FrancophonIA/ELRC3.0 huggingface dataset:
English: Urticaria (uncommon) was only reported in subjects 9 to 17 years of age (none in adults).
Maltese: L-urtikarja (mhux komuni) ġiet irrappurtata biss f'individwi ta' età ta' 9 sa 17-il sena (l-ebda fl-adulti).
English: Pooled * CYD14+CYD15+ CYD23
Maltese: Miġbura* CYD14+CYD15+ CYD23
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva
English: Serotype 3
Maltese: Serotip 3
English: The immunogenicity of the final formulation of the CYD dengue vaccine in adults aged 18 to 45 years in endemic areas was assessed in 3 studies conducted all in Asia-Pacific (CYD22 in Vietnam, CYD28 in Singapore and CYD47 in India).
Maltese: L-immunoġeniċità tal-formulazzjoni finali tal-vaċċin ta' dengue CYD f'adulti ta' 18 sa 45 sena f'żoni endemiċi ġiet ivvalutata fi 3 studji li saru kollha fl-Asja Paċifiku (CYD22 fil-Vjetnam, CYD28 f'Singapore u CYD47 fl-Indja).
English: Rash Rash generalised
Maltese: Raxx ġeneralizzat
English: For the primary endpoint, the incidence of symptomatic VCD cases occurring during the 12-month period from 28 days after the third injection was compared to the Control Group.
Maltese: Għall-end-point primarju, l-inċidenza ta' każijiet ta' VCD sintomatika li seħħet waqt il-perjodu ta' 12il xahar minn 28 jum wara t-tielet injezzjoni tqabblet mal-Grupp ta' Kontroll.
English: • Individuals with congenital or acquired cell-mediated immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g. 20mg or 2mg/kg of prednisone for 2 weeks or more) within 4 weeks prior to vaccination.
Maltese: - Individwi b'defiċjenza immuni medjata miċ-ċelluli konġenitali jew akkwiżita, inkluż terapiji immunosoppressivi bħal kimoterapija jew dożi għoljin ta' kortikosterojdi sistemiċi (eż. 20 mg jew 2 mg/kg ta' prednisone għal ġimagħtejn jew aktar) fi żmien 4 ġimgħat qabel it-tilqim.
English: No specific studies have been performed on fertility.
Maltese: Ma sar l-ebda studju speċifiku dwar il-fertilità.
English: Dengvaxia is available in packs of 5 (vaccine and solvent vials provided in the same box).
Maltese: Dengvaxia jiġi f'pakketti ta' 5 (kunjetti ta' vaċċin u solvent ipprovduti fl-istess kaxxa).
English: 14 Espace Henry Vallée 69007 Lyon
Maltese: 69007 Lyon
English: PHARMACEUTICAL FORM AND CONTENTS Powder (5 doses) in vial + 2.5 mL of solvent in vial Pack size of 5.
Maltese: Trab (5 dożi) f'kunjett + 2.5 mL ta' solvent f'kunjett Daqs tal-pakkett ta' 5.
English: During clinical development, neutralizing antibody titres for each serotype were measured with the plaque reduction neutralization test (PRNT) and presented as geometric mean titres (GMTs).
Maltese: Waqt l-iżvilupp kliniku, tkejlu titers tal-antikorp newtralizzanti għal kull serotip bit-test ta' newtralizzazzjoni ta' tnaqqis tal-qoxra (PRNT) u ġew ippreżentati bħala titers medji ġeometriċi (geometric mean titer, GMT).
English: 3.1 Immunogenicity data for subjects 9 to 17 years of age in endemic areas
Maltese: 3.1. Dejta dwar l-immunoġeniċità għal individwi ta' età ta' 9 sa 17-il sena f'żoni endemiċi
English: Pooled CYD14+CYD15
Maltese: CYD14+CYD15
English: CYD22 19 CYD28 66 CYD47 109
Maltese: CYD47 109 324
English: After reconstitution, use within 6 hours if stored between 2°C and 8°C.
Maltese: Wara r-rikostituzzjoni, uża fi żmien 6 sigħat jekk jinħażen f'temperatura bejn 2°C u 8°C.
English: *Pooled results of CYD14, 15 and 23 need to be interpreted cautiously because of differences in the Dengue confirmatory test and acute febrile illness definition between CYD14/15 and CYD23.
Maltese: *Ir-riżultati miġbura ta' CYD14, 15 u 23 jeħtieġ li jiġu interpretati b'kawtela minħabba differenzi fit-test konfirmatorju ta' Dengue u d-definizzjoni ta' marda akuta bid-deni bejn CYD14/15 u CYD23.
English: In the absence of documented prior dengue virus infection, previous infection has to be confirmed by serotesting before vaccination.
Maltese: Fin-nuqqas ta' infezzjoni b'virus dengue preċedentement dokumentata, infezzjoni preċedenti jegħtieġ tiġi konfermata permezz ta' serotestjar qabel it-tilqim.
English: • ever fainted from an injection.
Maltese: • qatt takom ħass ħażin minn injezzjoni.
English: Dengvaxia is given to adults, young people and children (from 9 to 45 years of age) with prior dengue virus infection and who live in endemic areas (also see sections 2 and 3).
Maltese: Dengvaxia jingħata lil adulti, żgħażagħ u tfal (mill-età ta' 9 sa 45 sena) b'infezzjoni preċedenti b'virus dengue u li jgħixu f'żoni endemiċi (ara wkoll sezzjonijiet 2 u 3).
English: In subjects 2 to 8 years of age, as compared to subjects above 9 years of age, injection site erythema and swelling were more frequently reported (frequency: very common), and additional adverse events were reported (frequency: uncommon): injection site haemorrhage, decreased appetite and vomiting.
Maltese: F'individwi bejn l-età ta' sentejn sa 8 snin, meta mqabbel ma' individwi ta' età ‘l fuq minn 9 snin, eritema u nefħa fis-sit tal-injezzjoni ġew irrappurtati b'mod aktar frekwenti (frekwenza: komuni ħafna), u ġew irrappurtati avvenimenti avversi addizzjonali (frekwenza: mhux komuni): emorraġija fis-sit tal-injezzjoni, tnaqqis fl-aptit u rimettar.
English: After reconstitution, one dose (0.5 mL) contains:
Maltese: Wara r-rikostituzzjoni, doża waħda (0.5 ml) fiha:
English: Headache
Maltese: Dożi
English: In the two pivotal Phase III studies (CYD14 and CYD15), a total of approximately 31000 subjects aged 2 to 16 years were randomised to receive either Dengvaxia or placebo, regardless of previous dengue infection.
Maltese: III pivotali studies (CYD14 u CYD15), total ta' madwar 31,000 individwu li kellhom sentejn sa 16-il sena ġew randomizzati biex jirċievu jew Dengvaxia jew plaċebo, irrispettivament minn infezzjoni ta' dengue preċedenti.
English: Dengvaxia should not be used in children less than 9 years of age (see sections 4.8).
Maltese: Dengvaxia m'għandux jintuża fi tfal ta' età ta' inqas minn 9 snin (ara sezzjoni 4.8).
English: No pharmacokinetic studies have been performed on Dengvaxia.
Maltese: Ma sar l-ebda studju farmakokinetiku dwar Dengvaxia.
English: Previous dengue infection has to be assessed before vaccination by laboratory confirmed history of dengue or through an appropriately validated serological test (see section 4.4).
Maltese: Infezzjoni preċedenti ta' dengue jeħtieġ tiġi evalwanta qabel it-tilqim minn storja kkonfermata minn laboratorju ta' denguw jew permezz ta' test seroloġiku validat kif suppost (ara taqsima 4.4).
English: Injection site reactions (erythema, hematoma, swelling, pruritus)
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (eritema, ematoma, nefħa, pruritu)
English: Upper respiratory tract infection Nasopharyngitis
Maltese: Disturbi gastro-intestinali
English: • Breast-feeding women (see section 4.6).
Maltese: • Nisa tqal (ara sezzjoni 4.6).
English: Table 1: Adverse reactions from Clinical Studies and reported during commercial use in children (9 to 17 years old)
Maltese: Tabella 1: Reazzjonijiet avversi minn Studji Kliniċi u rrappurtati waqt l-użu kummerċjali fittfal (9 sa 17-il sena)
English: • rash (skin eruption)
Maltese: • raxx (eruzzjoni tal-ġilda)
English: The physician educational material should contain:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Immunogenicity data available from studies in adults aged 18 to 45 years in endemic regions show that post-injection 3 GMTs against each serotype are generally higher in adults than in children and adolescents in CYD14 and CYD15.
Maltese: Dejta dwar l-immunoġeniċità disponibbli minn studji f'adulti ta' 18 sa 45 sena f'reġjuni endemiċi turi li GMT ta' wara injezzjoni 3 kontra kull serotip huma ġeneralment ogħla fl-adulti milli fit-tfal u fladolexxenti f'CYD14 u CYD15.
English: Dengvaxia is a live attenuated vaccine, therefore Dengvaxia is contraindicated during pregnancy (see section 4.3).
Maltese: Dengvaxia huwa vaċċin attenwat ħaj għalhekk Dengvaxia m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: The GMTs post-dose 3 in subjects 18 to 45 years of age are shown in the Table 7
Maltese: Il-GMT wara doża 3 f'individwi ta' età ta' 18 sa 45 sena jidhru fit-Tabella 7.
English: Neck pain Arthralgia
Maltese: GMT wara injezzjoni
English: For storage conditions after reconstitution of Dengvaxia, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni ta' Dengvaxia, ara sezzjoni 6.3. 6.5
English: The post dose 3 GMTs in subjects 9 to 16 years of age in CYD14 and CYD15 are shown in the Table
Maltese: Il-GMT wara doża 3 f'individwi ta' età ta' 9 sa 16-il sena f'CYD14 u CYD15 jidhru fit-Tabella 6.
English: The Vaccine Efficacy (VE) against symptomatic VCD during the 25-month period after the first injection, in subjects 9 to 16 years of age dengue seropositives at baseline and for the immunogenicity subset for pooled CYD14 + CYD15+CYD23, is estimated at 81.9% (95% CI: 67.2 ; 90.0).
Maltese: L-Effikaċja tal-Vaċċin (VE) kontra VCD sintomatiċi fuq il-perjodu ta' 25 xahar wara l-ewwel injezzjoni, f'individwi seropożittivi ta' dengue minn 9 sa 16-il sena fil-linja bażi u għas-subsett ta' immunoġeniċità miġbura ta' CYD14 + CYD15+CYD23, huwa stmat bħala 81.9% (95% CI: 67.2 ;
English: Store in a refrigerator (2°C - 8°C).
Maltese: Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2°C-8°C).
English: This increased risk was not observed in individuals who have been previously infected by dengue virus, where it was estimated that 16 hospitalized dengue cases or 4 severe dengue cases could be prevented per 1000 vaccinees with previous dengue infection during 6 years of follow up from the first injection.
Maltese: Dan ir-riskju miżjud ma ġiex osservat f'individwi li preċedentement kienu infettati bil-virus dengue, fejn ġie stmat li 16-il każ ta' dengue li tikkawża dħul fl-isptar jew 4 każijiet ta' dengue severa jistgħu jiġu evitati għal kull 1,000 persuna li titlaqqam b'infezzjoni preċedenti ta' dengue matul 6 snin ta' segwitu mill-ewwel injezzjoni.
English: Table 7: Immunogenicity for dengue seropositive subjects 18 to 45 years of age from endemic areas
Maltese: Immunoġeniċità għal individwi seropożittivi għal dengue ta' età ta' 18 sa 45 sena minn żoni endemiċi
English: In subjects below 2 years of age, the most frequently reported adverse reactions following any injection of Dengvaxia were fever, irritability, appetite lost, abnormal crying and injection site tenderness.
Maltese: F'individwi taħt l-età ta' sentejn, ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti wara kwalunkwe injezzjoni ta' Dengvaxia kienu deni, irritabilità, telf ta' aptit, biki anormali u sensittività fis-sit tal-injezzjoni.
English: In an exploratory analysis of the long-term follow up from the first injection in three efficacy studies, an increased risk of hospitalisation for dengue including clinically severe dengue (predominantly Dengue Haemorrhagic Fever grade 1 or 2 [WHO 1997]) has been observed in vaccinees with no previous dengue infection.
Maltese: F'analiżi esploratorja ta' segwitu fuq terminu twil mill-ewwel injezzjoni fi tliet studji dwar l-effikaċja, ġie osservat riskju miżjud ta' dħul fl-isptar għal dengue inkluż dengue klinikament severa (b'mod predominanti Deni Emorraġiku Dengue ta' grad 1 jew 2 [WHO 1997]) f'persuni li tlaqqmu b'ebda infezzjoni preċedenti ta' dengue.
English: Vaccine efficacy was demonstrated for these endpoints in CYD14 and CYD15 (see Table 4).
Maltese: L-effikaċja tal-vaċċin intweriet għal dawn l-end-points f' CYD14 u CYD15 (ara Tabella 4).
English: NC: Not computed (the absence of cases in vaccine and control group does not permit to calculate VE nor CI) *Pooled results of CYD14, 15 and 23 need to be interpreted cautiously because of differences in the Dengue confirmatory test and acute febrile illness definition between CYD14/15 and CYD23.
Maltese: Mhux ikkalkolat (in-nuqqas ta' każijiet fil-grupp tal-vaċċin u ta' kontroll ma jippermettix il-kalkolu ta' VE u lanqas ta' CI) *Ir-riżultati miġbura ta' CYD14, 15 u 23 jeħtieġ li jiġu interpretati b'kawtela minħabba differenzi fit-test konfirmatorju ta' Dengue u d-definizzjoni ta' marda akuta bid-deni bejn CYD14/15 u CYD23.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Dengvaxia, powder for injection dengue tetravalent vaccine (live, attenuated)
Maltese: Dengvaxia, trab għall-injezzjoni vaċċin tetravalenti ta' dengue (ħaj, attenwat) SC
English: Vaccine efficacy against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes was 40.5% (95% CI: 22.7; 54.2) (pooled CYD14+CYD23).
Maltese: L-effikaċja tal-vaċċin kontra każijiet VCD sintomatiċi fuq il-perjodu ta' 12-il xahar li jibda minn 28 jum wara t-tielet injezzjoni minħabba xi waħda mill-erba' serotipi kienet ta' 40.5% (95% CI: 22.7; 54.2) (miġbura CYD14+CYD23).
English: Dengvaxia, powder and solvent for suspension for injection in multidose containers dengue tetravalent vaccine (live, attenuated)
Maltese: Dengvaxia, trab u solvent għal sospensjoni għall-injezzjoni f'kontenituri ta' ħafna dożi vaċċin tetravalenti ta' dengue (ħaj, attenwat)
English: • Dengvaxia must not be mixed with other medicinal products in the same syringe.
Maltese: • Dengvaxia m'għandux jitħallat ma' prodotti mediċinali oħra fl-istess siringa.
English: The recommended size of the needle to be used is 23G or 25G.
Maltese: Id-daqs rakkomandat tal-labra li għandu jintuża huwa 23G jew 25G.
English: Efficacy in subjects 2 to 8 years of age was assessed in 2443 subjects (1634 in vaccine group and 809 in control group) in phase IIb study and in 5300 subjects (3532 subjects in vaccine group and 1768 in control group) in the pivotal Phase III study (CYD14).
Maltese: IIb u f'5300 individwu (3532 individwu fil-grupp tal-vaċċin u 1768 fil-grupp ta' kontroll) fil-Fażi III ta' studju kruċjali (CYD14).
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Maltese: Česká republika Sanofi Pasteur divize. vakcín sanofi-aventis, s.r.o.
English: Cases: number of subjects with at least one symptomatic virologically-confirmed dengue episode in the considered period.
Maltese: Każijiet: numru ta' individwi b'tal-inqas episodju wieħed ta' dengue kkonfermata viroloġikament sintomatika fil-perjodu kkunsidrat.
English: The solvent (0.9% sodium chloride solution) is a limpid, colourless solution.
Maltese: Is-solvent (0.9% sodium chloride soluzzjoni) huwa soluzzjoni limpida, bla kulur.
English: • medicines called “immunoglobulins” or blood products containing immuno globulins, such as blood or plasma.
Maltese: • mediċini msejħa “immunoglobulini” jew prodotti tad-demm li fihom immunoglobulini, bħal demm jew plażma.
English: • Dengue seronegativity if the PRNT50 titre < the lower limit of quantification against any of the
Maltese: • Seronegattività għal dengue jekk it-titer ta' PRNT50 < il-limitu aktar baxx tal-kwantifikazzjoni kontra kwalunkwe wieħed mill-4 serotipi.
English: Exploratory vaccine efficacy analyses according to dengue serostatus measured by plaque reduction neutralization test (PRNT50) at baseline (before the first injection) were performed in the immunogenicity subset of 2000 subjects each in CYD14 and CYD15 and 300 subjects in CYD23.
Maltese: *Analiżi tal-effikaċja tal-vaċċin skont is-serostatus ta' dengue mkejla minn test ta' newtralizzazzjoni ta' tnaqqis tal-qoxra (plaque reduction neutralization test, PRNT50) fil-linja bażi (qabel l-ewwel injezzjoni) saret fis-subset tal-immunoġeniċità ta' 2,000 individwu kull wieħed f'CYD14 u CYD 15 u fi 300 individwu f'CYD23.
English: In vaccinees 2 to 8 years of age with no previous dengue infection, long-term safety follow-up data showed an increased risk of dengue disease requiring hospitalisation including clinically severe dengue.
Maltese: Fil-persuni li jitlaqqmu ta' età ta' 2 sa 8 snin b'ebda infezzjoni preċedenti ta' dengue, dejta ta' segwitu tas-sigurtà fit-tul uriet riskju miżjud ta' marda ta' dengue li kienet teħtieġ dħul fl-isptar inkluż dengue klinikament severa.
English: Individuals who have not been previously infected by dengue virus or for whom this information is unknown should not be vaccinated because an increased risk of hospitalisation for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Haemorrhagic Fever) has been observed in these individuals during the long-term follow up of clinical trials (see Section 4.8).
Maltese: Individwi li preċedentement ma ġewx infettati bil-virus dengue jew li għalihom din l-informazzjoni mhijiex magħrufa m'għandhomx jitlaqqmu għax ġie osservat riskju miżjud ta' dħul fl-isptar għal dengue u dengue klinikament severa (b'mod predominanti Deni Emorraġiku Dengue ta' grad 1 jew 2) f'dawn l-individwi waqt is-segwitu fit-tul tal-provi kliniċi (ara Sezzjoni 4.8).
English: The vaccination schedule consists of 3 injections of one reconstituted dose (0.5 mL) to be administered at 6-month intervals.
Maltese: L-iskeda tat-tilqim tikkonsisti minn 3 injezzjonijiet ta' doża rikostitwita waħda (0.5 mL) li għandhom jingħataw f'intervalli ta' 6 xhur.
English: • have a weak immune system (the body's natural defences).
Maltese: • għandek sistema immuni dgħajfa (id-difiżi naturali tal-ġisem).
English: • After reconstitution, one dose (0.5 mL) contains 4.5 - 6.0 log10 CCID50* of each serotype of the chimeric yellow fever dengue virus** (1, 2, 3 and 4) (live, attenuated).
Maltese: • Wara r-rikostituzzjoni, doża waħda (0.5 ml) fiha 4.5-6.0 log10 CCID50* ta' kull serotip talvirus tad-deni dengue kimeriku isfar** (1, 2, 3 u 4) (ħaj, attenwat).
English: Individuals who have not been previously infected by dengue virus or for whom this information is unknown should not be vaccinated because an increased risk of hospitalisation for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Hemorrhagic Fever) has been observed in these individuals during the long-term follow up of clinical trials (see Section 4.8).
Maltese: Individwi li preċedentement ma ġewx infettati bil-virus dengue jew li għalihom din l-informazzjoni mhijiex magħrufa m'għandhomx jitlaqqmu għax ġie osservat riskju miżjud ta' dħul fl-isptar għal dengue u dengue klinikament severa (b'mod predominanti Deni Emorraġiku Dengue ta' grad 1 jew 2) f'dawn l-individwi waqt is-segwitu fit-tul tal-provi kliniċi (ara sezzjoni 4.8).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Maltese: 12 Diċembru 2018
English: The solvent (0.4% sodium chloride solution) is a limpid, colourless solution.
Maltese: Is-solvent (0.4% sodium chloride soluzzjoni) huwa soluzzjoni limpida, bla kulur.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Dengvaxia - Powder (5 doses) in vial + 2.5 mL of solvent in vial.
Maltese: Ż-ŻGĦAR EWLENIN Dengvaxia - Solvent f'kunjett (2.5 mL)
English: Pharmacotherapeutic group: Vaccines, Viral vaccines, ATC code: J07BX/ Not Yet assigned
Maltese: Vaċċini, vaċċini virali, Kodiċi ATC:
English: • feeling dizzy
Maltese: • reazzjonijiet allerġiċi
English: Dengvaxia, powder and solvent for suspension for injection in pre-filled syringe dengue tetravalent vaccine (live, attenuated)
Maltese: Dengvaxia, trab u solvent għal sospensjoni għall-injezzjoni f'siringa mimlija għal-lest vaċċin tetravalenti ta' dengue (ħaj, attenwat)
English: Dengvaxia is reconstituted by transferring all of the solvent (0.4% sodium chloride solution) provided in the blue-labelled pre-filled syringe into the vial of freeze-dried powder with a yellowish green flip-off cap.
Maltese: Dengvaxia jiġi rikostitwit billi s-solvent ipprovdut kollu (0.4% sodium chloride soluzzjoni) jiġi ttrasferit fis-siringa mimlija għal-lest ittikkettjata blu fil-kunjett ta' trab imnixxef bil-friża b'tapp tat-tip flip-off aħdar jagħti fl-isfar.
English: Following administration, the viruses replicate locally and elicit neutralizing antibodies and cell-mediated immune responses against the four dengue virus serotypes (see detailed data below, subsection 3).
Maltese: Wara l-għoti, il-virusis jirrepplikaw lokalment u jirriżultaw f'antikorpi newtralizzanti u rispons immuni medjat miċ-ċelluli kontra l-erba' sirotipi tal-virus dengue (ara dejta ddettaljata hawn taħt, subsezzjoni 3)
English: Table 3: VE against symptomatic VCD cases over the 12-month period starting from 28 days after the third injection due to any of the 4 serotypes in subjects 9 to 16 years (any serostatus at baseline).
Maltese: Tabella 3: VE kontra każijiet ta' dengue VCD sintomatika waqt il-perjodu ta' 12-il xahar li beda minn 28 jum wara t-tielet injezzjoni minħabba xi wieħed mill-4 serotipi f'individwi ta' 9 sa 16-il sena, kwalunkwe serostatus fil-linja bażi.
English: N = 27380
Maltese: VE % (95% CI) N=27,380
English: STATEMENT OF ACTIVE SUBSTANCES After reconstitution, one dose (0.5 mL) contains 4.5 - 6.0 log10 CCID50 of each serotype of the chimeric yellow fever dengue virus (1, 2, 3 and 4) (live, attenuated).
Maltese: Wara r-rikostituzzjoni, doża waħda (0.5 mL) fiha 4.5 - 6.0 log10 CCID50 ta' kull serotip ta' virus ta' deni dengue isfar kimeriku (1, 2, 3 u 4) (ħaj, attenwat).
English: 2.2 Clinical efficacy data for subjects 9 to 16 years of age in endemic areas, dengue seropositive at baseline
Maltese: Dejta tal-effikaċja klinika għal individwi ta' età ta' 9 sa 16-il sena f'żoni endemiċi, dengue seropożittive fil-linja bażi
English: Allergic including anaphylactic reactions have been reported very rarely.
Maltese: Reazzjonijiet allerġiċi inkluż anafilattiċi ġew irrappurtati f'każijiet rari ħafna.
English: Transfer the entire content of the solvent vial (with a dark gray flip-off cap) into the vial containing the powder (medium brown flip-off cap).
Maltese: Ittrasferixxi l-kontenut kollu tal-kunjett tas-solvent (b'tapp tat-tip flip-off griż skur) filkunjett li fih it-trab (tapp tat-tip flip-off kannella medju).
English: Dengvaxia is reconstituted by transferring all of the solvent (0.9% sodium chloride solution) provided in the 5-dose vial with a dark grey flip-off cap into the 5-dose vial of freeze-dried powder with a medium brown flip-off cap, using a sterile syringe and needle.
Maltese: Dengvaxia jiġi rikostitwit billi s-solvent ipprovdut kollu (0.9% sodium chloride soluzzjoni) jiġi ttrasferit fil-kunjett ta' 5 dożi b'tapp tat-tip flip-off griż skur fil-kunjett ta' 5 dożi ta' trab imnixxef bil-friża b'tapp tat-tip flip-off kannella medju, permezz ta' siringa sterili u labra.
English: • itchy rash (urticaria).
Maltese: • raxx bil-ħakk (urtikarja).
English: • medicines that affect your body's natural defences (immune system) such as high-dose corticosteroids or chemotherapy.
Maltese: • mediċini li jaffettwaw id-difiżi naturali tal-ġisem (sistema immuni) bħal kortikosterojdi ta' doża għolja jew kimoterapija.
English: PHARMACEUTICAL FORM AND CONTENTS Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe with 2 separate needles Powder (1 dose) in vial + 0.5 mL of solvent in pre-filled syringe Pack size of 1 or 10
Maltese: Trab (doża 1) f'kunjett + 0.5 ml ta' solvent f'siringa mimlija għal-lest b'2 labriet separati Trab (doża 1) f'kunjett + 0.5 ml ta' solvent f'siringa mimlija għal-lest Daqs tal-pakkett ta' 1 jew 10
English: Serious allergic (anaphylactic) reactions
Maltese: Reazzjonijiet allerġiċi serji (anafilattiċi)