FrancophonIA/ELRC3.0 huggingface dataset:
English: MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly.
Maltese: MN għal A/Indonesia/5/2005 kixfu rata ta' seroprotezzjoni ta' 38% (31-45) fl-adulti (18-60 sena) u ta' 14% (8-20) fl-anzjani (≥61 sena); rata ta' serokonverżjoni ta' 58% (50-65) fl-adulti u ta' 30% (23-38) fl-anzjani u finalment GMR ta' 4.67 (3.95-5.56) fl-adulti u 2.19 (1.86-2.58) fl-anzjani.
English: MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
Maltese: MN għal A/Vietnam/1194/2004 kixfu rata ta' seroprotezzjoni ta' 10% (6-16) fl-adulti (18-60 sena) u ta' 6% (3-11) fl-anzjani (≥61 sena); rata ta' serokonverżjoni ta' 19% (13-25) fl-adulti u 7% (4-13) fl-anzjani u finalment GMR ta' 1.86 (1.63-2.12) fl-adulti u 1.33 (1.17-1.51) fl-anzjani.
English: Adults years)*
Maltese: Adulti 60 sena)*
English: Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against challenge with the A/Indonesia/5/2005 virus.
Maltese: Żewġ dożi tal-vaċċin ipproteġew 92% tal-annimali, u doża waħda tal-vaċċin ipproteġiet 50% tal-annimali kontra lespożizzjoni bil-virus A/Indonesia/5/2005.
English: A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age.
Maltese: Saret prova klinika (V87P6) b' AFLUNOV (A/Vietnam/1194/2004) f'471 tifel u tifla minn 6 xhur sa 17-il sena.
English: • Aching muscles
Maltese: • Uġigħ fil-muskoli
English: Children from 6 months to 17 years of age
Maltese: Tfal minn 6 xhur sa 17-il sena
English: Animals received one or two doses of vaccine containing 3.75 or 7.5 micrograms of antigen, followed by challenge with a lethal dose of A/Vietnam/1203/04 virus.
Maltese: L-annimali rċivew doża waħda jew żewġ dożi tal-vaċċin li kien fih 3.75 jew 7.5 mikrogrammi ta' antiġen, segwiti minn espożizzjoni għal doża letali tal-virus A/Vietnam/1203/04.
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015
Maltese: Data tal-aħħar tiġdid: 17 ta' Lulju 2015
English: Limited data were obtained from women who became pregnant during the course of clinical trials with AFLUNOV or similar pandemic H1N1v vaccines adjuvanted with MF59C.1.
Maltese: Inkisbet dejta limitata minn nisa li ħarġu tqal matul il-kors ta' provi kliniċi b'AFLUNOV jew vaċċini simili kontra l-pandemija tal-H1N1v adjuvanted b'MF59C.1.
English: The incidence of AFLUNOV (A/Vietnam/1194/2004) adverse reactions has been evaluated in one clinical trial (V87P6) in children (6 months to 17 years old).
Maltese: L-inċidenza ta' reazzjonijiet avversi għal AFLUNOV (A/Vietnam/1194/2004) ġiet evalwata fi prova klinika waħda (V87P6) fit-tfal (6 xhur sa 17-il sena).
English: Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
Maltese: Xi grad ta' immunità kross-reattiva ġie osservat kontra viruses H5N1 li jappartjenu għal gruppi differenti.
English: Paediatric population
Maltese: Popolazjoni pedjatrika
English: AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
Maltese: Vaċċin kontra l-influwenza żoonotika H5N1
English: AFLUNOV contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
Maltese: AFLUNOV fih anqas minn 1 mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg)
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/2005 was also tested.
Maltese: Ġiet ittestjata wkoll l-effikaċja kontra l-espożizzjoni għall-virus etorologu A/Indonesia/5/2005.
English: In a phase I clinical trial (V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine/A/Duck/Singapore/97, were administered 2 booster doses of AFLUNOV (A/Vietnam/1194/2004).
Maltese: Fi prova klinika ta' fażi 1 (V87P3) individwi adulti li kellhom bejn 18-65 sena li kienu pprajmjati għal 6-8 snin fil-passat b'żewġ dożi ta' vaċċin H5N3/A/Duck/Singapore/97 adjuvanted b'MF59, ġew mogħtija żewġ dożi booster ta' AFLUNOV (A/Vietnam/1194/2004).
English: However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV.
Maltese: Madankollu, huwa stmat li matul il-pandemija tal-H1N1 tal-2009 aktar minn 90,000 mara ġew imlaqqma waqt it-tqala b'Focetria (vaċċin kontra l-pandemija tal-H1N1 simili għal AFLUNOV) li fih l-istess ammont ta' adjuvant MF59C.1 daqs AFLUNOV.
English: Elderly (61-84 years)a
Maltese: Anzjani (61-84 sena) a
English: In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Maltese: MN kontra A/turkey/Turkey/1/2005 omologu jindikaw rata ta' seroprotezzjoni u rata ta' serokonverżjoni ta' 85% (79-90) u 93% (89-96), rispettivament.
English: SRH seroprotection rates ranged from 86% to 98%, seroconversion rated from 64% to 90%, and GMR ranged from 2.92 to 4.57.
Maltese: Ir-rati ta' seroprotezzjoni ta' SRH kienu jvarjaw minn 86% sa 98%, ir-rati tas-serkonverżjoni kienu jvarjaw minn 64% sa 90%, u l-GMR kienet tvarja minn 2.92 sa 4.57.
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inativated, adjuvanted)
Maltese: Vaċċin kontra l-Influwenza Żoonotika (H5N1) (antiġen tal-wiċċ, inattivat, adjuvanted)
English: Side effects from clinical study in children (6 months to 17 years of age) General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying.
Maltese: L-effetti sekondarji ġenerali rrappurtati b'mod komuni ħafna fil-grupp ta' etajiet ta' 6 xhur sa 35 xahar kienu ħmura fil-post tal-injezzjoni, uġigħ fil-muskoli, irritabilità u biki mhux normali.
English: Adults (19- 60 years)a
Maltese: Adulti (19- 60 sena) a
English: Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator).
Maltese: L-immunoġeniċità ta' AFLUNOV (A/turkey/Turkey/1/2005) f'individwi adulti (18 sa 60 sena) u anzjani (>61 sena) b'kundizzjonijiet mediċi sottostanti (Studju V87_25) jew kundizzjonijiet immunosoppressivi (fil-maġġoranza tagħhom individwi infettati bl-HIV) (Studju V87_26) meta mqabbla ma' adulti (18-60 sena) u anzjani (≥61 sena) b'saħħithom, kienet evalwata f'żewġ provi kliniċi kkontrollati ta' fażi
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 tat-tip I) b'tapp planġer (lastku tal-bromo-butyl).
English: Other medicines and AFLUNOV
Maltese: Kif jingħata AFLUNOV
English: MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively.
Maltese: MN kontra A/Vietnam/1194/2004 omologu jindikaw rata ta' seroprotezzjoni u rata ta' serokonverżjoni li tvarja minn 57% (50-64) sa 79% (68-87) u 55% (48-62) sa 58% (47-69),
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
Maltese: Razza tixbah lill-A/turkey/Turkey/1/2005 (H5N1) (NIBRG-23) (clade 2.2.1) 7.5 mikrogrammi ta' haemagglutinin
English: MicroNeutralisation (MN) results against homologous A/Vietnam/1194/2004) indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Maltese: Ir-riżultati tal-MikroNewtralizzazzjoni (MN) kontra A/Vietnam/1194/2004) omologu jindikaw rata ta' serokonverżjoni li tvarja minn 67% (60-74) sa 85% (78-90) u 65% (58-72) sa 83% (77-89),
English: • in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.
Maltese: • Fil-preżenza ta' defiċjenzi immuni, AFLUNOV jista' jingħata iżda jista' ma jkunx hemm rispons immuni ta' protezzjoni.
English: * propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
Maltese: ** imfissra f'mikrogrammi ta' haemagglutinin.
English: The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and a seasonal trivalent MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older:
Maltese: L-episodji avversi addizzjonali li ġejjin kienu rrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti mhux adjuvanted fil-gruppi kollha ta' etajiet u vaċċin kontra l-influwenza staġjonali, trivalenti, ta' sottounità u adjuvanted b'MF59 li huwa approvat għall-użu f'persuni anzjani minn 65 sena 'l fuq:
English: Elderly (61-91 years)a
Maltese: Anzjani (61-91 sena) a
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** a Ages 62-88 years; b Ages 61-68 years; c Ages 61-89 years * Seroprotection: SRH area ≥ 25 mm2
Maltese: CI)*** a Etajiet ta' 62-88 sena; b Etajiet ta' 61-68 sena; ċ Etajiet ta' 61-89 sena * Seroprotezzjoni: żona ta' SRH ≥25 mm2
English: Some heterologous immune response against A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2.1) and A/ Indonesia/5/2005 (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
Maltese: Xi rispons immuni eterologuż kontra A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2) u A/Indonesia/5/2005 (clade 2.1) deher kemm wara t-tieni tilqima kif ukoll wara t-tielet tilqima, u dan jindika kross-reattività tal-vaċċin clade 1 kontra razez clade 2.
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Maltese: Vaċċin kontra l-influwenza żoonotika (H5N1) (antiġen tal-wiċċ, inattivat, adjuvanted).
English: Adults (20- 60 years)a
Maltese: Adulti (20- 60 sena) a
English: - Keep this leaflet.
Maltese: trażmissjoni virali.
English: Uncommon (affects 1 to 10 users in 1.000):
Maltese: Mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000):
English: Common (affects 1 to 10 users in 100):
Maltese: Komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100):
English: ° measured by HI assay ≥ 40
Maltese: ° imkejla b'assaġġ HI ≥40
English: Rare (affects 1 to 10 users in 10.000):
Maltese: Rari (jaffettwaw minn 1 sa 10 utenti minn kull 10,000):
English: Based on data obtained from trials V87P1, V87P11 and V87_13, persistence of antibodies after primary vaccination in elderly subjects 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.
Maltese: Abbażi ta' dejta miksuba mill-provi V87P1, V87P11 u V87 13, il-persistenza tal-antikorpi wara t-tilqima primarja f'individwi anzjani kif imkejla b'testijiet ta' HI, SRH u MN, naqset minn 1/2 għal 1/5 tal-livell tagħhom ta' wara t-tilqima f'jum 202 meta mqabbel mal-jum 43 wara t-tlestija tal-iskedi ta' vaċċinazzjoni primarji.
English: Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
Maltese: Ipparagunat mal-livelli tal-antikorpi miksubin f'jum 43 wara t-tlestija tal-iskedi primarji, il-livelli tal-antikorpi f'jum 202 naqsu b'1/5 sa 1/2 mil-livelli preċedenti tagħhom.
English: 1 pre-filled syringe (0.5 ml) 10 pre-filled syringes (0.5 ml)
Maltese: 10 siringi mimlija għal-lest (0.5 mL)
English: However, in immunocompromised subjects 18 through 60 years of age, slightly higher rates of nausea (13.0%) were reported.
Maltese: f'individwi immunokompromessi ta' 18-il sena sa 60 sena, kienu rrappurtati rati ta' dardir (13.0%)
English: Study V87P2 Adults booster after 2nd dose
Maltese: Studju V87P2 Adulti booster wara t-tieni doża
English: Ferrets received one or two doses of vaccine (A/Vietnam/1194/2004).
Maltese: Linmsa rċivew doża waħda jew żewġ dożi tal-vaċċin (A/Vietnam/1194/2004).
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-trabi li għadhom kif telqu jimxu, l-iżjed reazzjonijiet lokali solleċitati msemmija b'mod komuni kienu l-eritema u s-sensibilità; l-irritabilità u l-biki mhux normali kienu l-iżjed reazzjonijiet sistemiċi solleċitati rrappurtati b'mod komuni.
English: Seroconversion rate (95%CI)°
Maltese: serokonverżjoni (95%
English: Elderly (61-79 years)a
Maltese: Anzjani (61-79 sena) a
English: In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
Maltese: III (V87P13), ġew irreġistrati 2,693 persuna adulta u 2,566 irċivew żewġ dożi ta' AFLUNOV (A/Vietnam/1194/2004)
English: It is important that procedures are in place to avoid injury from faints
Maltese: Huwa importanti li jkun hemm proċeduri biex jiġu evitati inċidenti waqt ħass ħażin.
English: • Injection site swelling
Maltese: • Sintomi jixbhu lill-influwenza
English: AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6.
Maltese: X'inhu AFLUNOV u gћalxiex jintuża AFLUNOV huwa vaċċin għall-użu f'persuni adulti li jkollhom minn 18-il sena 'il fuq, intenzjonat li jingħata fil-kuntest ta' tifqigħat ta' viruses tal-influwenza żoonotika (ġejja mill-għasafar) b'potenzjal pandemiku għall-prevenzjoni tal-influwenza kkawżata minn viruses tat-tip H5N1 simili għar-razza talvaċċin irrappurtati f'sezzjoni 6.
English: The incidence of adverse reactions has been evaluated in seven clinical trials in healthy subjects involving over 4300 adults and elderly receiving AFLUNOV (at least 7.5 µg HA, adjuvanted).
Maltese: L-inċidenza tar-reazzjonijiet avversi ġiet evalwata f'seba' provi kliniċi f'individwi b'saħħithom li kienu jinvolvu madwar 4,300 persuna adulta u anzjana li rċivew AFLUNOV (mill-inqas 7.5 µg HA, adjuvanted).
English: Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Maltese: Rispons immuni ta' kross-reattività miksub minn H5N1 A/turkey/Turkey/1/2005 kontra H5N1 A/Indonesia/5/2005 u H5N1 A/Vietnam/1194/2004
English: (A/Vietnam/1194/2004) dose, all vaccine schedule groups after 3 weeks from the 2nd vaccination achieved high levels of antibodies as evaluated with SRH.
Maltese: (A/Vietnam/1194/2004), il-gruppi kollha ta' skedi tal-vaċċin wara 3 ġimgħat mit-tieni tilqima laħqu livelli għolja ta' antikorpi kif ivvalutat b'SRH.
English: AFLUNOV suspension for injection in pre-filled syringe.
Maltese: U KONTENUT Suspensjoni għall-injezzjoni.
English: • Shivering
Maltese: • Dardir
English: • Anaphylaxis (severe allergic reactions).
Maltese: • Anafilassi (reazzjonijiet allerġiċi severi)
English: Respiratory disorders Cough.
Maltese: Mhux applikabbli.
English: Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Maltese: L-esperjenza ta' wara t-tqegħid fis-suq irrappurtat b'mod spontanju avvenimenti avversi u studju intervenzjonali ma jissuġġerixix effetti ta' ħsara diretti jew indiretti tal-esponiment għal Focetria fuq it-tqala.
English: Study V87P1 Adults booster after 2nd dose
Maltese: Studju V87P1 Adulti booster wara t-tieni doża
English: Across studies V87_25 and V87_26, the safety of AFLUNOV in healthy adult and elderly subjects was consistent with existing safety data from previous clinical trials.
Maltese: Fi studji V87_25 u V87_26, is-sigurtà ta' AFLUNOV f'individwi adulti u anzjani b'saħħithom kienet konsistenti ma' dejta dwar is-sigurtà li kienet diġà teżisti minn provi kliniċi preċedenti.
English: Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Maltese: Disturbi newroloġiċi, bħal enċefalomjelite, u s-sindrome ta' Guillain Barré
English: Elderly (>61 years)
Maltese: Anzjani (≥61 sena)
English: In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
Maltese: F'dan l-istudju, 100% tal-annimali kienu protetti kontra l-espożizzjoni omologa, u 81% tal-annimali kienu protetti kontra l-espożizzjoni etorologa.
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
Maltese: Razza li tixbah lill-A/turkey/Turkey/1/2005 (H5N1) (NIBRG-23) (clade 2.2.1) 7.5 mikrogrammi**
English: In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose occurred either 1, 2, 3 or 6 weeks after the first AFLUNOV
Maltese: Fi prova klinika li evalwat 4 skedi differenti ta' vaċċinazzjoni fuq 240 persuna minn 18 sa 60 sena,
English: In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
Maltese: MN kontra A/turkey/Turkey/1/2005 omologu jindikaw rata ta' seroprotezzjoni u rata ta' serokonverżjoni ta' 68% (59-75) u 81% (74-87), rispettivament.
English: In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.
Maltese: Barra minn hekk, rati ogħla ta' artralġja (li jaslu sa 23.3%) kienu rrappurtati kemm f'individwi adulti u anzjani, li kienu immunokompromessi jew li kellhom kundizzjonijiet mediċi sottostanti.
English: Local Systemic
Maltese: Sistemiċi
English: Any
Maltese: IM
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Maltese: Reazzjonijiet allerġiċi, anafilassi li tinkludi dispneja, bronkospażmu, edema fil-larinġi, li f'każijiet rari jwasslu għal xokk
English: MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions.
Maltese: MN kontra A/turkey/Turkey/1/2005 omologu jindikaw rata tas-serokonverżjoni ta' 66.67% f'adulti b'saħħithom, li kienu jvarjaw minn 33.57% għal 54.14% f'adulti b'kundizzjonijiet mediċi immunosoppressivi jew sottostanti, rispettivament; ir-rati tas-serokonverżjoni kienu jvarjaw minn
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 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide).
Maltese: Hija meħtieġa attenzjoni meta dan il-vaċċin jingħata lil persuni b'sensittività eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza attiva, għal xi waħda mis-sustanzi mhux attivi elenkati fis sezzjoni 6.1 u għar-residwi (bajd u proteini tat-tiġieġ, ovalbumina, kanamycin, neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide).
English: Baseline Serostatus
Maltese: Serostatus tal-linja bażi
English: These side effects may occur with AFLUNOV.
Maltese: Dawn l-effetti sekondarji jistgħu jseħħu b'AFLUNOV.
English: Adults and elderly (18 years of age and above):
Maltese: Adulti u anzjani (18-il sena u aktar):
English: Similar trends were observed for seroprotection rates in both studies.
Maltese: Tendenzi simili kienu osservati għal rati tas-seroprotezzjoni fiż-żewġ studji.
English: In consequence, as soon as the pandemic is declared and the zoonotic vaccine is used, the Marketing Authorisation Holder (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: B'konsegwenza ta' hekk, hekk kif tiġi ddikjarata l-pandemija u hekk kif jintuża l-vaċċin żoonotiku, idDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jibgħat rapporti ta' aġġornament tas-sigurtà perjodiċi ssimplifikati b'mod aktar frekwenti b'format u b'perjodiċità definiti fir-“Rakkomandazzjonijiet tas-CHMP għall-Pjan ta' Ġestjoni tar-Riskji Ewlieni għal Vaċċini tal-Influwenza imħejjijin minn virusijiet bil-potenzjal li jikkawżaw pandemija u maħsubin sabiex jintuża barra mill-kuntest tad-dossier attwali” (EMEA/49993/2008), u kwalunkwe aġġornament sussegwenti.
English: Cross-reactive immune response elicited by A/Vietnam/1194/2004 against A/turkey/Turkey/1/2005 and A/Indonesia/5/2005
Maltese: Rispons immuni ta' kross-reattività miksub minn H5N1 A/Vietnam/1194/2004 kontra H5N1 A/turkey/Turkey/1/2005 u H5N1 A/Indonesia/5/2005
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows:
Maltese: Ir-rata ta' seroprotezzjoni*, ir-rata ta' serokonverżjoni** u l-fattur ta' serokonverżjoni*** għall-antikorp anti-HA għall-H5N1 A/Vietnam/1194/2004 u għal H5N1 A/turkey/Turkey/1/2005 fil-persuni adulti mkejla b'assaġġ SRH kienu kif ġej:
English: Consistent with the data observed by trial for solicited reactions, there was a general trend towards decreased reports of local reactions after the second vaccination compared with the first injection.
Maltese: B'mod konsistenti mad-dejta osservata bi prova għar-reazzjonijiet solleċitati, kien hemm tendenza ġenerali ta' tnaqqis fir-rapporti ta' reazzjonijiet lokali wara t-tieni tilqima meta pparagunat mal-ewwel injezzjoni.
English: Headache, dizziness, somnolence, syncope.
Maltese: Uġigħ ta' ras, sturdament, ngħas, sinkope.
English: SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, revealed seroprotection and seroconversion rates of 100% (74100) and an 18-fold increase in SRH area (GMR).
Maltese: Ir-riżultati ta' SRH wara l-ewwel doża, li jimitaw il-priming prepandemiku flimkien ma' doża waħda booster eterologa, żvelaw rati ta' seroprotezzjoni u serokonverżjoni ta' 100% (74-100) u żieda ta' 18-il darba aktar fiż-żona ta' SRH
English: Injection 3
Maltese: ANNESS III
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Maltese: għall-antikorp anti-HA għal H5N1 A/Indonesia/5/2005 u A/H5N1/Vietnam/1194/2004 wara t-tieni doża fl-adulti (18-60 sena) u fl-anzjani (>61 sena), imkejla b'assaġġi SRH u HI kienu kif ġej: