natgillin/translations-raw huggingface dataset:
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. 
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.
Mod A/Vietnam 21 dage efter boosterdosis A/Vietnam n= 46 
Against A/Vietnam 21 days after boosting with A/Vietnam N=46
Seropositivitetsrate2 
Seropositivity rate2
Suspension: flerdosis-hætteglas indeholdende antigen, Emulsion: flerdosis-hætteglas indeholdende adjuvans. 
Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt. 
For storage conditions after mixing of the medicinal product, see section 6.3.
Mod A/Indonesia 21 dage efter boosterdosis A/Indonesia n= 49 
Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for denne vaccine af videnskabelige årsager. 
This means that for scientific reasons it has been impossible to get complete information on this medicine.
Efter tilberedning af vaccinen: Efter sammenblandingen, skal den færdige vaccine indsprøjtes inden for 24 timer og må ikke opbevares over 25 °C. 
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
• Varme, kløe eller blåt mærke ved det sted, hvor indsprøjtningen blev givet 
• Warmth, itching or bruising where the injection was given
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. 
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.
Seroprotektionsraten var 92 % mod A/Indonesia 21 dage efter boostervaccination og 69,2 % på dag 180. 
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Dette kan medføre hudrødme, ledsmerter og nyreproblemer. 
This can cause skin rashes, joint pain and kidney problems
Ved observation af et af de nævnte forhold (inklusive gummipartikler fra proppen) skal vaccinen kasseres. 
In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
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 
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
Adjupanrix indeholder natrium og kalium 
Adjupanrix contains sodium and potassium
Hjælpestof, som behandleren skal være opmærksom på Vaccinen indeholder 5 mikrogram thiomersal (se pkt. 
Excipient with known effect The vaccine contains 5 micrograms thiomersal (see section 4.4).
Knogler, led, muskler og bindevæv Meget almindelig: artralgi, myalgi 
Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
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). 
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.
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. 
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.
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. 
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.
• Reaktioner i huden, som f.eks. nældefeber (udslæt). 
• Generalised skin reactions including urticaria (hives)
Fortæl din læge, hvis du ved, at du er overfølsom over for andre ting. 
Tell your doctor if you have any known allergies.
• Øget svedtendens, kuldegysninger, influenzalignende symptomer 
• Increased sweating, shivering, flu-like symptoms
Snæver SMQ ”Anafylaktisk reaktion” og snæver SMQ 
narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
GMT1 Serokonverteringsrate2 
GMT1 Seroconversion rate2
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. 
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.
• Kontakt lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her. 
• If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet.
Seroprotektionsraten, boosterserokonverteringsraten og boosterfaktoren mod A/Indonesia/5/2005 var henholdsvis 100 %, 99,7 % og 123,8, 21 dage efter boostervaccination. 
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.
måned n = 35 
Month N=35
Seroprotektionsraten 6, 12, 24 og 36 måneder efter første dosis var følgende: 
The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows:
måned 6 n = 48 
Month 6 N=48
2,5 ml pr. hætteglas. 
2.5 ml per vial.
Krydsreaktionsimmunrespons imod A/Indonesia/05/2005 blev ligeledes observeret i dette studie. 
In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
Den færdigblandede vaccine er en hvidlig til gullig, homogen, mælkeagtig emulsion. 
The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
* opformeret i æg ** mikrogram hæmagglutinin 
*propagated in eggs **expressed in microgram haemagglutinin
Der foreligger ingen data om samtidig admnistration af Adjupanrix og andre vacciner. 
There are no data on co-administration of Adjupanrix with other vaccines.
Når suspension og emulsion fra hætteglassene sammenblandes, fremkommer en multidosisbeholder. 
The suspension and emulsion vials once mixed form a multidose container.
Der findes ingen data fra overvågning efter markedsføring for Adjupanrix. 
No post-marketing surveillance data are available following Adjupanrix administration.
Denne indlægsseddel blev senest ændret 
This leaflet was last revised in {MM/YYYY}.
måned 6 n = 40 
Month 6 N=40
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). 
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).
Adjupanrix består af to hætteglas: 
Adjupanrix consists of two containers:
dobbeltdosis (n = 131) 
Double dose (N=131)
Immunrespons mod A/Vietnam/1194/2004 (H5N1): 
Immune response against A/Vietnam/1194/2004 (H5N1):
Personer i studie D-Pan-H5N1-010, som fik en enkelt dosis blev fulgt og undersøgt for vedvarende anti-HA-antistof mod A/Indonesia/5/2005. 
Subjects from study D-Pan-H5N1-010 who received a single dose were followed-up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
• Diaré, opkastning, mavesmerter, utilpashed 
• Diarrhoea, vomiting, stomach pain, feeling sick
Børn: 
Children
Hændelser af Særlig Interesse (AESI) opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet). 
Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid ,dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchlorid, vand til injektionsvæsker 
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
• en pakning med 50 hætteglas a 2,5 ml suspension (antigen) 
• one pack containing 50 vials of 2.5 ml suspension (antigen)
0, 6 måneders program (D-Pan-H5N1-012) 
0, 6 months schedule (D-Pan-H5N1-012)
Emulsionen er en hvidlig til gullig, homogen, mælkeagtig væske. 
The emulsion is a whitish to yellowish homogeneous milky liquid.
måned n = 47 
Month N=47
0, 21 dages program (D-Pan-H5N1-002) 
0, 21 days schedule (D-Pan-H5N1-002)
Alle personer havde yderligere en neutraliserende antistoftiter på mindst 1:80. 
In addition, all subjects had neutralising antibody titres of at least 1:80.
• to pakningr med 25 hætteglas a 2,5 ml emulsion (adjuvans) 
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Personerne i studie D-Pan-H5N1-002 blev fulgt og undersøgt for vedvarende anti-HA-antistof mod A/Indonesia/5/2005. 
Subjects from study D-Pan-H5N1-002 were followed up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Seroprotektionsraten 6, 12 og 24 måneder efter vaccination var følgende: 
The seroprotection rates 6, 12 and 24 months after vaccination were as follows:
måned n = 38 
Month N=38
50 hætteglas: suspension 
Antigen suspension for injection 50 vials: suspension
dobbeltdosis (n = 81) 
Double dose (N=81)
Blod og lymfesystem Almindelig: lymfadenopati 
Blood and lymphatic system disorders
Virkning og anvendelse Det skal du vide, før du får Adjupanrix Sådan får du Adjupanrix Bivirkninger 
What Adjupanrix is and what it is used for What you need to know before you receive Adjupanrix How Adjupanrix is given
dag 21 n = 140 
Day 21 N=140
Immunrespons mod A/Indonesia/05/2005 (H5N1) 
Immune response against A/Indonesia/05/2005 (H5N1)
A/VietNam/1194/2004 (H5N1) -lignende stamme (NIBRG-14) i.m. 
A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) I.M.
I et klinisk studie (D-H5N1-009) blev reaktogeniciteten evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml) Adjupanrix (givet med 21 dages interval). 
A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of Adjupanrix.
- Anafylakse: 
- Anaphylaxis:
Anti-HA-respons mod A/Indonesia/05/2005 efter administration af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 var følgende: 
Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer): 
Very common: may affect more than 1 in 10 people
2 firdobbelt stigning i serumneutraliserende antidstoftiter 3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80 
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Adjupanrix. 
In the first few weeks after vaccination with Adjupanrix the results of these tests may not be correct.
3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80 
3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Hverken hos børn, som fik halv voksendosis, eller hos børn, som fik fuld voksendosis, blev der set nogen stigning i forekomsten af bivirkninger efter anden dosis, bortset fra nogle bivirkninger, hvor forekomsten var højere efter anden dosis, især for hyppigheden af feber hos børn < 6 år. 
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
50 hætteglas: emulsion (adjuvans) 
50 vials: suspension (antigen) 50 vials: emulsion (adjuvant)
Immunrespons mod A/Vietnam/1194/2004 (dag 42) 61-70 år 
Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
dag 42 n = 42 
Day 42 N=42
Vaskulitis med forbigående nyreproblemer 
Vasculitis with transient renal involvement.
• Hvis du tidligere har haft en pludselig, livstruende, overfølsomhedsreaktion over for et af indholdsstofferne i denne vaccine (anført i afsnit 6) eller over for andre stoffer, som kan være til stede i meget små mængder f.eks. æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat. 
• If you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
• Fra 18 år og opefter: Du vil få to vaccinationer med Adjupanrix. 
• From 18 years onwards: you will receive two doses of Adjupanrix.
21 dage efter den anden dosis var seroprotektionsraten og vaccineresponsraten imod A/Vietnam/1194/2004 henholdsvis 89,6 % og 95,7 % for personer, som havde modtaget vaccinen med 6 måneders interval. 
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively.
enkeltdosis (n = 86) 
Single dose (N=86)
En pakning Adjupanrix: 
One pack of Adjupanrix consists of:
Det anbefales at bruge en 23-G 
It is recommended to equip the syringe with a 23-G needle.
I kliniske immunogenisitetsstudier med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 til personer i alderen 18-60 år er følgende anti-hæmagglutinin (anti-HA)antistof set: 
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (antiHA) antibody responses were as follows:
De sete bivirkninger er opstillet ud fra følgende hyppighed: 
Adverse reactions reported are listed according to the following frequency: Frequencies are reported as:
En oversigt over alle spontane hændelser pr. land, opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet) og alvorlighed, i rapporteringsperioden og kumulativt. 
An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Immunrespons mod A/Vietnam/1194/2004 6 måneder efter vaccination 
Immune response to A/Vietnam/1194/2004 6 months after vaccination
Det neutraliserende antistofrespons var følgende: 
The neutralising antibody responses were as follows:
Snæver SMQ ”Guillain Barré Syndrom” 
narrow SMQ “Vasculitis” - Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome” - Demyelination:
Slovenská republika GlaxoSmithKline Slovakia s.r.o. 
GlaxoSmithKline Slovakia s.r.o.
Meget sjældne bivirkninger (kan forekomme hos færre end 1 ud af 10.000 personer): 
Very rare: may affect less than 1 in 10,000 people
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PAKNING MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
dobbeltdosis n = 10 
Double dose N=10
• hvis du har haft andre overfølsomhedsreaktioner end den pludselige, livstruende overfølsomhedsreaktion over for et af indholdsstofferne i Adjupanrix (anført i afsnit 6) eller over for thiomersal, æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat 
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient of Adjupanrix (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Nogle af de bivirkninger, der er nævnt i pkt. 
4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Mave-tarm-kanalen Ikke almindelig: gastro-intestinale symptomer (f.eks. diaré, opkastning, mavesmerter, kvalme) 
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) Skin and subcutaneous tissue disorders
Meget almindelig (≥ 1/10) Almindelig (≥ 1/100 til < 1/10) Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) 
Uncommon (≥1/1,000 to <1/100)
En dosis AS03-adjuveret vaccine indholdende 3,75 μg HA fra A/Indonesia/05/2005 administreret efter en eller to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004
21 dage efter anden dosis n = 48 
21 days after 2nd dose N = 48
Natriumchlorid (NaCl) Dinatriumhydrogenphosphat (Na2HPO4) Kaliumdihydrogenphosphat (KH2PO4) Kaliumchlorid (KCl) Magnesiumchlorid (MgCl2) Vand til injektionsvæsker 
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Hvis du vil have yderligere oplysninger om produktet, skal du henvende dig til den lokale repræsentant: 
For any information about this medicinal vaccine, please contact the local representative of the Marketing Authorisation Holder:
enkeltdosis n = 48 
Single dose N=48
Denne adjuvans indeholder squalen (10,69 mg), DLα-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg). 
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
dobbeltdosis n = 92 
Double dose N=92
Ved overvågning efter markedsføring af AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1) blev følgende bivirkninger rapporteret: 
AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1) From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: Immune system disorders
Adjuvans bruges for at få kroppen til at danne et bedre immunforsvar (en bedre forsvarsmekanisme) over for vaccinen. 
Adjuvants are used to improve the body's response to the vaccine.
dag 42 n = 140 
Day 42 N=140
• Fra 18 år og opefter: Du vil få en vaccination med Adjupanrix. 
• From 18 years onwards: you will receive one dose of Adjupanrix.
Ved sammenblanding af 1 hætteglas suspension (2,5 ml) og 1 hætteglas emulsion (2,5 ml) fås 10 vaccinedoser a 0,5 ml. 
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Andre bivirkninger 
Other side effects:
Data fra pandemisk beredskabsvaccinationen vil støtte den vaccinationsstrategi, der sandsynligvis vil blive anvendt til den pandemiske vaccine. 
Data obtained with the pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
En oversigt over alle spontane hændelser efter organklasse (SOC), High Level Term (HLT) og foretrukket term (PT), opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet), og indeholdende antal af fatale rapporter, i rapporteringsperioden og kumulativt. 
An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or nonmedically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
enkeltdosis n = 13 
Single dose N=13
- to pakker med 25 hætteglas (type I-glas), hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi). 
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
21 dage efter anden dosis n = 924 
21 days after 2nd dose N = 924
Der findes ingen data fra subkutan administration med Adjupanrix. 
There are no data with Adjupanrix using the subcutaneous route.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Emulsionen skal sammenblandes med antigen, suspension før administration. 
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
fuld dosis (n = 41) 
Full dose (N=41)
fuld dosis (n = 35) 
Full dose (N=35)
fuld dosis n = 35 
Full dose N=35
7 dage efter anden dosis n = 47 
7 days after 2nd dose N = 47
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststofferne (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine. 
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
dobbeltdosis n = 54 
Double dose N=54
Du må ikke få Adjupanrix: 
Adjupanrix should not be given
Før injektion skal de to væsker sammenblandes. 
Before the vaccine is given, the two parts will be mixed together.
Seroprotektionsrate1 1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40 
Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Snæver SMQ ”Kramper” 
narrow SMQ “Convulsions”
LÆGEMIDLETS NAVN Emulsion til Adjupanrix injektionsvæske, emulsion 
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Adjupanrix
Split influenzavirus, inaktiveret, indeholdende antigen svarende til: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 
Split influenza virus inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Meget almindelig: hovedpine Ikke almindelig: paræstesi, somnolens, svimmelhed 
Uncommon: paraesthesia, somnolence, dizziness
halv dosis n = 36 
Half dose N=36
- Demyelinering: 
- Encephalitis:
Immunrespons mod A/Indonesia/05/2005 
Immune response to A/Indonesia/05/2005