FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali,
English: Pharmaceutical form Route of administration
Maltese: mod ta' amministrazzjoni u applikanti fl-Istati Membri
English: Sildenafil Teva EMA/685375/2012
Maltese: EMA/685375/2012
English: The full EPAR for Sildenafil Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active ingredient in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva f'Sildenafil Teva, sildenafil, tifforma parti minn grupp ta' mediċini magħruf bħala inibituri tal-fosfodjesterażi tat-tip 5 (PDE5) (phosphodiesterase type 5 [PDE5] inhibitors).
English: This summary was last updated in 10-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2012.
English: Sildenafil Teva is a ‘generic medicine'.
Maltese: Sildenafil Teva huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Teva on 30 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Sildenafil Teva valida fl-Unjoni Ewropea kollha fit-30 ta' Novembru 2009.
English: Sildenafil Teva is a medicine that contains the active substance sildenafil.
Maltese: Sildenafil Teva huwa mediċina li fiha s-sustanza attiva sildenafil.
English: This is a summary of the European public assessment report (EPAR) for Sildenafil Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sildenafil Teva.
English: Because Sildenafil Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Maltese: Billi Sildenafil Teva huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Viagra.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: Waqt stimulazzjoni sesswali normali, fil-pene tiġi prodotta s-cGMP u tikkawża r-rilassament fil-korpora kavernoża (muskolu fit-tessut tal-pene li qisu sponża).
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Sildenafil Teva għandu kwalità komparabbli u li huwa bijoekwivalenti għal Viagra.
English: kidney problems should start treatment with the 25 mg dose.
Maltese: għandhom jibdew it-trattament bid-doża ta' 25 mg.
English: For Sildenafil Teva to be effective, sexual stimulation is required.
Maltese: Biex Sildenafil Teva jkun effettiv irid ikun hemm stimulazzjoni sesswali.
English: This means that Sildenafil Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Maltese: Dan ifisser li Sildenafil Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Viagra.
English: What are the benefits and risks of Sildenafil Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Sildenafil Teva?
English: Sildenafil Teva is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Sildenafil Teva jintuża fit-trattament ta' rġiel adulti bi problemi waqt erezzjoni (xi drabi tissejjaħ impotenza), meta ma jkunx jista' jkollhom jew ma jkunux jistgħu jżommu l-pene iebes (erezzjoni) biżżejjed għal attività sesswali sodisfaċenti.
English: Why has Sildenafil Teva been approved?
Maltese: Għaliex ġie approvat Sildenafil Teva?
English: Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Sildenafil Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: How has Sildenafil Teva been studied?
Maltese: Kif ġie studjat Sildenafil Teva?
English: What is Sildenafil Teva?
Maltese: Sildenafil Teva
English: Patients with liver problems or severe
Maltese: Il-pazjenti bi problemi fil-fwied jew problemi severi fil-kliewi
English: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark
Maltese: Janssen-Cilag A/S Bregnerødvej 133 3460
English: The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Maltese: Janssen-Cilag BV Dr. Paul Janssenweg
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Maltese: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Maltese: Janssen-Cilag International NV Turnhoutseweg 30, 2340
English: Vorgartenstraße 206B
Maltese: Vorgartenstraße 206B AT-1020 Vienna Austria
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
Maltese: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo
English: Denmark
Maltese: Birkerød Denmark
English: Buckinghamshire
Maltese: L-Awstrija
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm Way
Maltese: Il-Lussemburgu Janssen-Cilag NV Antwerpseweg 15-17
English: HP12 4EG,
Maltese: High Wycombe Buckinghamshire HP12 4EG,
English: Talk to your doctor or nurse before you or your child receive Bexsero: - if you or your child have a severe infection with a high temperature.
Maltese: Meta seħħ id-deni, dan ġeneralment segwa tendenza li setgħet tiġi mbassra, bil-maġġoranza tal-każijiet fiequ sal-jum ta' wara t-tilqima.
English: 50/50/50 micrograms
Maltese: 50/50/50 mikrogramma
English: Adsorbed on aluminium hydroxide (0.5 mg Al³+).
Maltese: Adsorbit fuq aluminium hydroxide (0.5 mg Al³+).
English: See section 5.1.
Maltese: Ara sezzjoni 5.1.
English: Date of latest renewal: 18 September 2017
Maltese: Data ta 'l-aħħar tiġdid: 18 ta' Settembru 2017
English: Bexsero contains sodium chloride
Maltese: Bexsero fih sodium chloride
English: Uncommon: fever (≥40°C)
Maltese: Mhux komuni: deni (≥40°C)
English: 25 micrograms produced in E. coli cells by recombinant DNA technology adsorbed on aluminium hydroxide (0.5 mg Al³+) NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Maltese: 25 mikrogramma prodott f'ċelluli E. coli permezz ta' teknoloġija ta' DNA rikombinanti adsorbit fuq aluminium hydroxide (0.5 mg Al³+) NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
English: ** GMT = geometric mean titer.
Maltese: ** GMT = titer medju ġeometriku.
English: For adsorbent see section 2.
Maltese: Għall-adsorbent ara sezzjoni 2.
English: Sodium chloride
Maltese: Sodium chloride Histidine
English: LIST OF EXCIPIENTS Excipients: sodium chloride, histidine, sucrose, water for injections.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: sodium chloride, histidine, sucrose, ilma għall-injezzjonijiet.
English: Name and address of the manufacturers of the biological active substance (OMV):
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva (OMV):
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 ta' Jannar, 2013
English: pre-vaccination titer ≥1:4
Maltese: titer qabel it-tilqima ≥1:4
English: pre-vaccination titer <1:4
Maltese: titer qabel it-tilqima <1:4
English: Sodium chloride, histidine, sucrose and water for injections (see section 2 for further information on sodium and latex).
Maltese: Sodium chloride, histidine, sucrose u ilma għall-injezzjonijiet (ara sezzjoni 2 għal aktar informazzjoni fuq sodium u latex).
English: Bellaria-Rosia 53018 Sovicille (Siena) Italy.
Maltese: GSK Vaccines S.r.l. Bellaria-Rosia 53018 Sovicille (Siena) L-Italja.
English: Do NOT use Bexsero:
Maltese: TUŻAX Bexsero:
English: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Maltese: GSK Vaccines S.r.l., Via Fiorentina 1, 53100
English: Name and address of the manufacturers of the biological active substances (NHBA, NadA, fHbp):
Maltese: Isem u indirizz tal-manifatturi tas-sustanzi bijoloġiċi attivi (NHBA, NadA, fHbp):
English: Experience of overdose is limited.
Maltese: Esperjenza ta' doża eċċessiva hi limitata.
English: Other medicines and Bexsero
Maltese: Mediċini oħra u Bexsero
English: Bellaria-Rosia IT-53018 Sovicille-Siena Italy
Maltese: GSK Vaccines S.r.l. Bellaria-Rosia IT-53018 Sovicille-Siena
English: Overall, 78% (95% confidence limits from 63-90%) of the approximately 1,000 strains were potentially susceptible to vaccine-induced antibodies.
Maltese: B'kollox, 78% (limiti ta' kunfidenza ta' 95% minn 63-90%) ta' bejn wieħed u ieħor 1,000 razza kienu potenzjalment suxxettibbli għal antikorpi li jiġu minħabba t-tilqima.
English: You may receive an additional injection (booster).
Maltese: Inti tista' tirċievi injezzjoni addizzjonali (booster).
English: After 24-36 months, the percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) declined, ranging across strains from 21% to 74% in children 4-7 years of age and from 47% to 86% in children 8-12 years of age.
Maltese: Wara 24-36 xahar, ilperċentwali ta' individwi seropożittivi (jiġifieri li kisbu hSBA ta' mill-inqas 1:4) naqsu, li varjaw bejn ir-razez minn 21 % sa 74 % fi tfal ta' età ta' 4-7 snin u minn 47 % sa 86 % fi tfal ta' età ta' 8-12il sena.
English: Pack sizes of 1 or 10 syringes.
Maltese: Daqsijiet tal-pakkett ta' 1 jew 10 siringi.
English: One dose (0.5 ml) contains:
Maltese: 1 doża (0.5 ml)
English: At 1 month following the 2-dose vaccination course, the percentages of subjects with hSBA ≥1:5 in individuals with complement deficiencies and asplenia or splenic dysfunction were 87% and 97% for antigen fHbp, 95% and 100% for antigen NadA, 68% and 86% for antigen PorA P1.4, 73% and 94% for antigen NHBA, respectively, indicating an immune response in these immunocompromised subjects.
Maltese: Wara li għadda xahar mill-kors ta' tilqim ta' żewġ dożi, il-perċentwal ta' individwi b'hSBA ≥1:5 f'individwi b'defiċjenzi tal-komplement u asplenja jew disfunzjoni tal-milsa kienu 87% u 97% għall-antiġen fHbp, 95% u 100% għall-antiġen NadA, 68% u 86% għall-antiġen PorA P1.4, 73% u 94% għall-antiġen NHBA, rispettivament, u dan jindika reazzjoni immuni f'dawn l-individwi immunokompromessi.
English: 0, 1 months
Maltese: 0, 1 xhur
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4 (against reference strains for fHbp, NadA, PorA P1.4 antigens) and an hSBA ≥ 1:5 (against reference strain for NHBA antigen).
Maltese: * % seropożittivi = il-perċentwali ta' individwi li kisbu hSBA ta' ≥1:4 (kontra r-razez ta' referenza għal antiġeni fHbp, NadA, PorA P1.4) u hSBA ≥ 1:5 (kontra r-razza ta' referenza għal antiġen
English: % 4-fold increase after 2nd dose
Maltese: % żieda ta' 4 darbiet wara t-tieni doża
English: The percentages of healthy subjects with hSBA ≥1:5 were 98% for antigen fHbp, 99% for antigen NadA, 83% for antigen PorA P1.4, and 99% for antigen NHBA.
Maltese: Il-perċentwali ta' individwi b'saħħithom b'hSBA ≥1:5 kienu 98% għall-antiġen fHbp, 99% għall-antiġen NadA, 83% għall-antiġen PorA P1.4, u 99% għall-antiġen NHBA.
English: Study V72P16 2, 3, 4 months fHbp
Maltese: Studju V72P16 xahrejn, 3 u 4 xhu r fHbp
English: It will be injected into a muscle, usually the thigh for infants or the upper arm for children, adolescents and adults.
Maltese: Se jiġi injettat ġo muskolu, normalment fil-koxxa fit-trabi jew fil-parti ta' fuq tad-driegħ fit-tfal, adolexxenti u adulti.
English: Recombinant Neisseria meningitidis group B NHBA fusion/NadA/fHbp fusion proteins
Maltese: fużjoni NHBA/NadA/fHbp
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment huwa ‘ħieles mis-sodium'.
English: Pharmacotherapeutic group: meningococcal vaccines, ATC code: J07AH09
Maltese: Kategorija farmakoterapewtika: tilqim meningokokkali, Kodiċi ATC:
English: Study V72P13 2, 4, 6 months
Maltese: Studju V72P13 xahrejn, 4 u 6 xhur
English: Among Bexsero recipients, 6837 were infants and children (less than 2 years of age), 1051 were children (2 to 10 years of age) and 2677 were adolescents and adults.
Maltese: Fost dawk li rċivew Bexsero, 6837 kienu trabi u tfal (li kellhom inqas minn sentejn), 1051 kienu tfal (li kellhom età bejn sentejn u 10 snin) u 2677 kienu adolexxenti u adulti.
English: Via Fiorentina, 1 IT-53100 Siena Italy
Maltese: GSK Vaccines S.r.l. Via Fiorentina, 1 IT-53100 Siena L-Italja
English: Suspension for injection (0.5 ml) 1 pre-filled syringe containing 0.5 ml suspension with needles 1 pre-filled syringe containing 0.5 ml suspension without needles
Maltese: Suspensjoni għall-injezzjoni (0.5 ml) 1 siringa mimlija għal-lest li fiha suspensjoni ta' 0.5 ml bil-labar 1 siringa mimlija għal-lest li fiha suspensjoni ta' 0.5 ml mingħajr labar
English: A decline in antibody titers to PorA P1.4 and fHbp antigens (reaching 9%-10% and 12%-20% of subjects with an hSBA ≥ 1:5, respectively) has been observed in an additional study in children 4 years of age who received a full priming and booster schedule as infants.
Maltese: Tnaqqis fit-titers tal-antikorpi għal PorA P1.4 u antiġeni ta' fHbp (li laħaq 9%-10% u 12%-20% tal-individwi b'hSBA ta' ≥ 1:5, rispettivament) ġie osservat fi studju addizzjonali fi tfal li kellhom 4 snin li rċivew skeda ta' priming u boosters sħiħa bħala trabi.
English: Study V72P12 2, 3, 4 months
Maltese: Studju V72P12 xahrejn, 3 u 4 xhur
English: 0, 2 months
Maltese: 0, 2 xhur
English: 0, 6 months fHbp
Maltese: 0, 6 xhur fHbp
English: 0, 2 months fHbp
Maltese: 0, 2 xhur fHbp
English: Immunogenicity in adolescents (from 11 years of age) and adults
Maltese: Immunoġeniċità fl-adolexxenti (li kellhom minn 11-il sena 'l fuq) u adulti
English: Immunogenicity in infants 6 to 11 months and children 12 to 23 months of age
Maltese: Immunoġeniċità fi trabi li jkollhom minn 6 sa 11-il sena u tfal minn12 sa 23 xahar
English: Comparable percentages of subjects were seropositive at 2 to 3 years after being previously vaccinated with either two doses followed by a booster of Bexsero (ranging from 35% to 91%) or three doses followed by a booster (ranging from 36% to 84%).
Maltese: Perċentwali komparabbli ta' individwi kienu seropożittivi sentejn sa 3 snin wara li jkunu tlaqqmu preċedentement b'żewġ dożi segwiti minn booster ta' Bexsero (li jvarjaw minn 35 % sa 91 %) jew tliet dożi segwiti minn booster (li jvjarjaw minn 36 % sa 84 %).
English: Contents of the pack and other information What Bexsero contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Bexsero
English: See section 5.1 for information on protection against specific group B strains.
Maltese: Ara sezzjoni 5.1 għal informazzjoni dwar protezzjoni kontra razez speċifiċi ta' grupp B.
English: Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions (see section 5.1).
Maltese: Id-dejta tal-immunoġeniċità hija disponibbli f'individwi b'defiċjenzi tal-komplement, asplenja jew disfunzjoni tal-milsa (ara sezzjoni 5.1)
English: % seropositive (95% CI)
Maltese: % seropożittivi (95% CI)
English: Very common: rash (children aged 12 to 23 months) (uncommon after booster) Common: rash (infants and children 2 to 10 years of age) Uncommon: eczema
Maltese: Komuni ħafna: raxx (tfal ta' età minn 12 sa 23 xahar) (mhux komuni wara l-booster) Komuni: raxx (trabi u tfal ta' età minn sentejn sa 10 snin)
English: - if you or your child have an allergy to the antibiotic kanamycin.
Maltese: - jekk inti jew it-tifel/tifla tiegħek għandkom allerġija għall-antibijotiku kanamycin.
English: If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.
Maltese: Jekk ikun preżenti, il-livelli ta' kanamycin fit-tilqima finali huma ta' inqas minn 0.01 ta' mikrogramma f'kull doża.
English: White opalescent liquid suspension.
Maltese: Suspensjoni likwida opalexxenti bajda.
English: - A booster will be given between 12 months and 15 months of age after an interval of at least 6 months from the last injection of the initial course.
Maltese: - Booster se tingħata bejn l-età ta' 12-il xahar u 15-il xahar wara intervall ta' mill-inqas 6 xhur mill-aħħar injezzjoni tal-kors inizjali.
English: In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone.
Maltese: Fi studji kliniċi fit-trabi li ngħataw it-tilqima fl-età ta' 2, 4 u 6 xhur, id-deni (≥38°C) ġie rrappurtat minn 69% sa 79% tal-individwi meta Bexsero ngħata flimkien ma' tilqim ta' rutina (li kien fihom l-antiġeni li ġejjin: konjugat pnewmokokkali 7-valenti, difterija, tetnu, pertussis aċellulari, epatitis B,
English: Adolescents (from 11 years) and adults*
Maltese: Adolexxenti (minn 11-il sena 'l fuq) u adulti*
English: Uncommon: pallor (rare after booster) Rare: Kawasaki syndrome
Maltese: Mhux komuni: sfurija (rari wara l-booster)
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
Maltese: * % seropożittivi = il-perċentwali ta' individwi li kisbu hSBA ta' ≥1:4.
English: % seropositive (95% CI) hSBA GMT (95% CI) * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4 (in the 6 to 11 months range of age) and an hSBA ≥ 1:5 (in the 12 to 23 months range of age).
Maltese: * % seropożittivi = il-perċentwali ta' individwi li kisbu hSBA ta' ≥1:4 (fil-medda ta' età ta' 6 sa 11-il xahar) u hsBA ta' ≥1:5 (fil-medda ta' età ta' 12 sa 23 xahar).
English: Two-dose primary series followed by a booster
Maltese: Serje primarja ta' żewġ dożi segwita minn booster
English: Bexsero is a Meningococcal group B Vaccine.
Maltese: Bexsero hu Tilqima Meningokokkali ta' grupp B.
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
Maltese: Vexxikuli tal-membrana ta' barra (OMV) minn Neisseria meningitidis grupp B razza NZ98/254 imkejla bħala ammont tal-proteina totali li fiha l-PorA P1.4
English: - A booster will be given after an interval of 12 to 23 months from the second injection.
Maltese: - Booster se tingħata wara intervall ta' 12-il xahar sa 23 xahar mit-tieni injezzjoni.
English: Fever (adolescents from 11 years of age and adults).
Maltese: Deni (adolexxenti minn 11-il sena u adulti).
English: Very common: headache
Maltese: Mhux komuni: ekżema
English: Bexsero can be given concomitantly with any of the following vaccine antigens, either as monovalent or as combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, heptavalent pneumococcal conjugate, measles, mumps, rubella, varicella, and meningococcal groups A, C, W, Y conjugate.
Maltese: Bexsero jista' jingħata fl-istess ħin ma' kwalunkwe minn dawn l-antiġeni tat-tilqim, jew bħala tilqim monovalenti jew bħala tilqim ikkombinat: difterija, tetnu, pertussis aċellulari, Haemophilus influenzae tip b, poljomajelite inattivata, epatite B, konjugat pnewmokokkali eptavalenti, ħosba, gattone, ħosba
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Maltese: Vexxikuli tal-membrana ta' barra (OMV) minn Neisseria meningitidis grupp B razza NZ98/254 imkejla bħala ammont tal-proteina totali li fiha l-PorA P1.4 2
English: % seropositive* (95% CI)
Maltese: % seropożittivi* (95% CI)
English: In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
Maltese: Fit-trabi u t-tfal żgħar (li kellhom inqas minn sentejn) l-iktar reazzjonijiet avversi lokali u sistemiċi komuni osservati fil-provi kliniċi kienu sensittività u eritema fis-sit tal-injezzjoni, deni u irritabilità.
English: Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3
Maltese: Proteina NadA rikombinanti Neisseria meningitidis grupp B 1, 2, 3
English: Yes, one dose between 12 and 15 months of age with an interval of at least 6 months between the primary series and booster dose b, c
Maltese: Iva, doża waħda bejn età ta' 12 u 15-il xahar b'intervall ta' mill-inqas 6 xhur bejn is-serje primarja u d-doża booster b, c
English: Immunisation with Bexsero is intended to stimulate the production of bactericidal antibodies that recognize the vaccine antigens NHBA, NadA, fHbp, and PorA P1.4 (the immunodominant antigen present in the OMV component) and are expected to be protective against Invasive Meningococcal Disease (IMD).
Maltese: Tilqima b'Bexsero hi intenzjonata biex tistimula l-produzzjoni ta' antikorpi batteriċidjali li jagħrfu l-antiġeni tat-tilqima NHBA, NadA, fHbp, u PorA P1.4 (l-antiġen immunodominanti preżenti fil-komponent
English: The Meningococcal Antigen Typing System (MATS) was developed to relate antigen profiles of different strains of meningococcal group B bacteria to killing of the strains in the serum bactericidal assay with human complement (hSBA).
Maltese: (MATS) ġiet żviluppata biex tassoċja profili ta' antiġeni ta' razez different ta' batterji meningokokkali ta' grupp B mal-qtil tar-razez fl-assaġġ batteriċidjali fis-serum mal-komplement uman (hSBA).
English: % seropositive after 2nd dose
Maltese: % seropożittivi wara t-tieni doża
English: The immunogenicity after two primary doses (at 3 and a half and 5 months of age) or three primary doses (at 2 and a half, 3 and a half and 5 months of age) of Bexsero followed by a booster dose in infants starting vaccination between 2 and 5 months of age has been evaluated in an additional phase 3 clinical study.
Maltese: L-immunoġeniċità wara żewġ dożi primarji (età ta' 3 xhur u nofs u 5 xhur) jew tliet dożi primarji (età ta' xahrejn u nofs, 3 xhur u nofs u 5 xhur) ta' Bexsero segwita minn doża booster fi trabi li jibdew tilqima bejn età ta' xahrejn u 5 xhur ġiet evalwata fi studju kliniku addizzjonali ta' fażi 3.
English: Bexsero is not expected to provide protection against all circulating meningococcal group B strains (see section 5.1).
Maltese: Bexsero mhux mistenni li jipprovdi protezzjoni kontra r-razez kollha meningokokkali ta' grupp B li qed jiċċirkolaw (ara sezzjoni 5.1).
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 18-23 months after 2nd dose
Maltese: GMT** (95% CI) 18-23 xahar wara t-tieni doża
English: Immunogenicity in children 2 to 10 years of age
Maltese: Immunoġeniċità fi tfal ta' bejn sentejn u 10 snin
English: GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Maltese: GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 at.info@gsk.com
English: hSBA GMT (95% CI)
Maltese: GMT (95% CI)