FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo.
Maltese: Fl-ewwel studju, il-perċentwal tal-pazjenti li esperjenzaw millinqas 50% tnaqqis fil-frekwenza tal-aċċessjonijiet kien 37.6% għall-pazjenti li ngħataw Fycompa f'doża ta' 8 mg u 36.1% għall-pazjenti li ngħataw Fycompa f'doża ta' 12 mg, meta mqabbla ma' 26.4
English: The CHMP considered that Fycompa, taken together with other anti-epileptic medicines, showed a consistent reduction in the frequency of epileptic fits and that no serious toxicity has been identified.
Maltese: Is-CHMP qies li meta meħud ma' mediċini antiepilettiċi oħrajn, Fycompa wera tnaqqis konsistenti filfrekwenza tal-aċċessjonijeit epilettiċi u li l-ebda tossiċità serja ma ġiet identifikata.
English: Fycompa is also used in patients from 12 years of age to treat primary generalised tonic-clonic seizures (major fits or convulsions, where the person becomes unconscious, falls down if standing, and jerks or shakes) associated with idiopathic generalised epilepsy (epilepsy with no apparent cause that is thought to have a genetic origin and that affects the whole brain).
Maltese: Fycompa jintuża wkoll f'pazjenti minn 12-il sena 'l fuq biex jikkura aċċessjonijiet toniċi-kloniċi primarji ġeneralizzati (aċċessjonijiet kbar jew konvulsjonijiet, meta l-persuna tintilef minn sensiha, taqa' meta tkun wieqfa, u tibda tiskossja jew tirtogħod) assoċjati ma' epilessija idiopatika ġeneralizzata (epilessija mingħajr kawża apparenti li huwa maħsub li għandha oriġini ġenetika u li taffetwa l-moħħ kollu).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fycompa on 23 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fycompa fit-23 ta' Lulju 2012.
English: What is Fycompa?
Maltese: X'inhu Fycompa?
English: Neurotransmitters are naturally-occurring chemicals in the nervous system that allow nerve cells to communicate with each other.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi naturali fis-sistema nervuża li jippermettu liċ-ċelloli tannervituri jikkomunikaw ma' xulxin.
English: In the management of partial onset seizures, Fycompa has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,491 patients aged 12 years and older with partial-onset seizures who did not respond to other treatments.
Maltese: Fl-immaniġġar tal-aċċessjonijiet parzjali tal-bidu, Fycompa tqabbel ma' plaċebo (kura finta) fi tliet studji ewlenin fuq total ta' 1,491 pazjent minn 12-il sena ‘l fuq li jsofru minn aċċessjonijiet parzjali talbidu u li ma rrispondewx għal kuri oħrajn.
English: What is the risk associated with Fycompa?
Maltese: X'inhu r-riskju assoċjat ma' Fycompa?
English: In these studies, Fycompa was given at a dose of 2, 4, 8 or 12 mg per day for up to 19 weeks.
Maltese: F'dawn l-istudji Fycompa ngħata f'dożi ta' 2, 4, 8 jew 12 mg kuljum sa 19-il ġimgħa.
English: Why has Fycompa been approved?
Maltese: Għaliex ġie approvat Fycompa?
English: The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg.
Maltese: It-tielet studju wera tnaqqis sinifikanti filfrekwenza tal-aċċessjonijiet f'pazjenti li ngħataw Fycompa f'dożi ta' 4 mg u 8 mg biss iżda mhux f'pazjenti li ngħataw doża ta' 2 mg.
English: Fycompa at doses from 4 mg to 12 mg was shown to be more effective than placebo in reducing the frequency of epileptic seizures.
Maltese: Intwera li l-għoti ta' Fycompa f'dożi bejn 4 mg sa 12 mg kien iżjed effikaċi mill-plaċebo fit-tnaqqis talfrekwenza tal-aċċessjonijiet epilettiċi.
English: How has Fycompa been studied?
Maltese: Kif ġie studjat Fycompa?
English: The most common side effects with Fycompa (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Maltese: L-effetti sekondarji l-aktar komuni bi Fycompa (li dehru f'aktar minn pazjent 1 minn 10) huma sturdament u l-ħedla (ngħas).
English: Fycompa is used to treat adults and children from 12 years of age with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Maltese: Fycompa jintuża fil-kura ta' adulti u tfal minn 12-il sena 'l fuq li jbatu minn aċċessjonijiet parzjali talbidu (attakki ta' epilessija) b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: All patients were also taking other antiepileptic medicines.
Maltese: Il-pazjenti kollha kienu qed jieħdu mediċini antiepilettiċi oħrajn.
English: The recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg/day to a maximum dose of 12 mg per day.
Maltese: Id-doża rakkomandata fil-bidu tal-kura hija 2 mg kuljum, u jekk din tiġi ttollerata sewwa t-tabib jista' jżidha bil-mod il-mod b'żidiet ta' 2 mg kuljum sa doża massima ta' 12 mg kuljum.
English: This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħalma huma movimenti għallgħarrieda, mimlija skossi ta' naħa waħda tal-ġisem, sens ta' smigħ, xamm jew viżta mhux ċari, tgħarix jew sens ta' biża' għall-għarrieda.
English: Glutamate is the main stimulatory neurotransmitter in nerve cells which can trigger and maintain seizures.
Maltese: Il-glutamat huwa n-newrotrasmettitur ta' stimulazzjoni prinċipali fiċ-ċelloli tan-nervituri li jista' jikkawża u jmantni l-aċċessjonijiet.
English: Secondary generalisation occurs when the excessive electrical activity subsequently reaches the whole brain.
Maltese: Il-ġeneralizzazzjoni sekondarja sseħħ meta l-attività elettrika eċċessiva sussegwentement tilħaq il-moħħ kollu.
English: The main measure of effectiveness was the percentage of patients who experienced at least a 50% decrease in seizure frequency.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-perċentwal ta' pazjenti li esperjenzaw tal-inqas tnaqqis ta' 50% fil-frekwenza talaċċessjonijiet.
English: Adults (18 to ≤ 65 years of age)
Maltese: Adulti (bejn 18 u ≤65 sena)
English: Rare: oedema peripheral
Maltese: Rari: edema periferali
English: Age group ≥75 years
Maltese: Grupp ta' età ≥75 sena
English: 95% Confidence Interval
Maltese: 95% Intervall talKunfidenza
English: corresponding to a potency of ≤ 460 ng ED50
Maltese: ≤ 460 ng ED50
English: <{MM/YYYY}>
Maltese: {numru}
English: Group B: HAVRIX + Placebo
Maltese: Grupp B: HAVRIX + Plaċebo
English: ATC code: J07BA02
Maltese: J07BA02
English: Total Study Population Age group >65 - <75years
Maltese: Popolazzjoni tal-Istudju Totali Grupp ta' età >65 - <75sena
English: IXIARO Day 0, 28
Maltese: IXIARO Jum 0, 28
English: Frequency of adverse reactions(%) by dose/age
Maltese: Frekwenza ta' reazzjonijiet avversi (%) skont id-doża/età
English: 0.5 ml N=628 3 to <18 years
Maltese: 0.5 ml N=628 3 snin sa <18-il sena
English: IXIARO contains potassium and sodium
Maltese: IXIARO fih potassium u sodium
English: 96% of subjects (64/67) still had protective antibody levels (PRNT50≥1:10), with a GMT of 148 (95%CI: 107; 207).
Maltese: 96% tal-individwi (64/67) kien għad kellhom livelli ta' antikorpi protettivi (PRNT50≥1:10), b'GMT ta' 148 (95%CI: 107; 207).
English: Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna Austria
Maltese: Valneva Austria GmbH Campus Vienna Biocenter 3 A-1030 Vienna
English: 1 dose (0.5 ml) of IXIARO contains:
Maltese: Doża (0.5 ml) ta' IXIARO fiha:
English: Oakbank Park Road, Livingston EH53 0TG, Scotland, United Kingdom
Maltese: Oakbank Park Road Livingston EH53 0TG Ir-Renju Unit
English: Group C: IXIARO + HAVRIX 1440
Maltese: IXIARO + HAVRIX 1440
English: Booster immunisation (adults)
Maltese: Immunizzazzjoni booster (adulti)
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]).
Maltese: Il-profil ta' sigurta ta' IXIARO kien imqabbel ma' vaċċini ta' Havrix bħala kontroll (tilqima kontra l-Epatite A, formulazzjoni pedjatrika 720 EL.U./0.5 ml) u Prevenar (Tilqima Konjugata kontra l-Pnewmokokki - 7 valenti) [proteina CRM 197 tad-Difterite].
English: IXIARO Day 0,28
Maltese: IXIARO Jum 0,28
English: Seroconversion rate
Maltese: Rata ta' Serokonverżjoni
English: Concomitant use (adults)
Maltese: Użu simultanju (adulti)
English: Conventional Schedule (N)
Maltese: Skeda Konvenzjonali (N)
English: Common: ≥ 1/100 to < 1/10
Maltese: Komuni: ≥ 1/100 sa < 1/10
English: Immunogenicity data were evaluated in 64 subjects.
Maltese: Id-dejta tal-immunoġeniċità ġiet evalwata f'64 individwu.
English: Geometric Mean Titer (N)
Maltese: Titer Ġeometriku Medju (N)
English: Longterm immunogenicity data were evaluated in 23 children, mean age 14.3 years, range 3 - 18 years).
Maltese: Id-dejta dwar limmunioġeniċità ġiet evalwata fi 23 tifel u tifla, età medja ta' 14.3 snin, firxa 3-18-il sena).
English: 2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al3+) 3 Antigen Units
Maltese: 2 assorbit fuq aluminium hydroxide, idratat (madwar 0.25 milligrammi Al3+)
English: Visit 0 (Screening) Visit 3 (Day 28) Visit 4 (Day 56)
Maltese: Żjara 0 (Skrining) Żjara 3 (Jum 28) Żjara 4 (Jum 56)
English: Booster dose 12 months after primary immunization N = 149
Maltese: Doża booster 12-il xahar wara l-immunizzazzjoni primarja N = 149
English: Day 21
Maltese: Jum 21
English: 0.25 ml N=783 2 months to <3 years
Maltese: 0.25 ml N=783 Xahrejn sa <3 snin
English: IXIARO Dose
Maltese: Doża tal
English: Na2HPO4 - 0.795 mg/mL
Maltese: NaCl - 9mg/mL KH2PO4 - 0.144 mg/mL Na2HPO4 - 0.795 mg/mL
English: GMT (plaque reduction neutralization test)
Maltese: GMT (test tan-newtralizzazzjoni tat-tnaqqis tal-plakka)
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.
Maltese: Fix-xahar 24, 48.3% (95% CI: 39.4, 57.3, N=116) ta' individwi li lestew l-immunizzazzjoni primarja rrakkomandata xorta waħda kellhom PRNT50 titrii ta' ≥1:10.
English: Seroprotection Rate (Rate of subjects with PRNT50≥1:10) % (n/N)
Maltese: Rata ta' Seroprotezzjoni (Rata ta' individwi bil-PRNT50≥1:10) % (n/N)
English: n.a. = not available
Maltese: n.a. = mhux disponibbli
English: Cardiac disorders Rare: palpitations, tachycardia
Maltese: Rari: palpitazzjonijiet, takikardija
English: Sodium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Water for injections
Maltese: Sodium chloride Potassium dihydrogen phosphate Disodium hydrogen phosphate Ilma għall-injezzjonijiet
English: Conventional Schedule % (n/N)
Maltese: Skeda Konvenzjonali % (n/N)
English: Seroprotection Rate % (n/N)
Maltese: Rata ta' Seroprotezzjoni % (n/N)
English: Day 0 Day 14
Maltese: Jum 0 Jum 14
English: Table 9:
Maltese: Tabella 9:
English: Uncommon: ≥1/1,000 to < 1/100 Rare: ≥1/10,000 to < 1/1,000
Maltese: Mhux komuni: ≥1/1,000 sa < 1/100 Rari:
English: Geometric Mean Titer (plaque reduction neutralization test) GMT [95%CI]
Maltese: (test ta' newtralizzazzjoni tat-tnaqqis tal-plakka) GMT [95%CI]
English: Pre-booster, Day 0 (n=198) Day 28 (n=198) Month 6 (n=197) Month 12 (n=194)
Maltese: Xahar 6 (n=197) Xahar 12 (n=194)
English: Antibody persistence (adults)
Maltese: Persistenza tal-antikorpi (adulti)
English: Uncommon: cough
Maltese: Mhux komuni: sogħla
English: Geometric Mean Titer
Maltese: Titer Ġeometriku Medju
English: Without Booster N = 150
Maltese: N = 150
English: Paediatric Population Children and adolescents from 3 years to < 18 years of age
Maltese: Popolazzjoni Pedjatrika Tfal u adolexxenti b'età minn 3 snin sa < 18-il sena
English: Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl - 9mg/mL
Maltese: Soluzzjoni ta' Phosphate Buffered Saline 0.0067 M (f'PO4) għandha l-kompożizzjoni ta' soluzzjoni ta' saline kif ġej:
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).
Maltese: L-immunoġeniċità tad-dożi booster kienu assessjati wkoll fl-istudju li jinvestiga l-persistenza tal-immunità wara reġimi ta' immunizzazzjoni primarja differenti (2x6 mcg: N=116, 1x12 mcg; N=116 jew 1x6
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.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għar-residwi protamine sulphate, formaldehyde, bovine serum albumin, DNA taċ-ċellula ospita,
English: The immune responses elicited by IXIARO are presented in Table 10.
Maltese: Ir-risponsi immuni kkawżati minn IXIARO huma preżentati f'Tabella 10.
English: Rapid schedule Persons aged 18 to ≤ 65 years can be vaccinated in a rapid schedule as follows:
Maltese: Il-persuni li għandhom bejn 18 u ≤65 sena jistgħu jitlaqqmu fi skeda rapida kif ġej:
English: Time point after primary immunization
Maltese: Punt ta' żmien wara l immunizzazzjoni primarja
English: IXIARO will not protect against encephalitis caused by other micro-organisms.
Maltese: IXIARO ma jipproteġix kontra enċefalite kkawżata minn mikro-organiżmi oħra.
English: 0.5 ml of suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer).
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'tapp planġer (chlorobutyl elastomer).
English: Date of first authorisation: 31 March 2009 Date of latest renewal: 22 November 2018
Maltese: 31ta' Marzu 2009 Data tal-aħħar tiġdid: 28 ta' Frar 2014
English: Elderly (>65 years of age)
Maltese: Anzjani (> 65 sena)
English: Blank white foil without any printed information.
Maltese: Folja bajda vojta mingħajr ebda informazzjoni stampata.
English: 1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3
Maltese: Doża waħda (0.5 ml) ta' IXIARO fiha: virus tal-enċefalite Ġappuniża tar-razza SA14-14-2 (inattivat)1,2
English: Rapid Schedule (N)
Maltese: Skeda Rapida (N)
English: Rapid Schedule % (n/N)
Maltese: Skeda Rapida % (n/N)
English: Phosphate buffered saline consisting of:
Maltese: Phosphate buffered saline li jikkonsisti minn:
English: Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions.
Maltese: Madwar 40% tal-individwi ttrattati esperjenzaw reazzjonijiet avversi sistemiċi u madwar 54% esperjenzaw reazzjonijiet avversi fis-sit tal-injezzjoni.
English: Booster following recommended primary immunization (2x6 mcg) Booster at Month 11 Booster at Month 23
Maltese: Booster wara limmunizzazzjoni primarja rrakkomandata (2x6 mcg) Booster fil-11-il Xahar
English: Rates of subjects with PRNT50≥1:10 were 82.8% (95% CI: 74.9, 88.6, N=116) at Month 6 and 58.3% at Month 12 (95% CI: 49.1, 66.9, N=115).
Maltese: 6 N=116) fix-Xahar 6 u 58.3% fix-Xahar 12 (95% CI: 49.1, 66.9, N=115).
English: Non-clinical toxicity data are limited.
Maltese: Informazzjoni mhux klinika dwar l-effett tossiku hija limitata.
English: Month 36
Maltese: Jum 56
English: GMT in these subjects was 16.2 (95% CI: 13.8, 19.0) at Month 24.
Maltese: GMT f'dawn l-indiwidwi kienu 16.2 (95% CI: 13.8, 19.0) fix-Xahar 24.
English: Concomitant administration of IXIARO with inactivated hepatitis A virus (HAV) vaccine (HAVRIX 1440) The concomitant use of IXIARO with inactivated hepatitis A virus (HAV) vaccine (HAVRIX 1440) has been explored in one clinical trial.
Maltese: L-użu simultanju ta' IXIARO ma' vaċċin tal-virus inattivat tal-epatite A (HAV) (HAVRIX 1440) ġie esplorat fi prova klinika waħda.
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+).
Maltese: 6 AU (Unità antiġen, li jikkorrispondi għal qawwa ta' ≤ 460 ng ED50) ta' virus inattivat tal-enċefalite Ġappuniża tar-razza SA14-14-2 (prodott f'ċelloli Vero) assorbit fuq aluminium hydroxide, idrat (madwar
English: Data are limited but there were no differences in the safety profile between the 0.25 ml and the 0.5 ml dose in this age group.
Maltese: Dejta hija limitata imma ma kienx hemm differenzi fil-profil tas-sigurtà bejn id-doża ta' 0.25 ml u dik ta' 0.5 ml f'dan il-grupp ta' etajiet.
English: Age Group ≥3 to <18 years
Maltese: Grupp t'Età ta' ≥3 sa <18-il sena
English: After immunisation with the rapid schedule a seroconversion rate of 99% has been observed 7 days after the second i.m.
Maltese: Wara l-immunizzazzjoni bl-iskeda rapida, 7 ijiem wara t-tieni tilqima i.m., ġiet osservata rata ta' serokonverżjoni ta' 99%.
English: IXIARO is a suspension for injection (0.5 ml in a glass syringe with or without a separate needle, pack size of 1).
Maltese: IXIARO huwa suspensjoni għal injezzjoni (0.5 ml f'siringa tal-ħġieġ bi jew mingħajr labra separata, pakkett ta' 1).
English: Seroprotection rate (SPR) defined as neutralizing antibody titer ≥1:10 and geometric mean titers (GMT) are presented in Table 11.
Maltese: Ir-rata ta' seroprotezzjoni (SPR) definita bħala titer ta' antikorp newtralizzanti ≥1:10 u titers medji ġeometriċi (GMT) huma ppreżentati fit-Tabella 11.
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
Maltese: Komuni ħafna: deni (28.9%), dijarea (11.8 %), marda tixbaħ lill-influwenza (11.2 %), irritabilità (11.0 %) Komuni: telf t'aptit, rimettar, raxx tal-ġilda
English: Time Point
Maltese: Punt ta'
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'.
Maltese: Din il-mediċina fiha potassium, anqas minn 1 mmol (39 mg) għal kull dożaġġ wieħed ta' 0.5 ml jiġifieri, essenzjalment “mingħajr potassium” u anqas minn 1 mmol sodium (23 mg) għal kull dożaġġ wieħed ta' 0.5 ml, jiġifieri essenzjalment “mingħajr sodium”.
English: The other ingredients are: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections
Maltese: Sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate,
English: Very common: ≥ 1/10
Maltese: Komuni ħafna: ≥ 1/10
English: Children and adolescents aged ≥ 3 to < 18 years received two vaccine doses of 0.5ml and children aged ≥ 2 months to < 3 years received two vaccine doses of 0.25ml on Day 0 and Day 28 by intramuscular injection.
Maltese: Tfal u adolexxenti b'età minn ≥ 3 sa 18-il sena rċevew żewġ dożi ta' tilqima ta' 0.5 ml u tfal b'età minn ≥ xahrejn sa < 3 snin irċevew żewġ dożi ta' tilqima ta' 0.25 ml f'Jum 0 u Jum 28 permezz ta' injezzjoni fil-muskoli.
English: Japanese encephalitis virus strain SA14-14-2 (inactivated)1,2 6 AU3 corresponding to a potency of ≤ 460 ng ED50
Maltese: Virus tal-enċefalite Ġappuniża tar-razza SA14-14-2 (inattivat)1,2 6 AU3
English: The SPRs and GMTs are displayed in Table 13.
Maltese: L-SPRs u lGMTs huma murija f'Tabella 13.
English: Other medicines and IXIARO
Maltese: Mediċini oħra u IXIARO
English: Vaccination schedules: IXIARO: Day 0/28, Rabipur: Day 0/7/28.
Maltese: Jum 0/28, Rabipur:
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).
Maltese: L-effett tal-età fuq ir-rispons immuni għal IXIARO u JE-VAX ġie vvalutat bħala punt ta' tmiem sekondarju f'dan l-istudju kkontrollat b'mod attiv, li qabbel individwi li għandhom aktar minn 50 sena (N=262, età medja 59.8) ma' dawk ta' inqas minn 50 sena (N=605, età medja 33.9).
English: 1 produced in Vero cells
Maltese: 1 prodott f'ċelloli Vero
English: IXIARO suspension for injection Japanese encephalitis vaccine Intramuscular (IM) use
Maltese: IXIARO suspensjoni għall-injezzjoni Vaċċin tal-enċefalite Ġappuniża (inattivat, assorbit)
English: IXIARO Day 0,7 Rabipur Day 0,3,7
Maltese: IXIARO Jum0,7 Rabipur Jum
English: After 0.5 mL Dose Primary Immunization
Maltese: Wara 0.5 mL Doża talImmunizzazzjoni Primarja
English: JEV neutralizing antibodies were determined 42 days after the second dose of the primary series (Day 70).
Maltese: L-antikorpi newtralizzanti JEV kienu ddeterminati 42 jum wara t-tieni doża tas-serje primarja (Jum 70).
English: Nervous system disorders Very common: headache Uncommon: migraine, dizziness Rare: paraesthesia, neuritis, dysgeusia, syncope*
Maltese: Mhux komuni: emikranja, sturdament Rari: parestesija, newrite, disgewżja, sinkope* Disturbi fl-għajnejn
English: GMT increased by Day 56 to 243.6 for IXIARO and to 102.0 for JE VAX, respectively.
Maltese: 93.8% għal IXIARO u JE-VAX, rispettivament). Sa Jum 56 il-GMT kienu żdiedu għal 243.6 għal IXIARO u għal 102.0 għal JE-VAX, rispettivament.
English: Rate of subjects with PRNT50≥1:10
Maltese: Rata ta' individwi bi PRNT50≥1:10
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi Muskolu-Skeletriċi u tat-Tessuti Konnettivi
English: Pivotal immunogenicity trial (adults)
Maltese: Prova pivitali dwar l-immunoġeniċità (adulti)
English: Table 11: Seroprotection Rates and Geometric Mean Titers with and without a booster of IXIARO at Month 12, 13, 24 and 36, Intent To Treat Population
Maltese: Tabella 11: Ir-Rati ta' Seroprotezzjoni u t-Titers Medji Ġeometriċi bi u mingħajr booster ta' IXIARO f'Xahar 12, 13, 24 u 36, Popolazzjoni b'Intenzjoni li Tiġi Kkurata
English: Japanese encephalitis vaccine (inactivated, adsorbed)
Maltese: Vaċċin tal-enċefalite Ġappuniża (inattivat, assorbit)
English: n.a. 95% Confidence Interval could not be established (single-subject data)
Maltese: 136 [n.a.] n.a. 95% Intervall ta' Kunfidenza ma setax jiġi stabbilit (dejta dwar suġġett wieħed)
English: No interference was observed with regards to geometric mean titer (GMT) and seroconversion rates for anti JEV neutralizing antibodies (Table 8).
Maltese: Ma ġiet osservata l-ebda interferenza fir-rigward tat-titrazzjoni ġeometrika medja (GMT) u r-rati ta' serokonverżjoni għal antikorpi newtralizzati kontra l-JEV (Tabella 8).
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)
Maltese: Tabella 4: Rati ta' individwi bi PRNT50≥1:10 u GMT qabel u fix-xhur 1, 6 u 12 wara doża waħda booster ta' 6 mcg (0.5 ml) mogħtija lill-individwi fix-xahar 15 wara immunizzazzjoni primarja rrakkomandata bi IXIARO (popolazzjoni ITT)
English: 6 months<12 months
Maltese: 3 snin< 12-il sena
English: IXIARO is used to prevent infection with the Japanese encephalitis virus (JEV).
Maltese: IXIARO jintuża biex jipprevjeni infezzjoni bil-virus tal-enċefalite Ġappuniża (JEV - Japanese encephalitis virus).
English: Phosphate buffered solution consisting of sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate and water for injections.
Maltese: Soluzzjoni bafferjata bil-phosphate li tikkonsisti minn sodium chloride, potassium dihydrogen phosphate, disodium hydrogen phosphate u ilma għall-injezzjonijiet.