FrancophonIA/ELRC3.0 huggingface dataset:
English: BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: BTVPUR huwa vaċċin li jintuża fin-nagħaġ u fil-frat biex jipproteġihom kontra l-marda tal-ilsien blu, infezzjoni kkawżata mill-virus tal-marda tal-ilsien blu li jiġi trażmess mill-insetti dipteri.
English: (Bluetongue virus inactivated vaccine containing either serotype 1, 2, 4 or 8 or a combination of any two)
Maltese: BTVPUR1 (Vaċċin inattivat tal-virus tal-marda tal-ilsien blu li fih jew serotip 1, 2, 4 jew 8 jew kombinazzjoni ta' kwalunkwe tnejn minnhom)
English: BTVPUR
Maltese: Fil-futur,
English: The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8.
Maltese: L-istudji wrew li l-vaċċin huwa sigur għan-nagħaġ u għall-frat u li jnaqqas is-sinjali tal-marda u jipprevjeni l-viremija fl-annimali mill-età ta' xahar li huma infettati bis-serotipi 1,4 u 8 tal-virus talmarda tal-ilsien blu.
English: The studies also showed that the vaccine reduces the signs of the disease in sheep and prevents viraemia in sheep and cattle from one month of age that are infected with bluetongue virus serotype 2.
Maltese: L-istudji wrew ukoll li l-vaċċin inaqqas is-sinjali tal-marda fin-nagħaġ u jipprevjeni viremija fin-nagħaġ u fil-frat mill-età ta' xahar li huma infettati bis-serotip 2 tal-virus tal-marda talilsien blu.
English: Further laboratory studies were conducted in calves using a vaccine containing bluetongue serotype 2 and in sheep and calves using a vaccine containing bluetongue serotype 4.
Maltese: Saru aktar studji fil-laboratorju fi frat permezz ta' vaċċin li fih serotip 2 tal-marda tal-ilsien blu u fin-nagħaġ u fil-frat permezz ta' vaċċin li fih serotip 4 tal-marda tal-ilsien blu.
English: How is BTVPUR used?
Maltese: Kif jaħdem BTVPUR?
English: The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 2, 4 or 8 or a combination of any two of these.
Maltese: Il-varjetà (serotip) tal-virus fil-vaċċin tintgħażel skont liema serotipi jkunu qegħdin jiċċirkolaw u jikkawżaw il-marda fil-ħin tal-produzzjoni, għalhekk jista' jkun fih is-serotip 1, 2, 4 jew 8 jew kombinazzjoni ta' kwalunkwe tnejn minn dawn.
English: The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age.
Maltese: L-effikaċja tal-vaċċin ġiet studjata fi studji fil-laboratorju bl-użu ta' vaċċini li fihom is-serotip 1 talmarda tal-ilsien blu, is-serotip 8 tal-marda tal-ilsien blu, jew it-tnejn, fin-nagħaġ u fil-frat ta' età żgħira.
English: The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease and has bluetongue virus antibodies.
Maltese: L-ewwel injezzjoni tingħata minn età ta' xahar f'annimali li qatt ma kienu esposti għall-marda, u minn età ta' xahrejn u nofs jekk omm l-annimal tkun diġà immuni għall-marda u jkollha antikorpi tal-virus tal-marda tal-ilsien blu.
English: The European Medicines Agency decided that BTVPUR's benefits are greater that its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' BTVPUR huma akbar mir-riskji tiegħu u li jista' jkun awtorizzat għall-użu fl-UE.
English: Date of latest renewal: 28 November 2017
Maltese: Data tal-aħħar tiġdid: 28 ta' Novembru 2017
English: See sections 4.4, 4.8 and 6.1.
Maltese: Ara sezzjonijiet 4.4, 4.8 and 6.1.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/453/002
Maltese: EU/1/08/453/002
English: See sections 4.4, 4.8 and 5.1.
Maltese: Ara sezzjonijiet 4.4, 4.8 u 5
English: Prepandrix contains thiomersal
Maltese: Prepandrix fih thiomersal
English: Prepandrix contains sodium and potassium
Maltese: Prepandrix fih sodium u potassium
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (76.6%), muscle aches (46.8%), fatigue (43.6%), headache (25.3%) and joint pain
Maltese: F'adulti bejn l-età ta' 18 u 60 sena, ir-reazzjonijiet avversi rrappurtati l-aktar frekwenti wara t-tilqim kienu uġigħ fis-sit tal-injezzjoni (76.6%), uġigħ fil-muskoli (46.8%), għeja (43.6%), uġigħ ta' ras (25.
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Maltese: Ir-rata ta' seroprotezzjoni kontra A/Indonesia 21 ġurnata wara t-tilqima booster kienet ta' 92% u ta' 69.2% f'ġurnata 180.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Maltese: Vaċċini ta' l-influwenza, Kodiċi ATC J07BB02 Effetti farmakodinamiċi
English: anti-HA antibody
Maltese: Antikorp anti-HA
English: Active immunisation against H5N1 subtype of Influenza A virus.
Maltese: Tilqim attiv kontra sottotip H5N1 tal-virus ta' l-Influwenza A.
English: Prepandrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Prepandrix fih thiomersal bħala preservattiv u huwa possibbli li inti jista' jkollok reazzjoni allerġika.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: Komuni ħafna (≥1/10) Komuni (≥1/100 sa <1/10) Mhux komuni (≥1/1,000 sa <1/100)
English: Prepandrix is a vaccine for use in adults from 18 years old.
Maltese: Prepandrix huwa vaċċin għall-użu fl-adulti ta' età minn 18-il sena.
English: The vaccine contains an ‘adjuvant' AS03.
Maltese: Il-vaċċin fih ‘suppliment' AS03.
English: Antigen suspension for injection 50 vials: suspension
Maltese: Suspensjoni tal-antiġen għall-injezzjoni 50 kunjett: suspensjoni
English: Adults from the age of 18 years:
Maltese: Adulti mill-età ta' 18- il sena:
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Maltese: Minbarra sorveljanza ta' wara t-tqegħid fis-suq fuq vaċċini trivalenti interpandemiċi, ir-reazzjonijiet avversi li ġejjin kienu rrappurtati:
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 tal metodu ELISA għal antikorpi tal-virus-1 ta' l-immunodefiċjenza umana (HIV-1), tal-virus ta'l-epatite C u speċjalment ta' l-HTLV-1.
English: * propagated in eggs ** haemagglutinin
Maltese: * propogat fil-bajd ** emagglutinina
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Maltese: Is-sustanzi l-oħra huma: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, ilma għall-injezzjonijiet.
English: Other medicines and Prepandrix
Maltese: Mediċini oħra u Prepandrix
English: For the full list of excipients see section 6.1.
Maltese: Għal-lista kompluta ta'eċċipjenti, ara sezzjoni 6.1.
English: List of adverse reactions Adverse reactions reported are listed according to the following frequency:
Maltese: Lista ta' reazzjonijiet avversi Reazzjonijiet avversi rrappurtati huma elenkati skond il-frekwenza li ġejja:
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 (prodott organomerkuriku) bħala preservattiv u għalhekk hemm il-possibilta` ta' reazzjonijiet ta' sensittivita` (ara sezzjoni 4.4).
English: Prepandrix should under no circumstances be administered intravascularly.
Maltese: Prepandrix m'għandu qatt jingħata b'mod intravaskulari.
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Maltese: Komuni ħafna: ebusija tal-ġilda, nefħa, uġigħ u ħmura fis-sit ta' l-injezzjoni, deni, għeja Komuni: tregħid, mard bħal ta' l-influwenza, reazzjonijiet fis-sit ta' l-injezzjoni (bħal sħana, ħakk) Mhux komuni: telqa
English: Single dose N=48
Maltese: Doża singla N=48
English: Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
Maltese: Respons immunitarju għal A/Vietnam/1194/2004 (D42) Minn 61 sa 70 sena Minn 71 sa 80 sena
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 disturbi transitorji fil-vista, paresteżija u movimenti toniċi-kloniċi tar-riġlejn u d-dirgħajn matul l irkupru.
English: Prepandrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Maltese: Prepandrix fih anqas minn 1mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg) f'kull doża.
English: Single dose N=13
Maltese: Doża singla N=13
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Maltese: Is-sinjali ta' l-influwenza pandemika huma simili għal dawk ta' l-influwenza normali imma jistgħu ikunu aktar serji.
English: A difference in the frequency of local and general solicited adverse reactions between half adult and adult doses was observed after each dose.
Maltese: Differenza fil-frekwenza tar-reazzjonijiet avversi mqanqla, lokali u ġenerali, bejn nofs id-doża tal adulti u d-doża sħiħa tal-adulti ġiet osservata wara kull doża.
English: Shivering NA=not available
Maltese: Tertir NA=mhux disponibbli
English: How Prepandrix works
Maltese: Prepandrix.
English: Single dose N=91
Maltese: Doża singla N=91
English: Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Maltese: mikrogrammi ta' HA ġew ittesjati fl-esperiment ta' sfida omologu, u dożi ta' 15, 7.5, 3.8 jew 1.75
English: AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Maltese: Is-suppliment AS03 magħmul minn squalene, DL-α-tocopherol u polysorbate 80 * emagglutinina
English: Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Maltese: Mhux komuni: sintomi gastro-intestinali (bħal dijarea, rimettar, uġigħ addominali, dardir)
English: Excipient with known effect The vaccines contains 5 micrograms thiomersal (see section 4.4).
Maltese: Il-vaċċin fih 5 mikrogrammi thiomersal (ara sezzjoni 4.4).
English: Nervous system disorders Febrile convulsions
Maltese: Disturbi fis-sistema nervuża Aċċessjonijiet bid-deni
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħżin wara t-taħlit tal-prodott mediċinali, ara s-sezzjoni 6.3.
English: In subjects > 60 years of age, the most frequently reported adverse reaction after vaccination was injection site pain (32.6%).
Maltese: F'individwi li għandhom > 60 sena, ir-reazzjoni avversa rrappurtata l-aktar frekwenti wara t-tilqim kienet uġigħ fis-sit tal-injezzjoni (32.6%).
English: • From 18 years onwards: you will receive two doses of Prepandrix.
Maltese: • Minn 18-il sena 'l fuq: inti se tirċievi żewġ dożi ta' Prepandrix.
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Maltese: L-inmsa kienu mlaqqma fil-ġranet 0 u 21 u ngħataw doża ta' sfida ġot-trakea fil-ġurnata 49 b'doża letali ta' H5N1/A/Vietnam/1194/04 jew H5N1/A/Indonesia/5/05 eterologu.
English: Psychiatric disorders Uncommon: insomnia
Maltese: Mhux komuni: insomnja
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Maltese: Respons immuni għal A/Vietnam/1194/2004 skeda 0, 21 ġurnata
English: 2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml)
Maltese: 2.5 ml Wara li jitħallat mal-emulsjoni tal-istimulant: 10 dożi (ta' 0.5 ml)
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, stimulat)
English: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
Maltese: Razza tixbaħ A/Indonesia/05/2005 (H5N1) użat (PR8-IBCDC-RG2) 3.75 mikrogrammi**
English: 50 vials: emulsion (adjuvant)
Maltese: 50 kunjett: suspensjoni (antiġen) 50 kunjett: emulsjoni (stimulant)
English: In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Maltese: Barra minn hekk, 44.8% u 56.1% tal-individwi fi gruppi ta' dożi rispettivi kellhom żjieda ta' 4-darbiet aktar fit-titri ta' antikorpi newtraliżżanti fis-serum minn ġurnata 0 sa ġurnata 42 u 96.6% u 100% tal individwi kellhom titru ta' almenu 1:80 f'ġurnata 42.
English: • From 80 years onwards: you may receive two double injections of Prepandrix.
Maltese: • Minn 80 sena 'l fuq: inti tista tieħu żewġ injezzjonijiet doppji ta' Prepandrix.
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Maltese: Mard newroloġiku, bħal enċefalomajelite, newrite u s-sindrome ta' Guillain Barré.
English: • Other ingredients:
Maltese: • Suppliment:
English: The safety and efficacy of Prepandrix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Prepandrix fit-tfal b'età anqas minn 3 snin u fi tfal u adolexxenti bejn l-età ta' 10 u 17-il sena għadhom ma ġewx determinati s'issa.
English: Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Maltese: Respons immuni cross-reactive misluta minn vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Indonesia/5/2005 (H5N1)
English: Clinical data in children less than 6 years of age who received two doses of pandemic preparedness or zoonotic influenza vaccine (H5N1) 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 ta' preparazzjoni ghal pandemika jew vaċċin ta' l-influwenza żoonotika (H5N1) indika żieda fil-frekwenza tad-deni (awżiljarju≥38°C) wara l-amministrazzjoni tat-tieni doża.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Maltese: Dan is-suppliment fih squalene (10.69 milligrammi), DL-αtocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi).
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 0.5 ml vaccine
Maltese: Il-volum wara li jitħallat kunjett 1 ta' suspensjoni (2.5ml) ma' kunjett 1 ta' emulsjoni (2.5ml) jikkorrispondi għal 10 dożi ta' 0.5 ml ta' vaċċin
English: Immune response to A/Indonesia/5/2005 6 to 9 years
Maltese: Rispons immuni għal A/Indonesia/5/2005 6 sa 9 snin
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Maltese: Għoti ta' tilqima awżiljata b'AS03 li fiha 3.75 µg ta' HA mnissla minn A/Vietnam/1194/2004 (H5N1)
English: Split influenza virus inactivated, containing antigen* equivalent to:
Maltese: Virus tal-influwenza maqsum, inattivat, li fih antiġen* ekwivalenti għal:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals
English: Animal studies with Prepandrix containing A/Vietnam/1194/2004 do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali b'Prepandrix li fih A/Vietnam/1194/2004 ma jindikawx tossiċita fuq is-sistema ripproduttiva (ara sezzjoni 5.3).
English: • They will give Prepandrix as an injection into a muscle.
Maltese: • Huma se jagħtu Prepandrix bħala injezzjoni ġol-muskolu.
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: Suppliment AS03 magħmul minn squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi)
English: Emulsion vial:
Maltese: Popolazzjoni speċjali:
English: • Adjuvant:
Maltese: Tfal:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' rapporti perjodiċi ta' aġġornament dwar is-sikurezza għal dan il prodott mediċinali huma stabbiliti fil-lista ta' dati ta' riferenza tal-Unjoni (EURD list) previsti skont lArtiklu 107c(7) tad-Direttiva 2001/83/KE u kull aġġornament sussegwenti ppublikata fuq il-webportal tal-mediċini Ewropej.
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Maltese: Din l-indikazzjoni hija bbażata fuq dejta ta' immunoġeniċità minn individwi b'saħħithom mill-età ta' 18-il sena ‘l fuq wara amministrazzjoni ta' żewġ dożi ta' vaċċin ippreparati b'subtipi ta' H5N1 (ara sezzjoni 5.1).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 14 ta' Mejju 2008
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21.
Maltese: Fi studju kliniku (D-Pan-H5N1-012), individwi ta' eta' ta' bejn it-18-60 sena ingħataw doża ta' vaċċin stimulat b'ASO3 li fih 3.75μg HA derivat jew minn A/Vietnam/1194/2004 jew minn Indonesia/5/2005 sitt xhur wara li kienu ħadu doża jew tnejn inizjali ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004 f'ġurnata 0 jew fi ġranet 0 u 21.
English: In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
Maltese: Fi studji kliniċi fejn individwi (N=201) irċevew Prepandrix li fih 3.75 mikrogrammi HA/AS03 tar razza A/Indonesia/05/2005 (H5N1), it-tipi u l-frekwenzi ta' reazzjonijiet avversi kienu komparabbli ma' dawk irrapurtati hawn taħt.
English: Immune response against A/Indonesia/05/2005 (H5N1) In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows: anti-HA antibody
Maltese: derivati minn A/Indonesia/05/2005 ingħataw fi ġranet 0 u 21 lil 140 individwu ta' eta' 18-60 sena, irresponsi ta' l-antikorp anti-HA kienu kif ġej:
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix
Maltese: Suspensjoni għal emulsjoni għall-injezzjoni għal Prepandrix
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Maltese: 1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ta' Fi studju kliniku ieħor (D-Pan-H5N1-010), 297 individwu ta' eta ta' >60 sena (stratifikati fi gruppi minn 61 sa 70, 71 sa 80 u >80 sena) ħadu jew doża ważda jew doppja ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivati minn A/Vietnam/1194/2004
English: A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose.
Maltese: Żjieda ta' 4-darbiet fuq it-titri ta' antikorpi newtraliżżanti fis-serum kontra A/Vietnam ġiet ottenuta f'49% tal-individwi wieħed u għoxrin ġurnata wara l-ewwel doża, 67.3% wieħed u għoxrin ġurnata wara t-tieni doża u 44.9% sitt xhur wara t-tieni doża.
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Maltese: - pakkett wieħed ta' 50 kunjett (ħġieġ tat-tip I) ta' 2.5 ml suspenjoni b'tapp (gomma butyl). - żewġ pakketti ta' 25 kunjett (ħġieġ tat-tip I) ta' 2.5 ml emulsjoni b'tapp (gomma butyl).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Maltese: 3.75 mikrogrammi emagglutinina/doża *Antiġen: razza tixbaħ lil A/Indonesia/05/2005 (H5N1) użata (PR8-IBCDC-RG2)
English: An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart.
Maltese: Intervall ta' dożaġġ estiż ġie investigat fi studju D-H5N1-012 li fih, grupp ta' individwi ta' 18-60 sena rċieva żewġ dożi ta' Prepandrix li kien fih ir-razza A/Vietnam/1194/2004, 6 xhur jew 12-il xahar il bogħod minn xulxin.
English: Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Prepandrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Maltese: Studji epidemijoloġiċi li għandhom x'jaqsmu ma' vaċċin aġġuvantat AS03 ieħor (Pandemrix H1N1, immanifatturat ukoll fl-istess faċilità bħal Prepandrix), f'bosta pajjiżi Ewropej indikaw riskju miżjud ta' nakrolepsija bi jew mingħajr cataplexy f'individwi mlaqqmin meta mqabbla ma' individwi mhux imlaqqmin.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Maltese: Storja ta' reazzjoni anafilattika (i.e. li tista' twassal għall-mewt) għal kwalunkwe wieħed millkostitwenti jew traċċi ta' residwi (proteina tal-bajd u tat-tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate u sodium deoxycholate) ta' dan il-vaċċin.