FrancophonIA/ELRC3.0 huggingface dataset:
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Ingelvac MycoFLEX and administered at one injection site.
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni Dejta disponibbli dwar il-kwalità, is-sigurtà u l-effikaċja turi li din it-tilqima tista' titħallat ma' Ingelvac MycoFLEX u tingħata f'sit wieħed tal-injezzjoni.
English: Each vial is closed with a chlorobutyl stopper and lacquered aluminium seal.
Maltese: Kull flixkun huwa magħluq b'tapp tal-chlorobutyl u siġill tal-aluminju lacquered.
English: - After the transfer of the full content of Ingelvac PCV FLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac PCV FLEX.
Maltese: - Wara t-trasferiment tal-kontenut kollu ta' Ingelvac PCV FLEX, aqla' u armi l-labra tat trasferiment u battal il-flixkun vojt tat-tilqima Ingelvac PCV FLEX.
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07
Maltese: Immunoloġiċi għal suidae, tilqim virali inattivat għall-qżieqeż Kodici ATC veterinarja:
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġika maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
Maltese: Waqt it-tilqim, luniformità tat-taħlita kkulurita għandha tiġi mmonitorjata u tinżamm permezz ta' aġitazzjoni kontinwa.
English: - Transfer the Ingelvac PCV FLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Maltese: - Ittrasferixxi t-tilqima Ingelvac PCV FLEX ġol-flixkun tat-tilqima ta' Ingelvac MycoFLEX.
English: Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight.
Maltese: Agħti doża waħda b'injezzjoni (2 ml) tat-taħlita ġol-muskoli lil kull qażquż, irrispettivament mill-piż tal-ġisem.
English: EU Number
Maltese: Numru ta'l-EU
English: 20 mg/g Transdermal ointment
Maltese: 20 mg/g Ingwent transdermali
English: Cats Transdermal use Tube (Alu) 5 g
Maltese: Tubu (Alu) 5 g tubu wieħed
English: Invented name
Maltese: Konten ut
English: 1 tube Not applicable
Maltese: Mhux applikabbli
English: Additional side effects in adults:
Maltese: Effetti sekondarji addizzjonali f'adulti:
English: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile France
Maltese: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Franza
English: EU/1/18/1338/001 EU/1/18/1338/002 EU/1/18/1338/003 EU/1/18/1338/004
Maltese: UE/1/18/1338/001 UE/1/18/1338/002 UE/1/18/1338/003 UE/1/18/1338/004
English: CI: confidence interval.
Maltese: CI: intervall ta' kunfidenza.
English: * Adverse reactions from spontaneous reporting.
Maltese: * Reazzjonijiet avversi minn rappurtar spontanju.
English: CYD22: Vietnam; CYD28: Singapore; CYD47: India;
Maltese: Il-Vjetnam; CYD28: Singapore;
English: CYD28: Low endemic country
Maltese: CYD28: Pajjiż endemiku baxx
English: Study N
Maltese: Studju N
English: Symptoms usually last for 2 to 7 days.
Maltese: Is-sintomi normalment idumu jumejn sa 7 ijiem.
English: Dengvaxia.
Maltese: dengue.
English: More information on dengue and vaccination QR Code to be included + http://qr.sanofi.com/dengvaxia
Maltese: Aktar informazzjoni dwar dengue u tilqim Kodiċi QR li għandu jiġi inkluż + http://qr.sanofi.com/dengvaxia
English: Powder: essential amino acids including Phenylalanine, non-essential amino acids, Arginine hydrochloride, sucrose, Trehalose dihydrate, Sorbitol, trometamol, urea.
Maltese: Trab: amminoaċidi essenzjali inkluż Phenylalanine, amminoaċidi mhux essenzjali, Arginine hydrochloride, sucrose, Trehalose dihydrate, Sorbitol, trometamol, urea.
English: Allergic including anaphylactic reactions*
Maltese: Reazzjonijiet allerġiċi inkluż anafilattiċi*
English: Sanofi Pasteur 14 Espace Henry Vallée 69007 Lyon France
Maltese: Sanofi Pasteur 14 Espace Henry Vallée 69007 Lyon Franza
English: Essential amino acids including Phenylalanine Non-essential amino acids Arginine hydrochloride Sucrose
Maltese: Amminoaċidi essenzjali inkluż Phenylalanine Amminoaċidi mhux essenzjali Arginine hydrochloride Sucrose
English: Sanofi-aventis AEBE Τηλ.+30 210 900 16 00
Maltese: Ελλάδα anofi-aventis AEBE Τηλ.+30 210 900 16 00
English: CYD15: Brazil, Colombia, Honduras, Mexico, Puerto Rico.
Maltese: CYD15: Il-Brażil, il-Kolombja, il-Honduras, il-Messiku, Puerto Rico.
English: Common: ≥ 1/100 to < 1/10
Maltese: Komuni: ≥1/100 sa <1/10
English: The adverse reactions were usually mild to moderate in severity and of short duration (0 to 3 days).
Maltese: Ir-reazzjonijiet avversi normalment kienu ħfief sa moderati fis-severità u ta' durata qasira (0 sa 3 ijiem).
English: Pack size of 5.
Maltese: Daqs tal-pakkett ta' 5.
English: Very rare: (<1/10 000)
Maltese: Rari ħafna: (<1/10,000)
English: Slovenija sanofi-aventis d.o.o.
Maltese: Slovenija sanofi-aventis d.o.o. Tel.:
English: 3.3 Long-term persistence of antibodies
Maltese: 3.3. Persistenza fit-tul tal-antikorpi
English: Protect from light.
Maltese: Protezzjoni fit-tul
English: Chimeric yellow fever dengue virus serotype 1 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 2 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 3 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose** Chimeric yellow fever dengue virus serotype 4 (live, attenuated)* ............ 4.5 - 6.0 log10 CCID50/dose**
Maltese: Virus tad-deni dengue kimeriku isfar serotip 1 (ħaj, attenwat)* ................... 4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 2 (ħaj, attenwat)* ................... 4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 3 (ħaj, attenwat)* ................... 4.5-6.0 log10 CCID50/doża** Virus tad-deni dengue kimeriku isfar serotip 4 (ħaj, attenwat)* ................... 4.5-6.0 log10 CCID50/doża**
English: Most of the subjects were 9 to 17 years of age (n= 2810).
Maltese: Ħafna mill-individwi kienu ta' età ta' 9 sa 17-il sena (n=2,810).
English: The same information is also available on the following URL: http://qr.sanofi.com/dengvaxia
Maltese: L-istess informazzjoni hija disponibbli fil-URL li ġej: http://qr.sanofi.com/dengvaxia
English: • The other ingredients are: essential amino acids including Phenylalanine, non-essential amino acids, Arginine hydrochloride, Sucrose, Trehalose dihydrate, Sorbitol (E420), trometamol, urea, sodium chloride, water for injections.
Maltese: • Is-sustanzi mhux attivi l-oħra huma: amminoaċidi essenzjali inkluż Phenylalanine, amminoaċidi mhux essenzjali, Arginine hydrochloride, Sucrose, Trehalose dihydrate, Sorbitol (E420), trometamol, urea, sodium chloride, ilma għall-injezzjonijiet.
English: Postinjection 3 GMT (95%CI)
Maltese: GMT wara injezzjoni 3 (95% CI)
English: *Produced in Vero cells by recombinant DNA technology.
Maltese: * Prodott f'ċelluli Vero permezz ta' teknoloġija rikombinanti tad-DNA.
English: SANOFI PASTEUR NVL 31-33 Quai Armand Barbès 69250 Neuville-sur-Saône France
Maltese: Sanofi Pasteur NVL 31-33 quai Armand Barbès 69250
English: The vaccine efficacy against symptomatic VCD is moderate for serotypes 1 and 2 and higher for serotypes 3 and 4 (see Table 4).
Maltese: L-effikaċja tal-vaċċin kontra VCD sintomatika hija moderata għal serotipi 1 u 2 u hija ogħla għal serotipi 3 u 4 (ara Tabella 4).
English: • muscle pain (myalgia)
Maltese: • uġigħ fil-muskoli (mijalġija)
English: Efficacy in subjects 9 to 11 years of age was assessed in 1554 subjects (1032 in vaccine group and 522 in Control Group).
Maltese: L-effikaċja f'individwi ta' età ta' 9 sa 11-il sena ġiet ivvalutata f'1,554 individwu (1,032 fi grupp tal-vaċċin u 522 fil-Grupp ta' Kontroll).
English: CYD14: Indonesia, Malaysia, the Philippines, Thailand, Vietnam.
Maltese: L-Indoneżja, il-Malażja, il-Filippini, it-Tajlandja, il-Vjetnam.
English: SANOFI PASTEUR Parc Industriel d'Incarville 27100 Val de Reuil France
Maltese: Sanofi Pasteur Parc Industriel d'Incarville 27100
English: In subjects 9 to 45 years of age, the most frequently reported reactions whatever the dengue serostatus prior to vaccination, were headache (54%), injection site pain (49%), malaise (44%), myalgia (43%), asthenia (34%), and fever (16%).
Maltese: F'individwi ta' età ta' 9 sa 45 sena, ir-reazzjonijiet irrappurtati bl-aktar mod frekwenti irrispettivament mis-serostatus ta' dengue qabel it-tilqim, kienu uġigħ ta' ras (54%), uġigħ fis-sit tal-injezzjoni (49%), telqa (44%), mijalġija (43%), astenija (34%), u deni (16%).
English: This product contains genetically modified organisms (GMOs).
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (GMOs).
English: Sanofi-aventis AEBE
Maltese: Ελλάδα anofi-aventis AEBE
English: Uncommon: ≥ 1/1000 to < 1/100 Rare: ≥ 1/10 000 to < 1/1000
Maltese: Mhux komuni: ≥1/1,000 sa <1/100 Rari:
English: Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas (see sections 4.2, 4.4 and 4.8).
Maltese: Dengvaxia huwa indikat għall-prevenzjoni ta' marda ta' dengue kkawżata minn virus dengue tas-serotipi 1, 2, 3 u 4 f'individwi ta' età ta' 9 sa 45 sena b'infezzjoni preċedenti tal-virus dengue dokumentata u li jgħixu f'żoni endemiċi (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 Doses - 2.5 mL
Maltese: Dożi - 2.5 mL
English: Preinjection 1 GMT (95%CI)
Maltese: GMT qabel injezzjoni 1 (95% CI)
English: Clinically severe VCD cases†
Maltese: klinikament severa†
English: Other medicines and Dengvaxia
Maltese: Mediċini oħra u Dengvaxia
English: Children and adults 9 to 45 years of age
Maltese: Tfal u adulti ta' età ta' 9 sa 45 sena
English: VE % (95%CI)
Maltese: (95% CI)
English: Ελλάδα
Maltese: Tifqigħat
English: The reactogenicity subset in subjects below 9 years of age includes 2960 subjects as follows: 1287 subjects below 2 years of age, 905 subjects between 2 and 5 years of age and 768 subjects between 6 and 8 years of age.
Maltese: Is-subsett tar-reattoġeniċità f'individwi taħt l-età ta' 9 snin jinkludi 2,960 individwu kif ġej: 1,287 individwu taħt l-età ta' sentejn, 905 individwi bejn l-età ta' sentejn u 5 snin u 768 individwu bejn l-età ta' 6 u 8 snin.
English: Dengvaxia is available in packs of 1 or 10.
Maltese: Dengvaxia jiġi f'pakketti ta' 1 jew 10.
English: In paediatric population, fever has been observed with a higher frequency (very common) than in adults (common).
Maltese: Fil-popolazzjoni pedjatrika, id-deni ġie osservat bi frekwenza ogħla (komuni ħafna) milli fl-adulti (komuni).
English: Use a sterile syringe and needle for the transfer of the solvent.
Maltese: Uża siringa sterili u labra għat-trasferiment tas-solvent.
English: Solvent: sodium chloride (0.4%), water for injections.
Maltese: Solvent: sodium chloride (0.4%), ilma għall-injezzjonijiet.
English: • Individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
Maltese: • Individwi b'infezzjoni tal-HIV sintomatika jew b'infezzjoni tal-HIV asintomatika meta tiġi akkumpanjata minn evidenza ta' funzjoni immuni indebolita.
English: The clinical efficacy of Dengvaxia was assessed in 3 studies: one supportive Phase IIb efficacy study (CYD23) in Thailand, and 2 pivotal large-scale Phase III efficacy studies, CYD14 in Asia (Indonesia, Malaysia, the Philippines, Thailand, Vietnam) and CYD15 in Latin America (Brazil, Colombia, Honduras, Mexico, Puerto Rico).
Maltese: III ta' skala kbira pivotali, CYD14 fl-Asja (l-Indoneżja, il-Malażja, il-Filippini, it-Tajlandja, il-Vjetnam) u CYD15 fl-Amerika Latina (il-Brażil, il-Kolombja, il-Honduras, il-Messiku, Puerto Rico).
English: Prior to launch of Dengvaxia in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Tqegħid fis-Suq (MAH) għandu jaqbel mal-kontenut u l-format tal-programm edukattiv, inkluż il mezzi ta' komunikazzjoni, il-modi ta' distribuzzjoni u kwalunkwe aspetti oħra tal-programm, malAwtoritajiet Nazzjonali Kompetenti.
English: At the start of the CYD14 and CYD15 trials, dengue seroprevalence for the overall population at the trial sites ranged from 52.8%-81.1% in CYD14 (Asia-Pacific) and 55.7%-92.7% in CYD15 (Latin America).
Maltese: Fil-bidu tal-provi CYD14 u CYD15, is-seroprevalenza ta' dengue għall-popolazzjoni globali fis-siti tal-provi varjat minn 52.8 %-81.1 % f'CYD14 (Asja-Paċifiku) u 55.7 %-92.7 % f'CYD15 (Amerika Latina).
English: CYD14 485 CYD15 1048
Maltese: CYD14 485
English: Additional side effects in children and adolescents (from 9 to and including 17 years of age): Uncommon: (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji addizzjonali fi tfal u adolexxenti (minn età ta' 9 sa u inkluż 17-il sena): Mhux komuni: (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: Solvent: sodium chloride (0.9%), water for injections.
Maltese: Solvent: sodium chloride (0.9%), ilma għall-injezzjonijiet.
English: SN NN
Maltese: SN
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 Dose - 0.5 mL
Maltese: Doża 1 - 0.5 mL
English: • Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskji (RMP)
English: Very common: ≥ 1/10
Maltese: Komuni ħafna: ≥1/10
English: Table 6: Immunogenicity for dengue seropositive subjects 9 to 16 years of age in CYD14 and CYD15 from endemic areas
Maltese: Tabella 6: Immunoġeniċità għal individwi seropożittivi għal dengue ta' età ta' 9 sa 16-il sena f'CYD14 u CYD15 minn żoni endemiċi
English: Control group
Maltese: Grupp ta' kontroll
English: Paediatric data in subjects 9 to 17 years of age
Maltese: Dejta pedjatrika f'individwi ta' età ta' 9 sa 17-il sena
English: Cases / personyears VE % (95%CI)
Maltese: Każijiet/snin ta' persuna VE % (95% CI)
English: • There is visible evidence of contamination, such as a change in appearance.
Maltese: • Hemm evidenza viżibbli ta' kontaminazzjoni, bħal bidla fid-dehra.
English: **CCID50: 50% Cell Culture Infectious Dose.
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (genetically modified organisms, GMOs). ** CCID50: 50 % Doża Infettiva tal-Koltura taċ-Ċelluli.
English: Serotype 1
Maltese: Serotip 1
English: Symptomatic VCD Any serotype
Maltese: VCD sintomatika
English: Do not administer by intravascular injection.
Maltese: Tagħtix permezz ta' injezzjoni intravaskulari.
English: Over a period of 6 years, in subjects with no previous dengue infection, the risk of severe dengue is increased by 2.41 fold (95% CI: 0.50; 11.75) in subjects 9 to 16 years of age vaccinated with Dengvaxia as compared to non-vaccinated subjects in the same age group.
Maltese: Matul perjodu ta' 6 snin, f'individwi li ma kellhomx infezzjoni dengue preċedenti, ir-riskju ta' dengue sever jiżdied bi 2.41 drabi (95% CI: 0.50; 11.75) f'individwi ta' età ta' 9 sa 16-il sena mlaqqma b'Dengvaxia meta mqabbla ma' individwi mhux imlaqqma fl-istess grupp tal-etajiet.
English: Severe dengue can give you a high fever and any of the following: severe abdominal (belly) pain, persistent sickness (vomiting), rapid breathing, severe bleeding, bleeding in the stomach, bleeding gums, feeling tired, feeling restless, coma, having fits (seizures) and organ failure.
Maltese: Dengue severa tista' tqabbdek deni għoli u xi waħda minn dawn li ġejjin: uġigħ addominali (ta' żaqq) sever, mard persistenti (rimettar), teħid tan-nifs malajr, fsada severa, fsada fl-istonku, ħanek bi fsada, tħossok għajjien, tħossok bla kwiet, koma, ikollok aċċessjonijiet (attakki ta' puplesija) u insuffiċjenza tal-organi.
English: Path to more information on dengue and vaccination by scanning the QR code included on the outer carton with a smartphone.
Maltese: Mod għal aktar informazzjoni dwar dengue u t-tilqim perezz ta' skennjar tal-kodiċi QR inkluż fuq ilkartuna ta' barra bi smartphone.
English: • Powder (5 doses) in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene) + 2.5 mL of solvent in vial (Type-I glass), with a stopper (halobutyl) and a flip-off cap (aluminium, polypropylene).
Maltese: • Trab (5 dożi) f'kunjett (ħġieġ tat-Tip I), b'tapp (halobutyl) u tapp tat-tip flip-off (aluminju, polypropylene) + 2.5 ml ta' solvent f'kunjett (ħġieġ tat-Tip I), b'tapp (halobutyl) u tapp tat-tip flip-off (aluminju, polypropylene).
English: Efficacy in subjects 9 years of age and older was assessed in 17 230 subjects who received Dengvaxia (3316 subjects in CYD14 and 13914 in CYD15) and 8596 subjects who received placebo (1656 in CYD14 and 6940 in CYD15).
Maltese: L-effikaċja f'individwi ta' età ta' 9 snin jew akbar ġiet ivvalutata fi 17,230 individwu li rċivew Dengvaxia (3,316-il individwu f'CYD14 u 13,914 f'CYD15) u 8,596 individwu li rċivew plaċebo (1,656 f'CYD14 u 6,940 f'CYD15).
English: • Dengue seropositivity if the PRNT50 titre ≥ 10 [1/dil] (the lower limit of quantification,
Maltese: • Seropożittività għal dengue jekk it-titer ta' PRNT50 ≥10 [1/dil] (il-limitu aktar baxx tal kwantifikazzjoni [lower limit of quantification, LLOQ]), kontra tal-inqas serotip wieħed.
English: Among these 5700 subjects, a total of 3104 subjects 9 to 45 years of age from endemic areas received at least one injection of Dengvaxia.
Maltese: Fost dawn il-5,700 individwu, total ta' 3,104 individwi ta' età ta' 9 sa 45 sena minn żoni endemiċi rċivew tal-inqas injezzjoni waħda ta' Dengvaxia.
English: Tabulated list of adverse reactions Adverse reactions are listed according to the following frequency categories:
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-kategoriji tal-frekwenza li ġejjin:
English: Table 2: Adverse reactions from Clinical Studies and reported during commercial use in adults (18 to 45 years old)
Maltese: Tabella 2: Reazzjonijiet avversi minn Studji Kliniċi u rrappurtati waqt l-użu kummerċjali fl-adulti (18 sa 45 sena)
English: Pack size of 5
Maltese: Daqs tal-pakkett ta' 5
English: • had an allergic reaction after using Dengvaxia before.
Maltese: • kellek reazzjoni allerġika wara li użajt Dengvaxia qabel.
English: Myalgia
Maltese: Miġbura
English: In subjects 9 to 16 years of age, the efficacy of Dengvaxia against symptomatic virologicallyconfirmed dengue (VCD) cases due to any of the 4 serotypes was demonstrated in all three studies, CYD14, CYD15 and CYD23 (see Table 3).
Maltese: F'individwi ta' età ta' 9 sa 16-il sena, l-effikaċja ta' Dengvaxia kontra każijiet ta' dengue kkonfermata viroloġikament (VCD) sintomatika minħabba xi wieħed mill-4 serotipi ntweriet fit-tliet studji kollha, CYD14, CYD15 u CYD23 (ara Tabella 3).
English: • swollen glands (lymphadenopathy)
Maltese: • glandoli minfuħin (limfadenopatija)
English: Vaccine Efficacy against symptomatic, severe and hospitalized VCD during the 25-month period after the first injection due to any serotype (pooled CYD14+CYD23), was respectively 42.2% (95% CI: 30.6; 51.8), 45.1% (95% CI: 29.3; 76.7), 47.6% (95% CI: 23.7; 64.0).
Maltese: L-Effikaċja tal-Vaċċin kontra VCD sintomatiku, severa u li teħtieġ dħul fl-isptar matul il-perjodu ta' 25 xahar wara l-ewwel injezzjoni minħabba kwalunkwe serotip (miġbur f'CYD14+CYD23), kienet rispettivament ta' 42.2% (95% CI: 30.6; 51.8), 45.1% (95% CI: 29.3; 76.7), 47.
English: After reconstitution, Dengvaxia is a clear, colourless liquid with the possible presence of white to translucent particles (of endogenous nature).
Maltese: Wara r-rikostituzzjoni, Dengvaxia huwa likwidu ċar, bla kulur bil-preżenza possibbli ta' partikuli bojod għal trasluċenti (ta' natura endoġena).
English: Adverse reactions collected within 28 days after any injection during clinical studies from 9 to 45 years of age, on a reactogenicity subset of 1306 adults and 3067 children, and adverse reactions observed during commercial use are presented in Table 1 for children 9 to 17 years old and in Table 2 for adults 18 to 45 years old.
Maltese: Ir-reazzjonijiet avvversi miġbura fi żmien 28 jum wara kwalunkwe injezzjoni waqt l-istudji kliniċi minn età ta' 9 sa 45 sena, fuq subsett ta' reattoġeniċità ta' 1,306 adulti u 3,067 wild, u r-reazzjonijiet avversi li ġew osservati waqt l-użu kummerċjali huma ppreżentati f'Tabella 1 għal tfal ta' 9 sa 17il sena u f'Tabella 2 għal adulti ta' 18 sa 45 sena.
English: In the Phase IIb study, a total of 4002 subjects aged 4 to 11 years were randomised to receive Dengvaxia or a control, regardless of previous dengue infection.
Maltese: IIb, total ta' 4,002 individwi li kellhom 4 sa 11-il sena ġew randomizzati biex jirċievu Dengvaxia jew kontroll, irrispettivament minn infezjoni ta' dengue preċedenti.
English: * CCID50: 50% Cell Culture Infectious Dose.
Maltese: * CCID50: 50 % Doża Infettiva tal-Koltura taċ-Ċelluli. ** Prodott f'ċelluli Vero permezz ta' teknoloġija rikombinanti tad-DNA.
English: Dengvaxia is provided as a powder in a 5-dose vial and a solvent in a 5-dose vial (2.5 mL).
Maltese: Dengvaxia huwa pprovdut bħala trab f'kunjett ta' 5 dożi u solvent f'kunjett ta' 5 dożi (2.5 ml).
English: During clinical development, immunogenicity data were collected in a total of approximately 5700 subjects 9 months to 60 years of age that received at least one injection of the vaccine.
Maltese: Waqt l-iżvilupp kliniku, inġabret dejta dwar l-immunoġeniċità f'total ta' madwar 5,700 individwu ta' età ta' 9 xhur sa 60 sena li rċivew tal-inqas injezzjoni waħda tal-vaċċin.
English: During a period of 6 years after the first injection, in subjects 9 years of age and above with previous dengue infection, the extrapolated vaccine efficacy (1-Hazard Ratio)*100 (obtained from an exploratory analysis) is estimated at 80 (95% CI: 69; 87) for hospitalized VCD and 84 (95% CI: 61; 94) for severe VCD.
Maltese: Fis-segwitu sa 6 snin wara l-ewwel injezzjoni, f'individwi ta' 9 snin u aktar b'infezzjoni preċedenti ta' dengue, l-effikaċja tal-vaċċin estrapolat (1- Proporzjon ta' Periklu) )*100 (miksuba minn analiżi esploratorja) hija stmata ta' 80 (95% CI: 69; 87) għal VCD li teħtieġ dħul fl-isptar u 84 (95% CI: 61; 94) għal VCD severa.
English: Of the 2930 subjects 9 to 16 years old in this subset (approximately 80%) who were dengue seropositive at baseline, 1974 subjects received the vaccine (901 subjects in CYD14 and 1073 in CYD15) and 956 subjects received placebo (444 in CYD14 and 512 in CYD15) (see also subsection 3).
Maltese: Mill-2930 individwu ta' età ta' 9 sa 16-il sena f'dan is-subset (madwar 80%) li kienu seropożittivi għal dengue fil-linja bażi, 1974 individwu rċevew il-vaċċin (901 individwu f'CYD14 u 1073 f'CYD15) u 956 individwu rċevew plaċebo (444 f'CYD14 u 512 f'CYD15) (ara wkoll subsezzjoni 3).
English: What is dengue and dengue disease?
Maltese: X'inhi dengue u marda ta' dengue?
English: Serotype 4
Maltese: Serotip 4
English: Dengvaxia is a vaccine.
Maltese: Dengvaxia huwa vaċċin.
English: 2.3 Clinical efficacy data for subjects 17 to 45 years of age in endemic areas
Maltese: 2.3. Dejta tal-effikaċja klinika għal individwi ta' età ta' 17 sa 45 sena f'żoni endemiċi
English: N: number of subjects with available antibody titre for the relevant endpoint Dengue seropositive subjects are subjects with titres above or equal to LLOQ against at least one dengue serotype at baseline CI: Confidence Interval
Maltese: N: numru ta' individwi b'titer tal-antikorp disponibbli għall-end-point rilevanti Individwi seropożittivi għal dengue huma individwi b'titers ‘il fuq jew daqs LLOQ kontra tal-inqas serotip ta' dengue wieħed fil-linja bażi
English: Serotype 2
Maltese: Serotip 2