FrancophonIA/ELRC3.0 huggingface dataset:
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:
Maltese: Id-doża rakkomandata għall-adulti, adolexxenti u tfal b'età minn 3 snin 'l fuq hija total ta' 2 injezzjonijiet ta' 0.5 ml kull waħda::
English: EXP:
Maltese: < PC:
English: Seroconversion Rates % (n/N)
Maltese: Rati ta' serokonverżjoni % (n/N)
English: These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.
Maltese: Newtralizzazzjoni tat-Tnaqqis tal-Plakka ta' mill-inqas 1:10 kienu protetti minn sfida letali bil-virus tal enċefalite Ġappuniża.
English: 0.5 mL Booster Dose N=67
Maltese: 0.5 mL Doża Booster
English: IXIARO is a vaccine against the Japanese encephalitis virus.
Maltese: IXIARO huwa vaċċin kontra l-virus tal-enċefalite Ġappuniża.
English: Month 12 Month 24
Maltese: Xahar 12 Xahar 24
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.
Maltese: L-immunoġeniċità ta' IXIARO ġiet studjata f'madwar 3,119 individwu f'saħħtu inklużi f'seba' provi randomised, ikkontrollati u ħames provi mhux ikkontrollati ta' Fażi 3, u f'madwar 550 tifel u tifla b'saħħithom inklużi f'żewġ provi kliniċi, randomised, ikkontrollati u tnejn mhux ikkontrollati ta' Fażi 3.
English: IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) Presentation for adults, adolescents and children
Maltese: Vaċċin tal-enċefalite Ġappuniża (inattivat, assorbit) Preżentazzjoni għal adulti, adolexxenti u tfal
English: Respiratory, Thoracic and Medistinal Disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: All of the 198 subjects treated were included in the ITT and Safety Populations.
Maltese: Il-198 individwu li ġew ikkurati kienu nklużi filPopolazzjonijiet ITT u tas-Sigurtà.
English: Shake the syringe to obtain a homogeneous suspension.
Maltese: Ħawwad is-siringa biex tikseb suspensjoni omoġenja
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).
Maltese: Is-sigurtà ta' IXIARO ġiet ivvalutata fi studji kliniċi kkontrollati u mhumiex ikkontrollati f'5,021 adult f'saħħtu (minn pajjiżi mhux endemiċi) u 1,559 tifel u tifla u adolexxent (fil-biċċa l-kbira tal- pajjiżi endemiċi).
English: Antibody persistence and booster dose in children and adolescents from a JEV-endemic country The persistence of JEV neutralizing antibodies after primary immunisation and safety and immunogenicity of an IXIARO booster dose 12 months after primary immunization were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic (300 children, mean age 5.3 years, range 1.2 - 17.3 years).
Maltese: Il-persistenza ta' antikorpi newtralizzanti ta' JEV wara l-immunizzazzjoni primarja u s-sigurtà u l immunoġeniċità ta' doża booster ta' IXIARO, 12-il xahar wara li l-immunizzazzjoni primarja ġew evalwati fi prova klinika randomised, ikkontrollata u open-label li twettqet fil-Filippini, fejn JEV huwa endemiku
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.
Maltese: Rati ta' individwi b'PRNT50≥1:10 u l-GMTs fix-Xhur 2, 6, 12, 24 u 36 huma miġburin fil-qosor f'Tabella 3 għall-popolazzjoni ITT.
English: Immunogenicity and safety of IXIARO in children and adolescents from a JEV-endemic country The safety and immunogenicity of IXIARO were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic.
Maltese: Immunoġeniċità u sigurtà ta' IXIARO fi tfal u adolexxenti f'pajjiż fejn JEV hu endemiku Is-sigurtà u l-immunoġeniċità ta' IXIARO kienu evalwati fi prova klinika randomised, ikkontrollata u open label magħmula fil-Filippini, fejn JEV hija endemika.
English: Proportion of Subjects Achieving an ≥4-fold Increase in JEV Antibody Titers % (n/N)
Maltese: Proporzjon ta' Individwi li Kisbu Żieda ta' ≥4 darbiet fit-Titers ta' Antikorpi għal JEV % (n/N)
English: A total of 217 subjects aged 18 to ≤ 65 years received IXIARO together with inactivated rabies vaccine (Rabipur) in a rapid immunisation schedule on Day 0 and Day 7 and 56 subjects received IXIARO alone in the conventional immunisation schedule on Day 0 and Day 28.
Maltese: vaċċin kontra r-rabbja inattivata (Rabipur) fi skeda ta' immunizzazzjoni rapida f'Jum 0 u Jum 7 u 56 individwu rċevew IXIARO waħdu fl-iskeda konvenzjonali ta' immunizzazzzjoni f'Jum 0 u Jum 28.
English: Mathematical modelling was applied to project the average duration of protection.
Maltese: Ġew applikati mudelli matematiċi sabiex jipproġettaw it-tul ta' żmien medju ta' protezzjoni.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
English: Pyrexia Influenza like illness Irritability Fatigue Injection site redness Injection site pain Injection site tenderness Injection site swelling Injection site hardening Injection site itching
Maltese: • jekk is-sistema immuni tiegħek jew tat-tifel/tifla tiegħek ma taħdimx sewwa (immunodefiċjenza) jew jekk inti u/jew it-tifel/tifla tiegħek qegħdin tieħdu mediċini li jaffettwaw is-sistema immuni tagħkom (bħal mediċina msejħa kortison jew mediċina kontra l-kanċer).
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)
Maltese: Rimettar, raxx tal-ġilda, tibdil fil-glandoli tal-limfa, emikranja (uġigħ ta' ras qawwi u jtektek, sikwit akkumpanjat minn dardir u rimettar u sensittività għad-dawl), sturdament, vertigo (sensazzjoni li kollox qed idur bik), dijarea, tgħereq iż-żejjed, uġigħ ta' żaqq, ħakk, tertir, kondizzjoni ġenerali meta tħossok ma tiflaħx,
English: Month 12 Month 13
Maltese: Xahar 12 Xahar 13
English: Shake to form a uniform suspension.
Maltese: Użu għal ġol-muskoli (IM). Ħawwad biex tifforma suspensjoni uniformi.
English: Age Group
Maltese: Grupp ta' Etajiet
English: There were no significant effects of age on geometric mean titer in the group receiving IXIARO.
Maltese: Ma kienx hemm effetti sinifikanti tal-età fuq it-tajter ġeometriku medju fil-grupp li rċieva IXIARO.
English: In adults a seroconversion rate of 29.4 % has been observed 10 days after the first i.m.
Maltese: Fl-adulti, ġiet osservata rata ta' serokonverżjoni ta' 29.4% 10 ijiem wara l-ewwel tilqima i.m., u 97.3% ġimgħa wara t-tieni tilqima i.m. fl-iskeda konvenzjonali.
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
Maltese: Tabella 8: Rati ta' serokonverżjoni (rata ta' individwi b'PRNT50≥1:10) u GMTs (test ta' newtralizzazzjoni tat-tnaqqis fil-plakka) għal antikorpi newtralizzanti kontra l-JEV wara l-għoti ta' IXIARO u
English: Attach a needle to the pre-filled syringe.
Maltese: Likwidu ċar bi preċipitat abjad.
English: The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4).
Maltese: L-immunizzazzjoni primarja għandha titlesta għallinqas ġimgħa qabel esponiment potenzjali għall-virus tal enċefalite Ġappuniża (JEV - Japanese encephalitis virus) (ara sezzjoni 4.4).
English: Concomitant administration of IXIARO with inactivated hepatitis A vaccine and with inactivated rabies vaccine in two different schedules has been evaluated in clinical studies.
Maltese: L-għoti simultanju ta' IXIARO ma' vaċċin inattivat tal-epatite A u b'vaċċin kontra r-rabbja inattivata f'żewġ skedi differenti ġie evalwat fi studji kliniċi.
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.
Maltese: Studji fuq l-annimali wrew li l-vaċċin iġiegħel lis-sistema immuni tipproduċi antikorpi kontra l-vijrus tal-enċefalite Ġappuniża li ħafna drabi huma protettivi.
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).
Maltese: Il-persuni anzjani għandhom rispons immunitarju aktar baxx għat-tilqima meta mqabbla ma' adulti iżgħar fl-età jew tfal, f'termini ta' rati ta' serokonverżjoni (perċentwal ta' individwi b'PRNT50 titrazzjoni ≥1:10) u titrazzjonijiet ġeometriċi medji (Tabella 9).
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.
Maltese: Limmunoġeniċità fuq perjodu fit-tul ta' IXIARO ġiet ivvalutata f'subsett ta' 181 individwu sax-xahar 24 (popolazzjoni bil-Ħsieb ta' Kura (ITT)) u f'152 individwu sax-xahar 36 wara l-ewwel vaċċinazzjoni ta'
English: IXIARO is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older.
Maltese: IXIARO huwa indikat għal immunizzazzjoni attiva kontra l-enċefalite Ġappuniża fl-adulti, adolexxenti, tfal u trabi b'età minn xaharejn 'l fuq.
English: Immunogenicity of the vaccine was evaluated in a randomized, active controlled, observer blinded, multicenter Phase 3 clinical trial including 867 healthy male and female subjects given IXIARO or the US licensed JEV vaccine JE VAX (on a 0, 7 and 28 day schedule by subcutaneous injection).
Maltese: L-immunoġeniċità tal-vaċċin ġiet evalwata fi prova klinika randomised, ikkontrollata b'mod attiv, observerblinded, b'aktar minn ċentru wieħed ta' Fażi 3 li kienet tinkludi 867 raġel u mara b'saħħithom li ngħataw IXIARO jew il-vaċċin tal-JEV illiċenzjat mill-US, JE-VAX (fuq skeda ta' 0, 7 u 28 jum b'injezzjoni taħt ilġilda).
English: Uncommon: musculoskeletal stiffness, arthralgia Rare: pain in extremity
Maltese: Komuni ħafna: uġigħ fil-muskoli Mhux komuni: ebusija muskoloskeletali, artralġja Rari: uġigħ fl-estremità
English: Antibody persistence after booster immunisation (adults) In an uncontrolled, open-label extension to the booster study described above, 67 subjects were followed up for determination of JEV neutralizing antibody titres at approximately 6 years after a booster dose.
Maltese: F'estensjoni mhux ikkontrollata, open-label tal-istudju dwar il-booster deskritt hawn fuq, 67 individwu ġew segwiti għal determinazzjoni ta' titres ta' antikorpi newtralizzanti ta' JEV f'bejn wieħed u ieħor 6 snin wara d-doża booster.
English: Cough
Maltese: Folja
English: GMT [95% CI]
Maltese: [95% CI]
English: 0.25 mL Booster Dose N=81
Maltese: 0.25 mL Doża Booster
English: Gastrointestinal disorders Common: nausea
Maltese: Rari: dispneja Disturbi gastrointestinali Komuni: dardir
English: 12 years< 18 years
Maltese: 12-il sena< 18-il sena
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.
Maltese: Fi studju observer-blind tal-Fażi 3, l-għoti fl-istess ħin ta' IXIARO u Rabipur ġie studjat f'adulti li għandhom bejn 18 sa ≤65 sena meta mqabbel ma' tilqimiet waħdiena rispettivi fi studju konvenzjonali.
English: There was no interference with the immune response to the JE virus and HAV, respectively.
Maltese: Ma kien hemm ebda interferenza mar-rispons immuni għall-virus tal-JE u l
English: VAX group (80.9 vs. 45.9, p=0.0236) but there was no significant difference at Day 56 for this treatment group.
Maltese: 45.9, p=0.0236) iżda ma kien hemm l-ebda differenza sinifikanti f'Jum 56 għal dan il-grupp ta' kura.
English: Geometric mean titer (by plaque reduction neutralization test) Time point
Maltese: Tajter ġeometriku medju (b'test ta' newtralizzazzjoni tat-tnaqqis tal-plakka)
English: Antibody persistence in children and adolescents from non-endemic countries
Maltese: Persistenza tal-antikorpi fi tfal u adolexxenti minn pajjiżi mhux endemiċi
English: The immune responses elicited by IXIARO were non inferior to those induced by JE VAX (Table 2).
Maltese: Ir-risponsi immuni kkawżati minn IXIARO ma kinux inferjuri għal dawk indotti minn JE-VAX (Tabella 2).
English: Adverse reactions are listed according to the following frequencies:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Uncommon: vomiting, diarrhoea, abdominal pain
Maltese: Mhux komuni: rimettar, dijarea, uġigħ addominali
English: In an uncontrolled, open-label phase 3 study a single 6 mcg (0.5 ml) booster dose of IXIARO was given at month 15 after primary immunization.
Maltese: Fi studju mhux ikkontrollat, open-label, f'fażi 3, doża waħda booster ta' 6 mcg (0.5 ml) ta' IXIARO ġiet mogħtija fix-xahar 15 wara l-immunizzazzjoni primarja.
English: Table 13: Seroprotection rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Maltese: Tabella 13: Rati ta' seroprotezzjoni u titer ġeometriku medju ta' antikorp newtralizzanti ta' JEV permezz ta' doża tal-vaċċin u grupp tal-età.
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.
Maltese: L-immonuġeniċità ta' IXIARO kienet evalwata fi prova mhux ikkontrollata, b'tikketta mikxufa f'200 persuna anzjana u b'saħħithom li għandhom bejn >65 u 83 sena, inklużi individwi b'kundizzjonijiet sottostanti stabbli bħal iperkolesterolemija, pressjoni għolja, mard kardjovaskulari jew dijabete mellitus mhux dipendenti fuq l-insulina.
English: The immunogenicity evaluation was performed in a subset of the study population and included the determination of the seroconversion rate (SCR), defined as JEV neutralizing antibody titer ≥1:10, the proportion of subjects achieving an at least fourfold increase in antibody titers and the geometric mean titer (GMT) at Day 56 and Month 7, by dose and by age group.
Maltese: L-evalwazzjoni tal-immunoġeniċità saret f'sottosett tal-popolazzjoni taħt studju u kienet tinkludi id determinazzjoni tar-rata ta' serokonverżjoni (SCR), imfissra bħala t-titer tal-antikorp newtralizzanti ta' JEV ta' >1:10, il-proporzjon ta' individwi li jilħqu tal-inqas żieda ta' erba' darbiet it-titers ta' antikorpi u t-titer ġeometriku medju (GMT) f'Jum 56 u Xahar 7, skont id-doża u l-grupp t'età.
English: Preparation for Administration of 0.25 ml Dose
Maltese: Preparazzjoni għall-għoti ta' Doża ta' 0.25 ml
English: Immunogenicity in elderly persons (>65 years)
Maltese: Immonoġeniċità f'persuni anzjani (>65 sena)
English: Suspension for injection.
Maltese: IXIARO suspensjoni għal injezzjoni
English: SCR and GMT at four weeks after a single 6 mcg booster dose administered to subjects with a PRNT50 <1:10 (PRNT50<1:10 means a subject is no longer seroprotected) at month 11 or month 23 after recommended primary immunization (2x 6 mcg) or incomplete (1x6 mcg) primary immunization with IXIARO (ITT population)
Maltese: Tabella 6: SCR u GMT fir-raba' ġimgħa wara doża waħda booster ta' 6 mcg mogħtija lill-individwi bilPRNT50<1:10 (PRNT50<1:10 ifisser li individwu m'għadux aktar seroprotettiv) fil-11-il xahar jew fit-23
English: There was no significant difference between seroconversion rates in subjects aged <50 years compared to those aged ≥50 years at Day 28 or Day 56 for either treatment group.
Maltese: Ma kien hemm ebda differenza sinifikanti bejn ir-rati ta' serokonverżjoni ta' IXIARO u JE-VAX f'individwi ta' <50 sena meta mqabbla ma' dawk ta' ≥50 sena f'Jum 28 jew f'Jum 56 wara t-tilqima.
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)
Maltese: Tabella 3: Rati ta' individwi b'PRNT50≥1:10 u tajters ġeometriċi medji (GMT) f'Xahar 2, 6, 12, 24 u 36
English: 1 dose, 0.5 ml
Maltese: Wara 0.5 mL
English: Paediatric population No interaction studies have been performed in children and adolescents.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni fi tfal u adolexxenti
English: Seroconversion Rate (Rate of subjects with PRNT50≥1:10)
Maltese: (Rata ta' individwi b'PRNT50≥1:10)
English: In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained.
Maltese: Barra minn hekk ma kien hemm ebda interferenza bir-rispons immunitarju għal Rapibur.
English: Most commonly reported adverse reactions in adults included headache (20% of subjects), myalgia (13%), injection site pain (33%), injection site tenderness (33%) and fatigue (12.9%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni fl-adulti kienu jinkludu uġigħ ta' ras (20% talindividwi), uġigħ fil-muskoli (13%) uġigħ fis-sit tal-injezzjoni (33%), u sensittività fis-sit tal-injezzjoni
English: Pharmacotherapeutic group: Vaccines, Viral vaccines, Encephalitis vaccines.
Maltese: Vaċċini, Vaċċini virali, Vaċċini tal-enċefalite.
English: In another open-label, follow-up Phase 3 study, the persistence of antibodies up to 24 months after primary vaccination was assessed.
Maltese: Fi studju ieħor open-label, ta' segwitu, f'Fażi 3, il-persistenza tal-antikorpi sa 24 xahar wara t-tilqima primarja ġiet assessjata.
English: A single 6 mcg (0.5 ml) booster dose was administered at 11 or 23 months after the first dose to subjects, which were determined to be seronegative (PRNT50 titers < 1:10) at month 6 and/or month 12 after the primary immunization.
Maltese: Doża booster waħda ta' 6 mcg (0.5 ml) ġiet mogħtija fil-11 u fit-23 xahar wara l-ewwel doża lill-individwi li kienu meqjusa seronegattivi (titri PRNT50<1:10) fix-xahar 6 u/jew fix-xahar 12 wara limmunizzazzjoni primarja.
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
Maltese: Komuni ħafna: uġigħ fis-sit tal-injezzjoni, sensittività fis-sit tal-injezzjoni, għeja Komuni: mard jixbah lill-influwenza, deni, reazzjonijiet fis-sit tal-injezzjoni eż. ħmura, twebbis, nefħa, ħakk Mhux komuni: tkexkix ta' bard, astenja
English: Hold the syringe in an upright position.
Maltese: IXARO m'għandu qatt jiġi injettat b'mod intravaskulari.
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.
Maltese: (300 tifel u tifla, età medja 5.3 snin, medda ta' 1.2 - 17.3 snin). 150 tifel u tifla ġew segwiti għal tliet snin mingħajr booster, 150 tifel u tifla addizzjonali rċevew booster wara sena (0.25 ml jekk fl-età < 3 snin fiżżmien tal-booster, 0.5 ml jekk fl-età ta' 3 snin u aktar) u kienu segwiti għal sentejn oħra.
English: Seroconversion rates and geometric mean titer for JEV neutralizing antibody at Day 70 n / N
Maltese: Rati ta' serokonverzjoni u titrazzjoni ġeometrika medja għall-antikorp newtralizzanti JEV fil-Jum 70
English: Aluminium hydroxide is included in this vaccine as an adjuvant.
Maltese: Aluminium hdroxide huwa inkluż f'dan il-vaċċin bħala adjuvant.
English: Intent-to-treat Population
Maltese: Popolazzjoni maħsuba għal Trattament
English: Keep this leaflet.
Maltese: HAV, rispettivament.
English: Frequency of adverse reactions observed in children given the 0.25 ml dose (2 months to <3 years of age) and in children and adolescents given the 0.5 ml dose (3 years to <18 years of age)
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet avversi osservati fi tfal mogħtija doża ta' 0.25 ml (b'età minn xahrejn sa < 3 snin) u fi tfal u adolexxanti li ngħataw id-doża ta' 0.5 ml (b'età minn 3 snin sa
English: Seroconversion rates and GMTs for anti-JEV neutralizing antibodies on Day 0, 14, 21, 35, 56 and 365 after immunisation with IXIARO and inactivated rabies vaccine in a rapid schedule and IXIARO alone in a conventional schedule (Per Protocol population)
Maltese: 35, 56 u 365 wara l-immunizzazzjoni b'IXIARO u vaċċin kontra r-rabbja inattivata fi skeda rapida u IXIARO waħdu fi skeda konvenzjonali (Skont il-Popolazzjoni tal-Protokoll)
English: Incomplete primary immunization (adults)
Maltese: Immunizzazzjoni Primarja
English: Table 12: Seroconversion rates and geometric mean titer of JEV neutralizing antibody by vaccine dose and age group.
Maltese: Tabella 12: Rati ta' serokonverżjoni u titers ġeometriċi medji ta' antikorp newtralizzanti ta' JEV bid-doża ta' tilqim u l-grupp t'età.
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
Maltese: Rati ta' serokonverzjoni ta' titrazzjoni ġeometrika medja ta' antikorp newtralizzati JEV filJum 70 fil-Popolazzjoni b'Intenzjoni li jiġu kkurati, għall-popolazzjoni tal-istudju sħiħa u stratifikati skont l-età
English: ), host cell protein.
Maltese: Mhux applikabbli.
English: Most commonly reported adverse reactions in children and adolescents included pyrexia, diarrhoea, influenza like illness, irritability, injection site pain, injection site tenderness, and injection site redness (see table 1).
Maltese: marda tixbaħ lill-influwenza, irritabilità, uġigħ fis-sit tal-injezzjoni, sensittività fis-sit tal-injezzjoni, u ħmura fis-sit tal-injezzjoni (ara tabella 1).
English: Seroconversion rates and geometric mean titer for anti-JEV neutralizing antibody at Day 56 % with SCR
Maltese: Rati ta' serokonverżjoni u tajter ġeometriku medju għall-antikorp newtralizzanti kontra l-JEV f'Jum 56
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
Maltese: f'Jum 56 u r-rati ta' serokonverżjoni u t-tajter ġeometriku medju għall-antikorp tal-HAV f'Jum28 fil-Popolazzjoni Skont il-Protokoll
English: How to store IXIARO
Maltese: X'fih IXIARO
English: Table 6:
Maltese: Tabella 10:
English: 0.5 ml single dose in a pre-filled syringe + 1 needle.
Maltese: Doża waħda ta' 0.5 ml f'siringa mimlija għal-lest.
English: Based on this model, it is estimated that average duration of protection will be 14 years and 75% of vaccinees will retain protective antibody levels (PRNT50≥1:10) for 10 years.
Maltese: Abbażi ta' dan il-mudell, huwa stmat li t-tul ta' żmien medju ta' protezzjoni jkun 14-il sena u 75% tal-vaċċini ser iżommu livelli ta' antikorpi protettivi (PRNT50≥1:10) għal 10 snin.
English: Please note that:
Maltese: JIS:
English: Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose.
Maltese: Tfal u adolexxenti mill-età ta' 3 snin sa < 18-il sena għandhom jirċievu doża booster ta' 0.5 ml waħda.