FrancophonIA/ELRC3.0 huggingface dataset:
English: Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Maltese: Bħall-isfida omologa, it-tilqima kontra sfida eterologa naqqset it-tagħbija tal-virus, u naqqset il-bidliet ematoloġiċi (lewkopenija) assoċjati ma' infezzjoni patoġenika ħafna tal-influwenza tat-tjur.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle (usually in the upper arm or upper thigh, depending on the muscle mass).
Maltese: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER jingħata bħala injezzjoni fil-muskolu (normalment fil-parti ta' fuq ta' driegħ jew fil-parti ta' fuq tal-koxxa, skont il-massa tal-muskoli).
English: • itching
Maltese: • telqa
English: • pain in joint or muscle
Maltese: • uġigħ tal-ġogi u tal-muskoli
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Maltese: 20 kunjetti b'ħafna dożi (10 dożi f'kull kunjett - 0.5 ml għal kull doża)
English: per 0.5 ml dose * produced in Vero cells ** haemagglutinin
Maltese: f'kull doża ta' 0.5 ml * prodott f'ċelluli Vero ** emagglutinin
English: Dose nd
Maltese: Għeja
English: Frequency 6 - 35 months 3 - 8 years
Maltese: 3 - 8 snin 9 - 17-il sena
English: Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3500 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions.
Maltese: Il-provi kliniċi saru b'dan il-vaċċin kontra H5N1 (ara sezzjoni 5.1 għal aktar informazzjoni fuq il-vaċċin kontra H5N1) f'madwar 3,500 individwu (li varjaw fi gruppi ta' età minn 18 sa 59 sena u 60 sena u aktar), u fi gruppi f'riskju speċjali li kien fihom madwar 300 persuna kull wieħed, li kienu jikkonsistu minn individwi b'sistema immunokompromessi u pazjenti b'kundizzjonijiet ta' mard kroniku.
English: • stomach pain, indigestion
Maltese: • uġigħ fl-istonku, indiġestjoni
English: Infants, children and adolescents: Adverse Reactions (Infants, Children and Adolescents)
Maltese: Reazzjonijiet Avversi (Trabi, Tfal u Adolexxenti)
English: Seroneutralization rate*
Maltese: Rata ta' seronewtralizzazzjoni*
English: In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term.
Maltese: Fl-istudji kliniċi li saru fl-adulti u persuni akbar fl-età b'PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, ħafna mill-effetti sekondarji kienu ta' natura ħafifa u ma damux.
English: Hypotension
Maltese: PANDEMIC
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Maltese: L-inmsa imlaqqma bid-doża ta' 7.5 µg talvaċċin A/Vjetnam/1203/2004 urew rata għolja ta' serokonverżjoni.
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: Ġabra fil-qosor tar-reazzjonijiet avversi spontaeji b'SOC, Terminu ta' Livell Għoli (High Level Term, HLT) u terminu preferut (PT), stratifikat skont it-tip ta' rapport (medikament ikkonfermati jew mhux medikament ikkonfermati) li jinkludi l-għadd ta' rapporti fatali, għall-perijodu kopert mir-rapport u b'mod kumulattiv.
English: Nasopharyngitis
Maltese: MEDJASTINALI
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq b'vaċċin kontra H1N1, virjon sħiħ, derivat minn ċelluli Vero, ġew irrapportati r-reazzjonijiet avversi li ġejjin (il-frekwenza ta' dawn ir-reazzjonijiet avversa mhijiex magħrufa (ma tistax tittieħed stima mid-data disponibbli):
English: • if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
Maltese: • jekk int allerġiku/a għal xi sustanzi jew residwi ta' traċċa kontenuti (formaldehyde, benzonase, sucrose) li jinsabu fil-vaċċin.
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Maltese: Vaċċin booster eterologu b'7.5 µg b'razza ta' vaċċin A/Indoneżja/05/2005 b'formulazzjoni non-adjuvanted ingħata 12-il xahar wara l-ewwel tilqima b'żewġ dożi tar-razza tal-vaċċin A/Vjetnam/1203/2004 fi tfal u adolexxenti ta' età minn 9 sa 17-il sena (N=196), tfal ta' età minn 3 sa 8 snin (N=79) u trabi u tfal ta' età minn 6 xhur sa 35 xahar (N=25).
English: In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated.
Maltese: Fi studju ieħor, sitta u sittin nemes ġew maqsuma f'6 koorti ta' 11-il nemes u ġew imlaqqma f'jum 0 u l-21 jum bi 3.75 µg jew 7.5 µg tal-vaċċin tal-Indoneżja jew ingħataw tilqima finta.
English: The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
Maltese: It-tilqima hi disponibbli bħala pakkett 1 li fih 20 kunjetti b'ħafna dożi (ħġieġ ta' tip 1) ta' 5 ml ta' suspensjoni (10 dożi).
English: The following information is intended for health care professionals only:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Seroprotection rate*
Maltese: Rata ta' seroprotezzjoni*
English: The most frequently occurring side effect was injection site pain, which was usually mild.
Maltese: L-aktar effett sekondarju frekwenti kien uġigħ fis-sit tal-injezzjoni, li normalment kien wieħed ħafif.
English: NERVOUS SYSTEM DISORDERS
Maltese: DISTURBI RESPIRATORJI,
English: The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Maltese: A/Vjetnam/1203/2004) ġiet evalwata fi tliet studji kliniċi fuq persuni adulti ta' bejn 18 - 59 sena (N=961) u fuq individwi aktar anzjani ta' 60 sena u aktar (N=391) billi kienet segwita skeda ta' 0, 21 ġurnata.
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: Suspensjoni għall-injezzjoni.
English: The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Maltese: Ġew irrappurtati dawn l-effetti sekondarji fl-istudji kliniċi f'adolexxenti ta' età minn 9 sa 17-il sena
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Maltese: Tagħrif miksub mat-tilqima finta tappoġġja strateġija ta' tilqim li x'aktarx tintuża għat-tilqima ta' kontra l-pandemika: tagħrif dwar l-immunoġeniċità klinika, is-sigurtà u r-reazzjoni għal ġeni miksub b'tilqim finta huwa relevanti għat-tilqim ta' kontra l-pandemija.
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome Reporting of suspected adverse reactions
Maltese: Disturbi newroloġiċi, bħal enċefalomajlite, nevrite u s-sindromu ta' Guillain Barré.
English: The MAH shall perfom the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Uncommon (affects 1 to 10 in 1,000 vaccinees):
Maltese: Mhux komuni (jaffettwaw minn 1 sa 10 persuni minn kull 1,000 persuna mlaqqma):
English: • rash, hives
Maltese: • raxx, ħorriqija
English: Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Seroneutralization rate* Seroconversion rate** Seroconversion factor***
Maltese: Ir-rata ta' serokonverżjoni**
English: Rare: neuralgia, transient thrombocytopenia
Maltese: • ebusija, ħmura, nefħa jew tbenġil fis-sit tal-injezzjoni
English: • Immunoglobulin is not to be given with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Maltese: • L-immunoglobulina m'għandhiex tingħata ma' PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Maltese: Ingħata wkoll booster eterologu wara 12 sa 24 xahar fi studju ta' fażi 3 f'persuni immunokompromessi u f'pazjenti b'kundizzjonijiet ta' mard kroniku.
English: For further information, see section 5.1.
Maltese: Għal aktar informazzjoni, ara sezzjoni 5
English: Chest discomfort
Maltese: DISTURBI VASKULARI
English: Ear pain
Maltese: TAD-DEMM
English: Cross-reactive immune response against related H5N1 strains In a phase 3 study in adults (N=270) and older subjects (N=272) after vaccination with the A/Vietnam/1203/2004 strain vaccine the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
Maltese: Fi studju ta' fażi 3 f'persuni adulti (N=270) u persuni aktar anzjani (N=272) wara tilqima bil-vaċċin bir-razza A/Vjetnam/1203/2004, ir-rata ta' individwi b'seroprotezzjoni għal antikorpi newtralizzanti inkroċjati kif imkejla mill-MN (tajter ≥ 20) kienu hekk:
English: Somnolence Hypoaesthesia
Maltese: Sodium chloride
English: Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Maltese: Reazzjonijiet avversi serji u mhux elenkati (SOC, HLT,PTs) stratifikati skont it-tip ta' rapport (medikament ikkonfermati jew mhux medikament ikkonfermati) għall-perijodu kopert mir-rapport u b'mod kumulattiv.
English: st
Maltese: U
English: Health care providers should carefully consider the potential risks and benefits for each specific patient before administering PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Maltese: Persuni li jipprovdu kura medika għandhom jikkunsidraw bir-reqqa r-riskji u l-benefiċċji potenzjali għal kull pazjenta speċifiku qabel jagħtu PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Maltese: Wara t-tilqima, ir-rata ta' individwi b'tajters ta' antikorpi li jinnewtralizzaw ta' > 20, rata ta' serokonverżjoni u fattur tas-serokonverżjoni kif imkejla mill-assaġġ tal-MN fi trabi, tfal u adolexxenti ta' età minn 6 xhur sa 17-il sena kienu kif ġej:
English: Day 42 a
Maltese: Jum 42
English: Injections of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER and immunoglobulin should be made into separate limbs.
Maltese: INFLUENZA VACCINE H5N1 BAXTER u tal-immunoglobulina għandhom jingħataw f'dirgħajn differenti.
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Maltese: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: • vertigo (motion sickness)
Maltese: • insonnja (diffikultà biex torqod)
English: Posology
Maltese: KONNETTIVI
English: • The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Maltese: • Ir-rispons immunoloġiku jista' jkun imnaqqas jekk il-pazjent ikun qiegħed fuq trattament immunosuppressanti.
English: The vaccine is available or as 1 pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection with a latex-free plunger stopper (halogeno-butyl rubber) with or without needles.
Maltese: It-tilqima hi disponibbli bħala pakkett 1 ta' siringa 1 ta' doża waħda mimlija għal-lest (ħġieġ ta' tip 1) li jkun fiha 0.5 ml ta' suspensjoni għall-injezzjoni bi stopper planġer mingħajr latex (tal-lastku tal-halogen-butyl) bi jew mingħajr labar.
English: Allergic reactions, including sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period.
Maltese: Reazzjonijiet allerġiċi, li jinkludu reazzjonijiet allerġiċi severi għal għarrieda u ta' periklu għall-ħajja (anafilassi), ġew irrappurtati b'vaċċin simili kontra l-influwenza H1N1 (vaċċin kontra s-swine flu) mogħti waqt perjodu pandemiku.
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: Ġabra fil-qosor għandha tiġi provduta fejn sinjali validati u setturi ta' tħassib għandhom jiġu enfasizzati, billi tiġi kkunsidrata l-informazzjoni li ġejja minn studju koorti prospettiv deskritt f'4.5.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Maltese: Matul il-pandemija, l-applikant ser iwettaq studju koorti prospettiv, kif identifikat fil-pjan tal-Farmakoviġilanza.
English: One single dose pre-filled syringe (containing 0.5ml suspension)
Maltese: Kunjett b'ħafna dożi (10 dożi ta' 0.5 ml kull kunjett)
English: * MN titre ≥ 20
Maltese: • imnieħer inixxi
English: Hyperhidrosis Pruritis Rash
Maltese: Ebusija fis-sit tal-injezzjoni
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi awtorizzazzjoni taħt ċirkustanzi eċċezzjonali skont l-Artikolu 14 (8) tar-Regolament (KE) 726/2004, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jagħmel, fiż-żmien stipulat, il-miżuri li gejjin:
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ‘exceptional circumstances'.
Maltese: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Maltese: U KONTENUT Suspensjoni għall-injezzjoni.
English: One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) with or without needles.
Maltese: Pakkett wieħed b'siringa 1 b'doża waħda mimlija għal-lest (ħġieġ ta' Tip I) li fiha 0.5 ml ta' suspensjoni għall-injezzjoni, b'tapp planġer bla latex (lastku tal-halogen-butyl) bi jew mingħajr labar.
English: After primary vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Maltese: Wara l-ewwel tilqima, ir-rata ta' individwi b'tajters ta' antikorpi li jinnewtralizzaw ta' > 20, rata ta' serokonverżjoni u fattur tas-serokonverżjoni kif imkejla mill-assaġġ tal-mikronewtralizzazzjoni (MN) f'persuni adulti li jkollhom minn 18 sa 59 sena u f'persuni aktar anzjani li jkollhom 60 sena jew iżjed kienu kif ġej:
English: • if you have a poor immune response (for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
Maltese: • jekk għandek rispons immunitarju dgħajjef (per eżempju, minħabba terapija immunosuppressiva, eż. trattamenti kortikosterojdi jew kimoterapija għall-kanċer);
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Maltese: Suspensjoni għall-injezzjoni Vaċċin kontra l-influwenza pandemika (H5N1) (virijon sħiħ, inattivat, ippreparat f'koltura taċ-ċelluli)
English: Fatigue Pyrexia Chills
Maltese: FULJETT TA' TAGĦRIF
English: Common Uncommon Common
Maltese: Komuni ħafna Komuni
English: Microneutralisation assay
Maltese: Assaġġ tal-mikronewtralizzazzjoni
English: * SRH area ≥ 25 mm²
Maltese: Booster wara 12-il xahar * erja SRH ≥ 25 mm²
English: Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Maltese: Ir-rati tas-seronewtralizzazzjoni (tajter MN ta' ≥ 20) wara 21 jum wara l-vaċċin booster bid-doża ta' 7.5 µg minn tilqima tar-razza A/Indoneżja/05/2005, ittestjati kontra kemm razez omologi kif ukoll eterologi, kienu kif ġej:
English: Seroprotection rate* Seroconversion rate** Seroconversion factor***
Maltese: Rata ta' serokonverżjoni**
English: During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Maltese: Matul il-pandemija, l-applikant ser jiġbor informazzjoni dwar is-sigurtà u l-effettività klinika tal-vaċċin kontra l-pandemija u jissottometti din l-informazzjoni lis-CHMP għall-evalwazzjoni.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Maltese: Profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata b'mod uffiċjali.
English: If it is necessary to provide immediate protection, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal or specific immunoglobulin.
Maltese: Jekk ikun meħtieġ li tiġi pprovduta protezzjoni immedjata, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER jista' jingħata fl-istess ħin ma' immunoglobulina normali jew speċifika.
English: A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been administered in a time window of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older people aged 60 years and above.
Maltese: Vaċċin booster b'7.5 µg b'razza ta' vaċċin A/Indoneżja/05/2005 eterologa ingħata f'intervall ta' żmien ta' 12 sa 24 xahar wara l-vaċċin priming b'żewġ dożi tal-vaċċin tar-razza A/Vjetnam/1203/2004 fi tliet studji kliniċi f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni aktar anzjani li kellhom 60 sena jew aktar.
English: 2nd Dose
Maltese: It-2 Doża
English: The side-effects are generally similar to those related to the influenza vaccine.
Maltese: L-effetti sekondarji huma ġeneralment simili għal dawk relatati mal-vaċċin tal-influwenza.
English: Common Common Uncommon
Maltese: Komuni Komuni ħafna
English: 2nd Dose 1st Dose
Maltese: L-1 Doża
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Maltese: - Il-każijiet mhux ikkonfermati b'mod mediku kollha huma dawk li jkunu ġew mdaħħla fid-dejtabejż mid-data-lock point.
English: Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Maltese: Fi prova klinika, il-vaċċin H5N1 ingħata lil 36 tarbija u tfal ta' età minn 6 sa 35 xahar.
English: The protective efficacy of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza
Maltese: L-effikaċja protettiva ta'PANDEMIC INFLUENZA VACCINE H5N1 BAXTER kontra morbożità u mortalità indotti mill-infezzjoni b'dożi letali tal-virus patoġeniku ħafna tal-influwenza tat-tjur H5N1 ġiet valutata mhux klinikament f'mudell ta' sfida fuq in-nemes.
English: After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Maltese: Wara li tħawdu, it-tilqima tkun suspensjoni ofwajt, opalexxenti u transluċida.
English: • Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Maltese: • Hija meħtieġa l-kawtela meta tagħti dan il-vaċċin lil persuni b'sensittività eċċessiva magħrufa (għajr reazzjoni anafilattika) għas-sustanza attiva, għal kwalunkwe sustanza mhux attiva u għal residwi ta' traċċa eż. formaldehyde, benzonase, jew sucrose.
English: Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Maltese: Vaċċin kontra l-influwenza pandemika (H5N1) (virijon sħiħ, inattivat, ippreparat f'koltura taċ-ċelluli)
English: The frequency cannot be estimated from the available data.
Maltese: Ma tistax tittieħed stima tal-frekwenza mid-data disponibbli.
English: • fits
Maltese: • mejt
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Maltese: Ir-rati tas-seronewtralizzazzjoni (tajter MN ta' ≥ 20) wara 21 jum wara l-vaċċin booster bid-doża ta' 7.5 µg wara 12 sa 24 xahar minn tilqima tar-razza A/Indoneżja/05/2005, ittestjati kontra kemm razez omologi kif ukoll eterologi, kienu kif ġej:
English: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances be administered intravascularly.
Maltese: • PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ma għandu qatt u taħt l-ebda ċirkostanza jingħata ġol-vini.
English: Sudden hearing loss
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: • if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at the end of the leaflet) or to formaldehyde, benzonase or sucrose.
Maltese: • jekk kellek kwalunkwe reazzjoni allerġika għal kwalunkwe sustanza li tinsab fil-vaċċin (ara sezzjoni 6 fl-aħħar tal-fuljett) jew għal formaldehyde, benzonase jew sucrose.
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI.
Maltese: Lil hinn mill-perijodu pandemiku, il-perijodiċità normali u l-format tar-Rapporti Perijodiċi t'Aġġornament dwar is-Sigurtà se jinżammu b'reviżjoni speċifika ta' AESI.
English: • dizziness
Maltese: • aċċessjonijiet
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Maltese: Fil-35 jum, l-inmsa kollha ġew sfidati mill-imnieħer b'doża qawwija tar-razza virulenti ħafna tal-virus H5N1, A/Vjetnam/1203/2004, u mmonitorjati għal 14-il jum.
English: Other medicines and PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Maltese: Mediċini oħra u PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Maltese: “Demijelinazzjoni” SMQ dejjaq (peress li s-Sindromu ta'Guillain Barré huwa inkluż ukoll f'dan l-SMQ, jista' jkun hemm għadd ta' każijiet li jidħlu f'xulxin għal dawn iż-żewġ kategoriji).
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people subjects.
Maltese: Il-profil tas-sigurtà f'persuni immunokompromessi u pazjenti b'kundizzjonijiet ta' mard kroniku hu simili għall-profil tas-sigurtà f'pazjenti adulti u dawk aktar anzjani b'saħħithom.