FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profiles of IXIARO and the other studied vaccines were not compromised when administered concomitantly.
Danish: Sikkerhedsprofilerne af IXIARO og de andre undersøgte vacciner blev ikke kompromitteret ved samtidig indgivelse.
English: The booster dose led to a pronounced increase in GMTs and seroprotection rate remained at 100% two years after the booster.
Danish: Boosterdosis førte til en markant stigning i GMT og seroprotektionsraten forblev på 100 % to år efter boosteren.
English: Subcutaneous administration could lead to a suboptimal response to the vaccine (see section 4.4).
Danish: Subkutan indgivelse kan føre til suboptimal vaccinationsrespons (se pkt.
English: If you and/or your child have a bleeding disorder (a disease that makes you bleed more than normal) or a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia).
Danish: • Hvis du og/eller dit barn har en bløderlidelse (en sygdom, der får dig og/eller dit barn til at bløde mere end normalt) eller nedsat antal blodplader, hvilket øger risikoen for blødning eller blå mærker (trombocytopeni)
English: The safety and efficacy of IXIARO in children younger than 2 months has not been established.
Danish: IXIAROs sikkerhed og virkning hos børn i alderen under 2 måneder er ikke klarlagt.
English: There were no significant effects of age on geometric mean titer in the group receiving IXIARO.
Danish: Der var ingen signifikante virkninger med hensyn til geometriske middeltitre i den gruppe, der fik IXIARO.
English: Uncommon: ≥1/1,000 to < 1/100 Rare: ≥1/10,000 to < 1/1,000
Danish: Ikke almindelig: ≥1/1.000 til < 1/100 Sjælden: ≥1/10.000 til < 1/1.000
English: Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
Danish: Tegn på en allergisk reaktion kan være et kløende udslæt, stakåndethed og hævelse af ansigt og tunge
English: Children below 2 months of age
Danish: Børn under 2 måneder
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.
Danish: Som for alle injicerbare vacciner skal der altid være adgang til passende medicinsk behandling og overvågning af anafylaktiske reaktioner, som i sjældne tilfælde kan forekomme efter indgivelse af vaccinen.
English: Without the second injection you and/or your child will not be fully protected against the disease.
Danish: Uden den anden injektion vil du og/eller dit barn ikke være fuldt beskyttet mod sygdommen.
English: The safety profile of IXIARO was compared to control vaccines Havrix (Hepatitis A vaccine, paediatric 720 EL.U./0.5 mL formulation) and Prevenar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 protein]).
Danish: IXIAROs sikkerhedsprofil blev sammenlignet med kontrolvaccinerne Havrix (Hepatitis A-vaccine, pædiatrisk 720 EL.E/0,5 ml-formulering) og Prevenar (Pneumococ 7-valent konjugatvaccine [Diphtheria CRM197 protein]).
English: For adults, adolescents, children and infants aged 1 year and older a booster dose can be given within the second year (i.e. 12 - 24 months) after the first dose of the recommended primary immunization.
Danish: Til voksne, teenagere, børn og spædbørn, der er mere end 1 år gamle, kan der gives en boosterdosis inden for det andet år (dvs. 12-24 måneder) efter den første dosis af den anbefalede primære immunisering.
English: 0.5 ml N=628 3 to <18 years
Danish: 0,5 ml N=628 3 til <18 år
English: JEV neutralizing antibodies were determined 42 days after the second dose of the primary series (Day 70).
Danish: JEV-neutraliserende antistoffer blev bestemt 42 dage efter den anden dosis i den primære serie (dag 70).
English: The proportion of subjects that seroconverted by 7 and by 28 days after the last immunisation was similar for both schedules.
Danish: Andelen af forsøgspersoner, der serokonverterede 7 og 28 dage efter den sidste immunisering, var ens for begge vaccinationsplaner.
English: The immunogenicity of IXIARO administered in a rapid vaccination schedule was evaluated in a randomized, observer-blind, phase 3 study.
Danish: Immunogeniciteten af IXIARO administreret i et hurtigt vaccinationsprogram blev evalueret i et randomiseret, observatørblindt, fase 3-studie.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale krav.
English: Pack size of 1 syringe with or without a separate needle.
Danish: Pakningsstørrelser med 1 sprøjte med eller uden en separat kanyle.
English: Time point after primary immunization
Danish: Tidspunkt efter primær immunisering
English: Diarrhoea Vomiting Nausea Abdominal pain
Danish: Diarré Opkastning Kvalme Abdominalsmerter
English: If you forget to get IXIARO
Danish: Hvis du har glemt at få IXIARO
English: If you and/or your child get any side effects, talk to your doctor.
Danish: Hvis du og/eller dit barn oplever bivirkninger, bør du tale med din læge.
English: When IXIARO is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites.
Danish: Når IXIARO indgives samtidig med injicerbare vacciner, skal de indgives med separate sprøjter på modsatte sider.
English: You should take appropriate precautions for you and your child to reduce mosquito bites (adequate clothing, use of repellents, mosquito nets) even after receiving IXIARO.
Danish: • Du bør træffe passende forholdsregler for at undgå myggestik (passende beklædning, brug af myggemidler, myggenet), selv når du har fået IXIARO.
English: As with any other vaccine, vaccination with IXIARO may not result in protection in all cases.
Danish: Ligesom med andre vacciner vil vaccination med IXIARO ikke nødvendigvis yde beskyttelse i alle tilfælde.
English: There is data showing that the second injection can be given up to 11 months after the first one.
Danish: Der er data, der viser, at den anden injektion kan gives op til 11 måneder efter den første.
English: After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m.
Danish: Efter immunisering efter den hurtige plan er der observeret en serokonverteringsrate på 99 % 7 dage efter den anden i.m.-vaccination.
English: Duration of protection is uncertain in elderly persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus.
Danish: Varigheden af beskyttelse er usikker, hvorfor en boosterdosis (tredje dosis) bør overvejes inden yderligere eksponering for JE-virus.
English: There was no interference with the immune response to the JE virus and HAV, respectively.
Danish: Der var ingen interferens med immunreaktionen på henholdsvis JE-virus og HAV-virus.
English: The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries).
Danish: IXIAROs sikkerhed blev vurderet i kontrollerede og ukontrollerede kliniske studier med 5.021 raske voksne (fra ikke-endemiske lande) og 1.559 børn og unge (hovedsagelig fra endemiske lande).
English: 0.25 ml N=783 2 months to <3 years
Danish: 0,25 ml N=783 2 måneder til <3 år
English: Studies in animals have shown that the vaccine triggers the immune system to produce antibodies against Japanese encephalitis virus that are most often protective.
Danish: Dyreforsøg har vist, at vaccinen får immunsystemet til at danne antistoffer, der i de fleste tilfælde virker beskyttende, mod det japanske encefalitisvirus.
English: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Danish: Ved opbevaring kan der ses et fint, hvidt bundfald med en klar, farveløs supernatant.
English: Group C: IXIARO + HAVRIX1440 Group A: IXIARO + Placebo
Danish: Gruppe C: IXIARO + HAVRIX1440 Gruppe A: IXIARO + Placebo
English: IXIARO should be given only to adults, adolescents, children and infants aged 2 months and older travelling to countries, where JE is endemic or who are at risk through work.
Danish: IXIARO bør kun gives til voksne, teenagere, børn og småbørn fra 2 måneder og opefter, som rejser i lande, hvor JE optræder, eller som udsættes for risiko i forbindelse med deres arbejde..
English: Push the plunger stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, to discard excess volume.
Danish: Skub stempelproppen op til kanten af den røde streg på sprøjtekammeret, angivet med en rød pil (se figur 1)*, for at fjerne overskydende volumen.
English: Immunogenicity in elderly persons (>65 years)
Danish: Immunogeniciteten hos ældre mennesker (>65 år)
English: Parents or subjects were asked for any unsolicited AEs on the day of the second vaccination and at in-person visits including a medical exam 28 days (Day 56) and 6 months (Month 7) after the second dose.
Danish: Forældre eller forsøgspersoner blev spurgt om eventuelle bivirkninger på dagen for den anden vaccination og ved personlige besøg, herunder en lægeundersøgelse 28 dage (Dag 56) og 6 måneder (Måned 7) efter den anden dosis.
English: In case you and/or your child suffer from a bleeding disorder, your doctor may decide to administer the vaccine under the skin (subcutaneously).
Danish: Hvis du/dit barn lider af en blødersygdom, kan lægen beslutte at give vaccinen under huden (subkutant)
English: IXIARO contains potassium and sodium
Danish: IXIARO indeholder kalium og natrium
English: If not, you and/or your child may not be fully protected against the disease.
Danish: Hvis du ikke gør det, er du/dit barn måske ikke fuldt beskyttet mod sygdommen.
English: If you and/or your child have any other known allergies.
Danish: • Hvis du og/eller dit barn har en kendt allergi
English: Visit 0 (Screening) Visit 3 (Day 28) Visit 4 (Day 56)
Danish: Besøg 0 (Screening) Besøg 3 (dag 28)
English: Common: ≥ 1/100 to < 1/10
Danish: Almindelig: ≥ 1/100 til < 1/10
English: Exceptionally, IXIARO can also be administered subcutaneously to patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration.
Danish: IXIARO kan undtagelsesvist indgives subkutant til patienter, som lider af trombocytopeni eller blødersygdomme, da blødning kan forekomme ved intramuskulær indgivelse.
English: If you and/or your child miss a scheduled injection, talk to your doctor and arrange another visit for the second injection.
Danish: Hvis og/eller dit barn du glemmer at få en planlagt indsprøjtning, så tal med lægen og få en ny tid til den anden injektion.
English: IXIARO will not protect against encephalitis caused by other micro-organisms.
Danish: IXIARO beskytter ikke mod encefalitis forårsaget af andre mikroorganismer.
English: By Day 56, the proportion of subjects who had seroconverted was similar for both treatment groups (96.4% vs. 93.8% for IXIARO and JE VAX, respectively).
Danish: På dag 56 var den andel af forsøgspersonerne, der var serokonverteret, ens for begge behandlingsgrupper (96,4 % mod 93,8 % for henholdsvis IXIARO og JE-VAX).
English: Vaccination schedules: IXIARO: Day 0/28, Rabipur: Day 0/7/28.
Danish: Vaccinationsplaner: IXIARO: Dag 0/28, Rabipur: Dag 0/7/28.
English: 96% of subjects (64/67) still had protective antibody levels (PRNT50≥1:10), with a GMT of 148 (95%CI: 107; 207).
Danish: 96 % af forsøgspersonerne (64/67) havde stadig beskyttende antistofniveau (PRNT50≥1: 10) med en GMT på 148 (95 % CI: 107; 207).
English: Tell your doctor if you and/or your child are taking or have recently taken, or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du og/eller dit barn tager eller for nylig har taget andre lægemidler, eller om du for nylig har fået en anden vaccination.
English: The rapid schedule was tested for concomitant administration of IXIARO and Rabipur but it can also be used for administration of IXIARO alone, as no immune interference of the two vaccines has been observed (see section 4.5).
Danish: Den hurtige vaccinationsplan blev testet ved samtidig indgivelse af IXIARO og Rabipur, men den kan også bruges ved administration af IXIARO alene, da der ikke er blevet observeret immuninterferens mellem de to vacciner (se pkt.
English: Do not use if the blister foil is not intact or packaging is damaged.
Danish: Må ikke anvendes, hvis blisterfolien ikke er intakt, eller hvis emballagen er beskadiget.
English: This medicine contains potassium, less than 1mmol (39 mg) per 0.5 ml single dosage i.e. essentially ‘potassium-free' and less than 1 mmol sodium (23 mg) per 0.5 ml single dosage, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (39 mg) kalium pr. 0,5 ml enkeltdosis, dvs. den er i det væsentlige kaliumfri, og mindre end 1 mmol natrium (23 mg) pr. 0,5 ml enkeltdosis, med andre ord er den i det væsentlige natriumfri.
English: The second injection should be given at least 1 week before you and/or your child will be at risk of exposure to JE virus.
Danish: Den anden injektion skal gives mindst 1 uge inden, du/dit barn kan risikere at blive udsat for JE-virus.
English: If you have any further questions, ask your doctor.
Danish: • Spørg lægen, hvis der er mere, du vil vide.
English: Pre-booster, Day 0 (n=198) Day 28 (n=198) Month 6 (n=197) Month 12 (n=194)
Danish: Præbooster, dag 0 (n=198) Dag 28 (n=198)
English: This leaflet was last revised in .
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: 150 children were followed-up for three years without booster, additional 150 children received a booster after 1 year (0.25 ml if aged <3 years at time of the booster, 0.5 ml if aged 3 years and above) and were followed-up for further two years.
Danish: 150 børn blev fulgt i tre år uden booster, yderligere 150 børn modtog en booster efter 1 år (0,25 ml, hvis de var <3 år på tidspunktet for boosteren, 0,5 ml, hvis de var 3 år og derover) og blev fulgt i yderligere to år.
English: 2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+) 3 Antigen Units
Danish: 2 adsorberet på aluminiumhydroxid, hydreret (omkring 0,25 milligram Al3+) 3 antigen enheder
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to IXIARO is negligible.
Danish: Der forventes ingen effekt på spæd-/småbørn, der får modermælk, da den ammende kvindes systemiske eksponering for IXIARO er minimal.
English: Day 56 Month 7
Danish: Dag 56 Måned 7
English: Valneva Scotland Ltd. Oakbank Park Road Livingston EH53 0TG United Kingdom
Danish: Valneva Scotland Ltd. Oakbank Park Road, Livingston EH53 0TG Storbritannien
English: The immunogenicity of booster doses was also assessed in the study investigating persistence of immunity following different primary immunization regimens (2x6 mcg: N=116, 1x12mcg: N=116 or 1x6 mcg: N=117).
Danish: Immunogeniciteten af boosterdoser blev også vurderet i undersøgelsen ved at undersøge persistensen af immunitet efter forskellige primære immuniseringsregimer (2 x 6 mikrogram: N=116, 1 x 12 mikrogram: N=116 eller 1 x 6 mikrogram: N=117).
English: IXIARO is a suspension for injection (0.5 ml in a glass syringe with or without a separate needle, pack size of 1).
Danish: IXIARO er en injektionsvæske, suspension (0,5 ml i en glassprøjte med eller uden en separat kanyle, pakningsstørrelse på 1).
English: Hold the syringe in an upright position.
Danish: Hold sprøjten i opret stilling.
English: It must not be injected into a blood vessel.
Danish: Det må ikke indsprøjtes i en blodåre.
English: Long term immunogenicity of IXIARO was assessed in a subset of 181 subjects up to month 24 (Intent-to-treat (ITT) population) and in 152 subjects up to month 36 after the first IXIARO vaccination.
Danish: Langtidsimmunogenicitet for IXIARO blev vurderet i en undergruppe på 181 forsøgspersoner i op til måned 24 ("Intent to Treat"-populationen (ITT) og hos 152 forsøgspersoner i op til 36 måneder efter den første IXIARO vaccination.
English: Clear liquid with a white precipitate.
Danish: Klar væske med hvidt bundfald.
English: Shake the syringe to obtain a homogeneous suspension.
Danish: Ryst sprøjten for at opnå en homogen suspension.
English: First dose at Day 0.
Danish: Første dosis på dag 0.
English: Elderly persons have a lower immune response to vaccination compared to younger adults or children, in terms of seroconversion rates (percentage of subjects with PRNT50 titer ≥1:10) and geometric mean titers (Table 9).
Danish: Ældre mennesker har et lavere immunrespons på vaccination sammenlignet med yngre voksne eller børn bedømt ved serokonverteringsrater (procentdel af forsøgspersoner med PRNT50 titer ≥1:10) og geometriske middeltitre (tabel 9).
English: vaccination.
Danish: Vaccinedosis
English: 1 dose, 0.5 ml
Danish: 1 dosis, 0,5 ml
English: PACKAGE LEAFLET: INFORMATION FOR THE USER IXIARO suspension for injection
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN IXIARO injektionsvæske, suspension
English: GMT increased by Day 56 to 243.6 for IXIARO and to 102.0 for JE VAX, respectively.
Danish: GMT steg på dag 56 til henholdsvis 243,6 for IXIARO og 102,0 for JE-VAX.
English: Preparation for Administration of 0.25 ml Dose
Danish: Klargøring til administration af 0,25 ml dosis
English: Geometric Mean Titer (plaque reduction neutralization test) GMT [95%CI]
Danish: Geometriske middeltiter (plakreduktionsneutraliseringstest) GMT [95 %CI]
English: No long-term seroprotection data beyond two years after a first booster administered 1 year after primary immunization has been generated in children.
Danish: Ingen langsigtede serobeskyttende data fra to år efter en første administration 1 år efter primær immunisering er blevet genereret hos børn.
English: Dispose of in accordance with local requirements.
Danish: Bortskaffelse i henhold til lokale retningslinjer.
English: Immunogenicity of IXIARO was studied in approximately 3,119 healthy adult subjects included in seven randomized, controlled and five uncontrolled Phase 3 trials and in approximately 550 healthy children included in two randomized, controlled and two uncontrolled Phase 3 clinical trials.
Danish: IXIARO's immunogenicitet blev undersøgt hos omkring 3.119 raske voksne forsøgspersoner, der deltog i syv randomiserede, kontrollerede og fem ukontrollerede fase 3-studier, og hos cirka 550 sunde børn, der deltog i to randomiserede, kontrollerede og to ukontrollerede kliniske fase 3-forsøg.
English: The effect of age on the immune response to IXIARO and JE-VAX was assessed as a secondary endpoint in this active controlled study, comparing subjects aged ≥ 50 years of age (N=262, mean age 59.8) with those below 50 years of age (N=605, mean age 33.9).
Danish: Alderens effekt på immunreaktionen på IXIARO og JE-VAX blev vurderet som et andet endepunkt i denne aktivt kontrollerede undersøgelse, idet forsøgspersoner ≥50 år (N = 262, gennemsnitsalder 59,8) blev sammenlignet med forsøgspersoner under 50 år (N = 605, gennemsnitsalder 33,9).
English: In a reproductive and pre-/post-natal toxicity study, no vaccine-related effects were detected on reproduction, foetal weight, survival and development of the off-spring.
Danish: I en reproduktiv og præ-/postnatal toksicitetsundersøgelse blev der ikke påvist nogen vaccinerelaterede virkninger på reproduktion, kropsvægt hos fostre, overlevelse og udvikling af afkommet.
English: Neutralising antibody titers against JEV were measured against the JEV strain SA14
Danish: Neutraliserende JEV-antistoftitre blev målt i forhold til stammen SA14
English: Day 21
Danish: Dag 21
English: 0.25 mL Booster Dose N=81
Danish: 0,25 ml boosterdosis N=81
English: Marketing Authorisation Holder: Valneva Austria GmbH Campus Vienna Biocenter 3
Danish: Indehaver af markedsføringstilladelsen: Valneva Austria GmbH Campus Vienna Biocenter 3
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDTE LÆGEMIDLER ELLER AFFALD HERAF
English: If a needle is not provided, use a sterile needle.
Danish: Hvis der ikke medfølger kanyle, bruges en steril kanyle.
English: BATCH NUMBER AND PRODUCT CODES
Danish: FREMSTILLERENS BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: 4.4 Special warnings and precautions for use
Danish: 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: The immunogenicity of IXIARO was evaluated in an open-label, uncontrolled trial in 200 healthy elderly persons aged >65 to 83 years, including subjects with stable underlying conditions like hypercholesterolemia, hypertension, cardiovascular disease or non insulin-dependent diabetes mellitus.
Danish: Immunogeniciteten af IXIARO blev evalueret i et open-label, ukontrolleret forsøg med 200 raske ældre mennesker i alderen >65-83 år, herunder forsøgspersoner med stabile underliggende tilstande som hyperkolesterolæmi, forhøjet blodtryk, kardiovæskulær sygdom eller ikke-insulinkrævende diabetes mellitus.
English: Like other intramuscular injections, this vaccine should not be administered intramuscularly to persons with thrombocytopenia, haemophilia or other bleeding disorders (see section 4.2).
Danish: Som andre intramuskulære injektioner bør denne vaccine ikke indgives intramuskulært til personer, som lider af trombocytopeni, hæmofili eller andre blødersygdomme (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton
English: It is unknown whether IXIARO is excreted in human milk.
Danish: Det vides ikke, om IXIARO udskilles i modermælk.
English: 6 AU (Antigen Units, corresponding to a potency of ≤ 460 ng ED50) of inactivated Japanese encephalitis virus strain SA14-14-2 (produced in Vero cells) adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+).
Danish: 6 AU (antigen enheder, svarende til en styrke på ≤ 460 ng ED50) inaktiveret japansk encefalitis virusstamme SA14-14-2 (produceret i veroceller) adsorberet på aluminiumhydroxid, hydrateret (omkring 0,25 mg Al3+).
English: Concomitant administration of IXIARO with other vaccines:
Danish: Samtidig indgivelse af IXIARO og andre vacciner:
English: 1 year< 3 years
Danish: 1 år< 3 år
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE EMBALLAGER Mærkat til fyldt injektionssprøjte
English: Results indicate that the second injection of the primary immunization series can be given up to 11 months after the first dose.
Danish: Resultaterne indicerer, at den anden injektion i den primære immuniseringsserie kan gives op til 11 måneder efter den første dosis.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette produkt er tilgængelige på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: A. på anmodning fra Det Europæiske Lægemiddelagentur B. når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: * If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used.
Danish: *Hvis stemplet skubbes forbi den røde streg, er en dosis på 0,25 ml ikke garanteret, og der bør anvendes en ny sprøjte.
English: The immune responses elicited by IXIARO were non inferior to those induced by JE VAX (Table 2).
Danish: De ønskede immunreaktioner ved IXIARO var ikke dårligere end de reaktioner, som JE-VAX medførte (tabel 1).