FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Maltese: Tabella 9: Risponsi ta' antikorpi batteriċida tas-serum għal Menveo xahar wara l-vaċċinazzjoni fost individwi ta' bejn 19-55 sena Serogrupp
English: Powder in vial (type I glass) with a stopper (butyl rubber with fluoropolymer coated surface) and solution in vial (type I glass) with a stopper (butyl rubber).
Maltese: Trab f'kunjett (ħġieġ tip I) b'tapp (gomma butyl b'wiċċ miksi bil-fluoropolymer) u soluzzjoni f'kunjett (ħġieġ tip I) b'tapp (gomma butyl).
English: In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Maltese: Fuq l-adolexxenti (mill-età ta' 11-il sena) u fl-adulti, l-aktar effetti sekondarji komuni rrappurtati matul il-provi kliniċi huma elenkati hawn taħt.
English: Immunogenicity was evaluated in randomised, multicenter, active controlled clinical trials that enrolled children (2-10 years of age), adolescents (11-18 years of age), adults (19-55 years of age) and older adults (56-65 years of age).
Maltese: (11-18-il sena), adulti (19-55 sena) u adulti akbar fl-età (56-65 sena).
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Maltese: Oligosaccharides tal-grupp meningokokkali Y 5 mikrogrammi konjugati mal-proteina Corynebacterium diphtheriae CRM197 5.6-10.0 mikrogrammi
English: Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: After reconstitution 0.5 ml dose contains:
Maltese: Wara r-rikostituzzjoni, doża ta' 0.5 ml fiha:
English: Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
Maltese: Il-persistenza tal-antikorp 5 snin wara t-tilqima primarja ġiet evalwata fi studju V59P20E1; dan kien estensjoni ta' studju V59P20.
English: Intramuscular injection.
Maltese: Mhux applikabbli.
English: Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Maltese: Xahar wara l-aħħar tilqima, il-perċentwali ta' individwi b'hSBA ta' ≥ 1:8 fil-grupp ta' 2 dożi u fil-grupp ta' doża waħda fiż-żewġ saffi ta' età kienu: 90%-95% vs 76%-80% għal serogrupp A, 98%-99% vs 76%-87% għal serogrupp C, 99% vs 93%-96% għal serogrupp W-135,
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Maltese: W-135 5 mikrogrammi konjugati mal-proteina Corynebacterium diphtheriae CRM197 3.3-8.3 mikrogrammi
English: Pack size of one dose (2 vials) or five doses (10 vials).
Maltese: (2 kunjetti) jew ħames dożi (10 kunjetti).
English: Very common: myalgia
Maltese: Komuni ħafna: majalġja Komuni: artalġja
English: The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.
Maltese: L-iktar effetti sekondarji komuni rrappurtati matul il-provi kliniċi normalment damu biss jum wieħed sa tnejn u normalment ma kinux severi.
English: In study V59P13E1, the persistence of immune responses against serogroups A, C, W-135 and Y was assessed at 21 months, 3 years and 5 years post primary vaccination among subjects aged 11-18 years at the time of vaccination.
Maltese: Il-persistenza tar-rispons immuni u rispons għall-booster fl-adolexxenti Fi studju V59P13E1, il-persistenza ta' risponsi immuni kontra serogruppi A, C, W-135 u Y ġiet evalwata wara 21 xahar, 3 snin u 5 snin wara t-tilqima primarja fost individwi li kellhom 11-18-il sena meta ngħataw it-tilqima.
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Maltese: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: In a randomised, observer-blind study (V59P10) conducted in Argentina, children were immunized with a single dose of either Menveo (N=949) or ACWY-PS (N=551).
Maltese: Fi studju randomizzat u osservat u bl-agħma (V59P10) li sar fl-Arġentina, tfal rċivew immunizzazzjoni b'doża waħda jew ta' Menveo (N=949) jew ta' ACWY-PS (N=551).
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Maltese: A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
English: hSBA GMTs (95% CI)
Maltese: hSBA (95% CI
English: • Meningococcal group A oligosaccharide
Maltese: • Oligosaccharide ta' grupp meningokokkali A
English: Using a syringe and suitable needle (21G, 40 mm length or 21 G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Maltese: Billi tuża siringa u labra xierqa (21G, tul ta' 40 mm jew 21 G, tul ta' 1½ pulzieri), iġbed il-kontenut kollu tal-kunjett tas-soluzzjoni u injetta fil-kunjett ta' trab biex tirrikostitwixxi l-komponent ta' konjugat ta' MenA.
English: Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease.
Maltese: Menveo huwa indikat għat-tilqim attiv ta' tfal (minn sentejn), adolexxenti u adulti f'riskju ta' esponiment għal gruppi ta' Neisseria meningitidis A, C, W-135 u Y, sabiex jimpedixxi marda invażiva.
English: In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was compared to that of ACWY-PS.
Maltese: Fi studju ieħor (V59P6) li sar f'524 adoloxxent, l-immunoġeniċità ta' Menveo tqabblet ma' dik ta'
English: There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Maltese: M'hemm ebda dejta dwar l-applikabbiltà tal-vaċċin għal profilassi wara esponiment.
English: The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
Maltese: (N=2663) u 19 sa 55 sena (N=1606), rispettivament.
English: In a randomized, observer-blind study (V59_57) conducted in US, immunogenicity of a 2-dose series and a single dose of Menveo was compared in children 2 through 5 and 6 through 10 years of age (N=715).
Maltese: Fi studju li fih il-parteċipanti ntgħażlu b'mod każwali (V59_57), tat-tip observer-blind, li twettaq fl-Istati Uniti, l-immunoġeniċità ta' serje b'2 dożi u doża waħda ta' Menveo, ġiet ipparagunata fi tfal li kellhom minn sentejn sa 5 snin u minn 6 sa 10 snin (N=715).
English: A total of 199 subjects 2-5 years of age were in the Menveo per protocol immunogenicity population and 81 subjects 3-5 years of age were in the ACWY-PS group.
Maltese: immunoġeniċità ta' Menveo skont il-protokoll u 81 suġġett ta' bejn it-3-5 snin kienu fil-grupp ACWY-PS.
English: The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown.
Maltese: Ir-rilevanza klinika tat-tnaqqis fit-titres ta' hSBA tal-antikorpi kontra s-serogrupp A mhijiex magħrufa.
English: Not known: vertigo
Maltese: Mhux magħruf: mejt
English: Pharmacotherapeutic group: Meningococcal vaccines, ATC code: J07AH08.
Maltese: Vaċċini meningokokkali, Kodiċi ATC:
English: V59P13E
Maltese: V59P13E (3 snin wara t-tilqima
English: Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y, even if they develop antibodies following vaccination with Menveo.
Maltese: Individwi b'defiċjenzi fil-kompliment familjali (pereżempju, defiċjenzi ta' C3 jew C5) u individwi li jirċievu kuri li jinibixxu l-attivazzjoni tal-kompliment terminali (pereżempju, eculizumab) jinsabu f'riskju miżjud għal marda invażiva kkawżata minn Neisseria meningitidis grupp A, C, W-135 u Y, anki jekk dawn jiżviluppaw antikorpi wara tilqim b'Menveo.
English: The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
Maltese: bejn 56-65 sena, fl-istudju V59P17.
English: The list provided below presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class.
Maltese: Il-lista pprovduta hawn taħt tippreżenta r-reazzjonijiet avversi rrappurtati fi tliet provi kliniċi importanti ħafna u fi tnejn ta' appoġġ skont is-sistema ta' klassifika tal-organi.
English: Using a syringe and suitable needle (21G, 40 mm length or 21G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Maltese: Billi tuża siringa u labra xierqa (21G, tul ta' 40 mm jew 21G, tul ta' 1½ pulzier), iġbed il-kontenut kollu tal-kunjett tas-soluzzjoni u injetta fil-kunjett ta' trab biex tirrikostitwixxi l-komponent ta' konjugat ta' MenA.
English: and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Maltese: Kien hemm persistenza tal-antikorp osservata kontra serogruppi C, W135 u Y, bil-perċentwali ta' individwi b'hSBA ≥ 1:8 li kienu 32% u 56% kontra serogrupp C f'individwi li kellhom minn sentejn sa 5 snin u 6-10 snin, rispettivament, 74% u 80% kontra serogrupp W-135, u 48% u 53% kontra serogrupp Y.
English: Even if you have been vaccinated with Menveo you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.
Maltese: Anki jekk inti tlaqqamt b'Menveo, inti tibqa' f'riskju miżjud ta' marda kkawżata mill-batterja Neisseria meningitidis ta' gruppi A, C, W-135 u Y.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT
Maltese: TIKKETTA TAL-KUNJETT KOMPONENT KONJUGAT LIKWIDU MENCWY
English: These adverse reactions were:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Maltese: Vaċċin konjugat tal-Grupp meningokokkali A, C, W-135 u Y
English: • Meningococcal group Y oligosaccharide
Maltese: • Oligosaccharide ta' grupp meningokokkali
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
English: Table 7: Persistence of immune responses approximately 12 months and 5 years after vaccination with Menveo and ACWY-PS (subjects were aged 11-18 years at the time of vaccination)
Maltese: Il-persistenza ta' risponsi immuni wara madwar 12-il xahar u 5 snin wara t-tilqima b'Menveo u ACWY-PS (l-individwi kellhom 11-18-il sena meta ngħataw it-tilqima)
English: Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Maltese: Komuni: raxx, ħmura fis-sit tal-injezzjoni (>50 mm), ebusija fis-sit tal-injezzjoni (>50 mm), uġigħ fil-ġogi, deni ≥ 38°C, tertir ta' bard
English: In study V59P6E1, at one year post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C, W-135 and Y, and similar between the two study groups for serogroup A. hSBA GMTs for serogroups W-135 and Y were higher among Menveo recipients.
Maltese: Fi studju V59P6E1, sena wara t-tilqima, il-perċentwali ta' dawk li rċivew Menveo b'hSBA ta' ≥ 1:8 baqa' ogħla b'mod sinifikanti meta mqabbel ma' dawk li rċivew ACWY-PS għal serogruppi C, W-135 u Y, u kien simili bejn iż-żewġ gruppi tal-istudju għal serogrupp A.
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Maltese: Komuni ħafna: irritabilità, telqa, uġigħ fis-sit tal-injezzjoni, eritema fis-sit tal-injezzjoni (≤50 mm),
English: Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Maltese: Tabella 1: Risponsi ta' antikorpi batteriċida tas-serum wara Menveo xahar wara l-vaċċinazzjoni fost individwi ta' bejn 2-5 snin
English: It cannot protect against other types of meningococcal bacteria other than groups A, C, W-135 and Y, or against other causes of meningitis and sepsis (blood poisoning).
Maltese: Ma jistax jipproteġi kontra tipi oħrajn ta' batterji meningokokkali għajr batterji A, C, W-135 u Y, jew kontra kawżi oħrajn ta' meninġite u sepsis (avvenelament tad-demm).
English: The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.
Maltese: Il-profil tar-reattoġeniċità u r-rati ta' episodji avversi fost individwi ta' bejn il-56 u 65 sena li rċivew Menveo
English: Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma.
Maltese: Menveo ma ġiex evalwat f'persuni bi tromboċitopenja, disturbi ta' fsada jew f'persuni li qegħdin jirċievu terapija antikoagulanti, minħabba r-riskju ta' ematoma.
English: Uncommon (may affect up to 1 in 100 people): injection site itching
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): ħakk fis-sit tal-injezzjoni
English: The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.
Maltese: Il-karatterizzazzjoni tal-profil tas-sigurtà ta' Menveo fi tfal minn sentejn sa 10 snin hu bbażat fuq dejta minn erba' provi kliniċi li fihom 3181 individwu irċivew Menevo.
English: Menveo cannot cause bacterial meningitis.
Maltese: Menveo ma jistax jikkawża meninġite batterjali.
English: Menveo is a vaccine that is used for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to a bacterium named Neisseria meningitidis serogroups A, C, W-135 and Y, to prevent invasive disease.
Maltese: Menveo huwa vaċċin li jintuża għall-immunizzazzjoni attiva ta' tfal (minn età ta' sentejn) adolexxenti u adulti f'riskju ta' esponiment għal batterju li jissejjaħ Neisseria meningitidis serogruppi ta' A, C, W135 u Y, sabiex jimpedixxi marda invażiva.
English: Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness (>50mm) and injection site firmness (>50mm)
Maltese: rimettar, dijarea, raxx, uġigħ fil-muskoli, uġigħ fil-ġogi, tertir ta' bard, deni ≥ 38°C, ħmura tas-sit tal-injezzjoni (>50 mm), sodezza fis-sit tal-injezzjoni (>50 mm)
English: EXP
Maltese: GMTs
English: However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
Maltese: Madankollu, l-istabbiltà kimika u fiżika wara rikostituzzjoni ntweriet għal 8 sigħat taħt temperatura ta' 25°C.
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Maltese: Komuni ħafna: uġigħ ta' ras, dardir, uġigħ fis-sit tal-injezzjoni, ħmura fis-sit tal-injezzjoni (≤50 mm), sodezza fis-sit tal-injezzjoni (≤50 mm), uġigħ fil-muskoli, tħossok ma tiflaħx b'mod ġenerali
English: Table 6: Persistence of immune responses approximately 21 months, 3 years and 5 years after vaccination with Menveo (subjects were aged 11-18 years at the time of vaccination)
Maltese: Il-persistenza ta' risponsi immuni wara madwar 21 xahar, 3 snin u 5 snin wara t-tilqima b'Menveo (l-individwi kellhom 11-18-il sena meta ngħataw it-tilqima)
English: 12 months post-vaccination hSBA ≥1:8
Maltese: 12-il xahar wara l-vaċċinazzjoni hSBA ≥ 1:8
English: In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
Maltese: (401/563); serogrupp W-135 82% (131/160); serogrupp Y 66% (173/263).
English: (Originally contained in the solution) • Meningococcal group C oligosaccharide
Maltese: (Oriġinarjament kien jinsab fis-soluzzjoni)
English: 12 mont hs
Maltese: 12-il xahar
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Maltese: Komuni: eritema fis-sit tal-injezzjoni (≤50 mm), twebbis fis-sit tal-injezzjoni (≤50 mm), deni ≥ 38°C,
English: Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age.
Maltese: Hemm dejta limitata dwar l-użu ta' Menveo waqt it-tqala.
English: Uncommon: injection site pruritus
Maltese: Mhux komuni: sturdament Disturbi gastro-intestinali:
English: In the pivotal study (V59P13), adolescents or adults received either a dose of Menveo (N = 2649) comparator vaccine ACWY-D (N = 875).
Maltese: Immunoġeniċità f'individwi ta' aktar minn 11-il sena Fl-istudju importanti ħafna (V59P13), adolexxenti jew adulti rċivew jew doża ta' Menveo (N = 2649) jew vaċċin komparatur (ACWY-D)
English: At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Maltese: 7 ijiem wara t-tilqima, 64% tal-individwi kisbu hSBA ta' ≥1:8 kontra serogrupp A, u 88% sa 90% tal-individwi kellhom antikorpi batteriċidjali kontra serogruppi C, W-135 u Y.
English: Neisseria meningitidis serogroup A, C, W-135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Maltese: Batterji ta' Neisseria meningitidis grupp A, C, W-135 u Y jistgħu jikkawżaw infezzjonijiet serji u li xi kultant huma ta' theddida għall-ħajja bħall-meninġite u sepsis (avvenelament tad-demm).
English: Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine.
Maltese: tilqima oħra konjugata meningokokkali jew tilqima polysaccharide meningokokkali mhux konjugata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Maltese: U KWANTITATTIVA Doża waħda (0.5 ml tal-vaċċin rikostitwit) fiha: (Oriġinarjament kien jinsab fit-trab)
English: The presence of a minor infection is not a contraindication.
Maltese: Il-preżenza ta' infezzjoni minuri mhijiex kontraindikazzjoni.
English: • Meningococcal group W-135 oligosaccharide
Maltese: • Oligosaccharide ta' grupp meningokokkali C
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Maltese: TIKKETTA TAL-KUNJETT KOMPONENT KONJUGAT LAJOFILIZZAT MENA
English: Common: rash
Maltese: OĦRAJN
English: Uncommon: dizziness
Maltese: Komuni ħafna: dardir
English: Immunogenicity in older adults
Maltese: Immunoġeniċità f'adulti akbar fl-età
English: ACWY
Maltese: Trab
English: In the children 2-10 years of age, as well as in each age strata (2-5 and 6-10 years), immune response as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs were not only non-inferior to comparator vaccine ACWY-PS, but all were statistically higher than the comparator for all serogroups and all immune measurements at 1 month post vaccination.
Maltese: individwi b'serorispons, hSBA ≥ 1:8 u GMTs mhux biss kienu mhux inferjuri għall-vaċċin kompartur ACWY-PS, imma kollha kienu statistikament ogħla mill-komparatur għas-serogruppi kollha u għall-kejl immuni kollu xahar wara l-vaċċinazzjoni.
English: A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Maltese: 7 ijiem wara d-doża booster, 98%-100% tal-individwi li rċivew Menveo fil-passat u 73%-84% tal-individwi li rċivew ACWY-PS fil-passat, kisbu hSBA ta' ≥1:8 kontra serogruppi A, C, W-135 u Y.
English: Serogroup hSBA ≥1:8
Maltese: Perċenwali ta' individwi b'hSBA≥1:8
English: (3 years post vaccinati on)
Maltese: (elenkati fis-sezzjoni 6)
English: Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C, W-135 and Y bacteria.
Maltese: It-tabib jew l-infermier tiegħek xorta waħda jistgħu jirrakkomandaw li inti tirċievi Menveo jekk inti f'riskju kbir ta' infezzjoni b'batterji tal-grupp meningokokkali A, C, W-135 u Y.
English: At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
Maltese: Sena wara l-vaċċinazzjoni f'dawn l-istess individwi, meta mqabbla ma' ACWY-PS, proporzjon ogħla ta' individwi mlaqqmin b'Menveo kellhom hSBA ≥ 1:8 għal serogruppi C, W-135 u Y, b'livelli komparabbli għal serogrupp A.
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Maltese: Tel: +39 (0)45 9218 111
English: Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Maltese: Vaċċini li jingħataw fl-istess ħin għandhom dejjem jingħataw f'siti ta' injezzjoni separati u preferibbilment kontralaterali.
English: NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Maltese: Vaċċin konjugat tal-grupp meningokokkali A, C, W-135 u Y
English: Uncommon: dizziness, injection site itching
Maltese: Mhux komuni: prurite fis-sit tal-injezzjoni
English: In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Maltese: Fuq tfal (minn sentejn sa 10 snin), l-effetti sekondarji li kienu rrappurtati matul il-provi kliniċi huma elenkati hawn taħt.
English: MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l.
Maltese: Menveo trab u soluzzjoni għal soluzzjoni għall-injezzjoni.