvis du bruger anden medicin eller har gjort det for nylig eller hvis du for nylig har fået en anden vaccine.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml 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 1 ml injektionssprøjte og administreres intramuskulært.
English: Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age.
Danish: To kliniske studier evaluerede administrationen af en halv (0,25 ml) og en fuld (0,5 ml) voksendosis Pandemrix hos raske børn i alderen 10-17 år.
English: • Feeling sick, diarrhoea, vomiting, stomach pain
Danish: • kvalme, diarré, opkastning, mavesmerter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SUSPENSION HÆTTEGLAS
English: In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
Danish: Hos personer over 60 år, var de hyppigst rapporterede bivirkninger efter vaccination smerte ved injektionsstedet (59,0 %), myalgi (20,6 %), træthed (17,9 %), hovedpine (17,6 %) og artralgi (14,3 %).
English: Injection site reactions (such as inflammation, mass, ecchymosis)
Danish: Reaktioner ved injektionsstedet (såsom inflammation, knude, ekkymose)
English: PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Adjuvans, emulsion til injektionsvæske 25 hætteglas: emulsion
English: Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Pandemrix indeholder konserveringsmidlet tiomersal, der kan give allergiske reaktioner.
English: Pandemrix may be administered in lactating women.
Danish: Pandemrix kan gives til ammende kvinder.
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%).
Danish: Hos voksne i alderen 18-60 år var de hyppigst rapporterede bivirkninger efter vaccination smerte ved injektionsstedet (87,8 %), træthed (32,9 %), hovedpine (28,1 %), artralgi (17,9 %), myalgi (30,0 %), kulderystelser (19,4 %), hævelse ved injektionsstedet (11,5 %) og svedtendens (11,3 %).
English: The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Danish: Efter sammenblanding af suspension og emulsion fremkommer en vaccine i et flerdosishætteglas.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Overfølsomhedsreaktioner, som i sjældne tilfælde kan medføre shock, kan forekomme efter vaccination.
English: If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Danish: Hvis yderligere en dosis på 0,25 ml gives, skal denne gives mindst tre uger efter den første dosis.
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 af hætteglasset med adjuvans op vha. en 5 ml injektionssprøjte og tilsætte dette til hætteglasset med antigen.
English: Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody
Danish: Seroprotektionsraten tolv måneder efter første dosis var følgende: Anti-HA antistof
English: One dose of 0.25 ml at an elected date.
Danish: Én dosis på 0,25 ml gives på en udvalgt dag.
English: Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Danish: Data opnået i forbindelse med administration af en ikke-adjuveret sæsoninfluenza-vaccine (Fluarix, som beskrevet ovenfor) tre uger før administration af en dosis Pandemrix (H1N1)v til raske voksne over 60 år, indikerede ikke nogen signifikant interferens i immunresponset over for Pandemrix (H1N1)v. Data indikerer derfor, at Pandemrix kan gives tre uger efter administration af ikkeadjuverede sæsoninfluenza-vacciner.
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Danish: I et prospektivt klinisk studie, som fulgte over 100 graviditeter, var der ingen evidens for en øget risiko for bivirkninger.
English: The per-dose frequency of the following adverse reactions was as shown in the table:
Danish: Hyppigheden pr. dosis af nedennævnte bivirkninger er vist i tabellen:
English: The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.
Danish: I kliniske forsøg sås samme hyppighed af bivirkninger hos børn fra 10-17 år som hos voksne med undtagelse af rødme, hvor indsprøjtningen blev givet, som var meget almindelig, og svedtendens, som var almindelig.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING INDEHOLDENDE 1 PAKNING MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION OG 2 PAKNINGER MED HVER 25 HÆTTEGLAS INDEHOLDENDE EMULSION
English: Allergic reactions:
Danish: Overfølsomhedsreaktioner:
English: Very common Arthralgia, myalgia
Danish: Artralgi, myalgi
English: Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.
Danish: Data fra co-administration af Pandemrix (H1N1)v og ikke-adjuveret sæsoninfluenza-vaccine (Fluarix, split virion vaccine) til raske voksne over 60 år indikerede, at der ikke var nogen signifikant interferens i immunresponset over for Pandemrix (H1N1)v. Immunresponset over for Fluarix var tilfredsstillende.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Pandemrix i.m.
English: 4according to protocol
Danish: svarende til protokollen.
English: A dose (0.25 ml) of the vaccine will be given.
Danish: En dosis (0,25 ml) vaccine gives.
English: Neuralgia
Danish: Neuralgi
English: Pandemrix should not be given:
Danish: Du må ikke få Pandemrix:
English: A dose (0.5 ml) of the vaccine will be given.
Danish: En dosis (0,5 ml) vaccine gives.
English: What Pandemrix is and what it is used for What you need to know before you receive Pandemrix How Pandemrix is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Pandemrix Sådan får du Pandemrix Bivirkninger
English: In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years.
Danish: Efter to voksendoser (a 0,5 ml) var seroprotektionsraten 100 % tolv måneder efter første dosis hos børn i aldersgruppen 3-5 år og 98,0 % hos børn i aldersgruppen 6-9 år.
English: Very common Sweating increased Uncommon Pruritus, rash
Danish: Øget svedtendens Ikke almindelig Pruritus, udslæt
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Danish: serokonverteringsfaktor: forholdet mellem geometrisk middeltiter (GMT) efter vaccinationen og GMT før vaccinationen.
English: See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
Danish: Immunrespons efter en og to doser Pandemrix (H1N1)v, inklusive antistofniveau efter 6 og 12 måneder, er anført i pkt.
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Danish: • to pakninger med 25 hætteglas a 2,5 ml emulsion (adjuvans)
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Danish: Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid, dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchlorid, vand til injektionsvæsker.
English: Pandemrix consists of two containers:
Danish: Pandemrix består af to hætteglas:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER EMULSION HÆTTEGLAS
English: There are no data on co-administration of Pandemrix with other vaccines.
Danish: Der foreligger ingen data om co-administration med andre vacciner.
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8).
Danish: Pandemrix bør kun anvendes, hvis de anbefalede årlige trivalente/tetravalente sæsoninfluenzavacciner ikke er tilgængelige, og hvis immunisering mod (H1N1)v vurderes at være nødvendig (se pkt.
English: Very common Swelling and pain at the injection site, fatigue, shivering
Danish: Hævelse og smerte ved injektionsstedet, træthed, kulderystelser
English: • if you have a bleeding problem or bruise easily.
Danish: • hvis du har forstyrrelser i blodets evne til at størkne eller nemt får blå mærker.
English: • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Danish: • overfølsomhedsreaktioner (allergiske reaktioner), som kan medføre et alvorligt blodtryksfald,
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100% in both age groups.
Danish: På dag 180 var seroprotektionsraten hos de børn, som havde fået to halve doser (0,25 ml), 100 % i begge aldersgrupper.
English: Rare (≥1/10,000 to <1/1,000)
Danish: Almindelig (≥ 1/100 til < 1/10) Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000)
English: 4all subjects seronegative prior to vaccination
Danish: 2 alle seronegative før vaccination.
English: Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses.
Danish: Tolv måneder efter første dosis var seroprotektionsraten 90,2 % hos de børn, som havde fået to halve doser (0,25 ml), og 100 % hos de børn, som havde fået to fulde voksendoser (0,5 ml).
English: In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common.
Danish: Hos børn fra 3-9 år, som fik 2 doser Pandemrix (H1N1)v på 0,25 ml, sås de samme bivirkninger som hos voksne med undtagelse af, at rødme, hvor indsprøjtningen blev givet, og symptomer fra mave og tarm var meget almindelige, og at kulderystelser og svedtendens var almindelige.
English: Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Pandemrix after an interval of at least three weeks.
Danish: Hvis du tidligere har fået en sæsoninfluenza-vaccine, som ikke indeholdt adjuvans, må Pandemrix først gives tidligst tre uger efter denne vaccination..
English: There are no data with Pandemrix using the subcutaneous route.
Danish: Der findes ingen data for subkutan administration af Pandemrix.
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
Danish: LÆGEMIDLETS NAVN Emulsion til Pandemrix injektionsvæske, emulsion
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Danish: Split influenzavirus, inaktiveret, indeholdende antigen svarende til: A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme 3,75 mikrogram* AS03-adjuvans bestående af squalen, DL-α-tocopherol og polysorbat 80 * hæmagglutinin
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Danish: På dag 180 var seroprotektionsraten for de børn, som havde fået to halve doser (0,25 ml), 100 %.
English: Children from 6 months to 9 years of age
Danish: Børn i alderen fra 6 måneder til 9 år
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Danish: Hævelse Kulderystelser Svedtendens Feber > 38 °C Feber > 39 °C Artralgi
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions,
Danish: • At visse bivirkninger i forbindelse med indberetning skal opprioriteres, dvs. dødelige og livstruende bivirkninger, uventede alvorlige bivirkninger, bivirkninger af speciel interesse
English: The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses of 0.5 ml 21 days apart were as follows:
Danish: Anti-HA-antistofrespons hos raske personer i alderen over 60 år, som fik enten en eller to doser a 0,5 ml med 21 dages mellemrum, er anført nedenfor:
English: In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
Danish: Hos børn fra 6-35 måneder, som fik 2 doser Pandemrix (H1N1)v på 0,25 ml, sås en øget hyppighed af smerter, rødme og hævelse, hvor indsprøjtningen blev givet, samt feber (> 38 °C), døsighed, pirrelighed og appetitmangel efter den anden dosis i forhold til efter første dosis.
English: 4.7 Effects on ability to drive and use machines
Danish: 4.8, kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/California/07/2009 (H1N1) afledt fra NYMC X-179A-stamme
English: In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 ml doses of Pandemrix (H1N1)v, higher rates of general solicited symptoms (such as fatigue, headache, arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the first dose.
Danish: I kliniske studier, hvor reaktogeniciteten blev evalueret hos raske voksne i alderen 18 år og ældre, som fik to 0,5 ml doser Pandemrix (H1N1)v, blev der observeret en øget hyppighed af de undersøgte generelle symptomer (såsom træthed, hovedpine, artralgi, myalgi, kulderystelser, svedtendens og feber) efter den anden dosis i forhold til efter den første dosis.
English: NA= not available
Danish: Hovedpine - = ikke tilgængelig.
English: There is no information on administration of Pandemrix with other vaccines.
Danish: Der er ingen oplysninger om samtidig vaccination med Pandemrix med andre vacciner.
English: Angioedema, generalised skin reactions, urticaria
Danish: Angiødem, generaliserede hudreaktioner, urticaria
English: Rate2
Danish: Responsrate2
English: In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8).
Danish: Hos børn i alderen 6-35 måneder (n = 51), som fik to doser a 0,25 ml (halv voksendosis) med et interval på tre uger, sås efter den anden dosis en øget hyppighed af reaktioner på administrationsstedet og generelle symptomer (se pkt.
English: antibody
Danish: antistof
English: Gastrointestinal Headache
Danish: Gastrointestinale symptomer Hovedpine
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Danish: Pandemrix bør kun bruges, hvis de anbefalede årlige trivalente/tetravalente sæsoninfluenzavacciner ikke er tilgængelige, og hvis immunisering mod (H1N1)v vurderes at være nødvendig (se pkt.
English: Six months after the first dose, the seroprotection rate was as follows:
Danish: Seroprotektionsraten seks måneder efter første dosis var følgende:
English: In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
Danish: En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Pandemrix.
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)vlike strains.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Vaccinen forventes kun at beskytte mod influenza forårsaget af A/California/07/2009 (H1N1)vlignende stammer.
English: In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
Danish: I et klinisk studie (D-Pan-H1N1-009) med raske børn i alderen 6-35 måneder (stratificeret i aldersgrupperne fra 6-11 måneder, 12-23 måneder og 24-35 måneder) var anti-HA-antistofresponset 21 dage efter første og anden halve voksendosis (dvs. 0,25 ml) eller voksendosis (dvs. 0,5 ml) Pandemrix følgende:
English: Total enrolled subjects N=120
Danish: Inkluderede personer i alt n = 120
English: • Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
Danish: • reaktioner, hvor indsprøjtningen blev givet, f.eks. smerte, rødme, blå mærker, hævelse og varmefølelse (vævsirritation), hård knude.