FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available for individuals with significant clinical immunodeficiency.
Maltese: Ma hemmx informazzjoni disponibbli għal individwi b'immunodefiċjenza klinika sinifikanti.
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
Maltese: • jekk it-tabib tiegħek ikun qallek li għandek sistema immuni mdgħajfa bħala riżultat ta' marda, mediċina, jew trattament ieħor.
English: In clinical study CIR 239, the safety, infectivity, and immunogenicity of a live attenuated vaccine derived from A/Hong Kong/213/2003 (H5N1) influenza isolate were evaluated in 17 subjects who received one dose of 10
Maltese: Fl-istudju kliniku CIR 239, is-sigurtà, l-infettività, u l-immunoġeniċità ta' vaċċin ħaj attenwat derivat minn iżolat A/Hong Kong/213/2003 (H5N1) tal-influwenza ġew ivvalutati fi 17-il individwu li rċevew doża unika ta' 10
English: Of these subjects, 319 received a second dose (256 subjects monovalent vaccine; 63 subjects placebo).
Maltese: Minn dawn l-individwi, 319 irċevew it-tieni doża (256 individwu irċevew il-vaċċin monovalenti; 63 individwu irċevew plaċebo).
English: H1N1 pandemic LAIV vaccine in children aged 2 to 17 years
Maltese: Tilqima LAIV kontra l-pandemija tal-H1N1 fi tfal bejn is-2 u s-17-il sena
English: Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.
Maltese: Profilassi ta' influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment fi tfal u adolexxenti minn 12il xahar sa inqas minn 18-il sena.
English: Subjects in Groups 1 to 4 received a single 45-μg dose of the A/Vietnam/1203/2004 pandemic inactivated influenza vaccine (P/IIV) while subjects in Group 5 received 2 doses, approximately 28 days apart.
Maltese: L-individwi fil-Gruppi 1 sa 4 irċevew doża unika ta' 45-μg tal-vaċċin inattivat kontra l-influwenza pandemika A/Vietnam/1203/2004 (P/IIV) filwaqt li l-individwi fil-Grupp 5 irċevew 2 dożi, bejn wieħed u ieħor 28 jum bogħod minn xulxin.
English: The most common adverse reactions observed in clinical studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in healthy adults was headache (25.4%) and upper respiratory infection (10.2%).
Maltese: L-aktar reazzjonijiet avversi komuni osservati fi studji kliniċi li saru bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca f'adulti b'saħħithom kienu uġigħ ta' ras (25.4%) u infezzjoni fl-apparat respiratorju ta' fuq (10.
English: Other possible side effects of Pandemic influenza vaccine H5N1 AstraZeneca:
Maltese: Effetti sekondarji oħra possibbli tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca:
English: Table 3 Serum microneutralization (MN) and haemagglutination inhibition (HAI) assay antibody responses on Days 28 and 56 following administration of an inactivated H5N1 vaccine
Maltese: Tabella3 Rispons ta' antikorpi tal-mikronewtralizzazzjoni (MN) u assaġġ tal-inibizzjoni ta' emagglutinazzjoni (HAI) fis-serum fil-Jiem 28 u 56 wara l-għoti ta' vaċċin inattivat kontra H5N1
English: Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Maltese: Mhux komuni: Reazzjonijiet ta' sensittività eċċessiva (fosthom edema tal-wiċċ, urtikarja u rari ħafna reazzjonijiet anafilattiċi)
English: Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
Maltese: Id-dejta għall-Grupp 3, individwi li inizjalment tlaqqmu bil-P/LAIV kontra H7N3 mhijiex murija.
English: Children and adolescents under 18 years of age receiving salicylate therapy should avoid vaccination with Pandemic influenza vaccine H5N1 AstraZeneca (see section 4.4).
Maltese: Tfal u adolexxenti taħt it-18-il sena li jkunu qed jirċievu terapija saliċilata għandhom jevitaw tilqim bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca (ara sezzjoni 4.4).
English: In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% T/LAIV versus 3.8% injectable influenza vaccine).
Maltese: Fl-istess studju, fit-trabi u fit-tfal żgħar bejn is-6-23 xahar kienet osservata rata ogħla ta' tħarħir sa 42 jum (5.9% għat-T/LAIV kontra 3.8% għat-tilqima injettabbli kontra l-influwenza).
English: Overall, the safety profile of T/LAIV in a limited number of subjects with mildly to moderately nonHIV related compromised immune function, asymptomatic or mildly symptomatic HIV infection, or cancer (solid tumors and haematological malignancies) was comparable to that in healthy individuals and does not indicate any untoward effect.
Maltese: B'mod ġenerali, il-profil tas-sigurtà tat-T/LAIV f'għadd limitat ta' individwi b'funzjoni immuni minn ħafifa għal moderatament kompromessa mhux minħabba l-HIV, b'infezzjoni asintomatika jew kemmxejn sintomatika tal-HIV, jew b'kanċer (tumuri solidi u tumuri malinni ematoloġiċi) kien komparabbli ma' dak f'individwi b'saħħithom u ma jindikax effetti mhux mistennija.
English: USA, Europe, Asia/Oceania
Maltese: L-Istati Uniti tal-Amerka, l-Asja/lOċeanja
English: Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna: Konġestjoni fl-imnieħer/rinoreja Mhux komuni: Epistassi
English: For children regardless of baseline serostatus, seroresponse rates after receipt of monovalent vaccine were 7.8% and 11.1% for Days 15 and 29, respectively, and 32.0% on Day 57.
Maltese: Għat-tfal irrispettivament mill-istatus ta' antikorpi fis-serum fil-linja bażi, ir-rati tar-rispons talantikorpi fis-serum wara li rċevew il-vaċċin monovalenti kienu ta' 7.8% u ta' 11.1% fil-Jiem 15 u 29, rispettivament, u ta' 32.0% fil-Jum 57.
English: History of an anaphylactic (i.e. life-threatening) reaction to the active substance or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), to eggs or to egg proteins (e.g. ovalbumin).
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' periklu għall-ħajja) għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (eż. ġelatina), jew għal gentamicin (residwu traċċa possibbli), għall-bajd jew għall-proteini tal-bajd (eż. ovalbumina).
English: Similar responses were seen with P/LAIV H7N7- and H7N9-primed subjects who developed vigorous antibody responses to the corresponding wild-type viruses upon subsequent exposure to the inactivated vaccine from the same subtype.
Maltese: Risponsi simili dehru f'individwi pprajmjati bil-P/LAIV kontra H7N7 u H7N9 li żviluppaw rispons qawwi tal-antikorpi għall-virusijiet korrispondenti tat-tip selvaġġ wara esponiment sussegwenti għallvaċċin inattivat mill-istess sottotip.
English: • fever
Maltese: • tifriġ
English: Table 2 T/LAIV relative efficacy in active-controlled paediatric studies with seasonal injectable influenza vaccine
Maltese: Tabella 2 Effikaċja relattiva tat-T/LAIV fi studji pedjatriċi kkontrollati b'mod attiv bit-tilqima staġjonali injettabbli kontra l-influwenza
English: In a study (AV010) of children and adolescents 9 to 17 years of age with moderate to severe asthma (seasonal T/LAIV: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
Maltese: Fi studju (AV010) ta' tfal u adolexxenti bejn id-9 u s-17-il sena b'ażma moderata għal severa (T/LAIV staġjonali: n=24, plaċebo: n=24), it-tibdil fil-perċentwali mbassra tal-volum espiratorju sfurzat f'sekonda (FEV1) imkejjel qabel u wara t-tilqima, ma kienx differenti bejn il-fergħat ta' kura.
English: In an active-controlled clinical study (MI-CP111) conducted with T/LAIV in comparison to the injectable influenza trivalent vaccine, an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants 6-11 months of age (6.1% T/LAIV versus 2.6% injectable influenza vaccine).
Maltese: Fi studju kliniku kkontrollat b'mod attiv (MI-CP111) li sar bit-T/LAIV meta mqabbla mat-tilqima trivalenti injettabbli kontra l-influwenza, kienet osservata żieda fir-rata ta' pazjenti li kellhom jiddaħħlu l-isptar (għal kwalunkwe raġuni) sa 180 jum wara l-aħħar doża tat-tilqima fi trabi bejn is6-11-il xahar (6.1% għat-T/LAIV kontra 2.6% għat-tilqima injettabbli kontra l-influwenza).
English: The adverse reactions reported were similar to those seen with the recommended single dose of T/LAIV and Fluenz Tetra.
Maltese: Ir-reazzjonijiet avversi rrappurtati kienu simili għal dawk osservati bid-doża unika rakkomandata tat-T/LAIV u ta' Fluenz Tetra.
English: Improved efficacy (95% CI) matched strains
Maltese: Effikaċja mtejba (95% CI) razez li jaqblu
English: PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS)
Maltese: DAQS TAL-PAKKETT TA' 10 APPLIKATURI
English: Subjects who were primed with either the A/Vietnam/1203/2004 P/LAIV or the A/Hong Kong/213/2003 P/LAIV had a significantly better response to a single dose of inactivated H5N1 vaccine than P/LAIV-naïve subjects.
Maltese: Individwi li kienu pprajmjati jew bil-P/LAIV kontra A/Vietnam/1203/2004 jew bil-P/LAIV kontra A/Hong Kong/213/2003 kellhom rispons ferm aħjar għal doża unika tal-vaċċin inattivat kontra H5N1 millindividwi li qatt ma kienu ngħataw il-P/LAIV.
English: Table 1 T/LAIV efficacy in placebo controlled paediatric studies
Maltese: Tabella 1 Effikaċja tat-T/LAIV fi studji pedjatriċi kkontrollati bi plaċebo
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine or placebo.
Maltese: Id-dejta ppreżentata għall-prova klinika D153-P504 hija għal parteċipanti fl-istudju li rċevew żewġ dożi tattilqima tal-istudju jew tal-plaċebo.
English: Clinical studies have evaluated the incidence of adverse reactions in 59 adults from 18 to 49 years of age receiving at least one dose of Pandemic influenza vaccine H5N1 AstraZeneca.
Maltese: Studji kliniċi vvalutaw l-inċidenza ta' reazzjonijiet avversi f'59 adult bejn it-18 u d-49 sena li talanqas kienu irċevew doża waħda tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca.
English: Data regarding co-administration of the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) with live attenuated vaccines (measles, mumps, and rubella vaccine (MMR), varicella vaccine, and orally-administered poliovirus) are available and suggest that concomitant admininstration of Pandemic influenza vaccine H5N1 AstraZeneca with these live vaccines may be acceptable.
Maltese: Id-dejta disponibbli dwar l-għoti flimkien tat-tilqima trivalenti kontra l-influwenza staġjonali ħajja, ġol-imnieħer (T/LAIV) ma' vaċċini ħajjin attenwati (it-tilqima kontra l-ħożba, il-gattone u rrubella (MMR), it-tilqima kontra l-variċella, u l-poljovirus li jingħata mill-ħalq) tissuġġerixxi li l-għoti konkomitanti tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ma' dawn il-vaċċini ħajjin jista' jkun aċċettabbli.
English: T/LAIV has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Maltese: It-T/LAIV uriet superjorità fi 3 studji b'kontroll b'mod attiv bit-tilqima injettabbli kontra l-influwenza.
English: In a study with the seasonal trivalent live attenuated influenza vaccine (T/LAIV), an increased incidence of medically significant wheezing was seen in children 12-23 months of age (see section
Maltese: Fi studju bit-tilqima tal-influwenza ħajja attenwata trivalenti staġjonali (T/LAIV), dehret żieda flinċidenza ta' tħarħir medikament sinifikanti fi tfal fl-età ta' 12-23 xahar (ara sezzjoni 4.8).
English: H5N1 P/LAIV-primed subjects developed antibody responses that neutralised 2 or more clades of H5N1 viruses from the A/Goose/Guangdong/1996 H5N1 lineage, whereas few subjects even in the 2-dose inactivated H5N1 vaccine group developed cross-clade neutralising antibodies.
Maltese: Individwi pprajmjati bil-P/LAIV kontra H5N1 żviluppaw rispons tal-antikorpi li nnewtralizza 2 clades jew aktar tal-virus H5N1 minnisel tal-A/Goose/Guangdong/1996 H5N1, filwaqt li ftit individwi anke fil-grupp li rċevew 2-dożi talH5N1 inattivat żviluppaw antikorpi li jinnewtralizzaw inkroċjar tal-clades.
English: In order to further corroborate the efficacy of Pandemic influenza vaccine H5N1 AstraZeneca, the MAH should conduct an observational effectiveness study in community dwelling children and adolescents from 12 months to less than 18 years of age against laboratory confirmed influenza during the next declared pandemic.
Maltese: Sabiex jikkorrabora aktar l-effikaċja tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, il-MAH għandu jwettaq studju osservazzjonali dwar l-effikaċja fi tfal u adolexxenti li jgħixu fil-komunità mill-età ta' 12-il xahar sa anqas minn 18-il sena kontra influwenza kkonfermata fil-laboratorju waqt il-pandemija ddikjarata li jmiss.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi awtorizzazzjoni għat-tqegħid fis-suq kondizzjonali u skont l-Artikolu 14(7) tarRegolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: Pandemic influenza vaccine H5N1 AstraZeneca is similar to Fluenz Tetra (a nasal influenza vaccine containing four strains), except Pandemic influenza vaccine H5N1 AstraZeneca provides protection against a single influenza strain in an officially declared pandemic.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija simili għal Fluenz Tetra (tilqima kontra l-influwenza li tingħata mill-imnieħer li fiha erba' razez), ħlief li t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca tipprovdi protezzjoni kontra razza unika ta' influwenza f'pandemija ddikjarata uffiċjalment.
English: The recommended dose for children and adolescents is 0.2 ml Pandemic influenza vaccine H5N1 AstraZeneca, administered as 0.1 ml in each nostril.
Maltese: Id-doża rakkomandata għat-tfal u għall-adolexxenti hija ta' 0.2 ml tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, li tingħata bħala 0.1 ml f'kull minfes.
English: From clinical studies and post-marketing surveillance with T/LAIV and Fluenz Tetra in over 110,000 children and adolescents 2 to 17 years of age, the following adverse reaction frequencies are reported: Very common (≥ 1/10)
Maltese: Minn studji kliniċi u minn sorveljanza wara t-tqegħid fis-suq bit-T/LAIV u bi Fluenz Tetra fuq aktar minn 110,000 tifel u tifla u adolexxenti bejn is-2 u s-17-il sena, ir-reazzjonijiet avversi ġew irrapportati bil-frekwenzi segwenti:
English: In a pandemic situation, healthcare providers need to assess the potential benefits, alternatives, and risks of administering the vaccine to children and adolescents with significant clinical immunodeficiency due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Maltese: F'sitwazzjoni pandemika, il-fornituri tal-kura tas-saħħa jridu jqisu l-benefiċċji potenzjali, l-alternattivi, u r-riskji tal-għoti tal-vaċċin lil tfal u adolexxenti b'immunodefiċjenza klinika sinifikanti minħabba kundizzjonijiet jew terapija immunosoppressiva bħal: lewkimji akuti u kroniċi; limfoma; infezzjoni sintomatika bl-HIV; defiċjenzi immuni ċellulari; u kortikosterojdi f'doża għolja.
English: Efficacy (95% CI) matched strains
Maltese: Effikaċja (95% CI) razez li jaqblu
English: Pandemic influenza vaccine H5N1 AstraZeneca Pandemic influenza vaccine
Maltese: Tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca Tilqima kontra l-influwenza pandemika
English: Pandemic influenza vaccine H5N1 AstraZeneca nasal spray, suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Maltese: Tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca sprej għall-imnieħer, sospensjoni Tilqima kontra l-influwenza pandemika (H5N1) (ħajja attenwata, għall-imnieħer)
English: The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Maltese: It-tilqima jista' jkun fiha residwi tas-sustanzi li ġejjin: proteini tal-bajd (eż. ovalbumina) u gentamicin.
English: Pandemic influenza vaccine H5N1 AstraZeneca is not indicated for use in infants younger than 12 months of age (see section 4.2).
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca mhijiex indikata għall-użu fi trabi ta' inqas mill-età ta' 12-il xahar (ara sezzjoni 4.2).
English: Region Age range
Maltese: Numru tal-istudju
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Maltese: L-influwenza pandemika hija tip ta' influwenza li sseħħ f'intervalli li jvarjaw bejn inqas minn 10 snin sa diversi għexieren ta' snin.
English: (See also How Pandemic influenza vaccine H5N1 AstraZeneca is given, in section 3).
Maltese: (Ara wkoll Kif tingħata t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, fis-sezzjoni 3).
English: Adult studies
Maltese: Studji fuq l-adulti
English: Clinical study CIR 277 assessed whether prior recipients of pandemic live attenuated influenza H5N1 vaccines were primed or established long-lasting immunity that could be detected following the subsequent administration of an inactivated H5N1 vaccine.
Maltese: L-istudju kliniku CIR 277 ivvaluta jekk persuni li qabel kienu irċevew tilqim ħaj attenwat kontra linfluwenza pandemika H5N1 kinux ġew ipprajmjati jew kinux stabbilixxew immunità fit-tul li setgħet tiġi skoperta wara l-għoti sussegwenti tal-vaċċin inattivat tal-H5N1.
English: For placebo recipients regardless of baseline serostatus, seroresponse rate was 6.3% on Days 15 and 29 and 14.5% on Day 57.
Maltese: Għal dawk li rċevew plaċebo irrispettivament mill-istatus ta' antikorpi fis-serum fil-linja bażi, ir-rata tar-rispons tal-antikorpi fis-serum kienet ta' 6.3% fil-Jiem 15 u 29 u ta' 14.5% fil-Jum 57.
English: Similarly from the VAERS, in 113 reports of pregnant women who had received AstraZeneca's (H1N1) 2009 Monovalent Vaccine Live, Intranasal, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Maltese: Bl-istess mod bħall-VAERS, f'113-il rapport ta' nisa tqal li kienu rċevew it-Tilqima Monovalenti Ħajja ta' AstraZeneca (H1N1) tal-2009, ma ġie osservat l-ebda mudell mhux tas-soltu ta' komplikazzjonijiet fit-tqala jew riżultati fuq il-fetu.
English: • It is recommended that Pandemic influenza vaccine H5N1 AstraZeneca is not given at the same time as influenza-specific antiviral medicines such as oseltamivir and zanamivir.
Maltese: • Huwa rrakkomandat li t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ma tingħatax fl-istess ħin ma' mediċini antivirali speċifiċi għall-influwenza bħal oseltamivir u zanamivir.
English: Pregnancy
Maltese: LEwropa
English: Based upon the potential for influenza antiviral agents to reduce the effectiveness of Pandemic influenza vaccine H5N1 AstraZeneca, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Maltese: Abbażi tal-potenzjal ta' aġenti antivirali kontra l-influwenza li jnaqqsu l-effikaċja tat-tilqima kontra linfluwenza Pandemika H5N1 AstraZeneca, huwa rrakkomandat li t-tilqima ma tingħatax sa 48 siegħa wara l-waqfien tat-terapija antivirali kontra l-influwenza.
English: After declaration in the EU of a pandemic and after implementation of the pandemic vaccine
Maltese: Wara ddikjarazzjoni fl-UE ta' pandemija u wara limplimentazzjoni tat-tilqima pandemika
English: How to store Pandemic influenza vaccine H5N1 AstraZeneca
Maltese: Kif taħdem it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca
English: Non-interventional post-authorisation safety study (PASS) in order to further investigate the tolerability of Pandemic influenza vaccine H5N1 AstraZeneca and estimate the incidence of adverse reactions of special interest in children and adolescents.
Maltese: L-istudju dwar is-sigurtà mhux intervenzjonali wara l-awtorizzazzjoni (PASS) jinvestiga t-tollerabilità tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca u jagħti stima tal-inċidenza ta' reazzjonijiet avversi ta' interess speċjali fi tfal u adolexxenti.
English: In clinical study CIR 217, the safety, infectivity and immunogenicity of a live attenuated vaccine derived from A/Vietnam/1203/2004 (H5N1) influenza isolate were evaluated in 21 subjects who received one 10
Maltese: Fl-istudju kliniku CIR 217, is-sigurtà, l-infettività u l-immunoġeniċità ta' vaċċin ħaj attenwat derivat minn iżolat A/Vietnam/1203/2004 (H5N1) tal-influwenza ġew ivvalutati f'21 individwu li rċevew doża infettiva medjana waħda ta' koltura ta' tessut (TCID50), u 18 minn dawk l-individwi irċevew ittieni doża wara 4-8 ġimgħat.
English: No data exist regarding the possible effects of Pandemic influenza vaccine H5N1 AstraZeneca on male and female fertility.
Maltese: Ma teżisti l-ebda dejta dwar l-effetti possibbli tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca fuq il-fertilità maskili u femminili.
English: However, in a pandemic situation, your doctor may recommend to give you the vaccine provided that appropriate medical treatement is immediately available in case of an allergic reaction.
Maltese: Madankollu, f'sitwazzjoni pandemika, it-tabib tiegħek jista' jirrakkomandalek li tingħata t-tilqima sakemm ikun hemm kura medika xierqa immedjatament disponibbli f'każ ta' reazzjoni allerġika.
English: Corresponding rates for infants and toddlers 12-23 months of age were 5.4% and 3.6% for T/LAIV and injectable influenza vaccine, respectively.
Maltese: Ir-rati korrispondenti għat-trabi u għat-tfal żgħar bejn it-12-23 xahar kienu ta' 5.4% u 3.6% għat-T/LAIV u għat-tilqima injettabbli kontra l-influwenza, rispettivament.
English: Pandemic influenza vaccine H5N1 AstraZeneca, nasal spray suspension Pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Maltese: Tilqima kontra l-influwenza pandemika H5N1 AstraZeneca Tilqima kontra l-influwenza pandemika (H5N1) (ħajja attenwata, għall-imnieħer)
English: In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat and sinuses).
Maltese: Fi studji kliniċi b'adulti li rċevew it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, leffetti sekondarji l-aktar komuni kienu uġigħ ta' ras u infezzjoni fl-apparat respiratorju ta' fuq (infjammazzjoni tal-imnieħer, tal-griżmejn u tas-sinuses).
English: There are no data with Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents younger than 18 years of age receiving salicylate therapy.
Maltese: Ma hemm l-ebda dejta dwar it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca fi tfal u adolexxenti taħt it-18-il sena li jkunu qed jirċievu terapija saliċilata.
English: TCID50 of the vaccine intranasally in isolation, with 16 of those subjects receiving a second dose 4-8 weeks later.
Maltese: TCID50 tal-vaċċin fl-imnieħer f'iżolament, u 16 minn dawk l-individwi irċevew ittieni doża wara 4-8 ġimgħat.
English: Seven of 11 (64%) subjects in Group 1 (ca A/Vietnam/1204/2004 [H5N1]) had ≥4-fold rises in HAI antibody titer by Day 7 following receipt of the inactivated vaccine, with a geometric mean titer (GMT) of 165 and a titer range of 20 to 1280 in responders.
Maltese: [H5N1]) kellhom żieda ta' ≥4-darbiet fit-titru tal-antikorp HAI sal-Jum 7 wara li kienu irċevew il-vaċċin inattivat, b'titru medju ġeometriku (GMT) ta' 165 u medda ta' titri bejn 20 u 1280 f'dawk li rrispondew.
English: T/LAIV's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Maltese: Dejta dwar l-effikaċja tat-T/LAIV fil-popolazzjoni pedjatrika tikkonsisti f'9 studji kkontrollati li fihom ħadu sehem aktar minn 20,000 tarbija u tfal żgħar, tfal u adolexxenti, li saru matul 2 staġuni talinfluwenza.