FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemi er frekvensen for indsendelse af PSUR som nævnt i artikel 24 i EU's forordning nr. 726/2004 ikke relevant i forbindelse med sikkerhedsmonitorering af en pandemisk vaccine, hvor patienterne forventes at blive udsat for høj eksponering i løbet af kort tid.
English: This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Danish: Dette produkt indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. det er i alt væsentlighed natrium- og kaliumfrit.
English: At day 42, the anti-HA antibody responses were as follows:
Danish: På dag 42 var anti-HA-antistofresponset følgende:
English: The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version V03 (dateret 19. november 2007) i Modul 1.8.1 i ansøgningsmaterialet til markedsføringstillladelsen, er på plads og fungerer, før produktet når markedet, og så længe produktet markedsføres.
English: Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Danish: Før emulsionen og suspensionen sammenblandes, bør de to komponenter have stuetemperatur, omrystes og inspiceres visuelt for fremmede partikler og/eller ændringer i det fysiske udseende.
English: Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Danish: Neutraliserende-antistoftitere på mindst 1:40 eller mindst 1:180 blev opnået hos henholdsvis 87 % og 67 % af de 87 undersøgte personer.
English: The emulsion vial contains an ‘adjuvant' (AS03).
Danish: Hætteglasset med emulsion indeholder adjuvans (AS03).
English: 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.
Danish: 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.
English: The vaccine should never be given into a vein or into the skin.
Danish: Vaccinen må aldrig indsprøjtes i en vene (blodåre) eller lige under huden.
English: • Severe stabbing or throbbing pain along one or more nerves
Danish: • Stærke, stikkende eller dunkende smerter langs en eller flere nerver.
English: Vial B
Danish: Hætteglas B
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode J07BB02.
English: Adverse reactions reported are listed according to the following frequency:
Danish: De sete bivirkninger er opstillet ud fra følgende hyppighed:
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breastfeeding.
Danish: Din læge vil vurdere fordele og risiko ved at give dig vaccinen, hvis du er gravid eller ammer.
English: • if you have problems with your immune system, since your response to the vaccine may then be
Danish: • hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat
English: Immune response to A/Vietnam/1194/2004 (D42) 71 to 80 years
Danish: Immunrespons mod A/Vietnam/1194/2004 (dag 42) 71 til 80 år
English: 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.
Danish: 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.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Danish: Anden vaccinedosis på 0,5 ml bør gives mindst 3 uger senere.
English: 25 vials x 2: emulsion
Danish: 25 hætteglas x 2: emulsion
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske forstyrrelser, fx encefalomyelitis, neuritis og Guillain-Barré-syndrom.
English: 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).
Danish: Dyreforsøg viser ingen direkte eller indirekte skadelige virkninger, hvad angår fertilitet, graviditet, fosterudvikling, fødsel og udvikling efter fødslen (se pkt.
English: 7 days after 2nd dose
Danish: 7 dage efter anden dosis
English: Vial A
Danish: Hætteglas A
English: 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
Danish: 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
English: 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.
Danish: En firdobbelt stigning i serumneutraliserende antistoftiter fra dag 0 blev set hos 85,7 % på dag 42 og hos 72 % på dag 180.
English: A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
Danish: En firdobbelt stigning i serum-neutraliserende antistof mod A/Indonesia/05/2005 blev opnået hos > 90 personer efter to doser uafhængigt af vaccinationsprogram.
English: If any of these side effects occur, please tell your doctor or pharmacist immediately.
Danish: Hvis du får nogle af ovennævnte bivirkninger skal du straks fortælle det til din læge eller på apoteket.
English: Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Danish: Fordele og potentielle risici skal derfor vurderes i henhold til de officielle anbefalinger, når vaccinen administreres til gravide kvinder.
English: • Swollen glands in the neck, armpit or groin
Danish: • Hævede kirtler i nakke, armhule eller lyske
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: induration, hævelser, smerter og rødmen ved administrationsstedet, feber, træthed Almindelig: kuldegysninger, influenzalignende symptomer, reaktioner på administrationsstedet (fx varme, kløe)
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Danish: Seroprotektionsraten var 92 % mod A/Indonesia 21 dage efter boostervaccination og 69,2 % på dag
English: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Danish: Hver enkel vaccinedosis (0,5 ml) udtrækkes vha. en injektionssprøjte.
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Danish: Fritterne blev vaccineret på dag 0 og 21 og eksponeret intra-trachealt på dag 49 med en letal dosis af H5N1/A/Vietnam/1194/04 eller heterolog H5N1/A/Indonesia/5/05.
English: The needle used for withdrawal must be replaced by a needle suitable for intramuscular
Danish: Den kanyle, der bruges til udtrækning, skal udskiftes med en kanyle, der er beregnet til
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses (2.5 ml)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 doser (2,5 ml)
English: 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).
Danish: 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.
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Danish: Immunrespons mod A/Vietnam/1194/2004 0, 21 dages program
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Danish: Efter to doser givet med 21 dages- eller 6 måneders-mellemrum havde 96,0 % af personerne en firdobbelt stigning i serum-neutraliserende antistoftiter og 98-100 % af personerne havde en titer på mindst 1:80.
English: After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Danish: Efter sammenblanding indeholder en vaccinedosis (0,5 ml) 3,75 mikrogram hæmagglutinin fra følgende influenzavirusstamme:
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for destruktion <og anden håndtering>
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkel frekvensgruppe er bivirknigerne opstillet efter, hvor alvorlige de er.
English: In the event of either being observed, discard the vaccine.
Danish: I tilfælde af observation af et af de ovennævnte forhold, bør vaccinen kasseres.
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Danish: Nogle af de bivirkninger, der er nævnt i afsnit 4, kan påvirke din evne til at køre bil eller anvende maskiner.
English: Double dose N=10
Danish: dobbeltdosis N = 10
English: Single dose N=13
Danish: enkeltdosis N = 13
English: Suspension to be exclusively mixed with emulsion before administration
Danish: Suspension til sammenblanding med emulsion før administration.
English: Seroconversion factor3
Danish: Serokonverteringsfactor3
English: Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03.
Danish: Nedennævnte bivirkninger er vurderet i kliniske forsøg med ca. 5.000 personer på 18 år og derover, som fik en vaccine indeholdende mindst 3,75 μg HA/AS03.
English: This compound contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Danish: Denne består af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg).
English: 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;
Danish: 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;
English: Double dose N=43
Danish: Dobbeltdosis N = 43
English: To be mixed with Vial B before administration
Danish: Skal sammenblandes med hætteglas B før administration.
English: 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.
Danish: 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.
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
Danish: Ikke almindelige bivirkninger (det sker efter op til 1 ud af 100 vaccinedoser): • Reaktioner i huden, som nældefeber
English: Against A/Vietnam 21 days after boosting with A/Vietnam
Danish: Mod A/Vietnam 21 dage efter boosterdosis A/Vietnam N= 46
English: 21 days after 2nd dose N=48
Danish: 21 dage efter anden dosis N = 48
English: • 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.
Danish: • 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.
English: 21 days after 1st dose N=55
Danish: 21 dage efter første dosis N = 55
English: Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Danish: Ikke almindelig: gastro-intestinale symptomer (fx diaré, opkastning, mavesmerter, kvalme)
English: The double injections will be given in opposite arms.
Danish: Indsprøjtningerne vil blive givet i hver sin arm.
English: 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).
Danish: Meget begrænsede data for seronegative personer > 80 år (N = 5) viste, at ingen personer opnåede serobeskyttelse efter administration af to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1).
English: Very common (these may occur with more than 1 in 10 doses of the vaccine):
Danish: Meget almindelige (det sker efter mere end 1 ud af 10 vaccinedoser):
English: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Danish: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)
English: Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Danish: Immunrespons mod A/Indonesia/5/2005 0, 21 dages program
English: Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Danish: Hætteglas A: multidosishætteglas med antigen (suspension) Hætteglas B: multidosishætteglas med adjuvans (emulsion).
English: Intramuscular use Shake before use
Danish: Intramuskulær anvendelse Omrystes før brug Læs indlægssedlen inden brug
English: 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:
Danish: 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:
English: • one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
Danish: • en pakke med 50 hætteglas a 2,5 ml suspension (aktivt stof) til 10 doser
English: Allergic reactions, in rare cases leading to shock, have been reported.
Danish: Neuralgi, kramper, forbigående trombocytopeni Der er set allergiske reaktioner, som i sjældne tilfælde har ført til shock.
English: 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).
Danish: 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.
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Danish: Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1):
English: 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.
Danish: 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.
English: To be mixed with Vial A before administration
Danish: Skal sammenblandes med hætteglas A før administration.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION
English: OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with suspension before administration
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Emulsion til sammenblanding med suspension før administration.
English: 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
Danish: En pakke indeholder: - en pakke med 50 hætteglas (type I-glas) hver indeholdende 2,5 ml suspension (10 x 0,25 ml
English: • Warmth, itching or bruising at the injection site
Danish: • Varme, kløe eller blåt mærke ved det sted hvor indsprøjtningen blev givet
English: 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:
Danish: 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:
English: 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
Danish: Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid (NaCl), dinatriumhydrogenphosphat (Na2HPO4), kaliumdihydrogenphosphat (KH2PO4), kaliumchlorid (KCl), magnesiumchlorid (MgCl2), vand til injektionsvæsker
English: 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).
Danish: 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).
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
Danish: • to pakker med 25 hætteglas a 2,5 ml emulsion (adjuvans) til 10 doser
English: GlaxoSmithKline, Produtos Farmacêuticos, Lda.
Danish: Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
English: If you are not sure, talk to your doctor or pharmacist before having this vaccine.
Danish: Spørg din læge eller på apoteket, hvis der er noget, du er i tvivl om, før du får denne vaccine.
English: Split influenza virus, inactivated, containing antigen equivalent to A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen svarende til A/VietNam/1194/2004 (H5N1)lignende stamme (NIBRG-14)
English: Split influenza virus, inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/VietNam/1194/2004 (H5N1)-lignende stamme (NIBRG-14)