FrancophonIA/ELRC3.0 huggingface dataset:
English: No fertility data are available.
Maltese: Fertilità M'hemmx dejta disponibbli dwar il-fertilità.
English: Immune response against A/Indonesia/5/2005 (H5N1)
Maltese: Rispons immuni kontra A/Indonesia/5/2005 (H5N1) Adulti
English: The vaccine contains an ‘adjuvant' AS03.
Maltese: Il-vaċċin fih ‘stimulant', AS03.
English: Ear and labyrinth disorders Uncommon: vertigo
Maltese: Mhux komuni: vertigo
English: A titre of 1:80 was achieved in 84.2% of subjects aged 18-60 years and in 92.6% of subjects aged >60 years.
Maltese: Titre ta' 1:80 intlaħaq f'84.2% talindividwi b'età minn 18 sa 60 sena u f'92.6% tal-individwi b'età 'l fuq minn 60 sena.
English: 3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT.
Maltese: 3fattur booster: proporzjon tat-titre ġeometriku medju (GMT) wara l-booster u GMT qabel il-booster.
English: Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Maltese: Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
English: Pumarix consists of two containers:
Maltese: Pumarix jikkonsisti minn żewġ kontenituri:
English: • Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘Guillain
Maltese: Problemi fil-moħħ u nervituri bħal infjammazzjoni tas-sistema nervuża ċentrali (enkefalomjelite), infjammazzjoni tan-nervituri (nevrite) jew tip ta' paraliżi magħrufa bħala
English: Adults from the age of 18 years onwards:
Maltese: Adulti b'età minn 18-il sena 'l fuq:
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C).
Maltese: 8°C) jew f'temperatura tal-kamra (25°C - 30°C).
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 tilqim għall-influwenza, jistgħu jinkisbu riżultati pożittivi foloz f'testijiet seroloġiċi bl-użu talmetodu ELISA għall-antikorpi għall-virus-1 tal-immunodefiċjenza umana (HIV-1), tal-epatite Ċ u speċjalment tal-HTLV-1.
English: • Adults from 18 years onwards: you will receive one dose of Pumarix.
Maltese: • Adulti minn 18-il sena 'l fuq: inti se tirċievi żewġ dożi ta' Pumarix.
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Maltese: 2 żjieda ta' 4 darbiet aktar fit-titre ta' antikorpi newtralizzanti fis-serum 3 % ta' individwi li laħqu titre ta' antikorpi newtralizzanti fis-serum ta' mill-inqas 1:80
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: Dejta miksuba bil-vaċċin mock-up ssostni strateġija ta' tilqim li aktarx tintuża għall-vaċċin pandemiku: dejta ta' immunoġeniċità, sigurtà u reattoġeniċità klinika miksuba bil-vaċċini mock-up hija rilevanti għall-vaċċini pandemiċi.
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 mill-perijodu pandemiku, ser tinżamm il-perjodiċità u l-format normali tal-PSUR, filwaqt li jiġu riveduti AESI u avvenimenti avversi possibli relatati ma' supplimenti.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes).
Maltese: Qabel ma tħallat iż-żewġ komponenti, l-emulsjoni (stimulant) u s-suspensjoni (antiġen) għandhom jinġiebu għal temperatura tal-kamra (ħalli mill-inqas 15-il minuta).
English: Pumarix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Maltese: Pumarix fih sodium u potassium Pumarix fih anqas minn 1 mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg)
English: In such cases, the Western blot method is negative.
Maltese: F'każijiet bħal dawn, il-metodu Western blot huwa negattiv.
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Maltese: Żjieda ta' 4 darbiet aktar fl-antikorpi newtralizzanti fis-serum kontra A/Vietnam/1194/2004 intlaħqet f'44.7% tal-individwi f'ġurnata 21, fi 53.2% f'ġurnata 42 u fi 38.3% f'ġurnata 180.
English: nd dose
Maltese: Nofs doża
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Maltese: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, ilma għall-injezzjonijiet
English: Split influenza virus, inactivated, containing antigen* equivalent to:
Maltese: Virus maqsum, mhux attivat tal-influwenza li jkun fih antiġen* ekwivalenti għal:
English: Full dose N=29
Maltese: N=29
English: Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Maltese: H5N1 mal-istimulant AS03 kienet kapaċi tipproteġi kontra l-mortalità u tnaqqas il-viral loads u ttixrid tal-virus.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jkun akkompanjat minn diversi sinjali newroloġiċi bħal disturb transitorju fil-vista, parasteżija u movimenti toniċi-kloniċi tar-riġlejn u d-dirgħajn matul lirkupru.
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: Dan il-prodott mediċinali fih thiomersal (kompost organomerkuriku) bħala preservattiv u għalhekk hemm il-possibbiltà ta' reazzjonijiet ta' sensibilizzazzjoni (ara sezzjoni 4.4).
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Maltese: Wara li jiġi mħallat mal-emulsjoni tal-istimulant: 10 dożi ta' 0.5ml
English: At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years
Maltese: F'ġurnata 42, 100% tal-individwi b'età minn 18 sa 60 sena u 96.4% tal-individwi b'età > 60 sena kellhom titre ta' mill-inqas 1:80.
English: PSURs
Maltese: GmbH.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Maltese: Ir-rilevanza klinika ta' titre tal-inibizzjoni tal-emagglutinazzjoni (HI) titre ta' ≥1:40 fit-tfal mhux
English: During a pandemic situation (Phase 6 of the WHO global Influenza preparedness plan), bi-weekly "simplified PSUR" accompanied by a summary of vaccine distribution will be provided according to the cRMP guidance (Doc.
Maltese: Waqt sitwazzjoni pandemika (Fażi 6 tal-Pjan ta' tħejjija globali għall-influwenza tad-WHO), ser jiġi pprovdut "PSUR simplifikat" kull ġimagħtejn akkumpanjat minn sommarju tat-tqassim tal-vaċċin skont il-linji gwida tas-cRMP (Dok. Ref.
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Maltese: - żewġ pakketti ta' 25 kunjett (ħġieġ tat-tip I) ta' 2.5 ml ta' emulsjoni b'tapp (butyl rubber).
English: GlaxoSmithKline Kft.
Maltese: GlaxoSmithKline AB
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Maltese: Il-volum wara li jitħallat kunjett wieħed ta' suspensjoni (2.5 ml) ma' kunjett wieħed ta' emulsjoni (2.5 ml) jikkorrispondi għal 10 dożi ta' vaċċin (5 ml)
English: In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain
Maltese: F'individwi b'età > 64 sena, ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti wara t-tilqima kienu uġigħ fis-sit tal-injezzjoni (58.0%), uġigħ fil-muskoli (19.7%), għeja (13.5%), uġigħ ta' ras
English: Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet have this capability.
Maltese: Informazzjoni (IC) jew l-Empirical Bayesian Geometric Mean (EBMG)); dan mhux mandatorju peress li d-Detenturi ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq kollha bħalissa m'għandhomx din
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
Maltese: Stimulant AS03 magħmul minn squalene (10.69 milligramma), DL-α-tocopherol (11.86 milligramma)
English: This medicine has been authorised under 'exceptional circumstances'.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Redness
Maltese: INDIVIDWALI
English: Pumarix should under no circumstances be administered intravascularly.
Maltese: Pumarix m'għandu qatt jingħata b'mod intravaskulari.
English: Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest
Maltese: Komuni: ħmura fis-sit tal-injezzjoni, nefħa fis-sit tal-injezzjoni, deni, tregħid Mhux komuni: reazzjonijiet fis-sit tal-injezzjoni (bħal tbenġil, ebusija, ħakk, sħana), astenja, uġigħ fis
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination.
Maltese: Fi studju kliniku (Q-Pan-H5N1-010), doża booster ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Turkey/Turkey/1/2005 ingħatat 15-il xahar wara l-ewwel tilqima.
English: Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo.
Maltese: Studji kliniċi evalwaw l-inċidenza ta' reazzjonijiet avversi f'madwar 4,500 individwu b'età minn 18-il sena 'l fuq li rċevew Pumarix jew plaċebo.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Your doctor or nurse will give you Pumarix.
Maltese: It-tabib jew l-infermier tiegħek se jagħtuk Pumarix.
English: 3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80
Maltese: Stimulant AS03 magħmul minn squalene, DL-α-tocopherol u polysorbate 80
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Maltese: Disturbi newroloġiċi, bħal enċefalomjelite, nevrite u s-sindrome ta' Guillain Barré.
English: The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03
Maltese: Ir-riżultati ta' dan l-istudju ta' sfida eterologa jindikaw 80.7%-100% ta' protezzjoni f'kull vaċċin kandidat stimulat meta mqabbel ma' 43% ta' protezzjoni b'vaċċin mhux stimulat, u b'hekk juru l-benefiċċju ta' stimulazzjoni b'AS03.
English: In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows:
Maltese: Fi studju kliniku ieħor (Q-Pan-H5N1-001), ir-rispons anti-HA kontra A/Vietnam/1194/2004 wara l għoti ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Indonesia/5/2005 kien kif ġej:
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 l-vaċċin, is-sistema ta' difiża naturali tal-ġisem (sistema immuni) tipproduċi protezzjoni għaliha nnifisha (antikorpi) kontra l-marda.
English: Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Pumarix fih thiomersal bħala preservattiv u huwa possibbli li jista' jkollok esperjenza ta' reazzjoni allerġika.
English: Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali b'Pumarix ma jindikawx tossiċità fis-sistema ripproduttiva (ara sezzjoni 5.3).
English: - First data-lock point is 14 days later.
Maltese: - L-ewwel punt ta' waqfien tad-dejta huwa 14-il ġurnata wara.
English: Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%.
Maltese: Għaxart ijiem wara d-doża booster, ir-rata ta' seroprotezzjoni kontra A/Turkey/Turkey/1/2005 u kontra
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Maltese: Passat ta' reazzjoni anafilattika (i.e. ta' periklu għall-ħajja) għal xi wieħed mill-kostitwenti jew traċċi ta' residwi (proteini tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde u sodium deoxycholate) ta' dan il vaċċin.
English: Split influenza virus, inactivated, containing antigen* equivalent to: A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml
Maltese: Virus tal-influwenza maqsum, inattivat, li fih antiġen* ekwivalenti għal: Razza li tixbaħ lil A/H5N1/Indonesia/5/2005 intużat (PR8-IBCDC-RG2) 3.75 mikrogramma
English: - In Tables 1 to 5, numbers will be provided for events received during the reporting period and
Maltese: - F'Tabelli 1 sa 5, ser ikunu pprovduti numri għall-avvenimenti li waslu waqt il-perijodu ta'
English: Suspension and emulsion for emulsion for injection.
Maltese: Suspensjoni u emulsjoni għall-emulsjoni għall-injezzjoni.
English: EXP:
Maltese: JIS:
English: • Feeling dizzy
Maltese: • Thossok sturdut
English: Adults from the age of 18 years onwards: one dose of 0.5 ml at an elected date.
Maltese: Adulti b'età minn 18-il sena 'l fuq: doża waħda ta' 0.5 ml f'data magħżula.
English: In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age.
Maltese: F'ġurnata 42 fl-istudju ta' konsistenza (Q-Pan-H5N1-002), żjieda ta' 4 darbiet aktar fl-antikorpi li jinnewtralizzaw fis-serum kontra A/Vietnam/1194/2004 inkisbet f'65.5% tal-individwi b'età minn 18 sa 60 sena u f'24.1% tal-individwi b'età 'l fuq minn 60 sena.
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Maltese: - pakkett wieħed ta' 50 kunjett (ħġieġ tat-tip I) ta' 2.5 ml ta' suspenjoni b'tapp (butyl rubber).
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 listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde and sodium
Maltese: Attenzjoni hija meħtieġa meta dan il-vaċċin jingħata lil persuni b'sensittività eċċessiva magħrufa (minbarra reazzjoni anafilattika) għas-sustanza attiva, għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1, għal thiomersal u għar-residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin,
English: Protocol of the registry will be submitted as part of RMP, during the pandemic
Maltese: RMP, matul il-pandemija
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate.
Maltese: • jekk xi darba kellek reazzjoni allerġika li ma kenitx f'daqqa u ta' periklu għal-ħajja għal xi sustanza ta' dan il-vaċċin (elenkati fis-Sezzjoni 6) jew għal thiomersal, proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde jew sodium deoxycholate.
English: In adults 18 to 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (80.5%), muscle aches (37.2%), fatigue (25.2%), headache (25.1%), joint pain
Maltese: 5%), uġigħ fil-muskoli (37.2%), għeja (25.2%), uġigħ ta' ras (25.
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin kontra l-influwenza pandemika (H5N1) (virion maqsum, mhux attivat, stimulat)
English: Half dose N=44
Maltese: N=44
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre
Maltese: 3fattur ta' serokonverżjoni: proporzjon tat-titre ġeometriku medju (GMT) wara t-tilqim u GMT qabel
English: Suspension and emulsion for emulsion for injection
Maltese: Suspensjoni u emulsjoni għall-emulsjoni għall-injezzjoni
English: Fertility
Maltese: Treddigħ
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 tal-influwenza normali imma jistgħu jkunu aktar serji.
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Maltese: Il-ħila li tikkaġuna protezzjoni kontra razez omologi u eteroloġi tal-vaċċin kienet stmata b'mod mhux kliniku b'A/Indonesia/05/05 (H5N1) bl-użu ta' mudelli ta' sfida f'nemes.
English: A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180.
Maltese: intlaħqet f'76.6% tal-individwi f'ġurnata 21, 97.9% f'ġurnata 42 u 91.5% f'ġurnata 180 u 100% tal individwi kellhom titre ta' mill-inqas 1:80 fi ġranet 42 u 180.
English: Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine (H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose.
Maltese: Dejta klinika fi tfal iżgħar minn 6 snin li rċevew żewġ dożi tal-vaċċin tal-influwenza Pandemika H5N1, tindika żieda fil-frekwenza tad-deni (awżiljarju≥38°C) wara l-amministrazzjoni tat-tieni doża.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva IB Biomedical Corporation of Quebec doing business as
English: A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Maltese: Valutazzjoni kumulattiva tal-avvenimenti kollha rrappurtati waqt dan il-perijodu, stratifikata skont it-tip ta' rapportatur (pazjent jew professjonist fil-kura tas-saħħa), serjetà, kemm mistenni, u jekk spontanju jew soliċitat.
English: Non-clinical data obtained with Pumarix reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Maltese: Tagħrif mhux kliniku ottenut dwar Pumarix, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, effett tossiku fuq il-fertilità tal-mara, fuq l-embriju u l-fetu u wara t-twelid (sa tmiem il-perijodu ta' treddigħ), ma juri l-ebda
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pumarix
Maltese: Suspensjoni għall-emulsjoni għall-injezzjoni għal Pumarix
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Maltese: It-tilqim għandu jsir permezz ta' injezzjoni ġol-muskoli preferibbilment fil-muskolu deltojd jew finnaħa anterolaterali tal-koxxa (skont il-massa tal-muskolu).
English: Full dose N=41
Maltese: N=41
English: Half dose N=43
Maltese: N=43
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Sigurta', il-Pjan ta' Farmakoviġilanza jew l-attivitajiet ta' minimizzazzjoni tar-riskju
English: Musculoskeletal and connective tissue disorders Very common: joint pain, muscle aches
Maltese: Disturbi muskolu-skeletrali u tat-tessuti konnettivi
English: Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
Maltese: Il-gruppi ta' kontroll kienu jinkludi inmsa mlaqqma b'stimulant biss u b'vaċċin mhux stimulat (7.5 mikrogrammi ta' HA).
English: NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection.
Maltese: Pumarix suspensjoni u emulsjoni għall-emulsjoni għall-injezzjoni.
English: The anti-HA
Maltese: U L-UŻU
English: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Maltese: *Antiġen: intużat razza li tixbaħ lil A/Indonesia/5/2005 (H5N1) (PR8-IBCDC-RG2)
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Maltese: 1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ≥
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different
Maltese: Doża waħda ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Indonesia/5/2005 manifatturat bl-użu ta' proċess differenti mogħti wara doża waħda jew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004 manifatturat bl-użu ta' proċess differenti
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03.
Maltese: F'dan l-esperiment ta' protezzjoni, l-inmsa (sitt inmsa/grupp) kienu mlaqqma fil-muskoli b'vaċċin kandidat li fih tliet dożi differenti tal-antiġen H5N1 (7.5, 3.8 u 1.9 µg tal-antiġen HA) stimulat b'doża jew nofs doża stàndard ta' AS03.
English: In a clinical study (D-Pan-H5N1-009, -023), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75
Maltese: Fi studju kliniku (D-Pan-H5N1-009, -023), tfal b'età minn 3 snin sa 5 snin u minn 6 snin sa 9 snin irċevew żewġ dożi ta' doża sħiħa (0.5 ml) jew ta' nofs doża (0.25 ml) ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004
English: The per-dose frequency of local and general solicited adverse reactions observed in the groups of children who received two adult (0.5 ml) doses was higher than that observed in the groups of children who received two half adult (i.e. 0.25 ml) doses, except for redness in the 6-9 years of age group.
Maltese: Il-frekwenza għal kull doża tar-reazzjonijiet avversi mqanqla, lokali u ġenerali osservati fil-gruppi ta' tfal li rċevew żewġ dożi tal-adulti (0.5 ml) kienet ogħla minn dik osservata fil-gruppi ta' tfal li rċevew żewġ nofs dożi tal-adulti (i.e. 0.25 ml), ħlief għall-ħmura fil-grupp ta' età minn 6 snin sa 9 snin.
English: Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension.
Maltese: Jistgħu jiġu osservati sedimenti bojod fil-kunjett tas-suspensjoni; dawn is-sedimenti huma parti mid-dehra fiżika normali tas-suspensjoni.