FrancophonIA/ELRC3.0 huggingface dataset:
English: Xtandi - 80 mg film-coated tablets Yellow oval - film-coated tablets, debossed with E 80.
Maltese: Xtandi - 80 mg pilloli miksija b'rita Pilloli miksija b'rita - ovali, sofor, imnaqqxa b'E 80.
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC and Cmax in subjects with mild impairment increased by 14% and 19%, respectively, the AUC and Cmax in subjects with moderate impairment increased by 14% and decreased by 17%, respectively, and the AUC and Cmax in subjects with severe hepatic impairment increased by 34% and decreased by 27%, respectively, compared to healthy control subjects.
Maltese: Għall-ammont totali ta' enzalutamide mhux imwaħħal u l-metabolit attiv mhux imwaħħal, l-AUC u s-Cmax f'individwi b'indeboliment ħafif żdiedu b'14% u 19% rispettivament l-AUC u s-Cmax f'individwi b'indeboliment moderat żdied b'14% u naqas bi 17% rispettivament u l-AUC u Cmax f'individwi b'indeboliment tal fwied sever żdied b'34% u naqas b'27% rispettivament, meta mqabbla ma' individwi f'saħħithom li servew bħala kontroll.
English: Following oral administration of 14C-enzalutamide, 84.6% of the radioactivity is recovered by 77 days post dose: 71.0% is recovered in urine (primarily as the inactive metabolite, with trace amounts of enzalutamide and the active metabolite), and 13.6% is recovered in faeces (0.39% of dose as unchanged enzalutamide).
Maltese: 6% tar-radjoattività sa 77 jum wara t teħid tad-doża: 71.0% instabet fl-awrina (prinċipalment bħala l-metabolit mhux attiv, bi traċċi żgħar ħafna ta' enzalutamide u l-metabolit attiv), u 13.6% instabet fl-ippurgar (0.
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 77% while Cmax decreased by 19%.
Maltese: Għall-ammont totali ta' enzalutamide mhux magħqud flimkien mal-metabolit attiv mhux magħqud, l-AUC żdiedet b'77% filwaqt li s-Cmax naqas b'19%.
English: Seizures
Maltese: Pożoloġija
English: At the updated analysis 52% of enzalutamide-treated and 81% of placebo-treated patients had received subsequent therapies for metastatic CRPC that may prolong overall survival.
Maltese: Fl analiżi aġġornata 52% tal-pazjenti kkurati b'enzalutamide u 81% tal-pazjenti trattati bil-plaċebo kienu rċivew terapiji sussegwenti għal CRPC metastatiku li jistgħu jtawlu s-sopravivenza globali.
English: In preclinical studies, the absorption of enzalutamide was increased when dissolved in caprylocaproyl macrogolglycerides.
Maltese: Fi studji prekliniċi, l-assorbiment ta' enzalutamide żdied meta mdewweb f'caprylocaproyl macrogolglycerides.
English: - Swallow the soft capsules whole with water.
Maltese: - Ibla' l-kapsuli rotob sħaħ mal-ilma.
English: The mechanism by which enzalutamide may lower the seizure threshold is not known, but could be related to data from in vitro studies showing that enzalutamide and its active metabolite bind to and can inhibit the activity of the GABA-gated chloride channel.
Maltese: jkun relatat ma' dejta minn studji in vitro li juru li enzalutamide u l-metabolit attiv tiegħu jintrabtu ma' u jistgħu jinibixxu l-attività tal-kanal tal-kloru gated b'GABA.
English: At the pre-specified interim analysis for overall survival when 540 deaths were observed, treatment with enzalutamide demonstrated a statistically significant improvement in overall survival compared to treatment with placebo with a 29.4% reduction in risk of death [HR = 0.706 (95% CI: 0.60; 0.84), p < 0.0001].
Maltese: mewt, il-kura b'enzalutamide uriet titjib statistikament sinifikanti fis-soppravivenza globali meta mqabbla mal-kura bil-plaċebo bi tnaqqis ta' 29.4% fir-riskju ta' mewt [HR = 0.706 (CI ta' 95%: 0.60; 0.84), p < 0.0001].
English: Xtandi has moderate influence on the ability to drive and use machines as psychiatric and neurologic events including seizure have been reported (see section 4.8).
Maltese: Xtandi għandu effett moderat fuq il-ħila biex issuq u tħaddem magni peress li ġew irrappurtati episodji psikjatriċi u newroloġiċi inkluż aċċessjoni (ara sezzjoni 4.8).
English: Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations.
Maltese: Prodotti mediċinali b'medda terapewtika dejqa li huma substrati għal P-gp (eż. colchicine, dabigatran etexilate, digoxin) għandhom jintużaw b'kawtela meta jiġu amministrati flimkien ma' Xtandi u jista' jkun hemm bżonn aġġustament tad-doża biex jinżammu l-aħjar konċentrazzjonijiet fil-plażma.
English: After oral administration of radiolabeled 14C-enzalutamide to lactating rats at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the milk was reached 4 hours after administration and was up to 3.54-fold higher than that in the maternal plasma.
Maltese: 30 mg/kg (~ 1.9 darbiet tad-doża massima indikata fil-bnedmin), ir-radjoattività massima fil-ħalib intlaħqet 4 sigħat wara l-għoti u kienet sa 3.54 darbiet ogħla minn dik fil-plażma materna.
English: The PREVAIL study enrolled metastatic CRPC chemotherapy-naïve patients; whereas the AFFIRM study enrolled metastatic CRPC patients who had received prior docetaxel; and the PROSPER study enrolled patients with non-metastatic CRPC.
Maltese: istudju PREVAIL irreġistra pazjenti b'CRPC metastatiku li qatt ma ħadu kimoterapija fil-passat; filwaqt li l-istudju AFFIRM irreġistra pazjenti b'CRPC metastatiku li rċivew docetaxel fil-passat; u l istudju PROSPER irreġistra pazjenti b'CRPC mhux metastatiku.
English: Biocodex UAB Tel: +370 37 408 681
Maltese: Tel: +370 37 408 681
English: Medicinal products which prolong the QT interval
Maltese: Prodotti mediċinali li jtawlu l-intervall tal-QT
English: - Each carton contains 112 soft capsules in 4 blister wallets of 28 soft capsules each.
Maltese: - Kull kartuna fiha 112-il kapsula ratba f'4 kartieri bil-folji ta' 28 kapsula ratba kull waħda.
English: Consistent benefit of enzalutamide over bicalutamide on PFS was observed in all pre-specified patient subgroups.
Maltese: Ġie osservat benefiċċju konsistenti fuq il-PFS b'enzalutamide kontra bicalutamide fis-sottogruppi tal-pazjenti kollha speċifikati minn qabel.
English: Each Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Maltese: Kull pillola miksija b'rita ta' 80 mg ta' Xtandi fiha 80 mg ta' enzalutamide.
English: Xtandi - 40 mg soft capsules
Maltese: Xtandi ‑40 mg kapsuli rotob
English: The transport protein P-gp may also be induced, and probably other transporters as well, e.g. multidrug resistance-associated protein 2 (MRP2), breast cancer resistance protein (BCRP) and the organic anion transporting polypeptide 1B1 (OATP1B1).
Maltese: Tista' tiġi indotta wkoll il-proteina ta' trasport P-gp, u probabbilment trasportaturi oħra wkoll, eż. il-proteina ta' reżistenza għal mediċini multipli 2 (MRP2), il-proteina ta'
English: Taking Xtandi
Maltese: X'fih Xtandi
English: • Proton pump inhibitor (e.g. omeprazole)
Maltese: • Inibitur tal-pompa tal-protoni (eż. omeprazole)
English: Seizure occurred in 0.4% of enzalutamide-treated patients, 0.1% of placebo-treated patients and 0.3% in bicalutamide-treated patients.
Maltese: 1% tal-pazjenti kkurati bil-plaċebo u 0.3% tal-pazjenti kkurati b'bicalutamide.
English: No dose adjustment is necessary when Xtandi is co-administered with inhibitors of CYP3A4.
Maltese: Ma hemm bżonn ebda aġġustament tad-doża meta Xtandi jiġi koamministrat ma' inibituri ta' CYP3A4.
English: In a phase 2 clinical trial (TERRAIN) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving bicalutamide, 82.1% versus 20.9% (difference = 61.2%, p < 0.0001)
Maltese: Fi prova klinika tal-fażi 2 (TERRAIN) fuq pazjenti li qatt ma ħadu kimoterapija fil-passat, il-pazjenti li kienu qed jirċievu enzalutamide wrew rata ta' rispons totali għall-PSA ogħla b'mod sinifikanti (definita bħala tnaqqis ta' ≥ 50% mil-linja bażi) meta mqabbla ma' pazjenti li rċivew bicalutamide, 82.1% kontra
English: Figure 1: Kaplan-Meier Curves of metastasis-free survival in the PROSPER study (intent-totreat analysis)
Maltese: Tabella 2: Sommarju tar-riżultati tal-effikaċja fl-istudju PROSPER (analiżi b'intenzjoni li tiġi kkurata)
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni)
English: Not known*: face oedema, tongue oedema, lip oedema, pharyngeal oedema
Maltese: Mhux magħruf*: edema tal-wiċċ, edema tal-ilsien, edema tax xoffa u edema farinġeali.
English: Xtandi 40 mg film-coated tablets enzalutamide
Maltese: Xtandi 40 mg pilloli miksija b'rita enzalutamide
English: Astellas Pharma S.p.A. Tel: + 39 02 921381
Maltese: Tel: + 39 02 921381
English: According to prior chemotherapy history, the results proportion of patients with a ≥ 50% decrease in PSA levels were 22.1% and 23.2%, for the no prior chemotherapy and prior chemotherapy patient groups, respectively.
Maltese: 50% fil-livelli ta' PSA kienu 22.1% u 23.2%, għall-grupp ta' pazjenti li ma rċivewx kimoterapija filpassat u għall-grupp ta' pazjenti li kienu rċivew kimoterapija fil-passat, rispettivament.
English: An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: enzalutamide f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: Xtandi - 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide.
Maltese: Xtandi - 80 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 80 mg ta' enzalutamide.
English: Xtandi contains the active substance enzalutamide.
Maltese: Xtandi fih is-sustanza attiva enzalutamide.
English: The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR).
Maltese: L-effett ta' enzalutamide fuq is-substrati ta' P-gp ma ġiex evalwat in vivo; madankollu, f'kundizzjonijiet ta' użu kliniku, enzalutamide jista' jkun induttur ta' P-gp permezz tal-attivazzjoni ta' nuclear pregnane receptor (PXR).
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of enzalutamide in other races.
Maltese: M'hemmx dejta biżżejjed biex tevalwa d-differenzi potenzjali fil-farmakokinetika ta' enzalutamide f'razez oħrajn.
English: Prostate cancer is known to be androgen sensitive and responds to inhibition of androgen receptor signalling.
Maltese: Il-kanċer tal-prostata huwa magħruf li huwa sensittiv għall-androġen u jirrispondi għall-inibizzjoni tas-sinjalar tar-riċettur tal-androġen.
English: Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.
Maltese: Enzalutamide huwa induttur potenti tal-enzimi u jżid is-sintesi ta' ħafna enzimi u trasportaturi;
English: In the 9785-CL-0403 (UPWARD) single-arm trial to assess incidence of seizure in patients with predisposing factors for seizure (whereof 1.6% had a history of seizures), 8 of 366 (2.2%) patients treated with enzalutamide experienced a seizure.
Maltese: Fl-istudju b'parti waħda 9785-CL-0403 (UPWARD) biex tiġi evalwata l-inċidenza ta' aċċessjoni f'pazjenti b'fatturi li jippredisponuhom għal aċċessjonijiet (li minnhom 1.6% kellhom passat ta'
English: Each carton contains 112 film-coated tablets (4 wallets).
Maltese: Kull kartuna fiha 112-il pillola miksija b'rita (4 kartieri).
English: Tel: +386 14011 400
Maltese: Astellas Pharma d.o.o. Tel: + 386 14011 400
English: Enzalutamide competitively inhibits androgen binding to androgen receptors, and consequently; inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.
Maltese: Enzalutamide jinibixxi b'mod kompetittiv it-twaħħil ta' androġeni ma' riċetturi tal-androġen, u konsegwentement jinibixxi t-traslokazzjoni nukleari ta' riċetturi attivati u jinibixxi l assoċjazzjoni tar-riċettur tal-androġen attivat mad-DNA anki fil-kuntest ta' ammont eċċessiv tarriċettur ta' androġen u fiċ-ċelluli tal-kanċer tal-prostata reżistenti għall-antiandroġeni.
English: If patients must be co-administered a strong CYP2C8 inhibitor, the dose of enzalutamide should be reduced to 80 mg once daily (see section 4.2).
Maltese: Jekk il-pazjenti jkollhom jiġu koamministrati inibitur qawwi ta' CYP2C8, id-doża ta' enzalutamide għandha titnaqqas għal 80 mg darba kuljum (ara sezzjoni 4.2).
English: MDV3100-03 (PREVAIL) study (chemotherapy-naïve patients with metastatic CRPC)
Maltese: Studju MDV3100-03 (PREVAIL)
English: E.J.
Maltese: Ltd.
English: Busuttil Ltd. Tel: +356 21 447184
Maltese: Tel: + 356 21 447184
English: Time to first use of new antineoplastic therapy
Maltese: Żmien għall-ewwel użu ta' terapija b'antineoplastiċi ġdida
English: The median time to PSA progression was 8.3 months for patients treated with enzalutamide and 3.0 months for patients who received placebo [HR = 0.25 (95% CI: 0.20, 0.30), p < 0.0001].
Maltese: Iż-żmien medjan għall-progressjoni tal-PSA kien 8.3 xhur għall-pazjenti kkurati b'enzalutamide u 3.0 xhur għall-pazjenti li rċivew plaċebo [HR = 0.25, CI ta' 95%: 0.20, 0.30), p < 0.0001].
English: xtandi 80 mg film-coated tablets
Maltese: xtandi 80 mg pilloli miksija b'rita
English: Uncommon: leucopenia, neutropenia Not known*: thrombocytopenia
Maltese: Mhux magħruf*: sindromu tal-enċefalopatija riversibbli posterjuri
English: Each Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
Maltese: Kull pillola miksija b'rita ta' 40 mg ta' Xtandi fiha 40 mg ta' enzalutamide.
English: Deaths (%) Median survival (months) (95% CI)
Maltese: Numru ta' mwiet (%) Medjan ta''soppravivenza, xhur (CI ta' 95%)
English: Theoretically, induction of these transporters is also possible, and the net effect is presently unknown.
Maltese: Teoretikament, l-induzzjoni ta' dawn it-trasportaturi hija possibbli wkoll, u attwalment l effett nett mhuwiex magħruf.
English: The recommended dose is 160 mg enzalutamide (four 40 mg film-coated tablets or two 80 mg film-coated tablets) as a single oral daily dose.
Maltese: Id-doża rakkomandata hija 160 mg ta' enzalutamide (erba' pilloli miksija b'rita ta' 40 mg jew żewġ pilloli miksija b'rita ta'80 mg) bħala doża waħda orali kuljum.
English: White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side.
Maltese: - Il-kapsuli rotob Xtandi huma kapsuli oblongi rotob, bojod sa bojod jagħtu fil-griż (bejn wieħed u ieħor 20 mm x9 mm) b'“ENZ” miktuba fuq naħa waħda.
English: In preclinical studies enzalutamide lacks androgen receptor agonist activity.
Maltese: Fi studji ta' qabel l-użu kliniku, enzalutamide m'għandux l-attività agonista tar-riċettur tal-androġen.
English: This leaflet was last revised in MM/YYYY.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed.
Maltese: Pazjenti bi storja medika ta' insuffiċjenza tal-qalb minn ħafifa sa moderata (NYHA Klassi I jew II), u pazjenti li jkunu qed jieħdu prodotti mediċinali assoċjati mat-tnaqqis tal-limitu ta' aċċessjonijiet kienu permessi.
English: It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis.
Maltese: Huma mistennija interazzjonijiet ma' ċerti prodotti mediċinali li jiġu eliminati permezz talmetaboliżmu jew it-trasport attiv.
English: Changes in the reproductive organs in both species were consistent with the pharmacological activity of enzalutamide and reversed or partially resolved after an 8-week recovery period.
Maltese: Il bidliet fl-organi riproduttivi fiż-żewġ speċi kienu konsistenti mal-attività farmakoloġika ta' enzalutamide u treġġgħu lura jew fiequ parzjalment wara perjodu ta' rkupru ta' 8 ġimgħat.
English: Xtandi - 40 mg film-coated tablets Yellow round - film-coated tablets, debossed with E 40.
Maltese: Xtandi - 40 mg pilloli miksija b'rita Pilloli miksija b'rita - tondi, sofor, imnaqqxa b'E 40.
English: • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Maltese: • kura tal-kanċer metastatiku CRPC f'irġiel adulti li l-marda tagħhom tkun żviluppat waqt jew wara terapija b'docetaxel.
English: In the MDV3100-09 clinical trial (STRIVE) of non-metastatic and metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher total confirmed PSA response rate (defined as a ≥ 50% reduction from baseline) compared with patients receiving bicalutamide, 81.3% versus 31.3% (difference = 50.0%, p < 0.0001).
Maltese: Fil-prova klinika MDV3100-09 (STRIVE) ta' CRPC mhux metastatiku u metastatiku, il-pazjenti li kienu qed jirċievu enzalutamide wrew rata ta' rispons ikkonfermat totali għall-PSA sinifikament ogħla (definita bħala tnaqqis ta' ≥ 50% mil-linja bażi), meta mqabbla ma' pazjenti li rċivew bicalutamide,
English: Table 3: Overall survival of patients treated with either enzalutamide or placebo in the PREVAIL study (intent-to-treat analysis)
Maltese: Tabella 3: Sopravivenza globali ta' pazjenti kkurati b'jew enzalutamide jew bi plaċebo fl-istudju PREVAIL (analiżi b'intenzjoni li tikkura)
English: You may have an increased risk of seizure or other side effects.
Maltese: Jista' jkun li jkollok riskju ikbar ta' aċċessjoni jew effetti sekondarji oħra.
English: Progression-free survival was defined as objective evidence of radiographic disease progression by independent central review, skeletal-related events, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.
Maltese: Is-sopravivenza mingħajr progressjoni kienet definita bħala evidenza oġġettiva ta' progressjoni ta' mard radjografiku minn reviżjoni ċentrali indipendenti,
English: Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black.
Maltese: Il-parti l-kbira tal-pazjenti (madwar 71%) fl-istudju kienu Kawkasi; 16% kienu Asjatiċi u 2%
English: Each film-coated tablet contains 80 mg enzalutamide.
Maltese: Kull pillola miksija b'rita fiha 80 mg ta' enzalutamide.
English: Median MFS
Maltese: It-Tnejn It-Tlieta
English: Xtandi - 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide.
Maltese: Xtandi - 40 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 40 mg ta' enzalutamide.
English: Median time to first use of new antineoplastic therapy was 39.6 months (95% CI: 37.7, NR) on the enzalutamide arm versus 17.7 months (95% CI: 16.2, 19.7) on the placebo arm.
Maltese: NR) fil-grupp ta' enzalutamide kontra 17.7 xhur (CI ta' 95%: 16.2, 19.7) fil-grupp tal-plaċebo.
English: Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo [HR = 0.40 (95% CI: 0.35, 0.47), p < 0.0001].
Maltese: kienet 8.3 xhur għall-pazjenti kkurati b'enzalutamide u 2.9 xhur għall-pazjenti li rċivew plaċebo [HR = 0.40, CI ta' 95%: 0.35, 0.47), p < 0.0001].
English: Despite low or even undetectable levels of serum androgen, androgen receptor signalling continues to promote disease progression.
Maltese: Minkejja livelli baxxi jew saħansitra livelli li ma jistgħux jitkejlu ta' androġen fis-serum, is-senjalazzjoni tar-riċettur tal-androġen ikompli jippromwovi l-progressjoni tal-marda.
English: Dose appears to be an important predictor of the risk of seizure, as reflected by preclinical data, and data from a dose-escalation study.
Maltese: Id-doża tidher li hi ħabbar importanti tar-riskju ta' aċċessjoni, kif rifless minn dejta preklinika, u dejta minn studju dwar eskalazzjoni tad-doża.
English: Study treatment continued until disease progression (evidence of radiographic progression, a skeletalrelated event, or clinical progression) and the initiation of either a cytotoxic chemotherapy or an investigational agent, or until unacceptable toxicity.
Maltese: Il-kura tal-istudju kompliet sal-progressjoni tal-marda (evidenza ta' progressjoni radjografika, avveniment relatat mal-iskeletru, jew progressjoni klinika) u l-bidu ta' jew kimoterapija ċitotossika jew mediċina investigattiva, jew sa meta seħħet tossiċità inaċċettabbli.
English: Co-administration of enzalutamide has no clinically relevant effect on the pharmacokinetics of intravenous docetaxel (see section 4.5); however, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded.
Maltese: Il-koamministrazzjoni ta' enzalutamide m'għandha l-ebda effett klinikament rilevanti fuq ilfarmakokinetika ta' docetaxel mogħti ġol-vini (ara sezzjoni 4.5); madankollu, żieda fl-okkorrenza ta' newtropenija indotta minn docetaxel ma tistax tiġi eskluża.
English: Primary Endpoint Metastasis-free survival
Maltese: Punt Aħħari Primarju Sopravivenza mingħajr metastasi
English: For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC increased by 27% while Cmax was again unchanged.
Maltese: Għall-ammont totali ta' enzalutamide mhux magħqud flimkien mal-metabolit attiv mhux magħqud, l-AUC żdiedet b'27% filwaqt li s-Cmax għal darba oħra ma nbidilx.
English: A total of 1717 asymptomatic or mildly symptomatic chemotherapy-naïve patients were randomised 1:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 872) or placebo orally once daily (N = 845).
Maltese: 160 mg darba kuljum (N = 872) jew plaċebo b'mod orali darba kuljum (N = 845).
English: After oral administration of radiolabeled 14C-enzalutamide to rats on day 14 of pregnancy at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the fetus was reached 4 hours after administration and was lower than that in the maternal plasma with tissue/plasma ratio of 0.27.
Maltese: Wara l-għoti orali ta' 14C-enzalutamide radjotikkettat lil firien fl-14-il jum tat-tqala f'doża ta' 30 mg/kg (~ 1.9 darbiet tad-doża massima indikata fil-bnedmin), ir-radjoattività massima fil-fetu ntlaħqet 4
English: The AFFIRM study excluded patients with medical conditions that may predispose them to seizures (see section 4.8) and medicinal products known to decrease the seizure threshold, as well as clinically significant cardiovascular disease such as uncontrolled hypertension, recent history of myocardial infarction or unstable angina, New York Heart Association class III or IV heart failure (unless ejection fraction was ≥ 45%), clinically significant ventricular arrhythmias or AV block (without permanent pacemaker).
Maltese: L-istudju AFFIRM eskluda pazjenti b'kundizzjonijiet mediċi li jistgħu jippredisponuhom għal aċċessjonijiet (ara sezzjoni 4.8) u prodotti mediċinali magħrufa li jżidu l-limitu ta' aċċessjoni, kif ukoll mard kardjovaskolari klinikament sinifikanti bħal pressjoni għolja mhux ikkontrollata, passat riċenti ta' infart mijokardijaku jew anġina mhux stabbli, insuffiċjenza tal-qalb meqjusa mill-Assoċjazzjoni tal-Qalb ta' New York (NYHA) bħala Klassi
English: In another phase 3 clinical trial (PREVAIL) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Maltese: Fi prova klinika oħra tal-fażi 3 (PREVAIL) fuq pazjenti li qatt ma ħadu kimoterapija fil-passat, ilpazjenti li kienu qed jirċievu enzalutamide wrew rata ta' rispons totali għall-PSA ogħla b'mod sinifikanti (definita bħala tnaqqis ta' ≥ 50% mil-linja bażi), meta mqabbla ma' pazjenti li rċivew plaċebo, 78.0%
English: Figure 3: Kaplan-Meier Curves of progression-free survival in the STRIVE study (intent-totreat analysis)
Maltese: Kaplan-Meier tas-sopravivenza mingħajr progressjoni fl-istudju STRIVE