FrancophonIA/ELRC3.0 huggingface dataset:
English: What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder.
Danish: VEYVONDI er et hvidt til råhvidt pulver.
English: Do not remove the Mix2Vial device from the package.
Danish: Lad Mix2Vial-sættet blive i pakningen.
English: Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly.
Danish: Inhibitorer (antistoffer) over for VWF kan opstå hos nogle patienter, der får lægemidlet.
English: VWF:RCo Target Trough Plasma Level
Danish: VWF:RCo Mål for dalniveau i plasma
English: 5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI powder.
Danish: 5 Forbind hætteglasset med solvens til VEYVONDI-hætteglasset ved at vende hætteglasset med solvens med bunden opad og anbringe det oven på hætteglasset med VEYVONDI-pulver.
English: 9 Leaving the VEYVONDI vial (containing the reconsituted product) on your flat work surface, connect the syringe to the clear plastic connector and turning the syringe clockwise.
Danish: 9 Lad VEYVONDI-hætteglasset (med det opløste lægemiddel) stå på den jævne arbejdsflade, montér sprøjten på den gennemsigtige plastikkonnektor, og drej sprøjten med uret.
English: 5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI concentrate.
Danish: 5 Forbind hætteglasset med solvens til VEYVONDI-hætteglasset ved at vende hætteglasset med solvens med bunden opad og anbringe det oven på hætteglasset med VEYVONDI-koncentrat.
English: 0.80 - 1 IU/mL Δ
Danish: 0,80-1 IE/ml b
English: How to use VEYVONDI
Danish: Sådan skal du bruge VEYVONDI
English: VEYVONDI 1300 IU powder and solvent for solution for injection.
Danish: VEYVONDI 1300 IE pulver og solvens til injektionsvæske, opløsning.
English: 1 vial contains 650 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 5 mL water for Injections
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 650 IE vonicog alfa, ca. 130 IE/ml efter rekonstitution med 5 ml vand til injektionsvæsker
English: Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Danish: Vonicog alfa er en oprenset rekombinant human von Willebrand-faktor (rVWF).
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial, 1 vial with solvent (5 mL), 1 Mix2Vial device
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning Indhold: 1 hætteglas med pulver, 1 hætteglas med solvens (5 ml), 1 Mix2Vial-sæt
English: 1 vial contains1300 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 10 mL Water for Injections
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 1300 IE vonicog alfa, ca. 130 IE/ml efter rekonstitution med 10 ml vand til injektionsvæsker
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning Indhold: 1 hætteglas med pulver, 1 hætteglas med solvens (10 ml), 1 Mix2Vial-sæt
English: If you stop using VEYVONDI
Danish: Hvis du har brugt for meget VEYVONDI
English: VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
Danish: VEYVONDI 650 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas med pulver indeholder nominelt 650 internationale enheder (IE) vonicog alfa.
English: FVIII:C Target Trough Plasma Level
Danish: FVIII:C Mål for dalniveau i plasma
English: Thrombogenicity
Danish: Dyb venetrombose
English: Table 2 VWF:RCo and FVIII:C Target Levels Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Danish: Målniveau for VWF:RCo og FVIII:C Anbefalet maksimalt målniveau i plasma af VWF:RC og VFVIII:C skal opnås før et kirurgisk indgreb til profylakse af omfattende blødning under og efter kirurgiske indgreb
English: FVIII:C Target Peak Plasma Level a
Danish: Maksimalt målniveau for FVIII:C i plasma a
English: Each pack of VEYVONDI 1300 IU contains: - powder in a vial (type I glass), with a butyl rubber stopper - 10 mL of solvent in a vial (type I glass), with a rubber stopper (bromobutyl) - one reconstitution device (Mix2Vial)
Danish: Hver pakning med VEYVONDI 1300 IE indeholder: - pulver i et hætteglas (type I-glas) med prop af butylgummi - 10 ml solvens i et hætteglas (type I-glas) med gummiprop (bromobutyl) - et rekonstitutionssæt (Mix2Vial)
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Danish: VEYVONDI 650 IE pulver og solvens til injektionsvæske, opløsning vonicog alfa (rekombinant human von Willebrand-faktor)
English: VEYVONDI 650 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper - 5 mL of solvent in a vial (type I glass), with a rubber stopper (chlorobutyl) - one reconstitution device (Mix2Vial)
Danish: VEYVONDI 650 IE pulver og solvens til injektionsvæske, opløsning Hver pakning indeholder: - pulver i et hætteglas (type I-glas) med prop af butylgummi - 5 ml solvens i et hætteglas (type I-glas) med gummiprop (chlorbutyl) - et rekonstitutionssæt (Mix2Vial)
English: Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Danish: Kontrollér udløbsdatoen, og sørg for, at hætteglasset med VEYVONDI-pulver og vandet til injektionsvæsker (solvens) har stuetemperatur inden klargøring.
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Danish: VEYVONDI 1300 IE pulver og solvens til injektionsvæske, opløsning vonicog alfa (rekombinant human von Willebrand-faktor)
English: For prevention of excessive bleeding in case of elective surgery, within 3 hours prior to initiation of any surgical procedure, the FVIII:C levels should be assessed.
Danish: For at hindre omfattende blødninger ved elektiv kirurgi skal FVIII:C-niveauet vurderes inden for 3 timer før et kirurgisk indgreb .
English: Each pack of VEYVONDI 650 IU contains: - powder in a glass vial with a rubber stopper - 5 mL of solvent in a glass vial with a rubber stopper - one reconstitution device (Mix2Vial)
Danish: Hver pakning med VEYVONDI 650 IE indeholder: - pulver i et hætteglas (type I-glas) med gummiprop - 5 ml solvens i et hætteglas (type I-glas) med gummiprop - et rekonstitutionssæt (Mix2Vial)
English: Table 3 VWF:RCo and FVIII:C Target Trough Plasma Level and Minimum Duration of Treatment Recommendations for Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery
Danish: Anbefalet mål for VWF:RCo- og FVIII:C-dalniveau i plasma og minimum varighed af behandling for efterfølgende vedligeholdelsesdoser til profylakse af omfattende blødninger efter kirurgiske indgreb
English: Thrombolism and embolism
Danish: Trombolisme og embolisme (blodpropper)
English: c[(IU/dL)/(U VWF:RCo/kg)]
Danish: AUC0inf/dosis e a[timer], b[dl/kg/timer], c[(IE/dl)/(E VWF:RCo/kg)] d[(time*IE/dl)] e[(time*IE/dl)/(IE VWF:RCo/kg)]
English: Ensure that the VEYVONDI powder vial and the Sterilised Water for Injections (solvent) are at room temperature prior to preparation.
Danish: Sørg for, at hætteglasset med VEYVONDI-pulver og det steriliserede vand til injektionsvæsker (solvens) har stuetemperatur inden klargøring.
English: Table 2 Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C to be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Danish: Anbefalet maksimalt målniveau for VWF:RCo og FVIII:C i plasma, som skal opnås før et kirurgisk indgreb til profylakse af omfattende blødning under og efter kirurgiske indgreb
English: 0.40 IU/mL
Danish: 0,40 IE/ml
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection.
Danish: VEYVONDI 650 IE pulver og solvens til injektionsvæske, opløsning.
English: Instructions for reconstitution
Danish: Instruktioner vedrørende klargøring
English: - Ensure that the VEYVONDI powder vial and the sterilised water for injections (solvent) are at room temperature prior to preparation.
Danish: - Sørg for, at hætteglasset med VEYVONDI-pulver og det steriliserede vand til injektionsvæsker (solvens) har stuetemperatur inden klargøring.
English: - If your bleeding is not controlled with VEYVONDI, tell your doctor immediately.
Danish: - Fortæl det straks til lægen, hvis din blødning ikke holdes under kontrol med VEYVONDI.
English: After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Danish: Efter rekonstitution med de medfølgende 5 ml solvens indeholder VEYVONDI ca. 130 IE/ml vonicog alfa.
English: Steps
Danish: Trin
English: Inspect the syringe visually for particulate matter; the solution in the syringe should be clear.
Danish: Inspicer sprøjten visuelt for partikelmateriale.
English: After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Danish: Efter rekonstitution med de medfølgende 10 ml solvens indeholder VEYVONDI 130 IE/ml vonicog alfa.
English: 0.5-0.6 IU/mL 0.4 - 0.5 IU/mL Δ
Danish: 0,50 IE/ml > 0,40 IE/ml
English: 0.30 IU/mL
Danish: 0,30 IE/ml
English: VWF:RCo Target Peak Plasma Level
Danish: Maksimalt målniveau for VWF:RCo i plasma
English: 0.50 IU/mL
Danish: 0,50 IE/ml
English: VEYVONDI 1300 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper
Danish: VEYVONDI 1300 IE pulver og solvens til injektionsvæske, opløsning Hver pakning indeholder: - pulver i et hætteglas (type I-glas) med prop af butylgummi - 10 ml solvens i et hætteglas (type I-glas) med gummiprop (bromobutyl) - et rekonstitutionssæt (Mix2Vial)
English: To ensure pre-operative endogenous FVIII levels of at least 0.4 IU/mL for minor and oral and 0.8 IU/mL for major surgery, a dose of 40-60 IU/kg VEYVONDI may be administered 12-24 hours (pre-operative dose) prior to initiating elective surgery.
Danish: Hvis FVIII:C-niveauet er på det anbefalede målniveau på: - mindst 0,4 IE/ml ved mindre og orale kirurgiske indgreb og - mindst 0,8 IE/ml ved større indgreb, skal en dosis VEYVONDI administreres alene inden for 1 time før indgrebet.
English: Image example
Danish: Intet billede
English: Instructions for Administration
Danish: Instruktioner vedrørende indgivelse
English: VEYVONDI (Study 071001)
Danish: Fase 3 PK80 VEYVONDI (studiet 071001)
English: The solution should be slowly administered intravenously (see section 4.2) not exceeding 4 mL/min.
Danish: Opløsningen skal langsomt indgives intravenøst (se pkt.
English: Haemorrhage
Danish: Hedeture
English: AUC0-inf d
Danish: Cl b
English: Every year, the European Medicines Agency (EMA) will review any new information that may become available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur (EMA) alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
English: The vaccine would be given according to official recommendations.
Danish: Vaccinen gives i overensstemmelse med de officielle anbefalinger.
English: If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Danish: Hvis der er udbrudt en pandemi, kan det dog være hensigtsmæssigt at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed.
English: One main study in adults included 561 healthy volunteers, 281 of whom were over the age of 60 years.
Danish: Den første hovedundersøgelse omfattede 561 raske frivillige, hvoraf de 281 var over 60 år.
English: They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Danish: De kan dernæst afprøve denne vaccine på mennesker for at se, hvordan de reagerer på den, hvorved de kan forudsige, hvordan mennesker vil reagere, når influenzastammen, der er årsag til pandemien, indgår i vaccinen.
English: According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastlagt af Udvalget for Humanmedicinske Lægemidler (CHMP), skal en mockup-vaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af voksne for at kunne anses for egnet.
English: The study also looked at the effect of a booster dose given after twelve months in some of the children.
Danish: Undersøgelsen så også på virkningen af en boosterdosis efter 12 måneder hos nogle af børnene.
English: The vaccine contains a flu strain called A/VietNam/1203/2004 (H5N1).
Danish: Vaccinen indeholder influenzastammen A/VietNam/1203/2004 (H5N1).
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Danish: Vaccinen må ikke gives til personer, der har haft en anafylaktisk reaktion (svær allergisk reaktion) over for en af vaccinens komponenter eller over for et af de sporstoffer, den indeholder (meget lavt), f.eks. formaldehyd, benzonase eller sukrose.
English: It contains influenza (flu) viruses that have been inactivated (killed).
Danish: Den indeholder influenzavira, som er blevet inaktiveret (dræbt).
English: The main measure of effectiveness was the production of protective levels of antibodies 21 days after the second vaccination.
Danish: Det primære effektmål var produktionen af beskyttende niveauer af antistoffer 21 dage efter den anden vaccination.
English: A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: En influenzapandemi forekommer, når der opstår en ny type (stamme) af en influenzavirus, der let smitter fra menneske til menneske, fordi mennesker ikke har nogen immunitet over for den. En pandemi kan berøre de fleste lande og regioner i verden.
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Danish: I stedet kan virksomhederne fremstille en vaccine med en influenzavirusstamme, der specifikt udvælges, fordi ingen har været udsat for den, og ingen er immune over for den.
English: This vaccine is the same as the Celvapan H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Danish: Denne vaccine er den samme som Celvapan H5N1-mockup-vaccinen, der tidligere er godkendt i Den Europæiske Union (EU).
English: This vaccine contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Danish: Vaccinen indeholder en virus kaldet H5N1, som er blevet inaktiveret (dræbt), så den ikke længere forårsager sygdom.
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
Danish: Det er en vaccine, der kun må bruges, når Verdenssundhedsorganisationen eller Den Europæiske Union (EU) officielt har erklæret, at der er udbrudt en pandemi.
English: The full EPAR for Pandemic Influenza Vaccine H5N1 Baxter AG can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pandemic Influenza Vaccine H5N1 Baxter AG findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: whole virion influenza virus, propagated in vero cells (continuous cell line of mammalian origin), inactivated, containing antigen of pandemic strain
Danish: influenzavaccine, hele virion, dyrket i vero-celler (kontinuerlig cellelinje fra pattedyr), inaktiveret, indeholder antigen af pandemisk stamme
English: At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Danish: 21 dage efter den anden injektion havde 72 % af de voksne under 60 år (192 ud af 265) og 74 % af dem over 60 år (200 ud af 270) dannet nok antistoffer til at være beskyttet mod H5N1.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic Influenza Vaccine H5N1 Baxter AG on 16 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pandemic Influenza Vaccine H5N1 Baxter AG den 16. oktober 2009.
English: This is a special type of vaccine that is designed to help with the management of a future pandemic.
Danish: En mockup-vaccine er en særlig vaccinetype, der er udviklet for at kontrollere en fremtidig pandemi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pandemic Influenza Vaccine H5N1 Baxter AG.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Pandemic Influenza Vaccine H5N1 Baxter AG.
English: Although levels of antibodies slowly fell over the year after vaccination, a booster dose after 12 months resulted in protective levels of antibodies in 93 to 100% of children who received it.
Danish: Mængden af antistoffer faldt langsomt over det efterfølgende år, men en boosterdosis efter 12 måneder gjorde, at mellem 93 % og 100 % af de børn, som fik den, dannede nok antistoffer til at være beskyttet.
English: When the company that makes Pandemic Influenza Vaccine H5N1 Baxter AG includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Danish: Når virksomheden, som fremstiller Pandemic Influenza Vaccine H5N1 Baxter AG, inkluderer den influenzastamme, som er ansvarlig for pandemien, i vaccinen, skal den indsamle oplysninger om sikkerhed og virkning af den endelige pandemivaccine og forelægge disse for CHMP til evaluering.
English: For more information about treatment with Pandemic Influenza Vaccine H5N1 Baxter AG, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pandemic Influenza Vaccine H5N1 Baxter AG, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that made the Celvapan H5N1 mock-up vaccine has agreed that its scientific data can be used for Pandemic Influenza Vaccine H5N1 Baxter AG (‘informed consent').
Danish: Virksomheden, som fremstiller Celvapan H5N1-mockup-vaccinen, har indvilget i, at dets videnskabelige data kan anvendes på Pandemic Influenza Vaccine H5N1 Baxter AG (”informeret samtykke”).
English: Similarly in children, after the second 7.5-microgram dose, 85% of children aged 9 to 17 years, 73% of those 3 to 8 years, and 69% of those aged 6 to 35 months had protective levels of antibodies 21 days after the second injection.
Danish: Hos børnene, efter den anden 7,5-mikrogram dosis, havde 85 % af børnene i alderen 9-17 år, 73 % af børnene i alderen 3-8 år og 69 % af børnene på mellem 6 og 35 måneder ligeledes dannet nok antistoffer til at være beskyttet 21 dage efter den anden injektion.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet det inaktiverede virus som ”fremmed” og danner antistoffer mod det. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is given by injection into the shoulder muscle or thigh in two doses, at least three weeks apart.
Danish: Pandemic Influenza Vaccine H5N1 Baxter AG gives ved injektion i skuldermusklen eller låret i to doser med mindst tre ugers mellemrum.
English: This is a summary of the European public assessment report (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter AG.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter AG.
English: The most common side effects with Pandemic Influenza Vaccine H5N1 Baxter AG in adults (seen in more than 1 person in 10) are headache, fatigue (tiredness) and pain at the site of the injection.
Danish: De hyppigste bivirkninger ved Pandemic Influenza Vaccine H5N1 Baxter AG (som optræder hos flere end 1 ud af 10 patienter) hos voksne er hovedpine, træthed og smerter på injektionsstedet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pandemic Influenza Vaccine H5N1 Baxter AG, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pandemic Influenza Vaccine H5N1 Baxter AG, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: A risk management plan has been developed to ensure that Pandemic Influenza Vaccine H5N1 Baxter AG is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pandemic Influenza Vaccine H5N1 Baxter AG anvendes så sikkert som muligt.
English: This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Danish: Det betyder, at det ikke har været muligt at opnå fyldestgørende oplysninger om den endelige pandemiske vaccine, da det er en mockup-vaccine, som endnu ikke indeholder den influenzavirusstamme, der forårsager en pandemi.
English: The study looked at the ability of two 7.5 microgram doses of the vaccine, given 21 days apart, to trigger the production of antibodies (‘immunogenicity').The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Danish: Virkningen blev hovedsagelig bedømt på mængden af antistoffer i forhold til mængden af influenzavirus i blodet inden vaccinationen, på datoen for anden vaccination (dag 21), og 21 dage efter anden vaccination (dag 42).
English: The second main study involved 305 children aged 9 to 17 years, 306 aged 3 to 8 years and 73 aged 6 to 35 months, and also examined the effect of two 7.5 microgram doses of the vaccine 21 days apart.
Danish: Den anden hovedundersøgelse omfattede 305 børn i alderen 9-17 år, 306 børn i alderen 3-8 år og 73 børn på mellem 6 og 35 måneder.
English: Pandemic Influenza Vaccine H5N1 Baxter AG has been authorised under ‘Exceptional Circumstances'.
Danish: Pandemic Influenza Vaccine H5N1 Baxter AG er blevet godkendt under ‘særlige omstændigheder'.