FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolism and nutrition disorders very common: hypokalaemia common: hypertriglyceridaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni ħafna: ipokalimja komuni: ipertrigliċeridemija
English: • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
Maltese: • għall-kura ta' kanċer metastatiku tal-prostata sensittiv għall-ormoni (mHSPC, metastatic hormone sensitive prostate cancer) b'riskju għoli li jkun għadu kemm ġie dijanjostikat f'irġiel adulti flimkien ma' terapija ta' deprivazzjoni tal-androġen (ADT, androgen deprivation therapy) (ara sezzjoni 5.1)
English: Renal and urinary disorders common: haematuria
Maltese: Disturbi fil-kliewi u fis-sistema urinarja komuni: ematurja
English: CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see section 4.4).
Maltese: Impediment ta' CYP17 twassal ukoll għal żieda filproduzzjoni ta' mineralokortikojd permezz tal-glandoli adrenal (ara s-sezzjoni 4.4).
English: In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all prospectively-defined secondary endpoint measures as follows:
Maltese: Barra t-titjib osservat fis-sopravivenza globali u f'rPFS, intwera benefiċcju għal ZYTIGA vs. trattament bi plaċebo fil-kejl tal-iskopijiet sekondarji kollha ddefiniti b'mod prospettiv kif ġej:
English: Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 11.1 months for patients receiving ZYTIGA and 5.6 months for patients receiving placebo (HR = 0.488; 95% CI: [0.420; 0.568], p < 0.0001).
Maltese: Iż-żmien medjan għallprogressjoni indikata b'PSA kien ta' 11.1 xahar għall-pazjenti li kienu qed jingħataw ZYTIGA u 5.6 xhur għall-pazjenti li kienu qed jingħataw plaċebo (HR=0.488; 95% CI: [0.420; 0.568], p < 0.0001).
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose increased by approximately 11% and 260% in subjects with mild and moderate pre-existing hepatic impairment,
Maltese: Esponiment sistemiku għal abiraterone wara doża waħda ta' 1,000 mg mill-ħalq żdied b'madwar 11% u 260% f'individwi li diġà kellhom indeboliment tal-fwied ħafif u moderat, rispettivament.
English: A statistically significant improvement in median overall survival was seen in patients treated with ZYTIGA (see Table 7).
Maltese: Titjib sinifikanti b'mod statistiku fit-total medjan ta' sopravivenza deher f'pazjenti kkurati bi ZYTIGA (ara Tabella 7).
English: CTCAE (version 4.0) Grade 4 urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, hypokalemia, cardiac failure, atrial fibrillation, and fractures occurred in < 1% of patients.
Maltese: Infezzjoni fl-apparat urinarju, żieda fl-alanine aminotransferase u/jew żieda fl-aspartate aminotransferase, ipokalimja, insuffiċjenza tal-qalb, fibrillazzjoni tal-atriju, u ksur tal-Grad 4 ta' CTCAE (verżjoni 4.0) seħħew f'< 1% tal-pazjenti.
English: Each film-coated tablet contains 500 mg abiraterone acetate.
Maltese: Kull pillola miksija b'rita fiha 500 mg abiraterone acetate.
English: Each 30 day carton contains 60 film-coated tablets in 5 cardboard wallets of 12 film-coated tablets each.
Maltese: Kull kartuna ta' 30 jum fiha 60 pillola miksija b'rita f'5 portafolli tal-kartun ta' 12-il pillola lwieħed.
English: Time to initiation of chemotherapy: The median time to initiation of chemotherapy was not reached for patients receiving ZYTIGA and was 38.9 months for patients receiving placebo (HR = 0.443; 95% CI: [0.349, 0.561], p < 0.0001).
Maltese: Iż-żmien medjan għall-bidu tal-kimoterapija ma ntlaħaqx għallpazjenti li kienu qed jirċievu ZYTIGA u kien 38.9 xhur għall-pazjenti li kienu qed jirċievu plaċebo (HR = 0.443; 95% CI: [0.349, 0.561], p < 0.0001).
English: PSA serves as a biomarker in patients with prostate cancer.
Maltese: PSA jservi ta' biomarkatur f'pazjenti b'kanċer tal-prostata.
English: In studies 3011 and 302, patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Maltese: Fl-istudji 3011 u 302, ġew esklużi pazjenti b'fibrillazzjoni tal-atriju, jew arritmija oħra tal-qalb li kienet teħtieġ terapija medika.
English: Effects on the external genitalia were observed though abiraterone acetate was not teratogenic.
Maltese: Kienu osservati effetti fuq il-ġenitali esterni għalkemm abiraterone acetate ma kienx teratoġeniku.
English: CTCAE (version 4.0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients.
Maltese: Ipertrigliċeridemija u anġina pektoris tal-Grad 3 ta' CTCAE (verżjoni 4.0) seħħew f'< 1% tal-pazjenti.
English: - in combination with Ra-223 (which is used to treat prostate cancer).
Maltese: - flimkien ma' Ra-223 (li jintuża biex jitratta kanċer tal-prostata).
English: In another trial, the pharmacokinetics of abiraterone were examined in subjects with pre-existing severe (n = 8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function.
Maltese: Fi prova oħra, il-farmakokinetika ta' abiraterone kienet eżaminata f'individwi b'indebolimet tal-fwied sever (n=8) li kien jeżisti minn qabel (Child-Pugh Klassi Ċ) u fi 8 individwi b'saħħithom bħala kontroll b'funzjoni tal-fwied normali.
English: For patients who develop hepatotoxicity during treatment (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section 4.4).
Maltese: Għal pazjenti li jiżviluppaw tossiċità tal-fwied waqt il-kura (żidied ta' alanine aminotransferase [ALT] jew ta' aspartate aminotransferase [AST] aktar minn 5 darbiet ogħla mill-ogħla limitu tannormal [ULN]) il-kura għandha titwaqqaf minnufih (ara s-sezzjoni 4.4).
English: Pain progression was defined as an increase from baseline of ≥ 30% in the BPI-SF worst pain intensity score over the previous 24 hours without a decrease in analgesic usage score observed at two consecutive visits, or an increase of ≥ 30% in analgesic usage score observed at two consecutive visits.
Maltese: Żvilupp fluġigħ kien iddefinit bħala żieda ta' ≥ 30% mil-linja bażi fil-punteġġ BPI-SF tal-qawwa tal-agħar uġigħ fl-aħħar 24 siegħa mingħajr tnaqqis fil-punteġġ tal-użu ta' analġeżiċi osservat f'żewġ visti konsekuttivi, jew żieda ta' ≥ 30% fil-punteġġ ta' użu ta' analġeżiċi osservat f'żewġ visti konsekuttivi.
English: The time to PSA progression was approximately doubled with ZYTIGA treatment (HR = 0.488).
Maltese: Iż-żmien għall-progressjoni indikata b'PSA ġie bejn wieħed u ieħor irduppjat b'kura b'ZYTIGA (HR=0.488).
English: The pharmacokinetics of abiraterone acetate was compared in patients with end-stage renal disease on a stable haemodialysis schedule versus matched control subjects with normal renal function.
Maltese: Il-farmakokinetika ta' abiraterone acetate tqabblet f'pazjenti b'mard tal-kliewi tal-aħħar stadju fuq skeda stabbli ta' dijalisi versus individwi mqabbla ta' kontroll b'funzjoni normali tal-kliewi.
English: The median time to PSA progression was 10.2 months for patients treated with ZYTIGA and 6.6 months for patients treated with placebo (HR = 0.580; 95% CI: [0.462; 0.728], p < 0.0001).
Maltese: Iż-żmien medjan għal żvilupp ta' PSA kien ta' 10.2 xhur għal pazjenti kkurati bi ZYTIGA u 6.6 xhur għal pazjenti kkurati bi plaċebo (HR=0.580; 95% CI: [0.462; 0.728], p < 0.0001).
English: Hepatotoxicity
Maltese: KONKLUŻJONIJIET XJENTIFIĊI
English: Figure 4: Kaplan Meier curves of radiographic progression-free survival in patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
Maltese: Figura 4: Kurvi Kaplan Meier ta' sopravivenza ħielsa minn progressjoni radjugrafika talmarda f'pazjenti kkurati jew b'ZYTIGA jew inkella bil-plaċebo flimkien ma' prednisone jew prednisolone u anaolgi ta' LHRH jew tneħħija qabel ta' testikola u l-korda tal-isperma (Fit-tieni analiżi interim ta' OS - Eżaminata mill-Ġdid millInvestigatur)
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 biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: Overall Survival (months) Median (95% CI)
Maltese: Medjan (95% CI)
English: This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis.
Maltese: Dan jiġi minn impediment selettiv tal-enzima CYP17 li hija meħtieġa għall-biosintesi tal-androġen.
English: Time to opiate use for cancer pain: The median time to opiate use for prostate cancer pain at the time of final analysis was 33.4 months for patients receiving ZYTIGA and was 23.4 months for patients receiving placebo (HR = 0.721; 95% CI: [0.614; 0.846], p < 0.0001).
Maltese: Iż-żmien medjan sabiex jibdew jintużaw l-opjati għall-uġigħ tal-kanċer tal-prostata fiż-żmien tal-analiżi finali kien 33.4 xhur għall-pazjenti li kienu qed jirċievu ZYTIGA u ta' 23.4 xhur għall-pazjenti li kienu qed jirċievu plaċebo (HR=0.721; 95% CI: [0.614; 0.846], p < 0.0001).
English: Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with “AA” on one side and “500” on the other side.
Maltese: Pilloli vjola, miksijin b'rita, f'għamla ovali (b'tul ta' 20 mm u wisa' ta' 10 mm), imnaqqxin b'“AA” fuq naħa waħda u “500” fuq in-naħa l-oħra.
English: Aside from reproductive organ changes seen in all animal toxicology studies, non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Maltese: Apparti t-tibdiliet fl-organi riproduttivi li dehru fl-istudji kollha ta' tossiċità fl-annimali, informazzjoni mhux klinika magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u riskju ta' kanċer ma' turi l-ebda periklu speċjali għall-bnedmin.
English: Time to initiation of cytotoxic chemotherapy: The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA and 16.8 months for patients receiving placebo (HR = 0.580; 95% CI: [0.487; 0.691], p < 0.0001).
Maltese: 2 xhur għall-pazjenti li kienu qed jingħataw ZYTIGA u 16.8 xhur għallpazjenti li kienu qed jingħataw plaċebo (HR=0.580; 95% CI: [0.487; 0.691], p < 0.0001).
English: Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Maltese: Kastrazzjoni medika b'analogu tal-ormon li jerħi l-ormon luteinising (LHRH - luteinising hormone releasing hormone) għandha titkompla waqt il-kura f'pazjenti li ma jkunux kastrati b'operazzjoni.
English: = confidence interval; ECOG = Eastern Cooperative Oncology Group performance score; HR = hazard ratio; NE = not evaluable
Maltese: BPI=Inventarju Qasir tal-Uġigħ; C.I.=intervall ta' kunfidenza; ECOG=punteġġ ta' kapaċità tal-Koperattiva tal-Grupp tal-Onkoloġija tal-Lvant;
English: - The other ingredients are microcrystalline cellulose (silicified); croscarmellose sodium; hypromellose 2910 (15 mPa.S); lactose monohydrate; magnesium stearate; colloidal anhydrous silica; and sodium laurilsulfate (see section 2, “ZYTIGA contains lactose and sodium”) The film-coating contains iron oxide black (E172); iron oxide red (E172); macrogol 3350; polyvinyl alcohol; talc; and titanium dioxide.
Maltese: - L-ingredjenti l-oħra huma microcrystalline cellulose (silikifikat); croscarmellose sodium; hypromellose 2910 (15 mPa.S); lactose monohydrate; magnesium stearate; colloidal anhydrous silica; u sodium laurilsulfate (ara s-sezzjoni 2, “ZYTIGA fih lactose u sodium”).
English: If ZYTIGA is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess (see information above).
Maltese: Jekk ZYTIGA jitkompla wara li jkunu twaqqfu l-kortikosterojdi, il-pazjenti għandhom jiġu mmonitorjati għal sintomi ta' mineralokortikojd żejjed (ara l-informazzjoni hawn fuq).
English: ZYTIGA should not be used in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: ZYTIGA m'għandux jintuża f'pazjenti b'indeboliment qawwi tal-fwied (ara s-sezzjonijiet 4.2, 4.3 u 5.2).
English: Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels.
Maltese: Spironolactone jintrabat mar-riċettur tal-androġen u jista' jżid il-livelli tal-antiġen speċifiku talprostata (PSA - prostate specific antigen).
English: In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Maltese: Fi studju separat ta' interazzjoni farmakokinetika klinika fuq individwi b'saħħithom, l-għoti flimkien ta' ketoconazole, impeditur qawwi ta' CYP3A4, ma kellux effett klinikament sinifikanti fuq il-farmakokinetiċi ta' abiraterone.
English: The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG2 performance status grade and also in elderly patients (≥75 years).
Maltese: L-inċidenza u s-severità tal-avvenimenti avversi kienet ogħla fis-sottogrupp ta' pazjenti bi grad ta' stat ta' eżekuzzjoni ECOG2 fil-linja bażi u wkoll f'pazjenti anzjani (≥75 sena).
English: abiraterone acetate should not be used in patients with severe hepatic impairment (see sections 4.2, 4.3 and 4.4).
Maltese: Abiraterone acetate m'għandux jintuża f'pazjenti b'indeboliment qawwi tal-fwied (ara ssezzjonijiet 4.2, 4.3 u 4.4).
English: Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse.
Maltese: Abiraterone acetate ma kienx karċinoġeniku fi studju li dam sejjer 6 xhur fil-ġurdien transġeniku (Tf, rasH2).
English: Paediatric population There is no relevant use of ZYTIGA in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' ZYTIGA fil-popolazzjoni pedjatrika.
English: BLISTER 500 mg
Maltese: FOLJA 500 mg
English: What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are purple, oval-shaped, film-coated (20 mm long by 10 mm wide) with “AA” written on one side and “500” on the other side.
Maltese: Il-pilloli ZYTIGA huma vjola, għandhom forma ovali, miksijin b'rita (b'tul ta' 20 mm u wisa' ta' 10 mm), b'“AA”miktuba fuq naħa waħda u “500” fuq in-naħa l-oħra.
English: There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C).
Maltese: Ma hemm l-ebda dejta dwar is-sigurtà u l-effikaċja klinika ta' għoti ta' ħafna dożi ta' abiraterone acetate meta dawn jingħataw lil pazjenti b'indeboliment moderat jew qawwi tal-fwied (Child-Pugh Klassi B jew Ċ).
English: • Periodic Safety Update Report
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: A lower proportion of patients treated with ZYTIGA had pain progression compared to patients taking placebo at 6 (22% vs. 28%), 12 (30% vs. 38%) and 18 months (35% vs. 46%).
Maltese: ZYTIGA kellhom żvilupp fl-uġigħ meta mqabbel ma' pazjenti li ħadu plaċebo fix-xhur 6 (22% vs. 28%), 12 (30% vs.
English: IRL - Co. Cork P43 FA46 Tel: +353 1 800 709 122
Maltese: IRL - Co. Cork P43 FA46
English: Hazard ratio (95% CI) Updated Survival Analysis Deaths (%) Median survival (months) (95% CI) Hazard ratio (95% CI)
Maltese: Analiżi ta' Sopravivenza Aġġornata Mwiet (%) Medjan ta' sopravivenza (xhur) (95% CI) Proporzjon ta' periklu (95% CI)
English: Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Janssen-Cilag International NV Turnhoutseweg 30
English: ZYTIGA has no or negligible influence on the ability to drive and use machines.
Maltese: ZYTIGA m'għandu l-ebda influwenza jew influwenza negliġibbli fuq il-kapaċità ta' sewqan u tħaddim ta' magni.
English: Time to pain progression: The median time to pain progression was not reached for patients receiving ZYTIGA and was 16.6 months for patients receiving placebo (HR = 0.695; 95% CI: [0.583, 0.829], p <0.0001).
Maltese: Iż-żmien medjan għall-progressjoni tal-uġigħ ma ntlaħaqx għall-pazjenti li rċivew ZYTIGA u kien 16.6 xhur għall-pazjenti li rċivew plaċebo (HR = 0.695; 95% CI: [0.583, 0.829], p <0.
English: Assess cardiac function as clinically indicated, institute appropriate management and consider discontinuation of this treatment if there is a clinically significant decrease in cardiac function (see section 4.2).
Maltese: L-għoti lil pazjenti b'indeboliment talkliewi, li jinkludi indeboliment qawwi tal-kliewi, ma jeħtieġx tnaqqis fid-doża (ara s-sezzjoni 4.2).
English: The investigator radiographic review of rPFS performed as a follow up sensitivity analysis is presented in Table 5 and Figure 4.
Maltese: L-eżami radjugrafiku mill-ġdid tal-investigatur ta' rPFS li saret biex l-analiżi ta' sensittivtà tkompli tiġi segwita hija ppreżentata f'Tabella 5 u Figura 4.
English: The treatment effect of AA-P on rPFS and OS across the pre-specified subgroups was favorable and consistent with the overall study population, except for the subgroup of ECOG score of 2 where no trend towards benefit was observed, however the small sample size (n=40) limits drawing any meaningful conclusion.
Maltese: L-effett tat-trattament ta' AA-P fuq rPFS u OS fis-sottogruppi kollha speċifikati minn qabel kien favorevoli u konsistenti malpopolazzjoni totali tal-istudju, ħlief għas-sottogrupp tal-punteġġ ta' 2 ta' ECOG fejn ma kienet osservata l-ebda tendenza lejn benefiċċju, madankollu in-numru żgħir tal-kampjun (n=40) jillimita li tinġibed xi konklużjoni ta' sinifikat.
English: Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis.
Maltese: Reazzjonijiet avversi importanti oħra jinkludu, disturbi tal-qalb, tossiċità tal-fwied, ksur, u alveolite allerġika.
English: In Phase 3 clinical studies, treatment discontinuations due to ALT and AST increases or abnormal hepatic function were reported in 1.1% of patients treated with abiraterone acetate and 0.6% of patients treated with placebo; no deaths were reported due to hepatotoxicity events.
Maltese: Fi studji kliniċi ta' Fażi 3, it-twaqqif tal-kura minħabba żidiet fl-ALT u l-AST jew funzjoni mhux normali tal-fwied ġew irrappurtati f'1.1% tal-pazjenti kkurati b'abiraterone acetate u f'0.6% tal-pazjenti kkurati bi plaċebo; ma kienu rrappurtati l-ebda mwiet minħabba każijiet ta' tossiċità fil-fwied.
English: Final survival analysis Deaths Median overall survival in months (95% CI) p-value* Hazard ratio** (95% CI)
Maltese: valur p* Proporzjon ta' periklu** (95% CI) Analiżi finali ta' sopravivenza Imwiet (%) Medjan ta' sopravivenza f'xhur (95% CI) valur p* Proporzjon ta' periklu** (95% CI)
English: How to take ZYTIGA
Maltese: Mediċini oħra u ZYTIGA
English: 120 tablets.
Maltese: Kull flixkun fih 120 pillola.
English: These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40 x ULN and bilirubin elevations 2 to 6 x ULN.
Maltese: Dawn iż-żewġ pazjenti li kellhom funzjoni tal-fwied normali fil-linja bażi, kellhom żiediet ta' bejn 15 u 40 x l-ULN fil-livelli tal-ALT jew tal-AST u żidiet ta' bejn 2 u 6 x l-ULN fil-bilirubin.
English: Interim survival analysis Deaths (%) Median survival (months) (95% CI)
Maltese: Analiżi interim ta' sopravivenza Imwiet (%) Medjan ta' sopravivenza (xhur) (95% CI)
English: Each tablet contains 250 mg of abiraterone acetate.
Maltese: Kull pillola fiha 250 mg abiraterone acetate.
English: 56 film-coated tablets 60 film-coated tablets
Maltese: 56 pillola miksija b'rita 60 pillola miksija b'rita
English: As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive organs, and the adrenal, pituitary and mammary glands were observed.
Maltese: B'riżultat ta' dan, kien osservat tnaqqis fil-piżijiet tal-organi u tibdil istopatoloġiku u/jew morfoloġiku fl-organi tar-riproduzzjoni, u fil-glandoli adrenali, pitwitarji u mammarji.
English: Treatment with ZYTIGA decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH analogues (or orchiectomy).
Maltese: ZYTIGA tnaqqas ittestosterone fis-serum għal livelli li ma jistgħux jitkejlu (bl-użu ta' analiżi kummerċjali) meta jingħata ma' analogi ta' LHRH (jew tneħħija ta' testikola u l-korda tal-isperma).
English: C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
Maltese: C bħala kapsuli, abiraterone acetate jiġi idrolizzat f'abiraterone, li mbagħad jgħaddi minn metaboliżmu li jinkludi sulfazzjoni, idroksilazzjoni u ossidazzjoni l-aktar fil-fwied.
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI)
Maltese: Sopravivenza ħielsa minn Progressjoni Radjugrafika talMarda (rPFS) Progressjoni tal-marda jew mewt Medjan ta' rPFS f'xhur (95% CI)
English: The proportion of subjects with measurable disease at baseline who had an objective response was 36% in the ZYTIGA group and 16% in the placebo group (p < 0.0001).
Maltese: Il-proporzjon ta' individwi b'mard li jista' jitkejjel fil-linja bażi li kellhom rispons oġġettiv kien ta' 36% fil-grupp ta' ZYTIGA u 16% fil-grupp ta' plaċebo (p < 0.0001).
English: Each carton contains (56 film-coated tablets) 4 wallets.
Maltese: Kull kartuna fiha (56 pillola miksija b'rita) 4 portafolli
English: Film-coated tablet
Maltese: TAL-PRODOTT MEDIĊINALI
English: Based on this observed trend, the product information (SmPC Section 4.4) should be updated to reflect that rhabdomyolysis/myopathy may occur between 1 to 6 months after initiation of therapy with AA.
Maltese: Abbażi ta' din it-tendenza osservata, l-informazzjoni tal-prodott (Sezzjoni 4.4 tal-SmPC) għandha tiġi aġġornata biex turi li rabdomijolisi/mijopatija jistgħu jseħħu minn xahar sa 6 xhur wara l-bidu tat-terapija b'AA.
English: Safety in patients with left ventricular ejection fraction (LVEF) < 50% or NYHA Class III or IV heart failure (in study 301) or NYHA Class II to IV heart failure (in studies 3011 and 302) was not established (see sections 4.8 and 5.1).
Maltese: II sa IV ta' NYHA (fl-istudji 3011 u 302) ma ġietx stabbilita (ara s-sezzjonijiet 4.8 u 5.1).
English: ZYTIGA contains a medicine called abiraterone acetate.
Maltese: ZYTIGA fih mediċina msejħa abiraterone acetate.
English: Renal impairment
Maltese: Użu orali
English: Figure 6: Kaplan Meier survival curves of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Maltese: Meta inti tieħu din il-mediċina it-tabib tiegħek se jordnalek ukoll mediċina oħra msejħa prednisone jew prednisolone.
English: b 0.466 (0.394, 0.550) Note: += censored observation, NE=not estimable.
Maltese: 415; 95% CI: [0.346, 0.497], p <0.
English: Only patients with a baseline pain score of ≥ 4 and at least one post-baseline pain score were analysed (N = 512) for pain palliation.
Maltese: Dawk il-pazjenti b'punteġġ ta' uġigħ ta' ≥ 4 fil-linja bażi u mill-anqas punteġġ wieħed ta' uġigħ wara l-linja bażi biss kienu analizzati (N=512) għal uġigħ li taffa.