natgillin/translations-raw huggingface dataset:
Som en konsekvens heraf skal indehaveren af markedsføringstilladelsen, så snart en pandemi er erklæret (fase 6 i WHO's beredskabsplan for verdensomspændende influenza) og pandemivaccinen anvendt, med hyppige mellemrum indsende en simplificeret PSUR, hvis format og frekvens er anført i ”CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008 og tilhørende opdateringer. 
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Vaccinen må aldrig indsprøjtes i en vene (blodåre) eller lige under huden. 
The vaccine should never be given into a vein or into the skin.
• Stærke, stikkende eller dunkende smerter langs en eller flere nerver. 
• Severe stabbing or throbbing pain along one or more nerves
Hætteglas B 
Vial B
Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode J07BB02. 
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
De sete bivirkninger er opstillet ud fra følgende hyppighed: 
Adverse reactions reported are listed according to the following frequency:
Din læge vil vurdere fordele og risiko ved at give dig vaccinen, hvis du er gravid eller ammer. 
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breastfeeding.
• hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat 
• if you have problems with your immune system, since your response to the vaccine may then be
Immunrespons mod A/Vietnam/1194/2004 (dag 42) 71 til 80 år 
Immune response to A/Vietnam/1194/2004 (D42) 71 to 80 years
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen (RMP), som aftalt i version RMPv6 (dateret marts 2009) af Risikohåndteringsplanen (RMP) anført i modul 1.8.2. i ansøgningen om markedføringstilladelsen, og i efterfølgende CHMP-krav til opdateringer af RMP. 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv6 (dated March 2009) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Anden vaccinedosis på 0,5 ml bør gives mindst 3 uger senere. 
A second dose of 0.5 ml should be given after an interval of at least three weeks.
25 hætteglas x 2: emulsion 
25 vials x 2: emulsion
Neurologiske forstyrrelser, fx encefalomyelitis, neuritis og Guillain-Barré-syndrom. 
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Dyreforsøg viser ingen direkte eller indirekte skadelige virkninger, hvad angår fertilitet, graviditet, fosterudvikling, fødsel og udvikling efter fødslen (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonic/fetal development, parturition or post-natal development (see section 5.3).
7 dage efter anden dosis 
7 days after 2nd dose
Hætteglas A 
Vial A
Meget sjældne bivirkninger (det sker efter op til 1 ud af 10.000 vaccinedoser): • Smerter pga. kortvarig betændelse af hjerne og nerver, mathed og lammelser, som muligvis kan 
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may
En firdobbelt stigning i serumneutraliserende antistoftiter fra dag 0 blev set hos 85,7 % på dag 42 og hos 72 % på dag 180. 
A 4-fold increase in serum neutralising antibody titres from day 0 was observed in 85.7% at day 42 and 72% at day 180.
En firdobbelt stigning i serum-neutraliserende antistof mod A/Indonesia/05/2005 blev opnået hos > 90 personer efter to doser uafhængigt af vaccinationsprogram. 
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.
Hvis du får nogle af ovennævnte bivirkninger skal du straks fortælle det til din læge eller på apoteket. 
If any of these side effects occur, please tell your doctor or pharmacist immediately.
Fordele og potentielle risici skal derfor vurderes i henhold til de officielle anbefalinger, når vaccinen administreres til gravide kvinder. 
Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
• Hævede kirtler i nakke, armhule eller lyske 
• Swollen glands in the neck, armpit or groin
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: induration, hævelser, smerter og rødmen ved administrationsstedet, feber, træthed Almindelig: kuldegysninger, influenzalignende symptomer, reaktioner på administrationsstedet (fx varme, kløe) 
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
På dag 180 var seroprotektionsraten hos personer > 60 år 52,9 % efter administration af to enkeltdoser og 69,5 % for de personer, som fik to dobbeltdoser på dag 0 og dag 21. 
The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21.
Vaccinen blandes ved at trække indholdet af hætteglasset med emulsion (hætteglas B) ud vha. en injektionssprøjte og tilsætte dette til hætteglasset med suspension (hætteglas A). 
The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A).
Seroprotektionsraten var 92 % mod A/Indonesia 21 dage efter boostervaccination og 69,2 % på dag 
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Hver enkel vaccinedosis (0,5 ml) udtrækkes vha. en injektionssprøjte. 
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Fritterne blev vaccineret på dag 0 og 21 og eksponeret intra-trachealt på dag 49 med en letal dosis af H5N1/A/Vietnam/1194/04 eller heterolog H5N1/A/Indonesia/5/05. 
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.
Den kanyle, der bruges til udtrækning, skal udskiftes med en kanyle, der er beregnet til 
The needle used for withdrawal must be replaced by a needle suitable for intramuscular
INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 doser (2,5 ml) 
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses (2.5 ml)
Indikationen er basseret på immunogenicitetsdata fra raske personer i alderen fra 18 år og derover efter administration af to vaccinedoser fremstillet ud fra A/VietNam/1194/2004 NIBRG-14 (H5N1) (se pkt. 
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).
Immunrespons mod A/Vietnam/1194/2004 0, 21 dages program 
Immune response to A/Vietnam/1194/2004 0, 21 days schedule
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. 
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.
Efter sammenblanding indeholder en vaccinedosis (0,5 ml) 3,75 mikrogram hæmagglutinin fra følgende influenzavirusstamme: 
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
6.6 Regler for destruktion <og anden håndtering> 
6.6 Special precautions for disposal and other handling
Inden for hver enkel frekvensgruppe er bivirknigerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
I tilfælde af observation af et af de ovennævnte forhold, bør vaccinen kasseres. 
In the event of either being observed, discard the vaccine.
Nogle af de bivirkninger, der er nævnt i afsnit 4, kan påvirke din evne til at køre bil eller anvende maskiner. 
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
dobbeltdosis N = 10 
Double dose N=10
enkeltdosis N = 13 
Single dose N=13
Suspension til sammenblanding med emulsion før administration. 
Suspension to be exclusively mixed with emulsion before administration
Serokonverteringsfactor3 
Seroconversion factor3
Nedennævnte bivirkninger er vurderet i kliniske forsøg med ca. 5.000 personer på 18 år og derover, som fik en vaccine indeholdende mindst 3,75 μg 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.
Denne består af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg). 
This compound contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
1 seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1:40; 2 serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnår en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før vaccination og opnår en firdobbelt stigning af titer; 
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
Dobbeltdosis N = 43 
Double dose N=43
Skal sammenblandes med hætteglas B før administration. 
To be mixed with Vial B before administration
I tilfælde af en officielt erklæret influenzapandemi kan personer, som tidligere er blevet vaccineret med en eller to doser Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline 3,75 μg indeholdende HA-antigen fra en anden undergruppe af samme influenza-subtype end den pandemiske influenzastamme, få en enkelt dosis Pandemrix istedet for de to doser, som kræves til personer, som ikke tidligere er blevet vaccineret. 
However, in the event of an officially declared influenza pandemic, persons previously vaccinated with one or two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg that contained HA antigen derived from a different clade of the same influenza subtype as the pandemic influenza strain may receive a single dose of Pandemrix instead of two doses that are required in previously unvaccinated individuals.
Ikke almindelige bivirkninger (det sker efter op til 1 ud af 100 vaccinedoser): • Reaktioner i huden, som nældefeber 
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
Mod A/Vietnam 21 dage efter boosterdosis A/Vietnam N= 46 
Against A/Vietnam 21 days after boosting with A/Vietnam
21 dage efter anden dosis N = 48 
21 days after 2nd dose N=48
• hvis du tidligere har haft en pludselig, livstruende, overfølsomhedsreaktion mod et af indholdsstofferne i Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram (disse er anført sidst i denne indlægsseddel) eller over for et af følgende stoffer, som muligvis kan findes i sporstofmængder: æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat (antibiotikum) eller natriumdeoxycholat. 
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
21 dage efter første dosis N = 55 
21 days after 1st dose N=55
Ikke almindelig: gastro-intestinale symptomer (fx diaré, opkastning, mavesmerter, kvalme) 
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Indsprøjtningerne vil blive givet i hver sin arm. 
The double injections will be given in opposite arms.
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 following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Meget almindelige (det sker efter mere end 1 ud af 10 vaccinedoser): 
Very common (these may occur with more than 1 in 10 doses of the vaccine):
A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14) 
A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Immunrespons mod A/Indonesia/5/2005 0, 21 dages program 
Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Hætteglas A: multidosishætteglas med antigen (suspension) Hætteglas B: multidosishætteglas med adjuvans (emulsion). 
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Intramuskulær anvendelse Omrystes før brug Læs indlægssedlen inden brug 
Intramuscular use Shake before use
Anti-HA-responset mod A/Indonesia/05/2005 efter admiistration 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:
• en pakke med 50 hætteglas a 2,5 ml suspension (aktivt stof) til 10 doser 
• one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
Neuralgi, kramper, forbigående trombocytopeni Der er set allergiske reaktioner, som i sjældne tilfælde har ført til shock. 
Allergic reactions, in rare cases leading to shock, have been reported.
Baseret på meget få data kan ældre over 80 år have behov for dobbelt dosis Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline 3,75 μg på en bestemt dag og igen efter mindst 3 uger for at opnå et immunrespons (se pkt. 
Based on very limited data, adults aged >80 years may require a double dose of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1): 
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Opfølgning af 50 personer i alderen 18-60 år, som havde fået to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på dag 0 og 21 viste, at 84 % var serobeskyttet (HI-titer ≥ 1:40) på dag 42 sammenlignet med 54 % på dag 180. 
Follow up of 50 subjects aged 18-60 years who had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 at 0 and 21 days showed that 84% were seroprotected (HI titre ≥1:40) at day 42 compared with 54% at day 180.
Skal sammenblandes med hætteglas A før administration. 
To be mixed with Vial A before administration
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Emulsion til sammenblanding med suspension før administration. 
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with suspension before administration
En pakke indeholder: - en pakke med 50 hætteglas (type I-glas) hver indeholdende 2,5 ml suspension (10 x 0,25 ml 
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
• Varme, kløe eller blåt mærke ved det sted hvor indsprøjtningen blev givet 
• Warmth, itching or bruising at the injection site
I kliniske immunogenisitetsforsøg 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)antistofrespons 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:
Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid (NaCl), dinatriumhydrogenphosphat (Na2HPO4), kaliumdihydrogenphosphat (KH2PO4), kaliumchlorid (KCl), magnesiumchlorid (MgCl2), vand til injektionsvæsker 
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate(KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), water for injections
Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne, over for thiomersal og reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat og natriumdeoxycholat). 
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
• to pakker med 25 hætteglas a 2,5 ml emulsion (adjuvans) til 10 doser 
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda. 
GlaxoSmithKline, Produtos Farmacêuticos, Lda.
Spørg din læge eller på apoteket, hvis der er noget, du er i tvivl om, før du får denne vaccine. 
If you are not sure, talk to your doctor or pharmacist before having this vaccine.
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)
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)
Hvis du tager medicin, som nedsætter immunforsvaret, eller får en anden behandling (fx strålebehandling), som påvirker immunforsvaret, kan Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram stadig gives, men virkningen af vaccinen kan være nedsat. 
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
• Smerter, rødmen, hævelse eller en hårdhed, hvor indsprøjtningen blev givet 
• Pain, redness, swelling or a hard lump at the injection site
Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne > 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og seroprotektionsraterne > 90 % mod A/Vietnam efter en dosis af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005. 
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Hvis samtidig vaccination med andre vacciner er nødvendigt, gives den anden vaccine i den anden arm. 
However, if coadministration with another vaccine is considered to be essential, the vaccines should be injected into separate limbs.
GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208 www.gsk.ro 
GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208
Hvis du er gravid, forsøger at blive gravid eller ammer, fortæl det til lægen, 
Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat 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.
Almindelige (det sker efter op til 1 ud af 10 vaccinedoser): 
Common (these may occur with up to 1 in 10 doses of the vaccine):
Ikke almindelige (det sker efter op til 1 ud af 100 vaccinedoser): 
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
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.
Hos 152 personer i alderen over 60 år var anti-HA-antistof-serobeskyttelsen og serokonverteringsraten 23 % mod A/Indonesia/05/2005 på dag 42 efter to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og serokonverteringsfaktoren var 2,7. 
In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
En mindre infektion, fx forkølelse, er normalt ikke noget problem, men lægen afgør, om du kan vaccineres med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3,75 mikrogram. 
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.