FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional information in special populations: Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4).
Maltese: Apnea fi trabi prematuri ħafna ( 28 ġimgħa ta' tqala) (ara sezzjoni 4.4).
English: Special Populations
Maltese: Eritema multiforme
English: Placebo group
Maltese: Grupp talplaċebo
English: Bacteraemic pneumonia (approximately 80% of IPD in adults), bacteraemia without a focus, and meningitis are the most common manifestations of IPD in adults.
Maltese: Il-pnewmonja batterimika (madwar 80% ta' IPD fl-adulti), il-batteremija mingħajr fokus, u lmeninġite huma l-aktar manifestazzjonijiet komuni tal-IPD f'adulti.
English: OPA GMT levels at baseline OPA GMT levels one year after Prevenar 13
Maltese: Livelli OPA GMT sena wara Prevenar 13
English: • Vomiting; diarrhoea
Maltese: • Rimettar; dijarea
English: Diarrhoea; vomiting (in adults aged 18 to 49 years)
Maltese: Dijarea; rimettar (f'adulti li kellhom minn 18 sa 49 sena)
English: Adverse reactions from clinical studies
Maltese: Reazzjonijiet avversi mill-istudji kliniċi
English: The third (booster) dose is recommended between 11 and 15 months of age (see section 5.1).
Maltese: It-tielet doża (booster) hi rakkomandata li tingħata bejn l-età ta' 11 u 15-il xahar (ara sezzjoni 5.1).
English: The proportion of infants achieving a pneumococcal anti-capsular polysaccharide IgG concentration ≥ 0.35 g/ml one month after the second dose ranged from 79.6% to 98.5% across 11 of the 13 vaccine serotypes.
Maltese: Il-proporzjon ta' trabi li kisbu konċentrazzjoni ta' ≥ 0.35 μg/ml ta' IgG kontra l-kapsuli pnewmokokkali tal-polysaccharide xahar wara t-tieni doża, varjat minn 79.6% sa 98.5% għal 11 mit-13-il serotip tat-tilqima.
English: The active substances are polysaccharide CRM197 conjugates consisting of:
Maltese: L-eċċipjenti huma konjugati ta' polysaccharide CRM197 li jikkonsistu minn::
English: Between 11 and 15 months of age, your child will receive a fourth injection (booster).
Maltese: Bejn l-età ta' bejn 11 u 15-il xahar, it-tarbija tiegħek se tirċievi r-raba' injezzjoni (booster).
English: Using the screening method, serotype-specific effectiveness estimates for 2 doses under the age of 1 year in the UK were 66 % (-29, 91 %) and 100 % (25, 100 %) for serotype 6B and 23F, respectively.
Maltese: Bl-użu tal-metodu ta' screening, stimi dwar l-effikaċja ta' serotip speċifiku għal 2 dożi mogħtija lil trabi taħt l-età ta' sena fir-Renju Unit kienu 66% (-29, 91%) u 100% (25, 100%) għas-serotipi 6B u 23F, rispettivament.
English: Children and adolescents 5-17 years
Maltese: Tfal u adolexxenti 5 -17-il sena
English: 60-64 Years N=359-404
Maltese: Sena N=359-404
English: Immune system disorders: Uncommon:
Maltese: Disturbi fis-sistema immuni:
English: Prevenar 13 contains the 7 pneumococcal capsular polysaccharides that are in Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) all conjugated to CRM197 carrier protein.
Maltese: Prevenar 13 fih is-7 polysaccharides kapsulari pnewmokokkali li hemm fi Prevenar (4, 6B, 9V, 14, 18Ċ, 19F, 23F) flimkien ma' 6 polysaccharides addizzjonali (1, 3, 5, 6A, 7F, 19A) kollha konjugati mal-proteina carrier CRM197.
English: Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.
Maltese: Prevenar 13 jista' jingħata fl-istess ħin ma' kwalunkwe wieħed mill-antiġeni tat-tilqim li ġej, li jkunu jew bħala tilqim monovalenti inkella bħala taħlita ta' tilqim: difterite, tetnu, pertussis mingħajr ċelluli jew biċ-ċelluli sħaħ, Haemophilus influenzae ta' tip b, poljomelite inattivata, epatite B, (ara sezzjoni 4.4 għal gwida dwar Infanrix hexa), serogrupp Ċ meningokokkali, ħosba, gattone, ħosba Ġermaniża, ġidri r-riħ u vaċċin tar-rotavirus.
English: Table 6: Vaccine efficacy (VE) against clinical CAP
Maltese: Tabella 6: Effikaċja tat-tilqima (VE) kontra CAP
English: Table 4: Summary of effectiveness of 7-valent Prevenar for invasive pneumococcal disease Country (year of introduction)
Maltese: Tabella 4: Sommarju tal-effettività ta' Prevenar 7-valent għal mard pnewmokokkali invażiv Pajjiż (sena tal-introduzzjoni)
English: More than 85% achieved a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 µg/mL 1 month after the infant series, except for serotypes 5 (71.7%), 6A (82.7%), and 6B (72.7%) in the preterm group.
Maltese: Iktar minn 85% kisbu konċentrazzjoni ta' antikorpi pnewmokokkali li jeħlu ma' polysaccharide IgG ta' ≥ 0.35 mg/mL, xahar wara s-serje tat-trabi, ħlief għal serotipi 5 (71.7%), 6A (82.7%), u 6B (72.7%) fil-grupp ta' trabi prematuri.
English: % Incidence reduction (95% CI*)
Maltese: % Tnaqqis flinċidenza (95% CI*)
English: Children < 5
Maltese: Tfal < 5
English: Adults 18 to 49 years of age
Maltese: Adulti li għandhom bejn 18 sa 49 sena
English: Data published by Public Health England showed that, four years after the introduction of Prevenar as a two dose primary infant series with booster dose in the second year of life and with a 94% vaccine uptake, there was a 98% (95% CI 95; 99) reduction in disease caused by the 7 vaccine serotypes in England and Wales.
Maltese: Dejta ppubblikata minn Public Health England uriet li, erba' snin wara l-introduzzjoni ta' Prevenar bħala serje primarja ta' żewġ dożi fit-tfal flimkien ma' doża booster fit-tieni sena ta' ħajja u b'teħid tal-vaċċin ta' 94%, kien hemm tnaqqis ta' 98% (95% CI 95; 99) ta' mard ikkawżat mis-7 serotipi talvaċċin fl-Ingilterra u f'Wales.
English: CLINICAL PARTICULARS
Maltese: * klinika
English: Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine HIV-infected adults ≥ 18 years of age with CD4 ≥ 200 cells/µL (mean 609.1 cells/µL) and viral load < 50,000 copies/ml (mean 330.6 copies/ml), who were free of active AIDS-related illness and were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine administered at least 6 months prior to enrollment, received 3 doses of Prevenar 13, at enrollment, 6 months, and 12 months after the first dose of Prevenar 13.
Maltese: Adulti infettati bl-HIV li kellhom ≥18-il sena b'CD4 ≥200 ċellula/µL (medja ta' 609.1 ċellula/µL) u ammont virali ta' <50,000 kopja/ml (medja ta' 330.6 kopja/mL), li ma kellhomx mard attiv assoċjat mal-AIDS u li fil-passat ingħataw tilqima polysaccharide pnewmokokkali ta' 23 valent mill-inqas 6 xhur qabel ma ġew reġistrati fl-istudju, irċivew 3 dożi ta' Prevenar 13, fir-reġistrazzjoni, 6 xhur, u 12-il xahar wara l-ewwel doża ta' Prevenar 13.
English: The decrease in all cause pneumonia cases was most pronounced in the younger vaccinated age groups with a decrease of 31.8% (757 to 516 cases) and 16.6% (833 to 695 cases) in the age groups <2 years and 2 to 5 years, respectively.
Maltese: It-tnaqqis fil-każijiet ta' kull kawża ta' pnewmonja ma kienx daqshekk evidenti fil-gruppi ta' etajiet imlaqqim iżgħar bi tnaqqis ta' 31.8% (minn 757 għal 516-il każ) u 16.6% (minn 833 għal 695 każ) filgruppi ta' etajiet < sentejn u 2 sa 5 snin, rispettivament.
English: Immune responses to the additional 6 serotypes were also measured.
Maltese: Tkejlu wkoll risponsi immuni għas-6 serotipi addizzjonali.
English: Safety was evaluated in 592 children (294 children aged 5 to 10 years previously immunised with at least one dose of Prevenar and 298 children aged 10 to 17 years who had not received a pneumococcal vaccine).
Maltese: Is-sigurtà ġiet evalwata f'592 tifel/tifla (294 tifel/tifla ta' bejn 5 snin u 10 snin li kienu tlaqqmu qabel b'għallinqas doża waħda ta' Prevenar u 298 tifel/tifla ta' bejn 10 snin u 17-il sena li ma kinux irċievew vaċċin pnewmokokkali).
English: Table 1: Comparison of the proportion of subjects achieving a pneumococcal anti-polysaccharide IgG antibody concentration ≥ 0.35 μg/ml after dose 3 of the infant series - study 006
Maltese: Tabella 1: Paragun tal-proporzjonijiet ta' individwi li kisbu konċentrazzjoni ta' antikorp pnewmokokkali anti-polysaccharide ta' IgG ta' ≥ 0.35 μg/ml wara doża 3 tas-serje tat-trabiStudju 006
English: For 9 serotypes, immune responses were related to age, with adults in the 50-59 years group showing statistically significantly greater responses than adults aged 60-64 years.
Maltese: Għal 9 serotipi, ir-reazzjonijiet immuni kienu relatati mal-età, bl-adulti fil-grupp ta' età ta' bejn il-5059 sena juru rispons akbar, statistikament sinifikanti mill-adulti li kellhom bejn is-60-64 sena.
English: Pneumococcal polysaccharide serotype 9V
Maltese: Polysaccharide pnewmokokkali serotip 9V
English: Arthralgia; myalgia
Maltese: Rimettar, dijarrea
English: In the second year after the introduction of Prevenar 13 the total number of CAP cases due to the 6 additional vaccine serotypes in Prevenar 13 was reduced from 27 to 7 isolates (74%).
Maltese: Fit-tieni sena wara l-introduzzjoni ta' Prevenar 13, in-numru totali ta' każijiet ta' CAP minħabba s-6 serotipi ta' vaċċin addizzjonali fi Prevenar 13 tnaqqas minn 27 għal 7 iżolati (74%).
English: Suspension for injection 1 single-dose (0.5 ml) vial 5 single-dose (0.5 ml) vials 10 single-dose (0.5 ml) vials 25 single-dose (0.5 ml) vials 50 single-dose (0.5 ml) vials
Maltese: Suspensjoni għall-injezzjoni 1 kunjett b'doża waħda (0.5 ml) 5 kunjetti b'doża waħda (0.5 ml) 10 kunjetti b'doża waħda (0.5 ml) 25 kunjett b'doża waħda (0.5 ml) 50 kunjett b'doża waħda (0.5 ml)
English: OPA GMT levels at baseline
Maltese: Livelli OPA GMT fillinja bażi
English: Sodium chloride, succinic acid, polysorbate 80, 2-phenoxyethanol and water for injections
Maltese: Sodium chloride, succinic acid, polysorbate 80, 2-phenoxyethanol u ilma għall-injezzjonijiet
English: For the 7 common serotypes there were no differences between groups in the proportion of subjects with OPA titres ≥ 1:8.
Maltese: Għas-7 serotipi komuni ma kien hemm l-ebda differenzi bejn il-gruppi fil-proporzjon ta' persuni b'titres OPA ta' ≥ 1:8.
English: hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the initial course of injections)
Maltese: ebusija, nefħa fis-sit tat-tilqima ta' 2.5 ċm - 7.0 ċm (wara l-kors inizjali ta' injezzjonijiet).
English: Complete effectiveness for routine 2+1 schedule not yet available.
Maltese: Effikaċja sħiħa għal skeda 2+1 ta' rutina għadha mhux disponibbli.
English: • Hives (urticaria), redness and irritation (dermatitis) and itching (pruritus) at the vaccination-site; flushing
Maltese: • Ħorriqija (urtikarja), ħmura u irritazzjoni (dermatite) u ħakk (prurite) fis-sit tat-tilqima; fwawar
English: Table 3: Summary of efficacy of 7-valent Prevenar
Maltese: Tabella 3: Sommarju tal-effikaċja ta' Prevenar 7-valent
English: Based on a 5-year duration of protection.
Maltese: Ibbażat fuq tul ta' protezzjoni ta' 5 snin.
English: Prevenar 13 elicited increased antibody levels after each dose of Prevenar 13.
Maltese: Prevenar 13 ikkawża żieda fil-livelli ta' antikorpi wara kull doża ta' Prevenar 13.
English: Table 7: OPA GMTs in adults aged 60-64 years given Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) and in adults aged 50-59 years given Prevenar 13
Maltese: Tabella 7: OPA GMTs f'adulti ta' bejn is-60-64 sena li ngħataw Prevenar 13 jew il- vaċċin Polisakkaride pnewmokokkali ta' 23-valenti (PPSV23) u f'adulti ta' bejn il-50-59 sena li ngħataw Prevenar 13
English: 18C 1939 19A 19F 23F Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5.
Maltese: 18C 19A 19F 23F Nuqqas ta' inferjorità ġie definit bħala l-aktar limitu baxx tal-95% CI b'2-naħat għal GMR li kien akbar minn 0.5.
English: Smaller proportions of infants achieved this antibody concentration threshold for serotype 6B (27.9% to 57.3%) and 23F (55.8% to 68.1%) for all studies using a 2, 4 month regimen, compared to 58.4% for serotype 6B and 68.6% for 23F for a study using a 3, 5 month regimen.
Maltese: Porzjonijiet iżgħar ta' trabi kisbu dan il-limitu ta' konċentrazzjoni ta' antikorp għas-serotip 6B (27.9% sa 57.3%) u għal 23F (55.8% sa 68.1%) għall-istudji kollha bl-użu tas-sistema ta' tilqim fit-2, 4 xahar, meta mqabbel ma' 58.4% għas-serotip 6B u 68.6% għal 23F għal studju bl-użu tas-sistema ta' tilqim fit-3, 5 xahar.
English: In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5).
Maltese: Fl-istudji kollha tat-trabi, Prevenar 13 ingħata flimkien ma' tilqim pedjatriku ta' rutina (ara sezzjoni 4.5).
English: Non-inferiority was met for the 6 additional serotypes based on the proportion of infants achieving antibody concentrations ≥ 0.35 μg/ml and comparison of IgG ELISA GMCs in study 006 and was met for 5 out of the 6 serotypes, with the exception of serotype 3 for study 004.
Maltese: In-nuqqas ta' inferjorità ġiet issodisfata għas-6 serotipi addizzjonali bbażata fuq il-proporzjon ta' tfal żgħar li kisbu konċentrazzjonijiet ta' ≥ 0.35 μg/ml ta' antikorp u paragun ma' IgG ELISA GMCs fi studju 006 u ġiet issodisfata għal 5 mis-6 serotipi, bl-eċċezzjoni ta' serotip 3 għal studju 004.
English: 1 dose (0.5 ml) contains:
Maltese: Doża waħda (0.5 ml) fiha:
English: Recurrent AOM (3 episodes in 6 months, or 4 episodes in 1 year) Recurrent AOM (5 episodes in 6 months, or 6 episodes in 1 year) Tympanostomy tube placement
Maltese: AOM rikorrenti (3 episodji f'6 xhur, jew 4 episodji f'sena) AOM rikorrenti (5 episodji f'6 xhur, jew 6 episodji f'sena) Tqegħid ta' tubu tat-timpanostomija
English: Vaccine serotypes: Two doses under age 1: 85%
Maltese: Serotipi tat-tilqima: Żewġ dożi taħt l-età ta' sena: 85%
English: Prevenar (7-valent vaccine) protective efficacy in infants and children
Maltese: Effikaċja protettiva ta' Prevenar (tilqima 7-valent) fi trabi u tfal
English: Significant incidence reductions were also observed in older age groups who had not been vaccinated with Prevenar 13 (indirect effect).
Maltese: Tnaqqis sinifikanti flinċidenza kien osservat ukoll fil-gruppi ta' etajiet akbar li ma kinux tlaqqmu bi Prevenar 13 (effett indirett).
English: Each study included healthy adults and immuno-competent adults with stable underlying conditions known to predispose individuals to pneumococcal infection (i.e., chronic cardiovascular disease, chronic pulmonary disease including asthma, renal disorders and diabetes mellitus, chronic liver disease including alcoholic liver disease), and adults with risk factors such as smoking and alcohol abuse.
Maltese: Kull studju kien jinkludi adulti b'saħħithom u adulti immunokompetenti b'kundizzjonijiet sottostanti stabbli magħrufa li jippredisponu lill-individwi għal infezzjoni pnewmokokkali (jiġifieri, mard kardjovaskulari kroniku, mard pulmonari kroniku inkluż lażżma, mard renali u d-dijabete mellitus, mard kroniku tal-fwied inkluż mard tal-fwied alkoħoliku), u adulti b'fatturi ta' riskju bħal tipjip u abbuż tal-alkoħol.
English: In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%).
Maltese: Fi studju kliniku fi trabi mlaqqmin wara xahrejn, 3 xhur u 4 xhur ta' età, ġie rrapportat deni ≥ 38°C b'rati ogħla fost trabi li rċievew Prevenar (7-valenti) fl-istess ħin ma' Infanrix hexa (28.3% sa 42.3%) milli fi trabi li rċievew Infanrix hexa waħdu (15.
English: Additionally, all 13 serotypes met the pre-defined non-inferiority criterion for IgG GMCs (lower bound of the 97.5% CI of GMC ratio [GMR] was greater than 0.5).
Maltese: Barra minn hekk, it-13-il serotipi kollha ssodisfaw il-kriterju ta' nuqqas ta' inferjorità predefinit għal IgG GMCs (il-limitu l-aktar baxx ta' CI ta' 97.5% tal-proporzjon ta' GMC [GMR] kien ikbar minn 0.5).
English: For serotype 6A †, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR greater than 2.
Maltese: Għas-serotip 6A †, li huwa uniku għal Prevenar 13, rispons akbar, statistikament sinifikanti kien definit bħala l-aktar naħa baxxa tal-95% CI b'2-naħat għall-GMR li kien akbar minn 2.
English: The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and
Maltese: Ir-raba' doża (booster) hi rakkomandata bejn l-età ta' 11 u 15-il xahar (ara sezzjonijiet 4.4 u 5.1).
English: EU/1/09/590/007 EU/1/09/590/008 EU/1/09/590/009 EU/1/09/590/010 EU/1/09/590/011
Maltese: EU/1/09/590/007 EU/1/09/590/008 EU/1/09/590/009 EU/1/09/590/010
English: Pneumococcal polysaccharide serotype 19A
Maltese: Polysaccharide pnewmokokkali serotip 19A
English: 2 ml (4 x 0.5 ml doses) suspension for injection in a container (Type I glass) with a latex-free grey chlorobutyl rubber stopper and sealed with an aluminum flip-off seal and a polypropylene flip-off cap.
Maltese: 2 ml (4 x dożi ta' 0.5 ml) ta' suspensjoni għall-injezzjoni f'kunjett (ħġieġ tat-Tip I) b'tapp tal-lastku griż tal-chlorobutyl mingħajr latex u ssiġillat b'siġill flip-off tal-aluminju u għatu flip-off talpolypropylene.
English: IRR, also referred to as vaccine preventable disease incidence, is the number of cases of vaccine preventable disease per 100,000 person-years of observation.
Maltese: IRR, imsejħa wkoll inċidenza ta' mard li jista' jiġi evitat bit-tilqim, hija n-numru ta' każijiet ta' mard li jista' jiġi evitat bit-tilqim għal kull 100,000 sena ta' persuna ta' osservazzjoni.
English: When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Prevenar (7-valent) and Infanrix hexa (see section 4.8).
Maltese: Meta Prevenar 13 jingħata fl-istess ħin ma' Infanrix hexa (DTPa-HBV-IPV/Hib), ir-rati ta' reazzjonijiet ta' deni huma simili għal dawk li jidhru b'għoti fl-istess ħin ta' Prevenar (7-valenti) u Infanrix hexa (ara sezzjoni 4.8).
English: Safety and immunogenicity of Prevenar 13 given at 2, 3, 4 and 12 months was assessed in approximately 100 prematurely born infants (mean Estimated Gestational Age [EGA], 31 weeks; range, 26 to 36 weeks) and compared with approximately 100 infants born at term (mean EGA, 39 weeks; range, 37 to 42 weeks).
Maltese: Is-sigurtà u l-immunoġeniċità ta' Prevenar 13 mogħti wara 2, 3, 4 u 12-il xahar ġew evalwati f'madwar 100 tarbija prematura (medja ta' Età Smata tal-Ġestazzjoni [EGA - Estimated Gestational Age], 31 ġimgħa; medda, 26-36 ġimgħa) u mqabbla ma' madwar 100 tarbija li twieldu wara tqala normali (medja tal-EGA, 39 ġimgħa; medda, 37 sa 42 ġimgħa).
English: The vaccine is a white suspension for injection, provided in a multidose container (4 x 0.5 ml doses).
Maltese: It-tilqima hi suspensjoni bajda għall-injezzjoni, ipprovduta f'kontenitur b'ħafna dożi (4 x dożi ta' 0.5 ml).
English: Pneumococcal polysaccharide serotype 6A
Maltese: Polysaccharide pnewmokokkali serotip 6A
English: For all pivotal clinical trials, a serotype-specific opsonophagocytosis assay (OPA) was used as a surrogate to assess potential efficacy against invasive pneumococcal disease and pneumonia.
Maltese: Għall-provi kliniċi pivotali kollha, intużat analiżi ta' opsonophagocytosis speċifika għas-serotip (OPA) bħala sostitut biex tivvaluta l-effikaċja potenzjali kontra l-mard pnewmokokkali invażiv u l-pnewmonja.
English: 7-valent Prevenar serotypes
Maltese: Serotipi ta' Prevenar 7-valent
English: In children and adolescents aged 10 to 17 years of age OPA GMTs 1 month after vaccination were noninferior to OPA GMTs in the 5 to 10 year old age group for 12 of the 13 serotypes (except serotype 3).
Maltese: Fi tfal u adoloxxenti ta' bejn 10 snin u 17-il sena, OPA GMTs 1 xahar wara tilqima ma kinux inferjuri għal OPA GMTs fil-grupp ta' età ta' bejn 5 snin sa 10 snin għal 12 mit-13-il serotip (għajr serotip 3).
English: Vomiting; diarrhoea
Maltese: Rimettar; dijarea
English: EU/1/09/590/012 EU/1/09/590/013 EU/1/09/590/014 EU/1/09/590/015 EU/1/09/590/016
Maltese: EU/1/09/590/012 EU/1/09/590/013 EU/1/09/590/014
English: EU/1/09/590/012 - pack of 1 multidose container EU/1/09/590/013- pack of 5 multidose containers EU/1/09/590/014- pack of 10 multidose containers EU/1/09/590/015 - pack of 25 multidose containers EU/1/09/590/016- pack of 50 multidose containers
Maltese: EU/1/09/590/012 - pakkett ta' 1 kontenitur b'ħafna dożi EU/1/09/590/013 - pakkett ta' 5 kontenituri b'ħafna dożi EU/1/09/590/014 - pakkett ta' 10 kontenituri b'ħafna dożi EU/1/09/590/015 - pakkett ta' 25 kontenitur b'ħafna dożi EU/1/09/590/016 - pakkett ta' 50 kontenitur b'ħafna dożi
English: The most common adverse events in children and adolescents 6 to 17 years of age were:
Maltese: L-aktar avvenimenti avversi komuni fi tfal u adolexxenti ta' bejn 6 snin u 17-il sena kienu:
English: UK (England & Wales)
Maltese: Ir-Renju Unit (l-Ingilterra u Wales)
English: Pneumococcal polysaccharide serotype 7F
Maltese: Polysaccharide pnewmokokkali serotip 7F
English: Nervous system disorders: Common:
Maltese: Disturbi fis-sistema nervuża:
English: Pre-filled syringes:
Maltese: Disturbi gastro-intestinali:
English: NCKP: Clinical pneumonia with abnormal chest X-ray
Maltese: NCKP: Pnewmonja klinika b'X-ray anormali tas-sider
English: Prevenar 13 significantly reduced newly identified NP acquisition of the 6 additional serotypes (and serotype 6C) combined and of individual serotypes 1, 6A, 6C, 7F, 19A when compared with Prevenar.
Maltese: Prevenar 13 naqqas b'mod sinifikanti l-akkwiżizzjoni NP identifikata tas-6 serotipi addizzjonali (u s-serotip 6C) flimkien u ta' serotipi 1, 6A, 6C, 7F, 19A individwali meta mqabbla ma' Prevenar.
English: †, which is unique to Prevenar 13, a statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR being greater than 2.
Maltese: †, li huwa uniku għal Prevenar 13, rispons akbar, statistikament sinifikanti kien definit bħala l-aktar naħa baxxa tal-95% CI b'2-naħat għall-GMR li kien akbar minn 2.
English: Table 5: Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population)
Maltese: Effikaċja tat-tilqima (VE) għall-punti aħħarin primarji u sekondarji tal-istudju CAPiTA (popolazzjoni skont il-protokoll)
English: EU/1/09/590/007 - pack of 1 vial EU/1/09/590/008 - pack of 5 vials EU/1/09/590/009 - pack of 10 vials EU/1/09/590/010 - pack of 25 vials EU/1/09/590/011 - pack of 50 vials
Maltese: EU/1/09/590/007 - pakkett ta' 1 kunjett EU/1/09/590/008 - pakkett ta' 5 kunjetti EU/1/09/590/009 - pakkett ta' 10 kunjetti EU/1/09/590/010 - pakkett ta' 25 kunjett EU/1/09/590/011 - pakkett ta' 50 kunjett
English: Higher frequency in some solicited systemic reactions was observed when Prevenar 13 was administered concomitantly with trivalent inactivated influenza vaccine (TIV) compared to TIV given alone (headache, chills, rash, decreased appetite, arthralgia, and myalgia) or Prevenar 13 given alone (headache, fatigue, chills, decreased appetite, and arthralgia).
Maltese: F'ċerti reazzjonijiet sistemiċi solleċitati kienet osservata frekwenza ogħla meta Prevenar 13 ingħata flimkien mal-vaċċin trivalenti mhux attivat tal-influwenza (TIV) meta mqabbel ma' TIV mogħti waħdu (uġigħ ta' ras, tertir ta' bard, raxx, tnaqqis fl-aptit, artralġja, u majalġja) jew Prevenar 13 mogħti waħdu (uġigħ ta' ras, għeja, tertir ta' bard, tnaqqis fl-aptit, u artralġja).
English: Serotypes
Maltese: Serotipi
English: One of the 7 studies included a group of adults (n=899) ranging from 18 to 49 years who received Prevenar 13 and who were not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
Maltese: Wieħed mis-7 studji kien jinkludi grupp ta' adulti (n=899) li letà tagħhom kienet tvarja minn 18 sa 49 sena li rċivew Prevenar 13 u li fil-passat ma kinux imlaqqma b'tilqima polysaccharide pnewmokokkali ta' 23-valent.