FrancophonIA/ELRC3.0 huggingface dataset:
English: Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against the A/Indonesia/5/05 virus.
Maltese: Żewġ dożi tal-vaċċin ipproteġew 92% tal-annimali, u doża waħda tal-vaċċin ipproteġiet 50% tal-annimali kontra l-virus A/Indonesia/5/05.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Maltese: Rata ta' seroprotezzjoni (95% CI)* Rata ta' serokonverżjoni (95% CI)* Fattur ta' serokonverżjoni (95% CI)**
English: MN results against 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: MN kontra A/Vietnam/1194/2004 jindikaw rata ta' serokonverżjoni li tvarja minn 67% (60-74) sa 85% (78-90) u 65% (58-72) sa 83% (77-89), rispettivament.
English: MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/05 ranging from 10% (2-27) to 39% (32-46) and 10% (227) to 36% (29-43) respectively.
Maltese: MN għat-tliet studji kliniċi fit-Tabella ta' hawn fuq urew rata ta' seroprotezzjoni u rata ta' serokonverżjoni kontra A/turkey/Turkey/05 li kienu jvarjaw minn 10% (2-27) sa 39% (32-46) u 10% (2-27) sa 36% (29-43) rispettivament.
English: Palpitation, tachycardia.
Maltese: Disturbi fil-qalb Palpitazzjoni, takikardija.
English: Day 43 to Day 1 % SC (95% CI)
Maltese: Jum 43 sa Jum 1 % SC (95% CI) Jum 43
English: Very common:
Maltese: Rari:
English: Adverse reactions from clinical trials in adults (18 years old and above).
Maltese: Reazzjonijiet avversi minn provi kliniċi f'adulti (18-il sena u aktar)
English: Some heterologous immune response against A/H5N1/turkey/Turkey/05 (NIBRG23; clade2.2) and A/H5N1/Indonesia (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/H5N1/turkey/Turkey/05 (NIBRG23; clade 2.2) u A/H5N1/Indonesia (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: Name and address of the manufacturers of the biological active substance Novartis Vaccines and Diagnostics S.r.l.
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Novartis Vaccines and Diagnostics S.r.l.
English: Data on safety of a booster dose of the current Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics formulation are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults and 56 elderly.
Maltese: Id-dejta dwar is-sigurtà ta' doża booster tal-formolazzjoni attwali ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics hija limitata għal tliet provi (V87P1, V87P2 u V87P1E1) li inkludew 116-il adult u 56 anzjan..
English: Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Maltese: Disturbi newroloġiċi bħal enċefalomjelite (infjammazzjoni tas-sistema nervuża ċentrali), u tip ta' paraliżi magħrufa bħala s-Sindrome ta' Guillain-Barré.
English: MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Maltese: MN kontra A/Vietnam/1194/2004 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: Vasculitis with transient renal involvement and exudative erythema multiforme.
Maltese: Disturbi fis-sistema immuni Vaskulite b'involviment renali temporanju u eritema multiformi li tnixxi.
English: Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2
Maltese: Rata ta' seroprotezzjoni (95% CI)* Rata ta' serokonverżjoni (95% CI)* Fattur ta' serokonverżjoni (95% CI)** * imkejla b'assaġġ SRH ≥ 25 mm ** proporzjonijiet ġeometriċi medji ta' SRH
English: Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section
Maltese: Fi provi kliniċi ġiet osservata xi kross-protezzjoni kontra varjanti tal-virus H5N1 relatati (ara sezzjoni
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/05 was also tested.
Maltese: Ġiet ittestjata wkoll l-effikaċja kontra l-espożizzjoni għall-virus etorologu A/Indonesia/5/05.
English: STATEMENT OF ACTIVE SUBSTANCE One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, of strain:
Maltese: Doża waħda ta' 0.5 ml fiha: Sustanzi Attivi: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase), propagati fil-bajd, tar-razza:
English: In a phase 2 clinical trial (Study 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 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, met all CHMP criteria.
Maltese: Fi prova klinika ta' fażi 2 (Studju V87P3), suġġetti adulti ta' età bejn 18-65 sena li ġew primed 6-8 snin qabel b'2 dożi ta' vaċċin H5N3 adjuvanted b'MF59 /A/Duck/Singapore/97 ingħataw 2 dożi booster ta' Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Maltese: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase)* tar-razza:
English: Study V87P2 Adults booster after 2rd dose
Maltese: Studju V87P2 Adulti booster wara t-tieni doża
English: 1.175 milligrams per 0.5 ml
Maltese: 0.5 ml
English: A clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Maltese: Saret prova klinika (Studju V87P1) b'vaċċin tal-H5N1 ikkombinat ma' adjuvant MF59C.1 fi 312-il adult b'saħħtu.
English: H5N1 influenza vaccine
Maltese: H1N1v.
English: 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: A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Maltese: Saret prova klinika (Studju V87P6) b'vaċċin H5N1 kombinat ma' adjuvant MF59C.1 f'471 tifel u tifla minn 6 xhur sa 17-il sena.
English: Groups of 8 ferrets received one (day 21) or two (days 0 and 21) doses of vaccine containing 3.75 or 7.5 micrograms of antigen.
Maltese: Gruppi ta' 8 inmsa rċevew doża waħda (jum 21) jew żewġ dożi (jum 0 u 21) tal-vaċċin li kien fih 3.75 jew 7.5 mikrogrammi ta' antiġen.
English: Common: arthralgia
Maltese: Komuni: dardir
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Maltese: Wara t-tilqim kontra l-influwenza, jistgħu jinkisbu riżultati pożittivi foloz f'testijiet seroloġiċi bilmetodu ELISA għall-antikorpi kontra l-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), il-virus tal-epatite Ċ u, speċjalment, l-HTLV-1.
English: Posology:
Maltese: Adjuvant:
English: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Maltese: Reazzjonijiet allerġiċi, anafilassi fosthom dispneja, bronkospażmu, edema fil-larinġi, li f'każijiet rari jwasslu għal xokk.
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: In another clinical trial (Study V87P13) 2693 adult subjects were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
Maltese: Fi prova klinika oħra (Studju V87P13), ġew irreġistrati 2,693 persuna adulta u dawn irċevew żewġ dożi tal-vaċċin li fih H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/doża adjuvanted) mogħtija tliet ġimgħat minn xulxin.
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 liżjed reazzjonijiet sistemiċi solleċitati rrappurtati b'mod komuni.
English: Transient thrombocytopenia.
Maltese: Prodott mediċinali jingħata bir-riċetta tat-tabib.
English: Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Maltese: Disturbi fis-sistema nervuża Disturbi newroloġiċi, bħal enċefalomjelite, u s-sindrome ta' Guillain Barré.
English: Trial on different vaccination schedules:
Maltese: c) Prova bi skedi differenti ta' vaċċinazzjoni:
English: One dose of 0.5 ml will be given.
Maltese: Tingħata doża waħda ta' 0.5 ml.
English: In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine containing either 3.75 or 7.5 micrograms of antigen was administered.
Maltese: Fi studju simili, l-espożizzjoni mill-imnieħer ġiet posposta sa madwar 4 xhur wara ngħatat it-tieni doża tal-vaċċin li kien fih 3.75 jew 7.5 mikrogrammi ta' antiġen.
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Maltese: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ġie evalwat f'adulti b'saħħithom (18-60 sena) u f'anzjani b'saħħithom (ikbar minn 60 sena) billi ġiet segwita skeda ta' vaċċinazzjoni primarja ta' 1, 22 ġurnata, u vaċċinazzjoni booster (ara sezzjonijiet 4.8 u 5.1).
English: Respiratory disorders
Maltese: Disturbi respiratorji Sogħla.
English: 1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
Maltese: 1 x siringa mimlija għal-lest ta' doża waħda ta' 0.5 ml 10 x siringi mimlija għal-lest ta' doża waħda ta' 0.5 ml
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Maltese: * propagati fil-bajd ** imfissra f'mikrogrammi ta' haemagglutinin.
English: The following additional adverse events were reported from post-marketing surveillance with Focetria H1N1v (licensed for use from 6 months of age and with a composition that is similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics):
Maltese: L-episodji avversi addizzjonali li ġejjin kienu rrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'Focetria H1N1v (liċenzjat għall-użu mill-età ta' 6 xhur u b'kompożizzjoni simili għal Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics):
English: This medicinal 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: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodju (23 mg) u inqas minn 1 mmol ta' potassju (39 mg) għal kull doża ta' 0.5 ml, jiġifieri huwa essenzjalment mingħajr sodju u potassju.
English: b) Long term booster immune memory
Maltese: b) Memorja immuni fuq perjodu fit-tul tal-booster
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (jiġifieri ta' theddida għall-ħajja) għal xi wieħed mill-kostitwenti jew traċċi residwi (bajd u proteini tat-tiġieġ, ovalbumina, kanamycin u neomycin sulphate, formaldehyde u cetyltrimethylammonium bromide (CTAB)) ta' dan il-vaċċin.
English: Study V87P13 21 days after 2nd dose N=66
Maltese: Studju V87P13 21 jum wara t-tieni doża N=66
English: Limited data was obtained from women who became pregnant during the course of clinical trials with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics or H1N1v vaccines adjuvanted with MF59C.1.
Maltese: Inkisbet dejta limitata minn nisa li ħarġu tqal matul il-kors ta' provi kliniċi b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics jew vaċċini kontra l-H1N1v adjuvanted b'MF59C.1.
English: The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and an MF59 seasonal adjuvanted trivalent vaccine with a composition similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (surface antigen, inactivated, adjuvanted with MF59C.1) that is licensed for use in elderly subjects 65 years of age and older: Blood and lymphatic system disorders
Maltese: L-episodji avversi addizzjonali li ġejjin kienu rrappurtati mis-sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti staġjonali mhux adjuvanted fil-gruppi kollha ta' etajiet u vaċċin trivalenti staġjonali adjuvanat b'kompożizzjoni simili għal Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (antiġen tal-wiċċ, inattivat, adjuvanted b'MF59C.1) li huwa liċenzjat għall-użu f'persuni anzjani minn 65 sena 'l fuq:
English: 7.5 micrograms** per 0.5 ml dose
Maltese: (H5N1) (NIBRG-14) 7.5 mikrogrammi** għal kull doża ta' 0.5 ml
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics containing HA from A/Vietnam/1194/2004 (homologous to the challenge strain) and an Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics -like H5N1 vaccine, containing hemagglutinin from the A/turkey/Turkey/1/2005-like (heterologous to the challenge strain) were tested.
Maltese: Ġew ittestjati, Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics li fih HA mill-A/Vietnam/1194/2004 (omologu għar-razza tal-espożizzjoni) u vaċċin kontra l-H5N1 jixbah lil Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, li fih hemagglutinin mir-razza li tixbah lill-A/turkey/Turkey/1/2005 (etorologu għar-razza tal-espożizzjoni).
English: nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Maltese: Wara tliet ġimgħat mit-tieni tilqima (jum 43), ilgruppi kollha ta' etajiet (jiġifieri 6-35 xahar, 3-8 snin u 9-17-il sena) kisbu livelli għolja ta' antikorpi għal (A/Vietnam/1194/2004) kif imkejla b'assaġġi SRH u HI kif ippreżentati fit-tabella hawn taħt*.
English: Immunogenicity was assessed in a subset (n=197) of study population.
Maltese: Limmunoġeniċità ġiet ivvalutata f'subsett (n=197) tal-popolazzjoni tal-istudju.
English: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms haemagglutinin Adjuvant: MF59C.1 oil composed of squalene, polysorbate 80 and sorbitan trioleate.
Maltese: (H5N1) (NIBRG-14) 7.5 mikrogrammi ta' haemagglutinin
English: Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam Komuni ħafna: uġigħ fil-muskoli Komuni: artralġja
English: Study V87P13 21 days after 2nd dose N=143
Maltese: Studju V87P13 21 jum wara t-tieni doża N=143
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Maltese: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin kontra l-Influwenza Prepandemika (H5N1) (antiġen tal-wiċċ, inattivat, adjuvanted)
English: The symptoms of pandemic flu are similar to those of an ordinary flu but may be more severe.
Maltese: Is-sintomi tal-influwenza pandemika huma simili għal dawk ta' influwenza normali iżda jistgħu jkunu aktar qawwija.
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 għall-H5N1 A/Vietnam/1194/2004 f'persuni ta' aktar minn 60 sena (numru limitat ta' suġġetti kellhom aktar minn 70 sena), imkejla b'assaġġ SRH (ivvalutat f'żewġ studji kliniċi), kienu kif ġej:
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults (from 18 to 60 years old).
Maltese: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics huwa vaċċin għall-użu f'persuni adulti (minn 18 sa 60 sena) u anzjani ('il fuq minn 60 sena).
English: - Italy
Maltese: - Sustanzi
English: The side effects listed below have occurred with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in clinical studies in adults, including the elderly:
Maltese: L-effetti sekondarji elenkati hawn isfel seħħew b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics fi provi kliniċi fuq persuni adulti, inklużi l-anzjani:
English: Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Maltese: Disturbi muskolu-skeletriċi, tat-tessuti konnettivi u tal-għadam Dgħufija fil-muskoli, uġigħ fl-estremitajiet.
English: A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Maltese: It-tieni doża ta' 0.5 ml għandha tingħata wara intervall ta' mill-inqas 3 ġimgħat.
English: Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), and exudative erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
Maltese: Vaskulite (infjammazzjoni fil-vini u l-arterji li tista' tikkawża raxxijiet fil-ġilda, uġigħ fil-ġogi u problemi fil-kliewi), u eritema multiformi li tnixxi (tip ta' reazzjoni allerġika fil-ġilda li sseħħ b'reazzjoni għal medikazzjonijiet, infezzjonijiet, jew mard).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bi Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fl-immunizzazzjoni attiva kontra s-subtip H5N1 tal-virus tal-Influwenza A.
English: It is estimated that more than 90,000 women have been vaccinated during pregnancy with H1N1v vaccine Focetria which contains the same amount of adjuvant MF59C.1 as. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics However information on outcomes is currently limited.
Maltese: Huwa stmat li aktar minn 90,000 mara ġew imlaqqma waqt it-tqala bil-vaċċin Focetria kontra lH1N1v li fih l-istess ammont ta' adjuvant MF59C.1 daqs Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: Toddlers (6-<36 months)
Maltese: Trabi li telqu jimxu (6 -< 36 xahar)
English: Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Maltese: KIF TAĦŻEN PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED)
English: In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Maltese: B'konsegwenza ta' hekk, hekk kif tiġi ddikjarata l-pandemija u hekk kif jintuża l-vaċċin prepandemiku, il-MAH għandu jibgħat rapporti ta' aġġornament tas-sigurtà perjodiċi ssimplifikati b'mod aktar frekwenti b'format u b'perjodiċità definiti fir-“Rakkomandazzjonijiet tas-CHMP għallPjan ta' Ġestjoni tar-Riskji Ewlieni għal Vaċċini tal-Influwenza imħejjijin minn virusijiet bilpotenzjal li jikkawżaw pandemija u maħsubin sabiex jintuża barra mill-kuntest tad-dossier attwali" (EMEA/49993/2008), u kwalunkwe aġġornament sussegwenti.
English: A lethal challenge was administered by the intratracheal route on day 49.
Maltese: F'jum 49 ingħatat espożizzjoni letali minn ġot-trakea.
English: A single vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics but using the strain H5N3.
Maltese: Tilqima waħda b'Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) ikkawżat rispons seroloġiku qawwi u rapidu f'individwi li 6-8 snin qabel kienu ġew primed b'żewġ dożi ta' vaċċin sostitut differenti tal-H5N, li kellu l-istess formulazzjoni bħal Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics iżda li kien juża r-razza N5N3.
English: PSUR submission when Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic:
Maltese: Sottomissjoni ta' PSUR meta Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics jintuża matul pandemija tal-influwenza: