FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite (see section 2.
Danish: 6.1 eller over for reststofferne protaminsulfat, formaldehyd, bovint serumalbumin, værtscelle-DNA, natriummetabisulfit (se pkt.
English: Very common (affects more than 1 user in 10): headache, muscle pain, injection site pain, injection site tenderness, tiredness
Danish: Meget almindelig (rammer mere end 1 ud af 10 brugere): Hovedpine, muskelsmerter, reaktioner omkring injektionsstedet, ømhed ved injektionsstedet, træthed
English: Vaccination scheme IXIARO Day 0,7 Rabipur Day 0,3,7
Danish: Vaccinationsplan IXIARO Dag 0,7 Rabipur Dag 0,3,7
English: Rates of subjects with PRNT50≥1:10 and GMTs at Months 2, 6, 12, 24 and 36 are summarized in Table 3 for the ITT population.
Danish: Rater for forsøgspersoner med PRNT50≥1:10 og GMT'er efter 2, 6, 12, 24 og 36 måneder er sammenfattet i tabel 3 for ITT-populationen.
English: VAX group (80.9 vs. 45.9, p=0.0236) but there was no significant difference at Day 56 for this treatment group.
Danish: Geometriske middeltitre var signifikant højere på dag 28 hos forsøgspersoner <50 end hos forsøgspersoner ≥50 i JE-VAX gruppen (80,9 mod 45,9, p = 0,0236), men der var ingen signifikant forskel på dag 56 for denne behandlingsgruppe.
English: The recommended dosage for adults, adolescents and children aged 3 years of age and older is a total of 2 injections of 0.5 ml each:
Danish: Den anbefalede dosis til voksne, teenagere og børn på 3 år og derover er i alt 2 injektioner a 0,5 ml:
English: Pre-Vaccination 30% (3/10) Day 56 Month 7
Danish: Prævaccination Dag 56 Måned 7
English: Antibody persistence (adults)
Danish: Antistofpersistens (voksne)
English: Booster dose
Danish: Boosterdosis
English: IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
Danish: IXIARO bør overvejes til personer, som har risiko for at blive smittet med japansk encefalitis i forbindelse med rejser eller erhverv.
English: Antibody persistence was evaluated for three years after the primary vaccination with IXIARO in an uncontrolled, open-label follow-up clinical trial conducted in the United States, Europe and Australia.
Danish: Antistof vedholdenhed hos børn og teenagere fra ikke-endemiske lande Antistofvedholdenheden blev evalueret i tre år efter den primære vaccination med IXIARO i et ukontrolleret, open-label opfølgende klinisk forsøg udført i USA, Europa og Australien.
English: Month 12 Month 13
Danish: Måned 12 Måned 13
English: A booster dose (third dose) should be given within the second year (i.e. 12 - 24 months) after primary immunization, prior to potential re-exposure to JEV.
Danish: Der skal gives en boosterdosis (tredje dosis) inden for det andet år (dvs. 12-24 måneder) efter den primære immunisering og før potentiel reeksponering for JE-virus (JEV).
English: Seroconversion rates and geometric mean titers of IXIARO and JE VAX in the Per Protocol Population.
Danish: Serokonverteringsrater og geometriske middeltitre (GMT) for IXIARO og JE-VAX i perprotokolpopulationen.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: The SPRs and GMTs are displayed in Table 13.
Danish: Spurs og GMO'er er vist i tabel 13.
English: Primary immunization should be completed at least one week prior to potential exposure to JEV.
Danish: Primær immunisering bør fuldføres mindst en uge før potentiel udsættelse for JEV.
English: IXIARO will not prevent infections caused by other viruses than the Japanese encephalitis virus.
Danish: • IXIARO ikke forebygger infektioner forårsaget af andre virus end japansk encefalitisvirus
English: Uncommon (affects 1 to 10 users in 1,000): vomiting, skin rash, changes in the lymph-nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased)
Danish: Opkastning, hududslæt, ændringer i lymfeknuderne, migræne (dunkende hovedpine, ofte ledsaget af kvalme og opkastning og lysfølsomhed), svimmelhed, vertigo (følelse af, at alt kører rundt), diaré, mavesmerter, overdreven svedtendens, kløe, kuldegysninger, generel følelse af utilpashed, stivhed i muskler og skelet, ledsmerter, svaghed, unormale laboratorieresultater for leverfunktionsprøver (forhøjet leverenzymtal)
English: Paediatric Population Children and adolescents from 3 years to < 18 years of age
Danish: Børn og teenagere fra 3 år til < 18 år
English: As a precautionary measure, the use of IXIARO during pregnancy or breast-feeding should be avoided.
Danish: Som en forholdsregel bør brugen af IXIARO under graviditet og amning undgås.
English: IXIARO is a vaccine against the Japanese encephalitis virus.
Danish: IXIARO er en vaccine mod japansk encefalitisvirus (JE-virus).
English: Rates of subjects with PRNT50≥1:10 and GMT before and at months 1, 6 and 12 after a single 6 mcg (0.5 ml) booster dose administered to subjects at 15 months after recommended primary immunization with IXIARO (ITT population)
Danish: Rater for forsøgspersoner med PRNT50≥1:10 og GMT før og 1, 6 og 12 måneder efter en enkelt 6 mikrogram (0,5 ml) boosterdosis administreret til forsøgspersoner 15 måneder efter den anbefalede primære immunisering med IXIARO (ITT-population)
English: In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m.
Danish: Hos voksne er en serokonverteringsrate på 29,4 % observeret 10 dage efter den første i.m.-vaccination og på 97,3 % en uge efter den anden i.m.-vaccination i den konventionelle plan.
English: Phosphate buffered solution consisting of sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate and water for injections.
Danish: Opløsning indeholdende en phosphatbuffer bestående af natriumchlorid, kaliumdihydrogenphosphat, dinatriumhydrogenphosphat og vand til injektion.
English: Age Group ≥2 months to <3 years
Danish: Aldersgruppe ≥2 måneder til <3 år
English: Rates of subjects with PRNT50≥1:10 and geometric mean titers (GMT) at Month 2, 6, 12, 24 and 36 after vaccination with IXIARO (ITT population)
Danish: Rater for forsøgspersoner med PRNT50≥1:10 og geometriske middeltitre (GMT) 2, 6, 12, 24 og 36 måneder efter vaccination med IXIARO (ITT-population)
English: After 0.25 mL Dose Primary Immunization
Danish: Efter 0,25 ml dosis primkær immunisering
English: Adult and older adults (>65 years) population
Danish: Voksne og ældre (>65 years):
English: Conventional Schedule % (n/N)
Danish: Konventionel plan % (n/N)
English: Seroconversion rates and geometric mean titer of JEV neutralizing antibody at Day 70 in the Intent-to-treat Population, for the entire study population and stratified by age
Danish: Serokonverteringsrater og geometriske middeltitre af JEV-neutraliserende antistoffer på dag 70 i Intend to treat-populationen, for hele studiepopulationen og stratificeret efter alder
English: Seroconversion rates and geometric mean titer for HAV antibody at Day 28 % with SCR
Danish: Serokonverteringsrater og geometriske middeltitre for HAV-antistof på dag 28 % med SCR
English: Children from 2 months to < 3 years of age
Danish: Børn fra 2 måneder til < 3 år
English: Attach a needle to the pre-filled syringe.
Danish: Fastgør en kanyle på den fyldte sprøjte.
English: Other medicines and IXIARO
Danish: Brug af anden medicin sammen med IXIARO
English: At Month 24, 48.3% (95% CI: 39.4, 57.3, N=116) of subjects who completed the recommended primary immunization still had PRNT50 titers of ≥1:10.
Danish: Efter 24 måneder havde 48,3 % (95 % CI: 39;4; 57,3; N=116) af forsøgspersonerne, som fuldførte den anbefalede primære immunisering, stadig PRNT50 titre på ≥1:10. GMT hos disse forsøgspersoner var 16,2 (95 % CI: 13,8; 19,0) efter 24 måneder.
English: Rapid Schedule % (n/N)
Danish: Hurtig plan % (n/N)
English: 6 months<12 months
Danish: 6 måneder<12 måneder
English: The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections
Danish: De øvrige indholdsstoffer er natriumchlorid, kaliumdihydrogenphosphat, dinatriumhydrogenphosphat og vand til injektion.
English: • Official batch release
Danish: Officiel batchfrigivelse
English: Concomitant administration of IXIARO with inactivated rabies vaccine (Rabipur): In an observer-blind Phase 3 study, concomitant administration of IXIARO and Rabipur has been studied in adults aged 18 to ≤ 65 years of age in comparison to respective single vaccinations in conventional schedule.
Danish: I et observatørblindet fase 3-studie er samtidig indgivelse af IXIARO og Rabipur undersøgt hos voksne i alderen 18 til ≤65 år og sammenlignet med de respektive enkeltvaccinationer efter konventionel vacciantionsplan.
English: Additional side effects in children aged 2 months to <3 years
Danish: Yderligere bivirkninger hos børn fra 2 måneder til <3 år
English: Uncommon: cough
Danish: Ikke almindelig: Hoste
English: Under no circumstances should IXIARO be administered intravascularly.
Danish: IXIARO må ikke under nogen omstændigheder indgives intravaskulært.
English: 3 years< 12 years
Danish: 3 år< 12 år
English: Table 10: Seroconversion rates, rates of subjects with at least 4-fold increase in JEV neutralizing antibody titers and Geometric Mean Titers at baseline, Day 56 and Month 7 stratified by age group, Intent To Treat Population Vaccine Dose
Danish: Tabel 10: Serokonverterigsrater, andel af forsøgspersoner med mindst en 4-dobling af JEV-neutraliserende antistoftiter og geometriske gennemsnitstitre ved baseline, Dag 56 og Måned 7 stratificeret efter aldersgruppe, Intention to treat-population
English: The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
Danish: • Den anden injektion 28 dage efter den første injektion (dag 28).
English: The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule: First dose at Day 0.
Danish: Den primære vacinationsserie består af to separate doser på 0,5 ml efter følgende plan: Første dosis på Dag 0.
English: Seroconversion rates and geometric mean titer of anti JEV neutralizing antibody at Day 56 and seroconversion rates and geometric mean titer for HAV antibody at Day 28 in the Per Protocol Population
Danish: Serokonverteringsrater og geometriske middeltitre af anti-JEV-neutraliserende antistof på dag 56 og serokonverteringsrater og geometriske middeltitre for HAV-antistof på dag 28 i perprotokolpopulationen
English: In a phase 2 study in healthy Indian toddlers aged ≥1 year to <3 years, 24 children were vaccinated with 0.25 ml of IXIARO (the licensed dose for this age group) and 24 children received the adult 0.5 ml dose.
Danish: I et fase 2-studie med raske indiske børn i alderen ≥1 til <3 år blev 24 børn vaccineret med 0,25 ml IXIARO
English: Month 24 Month 36
Danish: Måned 24 Måned 36
English: What you need to know before you and/or your child receive IXIARO 3.
Danish: DET SKAL DU OG/ELLER DIT BARN VIDE OM IXIARO
English: In children aged 2 months to <3 years, the following side effects have been observed more frequently compared to children aged 3 years to <12 years, adolescents and adults: Very common: fever (28.9%), diarrhoea (11.8%), influenza like illness (11.2%), irritability (11.0%) Common: loss of appetite, vomiting, skin rash
Danish: Meget almindelig: Feber (28,9 %), diaré (11,8 %), influenzalignende sygdom (11,2 %), irritabilitet (11,0 %) Almindelig: Appetitløshed, opkastning, hududslæt
English: The safety and immunogenicity of IXIARO was evaluated in an uncontrolled, open-label clinical trial conducted in the United States, Europe and Australia in healthy male and female subjects with planned travel to JEV-endemic areas.
Danish: Immunogenicitet og sikkerhed hos børn og teenagere fra ikke-endemiske lande Sikkerhed og immunogenicitet for IXIARO blev vurderet i et ukontrolleret, open-label klinisk forsøg gennemført i USA, Europa og Australien på raske mandlige og kvindelige forsøgspersoner med planlagt rejse til JEV-endemiske områder.
English: 0.5 ml single dose in a pre-filled syringe + 1 needle.
Danish: 1 enkelt dosis på 0,5 ml i fyldt injektionssprøjte + 1 kanyle
English: Table 9:
Danish: Tabel 9:
English: IXIARO is injected into your or your child's upper arm muscle (deltoid muscle) by your doctor or a nurse.
Danish: Lægen eller en sygeplejerske giver IXIARO som en indsprøjtning i din/dit barns overarmsmuskel (deltoideus).
English: The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule:
Danish: Den primære vaccinationsserie består af to separate doser på 0,5 ml hver, der indgives i henhold til følgende konventionelle vaccinationsplan:
English: Geometric Mean Titer (N)
Danish: Geometrisk gennemsnitstiter (N)
English: Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 70 n / N
Danish: Serokonverteringsrater og geometriske middeltitre for JEV-neutraliserende antistoffer på dag 70 n / N
English: Month 12 Month 24
Danish: Måned 12 Måned 24
English: Rare: oedema peripheral
Danish: Øjne Sjælden: Øjenlågsødem
English: Seroconversion rates (rate of subjects with PRNT50≥1:10) and GMTs (plaque reduction neutralization test) for anti-JEV neutralizing antibodies after administration of IXIARO and Rabipur in conventional schedule, Per Protocol population Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 56
Danish: Serokonverteringsrater (raten for forsøgspersoner med PRNT50≥1:10) og GMT (neutraliserende plaque-reduktionsprøve) for anti-JEV-neutraliserende antistoffer efter indgivelse af IXIARO og Rabipur efter konventionel vaccinationsplan, Per-protocol befolkning
English: General disorders and administration site conditions Very common: injection site pain, injection site tenderness, fatigue Common: influenza like illness, pyrexia, other injection site reactions e.g. redness, hardening, swelling, itching
Danish: Meget almindelig: smerter på injektionstedet, ømhed på injektionstedet, træthed Almindelig: influenzalignende symptomer, pyreksi, andre reaktioner på injektionstedet: rødme, hårdhed, hævelse, kløe
English: Geometric mean titer (by plaque reduction neutralization test) Time point
Danish: Geometriske middeltitre (ved hjælp af en neutraliserende plaque-reduktionsprøve - PRNT)
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Oakbank Park Road, Livingston EH53 0TG, Scotland, United Kingdom
Danish: Livingston EH53 0TG
English: Uncommon: vomiting, diarrhoea, abdominal pain
Danish: Ikke almindelig: opkastning, diarré, mavesmerter
English: Group C: IXIARO + HAVRIX 1440
Danish: Gruppe C: IXIARO + HAVRIX 1440 Gruppe B: HAVRIX + Placebo
English: Seroconversion Rates % (n/N)
Danish: Serokonverteringsrater % (n/N)
English: Booster immunisation (adults)
Danish: Boosterimmunisering (voksne)
English: The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Danish: Den primære immunisering bør være fuldført mindst en uge før potentiel eksponering for japansk encefalitisvirus (JEV) (se pkt.
English: Seroconversion rates and geometric mean titer for anti-JEV neutralizing antibody at Day 56 % with SCR
Danish: Serokonverteringsrater og geometriske middeltitre for anti-JEV-neutraliserende antistof på dag 56 % med SCR
English: Table 12: Seroconversion rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Danish: Tabel 12: Serokonverteringsrater og geometrisk gennemsnitstiter for JEV-neutraliserende antistof efter vaccinedosis og aldersgruppe.
English: What you need to know before you and/or your child receive IXIARO Do not use IXIARO:
Danish: Virkning og anvendelse Det skal du og/eller dit barn vide om IXIARO Sådan får du/dit barn IXIARO Bivirkninger
English: Rate of subjects with PRNT50≥1:10
Danish: PRNT50≥1:10
English: Uncommon: hepatic enzymes increased *reported also from post-marketing experience Paediatric population (2 months to <18 years of age) Table 1:
Danish: Pædiatrisk population (2 måneder til < 18 år) Tabel 1:
English: How to use IXIARO
Danish: SÅDAN BRUGES IXIARO
English: Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria, erythema
Danish: Ikke almindelig: udslæt, pruritus, hyperhidrose Sjælden: nældefeber, erytem
English: Respiratory, Thoracic and Medistinal Disorders
Danish: Luftveje, thorax og mediastinum
English: Babies and children aged 2 months to < 3 years of age
Danish: Babyer og børn på 2 måneder til < 3 år:
English: Table 13: Seroprotection rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Danish: Tabel 13: Serobeskyttelsesraten og den geometriske middeltitre af HIV-neutraliserende antistof ved vaccinedosis og aldersgruppe.
English: However, in the absence of data and as a precautionary measure the use of IXIARO during lactation should be avoided.
Danish: Da der mangler data, bør IXIARO dog for en sikkerheds skyld undgås under amning.
English: Pivotal immunogenicity trial (adults)
Danish: Pivotalt immunogenicitetsforsøg (voksne)
English: 0.5 ml single dose in a pre-filled syringe.
Danish: 1 enkelt dosis på 0,5 ml i fyldt injektionssprøjte.
English: With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Danish: Det gælder for begge vaccinationsplaner, at den primære immunisering skal være gennemført mindst en uge før potentiel eksponering for japansk encefalitisvirus (JEV) (se pkt.
English: Rare (affects 1 to 10 users in 10,000): palpitations, rapid heartbeat, difficulty to breathe, abnormal sensation of skin (for example pins and needles), hives, skin redness, pain in leg or arm, platelet deficiency, nerve inflammation, limb swelling and ankle swelling, taste disturbance, swelling of eyelid, fainting
Danish: Hjertebanken, hurtige hjerteslag, åndedrætsbesvær, unormal hudfornemmelse (fx prikkende fornemmelse), nældefeber, rødmen, smerter i ben eller arme, mangel på blodplader, nervebetændelse, hævelser i lemmer og ankler, smagsforstyrrelser, hævede øjenlåg, besvimelse
English: For any information about this medicine, please contact the Marketing Authorization Holder by the following email-address:
Danish: For alle informationer om dette lægemiddel kontakt indehaveren af markedsføringstilladeolsen på følgende e-mail adresse: infoixiaro@valneva.com
English: Hence, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV).
Danish: Den primære immunisering bør derfor foretages mindst en uge forud for potentiel eksponering for japansk encefalitisvirus.
English: Uncommon: musculoskeletal stiffness, arthralgia Rare: pain in extremity
Danish: Knogler, led, muskler og bindevæv Meget almindelig: myalgi Ikke almindelig: muskuloskeletal stivhed, artralgi Sjælden: smerte i ekstremiteter
English: Seroprotection Rate % (n/N)
Danish: Serobeskyttelsesrate % (n/N)
English: For instruction on the preparation of the 0.25 ml dose, please refer to the end of this package leaflet.
Danish: Se sidst i denne indlægsseddel vedrørende instruktion i klargøring af 0,25 ml-dosen.
English: The primary vaccination series consists of two separate doses of 0.25 ml according to the following schedule:
Danish: Den primære vaccinationsserie består af to separate doser på 0,5 ml, der indgives i henhold til følgende konventionelle vaccinationsplan:
English: Keep this leaflet.
Danish: Se pkt.
English: Valneva Scotland Ltd.
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Valneva Scotland Ltd.
English: Information on the administration of a 0.5 ml dose of IXIARO for persons 3 years of age and above
Danish: Information om administration af en 0,5 ml dosis IXIARO til personer på 3 år og derover Til administration af hele 0,5 ml-dosen følges nedenstående trin:
English: For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below:
Danish: For instruktioner om klargøring af en 0,25 ml-dosis til børn i alderen 2 måneder til <3 år, se pkt.
English: as assessed by a Plaque Reduction Neutralization Test (PRNT) for the entire study population.
Danish: ≥1:10) og geometriske middeltitre (GMT) på dag 56 som vurderet i en neutraliserende plaque reduktionsprøve (PRNT) for hele undersøgelsesgruppen.
English: If you and/or your child have experienced any health problems after previous administration of any vaccine.
Danish: • Du og/eller dit barn er blevet dårlig i forbindelse med andre vaccinationer
English: Very common: ≥ 1/10
Danish: Bivirkningerne er opstillet ud fra følgende hyppighed: Meget almindelig: ≥ 1/10
English: <50 years compared to those aged ≥50 years at Day 28 or Day 56 following vaccination.
Danish: Der var ingen signifikant forskel mellem serokonverteringsraterne for IXIARO og JE-VAX hos forsøgspersoner < 50 år sammenlignet med forsøgspersoner ≥50 ved dag 28 eller dag 56 efter vaccination.
English: The recommended dosage for babies and children aged 2 months to < 3 years is a total of 2 injections of 0.25 ml each: The first injection on Day 0 The second injection 28 days after the first injection (Day 28).
Danish: Den anbefalede dosis til babyer og børn i alderen 2 måneder til < 3 år er i alt 2 injektioner a 0,25 ml.
English: Information on the preparation of a 0.25 ml dose of IXIARO for use in children below 3 years of age
Danish: Information om klargøring af en 0,25 ml dosis IXIARO til brug på børn under 3 år Til administration af en 0,25 ml dosis til børn fra 2 måneder til < 3 år følges nedenstående trin:
English: Common (affects 1 to 10 users in 100): Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching)
Danish: Kvalme, influenzalignende sygdom, feber, andre reaktioner omkring injektionsstedet (fx rødme, hårdhed, hævelse, kløe)
English: IXIARO suspension for injection Japanese encephalitis vaccine Intramuscular (IM) use
Danish: IXIARO injektionsvæske, suspension Japansk encefalitisvaccine.
English: C. OTHER CONDITIONS OR REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The co-primary endpoint was seroconversion rate (anti JEV antibody titer ≥1:10) and geometric mean titers (GMT) at Day 56
Danish: Det primære endepunkt var serokonverteringsrate (SCR) (anti-JEV-antistoftiter
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Valneva Scotland Ltd.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Blisterfolie
English: • Then once every 4 months.
Danish: • Dernæst én gang hver 4. måned.
English: The use of external filters is not required.
Danish: Det er ikke nødvendigt at anvende eksterne filtre.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 personer)
English: Missed or delayed doses
Danish: Glemte eller forsinkede doser
English: • Then around day 14, day 28 and day 63
Danish: • Dernæst omkring dag 14, dag 28 og dag 63
English: • On the first day of treatment, day 0
Danish: • På den første behandlingsdag, dag 0