FrancophonIA/ELRC3.0 huggingface dataset:
English: The initial dose of atorvastatin was 5 mg daily of a chewable tablet in Cohort A and 10 mg daily of a tablet formulation in Cohort B. The atorvastatin dose was permitted to be doubled if a subject had not attained target LDL-C of <3.35 mmol/L at Week 4 and if atorvastatin was well tolerated.
Maltese: Id-doża inizjali ta' atorvastatin kienet 5 mg kuljum ta' pillola li tomgħodha fil-Grupp A u 10 mg kuljum ta' formulazzjoni ta' pillola fil-Grupp B.
English: At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures.
Maltese: bħala medja, il-bidla perċentwali mil-linja bażi fl-LDL-C u t-TC kienet madwar 40% u 30%, rispettivament, tul il-medda tal-esponimenti.
English: The usual starting dose of {PRODUCT NAME} is 10 mg once a day in adults and children aged 10 years or older.
Maltese: TAL-PRODOTT} hija 10 mg darba kuljum f'persuni adulti u tfal ta' 10 snin jew aktar.
English: The maximum dose of {PRODUCT NAME}is 80 mg once daily for adults and 20 mg once daily for children.
Maltese: TAL-PRODOTT} hija 80 mg darba kuljum għal-adulti u 80 mg darba kuljum għat-tfal.
English: {PRODUCT NAME} chewable tablet contains aspartame which is a source of phenylalanine.
Maltese: TALPRODOTT} pillola li tomgħodha fiha l-aspartame li huwa sors ta' phenylalanine.
English: Further information
Maltese: Aktar informazzjoni
English: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day.
Maltese: Għal pazjenti ta' 10 snin u aktar, id-doża tal-bidu rrakkomandata ta' atorvastatin hija 10 mg kuljum b'titrazzjoni sa 20 mg kuljum.
English: 4.9 Overdose {To be completed nationally}.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu {Biex timtela mill-pajjiż partikolari}.
English: LIST OF EXCIPIENTS Contains aspartame.
Maltese: 3. LISTA TA' SUSTANZI MHUX ATTIVI Fih l-aspartame.
English: The Risk Management Plan should include the ongoing study A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
Maltese: Il-pjan tal-Immaniġjar tar-Riskju għandu jinkludi wkoll listudju li bħalissa għadu għaddejj A2581173 (studju ta' 3 snin fuq sigurta' kif ukoll studju ieħor segwenti fuq l-effikaċja ta' kura b'atorvastatin fi tfal u adoloxxenti li għandhom min 6 snin sa anqas minn 18 il-sena u li għandhom Iperkolesterolemija tat-tip heterozygous familial.
English: {PRODUCT NAME} 5 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 5 mg li tomgħodhom Atorvastatin calcium [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: What {PRODUCT NAME} contains
Maltese: TAL-PRODOTT} u l-kontenuti tal-pakkett {ISEM
English: .Avda.
Maltese: {ISEM
English: • Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Maltese: • Għandu jiġi pprovdut Pjan tal-Immaniġjar tar-Riskju (jew aġġornament tiegħu) għal-Sortis u għal-ismijiet assoċjati miegħu, li jikkunsidra wkoll l-informazzjoni ġdida fit-tfal u rrakkomandazzjonijiet tal-CHMP.
English: Nostrum Farma, S.A., Avda.
Maltese: Nostrum Farma, S.A., Avda. de Europa 20B Parque Empresarial la Moraleja
English: {PRODUCT NAME} are available in blister packs containing 30 chewable tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Il-pakketti ta' folji fihom 30 pillola li tomgħodha.
English: Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
Maltese: FIS-SUQ [Biex timtela mill-pajjiż partikolari] [Ara Anness I - Biex timtela mill-pajjiż partikolari] {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: {PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Maltese: TAL-PRODOTT} huwa indikat ukoll biex inaqqas il-C totali u l-LDL-C f'pazjenti adulti b'iperkolesterolemija omożigota familjali bħala żieda ma' trattamenti oħra għat-tnaqqis tal-lipidi (eż. aferesi tal-LDL) jew jekk dawn it-trattamenti ma jkunux disponibbli.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID
English: S.L.
Maltese: Kull {ISEM
English: In this leaflet:
Maltese: DATA TA' META JISKADI JIS:
English: Drug-drug interaction studies have only been performed in adults.
Maltese: Studji tal-interazzjoni tal-prodott ma' mediċini oħra saru biss fuq persuni adulti.
English: Note:
Maltese: Nota
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' sussegwentement tiġi aġġornata mill-awtoritajiet kompetenti talIstat Membru, f'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stipulati fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication, in line with the SmPC guideline.]
Maltese: Buccalin u ismijiet assoċjati: tfal mill-età ta' sentejn Għal Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum u l-ismijiet assoċjati tagħhom mhi meħtieġa l-ebda bidla fl-età minima awtorizzata attwalment; madankollu l-cut off tal-età għandu jiġi rifless ukoll fl-indikazzjoni, f'konformità mal-linja gwida tal-SmPC.] [It-tibdil relatat għandu jiġi implimentat kif meħtieġ fl-SmPC kollu]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication] [Related changes should be implemented as needed throughout the PL]
Maltese: Buccalin u ismijiet assoċjati: tfal mill-età ta' sentejn Għal Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum u l-ismijiet assoċjati tagħhom mhi meħtieġa l-ebda bidla fl-età minima awtorizzata attwalment; madankollu l-cut off tal-età għandu jiġi rifless ukoll fl-indikazzjoni] [It-tibdil relatat għandu jiġi implimentat kif meħtieġ fil-PL kollu]
English: Amendments to relevant sections of the Product Information
Maltese: Emendi għas-sezzjonijiet rilevanti tal-Informazzjoni dwar il-Prodott
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Maltese: [Għall-prodotti kollha fl-Anness I, l-informazzjoni dwar il-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir tat-test, kif xieraq) biex tirrifletti l-kliem maqbul kif ipprovdut hawn taħt]
English: Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>.
Maltese: L-użu ta' <prodott> fil-prevenzjoni tal-pulmonite mhuwiex rakkomandat, peress li m'hemm l-ebda data disponibbli mill-istudji kliniċi biex turi effett bħal dan.
English: No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia.
Maltese: M'hemm l-ebda data disponibbli mill-istudji kliniċi biex turi li l-użu ta' <prodott> jista' jipprevjeni lpulmonite.
English: Summary of product characteristics
Maltese: Sommarju tal-karatteristiċi tal-prodott
English: 4.1 Therapeutic indications [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Maltese: [Għall-prodott indikat fl-infezzjonijiet fl-apparat respiratorju fl-adulti, l-indikazzjoni għandha tiġi reveduta kif ġej]
English: Canada (Quebec)
Maltese: Il-Kanada (Quebec)
English: 23 to 2948
Maltese: 23 sa 2948
English: Persons ≥ 65
Maltese: Persuni ≥ 65
English: 18 to 381
Maltese: 18 sa 381
English: 5 to 186
Maltese: 5 sa 186
English: ** p<0.005 to cover 6A where p=0.002
Maltese: ** p<0.005 biex tkopri 6A fejn p=0.002
English: 19 to 733
Maltese: 19 sa 733
English: 9 to 122
Maltese: 9 sa 122
English: 20 to 1234
Maltese: 20 sa 1234
English: 2004 data.
Maltese: Dejta mill-2004.
English: January 2005 to December 2007.
Maltese: Jannar 2005 sa Diċembru 2007.
English: 18-49 Years N=836-866
Maltese: 18-49 Sena N=836-866
English: For adjuvant, see section 2.
Maltese: Għal adjuvant, ara sezzjoni 2.
English: 5 to 45
Maltese: 5 sa 45
English: 5 to 37
Maltese: 5 sa 37
English: Total episodes
Maltese: Episodji totali
English: 2005 data.
Maltese: Dejta mill-2005.
English: A reduction in carriage was also seen for serotype 3 (2.5% vs 1.1%; p=0.1).
Maltese: Tnaqqis fil-ġarr intwera wkoll għas-serotip 3 (2.5% vs 1.1%; p=0.1).
English: 50-59 Years N=350-384
Maltese: 50-59 Sena N=350-384
English: 2, 4, 6, + 12-15 months
Maltese: 2, 4, 6, + 12-15-il xahar
English: 4 x 0.5 ml doses
Maltese: 4 x dożi ta' 0.5 ml
English: Incidence per 100,000 personyears of observation (PYO)
Maltese: Inċidenza għal kull 100,000 sena ta' persuna ta' osservazzjoni (PYO)
English: Study of Prevenar 13 containing the preservative 2-phenoxyethanol (2-PE):
Maltese: Studju ta' Prevenar 13 li fih il-preservattiv 2-phenoxyethanol (2-PE):
English: Prevenar 13 contains sodium
Maltese: Prevenar 13 fih sodium
English: Prevenar 13 was administered to 48,806 adults; 2,616 (5.4%) aged 50 to 64 years, and 45,291 (92.8%) aged 65 years and older.
Maltese: Prevenar 13 ingħata lil 48,806 adulti; 2,616 (5.4%) li kellhom bejn il-50 sa 64 sena, u 45,291 (92.8%) li kellhom'l fuq minn 65 sena.
English: Additional serotypes in Prevenar 13
Maltese: Serotipi addizzjonali fi Prevenar 13
English: Episodes
Maltese: Episodji
English: Table 2: Serotype specific number of cases and incidence reductions of IPD in 2013/14 compared to 2008/09-2009/10 (2008/10) by age in England and Wales
Maltese: Tabella 2: Numru ta' każijiet speċifiċi għas-serotip u tnaqqis fl-inċidenza ta' IPD fl-2013/14 meta mqabbel mal-2008/09-2009/10 (2008/10) skont l-età fl-Ingilterra u f'Wales
English: Difference (95 % CI)
Maltese: Differenza (95% CI)
English: Prevenar 13 is stable at temperatures up to 25°C for four days.
Maltese: Prevenar 13 huwa stabbli f'temperaturi sa 25°C għal erbat ijiem.
English: 1 dose (0.5 ml) contains 0.125 mg aluminium.
Maltese: Doża waħda (0.5 ml) fiha 0.125 mg aluminium.
English: • 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F
Maltese: • 2.2 µg ta' polysaccharide għas-serotipi 1, 3, 4, 5, 6A, 7F, 9V, 14, 18Ċ, 19A, 19F u 23F
English: Children (12-59 months) completely immunised with Prevenar (7-valent)
Maltese: Tfal (12-59 xahar) kompletament imlaqqma bi Prevenar (7-valenti)
English: 7-valent Prevenar
Maltese: Prevenar 7-valent
English: Conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
Maltese: Konjugat mal-proteina carrier CRM197, adsorbit fuq aluminium phosphate.
English: The efficacy of 7-valent Prevenar was evaluated in two major studies - the Northern California Kaiser Permanente (NCKP) study and the Finnish Otitis Media (FinOM) study.
Maltese: L-effikaċja ta' Prevenar 7-valent ġiet evalwata f'żewġ studji kbar- l-istudju Northern California Kaiser Permanente (NCKP) u l-istudju Finnish Otitis Media (FinOM).
English: All seven common serotypes met pre-defined non-inferiority criteria for IgG ELISA GMCs.
Maltese: Is-seba' serotipi komuni kollha, issodisfaw il-kriterji pre-definiti tan-nuqqas ta' inferjorità għal IgG ELISA GMCs.
English: • 4.4 µg of polysaccharide for serotype 6B
Maltese: • 4.4 µg ta' polysaccharide għas-serotip 6B
English: • Decreased appetite
Maltese: • Nuqqas t'aptit
English: First episode of VT-IPD
Maltese: L-ewwel episodju ta' VT-IPD
English: Prevenar 13, provides protection against 13 types of Streptococcus pneumoniae bacteria, and replaces Prevenar, which provided protection against 7 types.
Maltese: Prevenar 13, jipprovdi protezzjoni kontra 13-il tip ta' batterji Streptococcus pneumoniae, u jissostitwixxi Prevenar, li kien jipprovdi protezzjoni kontra 7 tipi.
English: Vaccine serotypes: 76% All serotypes: 38%
Maltese: Serotipi tat-tilqima: 76% Is-serotipi kollha: 38%
English: 2-phenoxyethanol Water for injections
Maltese: 2-phenoxyethanol Ilma għall-injezzjonijiet
English: 6A 7F 19A The serotype in Prevenar with the lowest percent response rate was 6B in study 006 (87.1 %).
Maltese: 6A 7F 19A Is-serotip fi Prevenar bl-inqas perċentwali ta' rata ta' rispons kien 6B fi studju 006 (87.1%).
English: Per 100,000 person-years of observation.
Maltese: Għal kull 100,000 sena ta' persuna ta' osservazzjoni.
English: Pack sizes of 1, 5, 10, 25 and 50.
Maltese: Daqsijiet tal-pakkett ta' 1, 5, 10, 25 u 50.
English: NCKP: Acute Otitis Media (AOM) Total episodes
Maltese: NCKP: Infjammazzjoni Akuta fil-Parti tan-Nofs tal-Widna (AOM) Episodji totali
English: Preterm infants (<37 weeks gestation)
Maltese: Trabi prematuri (< 37 ġimgħa ta' tqala)
English: Vaccine serotypes: 98% All serotypes: 77%
Maltese: Serotipi tat-tilqima: 98% Is-serotipi kollha: 77%
English: Date of first authorisation: 09 December 2009 Date of latest renewal: 18 September 2014
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2014
English: Hampshire PO9 2NG United Kingdom
Maltese: Hampshire PO9 2NG Ir-Renju Unit
English: 5 to 64 years of age
Maltese: 5 sa 64 sena
English: 60-64 Years N=367-402
Maltese: Sena N=367-402
English: Results for study 004 were similar.
Maltese: Ir-riżultati għal studju 004 kienu simili.
English: There was no carriage of serotypes 1 and 5 observed.
Maltese: Ma kien hemm ebda ġarr ta' serotipi 1 u 5 osservat.
English: 1, 5, 10, 25, 50 multidose containers
Maltese: 1, 5, 10, 25, 50 kontenitur b'ħafna dożi
English: Prevenar 13 Relative to PPSV23, 60-64 Years
Maltese: Prevenar 13 mqabbel ma' PPSV23, 60-64
English: NCKP: Vaccine-serotype IPD
Maltese: NCKP: Tilqima-serotip IPD3
English: ≥65 years of age
Maltese: ≥65 sena
English: • Fever of more than 39°C; tenderness at the vaccination-site interfering with movement, redness,
Maltese: • Deni ta' iktar minn 39°C; sensittività fis-sit tat-tilqima li tinterferixxi mal-moviment, ħmura,
English: Reductions were 53% (167 to 79 cases) (p<0.001) for CAP cases with pleural effusion and 63% (64 to 24 cases) (p<0.001) for microbiologically confirmed pneumococcal CAP cases.
Maltese: It-tnaqqis kien ta' 53% (minn 167 għal 79 każ) (p<0.001) għall-każijiet ta' CAP b'effużjoni plewrali u 63% (64 għal 24 każ) (p<0.001) għal każijiet CAP pnewmokokkali mikrobijoloġikament ikkonfermati.
English: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm
Maltese: Reazzjoni ta' sensittività eċċessiva li tinkludi edima fil-wiċċ, dispnea, bronkospażmu
English: <5 years of age
Maltese: <5 snin
English: See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
Maltese: Ara sezzjonijiet 4.4 u 5.1 għal informazzjoni dwar il-protezzjoni kontra serotipi pnewmokokkali speċifiċi.
English: Table 8: OPA GMTs in adults aged 18-49 years and 60-64 years given Prevenar 13
Maltese: Tabella 8: OPA GMTs f'adulti li kellhom 18-49 sena u 60-64 sena li ngħataw Prevenar 13
English: 1, 5, 10, 25, 50 single dose vials
Maltese: 1, 5, 10, 25, 50 kunjett ta' doża waħda
English: 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium).
Maltese: Doża 1 (0.5 ml) fiha madwar 32 µg proteina carrier CRM197, adsorbita fuq aluminium phosphate (0.125 mg ta' aluminju).
English: The frequency is defined as follows: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Maltese: komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1,000 sa < 1/100), rari ( 1/10,000 sa < 1/1,000), rari ħafna (≤ 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode)
Maltese: • Kollass jew stat jixbah lil xokk (episodju ipotoniku-iporisponsiv)
English: Calculated vaccine effectiveness as of June 2008 (Broome method).
Maltese: L-effikaċja kkalkulata tat-tilqima sa Ġunju 2008 (metodu Broome).
English: For serotype 3, the percentages of Prevenar 13 recipients with serum IgG ≥ 0.35 μg/ml were 98.2% (study 006) and 63.5% (study 004).
Maltese: Għasserotip 3, il-perċentwali ta' reċipjenti ta' Prevenar 13 b'IgG ta' ≥ 0.35 µg/ml fis-serum kienu 98.2% (studju 006), 63.5% (studju 004).
English: * Patients with at least 2 of the following: Cough; purulent sputum, temperature >38°C or <36.1°C; pneumonia (auscultatory findings); leukocytosis; C-reactive protein value >3 times the upper limit of normal; hypoxemia with a partial oxygen pressure <60 mm Hg while breathing room air.
Maltese: Sogħla; bżieq purulenti, temperatura >38°C jew <36.1°C; pnewmonja (sejbiet awskultatorji); lewkoċitożi; valur tal-proteina C-reattiva >3 darbiet tal-limitu ta' fuq tannormal; ipoksimija bi pressjoni ta' ossiġnu parzjali <60 mm Hg waqt it-teħid tan-nifs tal-arja tal-kamra.
English: In an ongoing surveillance system (2004 to 2013) to document the impact of Prevenar and subsequently Prevenar 13 on CAP in children less than 5 years in Southern Israel using a 2 dose primary series with a booster dose in the second year of life, there was a reduction of 68% (95% CI 73; 61) in outpatient visits and 32% (95% CI 39; 22) in hospitalizations for alveolar CAP following the introduction of Prevenar 13 when compared to the period before the introduction of Prevenar.
Maltese: F'sistema ta' sorveljanza kontinwa (2004 sa 2013) biex jiġi ddokumentat l-impatt ta' Prevenar u sussegwentement Prevenar 13 fuq CAP fi tfal li għandhom anqas minn 5 snin fin-Nofsinhar ta' Iżrael permezz ta' serje primarja ta' 2 dożi b'doża booster fit-tieni sena ta' ħajja, kien hemm tnaqqis ta' 68% (95% CI 73; 61) fi żjarat outpatient u 32% (95% CI 39; 22) f'kura fl-isptar għal CAP ta' alveolar wara l-introduzzjoni ta' Prevenar 13 meta mqabbel mal-perjodu qabel l-introduzzjoni ta' Prevenar.
English: Chills; fatigue; vaccination-site erythema; vaccination-site induration/swelling; vaccination-site pain/tenderness (severe vaccination-site pain/tenderness very common in adults aged 18 to 39 years); limitation of arm movement (severe limitation of arm movements very common in adults aged 18 to 39 years)
Maltese: Tertir ta' bard; għeja; eritema fis-sit tat-tilqima; ebusija/nefħa fis-sit tattilqima; uġigħ/ sensittività fis-sit tat-tilqima (uġigħ sever fis-sit tattilqima/sensittività komuni ħafna f'adulti li kellhom minn 18 sa 39 sena); moviment limitat tad-drigħ (limitazzjoni severa tal-movimenti tad-driegħ kienet komuni ħafna f'adulti li kellhom minn 18 sa 39 sena)
English: One single dose.
Maltese: Doża unika.
English: The reductions ranged between 34% and 62% depending on serotype and antibiotic.
Maltese: It-tnaqqisijiet varjaw bejn 24% u 62% jiddependi fuq is-serotip u l-antibijotiku.
English: All serotypes: 73% Vaccine serotypes: 2-dose infant series: 99% Completed schedule:100%
Maltese: Serje ta' 2 dożi lit-trabi: 99% Skeda mitmuma:100%
English: Immune responses as measured by IgG GMCs were assessed in 168-211 evaluable subjects approximately 1 month after vaccination.
Maltese: Irrisponsi immuni kif imkejla minn IgG GMCs ġew evalwati f'168-211-il individwu li setgħu jiġu evalwati madwar xahar wara t-tilqima.
English: Hypotonic-hyporesponsive episode
Maltese: Episodju ipotoniku- iporisponsiv
English: 1 dose (0.5 ml) contains approximately 32 µg CRM197 carrier protein and 0.125 mg aluminium.
Maltese: Doża 1 (0.5 ml) fiha madwar 32 µg proteina carrier CRM197 u 0.125 mg ta' aluminju.
English: The protective efficacy of Prevenar 13 against IPD has not been studied.
Maltese: L-effikaċja protettiva ta' Prevenar 13 kontra IPD ma ġietx studjata.
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 t-tilqima primarja, 95.6% tal-individwi kellhom livelli ta' antikorpi ta' mill-inqas 0.35 μg/ml għas-seba' serotipi kollha li jinsabu fi Prevenar.
English: Suspension for injection in multidose container 1 multidose container (4 x 0.5 ml doses) 5 multidose containers (4 x 0.5 ml doses per containers) 10 multidose containers (4 x 0.5 ml doses per containers) 25 multidose containers (4 x 0.5 ml doses per containers) 50 multidose containers (4 x 0.5 ml doses per containers)
Maltese: Suspensjoni għall-injezzjoni f'kontenitur b'ħafna dożi 1 kontenitur b'ħafna dożi (4 x dożi ta' 0.5 ml) 5 kontenituri b'ħafna dożi (4 x dożi ta' 0.5 ml għal kull kontenitur) 10 kontenituri b'ħafna dożi (4 x dożi ta' 0.5 ml għal kull kontenitur) 25 kontenitur b'ħafna dożi (4 x dożi ta' 0.5 ml għal kull kontenitur) 50 kontenitur b'ħafna dożi (4 x dożi ta' 0.5 ml għal kull kontenitur)
English: NB/NI - non-bacteraemic/non-invasive VT-IPD - vaccine-type invasive pneumococcal disease
Maltese: NB/NI - mhux batteremika/mhux invażiva (non-bacteraemic/non-invasive)
English: Unvaccinated Children (12-23 months)
Maltese: Tfal mhux imlaqqma (12-23 xahar)
English: Prevenar 13 suspension for injection IM
Maltese: Prevenar 13 suspensjoni għall-injezzjoni IM
English: 1 dose (0.5 ml) contains 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 µg for serotype 6B conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
Maltese: Doża waħda (0.5 ml) fiha 2.2 µg ta' polysaccharide għas-serotipi 1, 3, 4, 5, 6A, 7F, 9V, 14, 18Ċ, 19A, 19F, 23F u 4.4 µg għas-serotip 6B konjugat mal-proteina carrier CRM197 adsorbit fuq aluminium phosphate.
English: These observations are consistent with adequate priming (the induction of immunologic memory).
Maltese: Dawn l-osservazzjonijiet huma konsistenti ma' tilqim ta' preparazzjoni adegwat (l-induzzjoni ta' memorja immunoloġika).
English: In a retrospective evaluation of a large US insurance database, AOM visits were reduced by 42.7 % (95 % CI, 42.4-43.1 %), and prescriptions for AOM by 41.9 % in children younger than 2 years of age, compared with a pre-licensure baseline (2004 vs. 1997-99).
Maltese: F'evalwazzjoni retrospettiva ta' database ta' kumpanija Amerikana kbira tal-assigurazzjoni, il-viżti minħabba AOM tnaqqsu bi 42.7% (95 % CI, 42.4-43.1 %), u r-riċetti għal AOM naqsu b'41.9% fi tfal iżgħar minn sentejn, meta mqabbla mal-linja bażi, qabel ma ngħatat il-liċenzja għal din il-mediċina (2004 vs. 1997-99).
English: • A fourth injection (booster) will be given between 11 and 15 months of age.
Maltese: • Ir-raba' injezzjoni (booster) ser tingħata bejn l-età ta' 11 u 15-il xahar.
English: The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high.
Maltese: Il-porzjonijiet tar-responders tal-antikorp funzjonali (titres OPA ≥ 1:8) għal serotipi 1, 3 u 5 kienu għolja.
English: Safety was assessed in 7 clinical studies including 91,593 adults ranging in age from 18 to 101 years.
Maltese: Is-sigurtà ġiet evalwata f'7 studji kliniċi li fihom ħadu sehem 91,593 adult li kellhom bejn it-18 u 101 sena.
English: Prevenar 13 elicited functional antibodies to all 13 vaccine serotypes in studies 004 and 006.
Maltese: Prevenar 13 ikkawża antikorpi funzjonali għat-13-il serotip kollha fi studji 004 u 006.