FrancophonIA/ELRC3.0 huggingface dataset:
English: ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox.
Maltese: ProQuad jingħata lit-tfal minn 12-il xahar ‘il fuq biex jgħin fil-protezzjoni tagħhom kontra dawn l-erba' mardiet: il-ħożba, il-gattone, ir-rubella u l-ġidri r-riħ.
English: However, children who received the first dose at nine months of age had a lower immune response against measles.
Maltese: Madankollu t-tfal li ngħataw l-ewwel doża fl-età ta' disa' xhur kellhom inqas rispons immunitarju kontra l-ħożba.
English: Measles, mumps, rubella and varicella vaccine (live)
Maltese: Vaċċin (ħaj) kontra l-ħożba, il-gattone, ir-rubella u l-ġidri r-riħ
English: This study looked at the ability of the vaccine to trigger immune responses in these age groups.
Maltese: Dan l-istudju stħarreġ l-abbiltà tal-vaċċin li jqanqal risponsi immunitarji f'dawn il-gruppi ta' età.
English: The CHMP decided that ProQuad's benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.
Maltese: ProQuad jista' jingħata wkoll lil tfal minn disa' xhur ‘il fuq f'ċerti sitwazzjonijiet, pereżempju bħala parti minn programm nazzjonali ta' tilqim, meta tfaqqa' xi epidemija jew meta jivvjaġġaw f'pajjiżi fejn il-ħożba tkun komuni.
English: ProQuad is available as a powder and solvent that are made up into a suspension for injection.
Maltese: ProQuad jiġi fi trab u solvent li jitħalltu f'sospensjoni għal injezzjoni.
English: The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults.
Maltese: Il-vaċċin huwa injettat f'muskolu jew minn taħt il-ġilda, preferibbilment fil-koxxa fi tfal żgħar u madwar l-ispalla fi tfal akbar u adulti.
English: 3 tablets
Maltese: 3 pilloli
English: 1 tablet
Maltese: 1 pillola
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes l t o r
Maltese: 4 siringi mimlija għal-lest t x
English: Nijmegen, 6545CG Netherlands
Maltese: Nijmegen, 6545CG L-Olanda
English: Africa, Latin America
Maltese: Afrika, Amerika Latina
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 20 November 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 4 ta' diċembru 2013 Data tal-aħħar tiġdid: 20 ta' Novembru 2018
English: Immunocompromised
Maltese: Individwi immunokompromessi
English: 6 to 59 M 7,852 2004-2005
Maltese: 6 sa 59 X 7,852 2004-2005
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: Mhux komuni ≥1/1,000 sa 1/100) Rari (≥1/10,000 sa <1/1,000)
English: For signs of allergic reactions, see section 4 “Possible side effects”.
Maltese: Għal sinjali ta' reazzjonijiet allerġiċi, ara sezzjoni 4 “Effetti sekondarji possibbli”.
English: ** produced in VERO cells by reverse genetic technology.
Maltese: ** magħmul f'ċelluli VERO permezz ta' teknoloġija ġenetika reverse.
English: 11 to 24 M 1,150 2002-2003
Maltese: 11 sa 24 X 1,150 2002-2003
English: .................................................................................................................per 0.2 ml dose
Maltese: .......................................................................................................f'kull doża ta' 0.2 ml
English: List of adverse reactions
Maltese: Lista reazzjonijiet avversi
English: Nasal spray, suspension
Maltese: Sprej għall-imnieħer, suspensjoni
English: The influenza virus strains in Fluenz Tetra are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Maltese: Ir-razez tal-virus tal-influwenza fi Fluenz Tetra huma (a) adattati skond il-ksieħ (cold-adapted, ca); (b) sensittivi għat-temperatura (temperature-sensitive, ts); u (ċ) attenwati (attenuated, att).
English: Pack size of 1 or 10.
Maltese: Daqs tal-pakkett ta' 1 jew 10.
English: Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting with Fluenz.
Maltese: Rapporti rari ħafna tas-sindrome ta' Guillain-Barré u aggravament ta' sintomi tas-sindrome ta' Leigh (enċefalomijopatija mitokondrijali) kienu wkoll osservati fl-isfond ta' wara t-tqegħid fis-suq bi Fluenz.
English: Danmark AstraZeneca A/S Tlf: +45 43 66 64 62
Maltese: AstraZeneca A/S Tlf: +45 43 66 64 62
English: Adult studies
Maltese: Studji fuq adulti
English: B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
Maltese: B/Phuket/3073/2013 - razza qisha (B/Phuket/3073/2013, MEDI 254977)
English: 6 to 35 M 1,886
Maltese: 6 sa 35 X 1,886
English: Fluenz Tetra Influenza vaccine 2019/2020 season
Maltese: Tilqima kontra l-influwenza Staġun 2019/2020
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje,
English: Fluenz safety
Maltese: Sigurtà ta' Fluenz
English: Europe, Asia/ Oceania, Latin America
Maltese: Ewropa, Asja/Oċeanja, Amerika Latina
English: Fluenz 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: Fluenz wera 64.4% (1.4, 88.8) inqas każijiet minn tilqima kontra l-influwenza li tista' tiġi injettata f'476 tfal żgħar u trabi li kellhom età ta' 6-23 xahar u 48.2% (12.7, 70.0) inqas każijiet f'1,609 tfal li kellhom età ta' 24-71 xahar.
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Maltese: A/Kansas/14/2017 razza qisha (H3N2) (A/Kansas/14/2017, MEDI 308763)
English: Other possible side effects of Fluenz Tetra
Maltese: Effetti sekondarji oħra possibbli ta' Fluenz Tetra
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Maltese: B/Colorado/06/2017- razza qisha (B/Colorado/06/2017, MEDI 293454)
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 li kienet qed tiċċirkola kienet dissimili b'mod antigeniku mir-razza H3N2 irrappreżentata fit-tilqima; l-effikaċja kontra r-razza mhux imqabbla A/H3N2 kienet ta' 85.9% (95% CI: 75.3, 91.9).
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Maltese: A/Brisbane/02/2018 razza qisha (H1N1)pdm09 (A/Switzerland/3330/2017, MEDI 307134)
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season
Maltese: Fluenz Tetra sprej għall-imnieħer, suspensjoni Tilqima kontra l-influwenza (ħajja attenwata, nażali) Staġun 2019/2020
English: Fluenz 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: Fluenz wera 55.7% (39.9, 67.6) inqas każijiet minn tilqima kontra l-influwenza li tista' tiġi injettata fi 3,686 tfal żgħar u trabi li kellhom età ta' 6-23 xahar u 54.4% (41.8, 64.5) inqas każijiet f'4,166 tfal li kellhom età ta' 24-59 xahar.
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' ovalbumin huwa inqas minn 0.024 mikrogrammi għal kull doża ta' 0.2 ml (0.
English: In clinical studies, the safety profile of Fluenz Tetra was similar to the safety profile of Fluenz.
Maltese: Fi studji kliniċi, il-profil tas-sigurtà ta' Fluenz Tetra kien simili għall-profil tas-sigurtà ta' Fluenz.
English: Fluenz Tetra 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: Fluenz Tetra hu fornut bħala 0.2 ml ta' suspensjoni f'applikatur ta' l-imnieħer li jintuża darba biss (ħġieġ ta' Tip 1), b'żennuna (tal-polypropylene b'valv tal-polyethylene għat-trasferiment), żennuna b'għatu għal protezzjoni tat-tarf (tal-lastku sintetiku), lasta tal-planġer, tapp tal-planġer (lastku tal-butyl) u klipp li taqsam id-doża.
English: Musculoskeletal and connective tissue disorders Common: Myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni: Mijalġja
English: • if the child is less than 24 months of age.
Maltese: • jekk it-tifel/tifla jkollhom inqas minn età ta' 24 xahar.
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) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination.
Maltese: Fil-parteċipanti fl-istudju li rċivew 2 dożi f'sena 1 u plaċebo f'sena 2, l-effikaċja f'sena 2 kienet ta' 56.2% (95% CI: 30.5, 72.7) u 44.8% (95% CI: 18.2, 62.9), rispettivament, f'D153-P501, u għaldaqstant dan jissapportja l-ħtieġa għal tilqima mill-ġdid fit-tieni staġun.
English: M=months.
Maltese: S=snin.
English: Reassortant influenza virus* (live attenuated) of the following four strains**:
Maltese: Virus tal-influwenza reassortant* (ħaj attenwat) għall-erba' razez li ġejjin**:
English: - Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue).
Maltese: Sensittività eċċessiva għas-sustanzi attivi, għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (eż. ġelatina) jew għal gentamicin (residwu-traċċa possibbli).
English: USA, Europe, Asia/Oceania
Maltese: Stati Uniti tal-Amerika, Ewropa, Asja/Oċeanja
English: 5 single-use nasal applicators (0.2 ml each)
Maltese: 5 applikaturi ta' l-imnieħer li jintużaw darba biss (0.2 ml kull wieħed)
English: Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Maltese: Fih ukoll: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, ġelatina (porcine, Tip A), arginine hydrochloride, monosodium glutamate monohydrate, ilma għal injezzjonijiet.
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (trivalent Fluenz: n=1,114, trivalent 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 li kellhom minn 6 sa 17-il sena bl-ażżma (Fluenz trivalenti: n=1,114, tilqima trivalenti kontra l-influwenza li tista' tiġi injettata: n=1,115), ma kien hemm l-ebda differenzi sinifikanti bejn il-gruppi tal-kura fl-inċidenza ta' aggravamenti tal-ażżma, il-medja tar-rata tal-fluss expiratorju, il-punteġġi tas-sintomi tal-ażżma, jew il-punteġġi ta' kemm persuna tqum matul il-lejl.
English: In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) and 56.3% (95% CI: 43.1, 66.7), respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children.
Maltese: Fil-parteċipanti fl-istudju li qatt ma ngħataw tilqima fil-passat li rċivew doża waħda f'sena 1, l-effikaċja kienet ta' 57.7% (95% CI: 44.7, 67.9) u 56.3% (95% CI: 43.1, 66.7), rispettivament, u għaldaqstant dan jissapportja l-ħtieġa għal żewġ dożi tat-tilqima lil tfal li qatt ma ngħataw tilqima fil-passat.
English: In 24 HIV-infected children and 25 HIV-negative children 1 through 7 years of age, and in 243 HIV-infected children and adolescents 5 through 17 years of age receiving stable anti-retroviral therapy, the frequency and duration of vaccine virus shedding were comparable to that seen in healthy individuals.
Maltese: F'24 tifel u tifla infettati bl-HIV u f'25 tifel u tifla negattivi għall-HIV li kellhom minn sena sa 7 snin, u f'243 tifel u tifla u adolexxenti infettati bl-HIV li kellhom minn 5 sa 17-il sena li kienu qed jirċievu terapija antiretrovirali stabbli, il-frekwenza u t-tul tat-tnaqqis tal-virus tat-tilqima kienu komparabbli għal dawk li ġew osservati f'individwi b'saħħithom.
English: Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age.
Maltese: Profilassi tal-influwenza f'tfal u adolexxenti minn età ta' 24 xahar sa inqas minn 18-il sena.
English: Do not administer Fluenz Tetra to children and adolescents receiving salicylate therapy (see section 4.3).
Maltese: Tagħtix Fluenz Tetra lil tfal u adolexxenti li jkunu qed jirċievu terapija b'salicylate (ara sezzjoni 4.3).
English: However, based upon the potential for influenza antiviral agents to reduce the effectiveness of Fluenz Tetra, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Maltese: Madankollu, ibbażat fuq il-potenzjal li mediċini antivirali kontra l-influwenza jnaqqsu l-effettività ta' Fluenz Tetra, hu rakkomandat li t-tilqima ma tingħatax sa 48 siegħa wara l-waqfien tat-terapija antivirali kontra l-influwenza.
English: A total of 2,312 children and adolescents were randomised by site at a 3:1:1 ratio to receive either Fluenz Tetra or one of two formulations of comparator vaccine Fluenz, each containing a B strain that corresponded to one of the two B strains in Fluenz Tetra (a B strain of the Yamagata lineage and a B strain of the Victoria lineage).
Maltese: Total ta' 2,312-il tifel u tifla u adolexxenti ntgħażlu b'mod każwali skont is-sit fi proporzjon ta' 3:1:1 biex jirċievu jew Fluenz Tetra jew waħda miż-żewġ formulazzjonijiet tat-tilqima komparatur Fluenz, li kull ważda kien fiha razza B li kkorrispondiet għal waħda miż-żewġ razez B fi Fluenz Tetra (razza B tan-nisel Yamagata u razza B tan-nisel Victoria).
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Maltese: Dejta ppreżentata għal prova klinika D153-P504 hi għal parteċipanti fl-istudju li rċivew żewġ dożi tat-tilqima tal-istudju.
English: The incidence of wheezing within 15 days after vaccination was lower in Fluenz recipients relative to inactivated vaccine recipients (19.5% vs. 23.8%, P=0.02).
Maltese: L-inċidenza ta' tħarħir fi żmien 15-il jum wara t-tilqima kienet iktar baxxa f'dawk li kienu qed jirċievu Fluenz meta mqabbla ma' dawn li kienu qed jirċievu tilqima inattivata (19.5% vs. 23.8%, P=0.02).
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% Fluenz versus 3.8% injectable influenza vaccine).
Maltese: Fl-istess studju, kienet osservata żieda fir-rata ta' tħarħir sa 42 jum fi tfal żgħar u trabi li kellhom età ta' 6-23 xahar (5.9% Fluenz kontra 3.8% għat-tilqima kontra l-influwenza li tista' tiġi injettata).
English: Fluenz Tetra is a vaccine to prevent influenza (flu).
Maltese: Fluenz Tetra hu tilqima għal prevenzjoni tal-influwenza.
English: In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% Fluenz versus 2.6% injectable influenza vaccine).
Maltese: Fi studju kliniku kkontrollat b'mod attiv (MI-CP111), kienet osservata żieda fir-rata ta' pazjenti li kellhom jiddaħħlu l-isptar (minħabba kwalunkwe kawża) sa 180 jum wara d-doża tat-tilqima finali fi tfal żgħar u trabi li kellhom età ta' 6-11-il xahar (6.1% Fluenz kontra 2.6% għat-tilqima kontra l-influwenza li tista' tiġi injettata).
English: Safety data regarding use of Fluenz Tetra are based on data from Fluenz Tetra clinical studies in 2,231 children and adolescents 2 to 17 years of age, Fluenz clinical studies in over 29,000 children and adolescents 2 to 17 years of age and Fluenz post-authorisation safety studies in over 84,000 children and adolescents 2 to 17 years of age.
Maltese: Dejta dwar is-sigurtà fir-rigward tal-użu ta' Fluenz Tetra hi bbażata fuq dejta minn studji kliniċi dwar Fluenz Tetra f'2,231 tfal u adolexxenti li kellhom minn età ta' sentejn sa 17-il sena, minn studji kliniċi dwar Fluenz f'aktar minn 29,000 tfal u adolexxenti minn età ta' sentejn sa 17-il sena u minn studji dwar is-sigurtà ta' Fluenz f'aktar minnr 84,000 tfal u adolexxenti minn età ta' sentejn sa 17-il sena wara li nħarġet l-awtorizzazzjoni.
English: Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Maltese: Mhux komuni: Reazzjonijiet ta' sensittività eċċessiva (li jinkludu edema fil-wiċċ, urtikarja u reazzjonijiet anafilattiċi rari ħafna)
English: Influenza Season
Maltese: Staġun talInfluwenza
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: <r-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan ilprodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Remove dose-divider clip
Maltese: Lasta tal-planġer
English: Table 1 Fluenz Efficacy in Placebo Controlled Paediatric Studies
Maltese: Tabella 1 L-Effikaċja ta' Fluenz fi Studji Pedjatriċi Kkontrollati bi Plaċebo
English: Figure 1 Fluenz Tetra Administration
Maltese: Figura 1 L-Għoti ta' Fluenz Tetra
English: Fluenz'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 ta' Fluenz fil-popolazzjoni pedjatrika tikkonsisti f'9 studji kkontrollati li kienu jinkludu iżjed minn 20,000 tfal żgħar u trabi, tfal u adolexxenti, li twettqu matul 7 staġuni ta' influwenza.
English: Fluenz Tetra immunogenicity
Maltese: Immunoġeniċità ta' Fluenz Tetra
English: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Maltese: Fluenz Tetra sprej għall-imnieħer, suspensjoni Tilqima kontra l-influwenza (ħajja attenwata, nażali)
English: • It is recommended that Fluenz Tetra is not given at the same time as influenza-specific antiviral medicines, such as oseltamivir and zanamivir.
Maltese: • Hu rakkomandat li Fluenz Tetra ma jingħatax fl-istess ħin ma' mediċini antivirali speċifiċi għall-influwenza, bħal oseltamivir u zanamivir.
English: Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each)
Maltese: 1 applikatur ta' l-imnieħer li jintuża darba biss (0.2 ml) 10 applikaturi ta' l-imnieħer li jintużaw darba biss (0.2 ml kull wieħed)
English: Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Maltese: Dipotassium phosphatePotassium dihydrogen phosphate Ġelatina (porcine, Tip A)
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Maltese: Tilqim kontra l-influwenza, influwenza ħajja attenwata; Kodiċi ATC:
English: The effectiveness of Fluenz and Fluenz Tetra in preventing influenza illness in immunocompromised individuals has not been evaluated.
Maltese: L-effettività ta' Fluenz u Fluenz Tetra fil-prevenzjoni ta' mard tal-influwenza f'individwi immunokompromessi ma ġietx evalwata.
English: Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril).
Maltese: Tfal u adolexxenti minn 24 xahar: 0.2 ml (mogħti bħala 0.1 ml f'kull minfes).
English: In a study of children and adolescents 9 to 17 years of age with moderate to severe asthma (trivalent Fluenz: 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 ta' tfal u adolexxenti li kellhom minn 9 sa 17-il sena b'ażżma minn moderata sa severa (Fluenz trivalenti: n=24, plaċebo: n=24), il-kriterju primarju tas-sigurtà, tibdil fil-perċentwali mbassra tal-volum espiratorju sfurzat f'sekonda (FEV1) imkejjel qabel u wara t-tilqima, ma kienx differenti bejn il-partijiet tal-istudji.
English: - Children and adolescents with 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: Tfal u adolexxenti b'immunodefiċjenza klinika minħabba kundizzjonijiet jew terapija immunosoppressiva bħal: lewkimji akuti u kroniċi; limfoma; infezzjoni sintomatika bl-HIV; defiċjenzi immuni ċellulari; u doża qawwija ta' kortikosterojdi.
English: D153-P502 Europe 6 to 35 M 1,616
Maltese: D153-P501 Asja/Oċeanja 12 sa 35 X 2,764
English: AV006 USA 15 to 71 M 1,259
Maltese: 15 sa 71 X 1,259
English: Nervous system disorders Very common: Headache
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: Fluenz Tetra is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Maltese: Fluenz Tetra mhuwiex kontraindikat għall-użu f'individwi b'infezzjoni HIV asintomatika; jew individwi li jkunu qed jirċievu kortikosterojdi topiċi/li jinġibdu man-nifs jew doża baxxa ta' kortikosterojdi sistemiċi jew dawk li jkunu qed jirċievu kortikosterojdi bħala terapija ta' sostituzzjoni, eż. għal insuffiċjenza adrenali.
English: As a result, they replicate in the nasopharynx and induce protective immunity.
Maltese: B'riżultat ta' dan, jirreplikaw fin-nażofarinġi u jikkaġunaw immunità protettiva.
English: Stability data indicate that the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C.
Maltese: Data ta' stabilità tindika li l-komponenti tal-vaċċin huma stabbli għal 12-il siegħa meta jinħażen f'temperaturi minn 8 C sa 25 C.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZAI BIJOLOĠIKĊI ATTIVI U MANIFATTUR RESPONSABBLI
English: Other medicines, other vaccines and Fluenz Tetra
Maltese: Mediċini oħra, tilqim ieħor u Fluenz Tetra
English: Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had recently received chemotherapy) were randomised 1:1 to trivalent Fluenz or placebo.
Maltese: Għoxrin tifel u tifla u adolexxenti li kienu immunokompromessi b'mod minn ħafif sa moderat li kellhom minn 5 sa 17-il sena (li kienu qed jirċievu kimoterapija u/jew terapija permezz ta' radjazzjoni jew li dan l-aħħar kienu rċivew kimoterapija) intgħażlu b'mod każwali fi proporzjon ta' 1:1 għal Fluenz trivalenti jew plaċebo.
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) ser tipproduċi l-protezzjoni tagħha stess kontra l-virus tal-influwenza.
English: How Fluenz Tetra works
Maltese: Fluenz Tetra
English: • Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions.
Maltese: • Irreferi għad-dijagramma tal-għoti ta' Fluenz Tetra (Figura 1) għall-istruzzjonijiet tal-għoti pass pass.
English: - Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin).
Maltese: Reazzjoni allerġika severa (eż. anafilassi) għal bajd jew għal proteini tal-bajd (eż. ovalbumin).
English: Improved Efficacy (95% CI) Matched strains
Maltese: Effikaċja Mtejba (95% CI) Razez li Jaqblu