FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH should provide an inventory of all valuable database ready to be use to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Danish: Indehaveren af markedsføringstilladelsen skal indsende en statusopgørelse af alle værdifulde databaser, som kan bruges til straks at undersøge forhold, som påvirker risikobalancen for vaccinen.
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Danish: Efter en influenza-vaccination kan der forekomme falsk positive resultater m.h.t. antistoffer mod HIV1, hepatitis C-virus og specielt HTLV-1 i serum undersøgt med ELISA-metoden.
English: - Challenge with a heterologous pandemic H5N1 strain (A/Hong Kong/156/97)
Danish: - Forsøg med en heterolog pandemisk H5N1-stamme (A/Hong Kong/156/97)
English: • The Applicant/MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Arepanrix.
Danish: • Ansøgeren/indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale en måde, hvorpå patienter og sundhedspersonale vedvarende har tilgang til opdateret information om Arepanix.
English: What Arepanrix is and what it is used for Before you receive Arepanrix How Arepanrix is given Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Arepanrix Sådan bliver du behandlet med Arepanrix Bivirkninger
English: The MAH should check regarding the possible confounding layouts with other pandemic vaccine supplied in EU.
Danish: Indehaveren af markedsføringstilladelsen skal kontrollere, at der ikke er risiko for forveksling med andre pandemiske vacciner, der sælges i EU.
English: • Ongoing clinical studies in healthy subjects who received a single dose of Arepanrix (H1N1)
Danish: • Igangværende kliniske forsøg med raske personer, som har fået en enkelt dosis Arepanrix
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt i.
English: 31-January-2010
Danish: 31. januar 2010
English: Pharmacovigilance The Applicant/MAH commits to provide the results of a study in a pregnancy registry conducted with Arepanrix.
Danish: Pharmacovigilance Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til at fremsende resultater fra studie i graviditetsregister for Arepanrix.
English: Antigen suspension for injection 50 vials: suspension
Danish: Antigen, suspension til injektionsvæske 50 hætteglas: suspension
English: Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Danish: Hud og subkutane væv Angioødem, generaliserede hudreaktioner, nældefeber
English: • If a specific notification system has been put in place, how to report adverse reactions.
Danish: • Instruktion om indberetning af bivirkninger, såfremt der findes et særligt indberetningssystem.
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Danish: Suspension: multidosis-hætteglas indeholdende antigen Emulsion: multidosis-hætteglas indeholdende adjuvans.
English: In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Danish: Specielt steg hyppigheden af feber betydeligt (aksillær temperatur ≥ 38 ºC) efter den anden dosis.
English: METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Danish: ANVENDELSESMÅDE Blandes med antigen, suspension, før brug
English: • Diarrhoea, feeling sick
Danish: • Diaré, kvalme
English: Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) 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 Arepanrix, som indeholder 3,75 mikrogram HA fra A/Indonesia/05/2005 (H5N1) 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 ammeperioden).
English: • Unusual weakness
Danish: • Usædvanlig afmatning
English: Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Arepanrix after an interval of at least three weeks.
Danish: Hvis du tidligere har fået en sæsoninfluenza-vaccine, som ikke indeholdt adjuvans, må Arepanrix først gives mindst tre uger efter denne vaccination.
English: Blood and lymphatic system disorders Uncommon: lymphadenopathy
Danish: Blod og lymfesystem Ikke almindelig: lymfadenopati
English: - Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
Danish: - Forsøg med en homolog pandemisk H5N1-stamme (A/Indonesia/5/05)
English: Information from non-clinical studies:
Danish: Information fra prækliniske forsøg:
English: Arepanrix consists of two containers:
Danish: Arepanrix består af to hætteglas:
English: Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
Danish: Influenzaprofylakse ved en officielt erklæret pandemisk situation (se pkt.
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 præklinisk for A/Indonesia/05/05 (H5N1) ud fra et forsøg med fritter.
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 mikrogram H5N1 + fuld dosis AS03 og en kontrolgruppe blev immuniseret med ikke-adjuveret vaccine (3,75 mikrogram HA).
English: METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Danish: ANVENDELSESMÅDE Blandes med adjuvans, emulsion, før brug
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om denne medicin, skal du henvende dig til den lokale repræsentant:
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea
Danish: Luftveje, thorax og mediastinum Ikke almindelig: dyspnø
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, vil dette ske mindst tre uger efter den første dosis.
English: The European Medicines Agency (EMEA) will review any new information on this medicine and this SPC will be updated as necessary.
Danish: Det europæiske Lægemiddelagentur (EMEA) vil regelmæssigt vurdere ny information vedrørende produktet, og produktresuméet vil om nødvendigt blive opdateret.
English: Day 180 N=353
Danish: dag 180 n = 353
English: There are limited data available from clinical studies with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in adults aged over 60 years and very limited data in adults aged over 80 years.
Danish: Der er begrænsede data tilgængelig fra kliniske forsøg med AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, til voksne over 60 år og meget begrænsede data for voksne over 80 år.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Overfølsomhedsreaktioner, som i sjældne tilfælde kan føre til shock, kan forekomme efter vaccination.
English: These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly).
Danish: Disse bivirkninger er også set med samme hyppighed i kliniske forsøg med en tilsvarende vaccine (H1N1) til voksne inklusive ældre og børn i alderen 10-17 år, bortset fra rødme (”ikke almindeligt” for voksne og ”almindeligt” for ældre) og feber (”ikke almindeligt” hos voksne og ældre).
English: Fever (≥38°C) axillary Fever (≥39°C) axillary Drowsiness Irritability
Danish: Feber (aksillær temperatur ≥ 38 °C) Feber (aksillær temperatur ≥ 39 °C) Døsighed
English: Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Danish: Pharmacovigilance Ansøgeren/indehaveren af markedsføringstilladelsen forpligter sig til straks at undersøge fremkomne forhold, som påvirker risiko-balancen for vaccinen.
English: In two clinical studies (D-Pan H1N1-007 and D-Pan H1N1-008) that evaluated immunogenicity in healthy subjects aged 18-60 years the anti-HA antibody responses were as follows:
Danish: I to kliniske forsøg (D-Pan H1N1-007 og D-Pan H1N1-008), hvor immunogeniciteten blev undersøgt hos raske personer i alderen 18-60 år, blev følgende anti-HA-antistofrespons set:
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 PAKKE MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION OG 2 PAKKER MED HVER 25 HÆTTEGLAS INDEHOLDENDE EMULSION
English: Day 42 N=479
Danish: dag 42 n = 479
English: Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age.
Danish: Symptomer vedrørende mave-tarm-kanalen og kuldegysninger er set med en større hyppighed hos børn i alderen 10-17 år.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstitution indeholder 1 dosis (0,5 ml):
English: Adults aged 18-60 years
Danish: Voksne i alderen 18-60 år
English: (Arise from Q1 RR#13)
Danish: revurdere dette når data for H1N1 foreligger (fra Q1 RR#13)
English: There are no safety and immunogenicity data available from clinical studies with Arepanrix or with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in children aged less than 6 months.
Danish: Der er ingen tilgængelige sikkerheds- og immunogenicitetsdata fra kliniske forsøg med Arepanrix eller AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces, til børn under 6 måneder.
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Arepanrix with other H1N1 pandemic vaccines.
Danish: Der findes ingen sikkerheds-, immunogenicitets- eller effektdata, der støtter en udskiftning af Arepanrix med andre H1N1-pandemivacciner under et vaccinationsprogram.
English: A clinical study with Arepanrix (H1N1) provides limited safety and immunogenicity data obtained up to three weeks after administration of a single 0.5 ml dose to healthy adults aged 18-60 years.
Danish: Et klinisk forsøg med Arepanrix (H1N1) har frembragt begrænsede sikkerheds- og immunogenicitetsdata opnået 3 uger efter administration af en enkelt 0,5 ml-dosis til raske voksne i alderen 18-60 år.
English: Study D-Pan H1N1-008 evaluated immunogenicity in healthy subjects (N=120) aged >60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age).
Danish: I studie D-Pan H1N1-008 blev immunogeniciteten hos raske personer (n = 120) i alderen over 60 år (stratificeret i aldersgrupperne 61-70, 71-80 og over 80 år) vurderet.
English: Therefore the data indicate that Arepanrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Danish: Data indikerer således, at Arepanrix kan administreres samtidig med ikke-adjuverede sæsoninfluenzavacciner (injiceret i modsatte ekstremiteter).
English: Seroprotection rate1
Danish: Seroprotektionsrate1
English: The available data are as follows:
Danish: Nedenfor er anført de foreliggende data.
English: Two clinical studies evaluated the immunogenicity of a half (0.25 ml) dose and a full (0.5 ml) adult dose in healthy children 10 to 17 years of age.
Danish: I to kliniske forsøg blev immunogeniciteten af en halv (0,25 ml) og en fuld (0,5 ml) voksendosis hos raske børn i alderen 10-17 år vurderet.
English: Immunogenicity data obtained at three weeks after administration of Arepanrix (H1N1) in clinical studies suggest that a single dose may be sufficient.
Danish: Immunogenicitetsdata opnået tre uger efter administration af Arepanrix (H1N1) i kliniske forsøg tyder på, at en enkelt dosis er tilstrækkelig.
English: • The Applicant/MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
Danish: • Ansøgeren/indehaveren af markedsføringstilladelsen skal sammen med medlemslandene aftale en måde, hvorpå sundhedspersonalet får målrettet information, som indeholder følgende:
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature.
Danish: Inden emulsionen (adjuvans) og suspensionen (antigen) sammenblandes, skal de to komponenter have stuetemperatur.
English: The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Danish: Følgende bivirkninger er set i forbindelse med en tilsvarende vaccine (H1N1) efter markedsføring.
English: In a consistency study, the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Danish: I et klinisk forsøg var anti-hæmagglutinin (anti-HA)-antistofresponset 21 dage og seks måneder efter anden dosis følgende:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Children and adolescents aged 10-17 years
Danish: Børn og unge i alderen 10-17 år
English: Seroconversion factor3
Danish: Serokonverteringsfaktor3
English: The per-dose frequency of the following adverse reactions was as shown in the table:
Danish: Den samlede hyppighed per dosis af de nævnte bivirkninger er vist i tabellen:
English: 2.5 ml per vial.
Danish: 2,5 ml pr. hætteglas
English: Day 180 N=104
Danish: dag 180 n = 104
English: Store in the original package in order to protect from light
Danish: Opbevares i den originale pakning for at beskytte mod lys
English: One dose of 0.5 ml at an elected date.
Danish: Én dosis på 0,5 ml gives på en bestemt dag.
English: After the vaccine is mixed:
Danish: Efter tilberedning af vaccinen:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Arepanrix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Arepanrix i.m.
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Danish: Hvis co-administration af andre vacciner påtænkes, skal det ske i anden ekstremitet.
English: In another clinical study, the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Danish: I et sammenlignende forsøg var anti-hæmagglutinin (anti-HA)-antistofresponset hos personer i alderen 18-64 år følgende:
English: Reactogenicity was also evaluated in healthy adults aged 18-60 years who received a first 0.5 ml dose of either Arepanrix (H1N1) (N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process (N=167).
Danish: Reaktogeniciteten er også evalueret hos raske voksne i alderen 18-60 år, som enten har fået første dosis 0,5 ml af Arepanrix (H1N1) (n = 167) eller AS03-adjuvert vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces (n = 167).
English: Vasculitis with transient renal involvement.
Danish: Vaskulitis med forbigående nyreproblemer.
English: Study Q-Pan H1N1-032 (2-5 months, Safety/
Danish: Forsøg Q-Pan H1N1-032 (2-5 mdr., sikkerhed/immunogenicitet)
English: Take special care with Arepanrix:
Danish: Vær ekstra forsigtig med at anvende Arepanrix:
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Danish: Natriumchlorid (NaCl) Dinatriumhydrogenphosphat (Na2HPO4) Kaliumdihydrogenphosphat (KH2PO4) Kaliumchlorid (KCl) Vand til injektionsvæsker
English: In some age groups there are limited clinical study data (adults aged 60-79 years and children aged 10 to 17 years), very limited clinical study data (adults aged 80 years and older, children aged 6 months to 9 years) or no data (children aged less than 6 months) with an AS03-containing vaccine containing HA from H5N1 or from H1N1v manufactured using a different process as detailed in sections 4.4, 4.8 and
Danish: For nogle aldersgrupper er der begrænsede data fra kliniske forsøg (voksne i alderen 60-79 år og børn i alderen 10 til 17 år), meget begrænsede data fra kliniske forsøg (voksne i alderen 80 år og derover, børn i alderen 6 måneder til 9 år) eller ingen data (børn under 6 måneder) med AS03-adjuveret vaccine, som indeholder HA fra H5N1 eller fra H1N1v, som er fremstillet ved en anden proces), som angivet i pkt.
English: 26-February-2010
Danish: 26. februar 2010
English: Additional data on reactogenicity are available from clinical studies in healthy subjects of various age groups from 6 months of age upwards who received an AS03-containing vaccine containing HA from H1N1v manufactured using a different process.
Danish: Supplerende data vedrørende reaktogenicitet er tilgængelige fra kliniske forsøg med raske personer i forskellige aldersgrupper fra 6 måneder og opefter, som har fået AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces.
English: Clinical studies with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) provide additional safety and immunogenicity data in healthy adults, including the elderly.
Danish: Kliniske forsøg med en formulering af Arepanrix, som indeholder 3,75 mikrogram HA fra A/Indonesia/05/2005 (H5N1) har tilvejebragt sikkerheds- og immunogenicitetsdata for raske voksne inklusive ældre.
English: • Swollen glands in the axilla
Danish: • Hævede kirtler i armhulen
English: Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000)
Danish: Meget almindelige (forekommer hos flere end 1 ud af 10 vaccinerede personer) Almindelige (forekommer hos mellem 1 og 10 ud af 100 vaccinerede personer) Ikke almindelige (forekommer hos mellem 1 og 10 ud af 1.000 vaccinerede personer) Sjældne (forekommer hos mellem 1 og 10 ud af 10.000 vaccinerede personer) Meget sjældne (forekommer hos færre end 1 ud af 10.000 vaccinerede personer)
English: Suspension and emulsion for emulsion for injection.
Danish: Suspension og emulsion til injektionsvæske, emulsion.
English: The anti-HA antibody responses 21 days after a first dose were as follows:
Danish: Anti-HA-anstistofresponset 21 dage efter første dosis var følgende:
English: No data are available at present on reactogenicity after a second half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process in children aged 3 to 9 years.
Danish: Der er på nuværende tidspunkt ingen data tilgængelige vedrørende reaktogenicitet efter den anden halve voksendosis (a 0,25 ml) AS03-adjuvert vaccine, som indeholder HA fra H1N1, som er fremstillet ved en anden proces, for børn i alderen 3-9 år.
English: In a clinical study 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) were as follows:
Danish: I et klinisk forsøg med raske børn i alderen 6-35 måneder (stratificeret i aldergrupperne fra 6-11 måneder, 12-23 måneder og 24-35 måneder) var anti-HA-anstistofresponset 21 dage efter første og anden halve voksendosis (a 0,25 ml) følgende:
English: AS03-containing vaccine containing HA from H1N1v manufactured using a different process N=164
Danish: AS03-adjuveret vaccine, som indeholder HA fra H1N1v, som er fremstillet ved en anden proces n = 164
English: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Danish: Efter sammenblandingen, skal den færdige vaccine anvendes inden for 24 timer, og den må ikke opbevares over 25 °C.
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Danish: Efter sammenblanding med adjuvans, emulsion: 10 doser a 0,5 ml
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Danish: • to pakker med 25 hætteglas a 2,5 ml emulsion (adjuvans)
English: In another clinical study, anti-HA responses against A/Vietnam/1194/2004 following administration of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) were as follows:
Danish: I et andet klinisk forsøg var anti-HA-responset mod A/Vietnam/1194/2004 efter administration af en formulering af Arepanrix, som indeholder 3,75 mikrogram HA fra A/Indonesis/05/2005 (H5N1) følgende:
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Danish: Hvis dit barn bliver vaccineret, skal du være opmærksom på, at bivirkningerne kan være mere udtalte efter den anden vaccinedosis.
English: One dose of 0.25 ml at an elected date.
Danish: Én dosis på 0,25 ml gives på en bestemt dag.
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Danish: • en pakke med 50 hætteglas a 2,5 ml suspension (antigen)
English: Seroconversion rate2
Danish: Serokonvertering s-rate2
English: Day 180 N=141
Danish: dag 180 n = 141
English: Children aged 10-17 years
Danish: Børn i alderen 10-17 år
English: Immune response to A/California/7/2009 (H1N1)v-like Arepanrix (H1N1) N=164)
Danish: Immunrespons mod A/California/7/2009 (H1N1)v-lignende stamme Arepanrix (H1N1) n = 164)
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Danish: Udover de bivirkninger, som er rapporteret i de kliniske forsøg, er følgende rapporteret efter markedsføringen af AS03-adjuveret vaccine indholdende HA fra H1N1v, som er fremstillet ved en anden proces:
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Danish: En firdobbelt stigning i serum-neutraliserende antistoftiter mod A/Vietnam/1194/2004 blev opnået hos 44,7 % af personerne på dag 21, hos 53,2 % af personerne på dag 42 og hos 38,3 % af personerne på dag 180.
English: In children aged 3-9 years who received a first half adult dose of a similar vaccine (H1N1), the side effects were similar compared to the side effects reported in adults, with the exception of shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years.
Danish: Hos børn i alderen 3-9 år, som fik en halv voksendosis af en tilsvarende vaccine (H1N1), er set tilsvarende bivirkninger, som hos voksne bortset fra kuldegysning, svedtendens og mave-tarm symptomer, som ses oftere hos børn i alderen 3-9 år.
English: The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Danish: Når suspension og emulsion er sammenblandet, fås en multidosisvaccine i et hætteglas.
English: Emulsion vial:
Danish: Emulsion i hætteglas: