FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Maltese: U KWANTITATTIVA Gramma waħda ta' ġel fiha 50 mikrogramma ta' calcipotriol (bħala monohydrate) u 0.5 mg ta' betamethasone (bħala dipropionate).
English: Daivobet ointment
Maltese: DAIVOBET INGWENT
English: The clinical trial programme for Daivobet gel has so far included more than 4,700 patients of whom more than 2,100 were treated with Daivobet gel.
Maltese: Il-programm ta' provi kliniċi għal Daivobet ġel s'issa kien jinkludi iktar minn 4,700 pazjent, li minnhom iktar minn 2,100 kienu kkurati b'Daivobet ġel.
English: The CHMP commented that, as suggested from the MAH's wording, a patient using the maximum daily dose of 15 g will exceed the maximum weekly dose of 100 g, reaching 105 g. The MAH answered to this comment that some patients may need a daily dose of 15 g during the first few days of treatment, but since efficacy during the first week of treatment is high it would be reasonable to expect that patients would apply less treatment by the end of the week as the psoriasis lesions decrease in size and severity.
Maltese: Għalhekk ġie propost li tiżdied il-formolazzjoni tal-kliem "id-doża massima ta' kuljum ma għandhiex taqbeż 15 g, u d-doża massima ta' kuljum ma għandhiex taqbeż 100 g” u “l-erja tal-wiċċ tal-ġisem trattata bi prodotti li fihom calcipotriol ma għandhiex taqbeż 30%".
English: Take special care with Daivobet
Maltese: Kif tuża Daivobet:
English: Treatment of more than 30 % of the body surface should be avoided (see section 4.2).
Maltese: Il-kura ta' iktar minn 30% tal-wiċċ tal-ġisem għandu jiġi evitat (ara sezzjoni 4.2).
English: The MAH accepted the recommendation for rewording section 4.2 and the CHMP endorsed the proposed wording: “If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision”.
Maltese: Il-MAH aċċetta rrakkomandazzjoni biex terġa' tiġi fformulata s-Sezzjoni 4.2 u s-CHMP awtorizza l-formolazzjoni proposta: “Jekk ikun meħtieġ li jitkompla jew jerġa' jinbeda t-trattament wara dan il-perjodu, ittrattament għandu jitkompla wara reviżjoni medika jew taħt superviżjoni medika regolari”.
English: In rats, tissue distribution studies with radiolabelled calcipotriol and betamethasone dipropionate, respectively, showed that the kidney and liver had the highest level of radioactivity.
Maltese: Fil-firien, studji dwar id-distribuzzjoni fit-tessut b'calcipotriol radjutikkettat u betamethasone dipropionate, rispettivament, urew li l-kliewi u l-fwied kellhom l-ogħla livell ta' radjuattività.
English: A safety study in 634 psoriasis patients has investigated repeated courses of Daivobet ointment used once daily as required, either alone or alternating with Daivonex, for up to 52 weeks, compared with Daivonex used alone for 48 weeks after an initial course of Daivobet ointment.
Maltese: Studju dwar is-sigurtà li sar fuq 634 pazjent bil-psorjasi, investigat korsijiet ripetuti ta' Daivobet ingwent li ntuża darba kuljum skont il-ħtieġa, jew waħdu jew jalterna ma' Daivonex, għal sa 52 ġimgħa, meta mqabbel ma' Daivonex użat waħdu għal 48 ġimgħa wara kors inizjali ta' Daivobet ingwent.
English: Results for the primary response criterion (absent or very mild disease according to the IGA at week 8) showed that Daivobet gel was statistically significantly more effective than Daivonex Scalp solution.
Maltese: Ir-riżultati għall-kriterju tar-rispons primarju (marda assenti jew marda ħafifa ħafna skont l-IGA f'ġimgħa 8), urew li Daivobet ġel kien iktar effettiv b'mod statistikament sinifikanti milli minn Daivonex Soluzzjoni għal ġilda tar-ras.
English: Daivobet gel SPC: “Topical treatment of scalp psoriasis in adults.
Maltese: SPC ta' Daivobet ġel: “Trattament topiku tal-psorijażi tal-qurriegħa fl-adulti.
English: INFORMATION IN BRAILLE Carton for 15 g, 30 g, 60 g, 100 g or 120 g pack sizes: [To be completed nationally] Daivobet 50 micrograms/0.5 mg/g ointment
Maltese: INFORMAZZJONI BIL-BRAILLE Kaxxa tal-kartun għal daqsijiet tal-pakkett ta' 15g, 30g, 60g, 100g jew 120g:
English: A randomised, double-blind long-term clinical study including 873 patients with scalp psoriasis of at least moderate severity (according to the IGA) investigated the use of Daivobet gel compared with calcipotriol in the gel vehicle.
Maltese: Studju kliniku double-blind u fit-tul, li fih il-parteċipanti ntgħażlu b'mod każwali, li kien jinkludi 873 pazjent li kellhom psorjasi fil-ġilda tar-ras ta' mill-inqas severità moderata (skont l-IGA), investiga l-użu ta' Daivobet ġel meta mqabbel ma' calcipotriol fil-plaċebo tal-ġel.
English: These data do not contain any evidence that tapering the dose of Daivobet ointment will reduce the risk of rebound effects.
Maltese: Din id-dejta ma fihiex xi evidenza li l-għoti tad-doża għal xejn xejn ta' Daivobet ingwent inaqqas ir-riskji tal-effetti ta' rikaduta.
English: Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
Maltese: Id-dlik taħt dressings okklużivi għandu jiġi evitat għax iżid lassorbiment sistemiku tal-kortikosterojdi.
English: Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Daivobet.
Maltese: Effetti sekondarji inqas serji kkawżati mill-użu ta' betamethasone, jinkludu dawn li ġejjin.
English: Gel vehicle (n=136)
Maltese: Plaċebo tal-ġel (n=136)
English: The CHMP proposed that the MAH either omits a weekly dose and endorsed the following: “When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g.”
Maltese: Is-CHMP ippropona li l-MAH jew ineħħi doża ta' kull ġimgħa u jawtorizza dan li ġej: “Meta wieħed juża prodotti mediċinali li fihom calcipotriol, id-doża massima ta' kuljum ma għandhiex taqbeż 15 g.”
English: Dacogen decitabine
Maltese: Dacogen deċitabina
English: The full EPAR for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance decitabine.
Maltese: Fih is-sustanza attiva deċitabina.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Dacogen jinstab fis-sit elettroniku tal-Aġenzija: eema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
Maltese: Is-sustanza attiva ta' Dacogen, id-deċitabina, hija ‘analogu deossinukleoside taċ-citidina'.
English: This is a summary of the European public assessment report (EPAR) for Dacogen.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Dacogen.
English: Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Maltese: Dacogen ġie studjat fi studju ewlieni li involva 485 adult, li kien għadu kif saritilhom id-dijanjożi talAML, iżda ma kinux eliġibbli għal kimoterapija ta' induzzjoni standard.
English: Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Maltese: Pazjenti li ngħataw kura b'Dacogen għexu medja ta' 7.7 xhur apparagun ma' 5.0 xhur għal pazjenti li ngħataw kura ta' sostenn jew kura biċ-ċitarabina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Dacogen valida fl-Unjoni Ewropea kollha fl-20 ta' Settembru 2012.
English: The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Maltese: L-effetti sekondarji serji l-aktar komuni (li dehru f'aktar minn 20% tal-pazjenti) inkludew pulmonite (infezzjoni tal-pulmuni), tromboċitopenja, newtropenja (għadd baxx ta' newtrofili, tip ta' ċelloli tad-demm bojod ), newtropenia febrili (għadd baxx ta' ċelloli tad-demm bojod bid-deni) u anemija.
English: In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Maltese: Fil-ġisem id-deċitabine tiġi konvertita f'deċitabina trifosfat, li mbagħad tiġi inkorporata fid-DNA fejn timblokka l-attività tal-enzimi msejħin DNA metiltransferażi (DNMTs).
English: Why has Dacogen been approved?
Maltese: Għaliex ġie approvat Dacogen?
English: This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Maltese: Dan ifisser li hija simili għad-deossinukleoside citidina, komponent fundamentali tad-DNA (il-materjal ġenetiku) taċċelloli.
English: Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Maltese: Minħabba li l-għadd ta' pazjenti li għandhom AML huwa baxx, il-marda hija kkunsidrata ‘rari', u għaldaqstant Dacogen ingħata l-klassifikazzjoni ta' ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ġunju 2006.
English: The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Maltese: L-effetti sekondarji l-aktar komuni bil-kura b'Dacogen (li dehru f'aktar minn 35% tal-pazjenti) kienu deni, anemija (għadd baxx ta' ċelloli tad-demm ħomor) u tromboċitopenja (għadd baxx ta' pjastrini fiddemm).
English: Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Dacogen huwa trab li jingħamel f'soluzzjoni għal infużjoni (dripp fil-vina).
English: Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Maltese: Dacogen tqabbel jew ma' kura ta' sostenn (kwalunkwe mediċina jew teknika li tgħin lill-pazjenti, għajr mediċini jew kirurġija kontra lkanċer) jew ma' doża baxxa taċ-ċitarabina (mediċina oħra kontra l-kanċer).
English: What is Dacogen?
Maltese: X'inhu Dacogen?
English: The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
Maltese: Is-CHMP innota li t-titjib fis-sopravivenza li deher b'Dacogen f'pazjenti bl-AML kien modest iżda relevanti, minħabba li l-kuri attwali huma limitati għal pazjenti li mhumiex eliġibbli għal kimoterapija ta' induzzjoni standard.
English: In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Maltese: F'ċiklu ta' 4 ġimgħat, Dacogen jingħata kuljum għall-ewwel 5 ijiem.
English: At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Maltese: Huwa rrakkomandat li jsiru millinqas 4 ċikli ta' kura iżda dawn jistgħu jitkomplew sakemm l-AML tibqa' tkun ikkontrollata.
English: It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Maltese: Jintuża f'pazjenti li mhumiex eliġibbli għall-kimoterapija ta' induzzjoni standard (kura iniżjali bil-mediċini tal-kanċer).
English: For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b'Dacogen, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Dacogen?
Maltese: X'inhu r-riskju assoċjat ma' Dacogen?
English: What measures are being taken to ensure the safe and effective use of Dacogen?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Dacogen?
English: The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li lbenefiċċji ta' Dacogen huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għattqegħid fis-suq.
English: There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Maltese: Ma hemm l-ebda tħassib maġġuri dwar is-sigurtà ta' Dacogen u l-profil tassigurtà ġenerali kien simili għal dak tal-kura b'doża baxxa ta' ċitarabina, bl-eċċezzjoni ta' xi effetti sekondarji bħal infezzjonijet u newtropenja li kienu komuni bl-użu ta' Dacogen.
English: How has Dacogen been studied?
Maltese: Kif ġie studjat Dacogen?
English: Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Maltese: Dacogen jintuża biex jikkura adulti li tkun għadha kif saritilhom id-dijanjożi tal-lewkimja tal-majelojde akuta (AML), tip ta' kanċer li jaffettwa liċ-ċelloli bojod tad-demm.
English: 1105BJ Amsterdam Netherlands
Maltese: 1105BJ Amsterdam L-Olanda
English: Anti-HA antibody (SRH)
Maltese: Antikorp anti-HA (SRH)
English: Injection 1
Maltese: Injezzjoni 1
English: Fever ≥ 38°C (≥ 40°C)
Maltese: Deni ≥38°C (≥40°C)
English: (≥1/10,000 to
Maltese: (≥1/10,000 sa
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Maltese: Martino 53035 Monteriggioni (SI) L-Italja.
English: °° GMRs of HI
Maltese: °° GMRs ta' HI
English: Immunocompromised N=139
Maltese: Immunokompromessi N=139
English: V87P11 Adults (18-60 years) N=186
Maltese: V87P11 Adulti (18-60 sena) N=186
English: Other rare side effects observed after routine use:
Maltese: Effetti sekondarji rari oħrajn osservati wara użu ta' rutina:
English: AFLUNOV contains sodium and potassium.
Maltese: AFLUNOV fih sodium u potassium
English: Immunocompromised N=143
Maltese: Immunokompromessi N=143
English: Adjuvant MF59C.1 containing: squalene
Maltese: L-adjuvant MF59C.1 fih: squalene
English: Study V87_25
Maltese: Studju V87_25
English: The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.
Maltese: Il-vaċċin fih għal kull 0.5 mL, 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.
English: Study V87_26
Maltese: Studju V87_26
English: MN results yielded a GMR against A/turkey/Turkey/2005 ranging from 1.59 to 2.95.
Maltese: MN ipproduċew GMR kontra A/turkey/Turkey/2005 li kien ivarja minn 1.59 sa 2.95.
English: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
Maltese: Komuni ħafna (≥1/10); Komuni (≥1/100 sa <1/10); Mhux komuni (≥1/1,000 sa <1/100); Rari (≥1/10,000 sa <1/1,000);
English: SP= seroprotection SC= seroconversion
Maltese: SC= serokonverżjoni
English: EU/1/10/658/001 1 prefilled syringe EU/1/10/658/002 10 prefilled syringes
Maltese: EU/1/10/658/001 1 siringa mimlija għal-lest EU/1/10/658/002 10 siringi mimlijin għal-lest
English: For the full list of excipients see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: For the adjuvant, see section 2
Maltese: Għall-adjuvant, ara sezzjoni 2
English: Cross reactivity data in adults
Maltese: Dejta dwar kross-reattività fl-adulti
English: V87P11 Elderly (>61-89 years)a N=142
Maltese: V87P11 Anzjani (>61-89 sena)a N=142
English: • Neuritis (inflammation of nerves)
Maltese: • Nevrite (infjammazzjoni tan-nervi)
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' rezzjonijiet avversi
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E 509) Sodium citrate (E311) Citric acid (E330)Water for injections.
Maltese: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E509) Sodium citrate (E311) Citric acid (E330)
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Maltese: Is-sustanzi l-oħra huma: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid u ilma għall-injezzjonijiet.
English: In trial V87_25 and V87_26, 96 and 67 subjects, respectively, were over the age of 70 years.
Maltese: Fil-prova V87_25 u V87_26, 96 u 67 individwu, rispettivament, kellhom aktar minn 70 sena.
English: % SP (95% CI) Day 43
Maltese: % SP (95% CI) Jum 43
English: There were 3872 subjects 18-60 years of age, 365 subjects 61-70 years of age, and 89 subjects greater than 70 years of age.
Maltese: Kien hemm 3,872 persuni ta' 18-60 sena, 365 persuna minn 61-70 sena, u 89 persuna ta'
English: Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose.
Maltese: Il-vaċċin fih 1.899 milligrammi ta' sodium u 0.081 milligrammi ta' potassium f'kull doża ta' 0.5 mL.
English: % SP (95% CI) Day 43 GMR Day 43 to Day 1 % SC (95% CI)Day 43
Maltese: % SP (95% CI) Jum 43 GMR Jum 43 sa Jum 1 % SC (95% CI) Jum 43
English: Active immunisation against H5N1 subtype of Influenza A virus.
Maltese: Immunizzazzjoni attiva kontra l-viruses tal-Influwenza A ta' sottotip H5N1.
English: Adolescents(9-<18 years)
Maltese: Adoloxxenti (9 -<18-il sena)
English: • Convulsions
Maltese: • Konvulżjonijiet
English: It should be noted that the adverse reactions may be intensified.
Maltese: Ta' min jinnota li r-reazzjonijiet avversi jistgħu jiġu intensifikati.
English: Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Seqirus Vaccines Ltd
English: 1.175 milligrams per 0.5 ml
Maltese: 1.175 milligrammi għal kull 0.5 mL
English: STATEMENT OF ACTIVE SUBSTANCE
Maltese: − Is-Sustanza Attiva:
English: Adults (18-59 years)a
Maltese: Adulti (18-59 sena) a
English: N=83
Maltese: N=84a
English: • Urticaria (hives)
Maltese: • Urtikarja (ħorriqija)
English: Cardiac disorders Palpitation, tachycardia.
Maltese: Disturbi fil-qalb Palpitazzjoni, takikardija
English: Gaskill Road, Speke, Liverpool
Maltese: Gaskill Road, Speke, Liverpool L24 9GR
English: Data on safety of a booster dose of AFLUNOV are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults (18-60 years) and 56 elderly subjects (>61 years).
Maltese: Id-dejta dwar is-sigurtà ta' doża booster ta' AFLUNOV hija limitata għal tliet provi (V87P1, V87P2 u V87P1E1) li inkludew 116-il individwu adult (18-60 sena) u 56 individwu anzjan (≥61 sena).
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Maltese: MN kontra A/Vietnam/1194/2004 jindikaw rata ta' seroprotezzjoni ta' 99% (95% CI: 94-100), rata ta' serokonverżjoni li tvarja minn 97% (95% CI: 91-99) sa 99% (95% CI: 96-100) u GMR li jvarja minn 29 (95% CI: 25-35) sa 50 (95% CI: 44-58).
English: Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Maltese: Rispons immuni għal AFLUNOV A/Vietnam/1194/2004 (H5N1) u A/turkey/Turkey/1/2005 (H5N1)
English: Immunogenicity was assessed in 182 subjects.
Maltese: L-immunoġeniċità ġiet ivvalutata f'182 individwu.
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, human T-lymphotropic virus type 1 (HTLV-1).
Maltese: Wara t-tilqim kontra l-influwenza, jistgħu jinkisbu riżultati pożittivi foloz f'testijiet seroloġiċi bil-metodu ELISA għall-antikorpi kontra l-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), il-virus tal-epatite Ċ u, speċjalment, il-virus T-limfotropiku uman tat-tip 1 (HTLV-1).
English: 9.75 milligrams per 0.5 ml polysorbate 80
Maltese: 9.75 milligrammi għal kull 0.5 mL
English: Immunocompromised
Maltese: B'saħħithom Immunokompromessi
English: Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
Maltese: M'hemm l-ebda korrelat immuni ta' protezzjoni stabbilit għal influwenza A (H5N1).
English: Children (3-<9 years)
Maltese: Tfal (3 -<9 snin)
English: MedDRA System Organ class Very common
Maltese: Sistema talKlassifika tal-Organi
English: The following solicited adverse reactions were additionally collected in these two studies and reported with the following frequencies across subjects who received AFLUNOV irrespective of age or health status: diarrhoea (up to 11.9%), loss of appetite (up to 10.9%) and vomiting (up to 1.7%).
Maltese: Ir-reazzjonijiet avversi solleċitati kienu miġbura b'mod addizzjonali f'dawn iż-żewġ studji u rrappurtati bil-frekwenzi li ġejjin għall-individwi li rċivew AFLUNOV, irrispettivament mill-età u listat tas-saħħa: dijarea (sa 11.9%), telf ta' aptit (sa 10.9%), u rimettar (sa 1.7%).
English: N=124
Maltese: N=210b
English: Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate.
Maltese: MF59C.1 emulsjoni ta' żejt fl-ilma li jkun fiha squalene, bħala l-fażi taż-żejt, stabbilizzata bil-polysorbate 80 u sorbitan trioleate.
English: Heterologous immune response against A/Indonesia/5/2005 (clade 2.1) was detectable in study V87P11 after the second vaccination, indicating cross-reactivity of the clade 2.2.1 vaccine against clade 2.1 strains.
Maltese: Rispons immuni eterologuż kontra A/Indonesia/5/2005 (clade 2.1) kien traċċabbli fl-istudju V87P11 wara t-tieni tilqima, u dan jindika kross-reattività tal-vaċċin clade 2.2.1 kontra razez ta' clade 2.1.
English: Common (≥1/100 to <1/10)
Maltese: Komuni (≥1/100 sa
English: *actual age range of population enrolled
Maltese: *il-firxa ta' età attwali tal-popolazzjoni rreġistrata
English: Up to 50% (n=33) of the elderly subjects aged 62 to 88 years immunised with AFLUNOV in trial V87P1 were seroprotected at six months.
Maltese: Sa 50% (N=33) tal-individwi anzjani li kellhom minn 62 sa 88 sena li tlaqqmu b'AFLUNOVfil-prova V87P1 kienu seroprotetti wara sitt xhur.
English: MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively.
Maltese: MN għat-tliet studji kliniċi fit-Tabella ta' hawn fuq urew rata ta' seroprotezzjoni u rata ta' serokonverżjoni kontra A/turkey/Turkey/2005 li kienu jvarjaw minn 10% (2-27) sa 39% (32-46) u 10% (2-27) sa 36% (29-43) rispettivament.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Maltese: Antiġeni tal-wiċċ tal-virus tal-influwenza (haemagglutinin u neuraminidase)* tar-razza:
English: Immunogenicity was assessed in a subset (n=197) of subjects .
Maltese: L-immunoġeniċità ġiet ivvalutata f'subsett (N=197) ta'individwi.