FrancophonIA/ELRC3.0 huggingface dataset:
English: In a phase 3 clinical study, children and adolescents 2 through 17 years of age with complement deficiencies (40), with asplenia or splenic dysfunction (107), and age-matched healthy subjects (85) received two doses of Bexsero two months apart.
Maltese: Fi studju kliniku tat-tielet fażi, tfal u adolexxenti minn 2 sa 17-il sena b'defiċjenzi tal-komplement (40), b'asplenja jew b'disfunzjoni tal-milsa (107) u individwi b'saħħithom imqabblin skont l-età (85) irċevew żewġ dożi ta' Bexsero b'intervall ta' xahrejn bejniethom.
English: General disorders and administration site conditions Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability
Maltese: Komuni ħafna: deni (≥38°C), sensittività fis-sit tal-injezzjoni (li tinkludi sensittività severa fis-sit tal-injezzjoni definita bħala biki meta jiċċaqlaq ir-riġel/driegħ li jkun ġie injettat), eritema fis-sit tal-injezzjoni, nefħa fis-sit tal-injezzjoni, ebusija fis-sit tal-injezzjoni, irritabilità
English: % seropositive (95% CI) hSBA GMT (95% CI) 18-23 months after 2nd dose
Maltese: GMT (95% CI) 18-23 xahar wara t-tieni doża
English: Inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B and lower antibody titers to the pertussis pertactin antigen were also noted, but these data do not suggest clinically significant interference.
Maltese: Ġew osservati riżultati inkonsistenti fl-istudji dwar ir-risponsi għal poljovirus inattivat ta' tip 2 u konjugat pnewmokokkali ta' serotip 6B u titers iktar baxxi għall-antiġen ta' pertussis pertactin ġew ukoll osservati, iżda din id-dejta ma tissuġġerixxix interferenza klinikament sinifikanti.
English: A survey of approximately 1,000 different invasive meningococcal group B isolates collected during 2007-2008 in 5 European countries showed that, depending on the country of origin, between 73% and 87% of meningococcal group B isolates had an appropriate MATS antigen profile to be covered by the vaccine.
Maltese: Stħarriġ ta' madwar 1,000 iżolat meningokokkali invażiv differenti ta' grupp B miġbura matul 2007-2008 f'5 pajjiżi Ewropew urew li, skont il-pajjiż tal-oriġini, bejn 73% u 87% tal-iżolati meningokokkali ta' grupp B kellhom il-profil ta' antiġen MATS li suppost li ried ikun kopert mit-tilqima.
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Maltese: F'każ ta' doża eċċessiva, il-monitoraġġ tal-funzjonijiet vitali u kura sintomatika possibbli huma rakkomandati.
English: Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.
Maltese: It-tabib tiegħek xorta jista' jirrakkomanda li inti tirċievi Bexsero jekk tkun f'riskju ta' esponiment għal infezzjoni meningokokkali.
English: 6 to 11 months of age
Maltese: 4 sa 7 snin
English: Children, 12 months to 23 months
Maltese: 12 sa 23 xahar
English: Serum bactericidal antibody responses following Bexsero vaccination at 6 and 8 months of age or 13 and 15 months of age and persistence of bactericidal antibody one year after the two doses at 13 and 15 months of age
Maltese: Risponsi tal-antikorpi batteriċidjali fis-serum wara t-tilqima b'Bexsero meta t-tarbija kellha 6 xhur u 8 xhur jew 13 u 15-il xahar u l-persistenza tal-antikorpi batteriċidjali sena wara ż-żewġ dożi meta t-tarbija kellha 13 u 15-il xahar
English: There are no data on the use of Bexsero in adults above 50 years of age.
Maltese: M'hemmx dejta dwar l-użu ta' Bexsero f'adulti li jkollhom iktar minn 50 sena.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali ta' qtugħ ta' nifs u l-ħtieġa ta' monitoraġġ respiratorju għal 48-72 siegħa għandu jiġi kkunsidrat meta tingħata s-serje primarja tat-tilqima lil trabi li jkunu twieldu ħafna qabel iż-żmien (twieldu wara ≤28 ġimgħa ta' tqala) u b'mod partikulari għal dawk bi storja medika ta' immaturità respiratorja.
English: Histidine
Maltese: Treddigħ
English: There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.
Maltese: M'hemmx dejta dwar l-użu ta' Bexsero f'individwi li jkollhom iktar minn 50 sena u dejta limitata f'pazjenti b'kundizzjonijiet mediċi kroniċi.
English: When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials.
Maltese: Meta Bexsero ngħata waħdu, il-frekwenza ta' deni kienet simili għal dik assoċjata ma' tilqim ta' rutina lit-trabi mogħtija matul il-provi kliniċi.
English: % seropositive* after 2nd dose
Maltese: % seropożittivi*
English: hSBA GMT** (95% CI)
Maltese: GMT** (95% CI)
English: Age range
Maltese: ANNESS II
English: Infants, 6 months to 11 months
Maltese: Trabi, 6 xhur sa 11-il xahar
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: GlaxoSmithKline AS Tlf: + 47 22 70 20 00
Maltese: GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
English: STATEMENT OF ACTIVE SUBSTANCE(S) 0.5 ml dose contains:
Maltese: Doża waħda (0.5 ml) fiha:
English: Bexsero can be given at the same time as any of the following vaccine components: diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox, and meningococcus A, C, W, Y. Talk to your doctor or nurse for further information.
Maltese: Bexsero jista' jingħata fl-istess ħin flimkien mal-komponenti tat-tilqima li ġejjin: difterija, tetnu, sogħla konvulżiva (pertussis), Haemophilus influenzae tip b, poljo, epatite B, pnewmokokkus, ħosba,
English: 6 to 10 years of age fHbp
Maltese: 6 sa 10 snin fHbp
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) across strains ranged from 46% to 95% at one month after the first dose and from 69% to 100% at one month after the second dose (Table 6).
Maltese: (jiġifieri, li kisbu hSBA ta' tal-inqas 1:4) fir-razez varjaw minn 46 % għal 95 % xahar wara l-ewwel doża u minn 69 % għal 100 % xahar wara t-tieni doża (Tabella 6).
English: Serum bactericidal antibody responses to each of the vaccine antigens NadA, fHbp, NHBA and PorA P1.4 was evaluated using a set of four meningococcal group B reference strains.
Maltese: Ir-risponsi tal-antikorpi batteriċidjali fis-serum għal kull wieħed mill-antiġeni tat-tilqima NadA, fHbp, NHBA u PorA P1.4 ġew evalwati billi ntuża sett ta' erba' razez meningokokkali ta' referenza ta' grupp B.
English: In case of delay, the booster should not be given later than 24 months of age.
Maltese: F'każ ta' dewmien, il-booster m'għandux jingħata aktar tard minn età ta' 24 xahar.
English: A two-dose schedule followed by a booster has been evaluated in infants 3 months to 5 months of age in a clinical study.
Maltese: Ġiet evalwata skeda ta' żewġ dożi segwita minn booster fi trabi li kellhom minn 3 xhur sa 5 xhur fi studju kliniku.
English: Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
Maltese: Proteina ta' fużjoni fHbp rikombinanti Neisseria meningitidis grupp B 1, 2, 3
English: Bexsero is a suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Maltese: Bexsero hu suspensjoni f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'tapp planġer (lastku tal-bromobutyl ta' Tip I) u b'għatu protettiv tat-tarf (lastku ta' Tip I jew Tip II) bi jew mingħajr labar.
English: Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Maltese: Trabi li jkollhom minn 6 xhur sa 11-il xahar għandhom jirċievu żewġ injezzjonijiet tat-tilqima segwiti minn injezzjoni addizzjonali (booster).
English: * pre-booster time point represents persistence of bactericidal antibody at 8 months after Bexsero vaccination at 2, 3 and 4 months of age and 6 months after Bexsero vaccination at 2, 4 and 6 months of age.
Maltese: * il-punt ta' żmien qabel il-booster jirrappreżenta l-persistenza tal-antikorpi batteriċidjali 8 xhur wara t-tilqima b'Bexsero meta t-tarbija kellha xahrejn, 3 xhur u 4 xhur u 6 xhur wara t-tilqima b'Bexsero meta t-tarbija kellha xahrejn, 4 xhur u 6 xhur.
English: Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Maltese: Tilqima ta' grupp B (rDNA, komponent, adsorbit)
English: Antibody persistence was evaluated in an extension study in children 3 to 4 years of age.
Maltese: Il-persistenza tal-antikorpi ġiet evalwata fi studju ta' estensjoni fi tfal li kellhom 3 sa 4 snin.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jwettaq l-attivitajiet u interventi meħtieġa ta' farmakoviġilanza deskritti fil-Pjan tal-immaniġġar tar-riskju (RMP) ippreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornamenti sussegwenti li kien hemm qbil dwarhom.
English: Sera were obtained both before vaccination, one month after the third vaccination (see Table 2) and one month after booster vaccination (see Table 3).
Maltese: Inkisbu sera kemm qabel it-tilqima kif ukoll xahar wara t-tielet tilqima (ara Tabella 2) u xahar wara t-tilqima booster (ara Tabella 3).
English: 10 pre-filled syringes each containing 0.5 ml suspension with needles 10 pre-filled syringes each containing 0.5 ml suspension without needles
Maltese: 10 siringi mimlija għal-lest li kull waħda fiha suspensjoni ta' 0.5 ml bil-labar 10 siringi mimlija għal-lest li kull waħda fiha suspensjoni ta' 0.5 ml mingħajr labar
English: At approximately 4 years after the two-dose primary series, the percentages of subjects with hSBA ≥ 1:5 generally declined from a range across strains of 68% to 100% after the second dose to a range across strains of 9% to 84%.
Maltese: individwi b'hSBA ≥ 1:5 ġeneralment naqsu minn medda bejn ir-razez ta' 68 % sa 100 % wara t-tieni doża għal medda bejn ir-razez ta' 9 % sa 84 %.
English: The bactericidal responses against the NHBA antigen were also high in infants vaccinated at the 2, 4, 6-month schedule, but this antigen appeared to be less immunogenic at the 2, 3, 4-month schedule.
Maltese: Ir-risponsi batteriċidjali kontra l-antiġen NHBA kienu wkoll għoljin fi trabi li tlaqqmu fl-iskeda meta kellhom xahrejn, 4, u 6 xhur, iżda dan l-antiġen deher li kien inqas immunoġeniku fl-iskeda ta' xahrejn, 3, u 4 xhur.
English: Yes, one dose with an interval of 12 months to 23 months between the primary series and booster dose c
Maltese: Iva, doża waħda b'intervall ta' 12-il xahar sa 23 xahar bejn is-serje primarja u d-doża booster c
English: % seropositive (95% CI) hSBA GMT (95% CI) 12 months after 2nd dose
Maltese: GMT (95% CI) 12-il xahar wara t-tieni doża
English: Serum bactericidal antibody responses in adolescents one month after two doses of Bexsero administered according to different two-dose schedules and persistence of bactericidal antibody 18 to 23 months after the second dose
Maltese: Risponsi tal-antikorpi batteriċidjali fis-serum fl-adolexxenti xahar wara żewġ dożi ta' Bexsero mogħtija skont skedi differenti ta' żewġ dożi u l-persistenza ta' antikorp batteriċidjali minn 18 sa 23 xahar wara t-tieni doża
English: DD/MM/YYYY
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: The response to a booster dose administered 24-36 months after the primary series was indicative of immunological memory as the percentages of seropositive subjects ranged across strains from 93% to 100% in children 4-7 years of age and from 96% to 100% in children 8-12 years of age.
Maltese: 93 % sa 100 % fi tfal ta' età ta' 4-7 snin u minn 96 % sa 100 % fi tfal ta' età ta' 8-12-il sena.
English: In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).
Maltese: Fi studju ta' estensjoni, il-persistenza tar-rispons immuni ġiet evalwata sena wara d-doża booster (ara Tabella 3).
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 B, even if they develop antibodies following vaccination with Bexsero.
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 B, anki jekk dawn jiżviluppaw antikorpi wara tilqim b'Bexsero.
English: The efficacy of Bexsero has not been evaluated through clinical trials.
Maltese: L-effikaċja ta' Bexsero ma ġietx evalwata permezz ta' studji kliniċi.
English: 0.5 ml suspension in a pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'tapp planġer (lastku tal-bromobutyl ta' Tip I) u b'għatu protettiv tat-tarf (lastku ta' Tip I jew Tip II) bi jew mingħajr labar.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Maltese: Madankollu, it-tilqima m'għandhiex tinżamm milli tingħata meta jkun hemm riskju ċar ta' esponiment għal infezzjoni meningokokkali.
English: Children 12 months to 23 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Maltese: Tfal li jkollhom minn 12-il xahar sa 23 xahar għandhom jirċievu żewġ injezzjonijiet tat-tilqima segwiti minn injezzjoni addizzjonali (booster).
English: In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
Maltese: Fl-adolexxenti u fl-adulti l-iktar reazzjonijiet avversi lokali u sistemiċi komuni osservati kienu wġigħ fis-sit tal-injezzjoni, telqa u wġigħ ta' ras.
English: Rare: urticaria
Maltese: Tqala u treddigħ
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 12 months after 2nd dose
Maltese: GMT** (95% CI) 12-il xahar wara t-tieni doża
English: Gastrointestinal disorders Very common: diarrhoea, vomiting (uncommon after booster)
Maltese: Komuni ħafna: dijarea, rimettar (mhux komuni wara l-booster)
English: At one month following a booster administered 6 months after the last dose, the percentages of seropositive subjects ranged from 87% to 100% for the two-dose schedule, and from 83% to 100% for the three-dose schedule.
Maltese: Xahar wara booster mogħtija 6 xhur wara l-aħħar doża, il-perċentwali ta' individwi seropożittivi varjaw minn 87 % għal 100 % għall-iskeda ta' żewġ dożi u minn 83 % għal 100 % għall-iskeda ta' tliet dożi.
English: Infants, 3 months to 5 months
Maltese: Trabi, 3 xhur sa 5 xhur
English: NAME OF THE MEDICINAL PRODUCT Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Maltese: Tilqima Meningokokkali ta' Grupp B (rDNA, komponent, adsorbit)
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.
Maltese: daqs inċert, mhuwiex dejjem possibbli li ssir stima tal-frekwenza tagħhom b'mod affidabbli u għaldaqstant huma elenkati bil-frekwenza mhux magħrufa.
English: Against each of the vaccine antigens, seroresponse rates and hSBA GMTs were high and similar after the two-dose series in infants 6-8 months of age and children 13-15 months of age.
Maltese: GMTs kienu għoljin u simili wara serje ta' żewġ dożi fi trabi li kellhom 6-8 xhur u tfal żgħar li kellhom 13-15 xahar.
English: Musculoskeletal and connective tissue disorders Very common: arthralgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.
Maltese: Is-sigurtà ta' Bexsero ġiet evalwata fi 17-il studju li kienu jinkludu 10 provi kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali b'10565 individwu (li kellhom minn xahrejn 'il fuq) li rċivew mill-inqas doża waħda ta' Bexsero.
English: Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.
Maltese: Bexsero kien immunoġeniku f'annimali ommijiet li ngħataw it-tilqima qabel it-treddigħ, u ġew osservati antikorpi fil-frieħ, iżda l-livelli ta' antikorpi fil-ħalib ma ġewx stabbiliti.
English: 2, 4, 6, 12 months fHbp pre-booster* % seropositive** (95% CI) hSBA GMT*** (95% CI)
Maltese: Fl-istess studju, ir-rispons għal doża addizzjonali kien indikattiv għal memorja immunoloġika, għax 81%-95% tal-individwi laħqu hSBA ta' ≥ 1:5 għal
English: Data on bactericidal antibody persistence at 8 months after Bexsero vaccination at 2, 3 and 4 months of age, and at 6 months after Bexsero vaccination at 2, 4 and 6 months of age (pre-booster time point) and booster data after a fourth dose of Bexsero administered at 12 months of age are summarised in Table 3.
Maltese: Dejta fuq persistenza tal-antikorpi batteriċidjali wara 8 xhur wara t-tilqima b'Bexsero meta t-tarbija kellha xahrejn, 3 xhur u 4 xhur, u 6 xhur wara t-tilqima b'Bexsero wara li t-tarbija kellha xahrejn, 4 xhur u 6 xhur (punt ta' żmien qabel il-booster) u dejta dwar il-booster wara r-raba' doża ta' Bexsero mogħti meta t-tarbija kellha 12-il xahar qed tintwera fil-qosor f'Tabella 3. Il-persistenza tar-rispons immuni sena wara d-doża booster qed tiġi ppreżentata wkoll f'Tabella 3.
English: Serum bactericidal antibody responses in adults after two doses of Bexsero administered according to different two-dose schedules
Maltese: Risponsi ta' antikorpi batteriċidjali fis-serum fl-adulti wara żewġ dożi ta' Bexsero mogħtija skont skedi differenti ta' żewġ dożi
English: Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating.
Maltese: L-impatt ta' mard invażiv fi gruppi differenti ta' età kif ukoll il-varjabilità ta' epidemijoloġija ta' antiġeni għal razez ta' grupp B f'żoni ġeografiċi differenti għandhom jiġu kkunsidrati meta tingħata t-tilqima.
English: The response to a booster dose administered 7.5 years after the primary series was indicative of immunological memory as the percentages of subjects reaching an hSBA ≥ 1:4 across strains ranged from 93% to 100%.
Maltese: Ir-rispons għal doża booster mogħtija 7.5 snin wara s-serje primarja kien indikattiv tal-memorja immunoloġika peress li l-perċentwali ta' individwi li laħqu hSBA ≥ 1:4 bejn ir-razez varjaw minn 93 % sa 100 %.
English: This will help to reduce some of the side effects of Bexsero.
Maltese: Dan se jgħin biex inaqqas xi wħud mill-effetti sekondarji ta' Bexsero.
English: Injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).
Maltese: L-għoti profilattiku ta' mediċini kontra d-deni waqt it-tilqima u qrib wara li tingħata jista' jnaqqas l-inċidenza u l-intensità ta' reazzjonijiet bid-deni li jseħħu wara t-tilqima.
English: Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis group B.
Maltese: Bexsero hu indikat għal tilqima attiva ta' individwi li jkollhom minn xahrejn 'il fuq kontra mard meningokokkali ikkawżat minn Neisseria meningitidis grupp B.
English: Infants, 2 months to 5 months a
Maltese: Trabi, bejn xahrejn sa 5 xhur a
English: Percentage of adolescents with seroresponse and at least 4-fold rise in bactericidal titers one month after two doses of Bexsero administered according to different two-dose schedules - stratified by pre-vaccination titers
Maltese: Perċentwali ta' adolexxenti b'serorispons u b'mill-inqas żieda ta' 4 darbiet fit-titers batteriċidjali sa xahar wara żewġ dożi ta' Bexsero mogħtija skont skedi differenti ta'
English: Infants 6 months to 11 months of age at the time of first dose
Maltese: Medda ta' età 6 sa 11-il xahar
English: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8).
Maltese: Reazzjonijiet relatati mal-ansjetà, li jinkludu reazzjonijiet vasovagali (sinkope), iperventilazzjoni jew reazzjonijiet relatati mal-istress jistgħu jseħħu b'rabta mat-tilqima bħala rispons psikoġeniku għall-injezzjoni bil-labra (ara sezzjoni 4.8).
English: Following Bexsero vaccination, a high percentage of subjects were seropositive and achieved 4-fold increases in hSBA titers independent of pre-vaccination status.
Maltese: Wara t-tilqima b'Bexsero, perċentwal għoli ta' individwi kienu seropożittiv u kisbu żieda ta' 4 darbiet fit-titers tal-hSBA indipendentement mill-istat ta' qabel it-tilqima.
English: The same study also evaluated antibody persistence data from an additional phase 3 initial study in adolescents.
Maltese: L-istess studju evalwa wkoll dejta dwar il-persistenza tal-antikorpi minn studju inizjali ta' fażi 3 addizzjonali fl-adolexxenti.
English: In the same study the response to an additional dose administered 2 to 3 years after the booster was indicative of immunological memory as shown by a robust antibody response against all Bexsero antigens, ranging from 81% to 100% and from 70% to 99%, respectively.
Maltese: Fl-istess studju, ir-rispons għal doża addizzjonali mogħtija minn sentejn sa 3 snin wara l-booster kien indikattiv tal-memorja immunoloġika kif murija minn rispons robust għall-anitkorpi kontra l-antiġeni ta' Bexsero kollha, li jvarja minn 81 %
English: *** GMT = geometric mean titer.
Maltese: Is-Sistema ta' Typing ta' Antiġen Meningokokkali (MATS).
English: Meningococcal B vaccine
Maltese: U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: IM use
Maltese: Tqala
English: % seropositive (95% CI) hSBA GMT (95% CI)
Maltese: (95% CI) hSBA
English: EXP:
Maltese: SN:
English: Musculoskeletal and connective tissue disorders Very common: myalgia, arthralgia
Maltese: Rari: urtikarja Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Uncommon (these may affect up to 1 in 100 people) - high fever (≥40°C) - seizures (including febrile seizures) - dry skin - paleness (rare after booster)
Maltese: - deni qawwi (≥40°C) - aċċessjonijiet (li jinkludu aċċessjonijiet bid-deni) - ġilda xotta