FrancophonIA/ELRC3.0 huggingface dataset:
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below: A. Summary of Product Characteristics
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, it-tikketta u l-fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba matul il-proċedura tal-grupp ta' koordinazzjoni bl-emendi li ġejjin (inseriment, sostituzzjoni jew tħassir ta' test kif xieraq) biex jirriflettu l-kliem kif ipprovduti hawn taħt:
English: Cardioxane is contraindicated in children and adolescents up to 18 years of age (see section 4.3).
Maltese: Cardioxane huwa kontraindikat fi tfal u adoloxxenti li għandhom sa 18-il sena (ara sezzjoni 4.3).
English: The safety and efficacy of Cardioxane in children aged 0 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cardioxane fi tfal ta' bejn iż-0 u 18-il sena ma ġewx determinati s'issa.
English: What you need to know before you are given Cardioxane You must not be given Cardioxane
Maltese: X'għandek tkun taf qabel ma tingħata Cardioxane
English: B. Package Leaflet
Maltese: TAL-KURA TASSAĦĦA
English: − If you are under 18 years old and your planned dose of anthracycline is considered low - talk to your doctor about this.
Maltese: − Jekk għandek inqas minn 18-il sena u d-doża ppjanata tiegħek ta' anthracycline hija meqjusa baxxa - kellem lit-tabib tiegħek dwar dan.
English: 4.2 Posology and method of administration
Maltese: B. Fuljett ta' tagħrif
English: 1105BJ Amsterdam Netherlands
Maltese: 1105BJ Amsterdam In-Netherlands
English: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool United Kingdom
Maltese: Seqirus Vaccines Limited Gaskill Road, Speke L24 9GR Liverpool Ir-Renju Unit
English: Fever (≥ 38°C)
Maltese: Deni (≥ 38°C)
English: Siena Tel: +39 0577 096400
Maltese: Seqirus S.r.l. Siena Tel: +39 0577 096400
English: % Lower Limit of OneSided 97.5% CI
Maltese: % Limitu t'Isfel ta' One Sided 97.5% CI
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA** per 0.5 ml dose * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
Maltese: A/Brisbane/02/2018 (H1N1)pdm09 - razza simili (A/Idaho/07/2018) 15-il mikrogramma HA** A/Kansas/14/2017 (H3N2) - razza simili (A/Indiana/08/2018) 15-il mikrogramma HA** B/Colorado/06/2017 - razza simili (B/Iowa/06/2017) 15-il mikrogramma HA** B/Phuket/3073/2013 - razza simili (B/Singapore/INFTT-16-0610/2016) 15-il mikrogramma HA**
English: Flucelvax Tetra is manufactured using Madin Darby Canine Kidney (MDCK) cells.
Maltese: Flucelvax Tetra tiġi manifatturata bl-użu ta' ċelluli Madin Darby Canine Kidney (MDCK).
English: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
Maltese: (≥ 1/10); Komuni (≥ 1/100 sa < 1/10); Mhux Komuni (≥ 1/1,000 sa < 1/100), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Uncommon (≥1/1,000 to
Maltese: Mhux komuni (≥ 1/1,000 sa
English: Abbreviations: GMT = geometric mean titre; CI = confidence interval.
Maltese: GMT = titru ġeometriku medju; CI = intervall tal-kunfidenza.
English: Myalgia1
Maltese: Mijalġija1
English: Date of first authorisation: 12 December 2018
Maltese: 12 ta' Diċembru 2018
English: Flucelvax Tetra contains sodium chloride and potassium chloride
Maltese: Flucelvax Tetra fih sodium chloride u potassium chloride
English: A total of 11,404 subjects were enrolled to receive TIVc (N = 3828), Agrippal (N = 3676) or placebo (N = 3900) in a 1:1:1 ratio.
Maltese: Total ta' 11,404 individwi ġew irreġistrati biex jirċievu TIVc (N = 3,828), Agrippal (N = 3,676) jew plaċebo (N = 3,900)
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Disodium phosphate dihydrate Potassium dihydrogen phosphate
English: • Fever (> 38°C)
Maltese: • Deni (≥ 38°C)
English: Common (≥1/100 to <1/10)
Maltese: Komuni (≥ 1/100 sa
English: V58P13 (Subjects 18 to < 50 years)
Maltese: V58P13 (Individwi ta' età minn 18 sa < 50 sena)
English: • beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.
Maltese: • beta-propiolactone, cetyltrimethylammonium bromide, jew polysorbate 80, li huma traċċi ta' residwi mill-proċess ta' manifattura.
English: HI data, egg-derived assay
Maltese: Data ta' HI, assaġġ derivat mill-bajd
English: MedDRA System Organ class Very common
Maltese: Sistema tal-Klassifika tal-Organi talMedDRA
English: a The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is
Maltese: It-tilqima tal-komparatur għat-tqabbil ta' nuqqas ta' inferjorità għal A/H1N1, A/H3N2 u B1 huwa TIV1c, għal
English: Similar rates of local and system adverse reactions were reported in the overall paediatric population 4 to < 18 years of age.
Maltese: Rati simili ta' reazzjonijiet avversi lokali u sistemiċi kienu rrappurtati fil-popolazzjoni pedjatrika globali ta' età minn 4 snin sa < 18-il sena.
English: Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Maltese: Tabella 3: Effikaċja komparattiva tat-tilqima ta' TIVc kontra plaċebo kontra influwenza kkonfermata mill-koltura skont is-sottotip virali tal-influwenza (V58P13)
English: Nausea, Diarrhoea, Vomiting2
Maltese: Dardir, Dijarea, Rimettar2
English: V58P12 (Subjects 9 to < 18 years)
Maltese: V58P12 (Individwi ta' età minn 9 sa < 18il sena)
English: Flucelvax Tetra injection Influenza vaccine 2019/2020 season
Maltese: Injezzjoni ta' Flucelvax Tetra Tilqima tal-influwenza Staġun 2019/2020
English: Name and address of the manufacturer(s) of the biological active substance(s) Seqirus Inc.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i Seqirus Inc.
English: Name and address of the manufacturer(s) responsible for batch release Seqirus Vaccines Ltd
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Seqirus Vaccines Ltd
English: This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Maltese: Din it-tilqima fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis sodium'.
English: B * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Maltese: B * Intervalli ta' kunfidenza simultanji one-sided 97.5% għall-effikaċja tat-tilqima ta' kull tilqima kontra linfluwenza meta mqabbla mal-plaċebo bbażati fuq l-intervalli ta' kunfidenza tal-punteġġ ikkoreġut permezz ta'
English: Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
Maltese: Rata' ta' Serokonverżjonib a Għar-razez ta' influwenza H1N1, H3N2 u B1, hija ppreżentata data ta' TIV1c , filwaqt li għar-razza ta' influwenza B2 hija ppreżentata data ta' TIV2c.
English: In this study, subjects received Flucelvax Tetra (N = 1159) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 593), or TIV2c (N = 580)].
Maltese: l-individwi rċevew Flucelvax Tetra (N = 1,159) jew formulazzjoni waħda mit-tnejn tal-komparatur tat tilqima trivalenti tal-influwenza bbażata fuq iċ-ċelloli (TIVc) [TIV1c (N = 593) u TIV2c (N = 580)].
English: A single syringe contains 0.5 ml of suspension for injection.
Maltese: Siringa waħda fiha 0.5 mL ta' suspensjoni għall-injezzjoni.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Maltese: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase), inattivati, tar-razez li ġejjin*:
English: Frequency not known3
Maltese: Frekwenza mhux magħrufa3
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata f'sezzjoni 6.1, jew għat-traċċi ta' residwi possibbli bħal beta-propiolactone, cetyltrimethylammonium bromide, u polysorbate 80.
English: Valneva Austria GmbH, Wien Tel: +43 1 20620
Maltese: GmbH, Wien Tel: +43 1 20620
English: Erythema, Induration1
Maltese: Għeja1,
English: Comparison of immunogenicity of TIVc in the paediatric and adult population
Maltese: Paragun tal-immunoġeniċità ta' TIVc fil-popolazzjoni pedjatrika u adulta
English: Placebo (N = 3843)
Maltese: (N=3,843)
English: In this study, 1159 paediatric subjects received Flucelvax Tetra (584 subjects aged > 9 to < 18 years; 575 subjects aged > 4 to < 9 years).
Maltese: F'dan l-istudju, 1,159 pazjent pedjatriku rċevew Flucelvax Tetra (584 individwu li kellhom > 9 sa < 18-il sena, 575 individwu li kellhom > 4 sa < 9 snin).
English: The most commonly reported (≥10%) reactions in subjects who received Flucelvax Tetra were pain at the injection site (34%), headache (14%), fatigue (14%), myalgia (14%), erythema (13%) and induration (10%).
Maltese: L-aktar reazzjonijiet irrappurtati b'mod komuni (≥ 10%) f'individwi li rċevew Flucelvax Tetra kienu uġigħ fis-sit tal-injezzjoni (34%), uġigħ ta' ras (14%), għeja (14%), majalġja (14%), eritema (13%) u ebusija (10%).
English: TIV2c.
Maltese: B2 huwa TIV2c.
English: A multinational, randomised, observer-blinded, placebo-controlled trial (V58P13) was performed to assess clinical efficacy and safety of TIVc during the 2007-2008 influenza season in adults aged 18 to less than 50 years.
Maltese: Prova multinazzjonali, fejn il-pazjenti ntgħażlu b'mod każwali, observer-blinded, ikkontrollata bil plaċebo (V58P13) twettqet biex tiġi evalwata l-effikaċja u sigurtà klinika ta' TIVc matul l-istaġun tal influwenza 2007-2008 f'adulti li kellhom minn 18 sa inqas minn 50 sena.
English: This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free'.
Maltese: Din it-tilqima fiha inqas minn 1 mmol (39 mg) ta' potassium f'kull doża, jiġifieri essenzjalment ‘ħielsa mill-potassium'.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq l-immaniġjar tat-tilqima qabel tingħata, ara sezzjoni 6.6.
English: EU/1/18/1326/001 10 pre filled syringes without needle EU/1/18/1326/002 1 pre filled syringe with needle EU/1/18/1326/003 10 pre filled syringes with needle
Maltese: EU/1/18/1326/002 1 siringa mimlija għal-lest b'labra EU/1/18/1326/003 10 siringi mimlijin għal-lest b'labra
English: Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Maltese: Tabella 2: Nuqqas ta' inferjorità ta' Flucelvax Tetra relattiva għat-TIVc fl-adulti ta' 18-il sena u 'l fuq - Sett ta' analiżi għal kull protokoll (V130_01)
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Maltese: Każijiet ta' influwenza ġew identifikati permezz ta' sorveljanza attiva u passiva ta' mard li jixbah lill-influwenza (influenza-like illness, ILI).
English: Adverse reactions reported are listed according to the following frequency categories: Very common
Maltese: L-effetti avversi rrappurtati huma elenkati skont il-kategoriji ta' frekwenza li ġejjin: Komuni ħafna
English: Paediatric population (9 to less than 18 years of age)
Maltese: Popolazzjoni pedjatrika (età minn 9 snin sa inqas minn 18-il sena)
English: Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati wara l-għoti tat-tilqima f'adulti ta' 18-il sena u aktar fil-provi kliniċi u fis-sorveljanza ta' wara t-tqegħid fis-suq
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat.
Maltese: Centers for Disease Control and Prevention (CDC), jiġifieri, deni (temperatura orali ta' ≥ 100.
English: The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Maltese: Id data dwar l-immunoġeniċità fil-popolazzjoni pedjatrika ta' età minn 4 snin sa inqas minn 9 snin ġiet miksuba fi prova V130_03.
English: Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Maltese: Flucelvax Tetra jista' jkun fih traċċi ta' beta-propiolactone, cetyltrimethylammonium bromide, u polysorbate 80.
English: It should be noted that both V58P12 and V58P13 were performed in the 2007-2008 northern hemisphere influenza season.
Maltese: Wieħed għandu jinnota li kemm V58P12 u kif ukoll V58P13 ġew imwettqa fl-istaġun tal-influwenza tal-2007-2008 fl-emisferu tat-tramuntana.
English: Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults
Maltese: Effikaċja klinika tat-tilqima trivalenti tal-influwenza bbażata fuq iċ-ċelloli (TIVc) kontra influwenza kkonfermata minn koltura fl-adulti
English: Immunogenicity of Flucelvax Tetra in Children and Adolescents 9 to less than 18 Years of Age
Maltese: Popolazzjoni pedjatrika Immoġeniċità ta' Flucelvax Tetra fit-Tfal u Adolexxenti li kellhom minn 9 snin sa 18-il sena
English: The non-inferiority data observed are summarised in Table 2.
Maltese: Id-dejta tan-nuqqas ta' konformità qed tintwera fil-qosor f'Tabella 2.
English: 1 Reported as Common in the elderly population 65 years of age and older 2 Reported as Uncommon in the elderly population 65 years of age and older 3 Adverse reactions reported from post-marketing surveillance
Maltese: 1 Irrappurtata bħala Komuni fil-popolazzjonijiet anzjani ta' 65 sena u akbar 2 Irrappurtat bħala Mhux komuni fil-popolazzjonijiet anzjani ta' 65 sena u akbar 3 Reazzjonijiet avversi rrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq
English: Age subgroup analyses in subjects 18 to less than 65 years of age and 65 years of age and above confirmed that HI antibody responses (GMT and differences in vaccine group seroconversion rates) met non-inferiority immunogenicity criteria 3 weeks following vaccination for all 4 influenza strains in both age groups.
Maltese: L-analiżi tas-sottogrupp tal-età f'individwi minn 18-il sena sa inqas minn 65 sena u minn 65 sena 'l fuq ikkonfermaw li r-rispons tal-antikorpi HI (GMT u differenzi fir-rati ta' serokonverżjoni tal-grupp ta'
English: Immunogenicity of Flucelvax Tetra in Adults 18 years of age and older
Maltese: Immunoġeniċità ta' Flucelvax Tetra f'Adulti ta' 18-il sena 'l fuq
English: TIVc = cell-based trivalent influenza vaccine; TIVeA = egg-based trivalent influenza vaccine (Agrippal); TIVeF = egg-based trivalent influenza vaccine (Fluvirin) a Seroconversion rate = percentage of subjects with either a pre-vaccination HI titre <1:10 and post-vaccination HI titre ≥1:40 or with a pre-vaccination HI titre ≥1:10 and a minimum 4-fold increase in post-vaccination HI antibody titre.
Maltese: TIVc = tilqima trivalenti tal-influwenza ibbażata fuq iċ-ċelluli; TIVeA = tilqima trivalenti tal-influwenza ibbażata fuq il-bajd (Agrippal); TIVeF = tilqima trivalenti tal-influwenza ibbażata fuq il-bajd (Fluvirin) a Rata ta' serokonverżjoni = perċentwali ta' individwi jew b'titru tal-HI ta' <1:10 ta' qabel it-tilqima u titru tal
English: The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season.
Maltese: It-tilqima hi konformi mar-rakkomandazzjonijiet tal-Organizzazzjoni Dinjija tas-Saħħa (World Health Organisation, WHO) (emisferu tat-Tramuntana) u mar-rakkomandazzjoni tal-UE għallistaġun 2019/2020.
English: Immunogenicity of Flucelvax Tetra was evaluated in adults 18 years of age and older in a randomised, double-blind, controlled study (V130_01).
Maltese: Ġiet evalwata l-immunoġeniċità ta' Flucelvax Tetra f'adulti ta' 18-il sena 'l fuq fi studju fejn il pazjenti ntgħażlu b'mod każwali, double-blind, u kkontrollat (V130_01).
English: The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Maltese: Is-sustanzi mhux attivi l-oħra huma: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall injezzjonijiet.
English: The most common (≥10%) adverse reactions reported in paediatric subjects of 9 to < 18 years of age were injection site pain (58%), headache (22%), erythema (19%), fatigue (18%), myalgia (16%), and induration (15%).
Maltese: L-aktar reazzjonijiet avversi komuni (≥ 10%) irrappurtati f'individwi pedjatriċi li kellhom minn 9 sa < 18-il sena kienu wġigħ fis-sit tal-injezzjoni (58%), uġigħ ta' ras (22%), eritema (19%), għeja (18%),
English: Paediatric Population (4 to less than 9 years of age)
Maltese: Popolazzjoni Pedjatrika (età minn 4 snin sa inqas minn 9 snin)
English: Seqirus S.r.l.
Maltese: F'dan l-istudju,
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jkun akkumpanjat minn diversi sinjali newroloġiċi bħal disturb fil-vista temporanju, parestesija u movimenti toniċi-kloniċi fir-riġlejn jew fid-dirgħajn matul l-irkupru.
English: Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Maltese: Flucelvax Tetra jipprovdi immunizzazzjoni attiva kontra erba' razez tal-virus tal-influwenza (żewġ sottotipi A u żewġ tipi B) li jinsabu fit-tilqima.
English: Similar rates of solicited local and systemic adverse reactions were reported in subjects who received Flucelvax Tetra and cell-based trivalent influenza vaccine comparator in this clinical trial.
Maltese: Rati simili ta' reazzjonijiet avversi lokali u sistemiċi ssoliċitati kienu rrappurtati f'individwi li rċevew Flucelvax Tetra u komparatur tat-tilqima trivalenti tal-influwenza bbażata fuq iċ-ċelluli f'din il-prova klinika.
English: In the paediatric population 4 to less than 6 years of age, the following additional solicited adverse reactions were reported: sleepiness (21%), irritability (19%) and change in eating habits (14%).
Maltese: Fil-popolazzjoni pedjatrika minn 4 snin sa inqas minn 6 snin, ir-reazzjonijiet avversi addizzjonali ssoliċitati li ġejjin kienu rrappurtati: ngħas (21%), irritabilità (19%) u bidla fid-drawwiet tal-ikel
English: • Extensive swelling of injected limb
Maltese: • Nefħa estensiva fid-driegħ injettat
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Maltese: Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) tipproduċi l-protezzjoni tagħha stess kontra l-virus tal-influwenza.
English: Store in a refrigerator (2°C - 8°C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2 °C - 8 °C).
English: Currently available safety and immunogenicity data are described in sections 4.8 and 5.1 but no recommendation on posology can be made.
Maltese: Data disponibbli dwar is-sigurtà u l-immunoġeneċità hija deskritta fis sezzjonijiet 4.8 u 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Fever was common in adolescents and children.
Maltese: Id-deni kien komuni fl-adolexxenti u t-tfal.
English: A single 0.5 ml dose.
Maltese: Doża waħda ta' 0.5 mL.
English: Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Maltese: Flucelvax Tetra iqanqal antikorpi umorali għal kontra l-haemagglutinins.
English: How to store Flucelvax Tetra 6.
Maltese: Kif taħżen Flucelvax Tetra 6.
English: Antibody against one influenza virus type or subtype confers limited or no protection against another.
Maltese: Antikorp għal kontra tip jew sottotip tal-virus tal-influwenza wieħed jagħti protezzjoni limitata jew ma jagħti l-ebda protezzjoni kontra ieħor.
English: Flucelvax Tetra is a vaccine against flu (influenza).
Maltese: Flucelvax Tetra hu tilqima kontra l-influwenza.
English: or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 677) or TIV2c (N = 669)].
Maltese: F'dan l-istudju, l-individwi rċevew Flucelvax Tetra (N = 1,334) jew formulazzjoni waħda mit-tnejn tal-komparatur tat-tilqima trivalenti tal-influwenza bbażata fuq iċ-ċelloli (TIVc) [TIV1c (N = 677) u TIV2c (N = 669)].
English: GMT (95% CI) Seroconversion Rateb
Maltese: GMT (95% CI) Rata ta'
English: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Maltese: Flucelvax Tetra suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Tilqima tal-influwenza (antiġen tal-wiċċ, inattivata, ippreparata f'kolturi taċ-ċelluli)
English: Prophylaxis of influenza in adults and children from 9 years of age.
Maltese: Profilassi tal-influwenza għall-adulti u tfal minn 9 snin 'il fuq.
English: Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle
Maltese: 1 siringa mimlija għal-lest (0.5 mL) b'labra 10 siringi mimlijin għal-lest (0.5 mL) b'labra
English: Immune responses following vaccination with TIVc in the paediatric population (9 to < 18 years) were similar to those observed in the adult population in study V58P13 (see Table 5) in whom efficacy was demonstrated (results on vaccine efficacy are presented in Table 3).
Maltese: Ir-risponsi immuni wara t-tilqima b'TIVc fil-popolazzjoni pedjatrika (ta' età minn 9 snin sa < 18-il sena) kienu simili għal dawk osservati fil-popolazzjoni adulta fl-istudju V58P13 (ara Tabella 5) li fiha ġiet murija l-effikaċja
English: Vaccine Group Difference (95% CI)
Maltese: Differenza talGrupp tatTilqim (95% CI)
English: The following side effects have been reported during clinical trials and during general use:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati waqt il-provi kliniċi u waqt l-użu ġenerali:
English: Immunogenicity of Flucelvax Tetra was evaluated in children 9 to less than 18 years of age as part of a randomised, double-blind, controlled study (V130_03) that was performed in the paediatric population 4 to less than 18 years of age.
Maltese: Ġiet evalwata l-immunoġeniċità ta' Flucelvax Tetra fit-tfal minn 9 snin sa inqas minn 18-il sena bħala parti minn studju fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, u kkontrollat (V130_03) li kien imwettaq fil-popolazzjoni pedjatrika ta' età minn 4 snin sa inqas minn 18-il sena.
English: Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility.
Maltese: Dejta mill-annimali, b'tilqima trivalenti talinfluwenza bbażata fuq iċ-ċelluli (TIVc), ma wrietx effetti fuq il-fertilità fin-nisa.
English: Pre-filled syringe label
Maltese: Numru ta' Individwi blInfluwenza
English: The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Maltese: Id-data dwar l-immunoġeniċità f'individwi ta' età minn 9 snin sa inqas minn 18-il sena tinsab miġbura fil-qosor f'Tabella 4.
English: Bold- CHMP immunogenicity criteria met.
Maltese: Sidak għaż-żewġ riskji relattivi.
English: Bold = Non-inferiority criterion met.
Maltese: Tipa Grassa = Il-kriterju ta' nuqqas ta' konformità ntlaħaq.