FrancophonIA/ELRC3.0 huggingface dataset:
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva
English: Pneumococcal polysaccharide serotype 4
Maltese: Polysaccharide pnewmokokkali serotip 4
English: Severe vaccination-site pain/tenderness and severe limitation of arm movement was very common in adults 18 to 39 years and common in all other age groups.
Maltese: Uġigħ sever fis-sit tat-tilqima/sensittività u limitazzjoni severa tal-moviment tad-driegħ kienu komuni ħafna f'adulti li kellhom minn 18 sa 39 sena u komuni fil-gruppi l-oħrajn kollha ta' età.
English: Adverse reactions from Prevenar 13 postmarketing experience Although the following adverse drug reactions were not observed in the Prevenar 13 clinical studies in infants and children, the following are considered adverse drug reactions for Prevenar 13 as they were reported in the postmarketing experience.
Maltese: Għalkemm ir-reazzjonijiet avversi tal-mediċina, li ġejjin, ma kinux osservati fl-istudji kliniċi bi Prevenar 13 fi trabi u tfal, dawn li ġejjin huma kkunsidrati bħala reazzjonijiet avversi tal-mediċina għal Prevenar 13 minħabba li ġew irrapportati fl-esperjenza ta' wara t-tqegħid fis-suq.
English: One year after the second dose, antibody levels measured by both IgG GMCs and OPA GMTs were higher than levels prior to the first dose of Prevenar 13, except for the IgG GMCs for serotypes 3 and 5 that were numerically similar.
Maltese: Sena wara t-tieni doża, il-livelli ta' antikorpi mkejla kemm minn IgG GMCs kif ukoll minn OPA GMTs kienu ogħla mil-livelli qabel l-ewwel doża ta' Prevenar 13, ħlief għall-IgG GMCs għal serotipi 3 u 5 li kienu numerikament simili.
English: Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).
Maltese: Prevenar 13 jista' jingħata wkoll fl-istess ħin bejn 12 u 23 xahar mal-vaċċin tas-serogruppi A, C, W u Y ta' polisakkaridi meninġokokkali konjugati ta' tossojdi tat-tetnu lil tfal li diġà jkunu ġew prajmjati b'mod adegwat bi Prevenar 13 (skont ir-rakkomandazzjonijiet lokali).
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine.
Maltese: Kull meta jkun irrakkomandat, it-tfal li jkunu qegħdin f'riskju li għandhom ≥ 24 xahar u li jkunu diġà tlaqqmu bi Prevenar 13, għandhom jirċievu tilqima bil-polysaccharide pnewmokokkali ta' 23-valent.
English: Pyrexia; irritability; any vaccination-site erythema, induration/swelling or pain/tenderness; somnolence; poor quality sleep Vaccination-site erythema or induration/swelling 2.5 cm-7.0 cm (after the booster dose and in older children [age 2 to 5 years])
Maltese: Deni; irritabilità; kwalunkwe eritema fis-sit tat-tilqima, ebusija/nefħa jew uġigħ/sensittività; ngħas; rqad mhux ta' kwalità tajba
English: Shake well prior to use to obtain a homogeneous white suspension.
Maltese: Ħawwad tajjeb qabel l-użu biex tikseb suspensjoni omoġenja bajda.
English: Infants aged 6 weeks-6 months
Maltese: Tfal u adolexxenti li għandhom bejn 6 snin u 17-il sena
English: After the first dose, Prevenar 13 elicited antibody levels, measured by both IgG GMCs and OPA GMTs that were statistically significantly higher when compared to levels prior to vaccination.
Maltese: Wara l-ewwel doża, Prevenar 13 ikkawża livelli ta' antikorpi, imkejla kemm minn IgG GMCs kif ukoll minn OPA GMTs li kienu ogħla b'mod statistikament sinifikanti meta mqabbla mal-livelli qabel it-tilqima.
English: Vaccine efficacy October 1995 to April 20, 1999 October 1995 to April 30, 1998
Maltese: FinOM: AOM Episodji totali AOM pnewmokokkali kollha Tilqima-serotip AOM Skont il-protokoll Effikaċja tat-tilqima Ottubru 1995 sal-20 t'April, 1999 Ottubru 1995 sat-30 t'April, 1998
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 h 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: Għandu jitqies il-fatt li jista' jkun hemm ir-riskju ta' apnea u li jkun meħtieġ monitoraġġ respiratorju għal 48-72 siegħa meta tingħata s-serje primarja tat-tilqim lil trabi prematuri ħafna (li twieldu ta' jew wara  28 ġimgħa ta' tqala), u b'mod partikolari lil dawk li fil-passat kellhom storja medika ta' immaturità respiratorja.
English: The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies in adults:
Maltese: Il-frekwenzi li ġejjin huma bbażati fuq reazzjonijiet avversi stmati fi studji kliniċi fi Prevenar 13 fl-adulti:
English: Vaccine efficacy (95% CI) (1-sided p-value)
Maltese: 1 (95% CI) (valur-p ta' naħa waħda)
English: Prevenar 13 suspension for injection Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed)
Maltese: Prevenar 13 suspensjoni għall-injezzjoni Tilqima ta' konjugat (13 valent, adsorbit) ta' polysaccharide pnewmokokkali
English: For 6 of the remaining 7 common serotypes, similar rates of NP acquisition were observed in both vaccine groups; for serotype 19F a significant reduction was observed.
Maltese: Għal 6 mis-7 serotipi komuni li baqa', rati simili ta' teħid ta' NP ġew osservati fiż-żewġ gruppi ta' vaċċini; għal serotip 19F, ġie osservat tnaqqis sinifikanti.
English: Prevenar 13 suspension for injection Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Maltese: Prevenar 13 suspensjoni għall-injezzjoni Tilqima ta' konjugat (13-valent, adsorbit) ta' polysaccharide pnewmokokkali
English: In children and adolescents aged 6 to 17 years, the incidence of pneumococcal disease is low, however, there is an increased risk of morbidity and mortality in those with underlying comorbidities.
Maltese: Fi tfal u adolexxenti ta' bejn 6 snin u 17-il sena, l-inċidenza ta' mard pnewmokokkali hija baxxa, madankollu, hemm riskju miżjud ta' morbidità u ta' mortalità f'dawk b'komorbiditajiet bażi.
English: Functional antibody titers (OPA titers) were not measured in this study.
Maltese: Titers funzjonali tal-antikorpi (titers OPA) ma tkejlux f'dan l-istudju.
English: Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series.
Maltese: Dejta minn studju kliniku ta' wara t-tqegħid fis-suq, li evalwa l-impatt tal-użu profilattiku ta' antipiretiċi (ibuprofen u paracetamol) fuq ir-rispons immuni għal Prevenar 13, tissuġġerixxi li l-għoti ta' paracetamol fl-istess ħin jew fl-istess jum tat-tilqima jista' jnaqqas ir-rispons immuni għal Prevenar 13 wara s-serje tat-trabi.
English: The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose.
Maltese: Is-sigurtà tat-tilqima ġiet evalwata fi studji kliniċi kkontrollati fejn ingħataw 14,267 doża lil 4,429 tarbija b'saħħitha li bdew l-ewwel tilqima meta kellhom 6 ġimgħat u li kellhom minn 11-16-il xahar meta ngħatat id-doża booster.
English: The annual overall pneumococcal incidence of OM declined from 9.6 to 2.1 cases per 1000 children (78%) between July 2004 (prior to the introduction of Prevenar) and June 2013 (post Prevenar 13 introduction).
Maltese: L-inċidenza pnewmokokkali globali annwali ta' OM naqset minn 9.6 għal 2.1 każijiet għal kull 1000 tifel u tifla (78%) bejn Lulju 2004
English: Statistically significantly greater response was defined as the lower bound of the 2-sided 95% CI for the GMR was greater than 1.
Maltese: Rispons akbar, statistikament sinifikanti kien definit bħala l-aktar naħa baxxa tal-95% CI b'2-naħat għall-GMR li kien akbar minn 1.
English: In a UK study, the functional antibody (OPA) responses were comparable for all serotypes including 6B and 23F in the Prevenar and Prevenar 13 arms after the primary series at two and four months of age and after the booster dose at 12 months of age.
Maltese: Fi studju fir-Renju Unit, ir-risponsi funzjonali tal-antikorp (OPA) kienu jixxiebhu għas-serotipi kollha, fosthom 6B u 23F fil-fergħat ta' Prevenar u Prevenar 13 wara s-serje primarja mogħtija fl-età ta' xahrejn u erba' xhur, u wara d-doża booster fl-età ta' 12-il xahar.
English: Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Maltese: Individwi b'indeboliment fir-rispons immuni, kemm jekk dan iseħħ minħabba l-użu ta' terapija immunosoppressiva, difett ġenetiku, infezzjoni bil-virus tal-immunodefiċjenza umana (HIV), jew kawżi oħrajn, jista' jkollhom tnaqqis fir-rispons tal-antikorpi għat-tilqima attiva.
English: For those events specifically identified as pneumococcal pneumonia, the observed reductions in hospitalisations and ambulatory visits were 57.6 % and 46.9 %, respectively, in children younger than 2 years of age, compared with a pre-licensure baseline (2004 vs. 1997-99).
Maltese: Għal dawk ilkażijiet identifikati b'mod speċifiku bħala pnewmonja pnewmokokkali, it-tnaqqis osservat fin-numru ta' pazjenti li kellhom jiddaħħlu l-isptar u jmorru għal viżta kien ta' 57.6% u 46.9%, rispettivament, fi tfal iżgħar minn sentejn, meta mqabbel mal-linja bażi qabel ma ngħatat il-liċenzja għal din il-mediċina (2004 vs. 1997-99).
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta.
English: Prevenar 13 will only protect against ear infections in children caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Maltese: Prevenar 13 ser jipproteġi biss kontra infezzjonijiet tal-widnejn fit-tfal ikkawżati mit-tipi ta' Streptococcus pneumoniae li għalihom it-tilqima ġiet żviluppata.
English: Prevenar 13 may be given to adults aged 50 years and older at the same time as the trivalent or quadrivalent inactivated influenza vaccine.
Maltese: Prevenar 13 jista' jingħata lil adulti li għandhom 50 sena u iktar fl-istess ħin mal-vaċċin inattivat trivalenti jew kwadrivalenti tal-influwenza.
English: The reported incidence of community-acquired pneumonia (CAP) and IPD in Europe varies by country, increases with age from 50 years and is highest in individuals aged ≥ 65 years.
Maltese: L-inċidenza rrappurtata ta' pnewmonja akkwiżita f'komunità (CAP) u IPD fl-Ewropa tvarja skont ilpajjiż, tiżdied mal-età minn 50 sena u hi l-ogħla f'individwi li jkollhom ≥ 65 sena.
English: In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine.
Maltese: Fi studji kliniċi meta Prevenar 13 ingħata sena wara l-vaċċin polisakkaride pnewmokokkali ta' 23-valenti r-rispons immuni kien aktar baxx għas-sertotipi kollha meta mqabbel ma' meta Prevenar 13 ingħata lil individwi li ma kienux preċedentement irċevew il-vaċċin polisakkaride pnewmokokkali ta' 23-valenti.
English: c c
Maltese: c ċ
English: USA (2000)
Maltese: Stati Uniti tal-Amerika
English: • Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm
Maltese: • Nodi jew glandoli tal-limfa minfuħin (limfadenopatija) qrib is-sit ta' tilqim, bħal taħt ir-riġel
English: It will not protect against other infectious agents that can cause ear infections.
Maltese: Mhux ser jipproteġi kontra organiżmi infettivi oħrajn li jistgħu jikkawżaw infezzjonijiet tal-widnejn.
English: Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of Prevenar 13 (see section 5.1).
Maltese: Individwi li jkollhom kundizzjoni diġà eżistenti li tippredisponihom għal mard pnewmokokkali invażiv (bħal marda taċ-ċelluli sickle jew infezzjoni bl-HIV), li jinkludu dawk li qabel ġew imlaqqma b'doża waħda jew aktar ta' tilqima polysaccharide pnewmokokkali ta' 23 valent jistgħu jirċievu millinqas doża waħda ta' Prevenar 13 (ara sezzjoni 5.1).
English: The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone.
Maltese: Ir-risponsi immuni għal Prevenar 13 ma kinux inferjuri meta Prevenar 13 ingħata flimkien mal-QIV meta mqabbel ma' meta Prevenar 13 ingħata waħdu.
English: The interval between the 13-valent pneumococcal conjugate vaccine (Prevenar 13) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Maltese: L-intervall bejn it-tilqima bil-konjugat pnewmokokkali ta' 13-valent (Prevenar 13) u ttilqima bil-polysaccharide pnewmokokkali ta' 23-valent, m'għandux ikun ta' inqas minn 8 ġimgħat.
English: In this age group, serotypes 1, 3, 5, 6A, 7F, and 19A account for 15.6% to 59.7% of invasive disease, depending on the country, the time period studied, and the use of Prevenar.
Maltese: F'dan il-grupp ta' età, is-serotipi 1, 3, 5, 6A, 7F, u 19A huma responsabbli għal 15.
English: OUTER CARTON
Maltese: Skeda rrakkomandata
English: First episode of confirmed VT pneumococcal CAP
Maltese: ikkawżata minn 13-il tip tal-batterju Streptococcus pneumoniae.
English: Pharmacotherapeutic group: vaccines, pneumococcal vaccines; ATC code: J07AL02
Maltese: NCKP: Tilqima-serotip IPD NCKP: Pnewmonja klinika b'X-ray anormali tas-sider
English: Local reactions and systemic events were solicited daily after each vaccination for 14 days in 6 studies and 7 days in the remaining study.
Maltese: Reazzjonijiet avversi u avvenimenti sistemiċi ġew solleċitati kuljum wara kull vaċċinazzjoni għal 14-il ġurnata f'6 studji u 7 ijiem fl-istudju l-ieħor.
English: • Redness, hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the booster dose and in older children [aged 2 to 5 years])
Maltese: • Ħmura, ebusija, nefħa fis-sit tat-tilqima ta' 2.5 ċm -7.0 ċm (wara d-doża booster u fi tfal li jkollhom aktar żmien [minn sentejn sa 5 snin])
English: Immune responses were assessed in 231-255 evaluable subjects approximately 1 month after each dose of Prevenar 13.
Maltese: Risponsi immuni ġew evalwati f'231-255 individwu li setgħu jiġu evalwati madwar xahar wara kull doża ta' Prevenar 13.
English: • children from 6 weeks to 17 years to help protect against diseases such as: meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections
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),
English: As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below).
Maltese: Kif rakkomandat millOrganizzazzjoni Dinjija tas-Saħħa (WHO) l-evalwazzjoni tal-effikaċja potenzjali kontra IPD fi trabi u tfal żgħar kienet ibbażata fuq paragun ta' risponsi immuni għas-seba' serotipi komuni, li huma l-istess fi Prevenar 13 u Prevenar, li għalihom ġiet ippruvata l-effikaċja protettiva (għall-effikaċja ta' Prevenar (7-valent) fit-trabi u fit-tfal, ara hawn taħt).
English: After the booster dose, all vaccine serotypes including 6B and 23F had immune responses consistent with adequate priming with a two-dose primary series.
Maltese: Wara d-doża booster, is-serotipi kollha tat-tilqima fosthom 6B u 23F, kellhom risponsi immuni li kienu konsistenti ma' tilqim ta' preparazzjoni adegwat bis-serje primarja li tikkonsisti f'żewġ dożi.
English: Children and adolescents with either HIV infection, sickle cell disease or a blood-forming stem cell transplant had similar side effects however the frequencies of headaches, vomiting, diarrhoea, fever, fatigue, joint and muscle pain were very common.
Maltese: Tfal u adolexxenti jew b'infezzjoni bl-HIV, bil-marda taċ-ċelluli sickle jew bi trapjant taċ-ċelluli staminali li jiffurmaw id-demm, kellhom effetti sekondarji simili, madankollu l-frekwenzi tal-uġigħat ta' ras, rimettar, dijarea, deni għeja u l-uġigħ fil-ġogi u wġigħ fil-muskoli kienu komuni ħafna.
English: Adults 60-64 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Maltese: Adulti ta' bejn is-60-64 sena li ma kienux preċedentement ivvaċċinati bil-vaċċin polisakkaride pnewmokokkali ta' 23-valenti
English: General disorders and administration site conditions: Very common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: One year after vaccination with Prevenar 13 in adults aged 70 years and over who were vaccinated with 23-valent pneumococcal polysaccharide vaccine, at least 5 years prior to study entry, OPA titers had declined compared to one month after vaccination, however, OPA titers for all serotypes remained higher than levels at baseline:
Maltese: Sena wara t-tilqim bi Prevenar 13 f'adulti li kellhom 'l fuq minn 70 sena li tlaqqmu bil-vaċċin polisakkaride pnewmokokkali ta' 23-valenti, mill-anqas 5 snin qabel l-istudju, it-titers OPA kienu naqsu meta mqabbla ma' xahar wara l-vaċċinazzjoni, madankollu, it-titers OPA għas-serotipi kollha baqgħu ogħla mill-livelli fil-linja bażi:
English: Pneumonia
Maltese: bronkospażmi
English: Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Maltese: Dejta limitata wriet li Prevenar 7-valent (serje primarja bi tliet dożi) jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il-marda tas-sickle cell, bi profil tas-sigurtà li jixbah lil dak osservat fi gruppi li mhux qegħdin f'riskju għoli (ara sezzjoni 5.1).
English: Single-dose vials:
Maltese: Komuni ħafna:
English: After the first dose, Prevenar 13 elicited antibody levels measured by both IgG GMCs and OPA GMTs that were statistically significantly higher when compared to levels prior to vaccination.
Maltese: Wara l-ewwel doża, Prevenar 13 ipproduċa livelli ta' antikorpi mkejla kemm minn IgG GMCs kif ukoll minn OPA GMTs li kienu statistikament ogħla b'mod sinifikanti meta mqabbla mal-livelli ta' qabel it-tilqima.
English: NNV also incorporates the length of the trial or duration of protection and is calculated as 1 divided by the product of the IRR and duration of protection (or length of trial) (=1/(IRR × duration).
Maltese: NNV jinkludi anke t-tul tal-prova jew it-tul ta' protezzjoni u huwa kkalkulat bħala 1 diviż bil-prodott tal-IRR u t-tul ta' protezzjoni (jew tul tal-prova) (=1/(IRR × tul).
English: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common.
Maltese: Adulti b'infezzjoni bl-HIV, għandhom frekwenzi simili ta' reazzjonijiet avversi, ħlief li d-deni u rrimettar kienu komuni ħafna u d-dardir kien komuni.
English: Young children (12-59 months) completely immunised with Prevenar (7-valent) Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes.
Maltese: Tfal żgħar li huma kkunsidrati mlaqqma għal kollox bi Prevenar (7-valenti) għandhom jirċievu doża waħda ta' 0.5 ml ta' Prevenar 13 biex ikollhom risponsi immuni għas-6 serotipi addizzjonali.
English: For children aged from 7 months to 5 years, age appropriate catch-up immunisation schedules (as described in section 4.2) result in levels of anti-capsular polysaccharide IgG antibody responses to each of the 13 serotypes that are at least comparable to those of a three-dose primary series in infants.
Maltese: Għal tfal li għandhom minn 7 xhur sa 5 snin, skedi ta' tilqim catch-up li huma adattati għall-età tagħhom (kif deskritt f'sezzjoni 4.2) jirriżultaw f'livelli ta' risponsi b'antikorp IgG kontra l-kapsuli polysaccharide għal kull wieħed mit-13-il serotip li mill-inqas huma komparabbli ma' dawk tas-serje primarja li tikkonsisiti fi tliet dożi fit-trabi.
English: Acute Otitis Media
Maltese: Kodiċi ATC:
English: General disorders and administration site conditions: Vaccination-site urticaria; vaccination-site dermatitis; vaccination-site pruritus; flushing
Maltese: Dejta addizzjonali dwar l-immunoġeniċità ta' Prevenar (7-valent): tfal bil-marda taċ-ċelluli sickle
English: The fourth (booster) dose is recommended between 11 and 15 months of age.
Maltese: Ir-raba' doża (booster) hi rrakkomandata li tingħata bejn l-età ta' 11 u 15-il xahar.
English: Please speak to your doctor, pharmacist, or nurse for more information.
Maltese: Jekk jogħġbok staqsi lit-tabib, lill-ispiżjar jew lill-infermier tiegħek għal aktar informazzjoni.
English: In adults, an antibody threshold of serotype-specific pneumococcal polysaccharide IgG binding antibody concentration associated with protection has not been defined.
Maltese: Fl-adulti, il-limitu ta' antikorpi ta' konċentrazzjoni ta' antikorpi li jingħaqdu ma' polisakkaride pnewmokokkali ta' IgG speċifiku għas-serotip assoċjat ma' protezzjoni ma ġiex definit.
English: Immune responses in Special Populations
Maltese: KONDIZZJONIJIET OĦRA TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Correspondingly, OPA GMTs were similar in both groups, except for serotype 3, which was lower, and serotype 18C, which was higher, in the group that received Prevenar 13 with 2-PE.
Maltese: B'hekk, l-OPA GMTs kienu simili fiż-żewġ gruppi, ħlief għal serotip 3, li kien aktar baxx, u serotip 18C, li kien ogħla, fil-grupp li rċieva Prevenar 13 b'2-PE.
English: Pneumonia is the most common clinical presentation of pneumococcal disease in adults.
Maltese: Il-pnewmonja hi l-iktar preżentazzjoni klinika komuni ta' mard pnewmokokkali fl-adulti.
English: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given.
Maltese: Inkella, meta Prevenar 13 jingħata bħala parti minn programm ta' tilqim ta' rutina lit-trabi, tista' tingħata serje li tikkonsisti fi tliet dożi, kull waħda ta' 0.5 ml.
English: Furthermore, in this study statistically significantly greater OPA GMTs were demonstrated for 10 of the 12 serotypes in common.
Maltese: Barra minn hekk, f'dan l-istudju intwerew OPA GMTs ogħla, statistikament sinifikanti għal 10 mit-12 is-serotipi in komuni.
English: OPA titres are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 %.
Maltese: Titres OPA huma espressi bħala r-reċiproċi tal-ogħla dilwizzjoni tas-serum li tnaqqas is-sopravivenza talpnewmokokki b'mill-anqas 50 %.
English: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and HHE when comparing groups which reported use of Prevenar 13 with Infanrix hexa to those which reported use of Prevenar 13 alone.
Maltese: Analiżi tar-rati ta' rappurtaġġ ta' wara t-tqegħid fis-suq tissuġġerixxi żieda fir-riskju potenzjali ta' konvulżjonijiet, bi jew mingħajr deni, u HHE meta ġew ipparagunati gruppi li rrappurtaw l-użu ta' Prevenar 13 ma' Infanrix hexa ma' dawk li rrappurtaw l-użu ta' Prevenar 13 waħdu.