FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
Maltese: F'dan l-istudju, ġew osservati wkoll risponsi immuni ta' kross-reattività kontra A/Indonesia/5/2005.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Maltese: “Demajlinizazzjoni” b'SMQ dejjaq (billi GBS huwa nkluż ukoll f'dan l-SMQ, se jkun hemm każi komuni fin-numru ta' każi għal dawn iż-żewġ kategoriji).
English: Date and time of mixing:
Maltese: DATA TA' SKADENZA JIS:
English: Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Adjupanrix fih thiomersal bħala preservattiv u jista' jkun li inti tista' tesperjenza reazzjoni allerġika.
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Maltese: Għalhekk, PSURs kull 6 xhur jew kull sena li jaqgħu taħt il-perjodu pandemiku jeħdulhom posthom “PSURs simplifikati” kull xahar (S-PSUR) li jkunu akkumpanjati minn sommarju tad-distribuzzjoni tal-vaċċin.
English: - Neuritis:
Maltese: - Nevrite:
English: Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
Maltese: Individwi ta' D-Pan-H5N1-002 kienu segwiti għall-persistenza tar-rispons immuni.
English: Adjupanrix consists of two containers:
Maltese: Adjupanrix jikkonsisti f'żewġ kontenituri:
English: The side effects listed below have happened with H1N1 AS03-containing vaccines.
Maltese: L-effetti sekondarji elenkati taħt seħħew b'vaċċini H1N1 li fihom AS03.
English: 21 days after 2nd dose
Maltese: 21 ġurnata wara 2ni doża
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Maltese: Meta s-CHMP taqbel li ma jkunx hemm aktar bżonn ta' S-PSUR, jiġi sottomess PSUR sħiħ li jkopri lperjodu mill-aħħar 'data-lock point' ta' l-aħħar PSUR ta' rutina fi żmien stipulat li għandu jkun bi qbil mar-Rapporteur.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
Maltese: 1rata ta' seroprotezzjoni: il-proporzjon ta' individwi b'titre ta' inibizzjoni tal-emagglutinazzjoni (HI) 2rata ta' serokonverżjoni: il-proporzjon ta' individwi li jew kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥1:40 wara t-tilqima, jew li kienu seropożittivi qabel it-tilqima u għandhom żieda ta' 4-darbiet aktar fit-titre;
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Adjupanrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Maltese: Studji epidemijoloġiċi li għandhom x'jaqsmu ma' vaċċin aġġuvantat AS03 ieħor (Pandemrix H1N1, immanifatturat ukoll fl-istess faċilità bħal Adjupanrix), f'bosta pajjiżi Ewropej indikaw riskju miżjud ta' nakrolessija bi jew mingħajr cataplexy f'individwi mlaqqmin meta mqabbla ma' individwi mhux imlaqqmin.
English: Available epidemiological data in adults aged over 20 years have indicated approximately 1 additional case per 100,000 vaccinated subjects.
Maltese: Dejta epidemijoloġika disponibbli f'adulti li għandhom aktar minn 20 sena indikat madwar każ addizzjonali wieħed għal kull 100,000 individwu mlaqqam.
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Maltese: Għandu jkun provdut sommarju qasir fejn is-sinjali validati u partijiet inkwetanti ikunu mmarkati, u tkun ikkunsidrata informazzjoni li tkun ħarġet mill-istudju kohort prospettiv deskritt f'4.5.
English: • From 80 years onwards: you may receive two double injections of Adjupanrix.
Maltese: • Minn 80 sena ‘l fuq : inti tista' tirċievi żewġ injezzjonijiet doppji ta' Adjupanrix.
English: Dispose of in accordance with local regulations
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: Your doctor or nurse will give you Adjupanrix.
Maltese: It-tabib jew infermier tiegħek se jagħtuk Adjupanrix.
English: Single dose N=49
Maltese: Nofs id-doża N=49
English: Suspension and emulsion for emulsion for injection.
Maltese: Adjupanrix, suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: For further information, see sections 4.4, 4.8 and 5.1.
Maltese: Għal aktar tagħrif, ara sezzjonijiet 4.4, 4.8 u 5
English: A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose.
Maltese: Żieda ta' 4-darbiet fuq it-titri ta' antikorpi newtraliżżanti fis-serum kontra A/Vietnam ġiet ottenuta f'49% tal-individwi wieħed u għoxrin ġurnata wara l-ewwel doża, 67.3% wieħed u għoxrin ġurnata wara t-tieni doża u 44.9% sitt xhur wara t-tieni doża.
English: Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Maltese: Individwi ta' D-Pan-H5N1-009 kienu segwiti għall-persistenza tar-rispons immuni.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (i.e. li tista' twassal għall-mewt) għal xi wieħed mill-kostitwenti jew traċċi ta' residwi (proteini tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate) ta' dan il-vaċċin.
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Maltese: L-inmsa kienu mlaqqma fil-ġranet 0 u 21 u ngħataw doża ta' sfida ġot-trakea fil-ġurnata 49 b'doża letali ta' H5N1/A/Vietnam/1194/04 jew
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: Stimulant AS03 magħmul minn squalene (10.69 milligramma), DL-α-tocopherol (11.86 milligramma)
English: This medicine has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: Anaphylaxis, allergic reactions
Maltese: Anafilassi, reazzjonijiet allerġiċi
English: Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03.
Maltese: Studji kliniċi evalwaw l-inċidenza ta' reazzjonijiet avversi imniżżla hawn taħt f'bejn wieħed u ieħor 5,000 individwu ta' 18-il sena jew aktar li rċievew formulazzjonijiet li kien fihom mill-anqas 3.75
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Maltese: 3fattur tal-booster: il-proporzjon ta' titru medju ġeometriku (GMT) wara l-booster u l-GMT qabel ilbooster.
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Maltese: Anzjani (>60 sena) Fi studju kliniku ieħor (D-Pan-H5N1-010), 297 individwu ta' eta' ta' > 60 sena (stratifikati f'sensiela ta' 61 sa 70, 71 sa 80 u > l-eta' ta' 80 sena) irċevew jew doża waħda jew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004
English: Only spontaneously reported data should be included in the PSUR.
Maltese: Għandha tkun inkluża dejta irrapurtata spontanjament biss fil-PSUR.
English: Month 24
Maltese: Xahar 24
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Maltese: Wara żewġ dożi mgħotija 21 ġurnata jew 6 xhur il-bogħod minn xulxin, 96.0% ta' l-individwi kellhom żieda fit-titres ta' antikorp li jinnewtralizza fis-serum ta' 4 darbiet aktar u 98-100% kellhom titru ta' almenu 1:80.
English: In each experiment, four groups of six ferrets were immunised intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
Maltese: F'kull esperiment erba' gruppi ta' 6 inmsa kienu mlaqqma fil-muskolu b'vaċċin stimulat b'AS03 li kien fih HA li tnisslet minn H5N1/A/Vietnam/1194/04
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Emulsjoni tal-istimulant għall-injezzjoni 25 kunjett: emulsjoni 2.5ml
English: • From 18 years onwards: you will receive one dose of Adjupanrix.
Maltese: • Minn 18-il sena ‘l fuq : inti tirċievi doża waħda ta' Adjupanrix.
English: However, in the case this needle size would not be available, a 21-G needle might be used.
Maltese: Madankollu, f'każ li dan id-daqs ta' labra ma jkunx disponibbli, tista' tintuża labra 21-G.
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
Maltese: 3fattur ta' serokonverżjoni: il-proporzjon tat-titre ġeometriku medju (GMT) wara t-tilqim u l-GMT
English: If you have previously received one or two doses of Prepandrix
Maltese: Persuni li ma ġewx imlaqqma qabel bi Prepandrix
English: Seroprotection rate1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 At day 42, and after 6, 12 and 24 months the neutralising antibody responses were as follows: Serum neutralising antibody
Maltese: Ir-rati ta' seroprotezzjoni f'xahar 6, 12 u 24 kienu kif ġej: antikorp anti
English: Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Maltese: Deni (>38°C) Deni (>39°C)
English: Additional side effects in children
Maltese: • Nuqqas ta' rqad Effetti sekondarji addizzjonali fit-tfal
English: Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Maltese: Individwi ta' D-Pan-H5N1-010 kienu segwiti għall-persistenza tar-rispons immuni.
English: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) I.M.
Maltese: (H5N1) użata (NIBRG-14) I.M.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre;
Maltese: 2rata ta' serokonverżjoni: proporzjon ta' individwi li jew kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥ 1:40 wara t-tilqim, jew kienu seropożittivi qabel it-tilqim u għandhom żieda ta' 4 darbiet aktar fit-titre;
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Maltese: *(HI) ≥ 1:40; 1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni ta' l-emagglutinina (HI) ≥
English: • Generalised skin reactions including urticaria (hives)
Maltese: • Reazzjonijiet ġeneralizzati tal-ġilda li jinkludu urtikarja (ħorriqija)
English: Immune response to A/Vietnam/1194/2004 Day 21
Maltese: Respons immuni għal A/Vietnam/1194/2004 Ġurnata 21
English: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Maltese: (H5N1) użat (NIBRG-14)
English: After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Maltese: Wara żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Indonesia/05/2005 li ingħata fi ġranet 0 u 21 lil 140 individwu ta' eta' bejn it-18-60 sena, ir-respons ta' antikorpi anti-HA għal A/Vietnam/1194/2004 kienu kif ġej:
English: A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of Adjupanrix.
Maltese: Fi studju kliniku, tfal ta' bejn it-3 u d-9 snin irċivew jew żewġ dożi sħaħ tal-adulti (0.5 ml) jew żewġ nofsijiet tad-doża tal-adulti (0.25 ml).
English: In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects.
Maltese: Fi tfal/adolexxenti (li għandhom sa 20 sena), dawn l-istudji indikaw minn 1.4 sa 8 każijiet addizzjonali f'100,000 individwu mlaqqma.
English: Common: lymphadenopathy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • Sleeplessness
Maltese: * emagglutinina
English: - Vasculitis:
Maltese: - Vaskulite:
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Wara li jitħallat mal-emulsjoni tal-istimulant: 10 dożi ta' 0.5 ml
English: One dose of 0.5 ml at an elected date.
Maltese: Doża waħda ta' 0.5ml f'data magħżula.
English: Immune response against A/Vietnam/1194/2004 (H5N1):
Maltese: Respons immuni kontra A/Vietnam/1194/2004
English: Shivering
Maltese: Treddigħ
English: AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1) From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: Immune system disorders
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati minn esperjenza ta' wara t-tqegħid fis-suq b'vaċċini li fihom AS03 li fihom 3.75 µg HA derivati minn A/California/7/2009 (H1N1):
English: • The double injections will be given in opposite arms.
Maltese: • L-injezzjonijiet doppji jingħataw f'dirgħajn opposti.
English: 24 months after vaccination
Maltese: 24 xahar wara ttilqima
English: If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Maltese: Jekk it-tifel/tifla tiegħek jirċievi/tirċievi t-tilqima, għandek tkun taf li l-effetti sekondarji jistgħu jkunu aktar intensi wara t-tieni doża, b'mod speċjali temperatura ta' aktar minn 38°C.
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Maltese: †1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni ta' l-emagglutinina (HI) ≥
English: An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or nonmedically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Maltese: Għoli (HLT) u Terminu Preferit (PT), stratifikat skond it-tip ta' rapport (konfermat medikament jew mhux konfermat medikament) u li jinkludi in-numru ta' rapporti fatali, għall-perjodu kopert mir-rapport u kumultivament.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Maltese: 8°C) jew f'temperatura tal-kamra ta' mhux aktar minn 25°C.
English: In other clinical studies where children 6 months to 17 years received zoonotic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Maltese: (H5N1 A/Indonesia/05/2005 immanifatturat fi Dresden, il-Ġermanja) dehru żidiet fil-frekwenza ta' xi effetti sekondarji (inkluż uġigħ fis-sit tal-injezzjoni, ħmura u deni) wara t-tieni doża fi tfal li għandhom inqas minn 6 snin.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Maltese: - Ir-rapport ta' assessjar tar-Rapporteur jitqassam mal-membri tas-CHMP f'Ġurnata 50.
English: Adverse reactions reported are listed according to the following frequency: Frequencies are reported as:
Maltese: Reazzjonijiet avversi rrappurtati huma elenkati skond il-frekwenza li ġejja:
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Għandha tingħata attenzjoni meta l-vaċċin jingħata lil persuni b'sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanzi attivi, għal xi wieħed mis-sustanzi mhux attivi elenkati fissezzjoni 6.1, għal thiomersal u għal residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde,
English: 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Maltese: 3 % ta' individwi li jilħqu titre tal-antikorp li jinnewtralizza fis-serum ta' mill-anqas 1:80
English: Full dose N=43
Maltese: Nofs id-doża N=43
English: • Keep this leaflet.
Maltese: • Sorveljanza ta' wara t-tqegħid fis-suq
English: In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Maltese: Fi studju kliniku ieħor (D-Pan-H5N1-015), 39 individwu ta' eta' bejn it-18-60 sena ingħataw doża booster ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Indonesia/5/2005 erbatax-il xahar wara li jkunu ingħataw żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg derivati minn A/Vietnam/1194/2004 li ngħataw f'ġurnata 0 u ġurnata 21.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Maltese: Dejta minn nisa tqal imlaqqma b'vaċċini differenti, inattivati, mhux stimulati tal-istaġun ma tissuġerix malformazzjonijiet jew tossiċità fil-fetu jew wara t-twelid.
English: GMT1 Seroconversion rate2
Maltese: serokonverżjoni2 1 Titre Ġeometriku Medju
English: In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows:
Maltese: Fi studju kliniku (Q-Pan-H5N1-001) fejn żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Indonesia/05/2005 kienu amministrati fi ġranet 0 u 21 lil 140 individwu ta' eta' bejn
English: Persons previously vaccinated with one or two doses of Prepandrix containing HA derived from a different clade of the same influenza subtype as the pandemic influenza virus:
Maltese: Vaċċini ta' tħejjija pandemika fihom antiġeni ta' l-influwenza differenti minn dawk fil-virus ta' linfluwenza li jkun qed jixtered fil-mument.
English: In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21.
Maltese: Fit-tieni studju, 49 individwu ta' eta' bejn it-18-60 sena irċevew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Indonesia/05/2005 fi ġranet 0 u 21.
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine
Maltese: Il-volum wara li jitħallat kunjett 1 ta' suspensjoni (2.5ml) ma' kunjett 1 ta' emulsjoni (2.5ml)
English: • Feeling tired
Maltese: Tqala u treddigħ
English: Not applicable.
Maltese: qabel it-tilqim.
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Maltese: Il-gruppi ta' kontroll kienu jinkludu inmsa mlaqqma bis-suppliment biss, bil-vaċċin mhux stimulat (15-il mikrogramma HA) jew b'soluzzjoni ta' salina ibbafferjata bil-fosfat.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħżin wara t-taħlit tal-prodott mediċinali, ara s-sezzjoni 6.3. 6.5
English: EXP
Maltese: Ebusija
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient of Adjupanrix (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Maltese: periklu għall-ħajja għal kwalunkwe ingredjent ta' Adjupanrix (elenkati f'sezzjoni 6) jew għal thiomersal, għal proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate
English: • Feeling dizzy
Maltese: • Tħossok sturdut
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Maltese: Fi studju kliniku (D-Pan-H5N1-012), individwi ta' eta' ta' bejn it-18-60 sena ingħataw doża ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat jew minn A/Vietnam/1194/2004 jew minn Indonesia/5/2005
English: Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) Skin and subcutaneous tissue disorders
Maltese: Mhux komuni: parestesija, ħeddla tan-ngħas, sturdament Disturbi gastro-intestinali
English: NAME OF THE MEDICINAL PRODUCT Adjupanrix suspension and emulsion for emulsion for injection.
Maltese: Adjupanrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: One pack of Adjupanrix consists of:
Maltese: Pakkett wieħed ta' Adjupanrix fih:
English: Adjupanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Adjupanrix takes due account of the officially declared pandemic strain.
Maltese: Adjupanrix jista' jitqiegħed fis-suq biss meta jkun hemm dikjarazzjoni uffiċjali ta' influwenza pandemika mill-WHO/EU, bil-kondizzjoni li d-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għal Adjupanrix jikkunsidra sew it-tip ta' influwenza pandemika uffiċjalment dikjarata.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adjupanrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine (see section 4.2 for information on paediatric use).
Maltese: Adjupanrix f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fl-infezzjoni tal-influwenza kkawżata minn razza tal-influwenza li hemm fit-tilqima jew marbuta ma' razza li hemm fit-tilqima (ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku).
English: For instructions on mixing of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Maltese: Waqt l-użu, l-istabbilità kimika u fisika ġiet ipprovata għal perjodu ta' 24 siegħa f'temperatura ta' 25°C.