FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest pain, malaise
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni ħafna: uġigħ fis-sit ta' l-injezzjoni, għejja Komuni: ħmura fis-sit ta' l-injezzjoni, nefħa fis-sit ta' l-injezzjoni, deni, tregħid Mhux komuni: reazzjonijiet fis-sit ta' l-injezzjoni (bħal tbenġil, ebusija, ħakk, sħana), astenja, uġigħ fis-sider, telqa
English: GlaxoSmithKline Pharma GmbH.
Maltese: GlaxoSmithKline Pharma
English: Post dose 1 Post dose
Maltese: .9 Doża eċċessiva
English: The frequency of adverse reactions was similar between the two groups.
Maltese: Il-frekwenza tar-reazzjonijiet avversi kienet simili bejn iż-żewġ gruppi.
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 vaccine (5 ml).
Maltese: Il-volum wara li tħallat kunjett wieħed ta' suspensjoni (2.5 ml) ma' kunjett wieħed ta' emulsjoni (2.5ml) jikkorisspondi għal 10 dożi ta' vaċċin (5ml).
English: Arepanrix should under no circumstances be administered intravascularly.
Maltese: Arepanrix m'għandu qatt jingħata b'mod intravaskulari.
English: Immune response to a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Maltese: Rispons immuni għall-verżjoni ta' Arepanrix li fiha 3.75 µg HA derivati minn A/Indonesia/05/2005 (H5N1):
English: Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Maltese: Testijiet seroloġiċi indikaw korrelazzjoni diretta bejn HI indott minn vaċċini u titres ta' antikorpi newtralizzanti f'annimali protetti meta mqabbel ma' kontrolli b'antiġeni u bi stimulant.
English: Cross-reactive immune responses elicited by a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Maltese: Rispons immuni cross-reactive li rriżulta minn verżjoni ta' Arepanrix li fiha 3.75 µg HA derivat minn A/Indonesia/05/2005 (H5N1):
English: Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Maltese: Wieħed u għoxrin ġurnata wara t-tieni doża, intlaħqet żjieda ta' 4 darbiet fl-antikorpi newtralizzanti fis-serum kontra A/Indonesia/5/2005 f'94.4% ta' l-individwi b'età minn 18 sa 60 sena u f'80.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: Dan l-istimulant fih squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi).
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Maltese: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, Iilma għall-injezzjonijiet
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: AS03 stimulant magħmul minn squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi)
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Maltese: Mard newroloġiku, bħal enċefalomelite, newrite u s-sindrome ta' Guillain Barré.
English: In a clinical study that evaluated the reactogenicity of the first 0.5 ml dose of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy adults aged 1860 (N=120) and above 60 years (N=120) the frequency of adverse reactions was similar between age groups, except for redness (more common in subjects aged >60 years) and shivering and sweating (more common in subjects aged 18-60 years).
Maltese: Fi studju kliniku li evalwa ir-reattoġeniċità ta' l-ewwel doża ta' 0.5 ml ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti f'adulti b'saħħithom b'età minn 18 sa 60 (N=120) u 'l fuq minn 60 sena (N=120) il-frekwenza tar-reazzjonijiet avversi kienet simili bejn ilgruppi ta' età, minbarra għall-ħmura (aktar komuni f'individwi b'età >60 sena) u tregħid u għaraq (aktar komuni f'individwi b'età minn 18 sa 60 sena).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to: 3.75 micrograms haemagglutinin/dose *Antigen: A/California/7/2009 (H1N1)v-like strain (X-179A)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen* ekwivalenti għal 3.75 mikrogrammi emagglutinina/doża *Antiġen: razza (X-179A) li tixbaħ lil A/California/7/2009 (H1N1)v
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: 2.5ml Wara li jitħallat ma' l-emulsjoni ta' l-istimulant: 10 dożi ta' 0.5 ml
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/03/2010
Maltese: Data ta' l-ewwel awtorizzazzjoni: 23/03/2010
English: The symptoms of pandemic flu are similar to those of ordinary flu but may be more severe.
Maltese: Is-sintomi ta' l-influwenza pandemika huma simili għal dawk ta' l-influwenza normali imma jistgħu ikunu aktar severi.
English: Seronegative subjects prior to vaccination N=61 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=61 [95% CI]
English: Antigen suspension for Arepanrix Pandemic influenza vaccine A/California/7/2009 (H1N1)v-like strain (X-179A) I.M.
Maltese: Antiġen suspensjoni għal Arepanrix Vaċċin għal influwenza Pandemika Razza (X-179A) li tixbaħ lil A/California/7/2009 (H1N1)v I.M.
English: - abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
Maltese: - rapport imqassar ta' wara doża 3 (immunità u sintomi mitluba u mhux mitluba, SAEs)
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA): http://www.emea.europa.eu/
English: The vaccine contains an ‘adjuvant' AS03 to stimulate a better response.
Maltese: Il-vaċċin fih ‘stimulant' (AS03) biex jistimula rispons aħjar.
English: In some age groups there are limited clinical study data (adults aged 60-79 years and children aged 10 to 17 years), very limited clinical study data (adults aged 80 years and older, children aged 6 months to 9 years) or no data (children aged less than 6 months) with an AS03-containing vaccine containing HA from H5N1 or from H1N1v manufactured using a different process as detailed in sections 4.4, 4.8 and
Maltese: F'xi gruppi ta' età hemm dejta limitata minn studji kliniċi (adulti b'età minn 60 sa 79 sena u tfal b'età minn 10 snin sa 17-il sena), dejta limitata ħafna minn studji kliniċi (adulti b'età minn 80 sena 'l fuq, tfal b'età minn 6 xhur sa 9 snin) jew m'hemm l-ebda dejta (tfal b'età inqas minn 6 xhur) b'vaċċin li fih AS03 li jkun fih HA minn H5N1 jew minn H1N1v manifatturat bl-użu ta' proċess differenti kif iddettaljat f'sezzjonijiet 4.4, 4.8 u 5
English: In the consistency study, a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
Maltese: Fl-istudju ta' konsistenza, intlaħqet żjieda ta' 4 darbiet fl-antikorpi newtralizzanti fis-serum kontra A/Vietnam/1194/2004 f'ġurnata 42 f'65.5% ta' l-individwi b'età minn 18 sa 60 sena u f'24.1% ta' lindividwi b'età 'l fuq minn 60 sena.
English: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza pandemika (H1N1) (virion maqsum, mhux attivat, stimulat)
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 and sodium deoxycholate).
Maltese: 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, għal thiomersal u għal residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde u sodium deoxycholate).
English: 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
Maltese: 3fattur ta' serokonverżjoni (i.e. proporzjon ta' GMT wara t-tilqim u GMT qabel it-tilqim)
English: Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension.
Maltese: Jistgħu jiġu osservati sedimenti bojod filkunjett tas-suspensjoni; dawn is-sedimenti huma parti mid-dehra fiżika normali tas-suspensjoni.
English: NAME OF THE MEDICINAL PRODUCT Arepanrix suspension and emulsion for emulsion for injection.
Maltese: Arepanrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni.
English: • Limited safety data obtained after administration of 0.25 ml or two doses of 0.5 ml to healthy children aged 10-17 years.
Maltese: • Dejta ta' sigurtà limitata miksuba wara l-għoti ta' 0.25 ml jew żewġ dożi ta' 0.5 ml lil tfal b'saħħithom b'età minn 10 snin sa 17-il sena.
English: Study Q-Pan H1N1-003 (6 months-8 yrs, Dose finding,)
Maltese: Studju Q-Pan H1N1-019 (18-60 sena, effett TIV u għoti fl-istess waqt)
English: Total enrolled subjects N=120 [95% CI]
Maltese: Individwi totali irreġistrati N=120 [95% CI]
English: AS03-containing vaccine containing HA from H1N1v manufactured using a different process N=164
Maltese: Vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti N=164
English: In another clinical study, anti-HA responses against A/Vietnam/1194/2004 following administration of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) were as follows:
Maltese: Fi studju kliniku ieħor, ir-rispons anti-HA kontra A/Vietnam/1194/2004 wara l-għoti ta' verżjoni ta' Arepanrix li fih3.75 µg HA derivat minn A/Indonesia/05/2005 (H5N1) kien kif ġej:
English: • Limited safety and immunogenicity data obtained after administration of two doses to healthy adults aged 18-60 years.
Maltese: • Dejta ta' sigurtà u immunoġeniċità limitata miksuba wara l-għoti ta' żewġ dożi lill-adulti b'saħħithom b'età minn 18 sa 60 sena.
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Maltese: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, ilma għall-injezzjonijiet
English: In a clinical study in which children aged 3 to 9 years old received a half adult dose (0.25 ml) of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/California/7/2009 (H1N1)v-like the anti-HA antibody responses 21 days after a first dose were as follows:
Maltese: Fi studju kliniku fejn tfal b'età minn 3 snin sa 9 snin irċevew nofs id-doża ta' l-adulti (0.25 ml) ta' vaċċin stimulat b'AS03 li fih 3.75 μg HA derivat minn razza li tixbaħ lil A/California/7/2009 (H1N1)v, ir-rispons ta' l-antikorp anti-HA 21 ġurnata wara l-ewwel nofs doża kien kif ġej:
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: A clinical study with Arepanrix (H1N1) provides limited safety and immunogenicity data obtained up to three weeks after administration of a single 0.5 ml dose to healthy adults aged 18-60 years.
Maltese: Studju kliniku b'Arepanrix (H1N1) jipprovdi dejta limitata ta' sigurtà u immunoġeniċità miksuba fi żmien tliet ġimgħat wara l-għoti ta' doża waħda ta' 0.5 ml lill-adulti b'saħħithom b'età minn 18 sa 60 sena.
English: There are limited data available from a clinical study with an AS03containing vaccine containing HA from H1N1v manufactured using a different process in healthy children aged from 10 to 17 years, very limited data with the AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy children aged from 6 to 35 months and limited data from a study with a version of an AS03-containing vaccine containing HA from H5N1 manufactured using a different process in children aged from 3 to 9 years.
Maltese: Hemm dejta limitata disponibbli minn studju kliniku b'vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti fi tfal b'saħħithom b'età minn 10 snin sa 17-il sena, dejta limitata ħafna disponibbli minn studju kliniku b'vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti fi tfal b'saħħithom b'età minn 6 xhur sa 35 xahar u dejta limitata minn studju b'verżjoni ta' vaċċin li fih AS03 li jkun fih HA minn H5N1 manifatturat bl-użu ta' proċess differenti fi tfal b'età minn 3 sa 9 snin.
English: Children from 6 months to 9 years of age
Maltese: Tfal b'età minn 6 xhur sa 9 snin
English: Date and time of mixing:
Maltese: DATA TA' META JISKADI JIS:
English: And also from:
Maltese: JIS:
English: Uncommon:
Maltese: Mhux Komuni:
English: Psychiatric disorders Uncommon: insomnia
Maltese: Disturbi psikjatriċi Mhux komuni: insomnja
English: Arepanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: Arepanrix suspensjoni u emulsjoni għal emulsjoni għall-injezzjoni Vaċċin ta' l-influwanza pandemika (H1N1) (virion maqsum, inattivat, stimulat)
English: One pack of Arepanrix consists of:
Maltese: Pakkett wieħed ta' Arepanrix fih:
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 vaccine (5 ml)
Maltese: Il-volum wara li jitħallat kunjett 1 ta' suspensjoni (2.5ml) ma' kunjett 1 ta' emulsjoni (2.5ml) jikkorrispondi għal 10 dożi ta' vaċċin (5 ml)
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Arepanrix
Maltese: U MNEJN GĦANDU JINGĦATA Stimulant emulsjoni għal Arepanrix
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Maltese: Il-ħila li jinduċi protezzjoni kontra razez omologi u eteroloġi tal-vaċċin kienet stmata b'mod mhux kliniku b'A/Indonesia/05/05 (H5N1) bl-użu ta' mudelli ta' sfida f'nemes.
English: Preliminary immunogenicity data obtained with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in a limited number of children aged 6-35 months show that there is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Maltese: Dejta preliminari dwar l-immunoġeniċità miksuba b'vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti minn numru limitat ta' tfal b'età minn 6 xhur sa 35 xahar turi li hemm rispons immuni ieħor għat-tieni doża ta' 0.25 ml mogħtija wara intervall ta' tliet ġimgħat.
English: Immune response to A/California/7/2009 (H1N1)v-like Arepanrix (H1N1) N=164)
Maltese: antikorp anti-HA Rispons immuni għal razza li tixbaħ lil A/California/7/2009 (H1N1)v Arepanrix (H1N1) N=164)
English: Swelling
Maltese: GmbH.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have also been reported:
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq fuq vaċċini trivalenti interpandemiċi, ir-reazzjonijiet avversi li ġejjin kienu rappurtati wkoll:
English: Musculoskeletal and connective tissue disorders Very common: joint pain, muscle aches
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03.
Maltese: F'dan l-esperiment ta' protezzjoni, l-inmsa (sitt inmsa/grupp) kienu mlaqqma fil-muskoli b'vaċċin kandidat li fih erba' dożi differenti ta' l-antiġen H5N1 (3.75, 1.5, 0.6 u 0.24 µg ta' l-antiġen HA) stimulat b'nofs doża ta' AS03.
English: - abridged report for post dose 2 Waves 1 and 2 (immuno data, solicited and unsolicited symptoms, SAEs )
Maltese: - rapport imqassar ta' wara doża 2, Mewġa 1 u 2 (dejta ta' immunità, sintomi mitluba u mhux mitluba, SAEs )
English: Total enrolled subjects N=75 [95% CI]
Maltese: Individwi totali irreġistrati N=75 [95% CI]
English: These side effects may occur with Arepanrix.
Maltese: Dawn l-effetti mhux mixtieqa jistgħu iseħħu b'Arepanrix.
English: Total enrolled subjects N=97 [95% CI]
Maltese: It-total ta' individwi irreġistrati N=97 [95% CI]
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur GlaxoSmithKline Biologicals s.a.
English: Seronegative subjects prior to vaccination N=76 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=76 [95% CI]
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=43 [95% CI]
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Maltese: Waqt sitwazzjoni pandemika, il-frekwenza ta' sottomissjoni ta' rapporti perjodiċi fuq aġġornament ta' sigurta' kif speċifikat f'Artiklu 24 tar-Regolament (EC) Nru 726/2004 ma jkunx biżżejjed għassorveljanza ta' sigurta' ta' vaċċin pandemiku li għalih ikun mistenni livelli għolja ta' espożizzjoni f'perijodu qasir ta' żmien.
English: - abridged report for post dose 1 Wave 1 immuno data, solicited and unsolicited symptoms, SAEs )
Maltese: - rapport imqassar ta' wara doża 1 Mewġa 1, dwar dejta ta' immunità, sintomi mitluba u mhux mitluba, SAEs )
English: STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Wara li titħallat, doża waħda (0.5 ml) ikun fiha:
English: Reactogenicity was also evaluated in healthy adults aged 18-60 years who received a first 0.5 ml dose of either Arepanrix (H1N1) (N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process (N=167).
Maltese: Ir-reatoġeniċità kienet ukoll evalwata f'adulti b'saħħithom b'età minn 18 sa 60 sena li rċevew l-ewwel doża ta' 0.5 ml ta' Arepanrix (H1N1) (N = 167) jew ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti (N = 167).
English: There are limited data available from clinical studies with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in adults aged over 60 years and very limited data in adults aged over 80 years.
Maltese: Hemm dejta limitata disponibbli minn studji kliniċi b'vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti f'adulti b'età 'l fuq minn 60 sena u dejta limitata ħafna f'adulti b'età 'l fuq minn 80 sena.
English: • Very limited safety and immunogenicity data obtained three weeks after a single administration of half the adult dose (i.e. 0.25 ml) to healthy children aged 6-35 months.
Maltese: • Dejta ta' sigurtà u immunoġeniċità limitata ħafna miksuba tliet ġimgħat wara għoti waħda ta' nofs id-doża ta' l-adulti (i.e. 0.25 ml) lil tfal b'saħħithom b'età minn 6 xhur sa 35 xahar.
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=23 [95% CI]
English: GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Maltese: KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
English: Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were reported very commonly.
Maltese: Barra dan, fi tfal b'età minn 3 snin sa 5 snin, ħedla, irritabilità u nuqqas ta' aptit kienu rrappurtati b'mod komuni ħafna.
English: Three clinical studies have evaluated the immunogenicity of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) in subjects from the age of 18 years onwards following a 0, 21 days schedule.
Maltese: Tliet studji evalwaw l-immunoġeniċità ta' verżjoni ta' Arepanrix li fiha 3.75 µg HA derivati minn A/Indonesia/05/2005 (H5N1) f'individwi b'età minn 18-il sena 'l fuq, fuq skeda ta' 0, 21 ġurnata.
English: Total enrolled subjects N=40 [95% CI]
Maltese: Individwi totali irreġistrati N=40 [95% CI]
English: Total enrolled subjects N=58 [95% CI]
Maltese: It-total ta' individwi irreġistrati N=58 [95% CI]
English: Seronegative subjects prior to vaccination N=27 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N = 27 [95% CI]
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
Maltese: 3fattur ta' serokonverżjoni: proporzjon tal-medja tat-titre ġeometriku (GMT) wara t-tilqim u GMT qabel it-tilqim.
English: • Very limited safety and immunogenicity data obtained three weeks after a single administration of half the adult dose (i.e. 0.25 ml) to healthy children aged 3-9 years.
Maltese: • Dejta ta' sigurtà u immunoġeniċità limitata ħafna miksuba tliet ġimgħat wara għoti waħda ta' nofs id-doża ta' l-adulti (i.e. 0.25 ml) lil tfal b'saħħithom b'età minn 3 snin sa 9 snin.
English: In two clinical studies (D-Pan H1N1-007 and D-Pan H1N1-008) that evaluated immunogenicity in healthy subjects aged 18-60 years the anti-HA antibody responses were as follows:
Maltese: F'żewġ studji kliniċi (D-Pan H1N1-007 u D-Pan H1N1-008) li evalwaw l-immunoġeniċità f'individwi b'saħħithom ta' bejn it-18 u s-60 sena ir-rispons ta' l-antikorpi anti-HA kien kif ġej:
English: 2.5 ml per vial.
Maltese: 2.5ml kull kunjett
English: Arepanrix has been authorised under “Conditional Approval”.
Maltese: Arepanrix kien awtorizzat taħt dik li tissejjaħ skema ta' ‘approvazzjoni b'kundizzjoni'.
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N = 29 [95% CI]
English: Take special care with Arepanrix:
Maltese: Oqgħod attent ħafna b'Arepanrix:
English: In children aged 3-9 years who received a first half adult dose of a similar vaccine (H1N1), the side effects were similar compared to the side effects reported in adults, with the exception of shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years.
Maltese: Fi tfal b'età minn 3 snin sa 9 snin li rċevew l-ewwel nofs tad-doża ta' l-adulti ta' vaċċin simili, l-effetti sekondarji kienu simili meta mqabbel ma' l-effetti sekondarji rrappurtati fl-adulti, bl-eċċezzjoni ta' tregħid, għaraq u sintomi gastro-intestinali li ġew irrappurtati b'rata ogħla fi tfal b'età minn 3 snin sa 9 snin.
English: Total enrolled subjects N=30 [95% CI]
Maltese: It-total ta' individwi irreġistrati N = 30 [95% CI]
English: • Aching muscles, joint pain
Maltese: • Uġigħ fil-muskoli, uġigħ fil-ġogi