FrancophonIA/ELRC3.0 huggingface dataset:
English: Confirmed PSA decline of 50% or 90% were 54.0% and 24.8%, respectively, for patients treated with enzalutamide and 1.5% and 0.9%, respectively, for patients who received placebo (p < 0.0001).
Maltese: It-tnaqqis ikkonfermat fil-PSA ta' 50% jew 90% kien 54.0% u 24.8%, rispettivament, għall-pazjenti kkurati b'enzalutamide u 1.5% u 0.9%, rispettivament, għall-pazjenti li rċivew plaċebo (p < 0.0001).
English: The AUC of docetaxel decreased by 12% [geometric mean ratio (GMR) = 0.882 (90% CI: 0.767, 1.02)] while Cmax decreased by 4% [GMR = 0.963 (90% CI:
Maltese: L-AUC ta' docetaxel naqset bi 12% [proporzjon medju ġeometriku (GMR) =0.882 (CI ta' 90%: 0.767, 1.02)] waqt li s-Cmax naqas b'4% [GMR = 0.963 ( CI ta' 90%: 0.834, 1.11)].
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: CYP2C8 and CYP3A4 inducers
Maltese: Indutturi ta' CYP2C8 u CYP3A4
English: Date of first authorisation: 21 June 2013 Date of latest renewal: 8 February 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Ġunju 2013 Data tal-aħħar tiġdid: 08 ta' Frar 2018
English: At the time of the primary analysis there were 1,633 patients randomised.
Maltese: Fiż-żmien tal-analiżi primarja kien hemm 1,633 pazjent magħżula b'mod każwali.
English: The hazard ratio was 0.24 (95% CI: 0.14, 0.42) and the median time to a PFS event was not reached in the enzalutamide group versus 8.6 months in the bicalutamide group.
Maltese: Il-proporzjon ta' periklu kien 0.24 (CI ta' 95%: 0.14, 0.42) u ż-żmien medjan għal avveniment ta' PFS ma ntlaħaqx fil-grupp ta' enzalutamide kontra 8.6 xhur fil-grupp ta' bicalutamide.
English: The protocol pre-specified interim analysis after 520 deaths showed a statistically significant superiority in overall survival in patients treated with enzalutamide compared to placebo (Table 4 and Figures 7 and 8).
Maltese: L-analiżi interim speċifikata minn qabel fil-protokoll wara 520 mewta wriet superjorità statistikament sinifikanti fis-sopravivenza globali f'pazjenti kkurati b'enzalutamide meta mqabbla ma' plaċebo (Tabella 4 u Figuri 7 u 8).
English: Figure 8: Overall survival by subgroup in the AFFIRM study - Hazard ratio and 95% confidence interval
Maltese: Figura 8: Sopravivenza globali skont is-sottogrupp fl-istudju AFFIRM - Proporzjon ta' periklu u intervall ta' kunfidenza ta' 95%
English: Based on in vitro data, inhibition of BCRP and MRP2 (in the intestine), as well as organic anion transporter 3 (OAT3) and organic cation transporter 1 (OCT1) (systemically) cannot be excluded.
Maltese: Abbażi tad-dejta in vitro, l-inibizzjoni ta' BCRP u MRP2 (fl-intestin), kif ukoll tat-trasportatur-3 talanijoni organiku (OAT3) u ta' trasportatur katijoniku organiku 1 (OCT1) (sistematikament), ma tistax tiġi eskluża.
English: • Anticancer agents (e.g. cabazitaxel)
Maltese: • Aġenti kontra l-kanċer (eż. cabazitaxel)
English: Astellas Pharmaceuticals AEBE Τηλ: +30 210 8189900
Maltese: Ελλάδα Τηλ: + 30 210 8189900
English: The half-life of enzalutamide was however doubled in patients with severe hepatic impairment compared with healthy controls (10.4 days compared to 4.7 days), possibly related to an increased tissue distribution.
Maltese: Madankollu, il-half-life ta' enzalutamide irdoppjat f'pazjenti b'indeboliment tal fwied sever meta mqabbla ma' individwi f'saħħithom li servew bħala kontroll (10.4 ijiem meta mqabbla ma' 4.7 ijiem), possibbilment relatat ma' distribuzzjoni akbar fit-tessuti.
English: CYP1A2 and CYP2C8 substrates
Maltese: Substrati ta' CYP1A2 u CYP2C8
English: 112 soft capsules
Maltese: 112-il kapsula ratba
English: Tel: +385 1 670 01 02
Maltese: Astellas d.o.o. Tel: + 385 1 670 01 02
English: Posterior Reversible Encephalopathy Syndrome (PRES)
Maltese: Sindromu tal-enċefalopatija riversibbli posterjuri (PRES)
English: UGT1A1 may have been induced as well.
Maltese: Jista' jkun li ġie indott ukoll UGT1A1.
English: There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro.
Maltese: Ma kien hemm l-ebda spostament tat-twaħħil tal-proteina bejn enzalutamide u prodotti mediċinali li jeħlu ħafna (warfarin, ibuprofen u salicylic acid) in vitro.
English: The median time to degradation in FACT-P was 11.3 months in the enzalutamide group and 5.6 months in the placebo group.
Maltese: Iż-żmien medjan għad-degradazzjoni f'FACT-P kien ta' 11.3 xhur fil-grupp ta' enzalutamide u 5.6 xhur fil-grupp tal-plaċebo.
English: The absolute difference in objective soft tissue response between enzalutamide and placebo arms was [53.9% (95% CI: 48.5, 59.1), p < 0.0001].
Maltese: Id-differenza assoluta fir-rispons oġġettiv tat-tessut artab bejn il-partijiet tal-istudju dwar enzalutamide u plaċebo kienet ta' [53.9% (CI ta' 95%: 48.5, 59.1), p<0.0001].
English: Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP.
Maltese: Enzalutamide mhuwiex substrat tat-trasportatur tal-effluss P-gp jew BCRP.
English: Patients were randomised 2:1 to receive either enzalutamide at a dose of 160 mg once daily (N = 933) or placebo (N = 468).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:1 biex jirċievu jew doża ta' 160 mg enzalutamide darba kuljum (N = 933) jew plaċebo (N = 468).
English: CYP2C8 plays an important role in the elimination of enzalutamide and in the formation of its active metabolite.
Maltese: CYP2C8 għandu rwol importanti fl-eliminazzjoni ta' enzalutamide u fil-formazzjoni tal-metabolit attiv tiegħu.
English: Enzalutamide demonstrated a statistically significant 93% reduction in the relative risk of PSA progression compared to placebo [HR = 0.07 (95% CI: 0.05, 0.08), p < 0.0001].
Maltese: Enzalutamide wera tnaqqis statistikament sinifikanti ta' 93% fir-riskju relattiv ta' progressjoni tal-PSA meta mqabbel ma' plaċebo [HR = 0.07 (CI ta' 95%: 0.05, 0.08), p < 0.0001].
English: Astellas Pharma B.V.
Maltese: Astellas Pharma Europe B. V.
English: Common: dry skin, pruritus Not known*: rash
Maltese: Komuni: ġilda xotta, ħakk Mhux magħruf*: raxx
English: † As evaluated by narrow SMQs of ‘Myocardial Infarction' and ‘Other Ischemic Heart Disease' including the following preferred terms observed in at least two patients in randomized placebo-controlled phase 3 studies: angina pectoris, coronary artery disease, myocardial infarctions, acute myocardial infarction, acute coronary syndrome, angina unstable, myocardial ischaemia, and arteriosclerosis coronary artery.
Maltese: Kif evalwat minn SMQs dojoq ta' ‘Infart Mijokardijaku' u ‘Mard tal-Qalb Iskemiku Ieħor' inklużi t-termini ppreferuti li ġejjin osservati f'tal-inqas żewġ pazjenti fi studji ta' fażi 3 kkontrollati bi plaċebo fejn il-pazjenti ntgħażlu b'mod każwali: anġina pectoris, mard tal-arterja koronarja, infarti mijokardijaki, infart mijokardijaku akut, sindrome koronarju akut, anġina li mhix stabbli, iskemija mijokardijaka, u arterjosklerożi tal-arterja koronarja.
English: Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy].
Maltese: L-effikaċja ta' enzalutamide ġiet stabbilita fi tliet studji kliniċi ta' fażi 3, li fihom il-parteċipanti ntgħażlu b'mod każwali, multiċentriċi, ikkontrollati bi plaċebo [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] ta' pazjenti b'kanċer progressiv tal-prostata li ma rnexxewx fuq terapija tal-privazzjoni tal-androġen [analogu ta' LHRH jew wara orkijektomija bilaterali]. L
English: A pre-specified follow-up rPFS analysis based on the investigator assessment of radiographic progression demonstrated a statistically significant improvement between the treatment groups with a 69.3% reduction in risk of radiographic progression or death [HR = 0.31 (95% CI: 0.27, 0.35), p < 0.0001].
Maltese: Analiżi follow-up tal-rPFS speċifikata minn qabel ibbażata fuq l-evalwazzjoni tal-investigatur tal-progressjoni radjografika, uriet titjib statistikament sinifikanti bejn il-gruppi tal-kura b'nuqqas ta' 69.3% fir-riskju ta' progressjoni radjografika jew mewt [HR = 0.31 (CI ta' 95%: 0.27, 0.35), p < 0.0001].
English: In a clinical study in patients with metastatic CRPC, Xtandi (160 mg once daily) had no clinically relevant effect on the pharmacokinetics of intravenously administered docetaxel (75 mg/m2 by infusion every 3 weeks).
Maltese: Fi studju kliniku f'pazjenti b'CRPC metastatiku, Xtandi (160 mg darba kuljum) ma kellu lebda effett klinikament rilevanti fuq il-farmakokinetika ta' docetaxel mogħti ġol-vini (75 mg/m2 permezz ta' infużjoni kull 3 ġimgħat).
English: Hazard ratio (95% CI)2
Maltese: Proporzjon ta' periklu (CI ta' 95%)2
English: Sixty-eight percent (68%) of patients had an ECOG performance status score of 0 and 32% patients had an ECOG performance status of 1.
Maltese: Tmienja u sittin fil-mija (68%) tal-pazjenti kellhom punteġġ ta' stat ta' prestazzjoni ECOG ta' 0, u 32% tal-pazjenti kellhom punteġġ ta' stat ta' prestazzjoni ECOG ta' 1.
English: In vitro data indicate that enzalutamide and its major metabolites do not inhibit the following transporters at clinically relevant concentrations: OATP1B1, OATP1B3, OCT2, or OAT1.
Maltese: Id-dejta in vitro tindika li enzalutamide u l-metaboliti ewlenin tiegħu ma jinibixxux it-trasportaturi li ġejjin f'konċentrazzjonijiet klinikament rilevanti: OATP1B1, OATP1B3, OCT2 jew OAT1.
English: The exposure levels achieved in this study in male rats at Week 26 at 100 mg/kg per day for enzalutamide plus its active metabolites M1 and M2 (AUC24: enzalutamide ~457 µg•h/mL, M1 ~321 µg•h/mL, M2 ~35 µg•h/mL) were less than or similar to those in prostate cancer patients at the recommended dose (160 mg/day) of enzalutamide (AUC24: enzalutamide ~322 µg•h/mL, M1 ~193 µg•h/mL, M2 ~278 µg•h/mL).
Maltese: Il livelli ta' esponiment miksuba f'firien irġiel f'dan l-istudju f'Ġimgħa 26 b'doża ta' 100 mg/kg kuljumgħal enzalutamide u l-metaboliti attivi tiegħu M1 u M2 (AUC24: enzalutamide ~457 µg·h/mL, M1 ~321 µg·h/mL, M2 ~35 µg·h/mL) kienu inqas minn jew simili għal dawk f'pazjenti b'kanċer tal prostata bid-doża rakkomandata (160 mg/jum) ta' enzalutamide (AUC24: enzalutamide ~322 µg·h/mL, M1 ~193 µg·h/mL, M2 ~278 µg·h/mL).
English: In controlled clinical studies, 13 patients (0.4%) experienced a seizure out of 3179 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient (0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure.
Maltese: Fl-istudji kliniċi ikkontrollati , 13-il pazjent (0.4%) kellhom aċċessjoni minn 3179 pazjent ikkurati b'doża ta' kuljum ta' 160 mg ta' enzalutamide, filwaqt li pazjent wieħed (0.1%) li kien qed jirċievi plaċebo u pazjent wieħed (0.3%) li qed jirċievi bicalutamide, kelhom aċċessjoni.
English: Most patients in the controlled clinical trials (> 74%) were Caucasian.
Maltese: Il-parti l-kbira tal-pazjenti fil-provi kliniċi kkontrollati (> 74%) kienu Kawkasi.
English: In consideration of the long half-life of enzalutamide (5.8 days, see section 5.2), effects on enzymes may persist for one month or longer after stopping enzalutamide.
Maltese: Jekk jiġi kkunsidrat il-half-life twila ta' enzalutamide (5.8 ijiem, ara sezzjoni 5.2), l-effetti fuq l-enzimi jistgħu jippersistu għal xahar jew iktar wara li jitwaqqaf enzalutamide.
English: Xtandi - 40 mg film-coated tablets Xtandi - 80 mg film-coated tablets
Maltese: Xtandi - 40 mg pilloli miksija b'rita Xtandi - 80 mg pilloli miksija b'rita
English: The radioactivity in the fetus decreased to 0.08 times the maximum concentration at 72 hours after administration.
Maltese: Ir-radjoattività fil-fetu naqset għal 0.08 darbiet tal-konċentrazzjoni massima 72 siegħa wara lgħoti.
English: There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive).
Maltese: N-desmethyl enzalutamide (attiv) u derivattiv ta' carboxylic acid (mhux attiv).
English: Treatment with enzalutamide decreased the risk of FACT-P degradation by 37.5% compared with placebo (p < 0.0001).
Maltese: Il-kura b'enzalutamide naqqset ir-riskju ta' degradazzjoni FACT-P b'37.5% meta mqabbla ma' plaċebo (p<0.
English: Enzalutamide is metabolised by CYP2C8 and to a lesser extent by CYP3A4/5 (see section 4.5), both of which play a role in the formation of the active metabolite.
Maltese: Enzalutamide jiġi metabolizzat minn CYP2C8 u xi ftit inqas minn CYP3A4/5 (ara sezzjoni 4.5), u t-tnejn li huma għadhom rwol fil-formazzjoni tal-metabolit attiv.
English: Following oral administration of the soft capsule formulation (Xtandi 160 mg daily) in patients with metastatic CRPC, the steady-state plasma mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% CV) and 12.7 μg/mL (30% CV), respectively.
Maltese: Wara l-għoti orali tal-formulazzjoni tal-kapsuli rotob (Xtandi 160 mg kuljum) f'pazjenti b'CRPC metastatiku, il-medja tal-valuri tas-Cmax fil-plażma fl-istat fiss għal enzalutamide u l-metabolit attiv tiegħu huma ta' 16.6 μg/mL (23% CV) u 12.7 μg/mL (30% CV), rispettivament.
English: Under conditions of clinical use, enzalutamide is a strong inducer of CYP3A4, a moderate inducer of CYP2C9 and CYP2C19, and has no clinically relevant effect on CYP2C8 (see section 4.5).
Maltese: F'kundizzjonijiet ta' użu kliniku, enzalutamide huwa induttur qawwi ta' CYP3A4, induttur moderat ta' CYP2C9 u CYP2C19, u m'għandu l-ebda effett klinikament rilevanti fuq CYP2C8 (ara sezzjoni 4.5).
English: The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group.
Maltese: L-rPFS medjan kien ta' 19.7 xhur fil-grupp ta' enzalutamide u 5.4 xhur fil-grupp tal-plaċebo.
English: Other tumours, which are also potentially related to the primary pharmacology include fibroadenoma of mammary glands and benign thymoma of thymus in males, benign granulosa cell tumours of ovaries in females, and adenoma of pituitary pars distalis in both sexes.
Maltese: Tumuri oħra, li huma wkoll meqjusa potenzjalment relatati mal-farmakoloġija primarja, jinkludu fibroadenoma tal-glandoli mammarji u timoma beninna tat-timu fl-irġiel, tumuri beninni taċ-ċelluli granulosa tal-ovarji fin-nisa, u adenoma tal-pars distalis pitwitarja fiż-żewġ sessi.
English: Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol.
Maltese: Kull kapsula ratba fiha 57.8 mg ta' sorbitol.
English: Based on a population pharmacokinetic analysis, no dose adjustment is necessary for patients with calculated creatinine clearance (CrCL) values ≥ 30 mL/min (estimated by the Cockcroft and Gault formula).
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, ma hemm bżonn ebda aġġustament tad-doża għall-pazjenti b'valuri ta' tneħħija tal kreatinina kkalkulata (CrCL) ≥ 30 mL/min (stmati bil-formula Cockcroft u Gault).
English: The PROSPER study enrolled 1401 patients with asymptomatic, high-risk non-metastatic CRPC who continued on androgen deprivation therapy (ADT; defined as LHRH analogue or prior bilateral orchiectomy).
Maltese: L-istudju PROSPER kellu rreġistrati 1401 pazjent b'CRPC asintomatiku, ta' riskju għoli u mhux metastatiku li komplew bit-terapija ta' privazzjoni tal-androġen (ADT; definita bħala analogu LHRH
English: (< 4 vs. ≥ 4).
Maltese: wġigħ medju (< 4 vs ≥ 4)
English: No major deviations from dose proportionality are observed over the dose range 40 to 160 mg.
Maltese: Ma ġew osservati ebda devjazzjonijiet maġġuri mill-proporzjonalità tad-doża fuq il-medda tad-doża bejn 40 u 160 mg.
English: Following oral administration of the strong CYP2C8 inhibitor gemfibrozil (600 mg twice daily) to healthy male subjects, the AUC of enzalutamide increased by 326% while Cmax of enzalutamide decreased by 18%.
Maltese: Wara l-amministrazzjoni orali tal-inibitur qawwi ta' CYP2C8 gemfibrozil (600 mg darbtejn kuljum) lil individwi rġiel b'saħħithom, l-AUC ta' enzalutamide żdiedet bi 326% filwaqt li sCmax ta' enzalutamide naqas bi 18%.
English: Posology The recommended dose is 160 mg enzalutamide (four 40 mg soft capsules) as a single oral daily dose.
Maltese: Id-doża rakkomandata hija 160 mg ta' enzalutamide (erba' kapsuli rotob ta' 40 mg) bħala doża waħda orali kuljum.
English: At study entry, 41% of randomised patients had PSA progression only, whereas 59% of patients had radiographic progression.
Maltese: Meta ngħaqdu fl-istudju, 41% tal-pazjenti magħżula b'mod każwali kellhom progressjoni tal-PSA biss, filwaqt li 59% tal-pazjenti kellhom progressjoni radjografika.
English: Hepatic impairment
Maltese: Reazzjonijiet ipersensittivi
English: Xtandi 80 mg film-coated tablets are yellow oval film-coated tablets, debossed with E 80 Each carton contains 56 tablets in 4 blister wallets of 14 tablets each.
Maltese: Il-pilloli miksija b'rita ta' 80 mg ta' Xtandi huma pilloli miksija b'rita sofor u ovali, imnaqqxa b'E 80 Kull kartuna fiha 56 pillola f'4 kartieri bil-folji, b'14-il pillola kull waħda.
English: A total of 1199 patients were randomised 2:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 800) or placebo once daily (N = 399).
Maltese: Total ta' 1,199 pazjent ġew magħżula b'mod każwali 2:1 biex jirċievu jew enzalutamide oralment f'doża ta' 160 mg darba kuljum (N = 800) jew plaċebo darba kuljum (N = 399).
English: Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Maltese: Reazzjonijiet avversi importanti oħra jinkludu waqgħa, disturb konoxxittiv, u newtropenija.
English: Of the 3179 patients in the controlled clinical trials who received enzalutamide, 2518 patients (79%) were 65 years and over and 1162 patients (37%) were 75 years and over.
Maltese: Mit-3179 pazjent fil-provi kliniċi kkontrollati li rċivew enzalutamide, 2518 pazjent (79%) kellhom 65 sena jew aktar u 1162 pazjent (37%) kellhom 75 sena u aktar.
English: Macrogol (8000) Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Iron oxide yellow (E172)
English: Eighty-one percent (81%) of patients had an ECOG performance status score of 0 and 19% patients had an ECOG performance status of 1.
Maltese: Wieħed u tmenin fil-mija (81%) tal-pazjenti kellhom punteġġ ta' stat ta' prestazzjoni ECOG ta' 0 u 19% tal-pazjenti kellhom stat ta' prestazzjoni ECOG ta' 1.
English: Overall survival was evaluated at two prespecified interim analyses to date; the first at the time of final MFS (n = 165) [HR = 0.80 (95% CI: 0.58, 1.09), p = 0.1519], and the second interim analysis (n = 288) [HR = 0.83 (95% CI: 0.65, 1.06), p = 0.1344].
Maltese: Is-sopravivenza globali ġiet evalwata f'żewġ analiżijiet interim speċifikati minn qabel sa issa; l-ewwel waħda fiż-żmien tal-MFS finali (n = 165) [HR = 0.80 (CI ta' 95%: 0.58, 1.09), p = 0.1519], u t-tieni analiżi interim (n = 288)
English: Very common: fractures‡
Maltese: Komuni ħafna: ksur‡
English: In a single arm trial (9785-CL-0410) of patients previously treated with at least 24 weeks of abiraterone (plus prednisone), 22.4% had a ≥ 50% decrease from baseline in PSA levels.
Maltese: Fi prova b'parti waħda (9785-CL-0410) fuq pazjenti preċedentement ikkurati b'mill-inqas 24 ġimgħa ta' abiraterone (flimkien ma' prednisone), 22.4% kellhom tnaqqis ta' ≥ 50% mil-linja bażi fil-livelli ta' PSA.
English: CRPC2 (AFFIRM) study (patients with metastatic CRPC who previously received chemotherapy)
Maltese: Studju CRPC2 (AFFIRM) (pazjenti b'CRPC metastatiku li rċivew kimoterapija fil-passat)
English: In a phase 3 clinical trial (AFFIRM) of patients who failed prior chemotherapy with docetaxel, 54% of patients treated with enzalutamide, versus 1.5% of patients who received placebo, had at least a 50% decline from baseline in PSA levels.
Maltese: Fi prova klinika tal-fażi 3 (AFFIRM) ta' pazjenti li fuqhom diġà ma ħadmitx il-kimoterapija b'docetaxel, 54% tal-pazjenti kkurati b'enzalutamide, kontra 1.5% tal-pazjenti li rċivew plaċebo, kellhom tal-anqas tnaqqis ta' 50% mil-linja bażi fil-livelli ta' PSA.
English: Median time to PSA progression was 37.2 months (95% CI: 33.1, NR) on the enzalutamide arm versus 3.9 months (95% CI: 3.8, 4.0) on the placebo arm.
Maltese: Iż-żmien medjan għallprogressjoni tal-PSA kien ta' 37.2 xhur (CI ta' 95%: 33.1, NR) fil-grupp ta' enzalutamide kontra 3.9 xhur (CI ta' 95%: 3.8, 4.0) fil-grupp tal-plaċebo.
English: Capsule contents
Maltese: Qoxra tal-kapsula
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets.
Maltese: Kartiera tal-kartun li tinkorpora folja tal PVC/PCTFE/aluminju ta' 28 pillola miksija b'rita.
English: Enzalutamide demonstrated a statistically significant 71% reduction in the relative risk of radiographic progression or death compared to placebo [HR = 0.29 (95% CI: 0.24, 0.35), p < 0.0001].
Maltese: Enzalutamide wera tnaqqis statistikament sinifikanti ta' 71% fir-riskju relattiv ta' progressjoni radjografika jew mewt meta mqabbel ma' plaċebo [HR = 0.29 (CI ta' 95%: 0.24, 0.35), p < 0.0001].
English: Additional changes to reproductive tissues included hypertrophy/hyperplasia of the pituitary gland and atrophy in seminal vesicles in rats and testicular hypospermia and seminiferous tubule degeneration in dogs.
Maltese: Bidliet addizzjonali fit-tessuti riproduttivi kienu jinkludu ipertrofija/iperplażija tal-glandola pitwitarja u atrofija fl-infafet seminali fil-firien u ipospermija fit-testikoli u deġenerazzjoni tat-tubulu seminiferuż fil-klieb.
English: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 soft capsules.
Maltese: Kartiera tal-kartun li tinkorpora folja tal PVC/PCTFE/aluminju ta' 28 kapsula ratba.
English: CYP3A4 plays a minor role in the metabolism of enzalutamide.
Maltese: CYP3A4 għandu rwol żgħir fil-metaboliżmu ta' enzalutamide.
English: The median rPFS was not reached (95% CI: 13.8, not reached) in the enzalutamide-treated group and was 3.9 months (95% CI: 3.7, 5.4) in the placebotreated group (Figure 6).
Maltese: L-rPFS medjan ma ntlaħaqx (CI ta' 95%: 13.8, mhux milħuq) fil-grupp ikkurat b'enzalutamide, u kien ta' 3.9 xhur (CI ta' 95%: 3.7, 5.4) fil-grupp ikkurat bil-plaċebo (Figura 6).
English: No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the elderly population pharmacokinetic analysis.
Maltese: Ma ġie osservat l-ebda effett klinikament rilevanti tal-età fuq il-farmakokinetika ta' enzalutamide flanaliżi tal-farmakokinetika tal-popolazzjoni anzjana.
English: Reproductive toxicology studies were not conducted with enzalutamide, but in studies in rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), atrophy, aspermia/hypospermia, and hypertrophy/hyperplasia in the reproductive system were noted, consistent with the pharmacological activity of enzalutamide.
Maltese: L-istudji tat-tossikoloġija riproduttiva ma twettqux b'enzalutamide, iżda fl-istudji fil-firien (4 u 26 ġimgħa) u l-klieb (4, 13 u 39 ġimgħa), ġew innutati atrofija, aspermija/ipospermija, u ipertrofija/iperplażija fis-sistema riproduttiva, f'konformità mal-attività farmakoloġika ta' enzalutamide.
English: Patients were excluded with a previous history of seizure, a condition that might predispose them to seizure, or certain prior treatments for prostate cancer (i.e., chemotherapy, ketoconazole, abiraterone acetate, aminoglutethimide and/or enzalutamide).
Maltese: Pazjenti bi storja medika fil-passat ta' aċċessjoni, kundizzjoni li tista' tippredisponi aċċessjoni, jew ċerti trattamenti preċedenti għall-kanċer tal-prostata (jiġifieri, kimoterapija, ketoconazole, abiraterone acetate, aminoglutethimide u/jew enzalutamide), ġew esklużi.
English: Each carton contains 56 film-coated tablets (4 wallets).
Maltese: Kull kartuna fiha 56 pillola miksija b'rita (4 kartieri).