FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Krka are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Emtricitabine/Tenofovir disoproxil Krka jiġu evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa għall-protezzjoni tal-pazjenti.
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Krka?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Emtricitabine/Tenofovir disoproxil Krka?
English: 3.75 micrograms**
Maltese: 3.75 mikrogramma**
English: Format of the simplified PSUR
Maltese: Format ta' PSUR simplifikat
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 18 July 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Ottubru 2009 Data tal-aħħar tiġdid: 18 July 2014
English: PT “Neuritis”
Maltese: PT “Nevrite”
English: Uncommon: insomnia
Maltese: Mhux komuni: insomnja
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Pandemic influenza vaccine (H5N1) (virion maqsum, mhux attivat, stimulat)
English: Older (>60 years)
Maltese: Anzjani (>60 sena)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/578/001
Maltese: EU/1/09/578/001
English: 2.5 ml per vial.
Maltese: 2.5ml kull kunjett.
English: PT “Vaccination failure”.
Maltese: PT “Falliment tal-vaċċin”.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Adjupanrix.
Maltese: Mhux komuni: sintomi gastro-intestinali (bħal dijarea, rimettar, uġigħ fl-addome, dardir) Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: The seroprotection rates were 2.2%, 4.7%, 2.4% and 7.8% at months 6, 12, 24 and 36, respectively.
Maltese: Ir-rati ta' seroprotezzjoni kienu ta' 2.2%, 4.7%, 2.4% u 7.8% f'xahar 6, 12, 24 u 36 rispettivament.
English: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium
Maltese: GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart
English: 0, 6 months schedule (D-Pan-H5N1-012)
Maltese: skeda 0, 6 xhur (D-Pan-H5N1-012)
English: narrow SMQ “Vasculitis” - Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome” - Demyelination:
Maltese: “Vaskulite” b'SMQ dejjaq - Sindrome ta' Guillain-Barré: “Sindrome ta' Guillain-Barré syndrome” b'SMQ dejjaq - Demajlinizazzjoni:
English: At day 180, the seroprotection rate was 13%.
Maltese: F'ġurnata 180, ir-rata ta' seroprotezzjoni kienet ta' 13%.
English: Immune response against A/Indonesia/05/2005 (H5N1)
Maltese: Respons immuni kontra A/Indonesia/05/2005 (H5N1)
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02.
Maltese: Vaċċini ta' l-influwenza, Kodiċi ATC J07BB02.
English: No fertility data are available.
Maltese: Fertilità M'hemm ebda dejta disponibbli dwar il-fertilità.
English: Double dose (N=131)
Maltese: Doża doppja (N=131)
English: Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Maltese: Kontra A/Indonesia 21 ġurnata wara booster b'A/Indonesia N=49
English: Adjupanrix contains thiomersal
Maltese: Adjupanrix fih thiomersal
English: Seroprotection rate*1
Maltese: Rata ta' seroprotezzjoni*1
English: Currently available data are described in section 4.4, 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment hija deskritta fis-sezzjoni 4.4, 4.8 u 5.1, iżda ma tista' tingħata ebda rakkomandazzjoni dwar il-pożoloġija.
English: Frequency of submission
Maltese: Frekwenza ta' sottomissjoni
English: The vaccine contains an ‘adjuvant' AS03.
Maltese: Il-vaċċin fih ‘stimulant' AS03.
English: Contents of the pack and otherinformation
Maltese: Kontenut tal-pakkett u informazzjoni oħra
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 69.2% f'ġurnata 180.
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Maltese: - Sottomissjoni ta' S-PSUR lir-Rapporteur u lis-CHMP f'Ġurnata 45.
English: GMT1
Maltese: GMT1 Rata ta'
English: Adjupanrix contains sodium and potassium
Maltese: Adjupanrix fih sodium u potassium
English: Antigen suspension for injection 50 vials: suspension
Maltese: 50 kunjett: suspensjoni
English: Double dose (N=81)
Maltese: Doża doppja (N=81)
English: - Convulsion:
Maltese: - Konvulżjoni:
English: Month 6 N=48
Maltese: Xahar 6 N=48
English: 50 vials: suspension (antigen) 50 vials: emulsion (adjuvant)
Maltese: 50 kunjett: emulsjoni (suppliment)
English: The percentage of subjects reaching neutralising antibody titres of >1/80 were 54.9% and 44.9% at months 12 and 24, respectively.
Maltese: Il-persentaġġ ta' individwi li laħqu titri ta' antikorpi li jinnewtralizzaw ta' >1/80 kien ta' 54.9% u 44.9% f'xahar 12 u 24, rispettivament.
English: Alternative schedules
Maltese: Skedi alternattivi
English: Uncommon (≥1/1,000 to <1/100)
Maltese: Komuni ħafna (≥1/10) Komuni (≥1/100 to <1/10) Mhux komuni (≥1/1,000 to <1/100) Rari (≥1/10,000 to <1/1,000)
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 Adjupanrix
Maltese: Mediċini oħra u Adjupanrix
English: - First data-lock point is 30 days later.
Maltese: - L-ewwel ‘data-lock point' hija 30 ġurnata wara.
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 għal antikorpi għall-virus-1 ta' l-immunodefiċjenza umana (HIV-1), ta' l-epatite ċ u speċjalment ta' l-HTLV-1.
English: Double dose N=92
Maltese: Doża doppja N=92
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Maltese: Ir-rilevanza klinika tat-titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ≥1:40 fit-tfal mhuwiex magħruf.
English: Sächsisches Serumwerk Dresden Branch of GlaxoSmithKline Biologicals Zirkusstraße 40, D-01069 Dresden Germany
Maltese: Zirkustraße 40, D-01069 Dresden
English: Against A/Vietnam 21 days after boosting with A/Vietnam N=46
Maltese: antikorp anti-HA Kontra A/Vietnam 21 ġurnata wara booster b'A/Vietnam N=46
English: Excipient with known effect The vaccine contains 5 micrograms thiomersal (see section 4.4).
Maltese: Il-vaċċin fih 5 mikrogrammi thiomersal (ara sezzjoni 4.4).
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 vaccin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Indonesia/05/2005 (H5N1)
English: 71 to 80 years
Maltese: Minn 61 sa 70 sena Minn 71 sa 80 sena
English: - Encephalitis:
Maltese: - Anafilassi:
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Maltese: Informazzjoni dwar ir-riżultati minn estimu ta' aktar minn 200,000 mara li ġew imlaqqma waqt it-tqala attwalment hija limitata.
English: Day 42 N=46
Maltese: Jum 42 N=46
English: Double dose N=10
Maltese: Doża doppja N=10
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Maltese: • pakkett wieħed li fih 50 kunjett ta' 2.5 ml suspensjoni (antiġen)
English: GlaxoSmithKline Slovakia s.r.o.
Maltese: Slovenská republika GlaxoSmithKline Slovakia s.r.o.
English: Month N=35
Maltese: Xahar N=35
English: At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6.
Maltese: serokonverżjoni ta' l-antikorp anti-HA kien ta' 98%, l-individwi kollha kienu seroprotetti u l-fattur ta'serokonverżjoni kien ta' 88.6.
English: Month 6 N=40
Maltese: Xahar 6 N=40
English: Month N=38
Maltese: Xahar N=38
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Maltese: Ma kienx hemm evidenza ta' riskju akbar ta' riżultati avversi f'aktar minn 100 tqala li ġew segwiti fi studju kliniku prospettiv.
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, parasteżija u movimenti toniċi-kloniċi tar-riġlejn u d-dirgħajn matul l irkupru.
English: Data obtained with the pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
Maltese: Dejta miksuba bil-vaċċin ta' tħejjija pandemika tiffavorixxi strateġija ta' vaċċinazzjoni li x'aktarx tintuża f'vaċċin pandemiku: dejta dwar immunoġeniċita` klinika, sigurta` u ġeneċita` reattiva miksuba minn vaċċini ta' tħejjija pandemika hi rilevanti għall-vaċċini pandemiċi.
English: Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Maltese: Adjupanrix fih anqas minn 1mmol ta' sodium (23 mg) u anqas minn 1 mmol ta' potassium (39 mg) f'kull doża.
English: It is recommended to equip the syringe with a 23-G needle.
Maltese: Huwa rrakkomandat li s-siringa tiġi mgħammra b'labra 23-G.
English: 7 days after 2nd dose N = 47
Maltese: 7 ijiem wara 2ni doża N = 47
English: Day 42 N=42
Maltese: Jum 42 N=42
English: Subjects from study D-Pan-H5N1-002 were followed up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Maltese: Individwi mill-istudju D-Pan-H5N1-002 kienu segwiti għall-persistenza ta' antikorpi anti-HA kontra A/Indonesia/5/2005.
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: mikrogramma ta' HA ġew ittesjati fl-esperiment ta' sfida omologu, u dożi ta' 15, 7.5, 3.8 jew 1.75
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: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Komuni ħafna: ħmura, nefħa, uġigħ u ħmura fis-sit ta' l-injezzjoni, deni, għejja Komuni: tregħid, mard bħal ta' l-influwenza, reazzjonijiet fis-sit ta' l-injezzjoni (bħal sħana, ħakk)
English: The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
Maltese: Ir-rata ta' seroprotezzjoni, ir-rata ta' serokonverżjoni tal-booster u l-fattur tal-booster kontra A/Indonesia/5/2005 21 ġurnata wara tilqima booster kienu ta' 100%, 99.7% u 123.8, rispettivament.
English: Half dose (N=47)
Maltese: Nofs doża (N=47)
English: NA=not available
Maltese: Tertir NA=mhux disponibbli
English: Prophylaxis of influenza in an officially declared pandemic situation.
Maltese: Profilassi ta' influwenza f'sitwazzjoni ta' influwenza pandemika ddikjarata uffiċjalment.
English: narrow SMQ “Convulsions”
Maltese: "Konvulżjonijet" b'SMQ dejjaq
English: Adjupanrix should under no circumstances be administered intravascularly.
Maltese: Adjupanrix m'għandu qatt jingħata b'mod intravaskulari.
English: - However, in a pandemic situation, you may still be given the vaccine.
Maltese: - Madankollu, f'sitwazzjoni pandemika, xorta għandu mnejn tingħata t-tilqima.
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Maltese: “Reazzjoni anafilattika” b'SMQ dejjaq u "Anġjoedema"
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Maltese: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Ilma għall-injezzjonijiet
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-perjodu pandemiku, tinżamm il-perjodiċita' normali u l-format tal-PSUR, filwaqt li jiġu riveduti AESI u eventi avversi possibli relatati ma' supplimenti.
English: 7 days after 2nd dose
Maltese: 7 ijiem wara t-2ni doża
English: It is essentially sodium- and potassium-free.
Maltese: Huwa essenzjalment mingħajr sodium u potassium.
English: Information from non-clinical studies:
Maltese: Informazzjoni minn studji mhux kliniċi:
English: • They will give Adjupanrix as an injection into a muscle.
Maltese: • Se jagħtu Adjupanrix bħala injezzjoni ġewwa muskolu.
English: Seroconversion factor3
Maltese: serokonverżjoni†3
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Maltese: Dan l-istimulant fih squalene (10.69 milligramma), DL-αtocopherol (11.86 milligramma) u polysorbate 80 (4.86 milligramma).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kontenut: stimulant AS03 magħmul minn squalene (10.69 milligramma), DL-α-tocopherol (11.86 milligramma) u polysorbate 80 (4.86 milligramma)
English: N=47
Maltese: Xahar N=47
English: 3 to 5 years
Maltese: 3 sa 5 snin
English: Immune response to A/Indonesia/05/2005
Maltese: Respons immuni għal A/Indonesia/05/2005
English: The seroprotection rates were 16.3% and 4.7% at months 12 and 24, respectively.
Maltese: Ir-rati ta' seroprotezzjoni kienu ta' 16.3% u 4.7% f'xahar 12 u xahar 24, rispettivament.
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 pandemika jew vaċċin ta' l-influwenza żoonotika (H5N1) tindika żieda fil-frekwenza tad-deni (awżiljarju≥38°C) wara lamministrazzjoni tat-tieni doża.
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: Id-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: 6 to 9 years
Maltese: 6 sa 9 snin
English: Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Maltese: Kienu milħuqa titri ta' antikorpi newtraliżżanti ta' almenu 1:40 jew almenu 1:80 f'87% u 67%, rispettivament, mis-87
English: A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms** per 0.5 ml dose
Maltese: (H5N1) użat (NIBRG-14) 3.75 mikrogramma** f'kull doża ta' 0.5 ml
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 żieda ta' 4-darbiet fit-titri ta' antikorpi newtraliżżanti fis-serum minn ġurnata 0 sa ġurnata 42 u 96.6% u 100% talindividwi kellhom titru ta' almenu 1:80 f'ġurnata 42.
English: What Adjupanrix is and what it is used for Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Maltese: Adjupanrix huwa vaċċin għall-użu fl-adulti minn 18-il sena biex jilqa' kontra l-influwenza pandemika.
English: Very rare: may affect less than 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw lil inqas minn persuna waħda minn kull 10,000
English: Adverse reactions from clinical trials with the pandemic preparedness vaccine are listed here below (see section 5.1 for more information on pandemic preparedness vaccines).
Maltese: Reazzjonijiet avversi minn provi kliniċi b'vaċċin ta' tħejjija pandemika huma elenkati hawn taħt (ara sezzjoni 5.1 għal aktar tagħrif dwar vaċċini ta' tħejjija pandemika).
English: Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Maltese: Mill-annimali li ħadu l-vaċċin stimulat, 87% u 96% kienu protetti kontra l-eżami omologu jew eterologu rispettivament, li seta' jikkaġuna l-mewt.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
Maltese: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Ilma għall-injezzjonijiet
English: Month 6
Maltese: 6 snin.
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
Maltese: • żewġ pakketti li fihom 25 kunjett ta' 2.5 ml emulsjoni (suppliment)
English: Split influenza virus inactivated, containing antigen equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Maltese: *Antiġen: razza tixbaħ lil A/VietNam/1194/2004 (H5N1) użata (NIBRG-14)
English: Booster factor3
Maltese: Fattur tal-booster3
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ ((2°Ċ - 8°Ċ).
English: Product-specific data can be evaluated during signal work-up.
Maltese: Dejta speċifika għall-prodott tista' tkun evalwata waqt ‘work-up' ta' sinjali.
English: - Anaphylaxis:
Maltese: - Enkefalite:
English: Booster seroconversion rate2
Maltese: serokonverżjoni tal booster2
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium
Maltese: GSK Biologicals,Rixensart - Il-Belġju
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Maltese: Respons immunitarju għal A/Vietnam/1194/2004 skeda 0, 21 ġurnata
English: Loss of appetite
Maltese: Telf t'aptit
English: There are limited safety and immunogenicity data available on the administration of Adjupanrix and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Maltese: Hemm dejta disponibbli limitata dwar is-sigurtà u l-immunoġeniċità dwar l-għoti ta' Adjupanrix u dwar għoti ta' nofs id-doża tat-tilqima (i.e. 1.875 µg ta' HA u nofs l-ammont ta' stimulat AS03) filjiem 0 u 21 fi tfal li għandhom bejn it-3 u d-9 snin.
English: A line listing of fatal cases will be provided in an Annex.
Maltese: Lista ta' każijiet fatali se tkunn provduta f'Anness.
English: In 297 subjects aged > 60 years the anti-HA antibody seroprotection and seroconversion rates against A/Indonesia/5/2005 at day 42 after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 23% and the seroconversion factor was 2.7.
Maltese: F'297 individwu ta' >60 sena ir-rati ta' seroprotezzjoni u serokonverżjoni ta' antikorp anti-HA kontra A/Indonesia/5/2005 f'ġurnata 42 wara żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75μg HA derivat minn A/Vietnam/1194/2004 kienu ta' 23% u l-fattur ta' serokonverżjoni kien ta' 2.7.
English: In addition, all subjects had neutralising antibody titres of at least 1:80.
Maltese: Barra minn hekk l-individwi kollha kellhom titru ta' antikorpi newtraliżżanti ta' almenu 1:80.
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 jkunu aktar serji.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur GlaxoSmithKline Biologicals s.a.
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Maltese: Barra dan, minn sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti interpandemiċi, kienu rappurtati r-reazzjonijiet avversi li ġejjin:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
Maltese: Virus tal-influwenza maqsum, inattivat, li fih antiġen* ekwivalenti għal: Razza tixbaħ lil A/Vietnam/1194/2004
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
Maltese: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Ilma għall-injezzjonijiet
English: Antigen suspension for
Maltese: KUNJETT TA' SUSPENSJONI
English: Double dose N=43
Maltese: Doża doppja N=43
English: Seroconversion rate2
Maltese: serokonverżjoni2
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Maltese: Waqt sitwazzjoni pandemika, ir-risorsi għandhom ikunu konċentrati fuq sorveljanza effettiva u f'waqtha tal-profil ta' sigurta' tal-vaċċini ta' l-influwenza użati waqt il-pandemija.
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Adjupanrix
Maltese: Suspensjoni għal emulsjoni għall-injezzjoni għal Adjupanrix
English: Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia
Maltese: Komuni ħafna: artralġja, mijalġja
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 (lastku butyl). - żewġ pakketti ta' 25 kunjett (ħġieġ tat-tip I) ta' 2.5 ml emulsjoni b'tapp (lastku butyl).
English: The following principles should be followed when compiling the data:
Maltese: Għandhom ikunu segwiti dawn il-prinċipji li ġejjin waqt li tkun qed tinġabar id-dejta:
English: *propagated in eggs **expressed in microgram haemagglutinin
Maltese: **espress bħala mikrogrammi ta' emaglutinina
English: In a different study (D-Pan-H5N1-007) in 50 subjects aged 18-60 years the anti-HA antibody seroprotection rates 21 days after the second dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were 20% against A/Indonesia/5/2005, 35% against A/Anhui/01/2005 and 60% against A/Turkey/Turkey/1/2005.
Maltese: 3.75μg HA derivat minn A/Vietnam/1194/2004 kienu ta' 20% kontra A/Indonesia/5/2005, 35% kontra A/Anhui/01/2005 u 60% kontra A/Turkey/Turkey/1/2005.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Wara li titħallat, doża waħda (0.5 ml) ikun fiha:
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni ta 'rapporti perjodiċi ta' aġġornament dwar is-sikurezza għal dan il prodott mediċinali mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: • Sleepiness
Maltese: • Aċċessjonijiet