FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogrammi dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.08 ml Sedadex /kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill-uġiġħ.
English: ICULARS T
Maltese: EKK MEĦT
English: ECIES
Maltese: DA
English: Box 8
Maltese: Forellenweg 16
English: ACKAGE S
Maltese: TANZI ATT
English: Colourless Type I glass vials of 10 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Maltese: In-natura u l-għamla tal-ewwel ippakkjar Kunjetti ta' 10 ml tal-ħġieġ mingħajr kulur tat-Tip I magħluqin b'tapp miksi tal-lastku tal-bromobutil u għatu tal-aluminjum ġo kaxxa tal-kartun.
English: C
Maltese: K
English: ONLY”
Maltese: MIEN TA'
English: SARY
Maltese: TIVI
English: EX
Maltese: IEĦOR
English: RINARY ME
Maltese: RINARJU
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Sedadex 0.5 mg/ml that was given to the cat.
Maltese: Il-volum tad-doża ta' atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa nofs (1/2) il-volum ta' Sedadex 0.5 mg/ml li ngħata lill-qattus.
English: Once broached use by:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Isem:
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Sedadex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogrammi dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.4 ml Sedadex /kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ milluġiġħ.
English: BA Lot {num
Maltese: MRU TA' D
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Sedadex 0.1 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Maltese: Il-volum ta' doża ta' atipamezole b'konċentrazzjoni ta' 5 mg/ml huwa wieħed f'ħamsa (1/5) tal-volum ta' doża ta' Sedadex 0.1 mg/ml li ngħata lill-kelb, ikun xi jkun il-mod ta' amministrazzjoni ta' Sedadex.
English: EATMENT
Maltese: KONTENUT
English: Brady- and tachyarrhythmias have been reported.
Maltese: Jistgħu jseħħu opaċitajiet tal-kornea waqt is-sedazzjoni.
English: Dogs: Dexmedetomidine doses are based on body surface area:
Maltese: Il-prodott veterinarju mediċinali huwa intenzjonat għal :
English: These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
Maltese: Dawn jistgħu jinkludu sinus bradycardia fil-fond, AV block tal-ewwel u ta' t-tieni grad, pawsa jew waqfien tas-sinus kif ukoll kumplessi prematuri atrijali, supraventrikulari u ventrikulari.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Sedadex 0.5 mg/ml that was given to the cat.
Maltese: Il-volum tad-doża ta' atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa nofs il-volum ta' Sedadex 0.5 mg/ml li ngħata lillqattus.
English: R ON SMAL
Maltese: TAGĦR ŻGĦAR
English: PH Solution
Maltese: G Soluzzjo
English: FORM
Maltese: PAKKETT
English: EUTICAL F n
Maltese: HER FUQ IL
English: Biotransformations in the cat occur by hydroxylation in the liver.
Maltese: Soluzzjoni ċara u bla kulur għall-injezzjoni.
English: 1 dose = 0.5 ml
Maltese: Doża 1 = 0.5 ml
English: Vial A
Maltese: Kunjett A
English: EU/1/08/478/001
Maltese: FIS-SUQ EU/1/08/478/001
English: Excipients: It contains 5 micrograms thiomersal
Maltese: Fih 5 mikrogrammi thiomersal
English: 25 vials x 2: emulsion
Maltese: 25 kunjett x 2: emulsjoni
English: * haemagglutinin
Maltese: * emagglutinina
English: A/Vietnam/1194/2004 (H5N1)
Maltese: A/Vietnam/1194/2004
English: Adults from the age of 18 years:
Maltese: Adulti mill-età ta' 18-il sena:
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Maltese: Ir-rata ta' seroprotezzjoni kontra A/Indonesia 21 ġurnata wara ttilqima booster kienet ta' 92% u 69.2% f'ġurnata 180.
English: Uncommon: Generalised skin reactions including urticaria
Maltese: Mhux komuni: Reazzjonijiet ġenerali fil-ġilda inkluż urtikarja
English: Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Maltese: Dożi ta' 15, 5, 1.7 jew 0.6 mikrogrammi ta' HA ġew ittesjati fl-esperiment ta' sfida omologu, u dożi ta' 15, 7.5, 3.8 jew 1.75 mikrogrammi ta' HA ġew ittesjati fl-esperiment ta' sfida eterologu.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Maltese: Vaċċini ta' l-influwenza, Kodiċi ATC J07BB02
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 ġurnata minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew tnaqqis ta' riskju)
English: Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Maltese: A/Indonesia/5/2005 skeda 0, 6 xhur 7 ijiem wara 2ni doża
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Komuni ħafna: artralġja, mijalġja
English: The emulsion vial contains an ‘adjuvant' (AS03).
Maltese: Il-kunjett ta' l-emulsjoni fih ‘suppliment' (AS03).
English: B-1330 Rixensart Belgium
Maltese: B-1330 Rixensart Il-Belġju
English: A 4-fold increase in serum neutralising antibody titres from day 0 was observed in 85.7% at day 42 and 72% at day 180.
Maltese: Żieda ta' 4 darbiet aktar fit-titres ta' l-antikorp li jinnewtralizza s-serum minn ġurnata 0 kienet osservata f'85.7% filġurnata 42 u fi 72% fil-ġurnata 180.
English: Against A/Indonesia 21 days after boosting with A/Indonesia
Maltese: Kontra A/Indonesia 21 ġurnata wara booster b'A/Indonesia N=49
English: Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Maltese: Kienu milħuqa titri ta' antikorpi newtraliżżanti ta' almenu 1:40 jew almenu 1:80 f'87% u 67%, rispettivament, mis-87 individwu ittestjat.
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate(KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), water for injections
Maltese: L-ingredjenti l-oħra huma: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate (KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), ilma għall-injezzjonijiet.
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Maltese: Wara tilqim għall-influwenza, jistgħu jinkisbu riżultati pożittivi foloz f'testijiet seroloġiċi bl-użu talmetodu ELISA għal antikorpi tal-virus-1 ta' l-immunodefiċjenza umana (HIV-1), tal-virus ta'l-epatite C u speċjalment ta' l-HTLV-1.
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Maltese: Respons immunitarju għal A/Vietnam/1194/2004 skeda 0, 21 ġurnata skeda 0, 6 xhur
English: 21 days after 2nd dose N=48
Maltese: 21 ġurnata wara 2ni doża N = 48
English: Emulsion for emulsion for injection 25 vials: emulsion
Maltese: Emulsjoni għal emulsjoni għall-injezzjoni 25 kunjett: emulsjoni
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 mikrogrammi HA/AS03.
English: Suspension for emulsion for injection 50 vials: suspension
Maltese: Suspensjoni għal emulsjoni għall-injezzjoni 50 kunjett: suspensjoni
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Maltese: Responsi immuni cross-reactive misluta minn vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004
English: • one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
Maltese: • pakkett wieħed li fih 50 kunjett ta' 2.5 ml suspensjoni (sustanza attiva) għal 10 dożi
English: Suspension and emulsion for emulsion for injection 50 vials: suspension
Maltese: Suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni 50 kunjett: suspensjoni
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv6 (dated March 2009) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jimpenja ruħu li jwettaq l-istudji u l-attivitajiet ta' farmakoviġilanza l-oħra dettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni RMPv6 (bid-data ta' Marzu 2009) tal-Pjan ta' lImmaniġġjar tar-Riskju (RMP) ppreżentata fit-Taqsima 1.8.2. ta' l-Applikazzjoni għallAwtorizzazzjoni għat-Tqegħid fis-Suq u f'xi aġġornamenti sussegwenti oħra ta' l-RMP miftehmin mas-CHMP.
English: Seroconversion factor3
Maltese: Fattur serokonverżjoni3
English: In a different study in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Maltese: Fi studju differenti f'50 individwu ta' eta' bejn it-18-60 sena ir-rati ta' seroprotezzjoni ta' antikorpi anti-HA 21 ġurnata wara it-tieni doża ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004 kienu ta' 20% kontra A/Indonesia/5/2005, 35% kontra A/Anhui/01/2005 u 60% kontra A/Turkey/Turkey/1/2005.
English: In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Maltese: Barra minn hekk, 44.8% u 56.1% tal-individwi fi gruppi ta' dożi rispettivi kellhom żieda ta' 4-darbiet fit-titri ta' antikorpi newtraliżżanti fis-serum minn ġurnata 0 sa ġurnata 42 u 96.6% u 100% tal-individwi kellhom titru ta' almenu 1:80 f'ġurnata 42.
English: This compound contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Maltese: Dan il-kompost fih squalene (10.68 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.85 milligrammi).
English: 21 days after 1st dose N=55
Maltese: 21 ġurnata wara l- 1el doża N=55
English: Booster seroconversion rate2
Maltese: Rata ta' serokonverżjoni talbooster2
English: The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.
Maltese: Is-sintomi ta' l-influwenza pandemika huma simili għal dawk ta' l-influwenza normali imma ġeneralment ikunu aktar severi.
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper (butyl rubber).
Maltese: - żewġ pakketti ta' 25 kunjett (ħġieġ tat-tip I) ta' 2.5 ml emulsjoni (10 dożi x 0.25 ml) b'tapp
English: In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Maltese: Bħala konsegwenza, hekk kif l-influwenza pandemika tkun dikjarata (Fażi 6 tal-pjan tal-WHO dwar tħejjija għal Influwenza globali) u l-vaċċin pandemiku jkun intuża, l-MAH għandu jibgħat rapporti perjodikament aġġornati dwar sigurta` aktar spiss u simplifikati f'format u perjodiċita' kif imfissra “Rakkomandazzjonijiet ta' CHMP għal Pjan ta' l-Immaniġġjar ta' Riskju Centrali għal Vaċċini ta' lInfluwenza preparati minn vajrus bil-potenzjal li jikkawżaw pandemiku u li huma intiżi għall-użu barra l-kuntest tad-dossier ċentali” (EMEA/49993/2008), u kull aġġornament li jiġi wara.
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni ħafna: ebusija tal-ġilda, nefħa, uġigħ u ħmura fis-sit ta' l-injezzjoni, deni, għeja Komuni: tregħid, mard bħal ta' l-influwenza, reazzjonijiet fis-sit ta' l-injezzjoni (bħal sħana, ħakk)
English: The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: L-MAH għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni V03 (bid-data ta' 19 ta' Novembru 2007) ppreżentata fit-Taqsima 1.8.1. ta' l-Applikazzjoni għall-Awtorizzazzjoni għatTqegħid fis-Suq, qiegħda f'postha u tiffunzjona qabel u waqt li l-prodott jitqiegħed fis-suq.
English: • Adjuvant:
Maltese: • Ingredjenti oħra:
English: Immune response againstA/Vietnam/1194/2004 :
Maltese: Respons immuni għal A/Vietnam/1194/2004
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
Maltese: Pakkett wieħed fih: - pakkett wieħed ta' 50 kunjett (ħġieġ tat-tip I) ta' 2.5 ml suspenjoni (10 dożi x 0.25 ml) b'tapp
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq fuq vaċċini trivalenti interpandemiċi, ir-reazzjonijiet avversi li ġejjin kienu rrappurtati:
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Maltese: 1rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni ta' l-emagglutinina (HI) ≥
English: - Keep this leaflet.
Maltese: vaċċini oħra.
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat)
English: Seroconversion rate2
Maltese: Rata serokonverżjoni2
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 doses (2.5 ml)
Maltese: INDIVIDWALI 10 dożi (2.5 ml)
English: • Severe stabbing or throbbing pain along one or more nerves
Maltese: • Uġigħ qawwi itektek ma wieħed jew aktar nervituri
English: Single dose N=13
Maltese: Doża waħda N=13
English: • Dizziness
Maltese: • Konvulżjonijiet
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Maltese: Sitwazzjoni bħal din titlob notifikazzjoni mgħaġġla dwar informazzjoni ta' sigurta` li jista' jkollha implikazzjonijiet kbar f'dak li hu bilanċ ta' riskju-benefiċċju waqt influwenza pandemika.
English: In 152 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Maltese: F'152 individwu ta' >60 sena ir-rati ta' seroprotezzjoni u serokonverżjoni ta' antikorp anti-HA kontra A/Indonesia/5/2005 f'ġurnata 42 wara żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004 kienu ta' 23% u l-fattur ta' serokonverżjoni kienet ta' 2.7.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Maltese: Informazzjoni li mhix klinka, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, effett tossiku fuq il-fertilità tal-mara, fuq l-embrijufetu u wara t-twelid (sa tmiem il-perijodu ta' treddiegħ) ma turi l-ebda periklu speċjali għall-bnedmin.
English: The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21.
Maltese: Ir-rata ta' seroprotezzjoni f'ġurnata 180, f'individwi >60 sena kienet ta' 52.9% għal dawk li kienu ħadu żewġ dożi singli u 69.5% għal dawk li ħadu żewġ dożi doppji f'ġurnata 0 u ġurnata 21.
English: In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (antiHA) antibody responses were as follows:
Maltese: Fi studji kliniċi li evalwaw l-immunoġeniċita' ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004 f'individwi ta' eta' bejn it-18-60 sena ir-responsi ta' antikorpi kontra lemagluttinina (anti-HA) kienu kif ġej:
English: Adverse reactions reported are listed according to the following frequency:
Maltese: Reazzjonijiet avversi rrappurtati huma elenkati skond il-frekwenza li ġejja:
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Maltese: • Meta tkun irċevuta informazzjoni ġdida li tistà tagħmel impatt fuq l-Ispeċifikazzjonijiet ta' Sigurtà kurrenti, il-Pjan ta' Farmakoviġilanza jew attivitajiet ta' tnaqqis ta' riskju.
English: Follow up of 50 subjects aged 18-60 years who had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 at 0 and 21 days showed that 84% were seroprotected (HI titre ≥1:40) at day 42 compared with 54% at day 180.
Maltese: Meta 50 individwu ta' eta' bejn 18-60 sena li kienu rċevew żewġ dożi ta' vaċċin stimulat bl-AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004 ġew segwiti f'ġurnata 0 u 21 intwera li 84% kienu seroprotetti (titru HI ≥1:40) f'ġurnata 42 meta mqabbla ma' 54% f'ġurnata 180.
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 li ingħataw 21 ġurnata jew sitt xhur il-bogħod minn xulxin, 96.0% ta' l-individwi kellhom żieda fit-titres ta' antikorp li jinnewtralizza s-serum ta' 4 darbiet aktar u 98-100% kellhom titru ta' almenu 1:80.
English: It should be noted that the adverse reactions may be intensified.
Maltese: Wieħed għandu jkun jaf li reazzjonijiet avversi jistgħu jkunu aktar qawwija.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: FIS-SUQ GlaxoSmithKline Biologicals s.a.
English: Against A/Vietnam 21 days after boosting with A/Vietnam
Maltese: antikorp anti-HA Kontra A/Vietnam 21 ġurnata wara
English: Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Maltese: Kunjett A: kunjett b'ħafna dożi li fih l-antiġen (suspensjoni), Kunjett B: kunjett b'ħafna dożi li fih is-suppliment (emulsjoni).
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: 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: In another clinical study, 152 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: Fi studju kliniku ieħor, 152 individwu ta' eta' ta' > 60 sena (stratifikati f'sensiela ta' 61 sa 70, 71 sa 80 u > minn l-eta' ta' 80 sena) irċevew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004
English: Neuralgia, convulsions, transient thrombocytopenia.
Maltese: Newralġja, aċċessjonijiet, tromboċitopenja li tgħaddi.
English: Split influenza virus, inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen ekwivalenti għal: Razza tixbaħ lil A/VietNam/1194/2004
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses
Maltese: • żewġ pakketti li fihom 25 kunjett ta' 2.5 ml emulsjoni (suppliment) għal 10 dożi
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, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Maltese: Għandha tingħata attenzjoni meta l-vaċċin jingħata lil persuni b'sensittivita` eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza attiva, għal xi wieħed mis-sustanzi mhux attivi, għal thiomersal u għar-residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate).
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Maltese: • jekk qatt kellek reazzjoni allerġika minbarra reazzjoni allerġika f'daqqa waħda li tkun ta' periklu għall-ħajja għal kwalunkwe ingredjent li fih il-vaċċin, għal thiomersal, għal proteini talbajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew għal sodium deoxycholate.
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Maltese: Indipendentement mill-fatt jekk ingħatatx doża waħda inizjali jew tnejn sitt xhur qabel, ir-rati ta' seroprotezzjoni kontra A/Indonesia kienu ta' >80% wara doża booster ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004 u r-rati ta' seroprotezzjoni kontra A/Vietnam kienu ta' >90% wara doża booster ta' vaċċin stimulat li fih 3.75μg HA derivati minn A/Indonesia/05/2005.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/09/2008
Maltese: Data ta' l-ewwel awtorizzazzjoni: 26/09/2008