FrancophonIA/ELRC3.0 huggingface dataset:
English: Pain: Treatment with ZYTIGA significantly reduced the risk of average pain intensity progression by 18% compared with placebo (p = 0.0490).
Maltese: Il-kura b'ZYTIGA naqqset b'mod sinifikanti r-riskju tal-progressjoni tal-intensità medja taluġigħ bi 18% meta mqabbla mal-plaċebo (p=0.0490).
English: The incidence of cardiovascular adverse reactions in the Phase 3 studies in patients taking abiraterone acetate versus patients taking placebo were as follows: atrial fibrillation 2.6% vs. 2.0%, tachycardia 1.9% vs. 1.0%, angina pectoris 1.7% vs. 0.8%, cardiac failure 0.7% vs. 0.2%, and arrhythmia 0.7% vs. 0.5%.
Maltese: 2.0%, takikardija 1.9% vs. 1.0%, anġina pectoris 1.7% vs. 0.8%, insuffiċjenza tal-qalb 0.7% vs. 0.2%, u arritmija 0.7% vs. 0.5%,
English: Moderate hepatic impairment (Child-Pugh Class B) has been shown to increase the systemic exposure to abiraterone by approximately four-fold following single oral doses of abiraterone acetate 1,000 mg (see section 5.2).
Maltese: Indeboliment moderat tal-fwied (Child-Pugh Klassi B) intwera li jżid l-esponiment sistemiku għal abiraterone b'madwar erba' darbiet aktar wara għoti ta' dożi waħdiet ta' 1,000 mg ta' abiraterone acetate mill-ħalq (ara s-sezzjoni 5.2).
English: Androgen deprivation treatment may increase the risk of heart rhythm problems.
Maltese: It-trattament b'deprivazzjoni ta' androġen jista' jżid ir-riskju ta' problemi tar-ritmu tal-qalb.
English: In a study to determine the effects of abiraterone acetate (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased approximately 2.9 fold.
Maltese: Fi studju biex jiġu stabbiliti l-effetti ta' abiraterone acetate (flimkien ma' prednisone) fuq doża waħda tas-sottostrat ta' CYP2D6 dextromethorphan, l-esponiment sistemiku (AUC) ta' dextromethorphan żdied b'madwar 2.9 darbiet.
English: General disorders and administration site conditions very common: oedema peripheral
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata komuni ħafna: edima periferali
English: The pharmacokinetics of abiraterone acetate was examined in subjects with pre-existing mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) and in healthy control subjects.
Maltese: Il-farmakokinetika ta' abiraterone acetate kienet eżaminata f'individwi li diġà kellhom indeboliment ħafif jew moderat tal-fwied (Child-Pugh Klassi A u B, rispettivament) u f'individwi f'saħħithom li servew ta' kontroll.
English: Dose reduction of medicinal products with a narrow therapeutic index that are metabolised by CYP2D6 should be considered.
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża ta' prodotti mediċinali b'indiċi terapewtiċi stretti li jiġu metabolizzati minn CYP2D6.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The median age of enrolled patients was 69 years (range 39-95).
Maltese: L-età medjana tal-pazjenti mdaħħla fl-istudju kienet ta' 69 sena (firxa 39-95).
English: CARTON 500 mg
Maltese: KARTUNA 500 mg
English: The apparent volume of distribution is approximately 5,630 l, suggesting that abiraterone extensively distributes to peripheral tissues.
Maltese: Il-volum ta' distribuzzjoni li jidher huwa ta' madwar 5,630 l, li jissuġġerixxi li abiraterone jiġi ddistribwit b'mod estensiv fit-tessuti periferali.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italy
Maltese: Janssen Borgo San Michele I-04100
English: A lower proportion of patients in the ZYTIGA group had skeletal-related events compared with the placebo group at 6 months (18% vs. 28%), 12 months (30% vs. 40%), and 18 months (35% vs. 40%).
Maltese: Proporzjon aktar baxx ta' pazjenti fil-grupp ta' ZYTIGA kellhom każijiet skeletriċi meta mqabbla mal-grupp ta' plaċebo fix-xhur 6 (18% vs. 28%), 12 (30% vs. 40%), u 18 (35% vs. 40%).
English: Radiographic progression included progression by bone scan (according to modified PCWG2) or progression of soft tissue lesions by CT or MRI (according to RECIST 1.1).
Maltese: Progressjoni radjugrafika kienet tinkludi progressjoni permezz ta' skan tal-għadam (skont PCWG2 modifikat) jew progressjoni ta' leżjonijiet fit-tessuti rotob permezz ta' CT jew MRI (skont RECIST 1.1).
English: High-risk prognosis was defined as having at least 2 of the following 3 risk factors: (1) Gleason score of ≥8; (2) presence of 3 or more lesions on bone scan; (3) presence of measurable visceral (excluding lymph node disease) metastasis.
Maltese: Pronjosi ta' riskju għoli kienet iddefinita li wieħed ikollu mill-inqas 2 mit-3 fatturi ta' riskju li ġejjin: (1) Punteġġ ta' Gleason ta' ≥8; (2) il-preżenza ta' 3 leżjonijiet jew aktar fuq skan tal-għadam; (3) preżenza ta' metastasi fil-vixxri (li teskludi mard talgħoqod tal-limfa) li tista' titkejjel.
English: Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol (the latter three medicinal products requiring CYP2D6 to form their active analgesic metabolites).
Maltese: Eżempji ta' prodotti mediċinali metabolizzati minn CYP2D6 jinkludu metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide,
English: Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Maltese: Problemi bil-glandoli adrenali (marbuta ma' problemi tal-melħ u l-ilma), ritmu ta' taħbit tal-qalb mhux normali (arritmija), debbulizza muskolari u/jew uġigħ muskolari.
English: Infections and infestations very common: urinary tract infection common: sepsis
Maltese: Infezzjonijiet u infestazzjonijiet komuni ħafna: infezzjoni fl-apparat tal-awrina komuni: sepsis
English: In patients treated with abiraterone acetate, CTCAE (version 4.0) Grades 3 and 4 hypokalaemia were observed in 6% and 2% of patients, CTCAE (version 4.0) Grades 3 and 4 hypertension were observed in 8% and 5% of patients, and fluid retention (peripheral oedema) Grades 3 and 4 were observed in 1% and 1% of patients, respectively.
Maltese: F'pazjenti kkurati b'abiraterone acetate, ipokalimja tal-Gradi 3 u 4 ta' CTCAE (verżjoni 4.0) kienet ossservata f'6% u 2% tal-pazjenti, pressjoni għolja tal-Gradi 3 u 4 ta' CTCAE (verżjoni 4.0) kienet osservata fi 8% u f'5% tal-pazjenti, u żamma tal-fluwidu (edima periferal) tal-Gradi 3 u 4 ta' CTCAE (verżjoni 4.0) kienet osservata f'1% u f'1% tal-pazjenti, rispettivament.
English: At the planned rPFS analysis there were 401 events, 150 (28%) of patients treated with ZYTIGA and 251 (46%) of patients treated with placebo had radiographic evidence of progression or had died.
Maltese: Fl-analiżi rPFS ippjanata kien hemm 401 każ, 150 (28%) tal-pazjenti kkurati b'ZYTIGA u 251 (46%) tal-pazjenti kkurati bi plaċebo kellhom xhieda radjugrafika ta' progressjoni tal-marda jew kienu mietu.
English: What ZYTIGA contains - The active substance is abiraterone acetate.
Maltese: X'fih ZYTIGA - Is-sustanza attiva hija abiraterone acetate.
English: Sixty-five percent (354 of 546) of patients treated with ZYTIGA, compared with 71% (387 of 542) of patients treated with placebo, had died.
Maltese: Ħamsa u sittin fil-mija (354 minn 546) ta' pazjenti kkurati b'ZYTIGA, mqabbla ma' 71% (387 minn 542) ta' pazjenti kkurati bi plaċebo, kienu mietu.
English: In all animal toxicity studies, circulating testosterone levels were significantly reduced.
Maltese: Fl-istudji kollha ta' tossiċità fl-annimali, il-livelli ta' testosterone li jiċċirkulaw tnaqqsu b'mod sinifikanti.
English: - The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32), colloidal anhydrous silica, and sodium laurilsulfate (see section 2, “ZYTIGA contains lactose and sodium”).
Maltese: - L-ingredjenti l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32),; silica, colloidal anhydrous silica, u sodium laurilsulfate (ara s-sezzjoni 2, “ZYTIGA fih lactose u sodium”).
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI) p-value* Hazard ratio** (95% CI)
Maltese: Sopravivenza ħielsa minn Progressjoni Radjugrafika tal-Marda (rPFS) Progressjoni jew mewt Medjan ta' rPFS f'xhur (95% CI) valur p* Proporzjon ta' periklu** (95% CI)
English: Patients receiving ZYTIGA demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 38% vs. 10%, p < 0.0001.
Maltese: Pazjenti li rċivew ZYTIGA urew rata ogħla b'mod sinifikanti fir-rispons tal-PSA totali (ddefinit bħala tnaqqis ta' ≥ 50% mill-linja bażi), meta mqabbla ma' pazjenti li rċivew plaċebo, 38% vs. 10%, p < 0.0001.
English: The proportion of patients with pain palliation was statistically significantly higher in the ZYTIGA group than in the placebo group (44% vs. 27%, p = 0.0002).
Maltese: Il-proporzjon ta' pazjenti li taffielhom l-uġigħ kien sinifikament ogħla b'mod statistiku fil-grupp ta' ZYTIGA milli fil-grupp ta' plaċebo (44% vs. 27%, p=0.0002).
English: Interactions with other medicinal products
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra
English: Moreover, sections 4.3 and 4.4 of the SmPC should be amended to reflect the contraindication of the use of Xofigo (Radium-223) in combination with abiraterone acetate and prednisone/prednisolone and the increased risk for fractures and mortality in patients treated with Radium-223 in combination with abiraterone.
Maltese: Barra minn hekk, sezzjonijiet 4.3 u 4.4 tal-SmPC għandhom jiġu emendati biex juru lkontraindikazzjoni tal-użu ta' Xofigo (Radium-223) flimkien ma' abiraterone acetate u prednisone/prednisolone u ż-żieda fir-riskju ta' ksur u mortalità f'pazjenti ttrattati b'Radium-223 flimkien ma' abiraterone.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: In a planned analysis conducted after 552 deaths were observed, 42% (333 of 797) of patients treated with ZYTIGA compared with 55% (219 of 398) of patients treated with placebo, had died.
Maltese: F'analiżi ppjanata li saret wara li kienu osservati 552 mewt, 42% (333 minn 797) tal-pazjenti kkurati bi ZYTIGA imqabbla ma' 55% (219 minn 398) tal-pazjenti kkurati bi plaċebo, kienu mietu.
English: Each carton contains (60 film-coated tablets) 5 wallets.
Maltese: Kull kartuna fiha (60 pillola miksija b'rita) 5 portafolli.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jista' jaffettwa sa persuna waħda minn kull 100):
English: Study 302 enrolled docetaxel naïve patients; whereas, study 301 enrolled patients who had received prior docetaxel.
Maltese: L-istudju 302 ġabar fih pazjenti li qatt ma kienu ħadu docetaxel; filwaqt li l-studju 301 ġabar fih pazjenti li kienu rċivew docetaxel qabel.
English: Study 3011 (patients with newly diagnosed high risk mHSPC) In Study 3011, (n=1199) the median age of enrolled patients was 67 years.
Maltese: Fl-Istudju 3011, (n=1199) il-medjan tal-età tal-pazjenti rreġistrati fl-istudju kien 67 sena.
English: The AUC to abiraterone increased by approximately 600% and the fraction of free drug increased by 80% in subjects with severe hepatic impairment compared to subjects with normal hepatic function.
Maltese: L-AUC ta' abiraterone żdied b'madwar 600% u l-porzjon ta' mediċina libera żdied bi 80% f'individwi b'indeboliment tal-fwied sever meta mqabbel ma individwi b'funzjoni tal-fwied normali.
English: In a Phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with abiraterone acetate, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels.
Maltese: Fi studju kliniku ta' Fażi 3 ta' pazjenti li fuqhom diġà ma ħadmitx kimoterapija b'taxanes, 38% tal-pazjenti kkurati bi abiraterone acetate, versus 10% talpazjenti kkurati bi placebo, kellhom tal-anqas tnaqqis ta' 50% mill-linja bażi fil-livelli ta' PSA.
English: Concomitant use of a corticosteroid reduces the incidence and severity of these adverse reactions (see section 4.4).
Maltese: L-użu konkomitanti ta' kortikosterojd inaqqas l-inċidenza u lqawwa ta' dawn ir-reazzjonijiet avversi (ara s-sezzjoni 4.4).
English: Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess ZYTIGA may cause hypertension, hypokalaemia and fluid retention (see section 4.8) as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition (see section 5.1).
Maltese: ZYTIGA jista' jikkawża pressjoni għolja, ipokalimja u żamma tal-fluwidi (ara s-sezzjoni 4.8) konsegwenza ta' żieda fil-livelli ta' mineralokortikojd ġejja minn inibizzjoni ta' CYP17 (ara ssezzjoni 5.1).
English: There have been rare post-marketing reports of acute liver failure and hepatitis fulminant, some with fatal outcome (see section 4.8).
Maltese: Wara t-tqegħid fis-suq kien hemm rapporti rari ta' insuffiċjenza akuta tal-fwied u epatite fulminanti, xi wħud minnhom b'riżultat fatali (ara s-sezzjoni 4.8).
English: In the 3011 trial, patients with baseline ALT and AST > 2.5 X ULN, bilirubin > 1.5 X ULN or those with active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction were excluded.
Maltese: Fil-prova 3011, pazjenti li fil-linja bażi kellhom ALT u AST > 2.5 X ULN, bilirubin > 1.5 X ULN jew dawk b'epatitie virali attiva jew bis-sintomi jew mard kroniku tal-fwied; axxite jew disturbi ta' ħruġ ta' demm minħabba funzjoni ħażina tal-fwied ġew esklużi.
English: Study 302 (chemotherapy naïve patients)
Maltese: Studju 302 (pazjenti li qatt ma ħadu kimoterapija)
English: Range p value Hazard ratio (95% CI)
Maltese: Valur p Proporzjon ta' periklu (95% CI)
English: ZYTIGA 500 mg film-coated tablets abiraterone acetate
Maltese: ZYTIGA 500 mg pilloli miksijin b'rita abiraterone acetate
English: Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2).
Maltese: Meta wieħed jieħu lpilloli mal-ikel dan iżid l-esponiment sistemiku għal abiraterone (ara s-sezzjonijiet 4.5 u 5.2).
English: C-abiraterone acetate 1,000 mg, approximately 88% of the radioactive dose is recovered in faeces and approximately 5% in urine.
Maltese: C, madwar 88% taddoża radjuattiva tiġi rkuprata fl-ippurgar u madwar 5% fl-awrina.
English: Dosage of prednisone or prednisolone For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily.
Maltese: Id-dożaġġ ta' prednisone jew prednisolone Għal mHSPC, ZYTIGA jintuża ma' 5 mg prednisone jew prednisolone kuljum.
English: In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone was increased by 46% and the AUCs for M-III and M-IV, the active metabolites of pioglitazone, each decreased by 10% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate.
Maltese: Fi prova ta' interazzjoni bejn mediċina u oħra f'individwi b'saħħithom, l-AUC ta' pioglitazone żdied b'46% u l-AUCs għal M-III u M-IV, il-metaboliti attivi ta' pioglitazone, kull wieħed naqas b'10% meta pioglitazone ngħata flimkien ma' doża waħda ta' 1,000 mg abiraterone acetate.
English: Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 33.2 months for patients receiving ZYTIGA and 7.4 months for patients receiving placebo (HR = 0.299; 95% CI: [0.255, 0.352], p <0.0001).
Maltese: Iż-żmien medjan għall-progressjoni ta' PSA kien 33.2 xahar għall-pazjenti li kienu qed jirċievu ZYTIGA u 7.4 xhur għall-pazjenti li kienu qed jirċievu plaċebo (HR = 0.299; 95% CI: [0.255, 0.352], p <0.
English: AA-P= subjects who received abiraterone acetate and prednisone.
Maltese: AA-P= individwi li rċivew abiraterone acetate u prednisone.
English: p-value is derived from a log-rank test stratified by ECOG performance status score (0-1 vs. 2), pain score (absent vs. present), number of prior chemotherapy regimens (1 vs. 2), and type of disease progression (PSA only vs. radiographic).
Maltese: Il-valur p jiġi kkalkulat permezz ta' test log-rank stratifikat minn punteġġ ta' status ta' prestazzjoni ECOG (0-1 vs. 2), punteġġ ta' uġigħ (nieqes vs. preżenti), l-għadd ta' skedi ta' kimoterpija li ngħataw qabel (1 vs. 2), u t-tip ta' żvilupp tal-marda (PSA biss vs. radjugrafiku).
English: Tell your doctor if you are receiving medicine - used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol); - known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].
Maltese: Għid littabib tiegħek jekk inti qed tieħu xi mediċina - li tintuża għat-trattament ta' problemi tar-ritmu tal-qalb (eż. quinidine, procainamide, amiodarone u sotalol); - magħrufa li żżid ir-riskju ta' problemi tar-ritmu tal-qalb [eż. methadone (li jintuża għal serħan mill-uġigħ u bħala parti minn detossifikazzjoni għall-vizzju tad-droga), moxifloxacin (antibijotiku), antipsikotiċi (li jintużaw għal mard mentali serju)].
English: The number of patients treated with ZYTIGA by racial group was Caucasian 520 (95.4%), Black 15 (2.8%), Asian 4 (0.7%) and other 6 (1.1%).
Maltese: 4%), Suwed 15 (2.8%), Asjatiċi 4 (0.7%) u razez oħra 6 (1.1%).
English: A statistically significant improvement in OS in favor of AA-P plus ADT was observed with a 38% reduction in the risk of death compared to Placebo plus ADT (HR=0.621; 95% CI: 0.509, 0.756; p<0.0001, crossing the pre-specified boundary for OS at Interim Analysis 1 of 0.010 (see Table 3 and Figure 2).
Maltese: Titjib sinifikanti b'mod statistiku f'OS favur AA-P flimkien ma' ADT kien osservat bi tnaqqis ta' 38% fir-riskju ta' mewt meta mqabbel ma' Plaċebo flimkien ma' ADT (HR=0.621; 95% CI: 0.509, 0.756; p<0.0001, qabeż il-limitu speċifikat minn qabel għal OS f'Analiżi Interim 1 ta' 0.010 (ara Tabella 3 u Figura 2).
English: Hyperglycaemia
Maltese: Il-Belġju
English: The proportion of subjects with a confirmed PSA response was greater in the ZYTIGA group than in the placebo group (62% vs. 24%; p < 0.0001).
Maltese: Il-proporzjon ta' individwi b'rispons ikkonfermat fil-PSA kien akbar filgrupp ta' ZYTIGA mill-grupp ta' plaċebo (62% vs. 24%; p < 0.0001).
English: Johnson & Johnson S.E.
Maltese: Johnson & Johnson România SRL Str.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jista' jaffettwa sa persuna waħda minn kull 10):
English: Johnson & Johnson d.o.o.
Maltese: Johnson & Johnson d.o.o. Šmartinska cesta 53
English: NE = Not Estimated * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Maltese: NE= Ma Ġiex Stmat (Not Estimated) * Il-valur p jinkiseb minn test ta' log-rank stratifikat skont il-punteġġ tal-ECOG (0 jew 1) fil-linja bażi ** Proporzjon ta' periklu < 1 huwa favur ZYTIGA
English: NE = Not estimated * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Maltese: NE= Ma ġiex stmat (Not estimated) * Il-valur p jinkiseb minn test ta' log-rank stratifikat skont il-punteġġ tal-ECOG (0 jew 1) fil-linja bażi ** Proporzjon ta' periklu < 1 huwa favur ZYTIGA
English: If you plan to take Ra-223 following treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
Maltese: Jekk tippjana li tieħu Ra-223 wara trattament b'ZYTIGA u prednisone/prednisolone, inti għandek tistenna 5 ijiem qabel tibda trattament b'Ra-223.
English: Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels.
Maltese: Kanċer tal-prostata sensittiv għall-androgen jirrispondi għal kura li tnaqqas il-livelli ta' androgen.
English: A score of 0-1 on Brief Pain Inventory-Short Form (BPI-SF) worst pain in last 24 hours was considered asymptomatic, and a score of 2-3 was considered mildly symptomatic.
Maltese: Punteġġ minn 0-1 fuq l-Inventarju Qasir tal-Uġigħ-Formola Qasira (BPI-SF - Brief Pain Inventory-Short Form) għall-agħar uġigħ fl-aħħar 24 siegħa kien ikkunsidrat mingħajr sintomi, u punteġġ ta' 2-3 kien ikkunsidrat bħala sintomi ħfief.
English: The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.
Maltese: Is-sustanza attiva, abiraterone, turi riskju ambjentali għall-ambjent akwatiku, speċjalment għall-ħut.
English: Table 4: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy ZYTIGA (N = 546)
Maltese: Tabella 6: Studju 302: Sopravivenza globali ta' pazjenti kkurati jew b'ZYTIGA jew inkella bi plaċebo flimkien ma' prednisone jew prednisolone u analogi ta' LHRH jew tneħħija qabel ta' testikola u l-korda tal-isperma ZYTIGA (N=546)
English: Cardiac disorders common: cardiac failure*, angina pectoris, atrial fibrillation, tachycardia uncommon: other arrhythmias not known: myocardial infarction, QT prolongation (see sections 4.4 and 4.5)
Maltese: Disturbi fil-qalb komuni: insuffiċjenza tal-qalb*, anġina pektoris, fibrillazzjoni tal-atriju, takikardija mhux komuni: arritmiji oħra mhux magħruf: infart mijokardjali,QT mtawwal (ara s-sezzjonijiet 4.4 u 4.5)
English: The median radiographic progression-free survival was 5.6 months for patients treated with ZYTIGA and 3.6 months for patients who received placebo (HR = 0.673; 95% CI: [0.585; 0.776], p < 0.0001).
Maltese: Is-sopravivenza medjana mingħajr żvilupp radjugrafiku kienet ta' 5.6 xhur għal pazjenti kkurati bi ZYTIGA u 3.6 xhur għal pazjenti li rċivew plaċebo (HR=0.673; 95% CI: [0.585; 0.776], p < 0.0001).
English: - ZYTIGA is taken with a medicine called prednisone or prednisolone.
Maltese: - ZYTIGA jittieħed ma' mediċina msejħa prednisone jew prednisolone.
English: * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Maltese: * Il-valur p jinkiseb minn test ta' log-rank stratifikat skont il-punteġġ tal-ECOG (0 jew 1) fil-linja bażi ** Proporzjon ta' periklu < 1 huwa favur ZYTIGA
English: Subgroup survival analyses showed a consistent survival benefit for treatment with ZYTIGA (see Figure 7).
Maltese: Analiżi ta' sottogrupp għal sopravivenza urew benefiċċju konsistenti ta' sopravivenza għal kura b' ZYTIGA (ara Figura 7).
English: In study 302, (n = 1,088) the median age of enrolled patients was 71 years for patients treated with ZYTIGA plus prednisone or prednisolone and 70 years for patients treated with placebo plus prednisone or prednisolone.
Maltese: Fl-istudju 302, (n=1088) l-età medjana tal-pazjenti mdaħħla fl-istudju kienet ta' 71 sena għall-pazjenti kkurati b'ZYTIGA flimkien ma' prednisone jew prednisolone u 70 sena għall-pazjenti kkurati bi plaċebo flimkien ma' prednisone jew prednisolone.
English: d.o.o.
Maltese: U L-UŻU.
English: Alanine aminotransferase increased and/or aspartate aminotransferase increased includes ALT increased, AST increased, and hepatic function abnormal.
Maltese: Rapporti spontaneji mill-esperjenza ta' wara t-tqegħid fis-suq Żieda fl-alanine aminotransferase u/jew żieda fl-aspartate aminotransferase inklużi żieda fl-ALT, żieda fl-AST, u funzjoni mhux normali tal-fwied.
English: Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated with abiraterone acetate.
Maltese: Tossiċità tal-fwied b'livelli għoljin tal-ALT, AST u bilirubin totali kienu rrappurtati f'pazjenti kkurati b'abiraterone acetate.