FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Adverse reactions identified in clinical studies and post-marketing System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi identifikati fi studji kliniċi u wara t-tqegħid fis-suq Klassi tas-Sistemi u tal-Organi
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Janssen-Cilag Polska Sp. z o.o. ul.
English: Skeletal muscle effects
Maltese: Effetti fuq muskoli skeletriċi
English: Placebo (N = 542)
Maltese: Plaċebo (N=542)
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara s-sezzjoni 6.1.
English: ZYTIGA contains lactose and sodium - ZYTIGA contains lactose (a type of sugar).
Maltese: ZYTIGA fih lactose u sodium - ZYTIGA fih lactose (tip ta' zokkor).
English: Endocrine disorders uncommon: adrenal insufficiency
Maltese: Disturbi fis-sistema endokrinarja mhux komuni: insuffiċjenza adrenali
English: Excipients with known effect Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
Maltese: Eċċipjenti b'effett magħruf Kull pillola fiha 189 mg ta' lactose u 6.8 mg ta' sodium.
English: A planned interim analysis (IA) for OS was conducted after 333 deaths were observed.
Maltese: Analiżi interim (IA - interim analysis) ippjanata ta' OS saret wara li ġew osservati 333 mewt.
English: CY-2234 Λευκωσία Τηλ: +357 22 207 700
Maltese: Λευκωσία Τηλ: +357 22 207 700
English: In Study 3011, grade 3 or 4 hepatotoxicity was observed in 8.4% of patients treated with ZYTIGA.
Maltese: Fl-istudju 3011, tossiċità tal-fwied ta' grad 3 jew 4 ġiet osservata fi 8.4% tal-pazjenti trattati b'ZYTIGA.
English: In vitro, the major metabolites abiraterone sulphate and N-oxide abiraterone sulphate were shown to inhibit the hepatic uptake transporter OATP1B1 and as a consequence it may increase the concentrations of medicinal products eliminated by OATP1B1.
Maltese: In vitro, il-metaboliti ewlenien abiraterone sulphate u N-oxide abiraterone sulphate ġew osservati li jimpedixxu t-teħid ta' trasportatur OATP1B1 ġol-fwied u bħala konsegwenza jista' jgħolli lkonċentrazzjonijiet ta' prodotti mediċinali eliminati permezz ta' OATP1B1.
English: UAB "JOHNSON & JOHNSON" Konstitucijos pr. 21C LT-08130 Vilnius Tel: +370 5 278 68 88
Maltese: JOHNSON" GKonstitucijos pr. 21C LT-08130 Vilnius Tel: +370 5 278 68 88
English: Use with Spironolactone
Maltese: Użu ma' Spironolactone
English: The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Maltese: L-AUC24 għal dextrorphan, il-metabolit attiv ta' dextromethorphan, żdiedet b'madwar 33%.
English: Use with products known to prolong QT interval Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc.
Maltese: Użu ma' prodotti magħrufa li jtawwlu l-intervall QT Minħabba li t-trattament b'deprivazzjoni ta' androġen jista' jtawwal l-intervall QT, hija rrakkomandata l-kawtela meta ZYTIGA jingħata ma' prodotti mediċinali magħrufa li jtawlu lintervall QT jew prodotti mediċinali li kapaċi jinduċu torsades de pointes bħal prodotti mediċinali antiarritmiċi ta' klassi IA (eż. quinidine, disopyramide) jew klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, antipsikotiċi, eċċ.
English: Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents, ATC code: L02BX03
Maltese: Kategorija farmakoterapewtika: terapija endokrinarja, antagonisti oħra tal-ormoni u sustanzi oħra marbuta magħhom, kodiċi ATC: L02BX03
English: See leaflet for further information.
Maltese: Sorsi oħra ta' informazzjoni
English: EU/1/11/714/002 (56 film-coated tablets) EU/1/11/714/003 (60 film-coated tablets)
Maltese: EU/1/11/714/0012 (56 pillola miksijin b'rita) EU/1/11/714/003 (60 pillola miksijin b'rita)
English: PL-02-135 Warszawa Tel.+48 22 237 60 00
Maltese: Warszawa Tel.+48 22 237 60 00
English: ZYTIGA 250 mg tablets abiraterone acetate
Maltese: ZYTIGA 250 mg pilloli abiraterone acetate
English: Table 3:
Maltese: Tabella 7:
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Excipients with known effect Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium.
Maltese: Eċċipjenti b'effett magħruf Kull pillola miksija b'rita fiha 253.2 mg ta' lactose u 13.5 mg ta' sodium.
English: ZYTIGA 250 mg tablets
Maltese: ZYTIGA 250 mg pilloli
English: th percentile was 7.4 months in the ZYTIGA group,
Maltese: th percentile kien ta' 7.4 xhur fil-grupp ta' ZYTIGA, versus
English: The median rPFS was 16.5 months in the abiraterone acetate group and 8.3 months in the placebo group.
Maltese: Il-medjan ta' rPFS kien 16.5 xhur fil-grupp ta' abiraterone acetate u 8.3 xhur fil-grupp tal-plaċebo.
English: Hypokalemia was observed in 20.4% of patients in the hormone sensitive population (study 3011) compared to 19.2% and 14.9% in 301 and 302, respectively).
Maltese: Ipokalimja kienet osservata f'20.4% tal-pazjenti fil-popolazzjoni sensittiva għall-ormoni (studju 3011) meta mqabbla ma' 19.2% u 14.9% fi 301 u 302, rispettivament).
English: The majority of exploratory endpoints favored treatment with abiraterone acetate and prednisone (AA-P) over Placebo.
Maltese: Il-maġġoranza tal-iskopijiet finali esploratorji ffavorixxew it-trattament b'abiraterone acetate u prednisone (AA-P) fuq il-Plaċebo.
English: Efficacy was established in three randomised placebo-controlled multicentre Phase 3 clinical studies (studies 3011, 302 and 301) of patients with mHSPC and mCRPC.
Maltese: L-effikaċja ġiet stabbilita fi tlett studji kliniċi randomised, ikkontrollati bi plaċebo multiċentriċi ta' Fażi 3 (studji 3011, 302 u 301) ta' pazjenti b'mHSPC u mCRPC.
English: Not reached (11.66; NE)
Maltese: Ma ntlaħaqx (11.66; NE)
English: Six hundred and seven (607) subjects had radiographic progression or died: 271 (50%) in the abiraterone acetate group and 336 (62%) in the placebo group.
Maltese: Sitt mija u seba' (607) individwi kellhom progressjoni radjugrafika tal-marda jew mietu: 271 (50%) fil-grupp ta' abiraterone acetate u 336 (62%) fil-grupp tal-plaċebo.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 832 (69.4%), Asian 246 (20.5%), Black or African American 25 (2.1%), other 80 (6.7%), unknown/not reported 13 (1.1%), and American Indian or Alaska Native 3 (0.3%).
Maltese: In-numru ta' pazjenti ttrattati b'ZYTIGA skont il-grupp tar-razza kien Kawkasi 832 (69.4%), Asjatiċi 246 (20.5%), Suwed jew Amerikani Afrikani 25 (2.1%), oħrajn 80 (6.7%), mhux magħrufa/mhux irrappurtata 13 (1.1%), u Indjani Amerikani jew Indiġeni tal-Alaska 3 (0.3%).
English: Microcrystalline cellulose (silicified) Croscarmellose sodium Hypromellose 2910 (15 mPa.S) Lactose monohydrate Magnesium stearate Colloidal anhydrous silica Sodium laurilsulfate
Maltese: Microcrystalline cellulose (silikifikat) Croscarmellose sodium Hypromellose 2910 (15 mPa.S) Lactose monohydrate Magnesium stearate Colloidal anhydrous silica Sodium laurilsulfate
English: България „Джонсън & Джонсън България” ЕООД ж.к.
Maltese: Джонсън България” ЕООД ж.к. Младост 4
English: Tablet White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side.
Maltese: Pilloli ovali, minn bojod sa offwajt (twal 15.9 mm x wisgħin 9.5 mm), imnaqqxin b'AA250 fuq naħa waħda.
English: Prior use of ketoconazole
Maltese: L-użu ta' ketoconazole qabel
English: Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).
Maltese: B'mod speċifiku, abiraterone jimpedixxi b'mod selettiv l-enzima 17α-hydroxylase/C17,20-lyase (CYP17).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali urew tossiċità riproduttiva (ara s-sezzjoni 5.3).
English: Figure 2: Kaplan-Meier Plot of Overall Survival; Intent-to-treat Population (Study PCR3011)
Maltese: Figura 2: Plot Kaplan-Meier ta' Sopravivenza Globali; Popolazzjoni bl-Intenzjoni li tiġi ttrattata (Studju PCR3011)
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Maltese: Kategoriji ta' frekwenza huma ddefiniti kif ġej: 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); rari ħafna (<1/10,000) u mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli).
English: WALLET 500 mg (30 days)
Maltese: PORTAFOLL 500 mg (30 jum)
English: A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 3011).
Maltese: Ġiet osservata inċidenza ogħla ta' ipertensjoni u ipokalimja fil-popolazzjoni sensittiva għall-ormoni (studju 3011).
English: Overall Survival, Stratified Analysis; Intent-to-treat Population (Study PCR3011) AA-P
Maltese: Ħielsa Minn Progressjoni - Analiżi Stratifikata; Popolazzjoni blIntenzjoni li tiġi ttrattata (Studju PCR3011) AA-P
English: CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond.
Maltese: CYP17 tikkatalizza il-bidla ta' pregnenolone u progesterone f'prekursuri ta' testosterone, DHEA u androstenedione, rispettivament, permezz ta' 17α-hydroxylation u qsim tar-rabta C17,20.
English: Time to skeletal-related event (SRE): There was a 30% reduction in the risk of skeletal-related events (HR = 0.703; 95% CI: [0.539, 0.916], p = 0.0086).
Maltese: Kien hemm tnaqqis ta' 30% fir-riskju ta' avvenimenti marbuta mal-iskeletru (HR = 0.703; 95% CI: [0.539, 0.916], p = 0.0086).
English: Heart attack, changes in ECG - electrocardiogram (QT prolongation).
Maltese: Attakk ta' qalb, bidliet fl-ECG - elettrokardjogramm (intervall QT mtawwal).
English: The number of patients treated with ZYTIGA by racial group was Caucasian 737 (93.2%), Black 28 (3.5%), Asian 11 (1.4%) and other 14 (1.8%).
Maltese: In-numru ta' pazjenti kkurati b'ZYTIGA skont il-grupp tar-razza kien Kawkasi 737 (93.2%), Suwed 28 (3.5%), Asjatiċi 11 (1.4%) u razez oħra 14 (1.8%).
English: th percentile in the ZYTIGA group was twice that of the control group at 9.9 months versus 4.9 months.
Maltese: th percentile tal-grupp ta' ZYTIGA kien id-doppju ta' dak fil-grupp ta' kontroll b'9.9 xhur versus 4.9 xhur.
English: Potential to affect exposures to other medicinal products Abiraterone is an inhibitor of the hepatic drug-metabolising enzymes CYP2D6 and CYP2C8.
Maltese: Il-potenzjal li jiġu affettwati esponimenti għal mediċini oħra Abiraterone huwa impeditur ta' enzimi CYP2D6 u CYP2C8 li jimmetabolizzaw mediċini fil-fwied.
English: A significant difference in rPFS between treatment groups was observed (see Table 2 and Figure 1).
Maltese: Kienet osservata differenza sinifikanti fl-rPFS bejn il-gruppi tat-trattament (ara Tabella 2 u Figura 1).
English: Figure 7: Overall survival by subgroup: hazard ratio and 95% confidence interval
Maltese: Figura 7: Sopravivenza totali ta' skont is-sottogrupp: proporzjon ta' periklu u intervall ta' kunfidenza ta' 95%
English: Time to degradation in the FACT-P (Total Score): Treatment with ZYTIGA decreased the risk of FACT-P (Total Score) degradation by 22% compared with placebo (p = 0.0028).
Maltese: Kura b'ZYTIGA naqqset irriskju ta' degradazzjoni fil-FACT-P (Punteġġ Totali) bi 22% meta mqabbla mal-plaċebo (p=0.0028).
English: Abiraterone acetate (ZYTIGA) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor.
Maltese: In vivo abiraterone acetate (ZYTIGA) jinbidel f'abiraterone, impeditur tal-biosintesi tal-androġen.
English: Potential for other medicinal products to affect abiraterone exposures In a clinical pharmacokinetic interaction study of healthy subjects pretreated with a strong CYP3A4 inducer rifampicin, 600 mg daily for 6 days followed by a single dose of abiraterone acetate 1,000 mg, the mean plasma AUC∞ of abiraterone was decreased by 55%.
Maltese: Il-potenzjali ta' prodotti mediċinali oħra li jaffettwaw l-esponimenti ta' abiraterone Fi studju ta' interazzjoni farmakokinetika klinika fuq individwi b'saħħithom ikkurati minn qabel bl-induttur qawwi ta' CYP3A4 rifampicin, 600 mg kuljum għal 6 ijiem segwiti minn doża waħda ta' abiraterone acetate 1,000 mg, il-plażma medja ta' AUC∞ ta' abiraterone tnaqqset għal 55%.
English: Figure 1: Kaplan-Meier Plot of Radiographic Progression-free Survival; Intent-to-treat Population (Study PCR3011)
Maltese: Figura 1: Plot Kaplan-Meier ta' Sopravivenza Ħielsa minn Progressjoni Radjufrafika; Popolazzjoni bl-Intenzjoni li tiġi Ttrattata (Studju PCR3011)
English: Of 15 detectable metabolites, 2 main metabolites, abiraterone sulphate and N-oxide abiraterone sulphate, each represents approximately 43% of total radioactivity.
Maltese: Mill-15-il metabolit li setgħu jitkejlu, 2 metaboliti prinċipali, abiraterone sulphate u N-oxide abiraterone sulphate, kull wieħed minnhom jirrappreżenta madwar 43% tar-radjuattività totali.
English: p-value* Hazard ratio** (95% CI)
Maltese: valur p* Proporzjon ta' periklu** (95% CI)
English: This medicinal product may pose a risk to the aquatic environment (see section 5.3).
Maltese: Dan il-prodott mediċinali jista' jkun ta' riskju għall-ambjent akwatiku (ara sezzjoni 5.3).
English: Strong inducers of CYP3A4 during treatment are to be avoided unless there is no therapeutic alternative, due to risk of decreased exposure to abiraterone (see section 4.5).
Maltese: Indutturi qawwija ta' CYP3A4 waqt il-kura għandhom jiġu evitati għajr meta ma jkunx hemm alternattiva terapewtika oħra, minħabba r-riskju ta' esponiment imnaqqas għal abiraterone(ara ssezzjoni 4.5).
English: The major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
Maltese: Il-komposti prinċipali preżenti flippurgar huma abiraterone acetate u abiraterone mhux mibdula (madwar 55% u 22% tad-doża mogħtija, rispettivament).
English: The radiographic progression and death are considered in defining the rPFS event.
Maltese: Il-progressjoni radjugrafika u mewt huma kkunsidrati fiddefinizzjoni tal-avveniment rPFS.
English: In an analysis of adverse reactions of composite Phase 3 studies with ZYTIGA, adverse reactions that were observed in ≥10% of patients were peripheral oedema, hypokalaemia, hypertension urinary tract infection, and alanine aminotransferase increased and/or aspartate aminotransferase increased.
Maltese: F'analiżi ta' reazzjonijiet avversi ta' studji komposti ta' Fażi 3 b'ZYTIGA, reazzjonijiet avversi li kienu osservati f'≥10% tal-pazjenti kienu edima periferali, ipokalimja, pressjoni għolja, infezzjoni flapparat tal-awrina u żieda fl-alanine aminotransferase u/jew żieda fl-aspartate aminotransferase.
English: PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet.
Maltese: Folja ta' PVdC/PE/PVC/aluminju ta' 14-il pillola miksija b'rita f'portafoll tal-kartun.
English: Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Maltese: (eż. phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) waqt il-kura għandhom jiġu evitati, għajr meta m'hemmx alternattiva terapewtika.
English: Use with ZYTIGA is not recommended (see section 5.1).
Maltese: L-użu ma' ZYTIGA mhuwiex irrakkomandat (ara ssezzjoni 5.1).
English: ZYTIGA is indicated with prednisone or prednisolone for:
Maltese: ZYTIGA huwa indikat flimkien ma' prednisone jew prednisolone:
English: Gastrointestinal disorders very common: diarrhoea common: dyspepsia
Maltese: Disturbi gastrointestinali komuni ħafna: dijarea komuni: dispepsja
English: In study 302, Grade 3 or 4 ALT or AST elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
Maltese: Fl-istudju 302, kienu osservati żiedet tal-grad 3 jew 4 fl-ALT jew l-AST f'35 (6.5%) pazjent ikkurat b'abiraterone acetate.
English: Combination of abiraterone and prednisone/prednisolone with Ra-223 Treatment with abiraterone and prednisone/prednisolone in combination with Ra-223 is contraindicated (see section 4.3) due to an increased risk of fractures and a trend for increased mortality among asymptomatic or mildly symptomatic prostate cancer patients as observed in clinical trials.
Maltese: It-trattament b'abiraterone u prednisone/prednisolone flimkien ma' Ra-223 huwa kontraindikat (ara sezzjoni 4.3) minħabba żieda fir-riskju ta' ksur u tendenza għal żieda fil-mortalità fost pazjenti b'kanċer tal-prostata bla sintomi jew b'sintomi ħfief kif osservat fi provi kliniċi.
English: The majority of circulating radioactivity (approximately 92%) is found in the form of metabolites of abiraterone.
Maltese: Il-parti l-kbira tar-radjuattività li tiċċirkola (madwar 92%) tinstab f'forma ta' metaboliti ta' abiraterone.
English: WALLET 500 mg (28 days)
Maltese: PORTAFOLL 500 mg (28 jum)
English: Co-primary efficacy endpoints were overall survival (OS) and radiographic progression-free survival (rPFS).
Maltese: L-iskopijiet finali ta' effikaċja koprimarja kienu sopravivenza globali (OS, overall survival) u sopravivenza mingħajr progressjoni radjugrafika (rPFS, radiographic progressionfree survival).
English: The ECOG performance status was 0 or 1 for 97% of patients.
Maltese: L-istat ta' eżekuzzjoni ta' ECOG kien 0 jew 1 għal 97% tal-pazjenti.
English: The following CTCAE (version 4.0) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 5%; urinary tract infection 2%; alanine aminotransferase increased and/or aspartate aminotransferase increased 4%; hypertension 6%; fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each.
Maltese: Ir-reazzjonijiet avversi tal-Grad 3 ta' CTCAE (verżjoni 4.0) li ġejjin seħħew f'pazjenti kkurati b'abiraterone acetate: ipokalimja 5%; infezzjoni fl-apparat tal-awrina 2%; żieda fl-alanine aminotransferase u/jew żieda fl-aspartate aminotransferase 4%; pressjoni għolja 6%; ksur 2%; edima periferali, insuffiċjenza tal-qalb, u fibrillazzjoni tal-atriju 1% kull waħda.
English: versus 4.7 months in the placebo group.
Maltese: 4.7 xhur fil-grupp ta' plaċebo.
English: Liver metastasis was present in 11% of patients treated with ZYTIGA.
Maltese: Metastasi tal-fwied kienet preżenti fi 11% tal-pazjenti kkurati b'ZYTIGA.
English: A statistically significant OS benefit in favour of the ZYTIGA-treated group was demonstrated with a 19.4% reduction in risk of death (HR = 0.806; 95% CI: [0.697; 0.931], p = 0.0033) and an improvement in median OS of 4.4 months (ZYTIGA 34.7 months, placebo 30.3 months) (see Table 6 and Figure 5).
Maltese: Intwera benefiċċju sinifikanti b'mod statistiku ta' OS favur il-grupp ikkurat b'ZYTIGA bi tnaqqis ta' 19.4% fir-riskju ta' mewt (HR=0.806; 95% CI: [0.697; 0.931], p=0.0033) u titjib fil-medjan ta' OS 4.4 xhur (ZYTIGA 34.7 xahar, plaċebo 30.3 xahar) (ara Tabella 6 u Figura 5).
English: The median time to degradation in FACT-P (Total Score) was 12.7 months in the ZYTIGA group and 8.3 months in the placebo group.
Maltese: Iż-żmien medjan għad-degradazzjoni f'FACT-P (Punteġġ Totali) kien ta' 12.7 xhur fil-grupp ta' ZYTIGA u 8.3 xhur fil-grupp ta' plaċebo.
English: Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
Maltese: Birkerød Tlf: +45 45 94 82 82
English: Pain
Maltese: Sentejn
English: For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily.
Maltese: Għal mCRPC, ZYTIGA jintuża ma' 10 mg prednisone jew prednisolone kuljum.
English: Subgroup analyses consistently favor treatment with ZYTIGA.
Maltese: Analiżi ta' sottogruppi tiffavorixxi trattament b'ZYTIGA b'mod konsistenti.
English: The median time to progression was 26.7 months in the ZYTIGA group and 18.4 months in the placebo group.
Maltese: Iż-żmien medjan għall-progressjoni kien ta' 26.7 xhur fil-grupp ta' ZYTIGA u 18.4 xhur fil-grupp ta' plaċebo.
English: Abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see section 5.1).
Maltese: In vivo abiraterone acetate jinbidel malajr f'abiraterone, impeditur biosintetiku tal-androġen (ara s-sezzjoni 5.1).
English: PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard wallet.
Maltese: Folja ta' PVdC/PE/PVC/aluminju ta' 12-il pillola miksija b'rita f'portafoll tal-kartun.
English: Hypertension was reported in 36.7% of patients in the hormone sensitive population (study 3011) compared to 11.8% and 20.2% in studies 301 and 302, respectively.
Maltese: Pressjoni għolja kienet irrappurtata f'36.7% tal-pazjenti fil-popolazzjoni sensittiva għall-ormoni (studju 3011) meta mqabbla ma' 11.8% u 20.2% fl-istudji 301 u 302, rispettivament.
English: CARTON 250 mg
Maltese: KARTUNA 250 mg
English: In Phase 3 studies, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with abiraterone acetate than in patients treated with placebo: hypokalaemia 18% vs.8%, hypertension 22% vs. 16% and fluid retention (peripheral oedema) 23% vs. 17%, respectively.
Maltese: Fi studji ta' Fażi 3 reazzjonijiet avversi mistennija tal-mineralokortikojd dehru b'mod aktar komuni f'pazjenti kkurati b'abiraterone acetate milli f'pazjenti kkurati bi plaċebo: ipokalimja 18% vs. 8%, pressjoni għolja 22% vs. 16% u żamma tal-fluwidi (edima periferali) 23% vs. 17%, rispettivament.
English: Treatment with abiraterone acetate decreased the risk of radiographic progression or death by 47% compared with placebo (HR = 0.530; 95% CI: [0.451; 0.623], p < 0.0001).
Maltese: Kura b'abiraterone acetate naqqset ir-risjku ta' progressjoni radjugrafika jew mewt b'47% meta mqabbla mal-plaċebo (HR=0.530; 95% CI: [0.451; 0.623], p < 0.0001).
English: EU/1/11/714/002 - 56 film-coated tablets (4 wallet packs of 14) EU/1/11/714/003 - 60 film-coated tablets (5 wallet packs of 12)
Maltese: EU/1/11/714/002 - 56 pillola miksijin b'rita (4 pakketti ta' portafolli ta' 14)
English: - ZYTIGA with prednisone or prednisolone is contraindicated in combination with Ra-223.
Maltese: Il-kombinazzjoni ta' abiraterone u prednisone/prednisolone ma' Ra-223
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jista' jaffettwa sa persuna 1 f'1,000):
English: The changes in the reproductive organs and androgen-sensitive organs are consistent with the pharmacology of abiraterone.
Maltese: It-tibdiliet fl-organi tar-riproduzzjoni u fl-organi sensittivi għall-androġen huma konsistenti mal-farmakoloġija ta' abiraterone.
English: Radiographic progression free survival (rPFS) was assessed with the use of sequential imaging studies as defined by PCWG2 criteria (for bone lesions) and modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for soft tissue lesions).
Maltese: Sopravivenza ħielsa minn progressjoni radjugrafika tal-marda (rPFS - radiographic progression free survival) ġiet stmata bl-użu ta' studji ta' immaġini sekwenzjali kif iddefinit mill-kriterji PCWG2 (għall-leżjonijiet fl-għadam) u l-kriterji modifikati tal-Kriterji għall-iStima tar-Rispons f'Tumuri Solidi (RECIST- Response Evaluation Criteria In Solid Tumors) (għal-leżjonijiet fit-tessut artab).
English: Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS).
Maltese: Il-ko-skopijiet prinċipali finali ta' effikaċja kienu sopravivenza globali (overall survival) u sopravivenza ħielsa minn progressjoni radjugrafika talmarda (rPFS radiographic progression-free survival).
English: Oreškovićeva 6h 10010 Zagreb
Maltese: Johnson & Johnson S.E. d.o.o. Oreškovićeva 6h 10010