FrancophonIA/ELRC3.0 huggingface dataset:
English: For the number of doses to be administered in the different age groups, see section 4.2.
Maltese: Għan-numru ta' dożi li jridu jingħataw fil-gruppi differenti ta' età, ara sezzjoni 4.2.
English: Preliminary data from England and Wales reported less than 1 year following introduction of routine immunisation at 2, 4 and 13 months with a single dose catch-up programme for children 13 to 23 months of age have suggested that effectiveness of this schedule might be lower against serotype 6B than against
Maltese: Dejta preliminari mill-Ingilterra u Wales irrappurtata inqas minn sena wara l-introduzzjoni ta' immunizzazzjoni ta' rutina fl-età ta' 2, 4 u 13-il xahar, bi programm ta' doża waħda catch-up għal tfal li kellhom minn 13 sa 23 xahar, issuġġeriet li l-effettività ta' din l-iskeda tista' tkun iktar baxxa kontra serotip 6B milli kontra s-serotipi oħrajn fit-tilqima.
English: Pfizer AB Tel: +46 (0)8 550 520 00
Maltese: Tel: +46 (0)8 550 520 00
English: At the time of the study, the serotypes included in the vaccine accounted for 89 % of IPD.
Maltese: Fiż-żmien tal-istudju, is-serotipi inklużi fittilqima ammontaw għal 89% tal-IPD.
English: Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
Maltese: Dejta dwar l-għoti fl-istess ħin ta' Prevenar ma' Infanrix hexa (tilqima DTaP/Hib(PRP-T)/IPV/HepB) ma wriet l-ebda interferenza klinikament rilevanti fir-rispons tal-antikorpi għal kull wieħed millantiġeni individwali, meta mogħtija bħala tilqima primarja ta' 3 dożi.
English: The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls.
Maltese: Ir-rispons tal-antikorpi għat-tilqim bil-konjugat tal-proteina tat-tetnu Hib (PRP-T), tetnu u Epatite B (HepB) kien simili għall-kontrolli.
English: Pneumococcal polysaccharide serotype 19F*
Maltese: Serotip polysaccharide pnewmokokkali 19F*
English: Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Maltese: L-infjammazzjoni akuta fil-parti tan-nofs tal-widna (acute otitis media - AOM) hi marda komuni tattfulija b'etjoloġiji differenti.
English: After primary immunisation, 95.6% of the subjects had antibody levels of at least 0.35 µg/ml for all seven serotypes found in Prevenar.
Maltese: Wara l-immunizzazzjoni primarja, 95.6% tat-tfal kellhom livelli ta' antikorpi ta' mill-anqas 0.35 µg/ml għas-seba' serotipi kollha li jinsabu fi Prevenar.
English: Efficacy against invasive disease was assessed in a large-scale randomised, double-blind, clinical trial in a multiethnic population in Northern California (Kaiser Permanente trial).
Maltese: L-effikaċja kontra mard invażiv kienet evalwata fi prova fuq skala kbira, randomised, double-blind, f'popolazzjoni multi-etnika f'Kalifornja tat-Tramuntana (prova Kaiser Permanente).
English: 0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger rod (polypropylene), a plunger stopper (latex free grey butyl rubber) and a protective-tip cap (latex free grey butyl rubber)
Maltese: 0.5 ml suspensjoni għall-injezzjoni f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'lasta tal-planġer (polypropylene), planġer-tapp (bla latex, griż, tal-lastku u butyl) u għatu b'tarf protettiv (bla latex,
English: Fever of greater than 39.5 °C per dose was observed in 0.6 to 2.8 % of infants receiving Prevenar and hexavalent vaccines (see section 4.4).
Maltese: Deni b'temperatura ta' iktar minn 39.5°C kull doża kien osservat f'0.6 sa 2.8% tat-trabi li kienu qed jirċievu Prevenar u tilqim eżavalenti (ara sezzjoni
English: 2 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
Maltese: 2 kontra serotipi 6B u 23F wara serje primarja b'żewġ dożi mqabbla direttament jew indirettament ma' serje primarja bi tliet dożi.
English: Injection site reactions (e.g. erythema, induration/swelling, pain/tenderness); fever  38 °C, irritability, crying, drowsiness, restless sleep.
Maltese: Reazzjonijiet fis-sit tal-injezzjoni (eż. eritema, ebusija/nefħa, uġigħ/sensittività); deni  38°C, irritabilità, biki, ngħas, irqad bla kwiet.
English: In the per-protocol analysis, the estimated risk reduction for the first episode of clinical pneumonia with abnormal chest radiograph (defined as the presence of infiltrates, effusion or consolidation) was 35 % (95 % CI: 4, 56).
Maltese: Fil-prova skont il-protokoll, it-tnaqqis fl-istima tar-riskju għall-ewwel episodju ta' pnewmonja klinika b'x-ray anormali tas-sider (definit bħala l-preżenza ta' infiltrati, effużjoni jew konsolidazzjoni) kien ta' 35% (95% CI: 4, 56).
English: Injection site swelling/induration and erythema >2.4 cm, tenderness interfering
Maltese: Nefħa/ebusija fis-sit tal-injezzjoni u eritema >2.4 ċm, sensittività li tinterferixxi mal
English: 0.5 ml suspension for injection in vial (Type I glass) with a grey butyl rubber stopper.
Maltese: 0.5 ml suspensjoni għall-injezzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp griż tal-lastku tal-butyl.
English: Important information about some of the ingredients of Prevenar: This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially sodium-free.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine.
Maltese: Fejn ikun rakkomandat, it-tfal f'riskju li għandhom ≥ 24 xahar u li jkunu diġà tlaqqmu bi Prevenar, għandhom jirċievu tilqima tal-polysaccharide pnewmokokkali li fiha 23 valent.
English: The expiry date refers to the last
Maltese: DATA TA' META JISKADI
English: The pneumococcus is responsible for 30-40% of all bacterial AOM and a greater fraction of severe AOM.
Maltese: Il-pnewmokokkus hu responsabbli għal 30-40% tal-AOMs batterjali kollha u għal porzjon akbar ta' AOM severa.
English: The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 6 % (95 % CI: -4, 16)
Maltese: L-impatt tattilqima fuq in-numru totali ta' episodji ta' infjammazzjoni fil-parti tan-nofs tal-widna irrispettivament mill-etjoloġija kien ta' tnaqqis ta' 6% (95% CI: -4, 16).
English: Redness or induration >2cm in diameter was reported in 22.6 % and 13.9 % of children respectively.
Maltese: Il-ħmura jew l-ebusija ta' >2 ċm fid-dijametru kienet irrappurtata fi 22.6% u fi 13.9% tat-tfal rispettivament.
English: However, the overall benefit was a 34 % (95 % CI: 21, 45) reduction in the incidence of all pneumococcal AOM.
Maltese: Madankollu, il-benefiċċju totali kien ta' tnaqqis ta' 34% (95% CI: 21, 45) fl-inċidenza tal-AOMs pnewmokokkali kollha.
English: The estimate of vaccine serotype specific efficacy was 94 % (95 % CI: 81, 99) in the intent-to-treat population and 97 % (95 % CI: 85, 100) in the per protocol (fully immunized) population (40 cases).
Maltese: L-istima ta' l-effikaċja speċifika għas-serotip tat-tilqima kienet ta' 94% (95% CI: 81, 99) fil-popolazzjoni intent-to-treat u 97% (95% CI: 85, 100) fil-popolazzjoni skont ilprotokoll (imlaqqma b'mod sħiħ) (40 każ).
English: No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exceptions being a higher rate of transient tenderness (36.5 %) and tenderness that interfered with limb movement (18.5 %) were seen with the booster dose.
Maltese: Ma kienet osservata l-ebda żieda konsistenti fir-reazzjonijiet lokali jew sistemiċi meta ngħataw dożi ripetuti matul is-serje primarja jew bid-doża booster, bl-eċċezzjonijiet ikunu rata ogħla ta' sensittività temporanja (36.5%) u sensittività li interferixxiet mal-moviment tar-riġlejn jew tad-dirgħajn (18.5%) li
English: 1 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
Maltese: 1 kontra serotipi 6B u 23F wara serje primarja b'żewġ dożi mqabbla direttament jew indirettament ma' serje primarja bi tliet dożi.
English: The effect of the vaccine in the per-protocol analysis was a 9 % reduction (95 % CI: 3, 15) in recurrent AOM (defined as 3 episodes in six months or 4 episodes in one year) or a 23 % (95 % CI: 7, 36) reduction for recurrent AOM (5 episodes in six months or 6 episodes in one year).
Maltese: L-effett tat-tilqima fl-analiżi skont il-protokoll kien tnaqqis ta' 9% (95% CI: 3, 15) f'AOM rikorrenti (definita bħala 3 episodji f'sitt xhur jew 4 episodji f'sena) jew tnaqqis ta' 23% (95% CI: 7, 36) għal AOM rikorrenti (5 episodji f'sitt xhur jew 6 episodji f'sena).
English: Prevenar will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Maltese: Prevenar ser jipproteġi biss kontra infezzjonijiet tal-widnejn ikkawżati mit-tipi ta' Streptococcus pneumoniae li għalihom it-tilqima kienet żviluppata.
English: In a study, including 1,662 children, fever of  38 °C was reported in 41.2 % of children who received Prevenar simultaneously with DTP as compared to 27.9 % in the control group.
Maltese: Fi studju, li kien jinkludi 1,662 tifel/tifla, deni b'temperatura ta'  38°C kien irrappurtat f'41.2% tat-tfal li rċivew Prevenar fl-istess ħin ma' DTP meta mqabbel ma' 27.9% fil-grupp tal-kontroll.
English: The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 7 % reduction (95 % CI: 4, 10).
Maltese: L-impatt tat-tilqima fuq in-numru totali ta' episodji ta' infjammazzjoni fil-parti tan-nofs tal-widna irrispettivament mill-etjoloġija kien ta' tnaqqis ta' 7% (95% CI: 4, 10).
English: When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Maltese: Meta Prevenar jingħata flimkien ma' tilqim eżavalenti (DTaP/Hib(PRP-T)/IPV/HepB), it-tabib għandu jkun konxju li dejta minn studji kliniċi tindika li r-rata ta' reazzjonijiet bid-deni kienet ogħla meta mqabbla ma' dik li sseħħ wara l-għoti ta' tilqim eżavalenti waħdu.
English: The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children  24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Maltese: L-użu ta' tilqima konjugata pnewmokokkali ma tissostitwixxix l-użu ta' tilqim tal-polysaccharide pnewmokokkali li fih 23 valent fit-tfal ta'  24 xahar b'kundizzjonijiet (bħal marda taċ-ċelluli sickle, asplenja, infezzjoni bl-HIV, mard kroniku jew li huma immunokompromessi) li jpoġġuhom f'riskju ogħla għal mard invażiv minħabba Streptococcus pneumoniae.
English: Pack size of 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Maltese: Daqs tal-pakkett ta' kunjett 1 b'siringa u 2 labar (1 biex tiġbed, 1 għall-injezzjoni).
English: In the USA in the same time frame, there was a 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/99).
Maltese: Fl-Istati Uniti tal-Amerika fl-istess perjodu ta' żmien, kien hemm tnaqqis ta' 94% fit-tip ta' tilqima IPD f'individwi li kellhom inqas minn 5 snin, meta mqabbla mal-linja bażi ta' qabel it-tilqima (1998/99).
English: In the first two years of the programme, with over 90% coverage, the observed effectiveness against IPD caused by vaccine serotypes was 93% (95% CI 75-98) for the 2 dose infant series and 100% (95% CI 91-100) for the completed schedule.
Maltese: Fl-ewwel sentejn tal-programm, b'kopertura ta' iktar minn 90%, leffettività osservata kontra l-IPD ikkawżata minn serotipi tat-tilqima kienet ta' 93% (95% CI 75-98) għas-serje ta' 2 dożi lit-trabi, u 100% (95% CI 91-100) għall-iskeda kompluta.
English: Administration of unconjugated pneumococcal polysaccharides at 13 months following the primary series with Prevenar elicited an anamnestic antibody response for the 7 serotypes included in the vaccine, indicating
Maltese: L-għoti ta' polysaccharides pnewmokokkali mhux konjugati fl-età ta' 13-il xahar wara s-serje primarja bi Prevenar, ikkawża rispons anamnestiku tal-antikorp għas-7 serotipi inklużi fit-tilqima, li jindika li l
English: Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months) and 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Maltese: It-tfal kienu mlaqqma bi Prevenar (3 dożi b'intervall ta' xahar bejniethom mill-età ta' xahrejn) u 46 minn dawn it-tfal irċivew ukoll tilqima tal-polysaccharide pnewmokokkali bi 23 valent fl-età ta' 15-18-il xahar.
English: Infants aged 7 to 11 months should receive two injections.
Maltese: Trabi li għandhom minn 7 sa 11-il xahar għandhom jirċievu żewġ injezzjonijiet.
English: Adverse reactions reported in clinical trials or from the post-marketing experience are listed in the following table per system organ class and per frequency and this is for all age groups.
Maltese: Reazzjonijiet avversi rrappurtati fil-provi kliniċi jew mill-esperjenza ta' wara t-tqegħid fis-suq huma elenkati fit-tabella li ġejja skont il-klassi tas-sistemi u tal-organi u skont il-frekwenza, u dan japplika
English: In European children between 2 to 5 years of age, Prevenar should cover about 62 % to 83 % of the clinical isolates responsible for invasive pneumococcal disease.
Maltese: Fi tfal Ewropej ta' bejn sentejn u 5 snin, Prevenar għandu jkopri madwar 62% sa 83% tal-iżolati kliniċi responsabbli għal mard pnewmokokkali invażiv.
English: In this follow-up, vaccine efficacy for frequent OM (defined as at least 3 episodes within 6 months) was 18 % (95 % CI: 1, 32), for chronic otitis media with effusion, 50 % (95 % CI: 15, 71), and for tympanostomy tube placement,
Maltese: F'dan il-follow-up, leffikaċja tat-tilqima għal OM frekwenti (definita bħala mill-anqas 3 episodji fi żmien 6 xhur) kienet ta' 18% (95% CI: 1, 32), għal infjammazzjoni kronika fil-parti tan-nofs tal-widna b'effużjoni, 50% (95% CI: 15, 71), u għat-tqegħid ta' tubu tat-timpanostomija, 39% (95% CI: 4, 61).
English: Pack sizes of 1 and 10 vials without syringe/needles.
Maltese: Daqs tal-pakkett ta' 1 u 10 kunjetti mingħajr siringi/labar.
English: 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Maltese: Kunjett 1 b'siringa u 2 labar (1 biex tiġbed, 1 għall-injezzjoni).
English: In parallel, there was a 62% reduction in vaccine type IPD in individuals over 5 years of age.
Maltese: Fl-istess żmien kien hemm tnaqqis ta' 62% fit-tip ta' tilqima IPD f'individwi li kellhom iktar minn 5 snin.
English: Infants aged 6 weeks to 6 months of age
Maltese: Trabi li jkollhom minn 6 ġimgħat sa 6 xhur
English: When compared with no vaccination, point estimates for the effectiveness of 2-, 3-, or 4-doses given on an infant schedule were similar: 96% (95% CI 88-99); 95% (95% CI 88-99); and 100% (95% CI 94-100), respectively.
Maltese: 95% (95% CI 88-99); u 100% (95% CI 94-100), rispettivament.
English: Redness was reported in 40.0 % of children, and induration was reported in 32.2 % of subjects.
Maltese: Il-ħmura kienet irrappurtata f'40.0% tat-tfal, u l-ebusija kienet irrappurtata fi 32.2% tat-tfal.
English: Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed
Maltese: Prevenar suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Tilqima konjugata saccharide pnewmokokkali, adsorbita
English: At the booster, some suppression of Hib antibody level was observed but all children had protective levels.
Maltese: Hib kien osservat, iżda t-tfal kollha kellhom livelli protettivi.
English: Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.
Maltese: Dejta limitata wriet li Prevenar jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il-marda taċ-ċelluli sickle, bi profil tas-sigurtà simili għal dak osservat fi gruppi li mhux qegħdin f'riskju għoli.
English: In a clinical trial that compared separate with concomitant administrations of Prevenar (three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) and Meningitec (meningococcal C conjugate vaccine; two doses at 2 and 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after
Maltese: Fi prova klinika li qabblet l-għoti separat mal-għoti fl-istess ħin ta' Prevenar (tliet dożi wara 2, 3.5, 6 xhur u doża booster wara madwar 12-il xahar) u Meningitec (tilqima konjugata Ċ meningokokkali; żewġ dożi wara xahrejn u 6 xhur u doża booster wara madwar 12-il xahar), ma kien hemm l-ebda evidenza ta' interferenza immuni bejn iż-żewġ tilqimiet konjugati wara s-serje primarja serje jew wara
English: 10 single-dose (0.5 ml) pre-filled syringes with separate needle.
Maltese: 10 siringi mimlijin għal-lest b'doża waħda (0.5 ml) b'labra separata.
English: The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age (see section 5.1)
Maltese: bit-tieni doża li tingħata mill-inqas xahrejn wara, u t-tielet doża (booster) li tingħata fl-età ta' 11-15-il xahar (ara sezzjoni 5.1)
English: Do not use Prevenar after the expiry date stated on the carton and label.
Maltese: Tużax Prevenar wara d-data ta' skadenza li tidher fuq il-kartuna u t-tikketta.
English: OUTER CARTON TEXT - 10 pre-filled syringes pack without needle: pack for multi pack presentation (5 x 10), without blue box
Maltese: KLIEM FUQ IL-KAXXA TA' BARRA - Pakkett b'10 siringi mimlijin għal-lest mingħajr labra: pakkett għal preżentazzjoni ta' pakkett multiplu (5 x 10), mingħajr il-kaxxa l-blu
English: The majority of the safety experience comes from the efficacy trial in which 17,066 infants received 55,352 doses of Prevenar.
Maltese: Il-maġġoranza tal-esperjenza dwar is-sigurtà tiġi mill-prova dwar l-effikaċja li fiha 17,066 tarbija rċivew 55,352 doża ta' Prevenar.
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Maltese: Fi trabi li twieldu prematuri ħafna (wara 28 ġimgħa jew aktar ta' tqala), jistgħu jseħħu intervalli bejn kull nifs għal 2-3 ijiem wara t-tilqima.
English: • Vomiting, diarrhoea, decreased appetite
Maltese: Komuni ħafna: Rimettar, dijarea, nuqqas t'aptit.
English: In a post licensure study involving 115 children between 2-5 years of age, tenderness was reported in 39.1 % of children; in 15.7 % of children the tenderness interfered with limb movement.
Maltese: Fi studju li sar wara li nħarġet il-liċenzja għal dan ilprodott, li kien jinvolvi 115 tifel u tifla li kellhom bejn sentejn u 5 snin, is-sensittività kienet irrappurtata f'sa 39.1% tat-tfal; fi 15.7% tat-tfal, is-sensittività interferixxiet mal-moviment tar-riġlejn jew tad-dirgħajn.
English: Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
Maltese: Alternattivament, meta Prevenar jingħata bħala parti minn programm ta' rutina ta' immunizzazzjoni lit-trabi, tista' tkun ikkunsidrata skeda b'żewġ dożi.
English: Epidemiological data between 1988 and 2003 indicated that in Europe coverage is lower and varies from country to country.
Maltese: Informazzjoni epidemjoloġika bejn is-sena 1988 u 2003 indikat li fl-Ewropa, il-kopertura hi iktar baxxa u tvarja minn pajjiż għall-ieħor.
English: Consequently, Prevenar should cover between 54 % and 84 % of isolates from invasive pneumococcal disease (IPD) in European children less than 2 years of age.
Maltese: Konsegwentement, Prevenar għandu jkopri bejn 54% u 84% tal-iżolati minn mard pnewmokokkali invażiv (invasive pneumococcal disease - IPD) fi tfal Ewropej li għandhom inqas minn sentejn.
English: Manufacturing Authorisation Holder responsible for batch release:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: LABEL TEXT - Outer wrapper label to be applied on the transparent foil for multi pack presentation (5 x 10), including the blue box
Maltese: KLIEM FUQ IT-TIKKETTA - Tikketta tat-tgeżwira ta' barra biex titwaħħal fuq il-fojl trasparenti għal preżentazzjoni ta' pakkett multiplu (5 x 10), li jinkludi l-kaxxa l-blu
English: Hypersensitivity reactions such as anaphylactic/anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
Maltese: Reazzjonijiet ta' sensittività eċċessiva bħal reazzjonijiet anafilattiċi/anafillattojdi li jinkludu xokk, edema anġjonewrotika, bronkospażmu, qtugħ ta' nifs, edema tal-wiċċ.
English: Lymphadenopathy localised to the region of the injection site
Maltese: Rari ħafna: Limfadenopatija lokalizzata fiż-żona tas-sit tal-injezzjoni
English: urticaria or urticaria-like rash (hives)
Maltese: • Raxx/ħorriqija (urtikarja)
English: Component of a multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes
Maltese: Komponent ta' pakkett multiplu b'5 pakketti, li kull wieħed ikun fih 10 siringi mimlijin għal-lest
English: • Erythema multiforme (a rash causing itchy red blotches)
Maltese: • Eritema multiforme (raxx li jikkawża tbajja' ħomor bil-ħakk)
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born  28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali ta' apnea u l-ħtieġa għal monitoraġġ respiratorju għal 48-72 siegħa għandhom ikunu kkunsidrati meta tagħti s-serje tal-immunizzazzjoni primarja lil trabi prematuri ħafna (li twieldu wara  28 ġimgħa ta' tqala) u partikularment lil dawk li kellhom storja medika ta' immaturità respiratorja.
English: Very rare side effects (these may occur with up to 1 in 10,000 doses of the vaccine) are: • Enlarged lymph nodes or glands (lymphadenopathy) near the injection site, such as under the arm or
Maltese: Effetti sekondarji rari ħafna (dawn jistgħu jseħħu b'sa 1 minn kull 10,000 doża tat-tilqima) huma:
English: There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
Maltese: M'hemm l-ebda informazzjoni disponibbli li tindika jekk l-għoti ta' tilqima tal-polysaccharide pnewmokokkali li fiha 23 valent lil tfal li ma jkunux tlaqqmu, jew lil tfal li jkunu diġà tlaqqmu bi Prevenar, jistax jirriżulta f'rispons eċċessiv għal dożi addizzjonali ta' Prevenar.
English: Each individual pack cannot be sold separately.
Maltese: Kull pakkett individwali ma jistax jinbiegħ separatament.
English: Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine or other micro-organisms that cause invasive disease or otitis media.
Maltese: Prevenar mhux ser jipproteġi kontra serotipi oħrajn ta' Streptococcus pneumoniae ħlief dawk inklużi fit-tilqima, jew kontra mikro-organiżmi oħrajn li jikkawżaw mard invażiv jew infjammazzjoni fil-parti
English: Limited data have demonstrated that Prevenar (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 (serje primarja bi tliet dożi) jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il-marda taċ-ċelluli sickle, bi profil tas-sigurtà simili għal dak osservat fi gruppi li mhux qegħdin f'riskju għoli (ara sezzjoni 5.1).