FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: • Diarrhoea, vomiting, stomach pain, feeling sick
Danish: • Diaré, opkastning, mavesmerter, utilpashed
English: Children
Danish: Børn:
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Danish: Hændelser af Særlig Interesse (AESI) opdelt ud fra type af rapport (medicinsk bekræftet eller ikke-medicinsk bekræftet).
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Danish: Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid ,dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchlorid, vand til injektionsvæsker
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Danish: • en pakning med 50 hætteglas a 2,5 ml suspension (antigen)
English: 0, 6 months schedule (D-Pan-H5N1-012)
Danish: 0, 6 måneders program (D-Pan-H5N1-012)
English: The emulsion is a whitish to yellowish homogeneous milky liquid.
Danish: Emulsionen er en hvidlig til gullig, homogen, mælkeagtig væske.
English: Month N=47
Danish: måned n = 47
English: 0, 21 days schedule (D-Pan-H5N1-002)
Danish: 0, 21 dages program (D-Pan-H5N1-002)
English: In addition, all subjects had neutralising antibody titres of at least 1:80.
Danish: Alle personer havde yderligere en neutraliserende antistoftiter på mindst 1:80.
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Danish: • to pakningr med 25 hætteglas a 2,5 ml emulsion (adjuvans)
English: Subjects from study D-Pan-H5N1-002 were followed up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Danish: Personerne i studie D-Pan-H5N1-002 blev fulgt og undersøgt for vedvarende anti-HA-antistof mod A/Indonesia/5/2005.
English: The seroprotection rates 6, 12 and 24 months after vaccination were as follows:
Danish: Seroprotektionsraten 6, 12 og 24 måneder efter vaccination var følgende:
English: Month N=38
Danish: måned n = 38
English: Antigen suspension for injection 50 vials: suspension
Danish: 50 hætteglas: suspension
English: Double dose (N=81)
Danish: dobbeltdosis (n = 81)
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Almindelig: lymfadenopati
English: What Adjupanrix is and what it is used for What you need to know before you receive Adjupanrix How Adjupanrix is given
Danish: Virkning og anvendelse Det skal du vide, før du får Adjupanrix Sådan får du Adjupanrix Bivirkninger
English: Day 21 N=140
Danish: dag 21 n = 140
English: Immune response against A/Indonesia/05/2005 (H5N1)
Danish: Immunrespons mod A/Indonesia/05/2005 (H5N1)
English: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) I.M.
Danish: A/VietNam/1194/2004 (H5N1) -lignende stamme (NIBRG-14) i.m.
English: 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.
Danish: 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).
English: - Anaphylaxis:
Danish: - Anafylakse:
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-respons mod A/Indonesia/05/2005 efter administration af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 var følgende:
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer):
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Danish: 2 firdobbelt stigning i serumneutraliserende antidstoftiter 3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
English: In the first few weeks after vaccination with Adjupanrix the results of these tests may not be correct.
Danish: En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Adjupanrix.
English: 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Danish: 3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
English: 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.
Danish: 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.
English: 50 vials: suspension (antigen) 50 vials: emulsion (adjuvant)
Danish: 50 hætteglas: emulsion (adjuvans)
English: Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
Danish: Immunrespons mod A/Vietnam/1194/2004 (dag 42) 61-70 år
English: Day 42 N=42
Danish: dag 42 n = 42
English: Vasculitis with transient renal involvement.
Danish: Vaskulitis med forbigående nyreproblemer
English: • 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.
Danish: • 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.
English: • From 18 years onwards: you will receive two doses of Adjupanrix.
Danish: • Fra 18 år og opefter: Du vil få to vaccinationer med Adjupanrix.
English: 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.
Danish: 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.
English: Single dose (N=86)
Danish: enkeltdosis (n = 86)
English: One pack of Adjupanrix consists of:
Danish: En pakning Adjupanrix:
English: It is recommended to equip the syringe with a 23-G needle.
Danish: Det anbefales at bruge en 23-G
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 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:
English: Adverse reactions reported are listed according to the following frequency: Frequencies are reported as:
Danish: De sete bivirkninger er opstillet ud fra følgende hyppighed:
English: 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.
Danish: 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.
English: Immune response to A/Vietnam/1194/2004 6 months after vaccination
Danish: Immunrespons mod A/Vietnam/1194/2004 6 måneder efter vaccination
English: The neutralising antibody responses were as follows:
Danish: Det neutraliserende antistofrespons var følgende:
English: narrow SMQ “Vasculitis” - Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome” - Demyelination:
Danish: Snæver SMQ ”Guillain Barré Syndrom”
English: GlaxoSmithKline Slovakia s.r.o.
Danish: Slovenská republika GlaxoSmithKline Slovakia s.r.o.
English: Very rare: may affect less than 1 in 10,000 people
Danish: Meget sjældne bivirkninger (kan forekomme hos færre end 1 ud af 10.000 personer):
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PAKNING MED 50 HÆTTEGLAS INDEHOLDENDE SUSPENSION
English: Double dose N=10
Danish: dobbeltdosis n = 10
English: • 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.
Danish: • 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
English: 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.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Nogle af de bivirkninger, der er nævnt i pkt.
English: Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) Skin and subcutaneous tissue disorders
Danish: Mave-tarm-kanalen Ikke almindelig: gastro-intestinale symptomer (f.eks. diaré, opkastning, mavesmerter, kvalme)
English: Uncommon (≥1/1,000 to <1/100)
Danish: 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)
English: 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
Danish: 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
English: 21 days after 2nd dose N = 48
Danish: 21 dage efter anden dosis n = 48
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Danish: Natriumchlorid (NaCl) Dinatriumhydrogenphosphat (Na2HPO4) Kaliumdihydrogenphosphat (KH2PO4) Kaliumchlorid (KCl) Magnesiumchlorid (MgCl2) Vand til injektionsvæsker
English: For any information about this medicinal vaccine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om produktet, skal du henvende dig til den lokale repræsentant:
English: Single dose N=48
Danish: enkeltdosis n = 48
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Danish: Denne adjuvans indeholder squalen (10,69 mg), DLα-tocopherol (11,86 mg) og polysorbat 80 (4,86 mg).
English: Double dose N=92
Danish: dobbeltdosis n = 92
English: 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
Danish: Ved overvågning efter markedsføring af AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1) blev følgende bivirkninger rapporteret:
English: Adjuvants are used to improve the body's response to the vaccine.
Danish: Adjuvans bruges for at få kroppen til at danne et bedre immunforsvar (en bedre forsvarsmekanisme) over for vaccinen.
English: Day 42 N=140
Danish: dag 42 n = 140
English: • From 18 years onwards: you will receive one dose of Adjupanrix.
Danish: • Fra 18 år og opefter: Du vil få en vaccination med Adjupanrix.
English: 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
Danish: Ved sammenblanding af 1 hætteglas suspension (2,5 ml) og 1 hætteglas emulsion (2,5 ml) fås 10 vaccinedoser a 0,5 ml.
English: 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)
Danish: 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)
English: Other side effects:
Danish: Andre bivirkninger
English: 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.
Danish: Data fra pandemisk beredskabsvaccinationen vil støtte den vaccinationsstrategi, der sandsynligvis vil blive anvendt til den pandemiske vaccine.
English: 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.
Danish: 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.
English: Single dose N=13
Danish: enkeltdosis n = 13
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Danish: - to pakker med 25 hætteglas (type I-glas), hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi).
English: 21 days after 2nd dose N = 924
Danish: 21 dage efter anden dosis n = 924
English: There are no data with Adjupanrix using the subcutaneous route.
Danish: Der findes ingen data fra subkutan administration med Adjupanrix.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Emulsionen skal sammenblandes med antigen, suspension før administration.
English: Full dose (N=41)
Danish: fuld dosis (n = 41)
English: Full dose (N=35)
Danish: fuld dosis (n = 35)
English: Full dose N=35
Danish: fuld dosis n = 35
English: 7 days after 2nd dose N = 47
Danish: 7 dage efter anden dosis n = 47
English: 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.
Danish: 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.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PAKNING MED 25 HÆTTEGLAS INDEHOLDENDE EMULSION
English: Double dose N=54
Danish: dobbeltdosis n = 54
English: Adjupanrix should not be given
Danish: Du må ikke få Adjupanrix:
English: Before the vaccine is given, the two parts will be mixed together.
Danish: Før injektion skal de to væsker sammenblandes.
English: Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Danish: Seroprotektionsrate1 1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
English: narrow SMQ “Convulsions”
Danish: Snæver SMQ ”Kramper”
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Adjupanrix
Danish: LÆGEMIDLETS NAVN Emulsion til Adjupanrix injektionsvæske, emulsion
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: Uncommon: paraesthesia, somnolence, dizziness
Danish: Meget almindelig: hovedpine Ikke almindelig: paræstesi, somnolens, svimmelhed
English: Half dose N=36
Danish: halv dosis n = 36
English: - Encephalitis:
Danish: - Demyelinering:
English: Immune response to A/Indonesia/05/2005
Danish: Immunrespons mod A/Indonesia/05/2005
English: Immune response to A/Vietnam/1194/2004 6-9 years
Danish: Immunrespons mod A/Vietnam/1194/2004 6-9 år
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Adjupanrix i.m.
English: Half dose N=38
Danish: halv dosis n = 38
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
Danish: Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat Kaliumchlorid Magnesiumchlorid Vand til injektionsvæsker
English: Immune response to A/Vietnam/1194/2004 3-5 years
Danish: Immunrespons mod A/Vietnam/1194/2004 3-5 år
English: Full dose (N=34)
Danish: fuld dosis (n = 34)
English: Immune response to A/Indonesia/5/2005 3 to 5 years
Danish: Immunrespons mod A/Indonesia/5/2005 3-5 år
English: In other clinical studies where children 6 months to 17 years received zoonotic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Danish: Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved administrationsstedet, rødme og feber) efter anden dosis til børn under 6 år blev observeret i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik zoonotisk influenzavaccine (H5N1 A/Indonesien/05/2005 fremstillet i Dresden, Tyskland).
English: Full dose N=27
Danish: fuld dosis n = 27
English: Full dose (N=26)
Danish: fuld dosis (n = 26)
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Adjupanrix
Danish: LÆGEMIDLETS NAVN Suspension til Adjupanrix injektionsvæske, emulsion
English: Immune response to A/Indonesia/5/2005 6 to 9 years
Danish: Immunrespons mod A/Indonesia/5/2005 6-9 år måned 6
English: • Sleepiness
Danish: • Søvnløshed
English: Breast-feeding
Danish: Feberkramper
English: Half dose N=37
Danish: halv dosis n = 37
English: Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
Danish: Den neutraliserende antistoftiter 12 og 24 måneder efter vaccination var følgende:
English: In another clinical study (D-Pan-H5N1-038), 387 subjects aged 18-60 years received 1 dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 36 months after they had received two doses of A/Vietnam/1194/2004.
Danish: I et andet klinisk studie (D-Pan-H5N1-038) fik 387 personer i alderen 18-60 år én dosis AS03adjuveret vaccine indeholdende 3,75 µg HA fra A/Indonesia/5/2005 36 måneder efter at have fået to doser indeholdende A/Vietnam/1194/2004.
English: In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows:
Danish: I et klinisk studie (Q-Pan-H5N1-001), hvor 140 personer i alderen 18-60 år fik to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21, var anti-HAantistofresponset følgende:
English: Full dose N=26
Danish: fuld dosis n = 26
English: If you are not sure, talk to your doctor or nurse before having this vaccine.
Danish: Spørg din læge eller sygeplejersken, hvis der er noget, du er i tvivl om, før du får denne vaccine.
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 6 months apart were 83.3% and 100%, respectively.
Danish: 21 dage efter den anden dosis var seroprotektionsraten og vaccineresponsraten henholdsvis 83,3 % og 100 % for personer, som havde modtaget vaccinen med 6 måneders interval.
English: Single dose N=49
Danish: enkeltdosis n = 49
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Danish: 1 seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40;
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Suspensionen skal sammenblandes med adjuvans, emulsion før administration.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
Danish: Natriumchlorid Dinatriumhydrogenphosphat Kaliumdihydrogenphosphat Kaliumchlorid Vand til injektionsvæsker
English: Half dose (N=27)
Danish: halv dosis (n = 27)
English: Half dose (N=37)
Danish: halv dosis (n = 37)
English: Half dose (N=47)
Danish: halv dosis (n = 47)
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively.
Danish: 21 dage efter den anden dosis var seroprotektionsraten og vaccineresponsraten henholdsvis 84,0 % og 100 % for personer, som havde modtaget vaccinen med 12 måneders interval.
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Danish: I et andet klinisk studie (D-Pan-H5N1-010) fik 297 personer over 60 år (stratificeret i grupper fra 6170 år, 71-80 år og > 80 år) enten en enkelt- eller en dobbeltdosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) på dag 0 og 21.
English: The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
Danish: For at lette udtagningen af al adjuvans i hætteglasset skal hætteglasset holdes med bunden opad.
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Danish: I et klinisk studie (D-Pan-H5N1-012) fik personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra enten A/Vietnam/1194/2004 eller A/Indonesia/05/2005 6 måneder efter administration af en eller to primære doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på henholdsvis dag 0 eller på dag 0 og 21.