FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: Prevenar (7-valent) effectiveness
Maltese: Effikaċja ta' Prevenar (7-valent)
English: Detailed information on this product is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Prevenar 13 50-59 Relative to 60-64 Years
Maltese: Prevenar 13 50-59 mqabbel ma' 60-64
English: Vaccination-site erythema, induration/swelling > 7.0 cm; crying
Maltese: Eritema fis-sit tat-tilqima, ebusija/nefħa ta' > 7.0 ċm; biki
English: 0.5 ml suspension for injection in a vial (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: 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 tal-polypropylene.
English: Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness.
Maltese: Reazzjonijiet avversi rrapportati fi studji klinikiċi jew f'esperjenza ta' wara t-tqegħid fis-suq għallgruppi ta' età kollha huma elenkati f'din is-sezzjoni skont is-sistema ta' klassifika tal-organi, f'ordni dixxendentali ta' frekwenza u serjetà.
English: EU/1/09/590/001 EU/1/09/590/002 EU/1/09/590/003 EU/1/09/590/004 EU/1/09/590/005 EU/1/09/590/006
Maltese: EU/1/09/590/001 EU/1/09/590/002 EU/1/09/590/003 EU/1/09/590/004
English: Irritability; any vaccination-site erythema; induration/swelling or pain/tenderness; somnolence; poor quality sleep; vaccination-site tenderness (including impaired movement)
Maltese: Irritabilità; kwalunkwe eritema fis-sit tat-tilqima; twebbis/nefħa jew uġigħ/sensittività; ħedla; irqad ta' kwalità dgħajfa; sensittività fis-sit talinjezzjoni (inkluż moviment indebolit)
English: Prevenar 13 immunogenicity clinical studies in infants, children and adolescents
Maltese: Studji Kliniċi dwar l-Immunoġeniċità ta' Prevenar 13 fi trabi, tfal u adolexxenti
English: For Prevenar 13 recipients, the proportion of responders with an OPA titre  1:8 was at least 87 % following the infant series, and at least 93% following the booster dose.
Maltese: Għar-reċipjenti ta' Prevenar 13, ilproporzjon ta' responders b'titre OPA  1:8 kien mill-inqas 87% wara s-serje tat-trabi, u mill-inqas 93% wara d-doża booster.
English: Pneumococcal polysaccharide serotype 23F
Maltese: Polysaccharide pnewmokokkali serotip 23F
English: Pyrexia > 39°C; vaccination-site movement impairment (due to pain); vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm (after infant series)
Maltese: Deni ta' > 39°C; indeboliment fiċ-ċaqliq fis-sit tat-tilqima (minħabba l-uġigħ); eritema fis-sit tat-tilqima jew ebusija/nefħa minn 2.5 ċm-7.0 ċm (wara s-serje tat-trabi)
English: This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).
Maltese: Din id-doża ta' Prevenar 13 għandha tingħata għallinqas 8 ġimgħat wara d-doża finali ta' Prevenar (7-valenti) (ara sezzjoni 5.1).
English: • Rash; hives (urticaria or urticaria-like rash)
Maltese: • Raxx; ħorriqija (urtikarja jew raxx simili għal urtikarja)
English: • Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
Maltese: • Reazzjoni allerġika severa li tinkludi xokk (kollass kardjovaskulari); anġjoedima (nefħa fix xufftejn,fil-wiċċ jew fil-gerżuma)
English: HIV infection
Maltese: Infezzjoni bl-HIV
English: Immune responses following a two-dose primary infant series
Maltese: Risponsi immuni wara serje primarja tat-trabi li tikkonsisti fi tliet dożi
English: Following the introduction of Prevenar and subsequently Prevenar 13 there was a decline in incidence from 2.1 to 0.1 cases per 1000 children (95%) for the Prevenar serotypes plus serotype 6A and a decline in incidence from 0.9 to 0.1 cases per 1000 children (89%) for the additional serotypes 1, 3, 5, 7F, and 19A in Prevenar 13.
Maltese: Wara l-introduzzjoni ta' Prevenar u sussegwentement Prevenar 13 kien hemm tnaqqis fl-inċidenza minn 2.1 għal 0.1 każijiet għal kull 1000 tifel u tifla (95%) għas-serotipi ta' Prevenar flimkien masserotip 6A u tnaqqis fl-inċidenza minn 0.9 għal 0.1 każijiet għal kull 1000 tifel u tifla (89%) għasserotipi addizzjonali 1, 3, 5, 7F u 19A f'Prevenar 13.
English: • Hives (urticaria or urticaria-like rash)
Maltese: • Ħorriqija (urtikarja jew raxx qisu tal-urtikarja)
English: Subsequently, four years following the switch to Prevenar 13, the additional reduction in incidence of IPD due to the 7 serotypes in Prevenar ranged from 76% in children less than 2 years of age to 91% in children 5-14 years of age.
Maltese: Sussegwentement, erba' snin wara l-qlib għal Prevenar 13, it-tnaqqis addizzjonali fl-inċidenza ta' IPD minħabba s-7 serotipi fi Prevenar varja minn 76% fit-tfal li għandhom anqas minn sentejn sa 91% fi tfal li għandhom bejn 5 u 14-il sena.
English: Non-inferiority for the proportion of subjects achieving an IgG concentration 0.35 μg/ml was demonstrated for all 13 serotypes (lower bound of the 97.5% confidence interval (CI) for the difference in percentage of responders at 0.35 µg/ml between groups was >-10%).
Maltese: In-nuqqas ta' inferjorità għall-proporzjon ta' individwi li kisbu konċentrazzjoni IgG 0.35 μg/ml intwera għat-13-il serotipi kollha (il-limit l-aktar baxx tal-intervall ta' kunfidenza ta' 97.5% (CI, confidence interval) għad-differenza fil-perċentwal ta' dawk li wieġbu f'0.35 µg/ml bejn gruppi kien >-10%).
English: Children and Adolescents 5 to 17 years of age
Maltese: Tfal u Adolexxenti ta' bejn 5 snin u 17-il sena
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Safety and immunogenicity of Prevenar 13 containing the preservative 2-PE (presented in a multidose container) given to healthy infants at 8, 12 and 16 weeks of age were compared to those of Prevenar 13 without added preservative (250 infants per group).
Maltese: Is-sigurtà u l-immunoġeniċità ta' Prevenar 13 li fihom il-preservattiv 2-PE (ippreżentat f'kontenitur ta' ħafna dożi) mogħti lil trabi f'saħħithom fl-età ta' 8, 12 u 16-il ġimgħa tqabblu ma' dawk ta' Prevenar 13 mingħajr preservattiv miżjud (250 tarbija għal kull grupp).
English: Additional serotypes covered by Prevenar 13
Maltese: Serotipi addizzjonali koperti minn Prevenar 13
English: 0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (latex-free chlorobutyl rubber) and protective-tip cap (latex-free isoprene bromobutyl rubber).
Maltese: 0.5 ml ta' suspensjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieġ tat-Tip I) bi planġer li tagħlaq (tal-lastku chlorobutyl mingħajr latex) u għatu li jipproteġi l-ponta (tal-lastku isoprene bromobutyl mingħajr latex).
English: Two-dose primary series
Maltese: Punt aħħarin sekondarji
English: Pneumococcal polysaccharide serotype 6B
Maltese: Polysaccharide pnewmokokkali serotip 6B
English: Based on surveillance data following the introduction of Prevenar but before the introduction of Prevenar 13 in childhood vaccination programmes, the pneumococcal serotypes in Prevenar 13 may be responsible for at least 50 - 76% (depending on country) of IPD in adults.
Maltese: Abbażi ta' dejta ta' sorveljanza wara l-introduzzjoni ta' Prevenar iżda qabel l-introduzzjoni ta' Prevenar 13 fi programmi ta' tilqim waqt it-tfulija, is-serotipi pnewmokokkali fi Prevenar 13 jistgħu jkunu responsabbli għal mill-inqas 50 - 76% (jiddependi mill-pajjiż) tal-IPD f'adulti.
English: Five clinical studies were conducted in Europe and the USA evaluating the immunogenicity of Prevenar 13 in different age groups ranging from 18-95 years of age.
Maltese: Saru ħames studji kliniċi fl-Ewropa u fl-Istati Uniti li evalwaw l-immunoġeniċità ta' Prevenar 13 fi gruppi differenti ta' età li varjaw minn 18-95 sena.
English: For serotype 6A
Maltese: Għas-serotip 6A
English: In all adults ≥ 50 years who received a single dose of Prevenar 13, the OPA titers to serotype 6A were significantly greater than in adults ≥ 60 years who received a single dose of 23-valent pneumococcal polysaccharide vaccine.
Maltese: Fl-adulti kollha ≥ 50 sena li rċevew doża unika ta' Prevenar 13, it-titers OPA għas-serotip 6A kienu ogħla b'mod sinifikanti milli fl-adulti ≥ 60 sena li rċevew doża unika tal-vaċċin polisakkaride pnewmokokkali ta' 23-valenti.
English: In adults aged 18-49 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: F'adulti li kellhom 18-49 sena, OPA GMTs għat-13-il serotip kollha fi Prevenar 13 kienu mhux inferjuri għar-risponsi ta' Prevenar 13 f'adulti li kellhom 60-64 sena.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: For each of the seven common serotypes, > 96% and >90 % of the Prevenar 13 recipients reached an OPA titre ≥ 1:8 one month after the primary series in studies 006 and 004, respectively.
Maltese: Għal kull wieħed mis-seba' serotipi komuni, > 96% u > 90% tar-reċipjenti ta' Prevenar 13 laħqu titre OPA ta' ≥ 1:8 xahar wara s-serje primarja fi studji 006 u 004, rispettivament.
English: Of the Prevenar 13 recipients 1,916 adults were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine at least 3 years prior to study vaccination, and 46,890 were 23-valent pneumococcal polysaccharide vaccine unvaccinated.
Maltese: Minn dawk li rċevew Prevenar 13, 1,916-il adult kienu rċevew vaċċin polisakkaride ta' 23-valenti qabel, mill-inqas 3 snin qabel it-tilqima taħt studju, u 46,890 ma kinux irċevew il-vaċċin polisakkaride pnewmokokkali ta' 23-valenti.
English: The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni fi tfal li għandhom bejn 6 ġimgħat u 5 snin kienu reazzjonijiet fis-sit ta' tilqim, deni, irritabilità, nuqqas t'aptit, u żieda u/jew tnaqqis fl-irqad.
English: Table 9: OPA GMTs in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Maltese: Tabella 9: OPA GMTs f'adulti vvaċċinati bil-polisakkaride pnewmokokkali li kellhom ≥ 70 sena li ngħataw jew Prevenar 13 jew il-vaċċin polisakkaride pnewmokokkali ta' 23-valenti (PPSV23)
English: In a surveillance study in France in children presenting with acute otitis media, changes in nasopharyngeal (NP) carriage of pneumococcal serotypes were evaluated following the introduction of Prevenar (7-valent) and subsequently Prevenar 13.
Maltese: Fi studju ta' sorveljanza fi Franza fuq tfal li ppreżentaw otite medja akuta, tibdiliet fil-ġarr nasofarinġeali (NP) ta' serotipi pnewmokokkali ġew evalwati wara l-introduzzjoni ta' Prevenar (7valenti) u sussegwentament ta' Prevenar 13.
English: The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immuno-compromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Maltese: L-użu ta' tilqima bil-konjugat pnewmokokkali ma tissostitwixxix l-użu ta' tilqim bil-polysaccharide pnewmokokkali ta' 23-valent fi tfal ta' ≥ sentejn b'kundizzjonijiet (bħal marda tas-sickle cell, asplenja, infezzjoni bl-HIV, mard kroniku, jew dawk li huma immunokompromessi) li jpoġġuhom f'riskju ogħla ta' mard invażiv permezz ta' Streptococcus pneumoniae.
English: Prevenar 13 non-inferiority (lower bound of the 95% CI for the difference in percentage of responders at 0.35 µg/ml between groups was >-10%) was demonstrated for all 7 common serotypes, except for serotype 6B in study 006 and serotypes 6B and 9V in study 004, which missed by a small margin.
Maltese: In-nuqqas ta' inferjorità ta' Prevenar 13 (limiti l-aktar baxxi tal- 95% CI għad-differenza bejn il-gruppi fil-perċentwal ta' dawk li rrispondew f'0.35 µg kien ta' >-10%) intwera għas-7 serotipi komuni kollha, ħlief għal serotip 6B fi studju 006 u serotipi 6B u 9V fi studju 004, li ma rnexxewx b'marġni żgħir.
English: See section 6.5 for the number of doses per container.
Maltese: Ara sezzjoni 6.5 għan-numru ta' dożi għal kull kunjett.
English: For 9 serotypes, the OPA titers were shown to be statistically significantly greater in Prevenar 13 recipients.
Maltese: Għal 9 serotipi, it-titers OPA intwerew li kienu akbar, statistikament sinifikanti f'dawk li rċevew Prevenar 13.
English: Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa (see section 4.8).
Maltese: Ġiet osservata żieda fir-rati ta' rappurtaġġ ta' konvulżjonijiet (bi jew mingħajr deni) kif ukoll episodju iporisponsiv ipotoniku (HHE) mal-għoti flimkien ta' Prevenar 13 u Infanrix hexa (ara sezzjoni 4.8).
English: The response to serotype 6A, which is unique to Prevenar 13, was assessed by demonstration of a 4-fold increase in the specific OPA titer above pre-immunised levels.
Maltese: Ir-rispons għas-serotip 6A, li huwa uniku għal Prevenar 13, kien ivvalutat mid-dimostrazzjoni ta' żieda ta' 4-darbiet fit-titer OPA speċifiku 'l fuq mill-livelli qabel l-immunizzazzjoni.
English: 2, 4, + 12 months
Maltese: 2, 4, u 12-il xahar
English: Adults 18-49 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Maltese: Adulti li kellhom 18-49 sena li fil-passat ma ġewx imlaqqma b'tilqima tal-polysaccharide pnewmokokkali ta' 23 valent
English: Pyrexia (very common in adults aged 18 to 29 years)
Maltese: Deni (komuni ħafna f'adulti li kellhom minn 18 sa 29 sena)
English: In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV).
Maltese: F'tielet studju f'adulti li kellhom minn 50-93 sena, intwera li Prevenar 13 jista' jingħata flimkien malvaċċin staġjonali kwadrivalenti mhux attivat tal-influwenza (QIV).
English: The serotype specific reductions for each of the 5 additional serotypes in Prevenar 13 (no cases of serotype 5 IPD were observed) by age group are shown in Table 2 and ranged from 68% (serotype 3) to 100% (serotype 6A) for children less than 5 years of age.
Maltese: It-tnaqqis speċifiku għas-serotip għal kull wieħed mill-5 serotipi addizzjonali fi Prevenar 13 (l-ebda każ ta' IPD tas-serotip 5 ma kien osservat) skont il-grupp ta' etajiet huwa indikat fit-Tabella 2 u kien ivarja minn 68% (serotip 3) sa 100% (serotip 6A) għal tfal li għandhom anqas minn 5 snin.
English: • Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing
Maltese: • Reazzjoni allerġika (ta' sensittività eċċessiva), inkluż nefħa fil-wiċċ u/jew xofftejn, diffikultà fit-teħid tan-nifs
English: Sodium chloride, succinic acid, polysorbate 80 and water for injections
Maltese: Sodium chloride, succinic acid, polysorbate 80 u ilma għall-injezzjonijiet
English: Pneumococcal polysaccharide serotype 19F
Maltese: Polysaccharide pnewmokokkali serotip 19F
English: Prevenar 13 group
Maltese: Grupp ta' Prevenar 13
English: Suspension for injection in multidose container (4 doses).
Maltese: Suspensjoni għall-injezzjoni f'kontenitur b'ħafna dożi (4 dożi).
English: Prevenar 13 significantly reduced NP carriage of the 6 additional serotypes (and serotype 6C) combined and individual serotypes 6C, 7F, 19A when compared with Prevenar.
Maltese: Prevenar 13 naqqas b'mod sinifikanti l-ġarr NP tas-6 serotipi addizzjonali (u s-serotip 6C) serotipi kkombinati u individwali 6C, 7F, 19A meta mqabbla ma' Prevenar.
English: • adults aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain), caused by 13 types of the bacteria Streptococcus pneumoniae.
Maltese: • adulti li għandhom minn 18-il sena 'l fuq biex jgħin fil-prevenzjoni ta' mard bħal: pnewmonja (infezzjoni tal-pulmun), sepsis jew batteremija (batterji fil-fluss tad-demm) u meninġite (infjammazzjoni madwar il-moħħ), ikkawżata minn 13-il tip tal-batterju Streptococcus pneumoniae.
English: • Nausea
Maltese: • Nawsea
English: Confidence intervals (CIs) for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
Maltese: Intervalli ta' kunfidenza (CIs) għall-proporzjon huma trasformazzjonijiet lura ta' intervall ta' kunfidenza bbażat fuq id-distribuzzjoni tal-Istudenti għad-differenza medja tal-logaritmi tal-kejl.
English: For each of the 6 additional serotypes, Prevenar 13 elicited OPA titres ≥ 1:8 in 91.4% to 100% of vaccinees one month after the primary series in studies 004/006.
Maltese: Għal kull wieħed mis-6 serotipi addizzjonali, Prevenar 13 ikkawża titres OPA ta' ≥ 1:8 f'91.4% sa 100% ta' persuni mlaqqma xahar wara s-serje primarja fi studji 004/006.
English: However, 3 (serotypes 1, 5 and 6A) of the 6 additional serotypes showed lower IgG GMC and OPA GMT when compared with children who had received at least one previous vaccination with
Maltese: Madankollu, 3 (is-serotipi 1, 5 u 6A) mis-6 serotipi addizzjonali wrew inqas IgG GMC u OPA GMT meta mqabbla ma' tfal li kienu rċevew preċedentement mill-inqas tilqima waħda bi Prevenar 13.
English: 1 single-dose (0.5 ml) pre-filled syringe with separate needle 1 single-dose (0.5 ml) pre-filled syringe without needle 10 single-dose (0.5 ml) pre-filled syringes with separate needles 10 single-dose (0.5 ml) pre-filled syringes without needle 50 single-dose (0.5 ml) pre-filled syringes with separate needles 50 single-dose (0.5 ml) pre-filled syringes without needle
Maltese: Siringa waħda mimlija għal-lest b'doża waħda (0.5 ml) b'labra separata Siringa waħda mimlija għal-lest b'doża waħda (0.5 ml) mingħajr labra 10 siringi mimlijin għal-lest b'doża waħda (0.5 ml) b'labar separati 10 siringi mimlijin għal-lest b'doża waħda (0.5 ml) mingħajr labra 50 siringa mimlijin għal-lest b'doża waħda (0.5 ml) b'labar separati 50 siringa mimlijin għal-lest b'doża waħda (0.5 ml) mingħajr labra
English: Lymphadenopathy localized to the region of the vaccination-site
Maltese: Limfadenopatija lokalizzata fiż-żona tat-tilqima
English: Studies of Prevenar 13 not containing the preservative 2-PE
Maltese: Studji ta' Prevenar 13 li ma fihomx il-preservattiv 2-PE.
English: The clinical relevance of the lower GMCs and GMTs is currently unknown.
Maltese: Ir-rilevanza klinika ta' dawn id-differenzi mhijiex magħrufa.
English: Table 7 compares the OPA GMTs, 1-month post-dose, in 60-64 year olds given either a single dose of Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine, and in 50-59 year olds given a single dose of Prevenar 13.
Maltese: It-Tabella 7 tqabbel l-OPA GMTs, xahar wara d-doża, f'persuni ta' bejn is-60-64 sena li ngħataw jew doża unika ta' Prevenar 13 jew tal-vaċċin polisakkaride pnewmokokkali ta' 23-valenti, u fuq persuni ta' bejn il-50-59 sena li ngħataw doża unika ta' Prevenar 13.
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 < 18 years of age with sickle cell disease who were previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine at least 6 months prior to enrollment.
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 tifel/tifla u adolexxenti li kellhom minn ≥6 sa <18-il sena u li kellhom il-marda tas-sickle cell u li filpassat tlaqqmu b'doża waħda jew aktar ta' tilqima polysaccharide pnewmokokkali ta' 23 valent millinqas 6 xhur qabel ma ġew reġistrati fl-istudju.
English: Prevenar OPA GMT Relative to PPSV23
Maltese: OPA GMT ta' Prevenar meta mqabbla ma' PPSV23
English: In a multicenter observational study in France comparing the periods before and after the switch from Prevenar to Prevenar 13, there was 16% (2060 to 1725 cases) reduction in all community acquired pneumonia (CAP) cases in emergency departments in children 1 month to 15 years of age.
Maltese: Fi studju multiċentriku ta' osservazzjoni fi Franza li jqabbel il-perjodi qabel u wara l-qlib minn Prevenar għal Prevenar 13, kien hemm tnaqqis ta' 16% (2060 għal 1725 każ) fil-każijiet kollha ta' pnewmonja akkwiżita f'komunità (CAP) fid-dipartimenti ta' emerġenza fi tfal li għandhom bejn xahar u 15-il sena.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodju'.
English: Pneumococcal polysaccharide serotype 14
Maltese: Polysaccharide pnewmokokkali serotip 14
English: Pneumococcal polysaccharide serotype 1
Maltese: Polysaccharide pnewmokokkali serotip 1
English: In this study, reductions of S. pneumoniae serotypes 19A, 19F, and 6A not susceptible to a number of antibiotics were documented.
Maltese: F'dan l-istudju, ġew iddokumentati tnaqqisijiet ta' serotipi 19A, 19F u 6A ta' S. pneumoniae mhux suxxettibbli għal għadd ta' antibijotiċi.
English: Musculoskeletal and connective tissue disorders: Very common:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Multidose containers:
Maltese: Kontenituri b'ħafna dożi:
English: A fourth (booster) dose is recommended 6 months after the third dose (see section 5.1).
Maltese: Ir-raba' doża (booster) hi rakkomandata li tingħata 6 xhur wara t-tielet doża (ara sezzjoni 5.1).
English: Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months), 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Maltese: It-tfal ġew imlaqqma bi Prevenar (3 dożi b'intervall ta' xahar bejniethom mill-età xahrejn), u 46 minn dawn it-tfal irċivew ukoll tilqima polysaccharide pnewmokokkali ta' 23 valent fl-età ta' 15-18-il xahar.
English: Immunogenicity studies in adults ≥18 years and the elderly
Maltese: Studji ta' immunoġeniċita fuq adulti ≥18-il sena u l-anzjani
English: The CAPiTA study enrolled volunteers ≥ 65 years of age whose demographic and health characteristics may differ from those seeking vaccination.
Maltese: L-istudju tal-CAPiTA ingaġġa voluntiera fl-età ta' ≥ 65 sena li l-karatteristiċi demografiċi u tas-saħħa tagħhom jistgħu jvarjaw minn ta' dawk li qed ifittxu l-vaċċinazzjoni.