FrancophonIA/ELRC3.0 huggingface dataset:
English: In an open-label study in 592 healthy children and adolescents including those with asthma (17.4%) who may be predisposed to pneumococcal infection, Prevenar 13 elicited immune responses to all 13 serotypes.
Maltese: Fi studju ta' tikketta miftuħa f'592 tifel/tifla u adolexxenti b'saħħithom inkluż dawk b'ażżma (17.4%) li jistgħu jkunu predisposti għal infezzjoni pnewmokokkali, Prevenar 13 wassal għal risponsi immuni għat-13-il serotip kollha.
English: The risk for CAP and IPD in adults also increases with chronic underlying medical conditions, specifically, anatomical or functional asplenia, diabetes mellitus, asthma, chronic cardiovascular, pulmonary, kidney or liver disease, and it is highest in those who are immune-suppressed such as those with malignant haematological diseases or HIV infection.
Maltese: Ir-riskju għal CAP u IPD fl-adulti jiżdied ukoll ma' kundizzjonijiet mediċi sottostanti kroniċi, speċifikament asplenija anatomika jew funzjonali, dijabete mellitus, ażżma, mard kroniku kardjovaskulari, mard pulmonari, mard tal-kliewi jew mard tal-fwied, u huwa l-ogħla f'dawk li jkunu immunosoppressi bħal dawk b'mard ematoloġiku malinn jew b'infezzjoni bl-HIV.
English: Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Maltese: Adulti li tlaqqmu fil-passat b'tilqima polysaccharide pnewmokokkali ta' 23 valent
English: EU/1/09/590/002 - pack of 1 with separate needle EU/1/09/590/001 - pack of 1 without needle EU/1/09/590/004 - pack of 10 with separate needles EU/1/09/590/003 - pack of 10 without needle EU/1/09/590/006 - pack of 50 with separate needles EU/1/09/590/005 - pack of 50 without needle
Maltese: EU/1/09/590/002 - pakkett b'wieħed b'labra separata EU/1/09/590/001 - pakkett b'wieħed mingħajr labra EU/1/09/590/004 - pakkett b'10 b'labar separati EU/1/09/590/003 - pakkett b'10 mingħajr labra EU/1/09/590/006 - pakkett b'50 b'labar separati EU/1/09/590/005 - pakkett b'50 mingħajr labra
English: The effect of pneumococcal conjugate vaccination on nasopharyngeal carriage was studied in a randomised double-blind study in which infants received either Prevenar 13 or Prevenar (7-valent) at 2, 4, 6 and 12 months of age in Israel.
Maltese: L-effett tat-tilqima tal-konjugat pnewmokokkali fuq il-ġarr nasofarinġeali ġie studjat fi studju doubleblind randomizzat li fih, it-trabi rċievew jew Prevenar 13 jew Prevenar (7-valenti) wara xahrejn, 4, 6 u 12-il xahar ta' età f'Israel.
English: Overall, the frequency categories were similar for all age groups, with the exception of vomiting which was very common ( 1/10) in adults aged 18 to 49 years and common ( 1/100 to < 1/10) in all other age groups, and pyrexia was very common in adults aged 18 to 29 years and common in all other age groups.
Maltese: B'mod ġenerali, il-kategoriji ta' frekwenza kienu simili għall-gruppi kollha ta' età, bl-eċċezzjoni ta' rimettar li kien komuni ħafna ( 1/10) f'adulti li kellhom bejn 18 sa 49 sena u komuni ( 1/100 sa < 1/10) fil-gruppi l-oħrajn kollha ta' età, u deni li kien komuni ħafna f'adulti li kellhom minn 18 sa 29 sena u komuni fil-gruppi l-oħrajn kollha ta' età.
English: The non-inferiority immune response comparisons for study 006, based on the proportion of infants achieving anti-polysaccharide IgG concentrations ≥ 0.35 μg/ml, are shown in Table 1.
Maltese: Il-paraguni tar-rispons immuni tan-nuqqas ta' inferjorità għal studju 006, ibbażati fuq il-proporzjon ta' tfal żgħar li kisbu konċentrazzjonijiet IgG anti-polysaccharide ta' ≥ 0.35 μg/ml, qed jintwerew f'Tabella 1.
English: Pregnancy
Maltese: Invażiv
English: Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.
Maltese: Tilqima attiva għall-prevenzjoni ta' mard invażiv u pnewmonja kkawżati minn Streptococcus pneumoniae f'adulti li għandhom ≥18-il sena u fl-anzjani.
English: Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥ 18 years of age and the elderly.
Maltese: Tilqima attiva għall-prevenzjoni ta' mard invażiv u pnewmonja kkawżati minn Streptococcus pneumoniae f'adulti li għandhom ≥ 18-il sena u fl-anzjani.
English: Excipients with known effect For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease The immunogenicity of Prevenar has been investigated in an open-label, multicentre study in 49 infants with sickle cell disease.
Maltese: L-immunoġeniċità ta' Prevenar ġiet investigata fi studju open-label, multiċentriku, li sar fuq 49 tarbija bil-marda taċ-ċelluli sickle.
English: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
Maltese: Tilqima attiva għall-prevenzjoni ta' mard invażiv, pnewmonja u infjammazzjoni akuta fil-parti tannofs tal-widna kkawżata minn Streptococcus pneumoniae fi trabi, tfal u adolexxenti li għandhom minn 6 ġimgħat sa 17-il sena.
English: Infants aged 6 weeks to 6 months of age
Maltese: Tfal u adolexxenti ta' bejn 6 snin u 17-il sena
English: After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone.
Maltese: 0% tat trabi li rċievew Prevenar (7-valenti) u Infanrix hexa fl-istess ħin meta mqabbel ma' 33.6% tat trabi li rċievew Infanrix hexa waħdu.
English: Immunogenicity and safety of Prevenar 13 has been demonstrated in adults aged 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.
Maltese: L-immunoġeniċità u s-sigurtà ta' Prevenar 13 intwerew f'adulti li għandhom 'l fuq minn 18-il sena inkluż dawk preċedentement ivvaċċinati bil-vaċċin polisakkaride pnewmokokkali.
English: A first episode of hospitalised, chest X-ray confirmed pneumonia was identified in about 2% of this population (n=1,814 subjects) of which 329 cases were confirmed pneumococcal CAP and 182 cases were VT pneumococcal CAP in the per protocol and modified intent to treat (mITT) populations.
Maltese: L-ewwel episodju ta' kura fl-isptar minħabba pnewmonja kkonfermata permezz ta' X-ray tas-sider, ġie identifikat f'madwar 2% ta' din il-popolazzjoni (n=1,814-il individwu) li minnhom 329 każ kienu CAP pnewmokokkali kkonfermata u 182 każ kienu CAP pnewmokokkali ta' VT fil-popolazzjonijiet skont il-protokoll u modifikati b'intenzjoni li jiġu kkurati (mITT).
English: Children and adults not previously vaccinated with a pneumococcal vaccine HIV-infected children and adults with CD4 ≥ 200 cells/µL (mean 717.0 cells/μL), viral load < 50,000 copies/ml (mean 2090.0 copies/ml), free of active AIDS-related illness and not previously vaccinated with a pneumococcal vaccine received 3 doses of Prevenar 13.
Maltese: Tfal u adulti infettati bl-HIV b'CD4 ta' ≥ 200 b'ċelluli/µL (medja 717.0 b'ċelluli/μL), ammont virali ta' < 50,000 kopji/mL (medja ta' 2090.
English: Pre-filled syringe
Maltese: Uġigħ fil-muskoli
English: Infants aged 7 to 11 months should receive two injections.
Maltese: Trabi li għandhom minn 7 xhur sa 11-il xahar għandhom jirċievu żewġ injezzjonijiet.
English: Metabolism and nutrition disorders: Very common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: In these two studies pneumococcal immune responses were compared using a set of non-inferiority criteria including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG ≥ 0.35 μg/ml one month after the primary series and the comparison of IgG geometric mean concentrations (ELISA GMCs); in addition, functional antibody titres (OPA) between subjects receiving Prevenar 13 and Prevenar were compared.
Maltese: F'dawn iż-żewġ studji, risponsi pnewmokokkali immuni tqabblu bl-użu ta' sett ta' kriterji dwar nuqqas ta' inferjorità fosthom il-perċentwal ta' individwi b'IgG anti-polysaccharide speċifiku għas-serotip ta' ≥ 0.35 μg/ml fis-serum xahar wara s-serje primarja u t-tqabbil tal-konċentrazzjonijiet ġeometriċi medji ta' IgG (ELISA GMCs); flimkien ma' dan, tqabblu t-titres funzjonali tal-antikorp (OPA) bejn lindividwi li kienu qed jirċievu Prevenar 13 u Prevenar.
English: Invasive Pneumococcal Disease
Maltese: Analiżi talepisodji kollha
English: The first dose was administered at 3 to 6 months after HSCT.
Maltese: Lewwel doża ngħatat minn 3 sa 6 xhur wara HSCT.
English: Prevenar 13 Effectiveness
Maltese: Prevenar 1 3 Prevenar
English: Clinical studies with Prevenar 13 currently provide immunogenicity data in adults aged 18 years and older, including adults aged 65 and older previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine, 5 years prior to enrollment.
Maltese: Bħalissa l-istudji kliniċi bi Prevenar 13 jipprovdu dejta dwar l-immunoġeniċità fl-adulti li għandhom 'l fuq minn 18-il sena, inkluż adulti 'l fuq minn 65 sena li preċedentement tlaqqmu b'doża waħda jew aktar tal-vaċċin polisakkaride pnewmokokkali ta' 23-valenti, 5 snin qabel l-istudju.
English: In adults aged 50-59 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years.
Maltese: Fl-adulti li kellhom bejn il-50-59 sena, l-OPA GMTs għat-13-il serotip kollha fi Prevenar 13 kienu non-inferjuri għar-reazzjonijiet għal Prevenar 13 fl-adulti li kellhom bejn is-60-64 sena.
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Maltese: Il-batterji jistgħu jkunu responsabbli għal 60-70% tal-episodji kliniċi ta' AOM. S. pneumoniae hu wieħed mill-iktar kawżi komuni ta' AOM batterjali madwar id-dinja.
English: Both studies were randomised, double-blind, active-control studies in which infants were randomised to receive either Prevenar or control vaccine (NCKP, meningococcal serogroup C CRM-conjugate [MnCC] vaccine; FinOM, hepatitis B vaccine) in a four-dose series at 2, 4, 6, and 12-15 months of age.
Maltese: Iż-żewġ studji kienu studji randomised, double-blind, b'kontroll attiv, fejn it-trabi ntgħażlu b'mod randomised biex jew jirċievu Prevenar jew inkella tilqima ta' kontroll (NCKP, tilqima meningokokkali tas-serogrupp C konjugat ma' CRM [MnCC]; FinOM, tilqima kontra l-epatite B) f'serje ta' erba' dożi f'etàjiet ta' xahrejn, 4 xhur, 6 xhur, u minn 12-15-il xahar.
English: A post-hoc analysis was used to estimate the following public health outcomes against clinical CAP (as defined in the CAPiTA study, and based on clinical findings regardless of radiologic infiltrate or etiologic confirmation): vaccine efficacy (VE), incidence rate reduction (IRR), and number needed to vaccinate (NNV) (Table 6).
Maltese: Intużat analiżi post-hoc biex issir stima tar-riżultati li ġejjin li nkisbu fil-qasam tas-saħħa pubblika kontra CAP klinika (kif definita fl-istudju CAPiTA, u bbażata fuq is-sejbiet kliniċi irrispettivament mill-infiltrat radjoloġiku jew konferma etjoloġika): effikaċja tat-tilqima (VE), tnaqqis fir-rata ta' inċidenza (IRR), u l-għadd meħtieġ għat-tilqim (NNV) (Tabella 6).
English: In adults vaccinated with pneumococcal polysaccharide vaccine at least 5 years prior to the clinical study, OPA GMTs to Prevenar 13 were non-inferior to the 23-valent pneumococcal polysaccharide vaccine responses for the 12 serotypes in common.
Maltese: Fl-adulti li tlaqqmu bil-vaċċin polisakkaride pnewmokokkali mill-inqas 5 snin qabel l-istudju kliniku, l-OPA GMTs għal Prevenar 13 kienu non-inferjuri għar-rispons għall-vaċċin polisakkaride pnewmokokkali ta' 23-valenti għat-12-il serotip in komuni.
English: Pneumococcal polysaccharide serotype 18C
Maltese: Polysaccharide pnewmokokkali serotip 18Ċ
English: Adults 50-59 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Maltese: Adulti ta' bejn il-50-59 sena li ma kienux preċedentement ivvaċċinati bil-vaċċin polisakkaride pnewmokokkali ta' 23-valenti
English: Table 8 shows OPA GMTs 1-month after a single dose of Prevenar 13 in 18-49 year olds compared to 60-64 year olds.
Maltese: Tabella 8 turi OPA GMTs xahar wara doża waħda ta' Prevenar 13 f'persuni li kellhom 18-49 sena meta mqabbla ma' dawk li kellhom 60-64 sena.
English: However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see section 5.1).
Maltese: Madankollu, it-titres medji ġeometriċi ta' OPA kienu iktar baxxi minn dawk kontra kull wieħed mill-bqija tas-serotipi tat-tilqima addizzjonali; ir-rilevanza klinika ta' din l-osservazzjoni għalleffikaċja protettiva mhijiex magħrufa (ara sezzjoni 5.1).
English: Tηλ: +357 22 817690
Maltese: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690
English: Three-dose primary series
Maltese: Punt aħħari primarju
English: S. pneumoniae is the most frequent cause of CAP, and is estimated to be responsible for approximately 30% of all CAP cases requiring hospitalisation in adults in developed countries.
Maltese: S. pneumoniae hi liktar kawża frekwenti ta' CAP, u hu stmat li hi responsabbli għal madwar 30% tal-każijiet kollha ta' CAP li jeħtieġu kura fl-isptar fl-adulti f'pajjiżi żviluppati.
English: • Decreased appetite; headaches; diarrhoea; vomiting (for those 18 to 49 years of age) • Chills; tiredness; rash; pain, redness, swelling hardness or tenderness at the vaccination-site,
Maltese: • Irritabilità; uġigħ, sensittività, ħmura, nefħa jew ebusija fis-sit tat-tilqima; ngħas; irqad bla kwiet; sensittività fis-sit tat-tilqima li tinterferixxi mal-moviment
English: Antibody persistence and immunological memory were evaluated in a study in healthy children who received a single dose of Prevenar 13 at least 2 years after they had been previously immunised with either 4 doses of Prevenar, a 3-dose infant series of Prevenar followed by Prevenar 13 at 12 months of age, or 4 doses of Prevenar 13.
Maltese: Il-persistenza tal-antikorpi u l-memorja immunoloġika ġew evalwati fi studju fi tfal b'saħħithom li rċevew doża waħda ta' Prevenar 13 mill-inqas sentejn wara li kienu preċedentement imlaqqma jew b'4 dożi ta' Prevenar, serje ta' 3 dożi ta' Prevenar għat-trabi segwiti minn Prevenar 13 fl-età ta' 12-il xahar, jew 4 dożi ta' Prevenar 13.
English: Pneumococcal polysaccharide serotype 5
Maltese: Polysaccharide pnewmokokkali serotip 5
English: Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age.
Maltese: L-għoti taħt il-ġilda ta' Prevenar 13 kien evalwat fi studju mhux komparattiv f'185 trabi u tfal Ġappuniżi f'saħħithom li rċivew 4 dożi meta kellhom 2, 4, 6 u 12-15-il xahar.
English: Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media.
Maltese: Prevenar 13 ser jipproteġi biss kontra s-serotipi ta' Streptococcus pneumoniae inklużi fit-tilqima, u mhux ser jipproteġi kontra mikro-organiżmi oħrajn li jikkawżaw mard invażiv, pnewmonja jew infjammazzjoni fil-parti tan-nofs tal-widna.
English: Effectiveness of Prevenar in a 3+1 schedule has also been observed against acute otitis media and pneumonia since its introduction in a national immunisation programme.
Maltese: L-effikaċja ta' Prevenar bi skeda 3+1 ġiet osservata wkoll kontra infjammazzjoni akuta fil-parti tannofs tal-widna u pnewmonja sa mill-introduzzjoni tagħha fi programm nazzjonali ta' tilqim.
English: In both the children 5 to 10 years of age and children and adolescents aged 10 to 17 years, the immune response to Prevenar 13 was non inferior to Prevenar for the 7 common serotypes and to Prevenar 13 for the 6 additional serotypes compared to the immune response after the fourth dose in infants vaccinated at 2, 4, 6 and 12-15 months of age as measured by serum IgG.
Maltese: Kemm fit-tfal ta' bejn 5 snin u 10 snin kif ukoll fl-adolexxenti ta' bejn 10 snin u 17-il sena, ir-rispons immuni għal Prevenar 13 ma kienx inferjuri għal Prevenar għas-7 serotipi komuni u għal Prevenar 13 għas-6 serotipi addizzjonali meta mqabbla mar-rispons immuni wara r-raba' doża fi trabi mlaqqma wara 2, 4, 6 u 12-15-il xahar kif imkejjel b'serum IgG.
English: A trend to lower frequency of adverse reactions was associated with greater age; adults > 65 years of age (regardless of prior pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally most common in the youngest adults, 18 to 29 years of age.
Maltese: Andament għal frekwenza iktar baxxa ta' reazzjonijiet avversi ġie assoċjata ma' età akbar; adulti li kellhom > 65 sena (irrispettivament mill-istat preċedenti ta' tilqima pnewmokokkali) irrappurtaw inqas reazzjonijiet avversi minn adulti iżgħar, bir-reazzjonijiet avversi li kienu ġeneralment l-iktar komuni fl-iżgħar adulti, li kellhom minn 18 sa 29 sena.
English: Urticaria or urticaria-like rash
Maltese: Urtikarja jew raxx qisu tal-urtikarja
English: Children and adolescents with sickle cell disease, HIV infection, or an haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that headaches, vomiting, diarrhoea, pyrexia, fatigue, arthralgia, and myalgia were very common.
Maltese: Tfal u adolexxenti bil-marda taċ-ċelluli sickle, infezzjoni bl-HIV jew li għandhom trapjant taċ-ċellola staminali ematopojetiku għandhom frekwenzi simili ta' reazzjonijiet avversi, ħlief li wġigħ ta' ras, rimettar, dijarea, deni, għeja, artralġja u wġigħ fil-muskoli kienu komuni ħafna.
English: Adults ≥ 70 years vaccinated with 23-valent pneumococcal polysaccharide vaccine at least 5 years prior
Maltese: Adulti li kellhom ≥ 70 sena vvaċċinati bilvaċċin polysaccharide pnewmokokkali 23valent mill-anqas 5 snin qabel
English: Overall, no significant differences in frequencies of adverse reactions were seen when Prevenar 13 was given to adults previously vaccinated with the pneumococcal polysaccharide vaccine.
Maltese: B'mod ġenerali, ma dehru l-ebda differenzi sinifikanti fil-frekwenzi ta' reazzjonijiet avversi meta Prevenar 13 ingħata lil adulti li preċedentement tlaqqmu bil-vaċċin polisakkaride pnewmokokkali.
English: • Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site;
Maltese: • Deni; irritabilità; uġigħ, sensittività, ħmura, nefħa, jew ebusija fis-sit tat-tilqima; ngħas, irqad bla kwiet
English: In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV).
Maltese: F'żewġ studji li saru fuq adulti li kellhom bejn il-50-59 u 'l fuq minn 65 sena, intwera li Prevenar 13 jista' jingħata flimkien mal-vaċċin trivalenti mhux attivat tal-influwenza (TIV).
English: Pack of 1, 10 and 50 pre-filled syringe, with or without needle - WITH BLUE BOX
Maltese: Pakkett b'1, b'10 u b'50 siringa mimlija għal-lest, bil-labra jew mingħajrha - BIL-KAXXA BLU
English: Rash; urticaria or urticaria-like rash
Maltese: Risponsi immuni wara l-għoti taħt il-ġilda
English: Pneumococcal immune responses were compared using non-inferiority criteria, including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG concentration ≥0.35 μg/ml and the comparison of IgG GMCs one month after the infant series.
Maltese: Ir-risponsi pnewmokokkali immuni tqabblu bl-użu ta' kriterji dwar nuqqas ta' inferjorità, inkluż ilperċentwal ta' individwi b'IgG anti-polysaccharide speċifiku għas-serotip ta' ≥0.
English: The duration of protective efficacy against a first episode of VT pneumococcal CAP, NB/NI VT pneumococcal CAP, and VT-IPD extended throughout the 4-year study.
Maltese: It-tul tal-effikaċja protettiva kontra l-ewwel episodju ta' CAP pnewmokokkali ta' VT, CAP pnewmokokkali ta' VT NB/NI, u VT-IPD estenda matul l-istudju ta' 4 snin.
English: Pivotal trials for Prevenar 13 were designed to show that functional OPA antibody responses for the 13 serotypes are non-inferior, and for some serotypes superior, to the 12 serotypes in common with the licensed 23-valent pneumococcal polysaccharide vaccine [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A,
Maltese: Il-provi pivotali għal Prevenar 13 ġew iddisinjati biex juri li hemm nuqqas ta' inferjorità fir-rispons tal-antikorp OPA funzjonali għat-13-il serotip, u għal xi serotipi huwa superjuri, għat-12-il serotip in komuni mal-vaċċin liċenzjat polisakkaride pnewmokokkali ta' 23-valenti [1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] xahar wara li ngħata l-vaċċin.
English: An open label single arm study in France, Italy, UK, US, Lebanon, Egypt and Saudi Arabia with 2 doses of Prevenar 13 given 6 months apart was conducted in 158 children and adolescents ≥ 6 to
Maltese: Studju open label, b'fergħa waħda fi Franza, l-Italja, ir-Renju Unit, l-Istati Uniti, il-Libanu, l-Eġittu u s-Sawdi Arabja, b'2 dożi ta' Prevenar 13 mogħtija b'intervall ta' 6 xhur bejniethom, twettaq fuq 158
English: Pneumococcal polysaccharide serotype 3
Maltese: Polysaccharide pnewmokokkali serotip 3
English: Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant (see section 5.1).
Maltese: Dejta dwar is-sigurtà u l-immunoġeniċità hi disponibbli għal numru limitat ta' individwi bil-marda taċ-ċelluli sickle, infezzjoni bl-HIV jew li għandhom trapjant taċ-ċellola staminali ematopojetiku (ara sezzjoni 5.1).
English: In Table 6, NNV is a measure that quantifies the number of people that need to be vaccinated in order to prevent one clinical CAP case.
Maltese: F'Tabella 6, NNV huwa kejl li jikkwantifika l-għadd ta' nies li għandhom bżonn jingħataw it-tilqima sabiex jiġi evitat każ wieħed ta' CAP klinika.
English: Disease reduction, % 95% CI
Maltese: Tnaqqis fil-mard, % 95% CI
English: Prevenar 13 is estimated to cover over 90% of serotypes causing antimicrobial-resistant IPD.
Maltese: Prevenar 13 hu stmat li jkopri iktar minn 90% tas-serotipi li jikkawżaw IPD reżistenti għallantimikrobiċi.
English: All pneumococcal AOM
Maltese: Ilma għall-injezzjonijiet
English: The other ingredients are sodium chloride, succinic acid, polysorbate 80, 2- phenoxyethanol and water for injections.
Maltese: Is-sustanzi l-oħra huma sodium chloride, succinic acid, polysorbate 80, 2- phenoxyethanol u ilma għall-injezzjonijiet.
English: Studies in unvaccinated children (12-23 months) with Prevenar (7-valent) demonstrated that 2 doses were required to achieve serum IgG concentrations for 6B and 23F similar to those induced by a 3-dose infant series.
Maltese: L-istudji mwettqa fi tfal mhux imlaqqma (12-23 xahar) bi Prevenar (7-valenti) urew li kienu meħtieġa 2 dożi sabiex jinkisbu konċentrazzjonijiet IgG ta' serum għal 6B u 23F li huma simili għal dawk indotti minn serje ta' 3 dożi għat-trabi.
English: (2006) 2, 4, + 13 months
Maltese: 2, 4, u 13-il xahar
English: Immune responses to serotype 6A were statistically significantly greater following vaccination with Prevenar 13 than after 23-valent pneumococcal polysaccharide vaccine.
Maltese: Ir-rispons immuni għas-serotip 6A kien akbar, b'mod sinifikanti wara l-vaċċinazzjoni bi Prevenar 13 milli wara l-vaċċin polisakkaride pnewmokokkali ta' 23-valenti.
English: Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5.
Maltese: Nuqqas ta' inferjorità kien definit bħala l-aktar limitu baxx tal-95% CI b'2-naħat għal GMR li kien akbar minn 0.5.
English: In the same study another group of adults aged 50-59 years and another group of adults aged 18-49 years received a single dose of Prevenar 13.
Maltese: Fl-istess studju grupp ieħor ta' adulti li kellhom bejn il-50-59 sena u grupp ieħor ta' adulti li kellhom minn 18 sa 49 sena rċevew doża unika ta' Prevenar 13.
English: Prevenar 13 elicited comparable, although slightly lower, antibody levels than Prevenar for the 7 common serotypes.
Maltese: Prevenar 13 kien komparabbli għalkemm ikkawża livelli ta' antikorp kemxejn aktar baxxi minn Prevenar għas-7 serotipi komuni.