FrancophonIA/ELRC3.0 huggingface dataset:
English: Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart.
Danish: Der blev administreret to doser vaccine med H5N3-stammen (A/Duck/Singapore/97) i 3 forskellige styrker (7,5; 15 og 30 µg HA/dosis) med tre ugers mellemrum.
English: Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Danish: Brugsklar injektionssprøjte, der indeholder en enkelt dosis på 0,5 ml.
English: Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1)
Danish: Af disse forsøgspersoner fik 3.618 forsøgspersoner den pandemiske beredskabsvaccine Foclivia (A/H5N1) (se pkt.
English: In this trial no vaccine related SAEs were observed.
Danish: I dette studie blev der ikke observeret nogen alvorlige vaccinerelaterede bivirkninger.
English: Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).
Danish: Der foreligger begrænsede data vedrørende en tredje dosis (booster) administreret 6 måneder efter den første dosis (se pkt.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Danish: Neurologiske symptomer som neuralgi, paræstesi, kramper og neuritis.
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43
Danish: Seroprotektion (95 % CI) Dag 43 Serokonverteringsfaktor (95 % CI)Dag 43 til Dag 1 Serokonvertering (95 % CI) Dag 43
English: A clinical trial (study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Danish: Der er blevet udført et klinisk studie (studie V87P6) med en H5N1-vaccine kombineret med MF59C.1-adjuvans hos 471 børn fra 6 måneder til 17 år.
English: Two doses of vaccine containing H9N2 (A/chicken/Hong Kong/G9/97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/dose), were administered four weeks apart.
Danish: Der blev administreret to doser vaccine, som indeholdt H9N2-stammen (A/chicken/Hong Kong/G9/97) i 4 forskellige styrker (3,75; 7,5; 15 og 30 µg HA/dosis) med fire ugers mellemrum.
English: Skin and subcutaneous tissue disorders Common (>1/100, <1/10): sweating
Danish: Hud og subkutane væv Almindelig (>1/100, <1/10): svedtendens
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Danish: Bivirkninger af speciel interesse (AESI) opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge).
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Danish: MN-resultater mod en A/Vietnam/1194/2004 viser en seroprotektion på 99 % (95 %CI: 94-100), en serokonvertering på 97 % (95 %CI: 91-99) til 99 % (95 %CI: 96-100) og en GMR på 29 (95 %CI: 25-35) til 50 (95 %CI: 44-58).
English: A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Danish: Der er blevet udført et klinisk fase II-studie (Studie V87P1) med en H5N1-vaccine kombineret med MF59C.1-adjuvans hos 312 raske voksne.
English: Package leaflet: Information for the user Foclivia suspension for injection
Danish: Indlægsseddel: Information til brugeren Foclivia injektionsvæske, suspension
English: Adolescents (9 to 17 years of age)
Danish: Unge (9- 17 år)
English: Foclivia contains Thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Danish: Foclivia indeholder thiomersal som konserveringsmiddel.
English: Nervous system disorders Common (>1/100, <1/10): headache
Danish: Nervesystemet Almindelig (>1/100, <1/10): hovedpine
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects.
Danish: Der blev med tre ugers mellemrum givet to doser vaccine, som indeholdt H5N1 (A/Vietnam/1194/2004; 7,5 µg HemoAgglutinin (HA)/dosis adjuveret) til 156 forsøgspersoner.
English: Common (>1/100, <1/10): sweating
Danish: Almindelig (>1/100, <1/10): svedtendens
English: Contents of the pack and other information What Foclivia contains
Danish: Pakningsstørrelser og yderligere oplysninger Foclivia indeholder:
English: Study V87P1 Adults Booster (6 months after 2nd dose
Danish: Studie V87P1 voksne booster (6 måneder efter 2. dosis)
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 tilfælde per land, opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) og sværhedsgrad, for perioden omfattet af rapporten og kumulativt.
English: Adolescents(9-<18 years)
Danish: Unge (9-<18 år)
English: - have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Danish: - har opleveret alvorlige allergiske (dvs. livstruende) reaktioner over for nogen af Foclivias indholdsstoffer - er overfølsom (allergisk) over for influenzavacciner eller et af de øvrige indholdsstoffer i Foclivia - er allergisk over for æg eller hønseprotein - er allergisk over for antibiotika, formaldehyd, cetyltrimethylammoniumbromid (CTAB) og polysorbat 80.
English: Respiratory, thoracic and mediastinal disorders Cough.
Danish: Luftveje, thorax og mediastinum Hoste.
English: Foclivia was evaluated in adults (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Danish: Foclivia er blevet vurderet hos voksne (18 til 60 år) og ældre (over 60 år) efter en primær vaccinationsplan med vaccination på dag 1 og dag 22.
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C. The multidose vial should preferably be used within 24 hours after first withdrawal.
Danish: Mellem hver brug opbevares flerdosishætteglas ved de anbefalede opbevaringsbetingelser mellem 2 °C og 8 °C.
English: A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137).
Danish: Der er blevet udført et klinisk studie (Studie V87P6) med en H5N1-vaccine kombineret med MF59C.1-adjuvans vs. sæsoninfluenzavaccine (n=137).
English: Seroconversion factor(95%CI)**
Danish: Serokonverteringsfaktor (95 % CI)**
English: Package leaflet: Information for the user Foclivia suspension for injection in multidose container
Danish: Indlægsseddel: Information til brugeren Foclivia injektionsvæske, suspension i flerdosisbeholder
English: Breast-feeding The vaccine may be used during lactation.
Danish: Amning Vaccinen kan anvendes under amning.
English: Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Danish: Meget sjælden: (kan forekomme hos færre end 1 af 10.000 vaccinerede) Vaskulitis (betændelse i blodkarrene, hvilket kan forårsage hududslæt, ledsmerter og nyreproblemer) og væskende Stevens-Johnsons syndrom (erythema multiforme).
English: Pandemic Influenza Vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Danish: Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26).
Danish: MN-resultater fra studie V87P13 gav en GMR mod A/turkey/Turkey/05 på 2,01 (1,78-2,26).
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig (>1/100, <1/10): rødme, hævelse, smerte, ekkymose, induration ved injektionsstedet.
English: Study V87P1 Elderly Booster (6 months after 2nd dos e)
Danish: Studie V87P1 ældre booster (6 måneder efter 2. dosis)
English: Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia
Danish: Knogler, led, muskler og bindevæv Almindelig (>1/100, <1/10): led-og muskelsmerter
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om Foclivia på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to that of Foclivia (an MF59C.1 adjuvanted H1N1 pandemic vaccines), the following additional adverse reactions have been reported:
Danish: Ved bivirkningsovervågning efter markedsføring af adjuverede, interpandemiske, trivalente vacciner med en sammensætning svarende til Foclivia (en MF59C.1-adjuveret pandemisk H1N1-vaccine -) er der rapporteret følgende yderligere bivirkninger:
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Danish: MN-resultater mod A/Vietnam/1194/2004 viser en seroprotektion og serokonvertering på henholdsvis 57 % (50-64) til 79 % (68-87) og 55 % (48-62) til 58 % (47-69).
English: narrow SMQ “Convulsions”
Danish: indsnævret SMQ “kramper”
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Danish: Anamnese med anafylaktisk (dvs. livstruende) reaktion på ethvert indholdsstof eller spor af æg, hønseproteiner, kanamycin og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB) i denne vaccine.
English: 0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Danish: 0,5 ml i enkeltdosis hætteglas (type I-glas) med prop (halobutylgummi).
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Danish: Knogler, led, muskler og bindevæv Muskelsvaghed, ekstremitetssmerter.
English: Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Danish: Flerdosishætteglasset omrystes forsigtigt, før en dosis (0,5 ml) trækkes op i en injektionssprøjte.
English: MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Danish: Mikroneutraliserings(MN)-resultater mod A/Vietnam/1194/2004 viser en seroprotektionsrate og serokonverteringsrate på henholdsvis 67 % (60-74) til 85 % (78-90) og 65 % (58-72) til 83 % (77-89).
English: Common (>1/100, <1/10): headache
Danish: Almindelig (>1/100, <1/10): hovedpine
English: In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
Danish: I et fase II klinisk studie (Studie V87P6) blev sikkerheden af en pandemisk adjuveret H5N1-beredskabsvaccine vurderet hos børn og unge (se pkt.
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 non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Danish: En oversigt over alle spontane bivirkninger inddelt efter systemorganklasse (SOC), højniveau-term (HLT) og foretrukket term (PT), opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge), herunder antal rapporter med dødsfald, for perioden omfattet af rapporten og kumulativt.
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Danish: Antistoffernes persistens efter primær vaccination i denne population vurderet med HI-, SRH- og MN-test faldt fra 1/2 til 1/5 af post-vaccinationsniveauet på dag 202 sammenlignet med dag 43 efter gennemførelse af de primære vaccinationsplaner vurderet med HI-, SRH- og MN-test. Op til 50 % af de ældre forsøgspersoner, der var blevet immuniseret med H5N1-vaccine kombineret med MF59C var serumbeskyttet ved seks måneder.
English: tiredness, headache, sweating, pain in muscles and joints.
Danish: Knogler, led, muskler og bindevæv
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
Danish: Almindelig (>1/100, <1/10): led- og muskelsmerter Almene symptomer og reaktioner på administrationsstedet Almindelig (>1/100, <1/10): rødme, hævelse, smerte, ekkymose, induration ved injektionsstedet.
English: MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Danish: MN-resultater fra V87P13 gav en GMR mod A/turkey/Turkey/05 på 2,77 (2,4-3,2).
English: MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Danish: MN-resultater fra studie V87P13 gav en GMR mod A/turkey/Turkey/05 på 2,77 (2,4-3,2).
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
Danish: Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 hos forsøgspersoner på over 60 år (et begrænset antal forsøgspersoner var over 70 år) målt med SRH og vurderet i to kliniske studier var som følger:
English: Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I.M.
Danish: Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret) i.m.-injektion i deltamusklen
English: If they persist, CONSULT YOUR DOCTOR.
Danish: TAL MED LÆGEN, hvis de varer ved.
English: 7.5 micrograms haemagglutinin
Danish: 7,5 mikrogram hæmagglutinin
English: From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Danish: 5.1 for yderligere information) var de fleste reaktioner lette, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson-influenzavacciner.
English: It is provided in a vial containing ten doses (0.5 ml each) for injection.
Danish: Hætteglas, der indeholder 10 doser (hver på 0,5 ml) til injektion.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Danish: Seroprotektion (95 %CI)* Serokonvertering (95 %CI)* Serokonverteringsfaktor (95 %CI)** * målt med SRH-analyse ≥ 25 mm2 ** geometriske middelværdier for SRH
English: PT “Bell's palsy” - Vaccination failure: PT “Vaccination failure”.
Danish: PT “vaccinationssvigt”.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL HÆTTEGLAS MED 10 DOSER
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Danish: Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 målt med SRH var som følger:
English: Package leaflet: Information for the user Foclivia suspension for injection in pre-filled syringe
Danish: Indlægsseddel: Information til brugeren Foclivia injektionsvæske, suspension i fyldt injektionssprøjte
English: All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Danish: Alle spontane bivirkninger (SOC, HLT, PT) hos gravide kvinder, opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt.
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13.
Danish: MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 11 % (3-25) (studie V87P1) til 30 % (24-37) (studie V87P13) og en serokonvertering på 25 % (19-31) for studie V87P13.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE TIL HÆTTEGLAS MED 1 DOSIS
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Danish: Alvorlige bivirkninger uden for listen (SOC, HLT, PT'er) opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt.
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by Single Radial Haemolysis (SRH) assay was as follows:
Danish: Seroprotektionsrate*, serokonverteringsrate* og serokonverteringsfaktor** for anti-HA-antistof mod H5N1 A/Vietnam/1194/2004 hos voksne målt med enkelt radial hæmolyse (SRH-analyse) var som følger:
English: Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Danish: Seroprotektion (95 % CI)° Serokonvertering (95 % CI)°
English: It is provided in a vial containing a single dose (0.5 ml) for injection.
Danish: Foclivia leveres: i et hætteglas, der indeholder en enkelt dosis (0,5 ml) til injektion.
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for V87P13 study.
Danish: MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 27 % (17-39) (V87P1) til 39% (32-46) (V87P13) og en serokonvertering på 36 % (29-43) for V87P13-studiet.
English: Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Danish: Vaccine, der er blevet trukket op i injektionssprøjten, skal opnå stuetemperatur før administration.
English: All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Danish: En oversigt over alle spontane bivirkninger opstillet efter aldersgruppe, SOC, HLT og PT, opdelt i henhold til rapporttype (bekræftet af en læge eller ikke bekræftet af en læge) for perioden omfattet af rapporten og kumulativt.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Danish: Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/turkey/Turkey/05 efter den 2. dosis hos voksne på 18-60 år målt med SRH- og HI-analyser var som følger:
English: MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13.
Danish: MN-resultater fra de kliniske studier i ovenstående tabel afslørede en seroprotektion mod A/turkey/Turkey/05 på 27 % (17-39) (studie V87P1) til 39% (32-46) (studie V87P13) og en serokonvertering på 36 % (29-43) for studie V87P13.
English: Very rare (may affect up to 1 in 10,000 people).
Danish: Sjælden: (kan forekomme hos 1-10 ud af 10.000 vaccinerede).
English: Uncommon: (may affect up to 1 in 100 people).
Danish: Almindelig: (kan forekomme hos 1-10 ud af 100 vaccinerede).
English: The other ingredients are: thiomersal, sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Danish: De øvrige indholdsstoffer er: thiomersal, natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat og vand til injektioner.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows:
Danish: Seroprotektion*, serokonvertering* og serokonverteringsfaktor** for anti-HA antistof mod H5N1 A/turkey/Turkey/05 efter den 2. dosis hos ældre >60 år målt med SRH- og HI-analyser var som følger:
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Danish: Seroprotektion (95 %CI)* Serokonvertering (95 %CI)* Serokonverteringsfaktor (95 %CI)**
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections.
Danish: De øvrige indholdsstoffer er: natriumchlorid, kaliumchlorid, kaliumdihydrogenphosphat, dinatriumphosphatdihydrat, magnesiumchloridhexahydrat, calciumchloriddihydrat og vand til injektioner.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)*
Danish: Seroprotektion (95 % CI)* Serokonvertering (95 % CI)*
English: Foclivia suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Danish: Foclivia injektionsvæske, suspension Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret)
English: Study V87P1 21 days after 2nd dose N=84
Danish: Studie V87P1 21 dage efter 2. dosis N=84
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)*
Danish: Seroprotektion (95 % CI)* Serokonvertering (95 % CI)* Serokonverteringsfaktor (95 % CI)**
English: Foclivia suspension for injection Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Danish: Foclivia injektionsvæske, suspension Pandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret)
English: Study V87P13 21 days after 2nd dose N=66
Danish: Studie V87P13 21 dage efter 2. dosis N=66
English: Study V87P1 21 days after 2nd dose N=70
Danish: Studie V87P1 21 dage efter 2. dosis N=70
English: Study V87P13 21 days after 2nd dose N=69
Danish: Studie V87P13 21 dage efter 2. dosis N=69