FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypothyroidism was reported for 8.1% of patients treated with Erleada and 2.0% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months.
Maltese: Ipotirojdiżmu ġie rrappurtat fi 8.1% tal-pazjenti ttrattati b'Erleada u 2.0% tal-pazjenti ttrattati bi plaċebo abbażi ta' stimi tal-ormon li jistimula t-tirojde (TSH, thyroid-stimulating hormone) kull 4 xhur.
English: Concomitant use of Erleada with medicinal products that are substrates of P-gp (e.g., colchicine, dabigatran etexilate, digoxin), BCRP or OATP1B1 (e.g., lapatinib, methotrexate, rosuvastatin, repaglinide) can result in lower exposure of these medicinal products.
Maltese: L-użu ta' Erleada flimkien ma' prodotti mediċinali li huma sustrati ta' of P-gp (eż., colchicine, dabigatran etexilate, digoxin), BCRP jew OATP1B1 (eż., lapatinib, methotrexate, rosuvastatin, repaglinide) jista' jwassal għal esponiment aktar baxx għal dawn il-prodotti mediċinali.
English: Following repeat once-daily dosing, apalutamide exposure (Cmax and area under the concentration curve [AUC]) increased in a dose-proportional manner across the dose range of 30 to 480 mg.
Maltese: Wara għoti ripetut ta' dożi darba kuljum, l-epsoniment għal apalutamide (is-Cmax u l-erja taħt il-kurva tal-konċentrazzjoni [AUC, area under the concentration curve]) żdied b'mod fi proporzjon mad-doża fil-firxa kollha tad-dożi bejn 30 u 480 mg.
English: Slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), debossed with “AR 60” on one side.
Maltese: Pilloli kemxejn sofor sa ħodor jagħtu fil-griż, f'għamla oblonga, miksija b'rita (twal 16.7 mm x wiesa' 8.7 mm), imnaqqxa b'“AR 60” fuq naħa waħda.
English: Patients with clinically significant cardiovascular disease in the past 6 months including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias were excluded from the clinical studies.
Maltese: Pazjenti b'mard kardjovaskulari sinifikanti b'mod kliniku fl-aħħar 6 xhur inklużi anġina severa/mhux stabbli, infart mijokardijaku, insuffiċjenza konġestiva tal-qalb bis-sintomi, avvenimenti tromboemboliċi fl-arterji jew fil-vini (eż., emboliżmu fil-pulmuni, inċident ċerebrovaskulari inklużi attakki iskemiċi temporanji), jew arritmiji tal-ventrikulu sinifikanti b'mod kliniku ġew esklużi millistudji kliniċi.
English: Medicinal products that inhibit CYP3A4
Maltese: Prodotti mediċinali li jinibixxu CYP3A4
English: • prevent blood clots (e.g. warfarin, clopidogrel, dabigatran etexilate)
Maltese: • jevitaw tagħqid tad-demm (eż. warfarin, clopidogrel, dabigatran etexilate)
English: Potential for apalutamide to affect exposures to other medicinal products
Maltese: Il-possibbiltà li apalutamide jaffettwa esponimenti għal prodotti mediċinali oħra
English: Erleada is indicated in adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease (see section 5.1).
Maltese: Erleada huwa indikat f'irġiel adulti għat-trattament ta' kanċer tal-prostata mhux metastatiku reżistenti għall-kastrazzjoni (NM-CRPC, non-metastatic castration-resistant prostate cancer) li jkunu f'riskju kbir li jiżviluppaw marda metastatika (ara sezzjoni 5.1).
English: Other important adverse reactions include fractures (12%) and hypothyroidism (8%).
Maltese: Reazzjonijiet avversi importanti oħra jinkludu ksur (12%) u ipotirojdiżmu (8%).
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
Maltese: Birkerød Tlf: +45 45 94 82 82
English: Seventy-three percent (73%) of subjects received prior treatment with a first generation anti-androgen; 69% of subjects received bicalutamide and 10% of subjects received flutamide.
Maltese: Tlieta u sebgħin fil-mija (73%) tal-individwi rċivew trattament qabel b'antiandroġen tal-ewwel ġenerazzjoni; 69% tal-individwi rċivew bicalutamide u 10% tal-individwi rċivew flutamide.
English: For the active moieties (sum of apalutamide plus the potency adjusted active metabolite), Cmax decreased by 22% while AUC was again similar.
Maltese: Għall-partjiet attivi (total ta' apalutamide flimkien mal-qawwa aġġustata tal-metabolit attiv), is-Cmax naqas bi 22% filwaqt li l-AUC reġa' kien jixxiebah.
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 22% while AUC was similar following co-administration of Erleada as a 240 mg single dose with itraconazole (strong CYP3A4 inhibitor).
Maltese: Fi studju dwar interazzjon bejn mediċina u oħra, is-Cmax ta' apalutamide naqas bi 22% filwaqt li l-AUC kien jixxiebah wara l-għoti flimkien ta' Erleada bħala doża waħda ta' 240 mg ma' itraconazole (inibitur qawwwi ta' CYP3A4).
English: If a seizure develops during treatment with Erleada, treatment should be discontinued permanently.
Maltese: Jekk tiżviluppa aċċessjoni waqt ittrattament b'Erleada, it-trattament għandu jitwaqqaf b'mod permanenti.
English: Apalutamide and N-desmethyl apalutamide do not affect CYP1A2 and CYP2D6 at therapeutically relevant concentrations.
Maltese: Apalutamide u N-desmethyl apalutamide ma jaffettwawx CYP1A2 u CYP2D6 f'konċentrazzjonijiet rilevanti b'mod terapewtiku.
English: June 2023
Maltese: Ġunju tal-2023
English: Skin rash led to Erleada treatment discontinuation in 9% of patients who experienced skin rash.
Maltese: Raxx fil-ġilda wassal għal twaqqif tat-trattament ta' 9% tal-pazjenti li kellhom raxx fil-ġilda.
English: Adverse reactions observed during clinical studies are listed below by frequency category.
Maltese: Reazzjonijiet avversi osservati waqt studji kliniċi huma elenkati taħt skont il-kategorija ta' frekwenza.
English: Erleada 60 mg film-coated tablets apalutamide
Maltese: Erleada 60 mg pilloli miksija b'rita apalutamide
English: All subjects enrolled were confirmed to be non-metastatic by blinded central imaging review and had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status score of 0 or 1 at study entry.
Maltese: L-individwi kollha rreġistrati fl-istudju ġew ikkonfermati li ma kinux metastatiċi permezz ta' reviżjoni ċentrali mgħammda tal-immaġini u kellhom punteġġ tal-iStat ta' Eżekuzzjoni tal-Koperattiva tal-Grupp ta' Onkoloġija tal-Lvant (ECOG PS, Eastern Cooperative Oncology Group Performance Status) ta' 0 jew 1 meta ddaħħlu fl-istudju.
English: • treat serious mental illnesses (e.g. haloperidol)
Maltese: • jitrattaw mard mentali serju (eż. haloperidol)
English: Postauthorisation efficacy study (PAES): In order to further evaluate the efficacy of Erleada, the MAH should submit the final clinical study report, including overall survival results, from study ARN-509-003 (SPARTAN) comparing the efficacy and safety of Apalutamide vs. placebo in subjects with high risk NonMetastatic (M0) Castration-Resistant Prostate Cancer.
Maltese: Sabiex issir aktar evalwazzjoni tal-effikaċja ta' Erleada, l-MAH għandu jissottometti r-rapport kliniku finali tal-istudju, inklużi r-riżultati ta' sopravivenza globali, mill-istudju ARN-509-003 (SPARTAN) li jqabbel l-effikaċja u s-sigurtà ta' Apalutamide vs. plaċebo f'individwi b'riskju għoli ta' Kanċer Mhux Metastatiku (M0) tal-Prostata Reżistenti għall-Kastrazzjoni.
English: Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributed to the clinical activity of apalutamide.
Maltese: Abbażi ta' esponiment sistemiku, qawwa relattiva, u propjetajiet farmakokinetiċi, N-desmethyl apalutamide x'aktarx li kkontribwixxa għallattività klinika ta' apalutamide.
English: Erleada is co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) however, a reduction of the Erleada dose based on tolerability should be considered (see section 4.2).
Maltese: (eż., ketoconazole, ritonavir, clarithromycin) madankollu, għandu jitqies tnaqqis fid-doża ta' Erleada abbażi tat-tollerabilità (ara sezzjoni 4.2).
English: Each film-coated tablet contains 60 mg of apalutamide.
Maltese: Kull pillola miksija b'rita contains 60 mg apalutamide.
English: In a drug-drug interaction study, the Cmax of apalutamide decreased by 21% while AUC increased by 68% following co-administration of apalutamide 240 mg single dose with gemfibrozil (strong CYP2C8 inhibitor).
Maltese: Fi studju dwar interazzjon bejn mediċina u oħra, is-Cmax ta' apalutamide naqas b'21% filwaqt li l-AUC żdied bi 68% wara l-għoti flimkien ta' doża waħda ta' apalutamide 240 mg ma' gemfibrozil (inibitur qawwi ta' CYP2C8).
English: Erleada did not cause clinically meaningful changes in exposure to the CYP2C8 substrate.
Maltese: Erleada ma kkawżax tibdil ta' sinifikat kliniku fl-esponiment għas-sustrat ta' CYP2C8.
English: The CL/F of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing.
Maltese: Is-CL/F ta' apalutamide huwa 1.3 L/siegħa wara għoti ta' doża waħda u jiżdied għal 2.0
English: In humans, Erleada is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9.
Maltese: Fil-bniedem, Erleada huwa induttur qawwi ta' CYP3A4 u CYP2C19, u induttur dgħajjef ta' CYP2C9.
English: humerus fracture, thoracic vertebral fracture, upper limb fracture, fractured sacrum, hand fracture, pubis fracture, acetabulum fracture, ankle fracture, compression fracture, costal cartilage fracture, facial bones fracture, lower limb fracture, osteoporotic fracture, wrist fracture, avulsion fracture, fibula fracture, fractured coccyx, pelvic fracture, radius fracture, sternal fracture, stress fracture, traumatic fracture, cervical vertebral fracture, femoral neck fracture, tibia fracture.
Maltese: Jinkludi ksur tal-kustilji, ksur ta' vertebri lumbari, ksur minn pressa fuq is-sinsla, ksur tas-sinsla, ksur fis-sieq, ksur filġenbejn, ksur fl-omeru, ksur tal-vertebri toraċiċi, ksur fid-dirgħajn, sakrum miksur, ksur tal-id, ksur fl-għadma pubika, ksur fl-aċetabulu, ksur fl-għaksa, ksur minħabba pressa, ksur fil-kartiliġ kostali, ksur fl-għadam tal-wiċċ, ksur fir-riġel, ksur osteoporotiku, ksur fil-polz, ksur minn avulżjoni, ksur fil-fibula, koksiks miksura, ksur fil-pelviċi, ksur fir-radjus, ksur fl-isternum, ksur minħabba pressjoni, ksur minn trawma, ksur tal-vertebri taċ-ċerviċi (għonq), ksur fl-għonq talfemur, ksur fit-tibja.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag International NV
Maltese: Janssen-Cilag International NV
English: Hypothyroidism occurred in 28% of patients already receiving thyroid replacement therapy in the Erleada arm and in 5.9% of patients in the placebo arm.
Maltese: Ipotirojdiżmu seħħ fi 28% talpazjenti li kienu diġà qed jirċievu terapija ta' sostituzzjoni għat-tirojde fil-fergħa ta' Erleada u f'5.9% tal-pazjenti fil-fergħa tal-plaċebo.
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Maltese: Anzjani Ma huwa meħtieġ l-ebda aġġustament fid-doża għal pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: Among patients with skin rash, dose interruption occurred in 28% and dose reduction occurred in 12% (see section 4.2).
Maltese: Fost il-pazjenti b'raxx fil-ġilda, interruzzjoni tad-doża saret fi 28% u tnaqqis fid-doża sar fi 12% (ara sezzjoni 4.2).
English: Male fertility is likely to be impaired by treatment with apalutamide based on findings in repeat-dose toxicology studies which were consistent with the pharmacological activity of apalutamide.
Maltese: Il-fertilità fl-irġiel x'aktarx li tkun indebolita bit-trattament b'apalutamide abbażi ta' sejbiet minn studji dwar tossiċità minn dożi ripetuti li kienu konsistenti mal-attività farmakoloġika ta' apalutamide.
English: Each 30-day carton contains 120 film-coated tablets in 5 cardboard wallet packs of 24 film-coated tablets each.
Maltese: Kull kartuna ta' 30 jum fiha 120 pillola miksija b'rita f'5 pakketti portafoll tal-kartun ta' 24 pillola miksija b'rita 'l waħda.
English: At steady-state, the maximum mean QTcF change from baseline was 12.4 ms (2-sided 90% upper CI: 16.0 ms).
Maltese: QTcF mil-linja bażi kienet 12.4 ms (CI tan-naħa ta' fuq ta' 90% b'żewġ naħat: 16.
English: The mean apparent volume of distribution at steady-state of apalutamide is about 276 L. The volume of distribution of apalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Maltese: Ilvolum ta' distribuzzjoni ta' apalutamide huwa akbar mill-volum tal-ilma totali tal-ġisem, li jindika distribuzzjoni ekstravaskulari estensiva.
English: CYP3A4 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Maltese: CYP3A4 għandu rwol fl-eliminazzjoni ta' apalutamide u fil-formazzjoni tal-metabolit attiv tiegħu.
English: • Each 30-day carton contains 120 film coated tablets in 5 cardboard wallet packs of
Maltese: • Kull kartuna ta' 30 jum fiha 120 pillola miksija b'rita f'5 pakketti portafolli tal-kartun ta'
English: Based on the population pharmacokinetic analysis using data from clinical studies in subjects with castration-resistant prostate cancer (CRPC) and healthy subjects, no significant difference in systemic exposure was observed in subjects with pre-existing mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] between 30 to 89 mL/min/1.73 m2; N=585) compared to subjects with baseline normal renal function (eGFR ≥ 90 mL/min/1.73 m2; N=372).
Maltese: L-effett individwi b'funzjoni tal-kliewi normali fil-linja bażi (eGFR ≥ 90 mL/min/1.73 m potenzjali ta' indeboliment sever tal-kliewi jew mard tal-kliewi fl-aħħar stadju (eGFR ≤29 mL/min/1.73 m2) ma ġewx iddeterminati minħabba data mhux suffiċjenti.
English: CYP2C8 plays a role in the elimination of apalutamide and in the formation of its active metabolite.
Maltese: CYP2C8 għandu rwol fl-eliminazzjoni ta' apalutamide u fil-formazzjoni tal-metabolit attiv tiegħu.
English: Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.
Maltese: Kastrazzjoni medika bl-analogu tal-ormon li jerħi gonadotropin (GnRHa, gonadotropin releasing hormone analogue) għandha titkompla waqt it-trattament f'pazjenti li ma jkunux kastrati b'operazzjoni.
English: Based on the drug-drug interaction study results with strong CYP3A4 inhibitor or strong CYP2C8 inhibitor, CYP3A4 or CYP2C8 inducers are not expected to have clinically relevant effects on the pharmacokinetics of apalutamide and the active moieties therefore no dose adjustment is necessary when Erleada is co-administered with inducers of CYP3A4 or CYP2C8.
Maltese: Abbażi tar-riżultati tal-istudju ta' interazzjoni bejn mediċina u oħra b'inibitur qawwi ta' CYP3A4 jew inibitur qawwi ta' CYP2C8, indutturi ta' CYP3A4 jew CYP2C8 mhumiex mistennija li jkollhom effetti rilevanti b'mod kliniku fuq il-farmakokinetika ta' apalutamide u l-partijiet attivi għalhekk ma huwa meħtieġ l-ebda aġġustament fid-doża meta Erleada jingħata flimkien ma' indutturi ta' CYP3A4 jew CYP2C8.
English: Musculoskeletal and connective tissue disorders very common: fracture+ very common: arthralgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi komuni ħafna: ksur komuni ħafna: artralġja
English: White opaque high-density polyethylene (HDPE) bottle with a polypropylene (PP) child-resistant closure.
Maltese: Flixkun abjad opak tal-polyethylene ta' densità għolja (HDPE, high-density polyethylene) b'għatu talpolypropylene (PP) li ma jistax jinfetaħ mit-tfal.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (16 count) (Blister sealed in inner wallet)
Maltese: FOLJA 60 mg (għadd ta' 16) (Folja ssiġillata fil-portafoll ta' ġewwa)
English: The side effects for Erleada include seizures.
Maltese: L-effetti sekondarji ta' Erleada jinkludu aċċessjonijiet.
English: Medicinal products utilised included topical corticosteroids, systemic corticosteroids and oral anti-histamines.
Maltese: Prodotti mediċinali li ntużaw kienu jinkludu kortikosterojdi topikali, kortikosterodji sistemiċi u antiistamini mill-ħalq.
English: Adverse reactions of skin rash were reported for 24% of patients treated with Erleada.
Maltese: Reazzjonijiet avversi ta' raxx fil-ġilda ġew irrappurtati f'24% tal-pazjenti ttrattati b'Erleada.
English: Apalutamide is a potent enzyme inducer and may lead to loss of efficacy of many commonly used medicinal products (see section 4.5).
Maltese: Apalutamide huwa induttur qawwi ta' enzimi u jista' jwassal għal telf ta' effikaċja ta' ħafna prodotti mediċinali użati b'mod komuni (ara sezzjoni 4.5).
English: N-desmethyl apalutamide is characterised by a flat concentration-time profile at steady-state with a mean peak-to-trough ratio of 1.27.
Maltese: N-desmethyl apalutamide huwa kkaratterizzat minn profil ċatt għall-konċentrazzjoni mal-ħin fl-istat fiss bil-medja tal-proporzjon bejn l-aktar konċentrazzjoni għolja u dik l-aktar baxxa ta' 1.27.
English: • lower blood glucose (e.g. repaglinide)
Maltese: • jbaxxu l-livelli tal-glukożju fid-demm (eż. repaglinide)
English: There were no statistically significant differences observed in the change from baseline analysis of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for the total score or any of the subscales between subjects on Erleada added to ADT versus placebo with ADT.
Maltese: Ma kienu osservati l-ebda differenzi sinifikanti b'mod statistiku fl-analiżi tal-bidla mil-linja bażi talIstima tal-Funzjoni tat-terapija għall-Kanċer tal-Prostata (FACT-P, Functional Assessment of Cancer Therapy-Prostate) għall-punteġġ totali jew għal kwalunkwe wieħed mis-sottoskali bejn individwi fuq Erleada miżjud ma' ADT versus plaċebo ma' ADT.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (30 days)
Maltese: KARTUNA 60 mg (30 jum)
English: The effect of apalutamide 240 mg once daily on the QTc interval was assessed in an open-label, uncontrolled, multi-center, single-arm dedicated QT study in 45 patients with CRPC.
Maltese: L-effett ta' apalutamide 240 mg darba kuljum fuq l-intervall QTc ġie stmat fi studju dedikat ta' QT, mhux ikkontrollat, b'ħafna ċentri, b'fergħa waħda, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża f'45 pazjent b'CRPC.
English: For the active moieties (sum of apalutamide plus the potency adjusted active metabolite), Cmax decreased by 21% while AUC increased by 45%.
Maltese: Għall-partijiet attivi (total ta' apalutamide flimkien mal-qawwa aġġustata talmetabolit attiv), is-Cmax naqas b'21% filwaqt li l-AUC żdied b'45%.
English: Taking Erleada
Maltese: X'fih Erleada
English: When substrates of CYP2B6 (e.g., efavirenz) are administered with Erleada, monitoring for an adverse reaction and evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Maltese: Meta sustrati ta' CYP2B6 (eż., efavirenz) jingħataw flimkien ma' Erleada, għandu jsir monitoraġġ għal reazzjoni avversa u evalwazzjoni għal telf ta' effikaċja tas-sustrat u jista' jkun meħtieġ aġġustament fid-doża tas-sustrat biex jinżammu l-aħjar konċentrazzjonijet fil-plażma.
English: Each 28-day carton contains 112 film-coated tablets in 4 cardboard wallet packs of 28 film-coated tablets each.
Maltese: Kull kartuna ta' 28 jum fiha 112-il pillola miksija b'rita f'4 pakketti portafoll tal-kartun ta' 28 pillola miksija b'rita 'l waħda.
English: No dose adjustment is necessary for patients with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża għal pazjenti b'indeboliment minn ħafif sa moderat tal-fwied fil-linja bażi (Klassi A u Klassi B ta' Child-Pugh, rispettivament).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (28 days)
Maltese: KARTUNA 60 mg (28 jum)
English: The elimination of apalutamide and formation of its active metabolite, N-desmethyl apalutamide, is mediated by both CYP2C8 and CYP3A4 to a similar extent at steady-state.
Maltese: L-eliminazzjoni ta' apalutamide u l-formazzjoni tal-metabolit attiv tiegħu, N-desmethyl apalutamide, huma medjati minn CYP2C8 u CYP3A4 bi grad jixxiebah fl-istat fiss.
English: Apalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Maltese: Apalutamide huwa induttur qawwi tal-enzimi u jżid is-sintesi ta' ħafna enzimi u trasportaturi; għalhekk, hija mistennija interazzjoni ma' ħafna prodotti mediċinali komuni li huma sustrati talenzimi jew tat-trasportaturi.
English: • treat heart conditions or lower blood pressure (e.g. digoxin, felodipine)
Maltese: • jitrattaw kondizzjonijiet tal-qalb jew ibaxxu l-pressjoni (eż. digoxin, felodipine)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 60 mg (BOTTLE)
Maltese: KARTUNA 60 mg (FLIXKUN)
English: An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite.
Maltese: Analiżi talesponiment ta' QT issuġġeriet żieda fil- QTcF li tiddependi mill-konċentrazzjoni għal apalutamide u lmetabolit attiv tiegħu.
English: Consistent improvement in MFS with Erleada was observed for all prespecified subgroups, including age, race, region of the world, nodal status, prior number of hormonal therapies, baseline PSA, PSA doubling time, baseline ECOG status and use of bone-sparing agents.
Maltese: Ġie osservat titjib konsistenti b'Erleada fl-MFS għassottogruppi kollha speċifkati minn qabel, inklużi l-età, ir-razza, ir-reġjun fid-dinja, l-istat nodali, innumru preċedenti ta' terapiji bl-ormoni, il-PSA fil-linja bażi, iż-żmien biex jirdoppja l-PSA, l-istat ta' ECOG fil-linja bażi u l-użu ta' sustanzi li jevitaw ħsara lill-għadam.
English: EXPIRY DATE EXP
Maltese: Reazzjoni avversa u frekwenza
English: In patients not receiving thyroid replacement therapy, hypothyroidism occurred in 5.7% of patients treated with Erleada and in 0.8% of patients treated with placebo.
Maltese: F'pazjenti li ma kinux qed jirċievu terapija ta' sostituzzjoni tattirojde, ipotirojdiżmu seħħ f'5.7% tal-pazjetni ttrattati b'Erleada u f'0.8% tal-pazjenti ttrattati bi plaċebo.
English: * Includes hypothyroidism, blood thyroid stimulating hormone increased, thyroxine decreased, autoimmune thyroiditis,
Maltese: * Jinkludi ipotirojdiżmu, żieda fl-ormon li jistimula t-tirojde fid-demm, tnaqqis fit-thyroxine, tirojdite awtoimmuni,
English: No initial dose adjustment is necessary when Erleada is co-administered with a strong inhibitor of CYP2C8 (e.g., gemfibrozil, clopidogrel) however, a reduction of the Erleada dose based on tolerability should be considered (see section 4.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża tal-bidu meta Erleada jingħata flimkien ma' inibitur qawwi ta' CYP2C8 (eż., gemfibrozil, clopidogrel) madankollu, għandu jitqies tnaqqis fid-doża ta' Erleada abbażi ta' tollerabilità (ara sezzjoni 4.2).
English: PVC-PCTFE foil blister with an aluminum push-through foil sealed inside a wallet pack.
Maltese: Folja tal-fojl tal-PVC-PCTFE b'fojl tal-aluminju biex minnu timbotta l-pillola issiġillat ġewwa pakkett portafoll.
English: The effects of renal impairment, hepatic impairment, age, race, and other extrinsic factors on the pharmacokinetics of apalutamide are summarised below.
Maltese: L-effetti ta' indeboliment tal-kliewi, indeboliment tal-fwied, l-età, ir-razza, u fatturi estrinsiċi oħra fuq il-farmakokinetika ta' apalutamide huma miġbura fil-qosor taħt.
English: Concomitant administration of Erleada with medicinal products that are substrates of UGT (e.g., levothyroxine, valproic acid) can result in lower exposure to these medicinal products.
Maltese: L-għoti ta' Erleada flimkien ma' prodotti mediċinali li huma sustrati ta' UGT (eż., levothyroxine, valproic acid) jista' jwassal għal esponiment inqas għal dawn il-prodotti mediċinali.
English: Fifteen percent (15%) of subjects had < 2 cm pelvic lymph nodes at study entry.
Maltese: Ħmistax fil-mija (15%) tal-indivdiwi kellhom għoqiedi tal-limfa filpelviċi ta' < 2 ċm meta ddaħħlu fl-istudju.