FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni (>1/100, <1/10): ħmura fil-post tal-injezzjoni, nefħa fil-post tal-injezzjoni, ebusija fil-post tal-injezzjoni, ekkimożi fil-post tal-injezzjoni u wġigħ fil-post tal-injezzjoni, deni, telqa, għeja u rogħda
English: °° geometric mean ratios of HI *** In V87P1: baseline not tested
Maltese: °° proporzjonijiet ġeometriċi medji of HI ***F'V87P1: il-linja bażi ma ġietx ittestjata
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Maltese: ** espressi f'mikrogrammi ta' haemagglutinin.
English: Study V87P1 Elderly Booster (6 months after 2nd dos e)
Maltese: Studju V87P1 Anzjani booster (6 xhur wara t-tieni doża)
English: Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Maltese: Kampjuni tas-serum kienu ttestjati kontra l-H5N3 oriġinali kif ukoll ma' numru ta' iżolati tal-H5N1.
English: Foclivia was evaluated in adults aged (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Maltese: Foclivia ġie evalwat f'adulti (li għandhom bejn 18-60 sena) u anzjani (aktar minn 60 sena) wara skeda ta' tilqim primarju ta' 1, 22 ġurnata.
English: Seroconversion factor(95%CI)**
Maltese: serokonverżjoni(95%CI)**
English: The vaccine contains an ‘adjuvant' (a compound containing squalene) to stimulate a better response.
Maltese: It-tilqima fiha ‘adjuvant' (kompost li fih squalene) biex jistimula rispons aħjar.
English: A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137).
Maltese: Saret prova klinika (Studju V87P6) b'tilqima tal-H5N1 ikkombinat ma' adjuvant MF59C.1 (n=334)
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' periklu għall-ħajja) għal xi wieħed mill-kostitwenti jew traċċi residwi tal-bajd, proteini tat-tiġieġ, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB) ta' din it-tilqima.
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Maltese: Is-sinjali ta' influwenza pandemika huma simili għal dawk ta' influwenza ordinarja, iżda jistgħu jkunu iktar serji.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Maltese: Disturbi newroloġiċi, bħal nevralġija, parastesija, konvulżjonijiet u nevrite.
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Maltese: Dan ifisser li għal raġunijiet xjentifiċi kien impossibbli li tinkiseb informazzjoni kompleta dwar din il-mediċina.
English: In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Maltese: Fit-tfal żgħar, eritema u sensittività kienu r-reazzjonijiet lokali solleċitati li ġew irrappurtati bl-aktar mod komuni; l-irritabilità u biki mhux tas-soltu kienu r-reazzjonijiet sistemiċi lokali solleċitati li ġew irrappurtati bl-aktar mod komuni.
English: Study V87P1 21 days after 2nd dose N=37
Maltese: Studju V87P1 21 ġurnata wara t-tieni doża N=37
English: ** geometric mean ratios of SRH
Maltese: ** proporzjonijiet ġeometriċi medji of SRH
English: How to store Foclivia
Maltese: X'fih Foclivia
English: This section describes the clinical experience with the H5N1 pandemic preparedness vaccines following a two-dose administration of 7.5 microgram.
Maltese: Din is-sezzjoni tiddeskrivi l-esperjenza klinika bit-tilqim ta' tħejjija kontra H5N1 pandemiku wara l-għoti ta' żewġ dożi ta' 7.5 mikrogrammi.
English: In such cases, the side effects may be more intense).
Maltese: F'każijiet bħal dawn, l-effetti sekondarji jistgħu jkunu aktar intensi).
English: - Vasculitis:
Maltese: Twissija:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by Single Radial Haemolysis (SRH) assay was as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għal H5N1 A/Vjetnam/1194/2004 fl-adulti mkejla permezz ta' assaġġ Single Radial Haemolysis (SRH) kienu kif ġej:
English: Data obtained with a pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with pandemic preparednessvaccines are relevant for the pandemic vaccines.
Maltese: Dejta miksuba b'tilqima ta' tħejjija għal pandemija se ssostni strateġija ta' tilqim li x'aktarx tintuża għat-tilqima pandemika: it-dejta dwar l-effikaċja u s-sigurtà fl-użu kliniku miksuba bit-tilqim ta' tħejjija għal pandemija hija rilevanti għat-tilqim pandemiku.
English: From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Maltese: Mill-provi kliniċi li twettqu bit-tilqima ta' tħejjija adjuvanted kontra H5N1 pandemiku fl-adulti u l-anzjani (ara sezzjoni 5.1 għal aktar informazzjoni), il-biċċa l-kbira tar-reazzjonijiet kienu ta' natura ħafifa, damu żmien qasir u kienu kwalitattivament simili għal dawk ikkawżati minn tilqim konvenzjonali kontra l-influwenza staġjonali.
English: The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Maltese: It-tilqima bl-adjuvant instab li stimulat antikorpi li taw protezzjoni inkroċjata kontra razez ta' H5N1 iżolati fl-2003 u l-2004, li jippreżentaw xi ċaqliqa antiġenika meta mqabbla mar-razez oriġinali.
English: - have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Maltese: - allerġiku/a għall-bajd, proteina tat-tiġieġ, - allerġiku/a għal xi antibijotiku, formaldehyde, cetyltrimethylammonium bromide (CTAB) u polysorbate 80.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
Maltese: Fattur ta' serokonverżjoni (95%CI)** * imkejla permezz ta' assaġġ SRH ≥ 25 mm2
English: Adverse reactions from clinical trial in adults and elderly (above 18 years old)
Maltese: Reazzjonijiet avversi minn provi kliniċi fuq adulti u fuq anzjani ('il fuq minn 18-il sena)
English: From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to that of Foclivia (an MF59C.1 adjuvanted H1N1 pandemic vaccines), the following additional adverse reactions have been reported:
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq b'tilqim interpandemiku trivalenti adjuvanted, b'kompożizzjoni simili għal dik ta' Foclivia (tilqim adjuvanted MF59C.1 kontra pandemija H1N1, kienu rrappurtati r-reazzjonijiet avversi addizzjonali li ġejjin:
English: Seroconversion factor (95%CI)°°
Maltese: Fattur ta' serokonverżjoni (95%CI)°°
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratios of HI for anti-HA antibody to H1N1 after administration of one and two7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months).
Maltese: Ir-rata ta' seroprotezzjoni u r-rata ta' serokonverżjoni mkejla b'assaġġ HI u l-fattur ta' serokonverżjoni espress bħala proporzjonijiet medji ġeometriċi ta' HI għal antikorp anti-HA għal H1N1 wara l-għoti ta' doża waħda u żewġ dożi ta' 7.5 µg ta' Focetria ġiet evalwata f'70 tifel u tifla u adolexxenti (9-17-il sena), 60 tifel u tifla (3-8 snin), 58 tifel u tifla (12-35 xahar) u 49 tarbija (6-11-il xahar).
English: Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays.
Maltese: Il-persistenza ta' antikorpi wara t-tilqima primarja f'din il-popolazzjoni kienet evalwata permezz ta' Hemagglutination Inibition (HI), u assaġġi SRH u MN.
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Maltese: 6-11-il xahar u 73 tifel u tifla żgħar li kellhom 12-35 xahar, li kienu qed jirċievu l-formulazzjoni ta' 7.5 µg kienu rrappurtati kif ġej:
English: General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni (>1/100, <1/10): ħmura fil-post tal-injezzjoni, nefħa fil-post tal-injezzjoni, ebusija fil-post tal-injezzjoni, ekkimożi fil-post tal-injezzjoni u wġigħ fil-post tal-injezzjoni, deni, telqa, għeja u rogħda Il-maġġoranza ta' dawn ir-reazzjonijiet ġeneralment jgħibu f'ġurnata jew tnejn mingħajr kura.
English: A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Maltese: Saret prova klinika ta' Fażi (Studju V87P1) b'tilqima tal-H5N1 ikkombinata ma' adjuvant MF59C.1 fuq 312-il adult b'saħħithom.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
Maltese: Żomm fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Maltese: Xi każijiet ġew osservati f' individwi bi storja medika ta' epilessija.
English: Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
Maltese: Il-persistenza tal-antikorpi wara t-tilqima primarja f'din il-popolazzjoni kif imkejla permezz ta' testijiet ta' HI, SRH u MN, naqset minn 1/2 għal 1/5 tal-livell tagħhom ta' wara t-tilqima f'jum 202 meta mqabbla ma' jum 43 wara t-tlestija tal-iskedi primarji kif imkejla permezz ta' testijiet ta' HI, SRH, u MN.
English: Postmarketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Maltese: Avvenimenti avversi rrappurtati b'mod spontanju wara t-tqegħid fis-suq u studju intervenzjonali ma jissuġġerixxux effetti ħżiena diretti jew indiretti tal-esponiment għal Focetria fuq it-tqala.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Maltese: Barra l-perjodu tal-pandemija, il-perjodiċità u l-format normali tal-PSUR sejrin jinżammu, b'reviżjoni speċifika tal-AESI u b'avvenimenti avversi possibbli relatati ma' adjuvant.
English: Caution is needed when administrating 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 eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Hija meħtieġa attenzjoni meta din it-tilqima tingħata lil persuni b'sensittività eċċessiva magħrufa (apparti r-reazzjoni anafilattika) għas-sustanza attiva, għal kwalunkwe mis-sustanzi mhux attivi elenkati f'sezzjoni 6 u għall-bajd, proteini tat-tiġieġ, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB).
English: Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Maltese: Tilqima kontra l-influwenza; Kodiċi ATC:
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below.
Maltese: Reazzjonijiet avversi minn provi kliniċi bit-tilqima ta' tħejjija għal pandemija Foclivia huma elenkati hawn taħt.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorpi anti-HA għal H5N1 A/turkey/Turkey/05 wara t-tieni doża fl-adulti ta' bejn it-18-60 sena, imkejla permezz ta' assaġġi SRH u HI kienu kif ġej:
English: PT “Bell's palsy” - Vaccination failure: PT “Vaccination failure”.
Maltese: PT “Paraliżi ta' Bell's”
English: While no data is available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia.
Maltese: Filwaqt l-ebda dejta mhi disponibbli mill-użu ta' Foclivia, każijiet ta' konvulżjoni bi u mingħajr deni ġew irrappurtati f'individwi mlaqqmin b'Focetria, tilqima adjuvanted MF59.1 kontra H1N1 pandemiku simili għal Foclivia.
English: A protective response may not be elicited in all vaccine recipients (see section 5.1).
Maltese: Rispons protettiv jista' ma jinkisibx f'dawk kollha li jirċievu t-tilqim (ara sezzjoni 5.1).
English: A third (booster) dose of H5N1 vaccine combined with MF59C was administered 6 months onwards after the primary vaccination series.
Maltese: It-tielet doża (booster) ta' tilqima kontra H5N1 kombinata ma' MF59C ingħatat minn 6 xhur ‘il quddiem wara s-serje ta' tilqim primarju.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Maltese: Flimkien mar-reazzjonijiet avversi rrappurtati fil-provi kliniċi, dawn li ġejjin ġew irrappurtati matul il-perjodu ta' sorveljanza ta' wara t-tqegħid fis-suq b'Focetria H1N1v:
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Maltese: huwa possibbli li jkun hemm reazzjonijiet ta' sensibilizzazzjoni (ara sezzjoni 4.4).
English: It has to be used in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
Maltese: Għandu jintuża f'adulti (minn 18 sa 60 sena) u f'anzjani (aktar minn 60 sena) għall-prevenzjoni ta' influwenza kkawżata mit-tip H5N1 tal-virus.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Maltese: - Ir-rapport ta' valutazzjoni tar-Rapporteur jiġi ċċirkolat lill-membri tas-CHMP f'Jum 50.
English: Very rare (may affect up to 1 in 10,000 people).
Maltese: Rari ħafna: (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna).
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 non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Maltese: Ħarsa ġenerali lejn ir-reazzjonijiet avversi spontanji kollha skont is-SOC, Perjodu ta' Livell Għoli (High Level Term - HLT) u Perjodu Ppreferut (Preferred Term - PT), stratifikati skont it-tip ta' rapport (ikkonfermati medikament jew mhux ikkonfermati medikament) u li tinkludi n-numru ta' rapporti fatali, għall-perjodu kopert mir-rapport u kumulattivament.
English: Foclivia suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Maltese: Foclivia suspensjoni għall-injezzjoni Tilqima kontra l-influwenza pandemika (H5N1) (antiġen tal-wiċċ, inattivat, adjuvanted)
English: Baseline Serostatus
Maltese: Serostatus fil-linja bażi
English: Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Maltese: Reazzjonijiet avversi fil-ġimgħa ta' wara t-tilqima b'Focetria H1N1v minn 77-tifel u tifla li kellhom 3-8 snin u 80 tifel u tifla u adolexxenti li kellhom 9-17-il sena li kienu qed jirċievu l-formulazzjoni ta'
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: filwaqt li tiġi kkunsidrsta l-informazzjoni li tirriżulta mill-istudju tat-tip cohort prospettiv deskritt f'sezzjoni 4.5.
English: Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta attwalment disponibbli f'individwi minn 6 xhur sa 18-il sena hija deskritta f'sezzjoni 5.1 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Maltese: Meta persuna tingħata t-tilqima, is-sistema naturali ta' difiża tal-ġisem (is-sistema immunitarja) tipproduċi l-protezzjoni tagħha (antikorpi) kontra l-mard.
English: Pandemic Influenza Vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Maltese: Tilqima kontra l-influwenza pandemika (H5N1) (antiġen tal-wiċċ, inattivat, adjuvanted)
English: Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3).
Maltese: Komuni (>1/100, <1/10): artralġja u majalaġja Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Maltese: - Il-perjodiċità ser tkun evalwata mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-(Ko-) Rapporteur f'intervalli ta' kull 6 xhur.
English: 0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Maltese: 0.5 ml f'kunjett ta' doża waħda (ħġieġ ta' tip I) b'tapp (lastku tal-halo-butyl).
English: The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Maltese: L-inċidenza ta' sintomi osservati f'individwi li kellhom 'il fuq minn 60 sena kienet inqas meta mqabbla mal-popolazzjoni ta' bejn it-18-60 sena.
English: Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorpi anti-HA għal H5N1 A/turkey/Turkey/05 wara t-tieni doża fl-anzjani ta' >60 sena, imkejla permezz ta' assaġġi SRH u HI kienu kif ġej:
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Maltese: 94-100), rata ta' serokonverżjoni li tvarja minn 97% (95%CI: 91-99) sa 99% (95%CI:
English: Respiratory, thoracic and mediastinal disorders Cough.
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sogħla.
English: Non-clinical data obtained with Foclivia and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Maltese: MF59C.1, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti,
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Maltese: Reazzjonijiet allerġiċi, anafilassi li tinkludi dispnea, bronkospażmu, edema larinġeali, li f'każijiet rari twassal għal xokk.
English: Foclivia 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 Foclivia takes due account of the officially declared pandemic strain.
Maltese: Foclivia huwa tilqima intenzjonata sabiex tingħata sabiex tipprevjeni influwenza f'pandemija ddikjarata b'mod uffiċjali.
English: Suspension for injection in pre-filled syringe.
Maltese: U KONTENUT Suspensjoni għall-injezzjoni.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)*
Maltese: SRH Rata ta' seroprotezzjoni (95%CI)* Rata ta' serokonverżjoni (95%CI)*
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Maltese: Rata ta' serokonverżjoni (95%CI)* Fattur ta' serokonverżjoni (95%CI)**
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni* u l-fattur ta' serokonverżjoni** għall-antikorp anti-HA għal H5N1 A/Vjetnam/1194/2004 f'individwi 'l fuq minn 60 sena (numru limitat ta' individwi kellhom 'il fuq minn 70 sena) imkejla permezz ta' assaġġ SRH evalwati f'żewġ studji kliniċi kienu kif ġej:
English: 0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Maltese: 0.5 ml f'siringa mimlija għal-lest (ħġieġ ta' tip I) bi planġer-għatu (lastku tal-bromo-butyl).
English: Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Maltese: Reazzjonijiet komuni ħafna rrappurtati fi tfal u adolexxenti li kellhom minn 3 sa 17-il sena: Uġigħ, ebusija u eritema, ħass ħażin, mijalġija, uġigħ ta' ras u għeja.
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Maltese: SMQ dejqa “Reazzjoni anafilattika” u SMQ dejqa
English: These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
Maltese: Dawn il-proteini virali huma ppreparati mir-razza ta' virus tal-influwenza li tikkonforma mar-rakkomandazzjonijiet tal-Organizzazzjoni Dinjija tas-Saħħa u d-deċiżjoni tal-UE f'sitwazzjoni Pandemika ddikjarata b'mod uffiċjali.