FrancophonIA/ELRC3.0 huggingface dataset:
English: Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells.
Maltese: newtrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw maċ-ċelloli tal-qrib.
English: What is Azilect?
Maltese: Kif jintuża Azilect?
English: In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease.
Maltese: Flewwel studju, żewġ dożaġġi differenti ta' Azilect meħuda waħedhom ġew imqabbla mal-plaċebo (trattament finta) f'404 pazjenti fl-istadju bikri tal-marda.
English: Azilect can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Maltese: Azilect jista' jintuża kemm waħdu, kif ukoll bħala żjieda ma' levodopa (mediċina oħra użata għall-marda tal-Parkinson) f'pazjenti li jkollhom ‘fluttwazzjonijiet' lejn it-tmiem tal-perjodu bejn dożi ta' levodopa.
English: Why has Azilect been approved?
Maltese: Għaliex ġie approvat Azilect?
English: There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Maltese: Għandu jkun hemm mill-anqas 14-il jum bejn il-waqfien tattrattament b'Azilect u l-bidu tal-kura b'inibitur monoamine oxidase ieħor jew b'pethidine.
English: How has Azilect been studied?
Maltese: Kif ġie studjat Azilect?
English: Azilect is used to treat Parkinson's disease.
Maltese: Id-doża standard ta' Azilect hija pillola waħda kuljum.
English: When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off' state more than placebo did.
Maltese: Meta użat bħala żjieda ma' levodopa, 1 mg ta' Azilect naqqas iż-żmien fl-istat ‘off' aktar milli għamel ilplaċebo.
English: The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Azilect huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Maltese: Biż-żjieda ta' dopamine f'partijiet tal-moħħ li jikkontrollaw il-moviment u lko-ordinazzjoni, Azilect itejjeb is-sinjali u s-sintomi tal-marda tal-Parkinson's, bħal ebusija u movimenti bil-mod.
English: It must also not be used with pethidine (a painkiller).
Maltese: Ma għandux jintuża wkoll ma' pethidine (mediċini ta' kontra l-uġigħ).
English: Further information on VeraSeal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/veraseal
Maltese: Aktar informazzjoni dwar VeraSeal tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/veraseal
English: VeraSeal received a marketing authorisation valid throughout the EU on 10 November 2017.
Maltese: VeraSeal ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-10 ta' Novembru 2017.
English: VeraSeal (human fibrinogen / human thrombin)
Maltese: VeraSeal (fibrinoġena tal-bniedem / trombina talbniedem)
English: Other information about VeraSeal
Maltese: Informazzjoni oħra dwar VeraSeal
English: VeraSeal has been shown to effectively stop bleeding during surgery, which can be expected to reduce blood loss, reduce time in the operating theatre and possibly shorten hospital stays.
Maltese: VeraSeal intwera li b'mod effettiv iwaqqaf il-fsada waqt il-kirurġija, u dan huwa mistenni li jnaqqas ittelf tad-demm, inaqqas il-ħin fit-teatru tal-operazzjoni u possibbilment iqassar iż-żmien ta' kemm wieħed idum l-isptar.
English: It is available as two prefilled syringes in a syringe holder, one containing a solution of human fibrinogen (80 mg/ml), and the other containing a solution of human thrombin (500 international units/ml).
Maltese: Dan jiġi bħala żewġ siringi mimlijin lesti f'ħowlder tas-siringa, waħda li fiha soluzzjoni ta' fibrinoġena talbniedem (80 mg/ml), u l-oħra li fiha soluzzjoni ta' trombina tal-bniedem (500 unità internazzjonali/ml).
English: In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).
Maltese: Fit-tieni studju tal-kirurġija tal-organi, VeraSeal kien effettiv daqs prodott ieħor Surgicel: 93 % talpazjenti ma kellhom l-ebda fsada 4 minuti wara l-kura b'VeraSeal (103 min 111), waqt li 81 % talpazjenti ma kellhom l-ebda fsada b'Surgicel (91 minn 113).
English: Finally, in a third study of soft tissue surgery, VeraSeal was as effective as Surgicel: 83% of the patients had no bleeding 4 minutes after treatment with VeraSeal (96 out of 116), compared with 78% of the patients after treatment with Surgicel (84 out of 108).
Maltese: Fl-aħħar nett, fit-tielet studju tal-kirurġija tat-tessut artab, VeraSeal kien effettiv daqs Surgicel: 83 % tal-pazjenti ma kellhom l-ebda fsada 4 minuti wara l-kura b'VeraSeal (96 min 116), meta mqabbel ma' 78 % tal-pazjenti wara l-kura b'Surgicel (84 minn 108).
English: Three main studies in 614 patients found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.
Maltese: Tliet studji ewlenin f'614-il pazjent sabu li VeraSeal huwa effettiv biex iwaqqaf il-fsada f'4 minuti millapplikazzjoni tiegħu waqt il-kirurġija.
English: The active substances in VeraSeal, fibrinogen and thrombin, are substances present in human plasma (the liquid part of the blood), which are involved in the normal blood clotting process.
Maltese: Is-sustanzi attivi f'VeraSeal, il-fibrinoġena u t-trombina, huma sustanzi preżenti fil-plażma tal-bniedem (il-parti likwida tad-demm), li huma involuti fil-proċess normali tal-koagulazzjoni.
English: As for all medicines, data on the use of VeraSeal are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' VeraSeal hija ssorveljata kontinwament.
English: In one study of blood vessel surgery, VeraSeal worked better than manual compression, with 76% of patients having no bleeding 4 minutes after treatment with VeraSeal (83 out of 109), compared with 23% after manual compression (13 out of 57).
Maltese: Fi studju wieħed tal-kirurġija tal-vażijiet, VeraSeal ħadem aħjar mill-kompressjoni manwali, b'76 % tal-pazjenti li ma kellhom l-ebda fsada 4 minuti wara l-kura b'VeraSeal (83 minn 109), meta mqabbel ma' 23 % wara kompressjoni manwali (13 minn 57).
English: What are the risks associated with VeraSeal?
Maltese: X'inhuma r-riskji assoċjati ma' VeraSeal?
English: The most common side effects with VeraSeal (which may affect up to 1 in 10 people) are nausea (feeling sick), pruritus (itchiness) and procedural pain (pain from the surgery).
Maltese: L-effetti sekondarji l-aktar komuni b'VeraSeal (li jistgħu jaffettwaw sa persuna waħda minn kull 10) huma nawżja (tħossok ma tiflaħx), prurite (ħakk) u wġigħ proċedurali (uġigħ mill-kirurġija).
English: The amount of VeraSeal to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Maltese: L-ammont ta' VeraSeal li għandu jintuża jiddependi minn għadd ta' fatturi, inkluż it-tip ta' kirurġija, id-daqs tal-ferita u n-numru ta' applikazzjonijiet.
English: How is VeraSeal used?
Maltese: Kif jaħdem VeraSeal?
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Maltese: Imbagħad, ilfibrin jingħaqad (jeħel flimkien) u jifforma embolu tal-fibrin li jgħin lill-ferita biex tfieq, b'hekk tiġi evitata l-fsada.
English: How does VeraSeal work?
Maltese: Kif jintuża VeraSeal?
English: Rarely, VeraSeal may cause an allergic reaction which can be severe especially when the medicine is used repeatedly.
Maltese: F'każijiet rari, VeraSeal jista' jikkawża reazzjoni allerġika li tista' tkun severa speċjalment meta l-mediċina tintuża b'mod ripetut.
English: VeraSeal is a sealant (glue) used to stop bleeding during surgery or to support stitches during surgery on blood vessels.
Maltese: L-effetti sekondarji rrappurtati b'VeraSeal huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: When the two active substances are mixed, thrombin cuts fibrinogen up into fibrin.
Maltese: Meta ż-żewġ sustanzi attivi jitħalltu flimkien, it-trombina tqatta' l-fibrinoġena f'fibrin.
English: For the full list of all side effects and restrictions with VeraSeal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'VeraSeal, ara l-fuljett ta' tagħrif.
English: Before use, the syringes are attached to a device supplied with the medicine that allows their contents to mix as they are dripped or sprayed on the wound.
Maltese: Qabel l-użu, is-siringi jitwaħħlu ma' apparat fornut mal-mediċina li jippermetti li lkontenut tagħhom jitħallat peress li dan jitqattar jew jiġi sprejjat fuq il-ferita.
English: Thromboembolic complications (blood clots) may occur if VeraSeal is accidentally injected into a blood vessel.
Maltese: Jistgħu jiżviluppaw kumplikazzjonijiet tromboemboliċi (emboli tad-demm) jekk VeraSeal jiġi injettat b'mod aċċidentali f'vażu.
English: The European Medicines Agency therefore decided that VeraSeal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' VeraSeal huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: The observed side effects were as expected with major surgeries or the patient's condition.
Maltese: L-effetti sekondarji osservati kienu kif mistennija b'kirurġiji maġġuri jew il-kondizzjoni tal-pazjent.
English: VeraSeal is used when standard surgery techniques do not work well enough.
Maltese: VeraSeal jintuża meta tekniki tal-kirurġija standard ma jaħdmux tajjeb biżżejjed.
English: It contains the active substances human fibrinogen and human thrombin.
Maltese: Dan fih is-sustanzi attivi fibrinoġena tal-bniedem u trombina tal-bniedem.
English: .......................................................................................................per 0.2 ml dose
Maltese: .......................................................................................................f'kull doża ta' 0.2 ml
English: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136)
Maltese: Razza A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136)
English: Pack size of 10.
Maltese: Pakkett ta' 10.
English: ** produced in VERO cells by reverse genetic technology.
Maltese: ** prodotta f'ċelloli VERO permezz ta' teknoloġija ġenetika inversa.
English: 6 to 35 M 1,041
Maltese: 6 sa 35 X 1,041
English: Liverpool L24 9JW United Kingdom
Maltese: Liverpool L24 9JW, Ir-Renju Unit
English: Södertälje Sweden
Maltese: Södertälje,
English: This medicine has been given “conditional approval”.
Maltese: Din il-mediċina ngħatat ‘approvazzjoni kondizzjonali'.
English: The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml).
Maltese: L-ammont massimu ta' ovalbumina huwa ta' inqas minn 0.024 mikrogramma f'kull doża ta' 0.2 ml (0.12-il mikrogramma kull ml).
English: Nasal spray, suspension
Maltese: Sprej għall-imnieħer, sospensjoni
English: See section 4.2 for information on paediatric use.
Maltese: Ara s-sezzjoni 4.2 għal informazzjoni dwar lużu pedjatriku.
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 4 April 2018
Maltese: Data tal-aħħar tiġdid: 4 ta' April 2018
English: 1 dose (0.2 ml) contains:
Maltese: doża 1 (0.2 ml) fiha:
English: A total of 20 subjects (12 T/LAIV, 0.3%; 8 injectable influenza vaccine, 0.2%) were hospitalised in association with medically significant wheezing.
Maltese: Total ta' 20 individwu (12 T/LAIV, 0.3%; 8 tilqima injettabbli kontra l-influwenza, 0.2%) kellhom jiddaħħlu l-isptar bi tħarħir medikament sinifikanti.
English: Additional data are provided from 289 adults enrolled in studies of vaccine candidates for an additional 7 influenza subtypes and from 240 adults and 259 children enrolled in studies of the monovalent 2009 H1N1 pandemic vaccine.
Maltese: Dejta addizzjonali ġiet ipprovduta minn 289 adult li ħadu sehem fi studji ta' kandidati għal tilqim għal 7 sottotipi addizzjonali tal-influwenza u minn 240 adult u 259 tifel u tifla li ħadu sehem fi studji tattilqima pandemika monovalenti H1N1 tal-2009.
English: The influenza virus strain in Pandemic influenza vaccine H5N1 AstraZeneca is (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Maltese: Ir-razza tal-virus tal-influwenza fit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija (a) adattata biex tikber f'temperaturi kesħin (cold-adapted) (ca); (b) sensittiva għat-temperatura (ts); u (c) attenwata (att).
English: Reporting of suspected adverse reactions
Maltese: Rapportar ta' reazzjonijiet avversi suspettati:
English: USA 15 to 71 M
Maltese: 15 sa 71 X
English: Reassortant influenza virus* (live attenuated) of the following strain**:
Maltese: Virus riassortit tal-influwenza* (ħaj attenwat) tar-razza segwenti**:
English: 12 to 35 M
Maltese: 12 sa 35 X
English: M = months.
Maltese: S = snin.
English: Serum samples were available from 7 subjects in Group 3 on Day 28 and from 18 subjects in Group 5 on Day 56.
Maltese: Il-kampjuni tas-serum kienu disponibbli minn 7 individwi fil-Grupp 3 fil-Jum 28 u minn 18-il individwu fil-Grupp 5 fil-Jum 56.
English: H5N1 Hong Kong
Maltese: H5N1 Hong Kong 2003 Xejn Xejn
English: Post-marketing experience with seasonal T/LAIV Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed.
Maltese: Kienu osservati wkoll rapporti rari ħafna tas-sindromu ta' Guillain-Barré u aggravar tas-sintomi tassindromu ta' Leigh (enċefalomijopatija mitokondrijali).
English: T/LAIV demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,609 children 24-71 months of age.
Maltese: It-T/LAIV uriet 64.4% (1.4, 88.8) anqas każijiet mit-tilqima injettabbli kontra l-influwenza f'476 tarbija u tfal żgħar minn 6-23 xahar u 48.2% (12.7, 70.0) anqas każijiet f'1,609 tifel u tifla bejn l-24-71 xahar.
English: D153-P514 Europe 6 to 71 M 2,085 2002-2003
Maltese: L-Ewropa 6 sa 71 X 2,085 2002-2003
English: Europe, Asia/ Oceania, Latin America
Maltese: LEwropa, l-Asja/ lOċeanja, lAmerika Latina
English: SINGLE-USE NASAL APPLICATOR
Maltese: Mhux applikabbli
English: In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6,
Maltese: Fi studju ta' sorveljanza li sar mis-CDC tal-Istati Uniti (Griffin, et al, 2011) l-effikaċja tat-tilqima LAIV kontra l-pandemija tal-H1N1 fi tfal bejn is-2 sa 9 snin kienet stmata li kienet ta' 81.9% (95% CI:13.6, 96.2).
English: In clinical study MI-CP217, the safety and descriptive immunogenicity of a live attenuated monovalent influenza virus vaccine (derived from A/California/7/2009) developed for the 2009 H1N1 pandemic were evaluated in a total of 326 randomised subjects (259 subjects monovalent vaccine; 65 subjects placebo) and 324 subjects received one dose of investigational product.
Maltese: Fi studju kliniku MI-CP217, is-sigurtà u l-immunoġeniċità deskrittiva ta' vaċċin ħaj attenwat monovalenti kontra l-virus tal-influwenza (li ġej minn A/California/7/2009) li ġie żviluppat għallpandemija tal-H1N1 tal-2009 ġew ivvalutati f'total ta' 326 individwu randomizzati (259 individwu bilvaċċin monovalenti; 65 individwu bi plaċebo) u 324 individwu irċevew doża unika tal-prodott taħt investigazzjoni.
English: MN HAI MN HAI MN HAI MN HAI
Maltese: U MNEJN GĦANDU JINGĦATA
English: FFU per 0.2 ml dose
Maltese: FFU f'kull doża ta' 0.2 ml
English: 5 single-use nasal applicators (0.2 ml each)
Maltese: 5 applikaturi tal-imnieħer li jintużaw darba biss (0.2 ml kull wieħed)
English: P/LAIV H5N1 vaccine
Maltese: Tilqima P/LAIV tal-H5N1
English: BATCH NUMBER
Maltese: Numru talistudju
English: P/LAIV priming dose
Maltese: T/LAIV.
English: Serological response defined as a ≥4-fold rise in antibody titer (≥1:20).
Maltese: Ir-rispons seroloġiku huwa definit bħala żieda ta' ≥4-darbiet fit-titru tal-antikorpi (≥1:20).
English: No data are available for individuals with severe immunosuppression (see section 4.4).
Maltese: Ma hemmx informazzjoni disponibbli għal individwi b'immunosoppressjoni severa (ara sezzjoni 4.4).
English: Africa, Latin America
Maltese: LAfrika LAmerika Latina
English: The study enrolled 69 subjects in 5 groups: Group 1 enrolled 11 subjects who had previously received 2 doses of the A/Vietnam/1203/2004 H5N1 pandemic live attenuated influenza vaccine (P/LAIV) in 2006-2007; Group 2 enrolled 10 subjects who had previously received 2 doses of the A/Hong Kong/213/2003 H5N1 P/LAIV in 2007; Group 3 enrolled 8 subjects who had previously received 2 doses of the A/British Columbia/CN-6/2004 H7N3 P/LAIV in 2010 (as a P/LAIV control group); Groups 4 and 5 each enrolled 20 subjects who had not been previously vaccinated with LAIV and were influenza H5 naïve.
Maltese: Fil-Grupp 1 ħadu sehem 11-il individwu li qabel kienu irċevew 2 dożi talvaċċin ħaj attenwat kontra l-influwenza pandemika A/Vietnam/1203/2004 H5N1 (P/LAIV) fl-20062007; fil-Grupp 2 ħadu sehem 10 individwi li qabel kienu irċevew 2 dożi tal-P/LAIV kontra A/Hong Kong/213/2003 H5N1 fl-2007; fil-Grupp 3 ħadu sehem 8 individwi li qabel kienu irċevew 2 dożi talP/LAIV kontra A/British Columbia/CN-6/2004
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (seasonal T/LAIV: n=1,114, seasonal injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
Maltese: Fi studju (D153-P515) ta' tfal bejn is-6 u s-17-il sena bl-ażma (T/LAIV staġjonali: n=1,114, tilqima staġjonali injettabbli kontra l-influwenza: n=1,115), ma kienx hemm differenzi sinifikanti bejn ilgruppi ta' kura fl-inċidenza ta' aggravar tal-ażma, fil-medja tar-rata massima tal-fluss espiratorju, filpunteġġ tas-sintomi tal-ażma, jew fil-punteġġ ta' qawmien bil-lejl.
English: T/LAIV demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
Maltese: It-T/LAIV uriet 55.7% (39.9, 67.6) anqas każijiet mit-tilqima injettabbli kontra l-influwenza f'3,686 tarbija u tfal żgħar minn 6-23 xahar u 54.4% (41.8, 64.5) anqas każijiet f'4,166 tifel u tifla bejn l-24-59 xahar.
English: Pandemic influenza vaccine H5N1 AstraZeneca is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca tiġi bħala sospensjoni ta' 0.2 ml f'applikatur tal-imnieħer li jintuża darba biss (ħġieġ tat-Tip 1), b'żennuna (tal-polipropelin b'valv tattrasferiment tal-polietilen), għatu għall-protezzjoni tal-ponta taż-żennuna (gomma sintetika), lasta talplanġer, tapp tal-planġer (gomma butyl), u klipp li taqsam id-doża.
English: AstraZeneca A.E. Τηλ: +30 2-10 6871500
Maltese: Τηλ: +30 2-10 6871500
English: The incidence of wheezing within 15 days after vaccination was lower in T/LAIV recipients relative to seasonal inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Maltese: L-inċidenza ta' tħarħir fil-ħmistax ta' wara t-tilqima kienet aktar baxxa f'persuni li rċevew it-T/LAIV meta mqabbla ma' persuni li rċevew it-tilqima staġjonali inattivata (19.5% kontra 23.8%, P=0.02).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini:http://www.ema.europa.eu.
English: Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Maltese: Fosfat tal-potassju dibażiku Fosfat tal-potassju monobażiku Ġelatina (porċina, Tip A) Arginine hydrochloride Monosodium glutamate monohydrate Ilma għall-injezzjonijiet
English: Influenza season
Maltese: Staġun talinfluwenza
English: Excipients: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Maltese: Eċċipjenti: sukrożju, fosfat tal-potassju dibażiku, fosfat tal-potassju monobażiku, ġelatina (porċina, Tip A), arginine hydrochloride, monosodium glutamate monohydrate, ilma għall-injezzjonijiet.
English: Nasal spray, suspension 10 single-use nasal applicators (0.2 ml each)
Maltese: Sprej għall-imnieħer, sospensjoni 10 applikaturi tal-imnieħer li jintużaw darba biss (0.2 ml kull wieħed)
English: Children and adolescents from 12 months to less than 18 years of age 0.2 ml (administered as 0.1 ml per nostril).
Maltese: Tfal u adolexxenti minn 12-il xahar sa inqas mill-età ta' 18-il sena 0.2 ml (li jingħata bħala 0.1 ml f'kull minfes).
English: The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Maltese: Ir-razza primarja ċirkolanti kienet antiġenikament differenti mir-razza H3N2 rappreżentata fit-tilqima; leffikaċja kontra r-razza A/H3N2 mhux imqabbla kienet ta' 85.9% (95% CI: (75.
English: Not applicable
Maltese: APPLIKATURI
English: Geometric mean titer
Maltese: Titru Medju Ġeometriku
English: Very rare (may affect up to 1 in 1,000,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 1,000,000):
English: 6 to 35 M
Maltese: 6 sa 35 X
English: Reassortant influenza virus (live attenuated) of the following strain:
Maltese: Virus riassortit tal-influwenza (ħaj attenwat) tar-razza segwenti:
English: In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) against matched strains and 44.8% (95% CI: 18.2, 62.9) against all strains regardless of match, respectively, in D153-P501, thus supporting the need for second-season revaccination.
Maltese: F'parteċipanti tal-istudji li rċevew 2 dożi fis-sena 1 u plaċebo fis-sena 2, l-effikaċja fis-sena 2 kienet ta' 56.2% (95% CI: 30.5, 72.7) kontra r-razez li jaqblu u ta' 44.8% (95% CI: 18.2, 62.9) kontra r-razez kollha irrispettivament minn jekk jaqblux, rispettivament, f'D153-P501, u dan jappoġġja l-ħtieġa għal rivaċċinazzjoni fit-tieni staġun.
English: Adults aged 22 to 54 years
Maltese: Adulti bejn it-22 u l-54 sena
English: Adults aged 18 to 49 years
Maltese: Adulti bejn it-18 u d-49 sena
English: T/LAIV efficacy
Maltese: Effikaċja tat-T/LAIV
English: Common: Pyrexia
Maltese: Studji pedjatriċi
English: In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) against matched strains and 56.3% (95% CI: 43.1, 66.7) against all strains regardless of match, respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children.
Maltese: Fil-parteċipanti fl-istudju li qatt ma kienu tlaqqmu qabel li rċevew doża waħda fis-sena 1, l-effikaċja kienet ta' 57.7% (95% CI: 44.7, 67.9) kontra r-razez li jaqblu u ta' 56.3% (95% CI: 43.1, 66.7) kontra r-razez kollha irrispettivament mit-tqabbil, rispettivament, u dan jappoġġja l-ħtieġa għal żewġ dożi tat-tilqima fi tfal li ma kinux tlaqqmu qabel.