FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to further investigate the safety and reactogenicity of Pandemic influenza vaccine H5N1 AstraZeneca, the MAH should conduct an open-label single arm interventional study to evaluate the safety and immunogenicity of P/LAIV in children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Maltese: Sabiex jinvestiga aktar is-sigurtà u r-reazzjoġeneċità tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca, il-MAH għandu jwettaq studju ta' intervent ta' fergħa waħda bit-tikketta mikxufa sabiex jevalwa s-sigurtà u l-immunoġeniċità ta' P/LAIV fi tfal u adolexxenti mill-età ta' 12-il xahar sa anqas minn 18-il sena waqt il-pandemija ddikjarata li jmiss.
English: Antibody response developed rapidly in P/LAIV H5N1-primed subjects.
Maltese: Ir-rispons tal-antikorpi f'individwi pprajmjati bil-P/LAIV kontra H5N1 kien ukoll usa'.
English: Due to the association of Reye's syndrome with salicylates and wild-type influenza infection, healthcare providers should assess the potential risks of administering the vaccine with the potential benefits in a pandemic situation (see section 4.5).
Maltese: Minħabba r-rabta tas-sindromu ta' Reye ma' saliċilati u infezzjoni tal-influwenza tat-tip selvaġġ (wild-type), f'sitwazzjoni pandemika lfornituri tal-kura tas-saħħa għandhom jivvalutaw ir-riskji potenzjali tal-għoti tat-tilqima kontra lbenefiċċji potenzjali (ara sezzjoni 4.5).
English: It is used in children and adolescents 12 months to less than 18 years of age.
Maltese: Tintuża fi tfal u adolexxenti minn 12-il xahar sa inqas minn 18-il sena.
English: The assessment of the safety profile for Pandemic influenza vaccine H5N1 AstraZeneca is based on a limited number of adult subjects.
Maltese: Il-valutazzjoni tal-profil tas-sigurtà għat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija bbażata fuq għadd limitat ta' individwi adulti.
English: Do not inject Pandemic influenza vaccine H5N1 AstraZeneca.
Maltese: Tinjettax it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca.
English: Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Maltese: Sakemm ma jkunx indikat medikament, l-użu ta' saliċilati fit-tfal u fl-adolexxenti għandu jiġi evitat għal 4 ġimgħat wara t-tilqima peress li s-sindromu ta' Reye ġie rrapportat wara l-użu ta' saliċilati waqt infezzjoni talinfluwenza tat-tip selvaġġ.
English: • severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Maltese: • reazzjoni allerġika severa: sinjali ta' reazzjoni allerġika severa jistgħu jinkludu qtugħ ta' nifs u nefħa tal-wiċċ jew tal-ilsien.
English: The antibody response in A/Vietnam/1203/2004 P/LAIV-primed subjects also exceeded that observed after 2 doses of inactivated vaccine in P/LAIV-naïve subjects (see Table 3).
Maltese: Ir-rispons tal-antikorpi f'individwi li kienu pprajmjati bil-P/LAIV kontra A/Vietnam/1203/2004 qabeż ukoll dak osservat wara 2 dożi tal-vaċċin inattivat f'individwi li qatt ma kienu ingħataw il-P/LAIV (ara Tabella 3).
English: Caution is needed when administering this vaccine to individuals with a known hypersensitivity (other than anaphylactic reaction) to the active substance, or to any of the excipients listed in section 6.1, or to trace residues (gentamicin, eggs or egg proteins, ovalbumin).
Maltese: Hija meħtieġa attenzjoni meta t-tilqima tingħata lil individwi b'sensittività eċċessiva magħrufa (minbarra reazzjoni anafilattika) għas-sustanza attiva, jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jew għar-residwi traċċa (gentamicin, bajd jew proteini tal-bajd, ovalbumina).
English: The affinity of antibodies against the HA1 domain of the H5 HA in the H5N1 P/LAIV-primed groups was significantly higher than the 2dose inactivated vaccine group, which correlated with cross-clade H5N1 neutralisation.
Maltese: HA fil-gruppi pprajmjati bil-P/LAIV kontra H5N1 kienet sinifikament ogħla mill-grupp li rċieva 2-dożi tal-vaċċin inattivat, li kienet korrelatata ma' newtralizzazzjoni ta' inkroċjar tal-clades tal-H5N1.
English: Asia/ Oceania
Maltese: L-Asja/ lOċeanja
English: Vaccine recipients under treatment with influenza antiviral agents should not receive Pandemic influenza vaccine H5N1 AstraZeneca until 48 hours after the cessation of influenza antiviral therapy.
Maltese: Riċevituri tal-vaċċin li jkunu qed jirċievu kura b'aġenti antivirali kontra l-influwenza ma għandhomx jirċievu t-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca sa 48 siegħa wara l-waqfien tatterapija antivirali kontra l-influwenza.
English: IgA seroresponse and nasal wash response were each detected in 18% of subjects.
Maltese: IgA u r-rispons wara ħasil tal-imnieħer ġie skopert fi 18% tal-individwi rispettivament.
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Maltese: Ara t-Tabella 1 u 2 għal sommarju tar-riżultati tal-effikaċja fil-popolazzjoni pedjatrika.
English: Number of Vietnam inactivat ed vaccine doses
Maltese: Għadd ta' dożi talvaċċin inattivat kontra Vietnam
English: In a pandemic situation, the use of Pandemic influenza vaccine H5N1 AstraZeneca in mildly to moderately immunosuppressed individuals may be considered after weighing the anticipated benefits against the potential risks for the individual.
Maltese: F'sitwazzjoni pandemika, l-użu tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca f'individwi immunosoppressi b'mod minn ħafif sa moderat jista' jitqies wara li jintiżnu l-benefiċċji antiċipati kontra r-riskji potenzjali għall-individwu.
English: There are a moderate amount of data from the use of T/LAIV and the seasonal Fluenz Tetra vaccine in pregnant women.
Maltese: Hemm ammont moderat ta' dejta dwar l-użu tat-T/LAIV u t-tilqima staġjonali Fluenz Tetra f'nisa tqal hija limitata.
English: Figure 1 Pandemic influenza vaccine H5N1 AstraZeneca Administration
Maltese: Figura 1 L-għoti tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca
English: In clinical studies with the vaccine, most side effects were mild in nature and short-term.
Maltese: Fi studji kliniċi bit-tilqima, ħafna mill-effetti sekondarji kienu ta' natura ħafifa u ma damux wisq.
English: AstraZeneca AB SE-151 85
Maltese: SE-151 85
English: Twenty-one additional subjects received one dose of the vaccine virus at TCID50, with 19 of those subjects receiving a second dose 4-8 weeks later.
Maltese: TCID50, u 19 minn dawk l-individwi irċevew it-tieni doża wara 4-8 ġimgħat.
English: Pandemic influenza vaccine H5N1 AstraZeneca is a vaccine to prevent influenza (flu) in an officially declared pandemic.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca hija tilqima għall-prevenzjoni talinfluwenza f'pandemija ddikjarata uffiċjalment.
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Maltese: Din it-tilqima hija ppreżentata bħala sospensjoni bħala sprej għall-imnieħer f'applikatur tal-imnieħer li jintuża darba biss (0.2 ml) f'pakkett ta' 10.
English: In clinical studies, the safety profile of Pandemic influenza vaccine H5N1 AstraZeneca was comparable to the safety profile of the seasonal vaccines T/LAIV and Fluenz Tetra (see section 5.1 for more information).
Maltese: Fi studji kliniċi, il-profil tas-sigurtà tat-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca kien komparabbli għall-profil tas-sigurtà tat-tilqim staġjonali
English: This is because of the risk of a very rare but serious disease (Reye's syndrome).
Maltese: Dan huwa minħabba r-riskju ta' marda rari ħafna iżda serja (sindromu ta' Reye).
English: • Do not give acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever) to children for 4 weeks after vaccination with Pandemic influenza vaccine H5N1 AstraZeneca unless your doctor, nurse or pharmacist tells you otherwise.
Maltese: • Tagħtix aċidu aċetilsaliċiliku (sustanza li tinsab f'ħafna mediċini użata biex itaffi l-uġigħ u tnaqqas id-deni) lil tfal sa 4 ġimgħat wara vaċċinazzjoni bit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ħlief jekk it-tabib, l-infermier jew l-ispiżjar tiegħek jgħidlek tagħmel mod ieħor.
English: After 1 or 2 doses of TCID50 vaccine, haemagglutination inhibition (HAI) and IgA seroresponses were each detected in 10% subjects, and nasal wash IgA responses were detected in 24% subjects.
Maltese: Mill-individwi li ma kinux ingħataw il-P/LAIV, 10% biss kellhom żieda ta' ≥4-darbiet sal-Jum 7.
English: How Pandemic influenza vaccine H5N1 AstraZeneca works
Maltese: Kif taħżen it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca
English: What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca How Pandemic influenza vaccine H5N1 AstraZeneca is given Possible side effects
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bittilqima kontra l-influwenza Pandemika H5N1 AstraZeneca f'subsett wieħed jew iktar tal-popolazzjoni pedjatrika fil-prevenzjoni ta' infezzjoni tal-influwenza.
English: Pandemic influenza vaccine H5N1 AstraZeneca vaccine virus is grown in chicken eggs.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ser tingħata bħala sprej f'kull minfes.
English: The MAH should conduct an observational prospective cohort safety study in a large sample of children and adolescents from 12 months to less than 18 years of age during the next declared pandemic.
Maltese: LMAH għandu jwettaq studju prospettiv osservazzjonali dwar is-sigurtà tal-koorti f'kampjun kbir ta' tfal u adolexxenti mill-età ta' 12-il xahar sa anqas minn 18-il sena waqt il-pandemija ddikjarata li jmiss.
English: Pandemic influenza vaccine H5N1 AstraZeneca will be administered under the supervision of a doctor, nurse or pharmacist.
Maltese: It-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca ser tingħata biss taħt issuperviżjoni ta' tabib, infermier jew spiżjar.
English: What Pandemic influenza vaccine H5N1 AstraZeneca contains
Maltese: Kif tidher it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca u l-kontenut tal-pakkett
English: How to store Pandemic influenza vaccine H5N1 AstraZeneca Contents of the pack and other information
Maltese: Kif taħżen it-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca Kontenut tal-pakkett u informazzjoni oħra
English: Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Maltese: AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 254 73 00
English: • Pandemic influenza vaccine H5N1 AstraZeneca is not recommended for breast-feeding women.
Maltese: • It-tilqima kontra l-influwenza Pandemika H5N1 MedImmune mhijiex rakkomandata għal nisa li jkunu qed ireddgħu.
English: Ask your doctor, nurse or pharmacist if you want more information about possible side effects from Pandemic influenza vaccine H5N1 AstraZeneca.
Maltese: Staqsi lit-tabib, lill-infermier jew lill-ispiżjar tiegħek jekk tixtieq aktar informazzjoni dwar l-effetti sekondarji possibbli mit-tilqima kontra l-influwenza Pandemika H5N1 AstraZeneca.
English: • if you have previously had a serious allergic reaction (i.e. life-threatening) to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
Maltese: • jekk xi darba kellek reazzjoni allerġika serja (jiġifieri ta' periklu għall-ħajja) għall-bajd, għall-proteini tal-bajd, għal gentamicin, jew għall-ġelatina jew għal xi sustanza oħra ta' dan ilvaċċin (elenkati fis-sezzjoni 6 “Kontenut tal-pakkett u informazzjoni oħra”).
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju validu tal- karatteristiċi tal-prodott, tikketta u l-fuljett tal-pakkett huma l-verżjonijiet finali miksubin waqt il-proċedura tal-grupp ta' Koordinazzjoni.
English: Summary of product characteristics, labelling and package leaflet
Maltese: Sommarju tal-karatteristiċi tal-prodott, tikketta u fuljett ta' tagħrif
English: Package sizes
Maltese: Il-pakkett
English: EU Numbers
Maltese: Numru ta' l-EU
English: Content
Maltese: Kunjetti
English: perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
Maltese: Daqs tal-pakkett mikrosferi li fihom perflutren, b' medja ta' dijametru fillimiti ta' bejn 2.5 u 4.5 µm.
English: 0.19 mg/ml.
Maltese: Ekwivalenti għal 0.19 mg gass ta' perflutren f'kull ml.
English: Pharmaceutical Form Route of administration Packaging
Maltese: Għamla farmaċewtika
English: 5 - 8 x 108 perflutren-containing microspheres with a mean diameter range of 2.5 - 4.5 μm; equivalent to 0.19 mg perflutren gas per ml
Maltese: 1 Kunjett mikrosferi l fihom perflutren, b' me ta' dijametru fil-limiti ta bejn 2.5 u 4.5 µm.
English: BE - Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Maltese: BE - Il - Belġju NV AstraZeneca SA Egide Van Ophemstraat 110
English: NO - Norway AstraZeneca AS Boks 200 Vinderen 0319 Oslo
Maltese: AstraZeneca AS Boks 200 Vinderen 0319 Oslo
English: FI - Finland Synthon B V Microweg 22
Maltese: Synthon B V Microweg 22
English: FI - Finland Alternova Oy Ab Rajatorpantie 41 C 01640 Vantaa
Maltese: Alternova Oy Ab Rajatorpantie 41 C 01640
English: FI - Finland Peseri Trading Limited El Greco House
Maltese: Peseri Trading Limited El Greco House
English: FI - Finland Avansor Pharma Oy Tekniikantie 14
Maltese: Avansor Pharma Oy Tekniikantie 14
English: HU - Hungary Pharmaconsult Kft.: 1141 Budapest, Ráskay Lea u. 44.
Maltese: Kft.: 1141 Budapest, Ráskay Lea u. 44.
English: AT - Austria Astra Zeneca Österreich GmbH Schwarzenbergplatz 7
Maltese: Astra Zeneca Österreich GmbH Schwarzenbergplatz 7
English: PT - Portugal Farma-APS, Produtos Farmacêuticos, S.A.
Maltese: Farma-APS, Produtos Farmacêuticos, S.A.
English: PT - Portugal AstraZeneca Produtos Farmacêuticos, Lda.
Maltese: AstraZeneca Produtos Farmacêuticos, Lda.
English: DA - Denmark AstraZeneca A/S Roskildevej 22
Maltese: AstraZeneca A/S Roskildevej 22
English: AT - Austria Genericon Pharma Ges.m.b.H.
Maltese: Genericon Pharma Ges.m.b.H.
English: AT - Austria Ratiopharm Arzneimittel VertriebsGmbH
Maltese: Ratiopharm Arzneimittel VertriebsGmbH
English: However, some trends were apparent in exploratory subgroup analyses.
Maltese: Madankollu xi tendenzi kienu evidenti f'analiżi ta' sottogrupp esploratorju.
English: SV - Sweden AstraZeneca AB Västra Mälarehamnen 9
Maltese: SV - L- Isvezja AstraZeneca AB Västra Mälarehamnen 9
English: EL - Greece Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki
Maltese: EL - Il- Greċja Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki
English: Valejas - 2745-663 Barcarena
Maltese: Rua Humberto Madeira, 7 Valejas - 2745-663 Barcarena
English: Bicalutamide is an oral anti-androgen used in the management of prostate cancer.
Maltese: Bicalutamide hu prodott anti-androġeniku orali użat fil-ġestjoni tal-kanċer tal-prostata.
English: FR - France AstraZeneca 1, place Renault 92844 Rueil-Malmaison Cedex
Maltese: FR- Franza AstraZeneca 1, place Renault 92844
English: At 7.4 years median follow up, 27.4% and 30.7% of all CASODEX and placebo-treated patients, respectively, had experienced objective disease progression.
Maltese: F'medjan ta' 7.4 snin follow-up, 27.4% u 30.7% talpazjenti kollha li ġew trattati b'CASODEX jew plaċebo, rispettivament, kellhom progressjoni oġġettiva talmarda.
English: No overall survival difference was seen at 7.4 years median follow up with 22.9% mortality (HR=0.99; 95% CI 0.91 to1.09).
Maltese: Ma dehret l-ebda differenza fis-sopravivenza totali f'medjan ta' 7.4 snin ta' follow up, bi 22.9% mortalità (HR = 0.99;95% CI 0.91 sa 1.09) .
English: In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16; 95% CI 0.99 to 1.37).
Maltese: F'dawn il-pazjenti kien hemm ukoll tendenza lejn tnaqqis fis-sopravivenza meta mqabbel ma' pazjenti li qed jirċievu plaċebo (HR=1.16; 95% CI 0.99 sa 1.37).
English: Benefit/ Risk considerations
Maltese: Kunsiderazzjonijiet tal-Benefiċċju/Riskju
English: FI - Finland Helm Pharmaceuticals GmbH Nordkanalstr.
Maltese: Helm Pharmaceuticals GmbH Nordkanalstr. 28
English: FI - Finland Orion Corporation Orionintie 1, PO Box 65
Maltese: Orion Corporation Orionintie 1, PO Box 65 02101 Espoo
English: CASODEX (Bicalutamide) 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of 3 placebo controlled double-blind studies in 8113 patients, where CASODEX was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation).
Maltese: CASODEX (bicalutamide) 150mg kien studjat bħala trattament għal pazjenti bil-kanċer tal-prostata mingħajr metastasi, lokalizzat (T1-T2, N0 jew NX, M0) jew lokalment avvanzat (T3-T4, kwalunkwe N, M0; T1-T2, N+, M0) f'analiżi kombinata ta' tlett studji kontrollati double-blind bi plaċebo b'8113-il pazjent fejn CASODEX ingħata bħala terapija ormonali immedjata jew bħal għajnuna wara li titneħħa l-prostata jew radjuterapija (l-aktar b'raġġ ta' radjazzjoni esterna).
English: Quinta da Beloura 2710-444 Sintra
Maltese: Office Park da Beloura - Edifício 4 Quinta da Beloura 2710-444
English: EL - Greece Alvia SA 18th klm Athens-Marathon Ave 153 44 Pallini Attiki
Maltese: SA 18th klm Athens-Marathon Ave 153 44 Pallini Attiki
English: EL - Greece Dermos Meπε -pharmaceitica 25 Paraschou str.
Maltese: EL - Il- Greċja Dermos Meπε -pharmaceitica 25
English: Radical prostatectomy
Maltese: Tneħħija radikali talprostata
English: BRNO Jeneweinova 51a
Maltese: Ingers Industrial Solutions S.R.O. BRNO Jeneweinova 51a
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bicalutamide 150 mg.
Maltese: - Il-Kumitat ikkunsidra r-referenza magħmula skond l-artiklu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom bicalutamide 150 mg.
English: In 2004, 2 publications were published detailing a pre-planned 2nd analysis of the Casodex (bicalutamide) Early Prostate Cancer (EPC) study programme.
Maltese: Fl-2004 kienu ppubblikati żewġ pubblikazzjonijiet b'dettalji dwar it-tieni analiżi tal-programm ta' studju ta' Casodex (bicalutamide) Early Prostate Cancer (EPC).
English: In particular, there is a statistically significant and clinically meaningful improvement in progression-free survival in the patients with locally advanced prostate cancer who received Casodex (bicalutamide) as compared to placebo (58% versus 69% progressors in patients who were not receiving adjuvant surgery or radiotherapy).
Maltese: B'mod partikolari, hemm titjib statistikament sinjifikanti u klinikament relevanti fis-sopravivenza mingħajr progressjoni fil-pazjeni b'kanċer tal-prostata lokalment avvanzat li kienu ħadu Casodex (bicalutamide) meta mqabbla ma' dawk li ħadu l-plaċebo (58% u 69% f'pazjenti li ma kinux qed jiġu ttrattati bir-radjuterapija jew bil-kirurġija).
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-PRODOTTI FARMAĊEWTIĊI, ROTTA MINN FEJN JINGĦATA, APPLIKANTI, DETENTURI TA' LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI
English: EL - Greece Astrazeneca SA 4 Theotocopoulou & Astronauton 151 25 Marousi-Athens
Maltese: Theotocopoulou & Astronauton 151 25
English: National Competent Authorities (NCA), coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtorijtajiet Nazzjonali Kompetenti (NCA), ikkoordinati mill-Istat Membru ta' Referenza (RMS), għandhom jiżguraw li d-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) jissodisfaw ilkundizzjonijiet li ġejjin:
English: Events (%) in Casodex patients
Maltese: Avvenimenti (%) filpazjenti li ngħataw Casodex
English: PL - Poland AstraZeneca UK Limited
Maltese: AstraZeneca UK Limited
English: FI - Finland Ratiopharm GmbH Graf-Arco-Strasse 3
Maltese: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Pharmaceutical Form
Maltese: Pharmaconsult
English: The 4 issues raised in the referral concern the analyses of the Early Prostate Cancer Programme (EPC): - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Maltese: L-erba' kwistjonijiet imressqa għar-referenza jikkonċernaw l-analiżi tal-programm Early Prostate Cancer (EPC) - in-nuqqas ta' benefiċċju globali fis-sopravivenza kontra l-avvenimenti mhux mixtieqa fil-‘kanċer tal prostata lokalment avvanzat'; - tħassib statistiku dwar il-multipliċità; - l-istandard tal-kura tal-grupp tal-plaċebo fl-istudji relevanti; - l-għadd ta' mwiet minħabba kollass tal-qalb.
English: IT - Italy
Maltese: PL - Il
English: Progression-free survival in locally advanced disease by therapy sub-group
Maltese: Sopravivenza mingħajr progressjoni f'marda lokalment avvanzata skond issottogrupp tat-terapija
English: How does the company justify the indication of bicalutamide 150 mg for locally advanced prostate cancer knowing the absence of statistically significant overall survival and the important side effects?
Maltese: Il-kumpanija kif tiġġustifika l-indikazzjoni ta' bicalutamide 150 mg għall-kanċer tal-prostata lokalment avvanzat meta taf li m'hemmx sopravivenza globali statistikament sinifikanti u hemm effetti mhux mixtieqa importanti?
English: IS - Iceland AstraZeneca UK Limited Silk Road Business Park Macclesfield
Maltese: IS - L-Islanda AstraZeneca UK Limited Silk Road Business Park Macclesfield
English: HU - Hungary AstraZeneca KFt. Park u. 3
Maltese: AstraZeneca KFt. Park u.
English: These results should of course be balanced against the well-known tolerability issues of Casodex (bicalutamide).
Maltese: Naturalment, dawn ir-riżultati għandhom jiġu bbilanċjati mal-kwistjonijiet magħrufa ħafna tat-tolerabilità ta' Casodex (bicalutamide).
English: BG - Bulgaria AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
Maltese: Capability Green Luton, Bedfordshire, LU1 3LU, UK
English: ET - Estonia Astrazeneca UK Ltd. Stanhope Gate 15
Maltese: ET- L- Estonja Astrazeneca UK Ltd.
English: However, it is not possible to entirely “rule out” thromboembolic events as contributory explanation of increased cardiovascular mortality.
Maltese: Madankollu, ma kienx possibbli li jkunu esklużi kompletament xi avvenimenti tromboembolitiċi bħala spjegazzjoni kontributorja għaż-żieda fil-mortalità kardjovaskulari.
English: FI - Finland Tad Pharma GmbH Heinz-Lohmann-Strasse 5
Maltese: Tad Pharma GmbH Heinz-Lohmann-Strasse 5 27472 Cuxhaven, Germany
English: NV AstraZeneca SA 110 rue E. Van Ophem B-1180 Bruxelles Belgium
Maltese: NV AstraZeneca SA 110 rue E.
English: Disease progression may be associated with problems such as painful bone metastases, cord compression, pathological fractures and urinary obstruction.
Maltese: Il-progressjoni tal-marda tista' tiġi assoċjata ma' problemi bħall-metastasi bl-uġigħ fil-għadam, kompressjoni tal-korda, ksur patoloġiku u ostakoli urinarju.
English: CS - Czech Republic
Maltese: CS- IrRepubblika