FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you feel feverish, - if you have any illness or infection, - if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).
Danish: - hvis du har feber, - hvis du er syg eller har en infektion, - hvis du får behandling, der undertrykker dit immunsystem, f.eks. kortikosteroidbehandling eller kemoterapi mod kræft, eller hvis du har en lidelse, som gør dig modtagelig for infektioner
English: Prophylaxis of influenza in an officially declared pandemic situation.
Danish: Profylakse mod influenza i forbindelse med en officielt deklareret influenzapandemi.
English: Adults and elderly (above 18 years old).
Danish: Voksne og ældre (over 18 år)
English: A protective response may not be elicited in all vaccine recipients (see section 5.1).
Danish: Et beskyttende respons kan ikke med sikkerhed opnås hos alle vaccinerecipienter (se pkt.
English: Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Danish: Data for spædbørn og småbørn i alderen 6-35 måneder tyder på en let nedsat reaktogenicitet efter anden dosis, uden øget forekomst af feber.
English: Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Danish: Data for børn og unge i alderen 3-17 år tyder på en let nedsat reaktogenicitet efter anden dosis, uden øget forekomst af feber.
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Danish: Meget almindelige reaktioner rapporteret hos børn og unge i alderen 3-17 år: Smerte, induration og erytem, utilpashed, myalgi, hovedpine og træthed.
English: Warnings and precautions Talk to your doctor or nurse before having this vaccine:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du får denne vaccine:
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Danish: Det er almindeligt accepteret, at den erende effekt, som medfører øget immunogenicitet, er forbundet med en let øget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke-adjuverede influenzavacciner.
English: narrow SMQ “Non-infectious encephalitis”
Danish: indsnævret SMQ “ikke-smitsom encefalitis”
English: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Danish: De aktive stoffer i vaccinen er rensede virus-proteiner (kaldet hæmagglutinin og neuraminidase).
English: The incidence of adverse reactions was evaluated in four clinical trials with different influenza strains and formulations (H5N3, H9N2 and H5N1); 3696 adults and elderly subjects were exposed.
Danish: Incidensen af bivirkninger blev evalueret i fire kliniske studier med forskellige influenzastammer og formuleringer (H5N3, H9N2 og H5N1); 3696 voksne og ældre forsøgspersoner blev eksponeret.
English: It has to be used in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
Danish: Det skal bruges til voksne (18-60 år) og ældre (over 60 år) for at forebygge influenza som følge af virus-typen H5N1.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Danish: Efter 3 uger fra den 2. vaccination (dag 43) havde alle aldersgrupper (dvs. 6-35 måneder, 3-8 år og 9-17 år) opnået høje antistofniveauer mod (A/Vietnam/1194/2004) evalueret med SRH- og HI-analyser som vist i nedenstående tabel*.
English: CHMP immunogenicity criteria set for adults (18-60 years) were met both after the 1st and the 2nd dose in all the above age strata (both in the overall population and in the subset seronegative at baseline).
Danish: De fastsatte CHMP-immunogenicitetskriterier for voksne (18-60 år) blev nået efter både 1. og 2. dosis i alle ovennævnte aldersgrupper (både i den samlede population og i den delgruppe, der var seronegativ ved baseline).
English: Foclivia should under no circumstances be administered intravascularly or subcutaneously.
Danish: Foclivia må under ingen omstændigheder gives intravaskulært eller subkutant.
English: These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
Danish: Disse virus-proteiner er tilberedt af stammen af den influenzavirus, som er i overensstemmelse med Verdenssundhedsorganisationens (WHO) anbefalinger og EU's bestemmelser vedrørende en officielt erklæret pandemisk situation.
English: Numbness or tingling sensations, involuntary muscle contractions or thrombocytopenia (reduction in the number of certain types of particles in the blood called plateles; a low number of these can result in excessive bruising or bleeding).
Danish: Følelsesløshed eller prikkende fornemmelse, ufrivillige muskelsammentrækninger eller trombocytopeni (nedsat antal af en særlig type celler i blodet, der kaldes blodplader, hvilket i enkelte tilfælde kan give voldsomme blå mærker eller blødning).
English: One dose (0.5 ml) contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hen's eggs from healthy chicken flocks, and adjuvanted with MF59C.1, of strain:
Danish: En dosis (0,5 ml) indeholder: Aktive stoffer: Influenzavirus overfladeantigener (hæmagglutinin og neuraminidase), formeret i befrugtede hønseæg fra sunde hønsehold og adjuveret med MF59C.1 af følgende stamme:
English: In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Danish: Hos småbørn var erytem og ømhed de hyppigst rapporterede lokale reaktioner, mens irritabilitet og usædvanlig gråd var de hyppigst rapporterede systemiske reaktioner.
English: Sorbitan trioleate
Danish: Sorbitantrioleat
English: Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays.
Danish: Antistoffernes persistens efter primær vaccination i denne population blev vurderet med Hæmagglutination-Inhibition-(HI-), SRH- og MN-analyser.
English: What you need to know before you receive Foclivia Foclivia should not be given if you:
Danish: Det skal du vide, før du får Foclivia Du må ikke få Foclivia, hvis du:
English: Non-clinical data obtained with Foclivia and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Danish: Prækliniske data opnået med Foclivia og med sæson-influenzavaccine indeholdende MF59C.1-adjuvans viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser, lokal tolerance, kvindelig fertilitet samt reproduktions- og udviklingstoksicitet (gennem hele ammeperioden).
English: Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Danish: Sammenlignet med antistofniveauer opnået på dag 43 efter gennemførelse af de primære vaccinationsserier var antistofniveauerne på dag 202 nedsat med 1/5 til 1/2 fra de tidligere niveauer.
English: Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3).
Danish: Sjælden (>1/10.000, <1/1.000): Trombocytopeni (nogle meget sjældne tilfælde var svære med trombocyttal under 5.000 per mm3).
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Derfor skal sundhedspersonalet overveje benefit/risk-forholdet inden administration af denne vaccine til personer med trombocytopeni eller andre blødningslidelser, som kontraindicerer intramuskulær injektion, medmindre den potentielle fordel opvejer risikoen for blødninger.
English: 9.75 milligrams
Danish: 9,75 milligram
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Danish: Vaccinen skal injiceres intramuskulært i musculus deltoideus eller anterolateralt i låret (afhængigt af muskelmasse).
English: Children and adolescents aged 6 months to 17 years:
Danish: Børn og unge i alderen 6 måneder til 17 år
English: The vaccine should not be administered intravascularly or subcutaneously.
Danish: Vaccinen må ikke administreres intravaskulært eller subkutant.
English: Record date and time of the first dose withdrawal on the vial label.
Danish: Registrér dato og klokkeslæt for første dosisudtrækning på hætteglasetiketten.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Danish: Ud over de rapporterede bivirkninger fra kliniske studier er følgende bivirkninger blevet rapporteret efter markedsføringen af Focetria H1N1v:
English: Headache, dizziness, somnolence, syncope.
Danish: Hovedpine, svimmelhed, døsighed, synkope.
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Danish: Hud og subkutane væv Generaliserede hudreaktioner, herunder pruritus, urticaria eller uspecifikt udslæt, angioødem.
English: Warning: Do not inject intravascularly or subcutaneously.
Danish: Advarsel: Må ikke injiceres intravaskulært eller subkutant.
English: ** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI *** In V87P1: baseline not tested
Danish: * målt med SRH-analyse ≥ 25 mm2 ** geometriske middelværdier for SRH ° målt med HI-analyse ≥ 40 °° geometriske middelværdier for HI *** I V87P1: baseline ikke testet
English: - Other Ingredients:
Danish: - Øvrige indholdsstoffer:
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Hvis noget af ovenstående gælder for dig, SKAL DU FORTÆLLE DET TIL LÆGEN ELLER SUNDHEDSPERSONALET, da det kan være, at du så ikke bør få vaccinen, eller at tidspunktet for, hvornår du skal have den, skal udskydes.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)
Danish: Influenzavirus overfladeantigen (hæmagglutinin og neuraminidase)* af følgende stamme: A/Vietnam/1194/2004 (H5N1)
English: Other medicines and Foclivia
Danish: Brug af anden medicin sammen med Foclivia
English: Fever ≥ 38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Danish: Feber ≥ 38 °C til 38,9 °C Feber 39 °C til 39,9 °C Feber ≥ 40 °C Enhver anden bivirkning
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Danish: Feber ≥38 °C til 38,9 °C Feber 39 °C til 39,9 °C Feber ≥ 40 °C Enhver anden bivirkning
English: 5 ml vial containing 10 doses (0.5 ml/dose)
Danish: 5 ml-hætteglas, som indeholder 10 doser (0,5 ml/dosis)
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Danish: indsnævret SMQ “anafylaktisk reaktion” og indsnævret SMQ “angioødem”
English: Children (3-<9 years)
Danish: Børn (3-<9 år)
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Danish: Feber ≥ 38 °C (≥ 40 °C)
English: Serologic responses obtained with the HI assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 µg injections.
Danish: Serologisk respons målt med HI-analyse viste, at 92 % af de vaccinerede opnåede seroprotektion, og 75 % serokonverterede efter to injektioner med 7,5 µg.
English: 1 x single dose (0.5 ml) pre-filled syringe with needle 1 x single dose (0.5 ml) pre-filled syringe without needle 10 x single dose (0.5 ml) pre-filled syringes with needle 10 x single dose (0.5 ml) pre-filled syringe without needle
Danish: 1 x fyldt injektionssprøjte med kanyle med enkeltdosis (0,5 ml) 1 x fyldt injektionssprøjte uden kanyle med enkeltdosis (0,5 ml) 10 x fyldt injektionssprøjte med kanyle med enkeltdosis (0,5 ml) 10 x fyldt injektionssprøjte uden kanyle med enkeltdosis (0,5 ml)
English: Redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
Danish: Rødme, hævelse, smerte ved injektionsstedet, blodudtrædninger, hårdere hud ved injektionsstedet.
English: The vaccine may be used during lactation.
Danish: Vaccinen kan anvendes under amning.
English: Third dose (12 months after second dose)
Danish: Tredje dosis (12 måneder efter anden dosis)
English: Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43 * In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
Danish: Seroprotektion (95 % CI) Dag 43 Serokonverteringsfaktor (95 % CI)Dag 43 til Dag 1 Serokonvertering (95 % CI) Dag 43 * I mangel af CHMP-immunogenicitetskriterier for børn blev de CHMP-immunogenicitetskriterier, der anvendes til at evaluere sæsoninfluenzavacciner hos voksne, anvendt på de serologiske data, der blev opnået efter vaccination af børn.
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Danish: Neurologiske lidelser som encefalomyelitis (betændelse i centralnervesystemet), neuritis (nervebetændelse) og en type af lammelse, som kaldes Guillain-Barrés syndrom.
English: Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines.
Danish: Da det anbefales at give en ekstra dosis, bør det bemærkes, at der ikke foreligger data vedrørende sikkerhed, immunogenicitet eller virkning, som understøtter, at Foclivia kan udskiftes med andre monovalente H5N1-vacciner.
English: Second dose (21 days after first dose)
Danish: Anden dosis (21 dage efter første dosis)
English: How to store Foclivia
Danish: Sådan får du Foclivia
English: Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 µg injections.
Danish: Serologisk respons målt med SRH-analyse viste, at 100 % af de vaccinerede opnåede seroprotektion, og at 100 % serokonverterede efter to injektioner med 7,5 µg.
English: Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks.
Danish: Når hætten er taget af, påsættes en kanyle på sprøjten ved at skrue den med uret, indtil den låser.
English: - Guillain-Barré narrow SMQ “Guillain-Barré syndrome”
Danish: indsnævret SMQ “vasculitis” - Guillain-Barrés syndrom: indsnævret SMQ “Guillain-Barrés syndrom” - Demyelinering:
English: 0.66 milligrams
Danish: 0,66 milligram
English: Injection 3
Danish: Injektion 3
English: Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Danish: Bivirkningsovervågning efter markedsføring med pandemivaccinen: Endnu ingen registreret.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du har problemer med, at dit blod ikke størkner, eller hvis du let får blå mærker.
English: What Foclivia is and what it is used for What you need to know before you receive Foclivia How Foclivia is given
Danish: Virkning og anvendelse Det skal du vide, før du får Foclivia Sådan får du Foclivia
English: Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.
Danish: Foclivia er en vaccine, som er beregnet til at blive givet for at forebygge en influenza, når den officielt er blevet erklæret pandemisk (udbredt over det meste af jordkloden).
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section 5.1).
Danish: Der er observeret en vis krydsbeskyttelse mod beslægtede H5N1-virusvarianter i kliniske forsøg (se pkt.
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Danish: I ugen efter vaccination med Focetria H1N1v hos 73 spædbørn i alderen 6-11 måneder og 73 småbørn i alderen 12-35 måneder, som fik 7,5 µg formuleringen, blev følgende bivirkninger rapporteret:
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional,
Danish: Det er almindeligt accepteret, at den adjuverende effekt, som medfører øget immunogenicitet, er forbundet med en let øget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke-adjuverede influenzavacciner.
English: Frequency of Adverse reactions in clinical trials and postmarketing surveillance is reported hereunder.
Danish: Bivirkningshyppighederne fra kliniske forsøg og overvågning efter markedsføring angives herunder.
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below.
Danish: De bivirkninger, der er observeret i kliniske studier med den pandemiske beredskabsvaccine Foclivia er opført nedenfor.
English: 0.04 milligrams
Danish: 0,04 milligram
English: It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.
Danish: Foclivia leveres i en brugsklar injektionssprøjte, der indeholder en enkelt dosis (0,5 ml), i æske med 1 eller 10 stk. med eller uden kanyle.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Danish: Mave-tarm-kanalen Gastrointestinale gener som kvalme, opkastning, mavesmerter og diarré.
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Danish: I ugen efter vaccination med Focetria H1N1v hos 77 børn i alderen 3-8 år og 80 børn og unge i alderen 9-17 år, som fik 7,5 µg formuleringen, blev følgende bivirkninger rapporteret:
English: Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia.
Danish: Sikkerhedsdata er tilgængelige, men de stammer fra gravide kvinder, som blev eksponeret for Focetria (en pandemisk H1N1-vaccine, som ligner Foclivia), der indeholder samme mængde MF59C.1 som Foclivia.
English: When using a pre-filled syringe without a needle supplied with a Luer Lock system, remove the tip cap by unscrewing it in a counter-clockwise direction.
Danish: Når der anvendes en fyldt injektionssprøjte uden kanyle, som leveres med et Luer-Lock system, fjernes hætten på sprøjtens spids ved at skrue den mod uret.
English: Children (3 to 8 years of age)
Danish: Børn (3-8 år)
English: Any adverse reaction Local
Danish: Alle bivirkninger Lokale
English: Toddlers (6-<36 months)
Danish: Småbørn (6-<36 måneder)
English: Packs of 10.
Danish: Pakninger med 10 stk.
English: Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1).
Danish: Af disse forsøgspersoner fik 3618 forsøgspersoner den pandemiske beredskabsvaccine Foclivia (A/H5N1) (se pkt.
English: While no data is available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia.
Danish: Der er ingen data tilgængelige fra brug af Foclivia, men der er rapporteret tilfælde af kramper med og uden feber hos personer, der blev vaccineret med Focetria, en MF59.1-adjuveret pandemisk H1N1-vaccine, som ligner Foclivia.
English: In two dose finding studies 78 adults received an adjuvanted pandemic preparednessvaccine (H5N3 or H9N2).
Danish: I to “dose-finding”-studier modtog 78 voksne en adjuveret pandemisk beredskabsvaccine (H5N3 eller H9N2).
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Danish: Neurologiske forstyrrelser, såsom encefalomyelitis, neuritis og Guillain Barrés syndrom.
English: A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Danish: En dosis (0,5 ml) vaccine injiceres i overarmen (deltamusklen).
English: Toddlers (12 to 35 months of age)
Danish: Småbørn (12-35 måneder)
English: The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratios of HI for anti-HA antibody to H1N1 after administration of one and two 7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months).
Danish: Seroprotektionsrate og serokonverteringsrate målt med HI-analyse og serokonverteringsfaktor udtrykt som geometriske middelværdier af HI for anti-HA-antistof til H1N1v efter administration af en og to 7,5 μg doser Focetria blev evalueret hos 70 børn og unge (9-17 år), 60 børn (3-8 år), 58 småbørn (12-35 måneder) og 49 spædbørn (6-11 måneder).
English: Safety data after the first and second dose in children and adolescents with a similar pandemic vaccine (Focetria H1N1v) suggest a comparable safety profile with that reported for the aH5N1 pandemic preparedness vaccine formulation (Foclivia).
Danish: Sikkerhedsdata efter den første og anden dosis hos børn og unge med en lignende pandemisk vaccine (Focetria H1N1v) tyder på, at sikkerhedsprofilen svarer til den rapporterede sikkerhedsprofil for den pandemiske aH5N1 -beredskabsvaccineformulering (Foclivia).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE AND 1-DOSE VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL INJEKTIONSSPRØJTE OG HÆTTEGLAS MED 1 DOSIS
English: Generalised skin reactions including itching, bumps on the skin or a non-specific rash.
Danish: Hudreaktioner over hele kroppen, herunder kløe, knopper på huden eller ikke-specifikt udslæt.
English: In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Danish: Et andet klinisk studie (fase III) (Studie V87P13) omfattede 2693 raske voksne, som fik to doser vaccine indeholdende H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/dosis adjuveret) med tre ugers mellemrum.
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Danish: De foreliggende data for børn i alderen 6 måneder til 18 år er beskrevet i pkt.
English: Seroconversion factor (95%CI)°°
Danish: Serokonverteringsfaktor (95 % CI)°°