FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half adult (i.e. 0.25 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (≥38°C).
Maltese: Fi studju kliniku li evalwa ir-reattoġeniċità fi tfal b'età minn 6 xhur sa 35 xahar li rċevew żewġ dożi ta' nofs id-doża ta' l-adulti (i.e. 0.25 ml) (21 ġurnata bogħod minn xulxin) ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti kien hemm żjieda fir-reazzjonijiet fis-sit ta' l-injezzjoni u fis-sintomi ġenerali wara t-tieni doża meta mqabbel ma' l-ewwel doża b'mod partikulari fir-rati ta' deni ta' taħt id-driegħ ≥38°C).
English: Seronegative subjects prior to vaccination N=38 [95% CI]
Maltese: Individwi seronegattivi qabel it-tilqim N=38 [95% CI]
English: Total enrolled subjects N=59 [95% CI]
Maltese: It-total ta' individwi irreġistrati N=59 [95% CI]
English: These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly).
Maltese: Dawn l-effetti sekondarji kienu osservati wkoll bi frekwenzi simili fi studji kliniċi f'adulti nkluż anzjani u fi tfal b'età minn 10 snin sa 17-il sena b'vaċċin simili, ħlief għal ħmura (mhux komuni fladulti u komuni fl-anzjani) u deni (mhux komuni fl-adulti u l-anzjani).
English: 04 June 2010
Maltese: 04 ta' Ġunju 2010
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 or to sodium deoxycholate.
Maltese: • jekk xi darba kellek reazzjoni allerġika li ma kenitx f'daqqa u ta' periklu għal-ħajja għal kwalunkwe ingredjent fil-vaċċin għal thiomersal, proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde jew sodium deoxycholate.
English: In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Maltese: B'mod partikulari, ir-rati ta' deni (temperatura ta' taħt id-driegħ ≥38°C) jistgħu jiżdiedu b'mod konsiderevoli wara t-tieni doża.
English: The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03 adjuvantation.
Maltese: 7%-100% ta' protezzjoni f'kull vaċċin kandidat stimulat meta mqabbel ma' 43% ta' protezzjoni b'vaċċin mhux stimulat, u b'hekk juru l-benefiċċju ta' stimulazzjoni b'AS03.
English: The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly.
Maltese: L-effetti mhux mixtieqa imniżżla hawn taħt seħħew b'Arepanrix (H5N1) fi studji kliniċi f'adulti, inkuż l-anzjani.
English: In children aged 6-35 months who received two doses of 0.25 ml (half of the adult dose) the side effects after the second dose were more intense, especially fever (≥38°C), which occurred very commonly.
Maltese: Fi tfal b'età minn 6 xhur sa 35 xahar li rċevew żewġ dożi ta' 0.25 ml (nofs id-doża ta' l-adulti) l-effetti sekondarji wara t-tieni doża kienu aktar intensivi, speċjalment deni (≥38°C), li seħħ b'mod komuni ħafna.
English: For the most up-to-date information please consult the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/.
Maltese: Għal l-aktar informazzjoni riċenti jekk jogħġbok ikkonsulta mas-sit ta' l-Aġenzija Ewropea dwar il-Mediċini (EMEA): http://www.emea.europa.eu/.
English: In a clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there were higher rates of most general solicited symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose compared to the first dose.
Maltese: Fi studju kliniku li evalwa r-reattoġeniċità f'adulti b'saħħithom b'età minn 18 sa 60 sena li rċevew żewġ dożi ta' 0.5 ml (21 ġurnata bogħod minn xulxin) ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti, kien hemm rati ogħla tas-sintomi l-aktar frekwenti (bħal għeja, uġigħ ta' ras, artralġja, tregħid, għaraq u deni) wara t-tieni doża meta mqabbel ma' lewwel doża.
English: Ferrets immunized with the non adjuvanted H5N1 influenza vaccine were not protected from death and showed similar lung viral loads and degree of viral shedding in the upper respiratory tract as those exhibited by ferrets immunized with the adjuvant alone.
Maltese: Inmsa mlaqqma b'vaċċin ta' l-influwenza H5N1 mhux stimulat ma kienux protetti minn mewt u wrew viral loads fil-pulmun simili u grad ta' tixrid virali fl-apparat respiratorju ta' fuq bħal dak li deher f'inmsa mlaqqma b'stimulant waħdu.
English: Prompt analysis of cumulative safety information, in light of the extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Maltese: Analiżi fil-pront ta' informazzjoni kumulativa ta' sigurta', fid-dawl tal-kwantita' ta' espożizzjoni, tkun kruċjali għal deċiżjonijiet regolatorji u protezzjoni tal-popolazzjoni li tkun se tkun vaċċinata.
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 perijodu ta' 24 siegħa f'temperatura ta' 25°C.
English: • Clinical studies in healthy subjects (including elderly subjects) who received two doses of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Maltese: Studji kliniċi f'individwi b'saħħithom (inkluż pazjenti anzjani) li rċevew żewġ dożi ta' verżjoni ta' Arepanrix li fiha 3.75 μg HA derivat minn A/Indonesia/05/2005 (H5N1)
English: The vaccine should be administered in accordance with the recommended posology (see section 4.2).
Maltese: Il-vaċċin għandu jingħata skond il-posoloġija rakkomandata (ara sezzjoni 4.2).
English: Total enrolled subjects N=5 [95% CI]
Maltese: Individwi totali irreġistrati N=5 [95% CI]
English: In a clinical study that evaluated immunogenicity in healthy subjects aged 18-60 years who received either Arepanrix (H1N1) (N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process (N=167), the anti-HA antibody responses 21 days after a first dose were as follows:
Maltese: Fi studju kliniku li evalwa l-immunoġeniċità f'individwi b'saħħithom b'età minn 18 sa 60 sena li rċevew Arepanrix (H1N1) (N=167) jew vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti (N=167), ir-rispons ta' l-antikorp anti-HA 21 ġurnata wara l-ewwel doża kien kif ġej:
English: The Applicant/MAH commits to provide abridged report for the following study performed in adults: Study Q-Pan H1N1-001 abridged report for post dose 1 and post dose 2 (≥ 18 yrs, Dose finding, adjuvanted vaccine vs plain)
Maltese: L-Applikant/MAH jikkommetti ruħu li jipprovdi rapport imqassar għall-istudju li ġej li sar fit-tfal: Studju Q-Pan H1N1-003 (6 xhur sa 8 yrs, Kisba tadDoża)
English: Adverse reactions reported are listed according to the following frequency:
Maltese: Reazzjonijiet avversi rrappurtati huma elenkati skont il-frekwenza li ġejja:
English: Details regarding databases (e.g., data sources, characteristics of the data, potential analysis) need to be
Maltese: Dettalji rigward databases (eż., sorsi tad-dejta, karatteristiċi tad-dejta, analiżi potenzjali) għandhom jiġu rrapportati.
English: Very limited data with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8).
Maltese: Dejta limitata ħafna b'vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti fi tfal b'età minn 6 xhur sa 35 xahar (N=51) li rċevew żewġ dożi ta' 0.25 ml (nofs id-doża ta' l-adulti) b'intervall ta' 3 ġimgħat bejn id-dożi tindika żjieda fir-rati ta' reazzjonijiet fis-sit ta' linjezzjoni u fis-sintomi ġenerali (ara sezzjoni 4.8).
English: Arepanrix 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 Arepanrix takes due account of the officially declared pandemic strain.
Maltese: Arepanrix 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 Arepanrix jikkunsidra sew it-tip ta' influwenza pandemika uffiċjalment dikjarata.
English: 1 seroprotection 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-emagglutinazzjoni (HI) ≥
English: In another clinical study, the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Maltese: Fi studju kliniku ieħor, ir-rispons ta' l-antikorp anti-haemagglutinin (anti-HA) f'individwi b'età minn 18 sa 64 sena kien kif ġej:
English: • Limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged 18-79 years.
Maltese: • Dejta ta' sigurtà u immunoġeniċità limitata miksuba tliet ġimgħat wara l-għoti ta' doża waħda lill-adulti b'saħħithom b'età minn 18 sa 79 sena.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde 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 u sodium deoxycholate) ta' dan il-vaċċin.
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Maltese: Individwi seronegattivi qabel ittilqim N=3 [95% CI]
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received a version of Arepanrix containing 3.75 microgram HA derived from A/Indonesia/5/2005 (H5N1).
Maltese: Studji kliniċi evalwaw l-inċidenza ta' reazzjonijiet avversi f'madwar 4,500 individwu b'età minn 18-il sena 'l fuq li rċevew verżjoni ta' Arepanrix li fiha 3.75 mikrogramma HA derivati minn A/Indonesia/5/2005 (H5N1).
English: 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 kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥ 1:40 wara t-tilqim, jew li kienu seropożittivi qabel it-tilqim u għandhom żieda ta' 4 darbiet aktar fit-titre;
English: • If a specific notification system has been put in place, how to report adverse reactions.
Maltese: • Jekk tkun tpoġġiet fil-post sistema speċifika ta' notifikazzjoni, kif tirraporta reazzjonijiet avversi,.
English: Important information about some of the ingredients of Arepanrix This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Tagħrif importanti dwar xi wħud mill-ingredjenti ta' Arepanrix Dan il-vaċċin fih thiomersal bħala preservattiv u huwa possibbli li inti jista' jkollok reazzjoni allerġika.
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Wara li jkun imħallat ma' l-emulsjoni ta' l-istimulant: 10 dożi ta' 0.5ml
English: Post dose
Maltese: Ħedla
English: Split influenza virus inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A)
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen ekwivalenti għal: Razza (X-179A) li tixbaħ lil A/California/7/2009/(H1N1)v
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature.
Maltese: Qabel ma tħallat iż-żewġ komponenti, l-emulsjoni (stimulant) u s-suspensjoni (antiġen) għandhom jitħallew jilħqu temperatura tal-kamra.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) tipproduċi protezzjoni għaliha nnifisha (antikorpi) kontra l-marda.
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Arepanrix Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Maltese: Suspensjoni għall-emulsjoni għall-injezzjoni għal Arepanrix Vaċċin ta' l-influwenza pandemika (H1N1) (virjon maqsum, inattivat, stimulat)
English: Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
Maltese: Tużax is-suspensjoni u l-emulsjoni wara d-data ta' skadenza li tidher fuq il-kartuna.
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or 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 tliet dożi differenti ta' l-antiġen H5N1 (7.5, 3.8 u 1.9 µg ta' l-antiġen HA) stimulat b'doża jew nofs doża stàndard ta' AS03.
English: In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received a single half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process, the frequency of the following adverse reactions was as shown in the table:
Maltese: Fi studju kliniku li evalwa r-reatoġeniċità fi tfal b'età minn 3 snin sa 5 snin u minn 6 snin sa 9 snin li rċevew nofs doża ta' l-adulti (i.e. 0.25 ml) waħda ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti, il-frekwenza tar-reazzjonijiet avversi li ġejjin kienet kif muri fit-tabella:
English: Retrospective cohort: to be initiated in Feb 2010; Preliminary analysis in April
Maltese: Analiżi preliminari f'April
English: Children aged 6-35 months
Maltese: Tfal b'età minn 6 xhur sa 35 xahar
English: 2seroconversion rate (i.e. 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 4-fold increase in titre);
Maltese: 2rata ta' serokonverżjoni (i.e. proporzjon ta' individwi li kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥ 1:40 wara t-tilqim, jew li kienu seropożittivi qabel it-tilqim u għandhom żjieda ta' 4 darbiet aktar fit-titre);
English: 4all subjects seronegative prior to vaccination
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Like all medicines, Arepanrix can cause side effects, although not everybody gets them.
Maltese: Bħal kull mediċina oħra, Arepanrix jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Maltese: Ħrug uffiċjali tal-lott: skont l-Artiklu 114 tad-Direttiva 2001/83/EC kif emendata, il-ħruġ uffiċjali tallott għandu jsir minn laboratorju ta' l-istat jew laboratorju disinjat għal dan il-għan.
English: A 4-fold increase in serum neutralising antibody titres against A/Indonesia/5/2005 was achieved in 76.6% of subjects at day 21, 97.9% at day 42 and 91.5% at day 180.
Maltese: 6% ta' l-individwi f'ġurnata 21, f'97.9% f'ġurnata 42 u f'91.5% f'ġurnata
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Maltese: • L-elementi ta' dejta minima li għandha tiġi trasmessa f'rapporti ta' sigurta' ta' każi individwali biex tkun faċilitata l-evalwazzjoni u l-identifikazzjoni tal-vaċċin li jkun ingħata lil kull individwu inkluż l-isem ivvintat, il-manifattur tal-vaċċin u n-numru tallott.
English: In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Maltese: Barra dan, grupp wieħed ta' sitt inmsa kienu mlaqqma b'vaċċin kandidat li fih 3.75 µg ta' H5N1 + doża sħiħa ta'AS03 u grupp ta' kontroll wieħed inkluda inmsa mlaqqma b'vaċċin mhux stimulat (3.75 mikrogramma ta' HA).
English: The suspension is a translucent to off white opalescent suspension, which may sediment slightly.
Maltese: Is-suspensjoni hija bla kulur sa abjad maħmuġ, tkanġi, u jista' jkollha ftit sediment.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (dated January 2010) 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 4 (datata Jannar 2010) tal-Pjan ta' l-Immaniġġjar tarRiskju (RMP) ppreżentata fit-Taqsima 1.8.2. ta' Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u f'xi aġġornamenti sussegwenti oħra ta' l-RMP miftehmin mas-CHMP.
English: Arthralgia
Maltese: Erja
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Maltese: Madankollu, f'sitwazzjoni ta' influwenza pandemika, jista' jkun jaqbel li tieħu l-vaċċin, basta li jkun hemm disponibbli kura medika xierqa immedjatament f'każ ta' reazzjoni allerġika.
English: The emulsion is a whitish homogeneous liquid.
Maltese: L-emulsjoni hija likwidu omoġenu bajdani.
English: Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) three weeks before a dose of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to the AS03-containing vaccine containing HA from H1N1v.
Maltese: Dejta miksuba dwar l-għoti tal-vaċċin ta' l-influwenza staġjonali mhux stimulat (Fluarix, vaċċin b'virjon maqsum) tliet ġimgħat qabel doża ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti f'adulti b'saħħithom b'età 'l fuq minn 60 sena, ma ssuġġeriet l-ebda interferenza sinifikanti fir-rispons immuni għal vaċċin li fih AS03 li jkun fih HA minn H1N1v.
English: Children and adolescents aged 10-17 years
Maltese: Tfal b'età minn 10 snin sa 17-il sena
English: The side-effects are generally similar to those related to seasonal flu vaccines.
Maltese: L-effetti sekondarji ġeneralment huma simili għal dawk relatati ma' vaċċini ta' linfluwenza staġjonali.
English: Adults including the elderly and children from the age of 10 years onwards: A dose (0.5 ml) of the vaccine will be given
Maltese: Adulti li jinkludu l-anzjani u tfal b'età minn 10 snin 'l fuq Tingħata doża waħda (0.5ml) tal-vaċċin.
English: • Limited immunogenicity data obtained three weeks after administration of a single dose of 0.25 ml or 0.5 ml to healthy children aged 10-17 years.
Maltese: • Dejta ta' immunoġeniċità limitata miksuba tliet ġimgħat wara l-għoti ta' doża waħda ta' 0.25 ml jew 0.5 ml lil tfal b'saħħithom b'età minn 10 snin sa 17-il sena..
English: A/California/7/2009 (H1N1)v-like strain (X-179A)
Maltese: Razza (X-179A) tixbaħ lil A/California/2009 (H1N1)v
English: Rare: Neuralgia, transient thrombocytopenia.
Maltese: Newralġja, tromboċitopenija li tgħaddi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
Maltese: KUNJETT TA' SUSPENSJONI U 2 PAKKETTI TA' 25
English: 26-February-2010
Maltese: 26 ta' Frar 2010
English: You should discuss with your doctor whether you should receive Arepanrix.
Maltese: Għandek tiddiskuti mat-tabib tiegħek jekk għandekx tieħu Arepanrix.
English: Data obtained on co-administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to the AS03-containing vaccine containing HA from H1N1v.
Maltese: Dejta miksuba wara l-għoti ta' vaċċin li fih AS03 li jkun fih HA minn H1N1v manifatturat bl-użu ta' proċess differenti flimkien ma' vaċċin mhux stimulat ta' l-influwenza staġjonali (Fluarix, vaċċin b'virion maqsum) f'adulti b'saħħithom b'età 'l fuq minn 60 sena ma ssuġġerit l-ebda interferenza sinnifikanti fir-rispons immuni għall-vaċċin li fih AS03 li jkun fih HA minn H1N1v.
English: Tell the doctor requesting these tests that you have recently been given Arepanrix.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Arepanrix is given”).
Maltese: Il-vaċċin għandu jingħata skond il-posoloġija rakkomandata (ara sezzjoni 3 “Kif għandek tieħu Arepanrix”).
English: Such situation requires rapid notification of safety information that may have the greatest implications for benefit-risk balance in a pandemic.
Maltese: Sitwazzjoni bħal din tirrikjedi notifikazzjoni ta' malajr ta' informazzjoni ta' sigurta' li jista' jkollha l-akbar implikazzjonijiet għal bilanċ tal-benefiċċju kontra r-riskjuf'pandemija.
English: EMA/552883/2014 EMEA/H/C/002439
Maltese: EMEA/H/C/002439
English: The full EPAR for Zoledronic acid Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The usual dose of Zoledronic acid Teva is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali ta' Zoledronic acid Teva hija ta' infużjoni waħda ta' 4 mg matul mill-inqas 15-il minuta.
English: It is available as a concentrate (4 mg/5 ml) to be used to make a solution for infusion (drip) into a vein, and as a solution for infusion (4 mg/100 ml).
Maltese: Jiġi bħala konċentrat (4 mg/5 ml) li jintuża biex issir soluzzjoni għal infużjoni (dripp) ġol-vina, u bħala soluzzjoni għal infużjoni (4 mg/100 ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva on 16 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid Teva fis-16 ta' Awwissu 2012.
English: Zoledronic acid Teva is a ‘generic medicine'.
Maltese: Zoledronic acid Teva huwa ‘mediċina ġenerika'.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku aċidu żoledroniku
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zoledronic acid Teva.