FrancophonIA/ELRC3.0 huggingface dataset:
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Il-barcode 2D li jġorr l-identifikatur uniku inkluż
English: Use with systemic immunosuppressive medicinal products
Maltese: Użu ma' prodotti mediċinali sistemiċi immunosoppressivi
English: Immunologic non-inferiority to 7-valent Prevenar
Maltese: Non-inferjorità immunoloġika għal Prevenar 7-valenti
English: GlaxoSmithKline Biologicals S.A. Parc de la Noire Epine Rue Fleming 20
Maltese: S.A. Parc de la Noire Epine Rue Fleming 20
English: Immunogenicity of Synflorix containing the preservative 2-phenoxyethanol (2-PE)
Maltese: Immunoġeniċità ta' Synflorix li fih il-preservattiv 2-phenoxyethanol (2-PE)
English: In prospective studies, Streptococcus pneumoniae was estimated to be responsible for 30-50% of pneumonia cases.
Maltese: Fi studji prospettivi, Streptococcus pneumoniae kien stmat li hu responsabbli għal 3050% tal-każijiet tal-pnewmonja.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2 °C -8 °C).
English: Booster doses of Synflorix may increase the risk of side effects.
Maltese: Dożi booster ta' Synflorix jistgħu jżidu r-riskju ta' effetti sekondarji.
English: Allergic reactions (such as eczema, allergic dermatitis, atopic dermatitis)
Maltese: Reazzjonijiet allerġiċi (bħal ekżema, dermatite allerġika, dermatite atopika)
English: Hypotonic-hyporesponsive episode
Maltese: Episodju ipotoniku-iporisponsiv
English: In COMPAS it was 66.7% (95% CI: 21.8; 85.9; 7 versus 21 cases).
Maltese: F'COMPAS kienet ta' 66.7% (95% CI: 21.8;85.9; 7 kontra 21 każ).
English: 9-16 micrograms
Maltese: 9-16-il mikrogramma
English: 0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Maltese: 1 adsorbit fuq aluminium phosphate total ta' 0.5 milligramma Al3+ 2 konjugat ma' proteina carrier ta' proteina D (derivata minn non-typeable Haemophilus influenzae)
English: The last injection (booster)
Maltese: L-aħħar injezzjoni (booster)
English: Synflorix contains sodium
Maltese: Synflorix fih sodium
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 March 2009
Maltese: Data tal-ewwel awtorizzazzjoni: 30 ta' Marzu 2009
English: Immune memory
Maltese: Memorja immunitarja
English: 3-6 micrograms
Maltese: 3-6 mikrogrammi
English: 4-dose container 3 years
Maltese: Kontenitur ta' 4 dożi 3 snin
English: Booster dose at 9-10 months of age
Maltese: Doża booster f'età ta' 9-10 xhur
English: The proportion of subjects who received the booster dose in the ATP cohort was 92.3% in both analyses.
Maltese: Il-proporzjon ta' individwi li rċevew doża booster fil-koorti ATP kien 92.3% fiż-żewġ analiżijiet.
English: Booster dose at 9-12 versus 15-18 months of age
Maltese: Doża booster f'età ta' 9-12-il xahar kontra 15-18-il xahar
English: Infants aged 7 to 11 months will receive 2 injections.
Maltese: Trabi b'età minn 7 sa 11-il xahar se jirċievu 2 injezzjonijiet.
English: Efficacy was 100% (95% CI: 41.9; 100) against bacteraemic pneumococcal pneumonia or empyema due to vaccine serotypes.
Maltese: L-effikaċja kienet 100% (95% CI: 41.9; 100) kontra pnewmonja pnewmokokkali batteremika jew empijema dovuta għal serotipi tal-vaċċin.
English: Each 0.5 ml dose contains 1 microgram of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14 and 23F, and 3 micrograms for serotypes 4, 18C and 19F
Maltese: Kull doża ta' 0.5 ml fiha mikrogramma waħda ta' polysaccharide għas-serotipi 1, 5, 6B, 7F, 9V, 14 u 23F, u 3 mikrogrammi għal serotipi 4, 18C u 19F
English: GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1.
Maltese: Kft. Homoki Nagy István utca 1. 2100
English: Pneumococcal polysaccharide serotype 18C1,3
Maltese: Polysaccharide pnewmokokkali serotip 18C1,3
English: EU/1/09/508/001 - pack of 1 without needle EU/1/09/508/002 - pack of 10 without needle EU/1/09/508/003 - pack of 1 with 1 needle EU/1/09/508/004 - pack of 10 with 10 needles EU/1/08/508/005 - pack of 1 with 2 needles EU/1/09/508/010 - pack of 50 without needle
Maltese: EU/1/09/508/001 - pakkett ta' 1 bla labra EU/1/09/508/002 - pakkett ta' 10 bla labra EU/1/09/508/003 - pakkett ta' 1 b'labra waħda EU/1/09/508/004 - pakkett ta' 10 b'10 labriet EU/1/09/508/005 - pakkett ta' 1 b'2 labriet EU/1/09/508/010 - pakkett ta' 50 bla labra
English: Synflorix can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measles-mumps-rubella vaccine (MMR), varicella vaccine (V), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and oral rotavirus vaccine.
Maltese: Synflorix jista' jingħata flimkien ma' kull wieħed mit-tilqim monovalenti jew kombinati li ġejjin [inkluż DTPa-HBV-IPV/Hib u DTPw-HBV/Hib]: tilqima bla ċelluli tad-difterite-tetnu-pertussis (DTPa), tilqima ta' l-epatite B (HBV), tilqima inattivata tal-polio (IPV), tilqima ta' l-Haemophilus influenzae tip b (Hib), tilqima b'ċelluli sħaħ tad-difterite-tetnu-pertussis (DTPw), tilqima tal-ħosbagattone-rubella (MMR), tilqima tal-variċella (V), tilqima konjugata tal-meningokokki ta' serogrupp Ċ (konjugati ta' CRM197 u TT), tas-serogruppi meningokokkali A, C, W-135 u l-vaċċin konjugat Y
English: Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively.
Maltese: Wara tilqim booster, l-aktar r-reazzjonijiet avversi komuni kienu uġigħ fil-post tal-injezzjoni u irritabilità, li seħħew f'madwar 51% u 53% rispettivament.
English: Pack size of 1, 10 or 50.
Maltese: Daqs tal-pakkett ta' 1, 10 jew 50.
English: Overall, the incidence of IPD was 35/100,000 person-years in those cohorts exposed to Synflorix, and 64/100,000 person-years in those exposed to 7-valent Prevenar, representing a statistically significant difference (p = 0.03).
Maltese: B'mod globali, l-inċidenza ta' IPD kienet ta' 35/100,000 sena tal-pazjent f'dawk il-gruppi esposti għal Synflorix, u 64/100,000 sena tal-pazjent f'dawk esposti għal Prevenar 7-valenti, li tirrappreżenta differenza statistikament sinifikanti (p = 0.03).
English: Likely bacterial CAP (B-CAP) is defined as radiologically confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non-alveolar infiltrates but with C reactive protein (CRP) ≥ 40 mg/l.
Maltese: Il-CAP probabbilment batterjali (B -CAP) hija definita bħala każijiet CAP ikkonfermati radjoloġikament b'konsolidazzjoni alveolari/effużjoni plewrali fuq ir-raġġi-X tas-sider, jew b'infiltrati mhux alveolari iżda bi proteina reattiva C (CRP) ≥ 40 mg/l.
English: 4 conjugated to diphtheria toxoid carrier protein
Maltese: 4 konjugat ma' proteina carrier ta' toxoid tad-difterite
English: In this age group, serotypes 1, 5 and 7F account for 3.3% to 24.1% of IPD depending on the country and time period studied.
Maltese: F'dan il-grupp ta' età, serotipi 1, 5 u 7F huma responsabbli għal 3.3% sa 24.1% ta' l-IPD skond il-pajjiż u l-perijodu ta' żmien studjati.
English: The difference between both vaccines in terms of percentage of subjects with OPA titres ≥ 8 was <5% for all serotypes in common, including 6B and 23F.
Maltese: Id-differenzi bejn iż-żewġ vaċċini f'termini ta' perċentwal ta' individwi b'titri ta' OPA ε 8 kienet <5% għas-serotipi kollha komuni, inkluż 6B u 23F.
English: Very common Irritability Uncommon Crying abnormal
Maltese: Komuni ħafna Irritabbiltà Mhux komuni
English: Any culture confirmed Any vaccine serotype(2)
Maltese: Kwalunkwe kultura kkonfermata Kwalunkwe serotip tal vaċċin(2)
English: Convulsions (including febrile convulsions)
Maltese: Rari konvulżjonijiet (inkluż bid-deni)
English: ГлаксоСмитКлайн ЕООД Тел.
Maltese: ГлаксоСмитКлайн ЕООД
English: The clinical relevance of these differences is unclear, as Synflorix was observed to be effective against IPD caused by serotype 6B in a doubleblind, cluster-randomized clinical study (see Table 1).
Maltese: Ir-rilevanza klinika ta' din id-differenza mhix ċara, billi Synflorix kien osservat li huwa effettiv kontra IPD ikkawżat mis-serotip 6B fi studju kliniku double-blind, b'raggruppamenti randomizzati (ara Tabella 1).
English: Pack size of 1, 10 or 100.
Maltese: Daqs tal-pakkett ta' 1, 10 jew 100.
English: VE Vaccine effectiveness (FinIP) or efficacy (COMPAS) N number of subjects per group
Maltese: VE Effettività tal-vaċċin (FinIP) jew effikaċja (COMPAS) N numru ta' individwi f'kull grupp
English: Infants from 6 weeks to 6 months of age:
Maltese: Trabi li għandhom età bejn 6 ġimgħat u 6 xhur:
English: For the cross-reactive serotype 19A, similar ELISA antibody GMCs were observed post-primary and post-booster for the 2-dose schedule [0.14 µg/ml (95% CI: 0.12; 0.17) and 0.73 µg/ml (95% CI: 0.58; 0.92)] and the 3-dose schedule [0.19 µg/ml (95% CI: 0.16; 0.24) and 0.87 µg/ml (95% CI: 0.69; 1.11)].
Maltese: Għas-serotip kross-reattiv 19A, kienu osservati GMCs ta' antikorpi imkejlin b'ELISA jixxiebhu wara ddoża primarja u wara d-doża booster għall-iskeda ta' 2 dożi [0.14 µg/ml (95% CI: 0.12; 0.17) u 0.73 µg/ml (95% CI: 0.58; 0.92)] u l-iskeda ta' 3 dożi [0.19 µg/ml (95% CI: 0.16; 0.24) u 0.87 µg/ml (95% CI: 0.69; 1.11)].
English: 3 conjugated to tetanus toxoid carrier protein
Maltese: 3 konjugat ma' proteina carrier ta' toxoid tat-tetnu
English: In both schedules, a booster response indicative of immunological priming was observed.
Maltese: Fiż-żewġ skedi, ġie osservat rispons booster indikattiv ta' priming immunoloġiku.
English: The booster dose of Synflorix in HIV+/+ and HIV+/- infants induced robust increases in ELISA antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A indicative of immunological priming.
Maltese: Id-doża booster ta' Synflorix fi trabi HIV+/+ u HIV+/- induċiet żidiet robusti fil-GMCs ta' antikorpi mkejlin b'ELISA u fil-GMTs ta' OPA għal kull serotip tal-vaċċin u għas-serotip 19A indikattivi ta' pprajmjar immunoloġiku.
English: 4-dose container Sodium chloride 2-phenoxyethanol Water for injections
Maltese: Kontenitur ta' 4 dożi Sodium chloride 2-phenoxyethanol Ilma għall-injezzjonijiet
English: Uncommon Rash Rare
Maltese: Biki mhux normali
English: Immunogenicity and safety of Synflorix were assessed in a limited number of primed or unprimed subjects with congenital or acquired asplenia, splenic dysfunction or complement deficiencies: 6 subjects 2-5 years of age and 40 subjects 6-17 years of age (Synflorix is indicated up to 5 years of age).
Maltese: Ġew ivvalutati l-immunoġeniċità u s-sigurtà ta' Synflorix f'numru limitat, imħejja (primed) jew mhux imħejja (unprimed), ta' individwi b'asplenja konġenitali jew akkwistata, disfunzjoni tal-milsa jew defiċjenzi tal-komplement: 6 individwi ta' età bejn 2-5 snin u 40 individwu ta' età bejn 6 u 17-il sena (Synflorix huwa indikat sa età ta' 5 snin).
English: For most vaccine serotypes and serotype 19A, group comparisons did not suggest any differences post-booster dose in ELISA antibody GMCs and OPA GMTs between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups.
Maltese: Għal ħafna mis-serotipi tal-vaċċin u għas-serotip 19A, it-tqabbil bejn ilgruppi ma ssuġġerixxiex xi differenza ta' wara d-doża booster fil-GMCs ta' anitkorpi mkejlin b'ELISA jew fil-GMTs ta' OPA bejn il-gruppi HIV+/+ u HIV-/-, jew il-gruppi HIV+/- u HIV-/-.
English: Impact on nasopharyngeal carriage (NPC)
Maltese: Impatt fuq il-ġarr nasofarinġeali (NPC)
English: HIV positive (HIV+/+) infants and HIV negative infants born from HIV positive mothers (HIV+/-)
Maltese: Trabi pożittivi għall-HIV (HIV+/+) u trabi negattivi għall-HIV li twieldu minn ommijiet pożittivi għall-HIV (HIV+/-)
English: may be given from the age of 9 months onwards.
Maltese: tista' tingħata mill-età ta' 9 xhur 'il fuq.
English: Table 6: Comparative analysis between 7-valent Prevenar and Synflorix in percentage of subjects with antibody concentrations > 0.20 µg/ml one month post-dose 3
Maltese: Analiżi komparattiva bejn Prevenar 7-valenti u Synflorix f'perċentwal ta' individwi b'konċentrazzjonijiet ta' antikorpi ta' > 0.20 µg/ml xahar wara t-tielet doża
English: Table 5: Rates of IPD and the corresponding rate reductions in Finland IPD
Maltese: Rati ta' IPD u t-tnaqqis korrispondenti fir-rati fil-Finlandja IPD
English: In a clinical study children received either Synflorix (N=603) or 7-valent Prevenar (N=203) concomitantly with a DTPw containing vaccine.
Maltese: Fi studju kliniku tfal irċevew Synflorix (N=603) jew Prevenar 7-valenti (N=203) flimkien ma' tilqima li fiha DTPw.
English: The protection against B-CAP before booster dose and at the time or after booster dose was 13.6% (95% CI: -11.3; 33.0) and 21.7% (95% CI: 3.4; 36.5) respectively.
Maltese: B-CAP qabel doża booster u fil-ħin jew wara d-doża booster kienet 13.6% (95% CI: -11.3; 33.0) u 21.7% (95% CI: 3.4; 36.5) rispettivament.
English: Relative rate reduction % (95% CI)
Maltese: Tnaqqis relattiv fir-rata(1) % (95% CI)
English: Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
Maltese: Tilqim attiv kontra mard invażiv, pnewmonja u otite medja akuta kkawżati minn Streptococcus pneumoniae fi trabi u tfal b'età minn 6 ġimgħat sa 5 snin.
English: In a head-to-head comparative trial with 7-valent Prevenar, non-inferiority of the immune response to Synflorix measured by ELISA was demonstrated for all serotypes, except for 6B and 23F (upper limit of the 96.5% CI around the difference between groups >10%) (Table 6).
Maltese: Fi prova komparattiva ras imbras ma' Prevenar 7-valenti, in-nuqqas ta' inferjorità tar-rispons immuni għal Synflorix mkejla b'ELISA ntwera għas-serotipi kollha, minbarra għal 6B u 23F (il-limitu ta' fuq ta' 96.5% CI madwar id-differenza bejn il-gruppi >10%) (Tabella 6).
English: 1-dose and 2-dose containers 4 years
Maltese: Kontenituri ta' doża 1 u ta' 2 dożi 4 snin
English: For serotypes 1, 5 and 7F, the percentages of Synflorix vaccinees reaching an OPA titre ≥ 8 were respectively 65.7%, 90.9% and 99.6% after the primary vaccination course and 91.0%, 96.3% and 100% after the booster dose.
Maltese: Għas-serotipi 1, 5 u 7F, il-perċentwal ta' tilqim Synflorix li laħqu titre ta' OPA ta' ε 8 kienu 65.7%, 90.9% u 99.6% rispettivament wara l-kors primarju ta' tilqim u 91.0%, 96.3% u 100% wara d-doża booster.
English: Overall, for each vaccine serotype at least 97.6% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 91.9% achieved OPA titres ≥ 8.
Maltese: Globalment, għal kull serotip tal-vaċċin mill-anqas 97.6% tal-individwi kisbu konċentrazzjonijiet ta' antikorpi mkejla b'ELISA ≥ 0.20 µg/ml u mill-anqas 91.9% kisbu titres ta' OPA ≥ 8.
English: Serotype specific efficacy against the first AOM episode was demonstrated for serotypes 6B (86.5%, 95% CI: 54.9; 96.0), 14 (94.8%, 95% CI: 61.0; 99.3), 19F (43.3%, 95% CI: 6.3; 65.4) and 23F (70.8%, 95% CI: 20.8; 89.2).
Maltese: L-effikaċja tat-tilqima 11 Pn-PD kontra l-ewwel okkorrenza ta' episodju ta' AOM ta' tilqima-serotip kienet 52.6% (95% CI: 35.0; 65.5). Effikaċja speċifika għas-serotip kontra l-ewwel episodju ta' AOM intweriet għas-serotipi 6B (86.5%, 95% CI: 54.9; 96.0), 14 (94.8%, 95% CI: 61.0; 99.3), 19F (43.3%, 95% CI: 6.3; 65.4) u 23F (70.8%, 95% CI: 20.8; 89.2).
English: Uncommon Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Maltese: Mhux komuni apneja fi trabi prematuri ħafna (≤28 ġimgħa ta' tqala) (ara sezzjoni 4.4)
English: There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against nontypeable Haemophilus influenzae.
Maltese: M'hemmx biżżejjed evidenza li Synflorix jipporovdi protezzjoni kontra serotipi pnewmokokkali li ma jinstabux fit-tilqima ħlief is-serotip kross-reattiv 19A (ara sezzjoni 5.1) jew kontra non-typeable Haemophilus influenzae.
English: Among the 15,447 children in the catch-up vaccinated cohorts, there were no culture-confirmed IPD cases in the Synflorix groups while 5 vaccine serotype IPD cases were observed in the control groups (serotypes 4, 6B, 7F, 14 and 19F).
Maltese: Fost il-15,447 tifel u tifla fil-gruppi li ħadu t-tilqima wara l-età rakkomandata, ma kien hemm l-ebda każ ta' IPD ikkonfermat permezz ta' kulturi fil-gruppi li ħadu Synflorix filwaqt li kienu osservati 5 każijiet ta' IPD mis-serotipi tal-vaċċin fil-gruppi ta' kontroll (serotipi 4, 6B, 7F, 14 u 19F).
English: Based on immunological bridging of the functional vaccine response (OPA) of Synflorix with the 11-valent formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM.
Maltese: Ibbażat fuq paragun immunoloġiku tar-rispons funzjonali tat-tilqima (OPA) ta' Synflorix malformulazzjoni 11 -valent użata f'POET, huwa mistenni li Synflorix jipprovdi effikaċja protettiva simili kontra AOM ikkawżata minn pnewmokokki.
English: 100 vials 100 x 1 dose (0.5 ml)
Maltese: 100 kunjett 100 x 1 dożi (0.5 ml)
English: Pneumococcal polysaccharide serotype 6B1,2
Maltese: Polysaccharide pnewmokokkali serotip 6B1,2
English: • Synflorix is available in vials for 1 dose in packs of 1, 10 or 100
Maltese: • Synflorix huwa disponibbli f'kunjetti għal doża 1 f'pakketti ta' 1, 10 jew 100.
English: Children aged 12 months to 5 years will receive 2 injections.
Maltese: Tfal b'età minn 12-il xahar sa 5 snin se jirċievu 2 injezzjonijiet.
English: At the end-of-study analysis (ATP cohort), the vaccine efficacy (first episodes) against B-CAP was 18.2% (95% CI: 4.1; 30.3), against C-CAP 22.4% (95% CI: 5.7; 36.1) and against clinically suspected CAP referred for X-ray 7.3% (95% CI: 1.6; 12.6).
Maltese: B-CAP kienet ta' 18.2% (95% CI: 4.1; 30.3), kontra C-CAP 22.4% (95% CI: 5.7; 36.1) u kontra CAP suspettata klinikament li ġiet riferuta għal raġġi-X 7.3% (95% CI: 1.6; 12.6).
English: Other medicines and Synflorix
Maltese: Mediċini oħra u Synflorix
English: The percentage of vaccinees reaching the threshold for the three additional serotypes in Synflorix (1, 5 and 7F) was respectively 97.3%, 99.0% and 99.5% and was at least as good as the aggregate 7-valent Prevenar response against the 7 common serotypes (95.8%).
Maltese: Il-perċentwal ta' tilqim li laħqu l-limitu għat-tliet serotipi addizzjonali f'Synflorix (1, 5 u 7F) kienu 97.3%, 99.0% u 99.5% rispettivament u dan kien mill-inqas tajjeb daqs ir-rispons totali ta' Prevenar 7valenti kontra s-7 serotipi komuni (95.
English: In a clinical study conducted in South Africa the immunogenicity of Synflorix administered as a 3-dose primary vaccination course (at 6, 10 and 14 weeks of age) followed by a booster dose (at 9 to 10 months of age) was assessed in 70 HIV positive (HIV+/+) infants, 91 HIV negative infants born from HIV positive mothers (HIV+/-) and 93 HIV negative infants born from HIV negative mothers (HIV-/-).
Maltese: Fi studju kliniku li twettaq fl-Afrika t'Isfel, ġiet evalwata l-immunoġeniċità ta' Synflorix mogħti bħala kors ta' tilqim primarju ta' 3 dożi (fl-età ta' 6, 10 u 14-il ġimgħa) segwit minn doża booster (fl-età ta' 9-10 xhur) f'70 tarbija pożittiva għall-HIV (HIV+/+), f'91 tarbija negattiva għall-HIV li twieldu minn ommijiet pożittivi għall-HIV (HIV+/-) u f'93 tarbija li twieldu minn ommijiet negattivi għallHIV(HIV-/-).
English: In COMPAS, 7,214 subjects [Total Vaccinated cohort (TVC)] were included in the AOM efficacy analysis of which 5,989 subjects were in the ATP cohort (Table 3).
Maltese: F'COMPAS, 7,214-il individwu [koorti Totali Mlaqqma (TVC)] ġew inklużi fl-analiżi tal-effikaċja tal-AOM li minnhom 5,989 individwu kienu fil-koorti tal-ATP (Tabella 3).
English: Contents of the pack and other information What Synflorix contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Synflorix
English: In both studies there were significant decrease of individual serotypes 6B and 19F.
Maltese: Fiż-żewġ studji kien hemm tnaqqis sinifikanti tas-serotipi individwali 6B u 19F.
English: For catch-up vaccination, vaccine effectiveness was 33.2% (95% CI: 3.0; 53.4) in the 7-11 month cohort and 22.4% (95% CI: -8.7; 44.8) in the 12-18 month cohort.
Maltese: Għat-tilqim ‘catch-up', l-effikaċja tat-tilqim kienet ta' 33.2% (95% CI: 3.0; 53,4) fil-koorti ta' 7 -11-il xahar u 22.4% (95% CI: -8.7; 44.8) fil-koorti ta' 12-18-il xahar.
English: Kawasaki disease
Maltese: Marda ta' Kawasaki
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jigifieri that is to say essenzjalment ‘mingħajr sodium'.
English: Synflorix can be given at the same time as other childhood vaccines such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, measles-mumps-rubella, varicella, oral rotavirus vaccines as well as meningococcal serogroup C and serogroups A, C, W-135, Y conjugate vaccines.
Maltese: Synflorix jista' jingħata flimkien ma' tilqim ieħor għat-tfal bħal tilqim għad-difterja, tetnu, pertussis (sogħla konvulsiva), Haemophilus influenzae tip b, tilqim tal-poljo mill-ħalq jew mhux attivat, epatite B, ħożba-gattone-rubella, variċella, rotavirus mill-ħalq kif ukoll tilqim konjugat ta' serogrupp meningokokkali Ċ u serogruppi A, C, W-135, Y.
English: Efficacy against any NTHi AOM episode was 35.3% (95% CI: 1.8; 57.4).
Maltese: L-effikaċja kontra kull episodju ta' NTHi AOM kienet ta' 35.3 (95% CI: 1.8; 57.4).
English: Table 4: Summary of effectiveness of Synflorix for IPD in Brazil Types of IPD(1)
Maltese: Tabella 4: Sommarju tal-effikaċja ta' Synflorix għall-IPD fil-Brażil Tipi ta' IPD(1)
English: Anti-6B 1100 65.9 372 79.0 13.12 7.53 18.28 Anti-9V 1103 98.1 374 99.5
Maltese: .9 372 79.0 13.12 Anti-9V 1103 98.1 374 99.5 1.37 Anti-14 1100 99.5
English: CI Confidence Interval (1) First episode (2) Follow up period for a maximum of 40 months from 2 weeks after third primary dose (3) Not statistically significant by pre-defined criteria (One sided p=0.032).
Maltese: Intervall ta' Kunfidenza (1) L-ewwel episodju (2) Perjodu ta' segwitu għal massimu ta' 40 xahar minn ġimagħtejn wara t-tielet doża primarja (3) Mhux statistikament sinifikanti skont kriterji definiti minn qabel (One sided p=0.032).
English: Very common Fever ≥ 38 °C rectally (age < 2 years), pain, redness, swelling at the injection site.
Maltese: Komuni ħafna Deni ≥38°C fir-rektum (età < sentejn), uġigħ, ħmura, nefħa fil-post tal-injezzjoni
English: Antibody
Maltese: Antikorp
English: Pneumococcal polysaccharide serotype 9V1,2
Maltese: Polysaccharide pnewmokokkali serotip 9V1,2
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber).
Maltese: 0.5 ml ta' suspensjoni f'kunjett (ħġieġ ta' tip I) għal doża 1 b'tapp (butyl rubber).
English: EU/1/09/508/013 - pack of 100
Maltese: EU/1/09/508/013 - pakkett ta' 100
English: Any vaccine serotype IPD(3) - Invasive pneumonia or bacteraemia - Meningitis
Maltese: Kwalunkwe IPD tas-serotip tal-vaċċin(3) - Pnewmonja invażiva jew batteremija
English: In FinIP the overall observed VE against culture-confirmed IPD was 100% (95% CI: 85.6; 100; 0 versus 14 cases) for the 3+1 schedule, 85.8% (95% CI: 49.1; 97.8; 2 versus 14 cases) for the 2+1 schedule and 93.0% (95% CI: 74.9; 98.9; 2 versus 14 cases) regardless of the primary vaccination schedule.
Maltese: 100; 0 kontra 14-il każ) għall-iskeda 3+1, 85.8 (95% CI: 49.1;97.8%; 2 kontra 14-il każ) għall-iskeda 2+1 u 93.0% (95% CI: 74.9;98.9; 2 kontra 14-il każ) irrispettivament milliskeda tal-vaċċinazzjoni primarja.
English: (2) Culture confirmed cases for serotypes 1, 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
Maltese: (2) Każijiet ikkonfermati mill-kultura għas-serotipi 1, 4, 6B, 7F, 9V, 14, 18C, 19F u 23F ikkontribixxew għall-analiżi.