FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of patients who received following prior therapies, n (%) Taxane
Maltese: Numru ta' pazjenti li rċivew terapiji preċedenti, n (%) Tassan
English: For patients with moderate renal impairment (30 mL/min ≤ CrCl < 60 mL/min), the recommended starting dose of Talzenna is 0.75 mg once daily.
Maltese: Għal pazjenti b'indeboliment talkliewi moderat (30 mL/min ≤ CrCl < 60 mL/min), id-doża tal-bidu rakkomandata ta' Talzenna hija 0.75 mg darba kuljum.
English: Abbreviations: BRCA=breast cancer susceptibility gene; ER=estrogen receptor; HER2=human epidermal growth factor receptor 2; N=number of patients; n=number of patients in category; PgR=progesterone receptor.
Maltese: BRCA=ġene ta' suxxettibbiltà għal kanċer tas-sider; ER=riċettur tal-estroġenu; HER2=riċettur 2 ta' fattur ta' tkabbir epidermali tal-bniedem; N=numru ta' pazjenti; n=numru ta' pazjenti filkategorija; PgR=riċettur tal-progesterone.
English: Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted.
Maltese: Kontraċettiv ormonali sistemiku Ma sarux studji tal-interazzjoni mediċinali bejn talazoparib u kontraċettivi orali.
English: Events, number (%) Median (95% CI), months Hazard ratio (95% CI) 2-sided p-valueb p=0.1053
Maltese: Avvenimenti, numru (%) Medjan (95% CI), xhur Proporzjon ta' periklu (95% CI) valur p b'żewġ naħat p=0.1053
English: Demographic, baseline, and disease characteristics - EMBRACA study Talazoparib
Maltese: Demografika, linja bażi u karatteristiċi tal-marda - l-istudju EMBRACA Talazoparib
English: ECOG performance status, n (%)
Maltese: Mhux irrappurtata Status tal-prestazzjoni ECOG, n (%)
English: P-gp is likely involved in talazoparib active renal secretion.
Maltese: P-gp aktarx hija involuta fis-sekrezzjoni tal-kliewi attiva ta' talazoparib.
English: Progression-Free Survival Probability (%)
Maltese: Probabilità ta'Sopravivenza Mingħajr Progressjoni (%)
English: Additional findings at higher exposures included dose-dependent increase in apoptosis/necrosis in the gastrointestinal (GI) tract, liver and ovary.
Maltese: Sejbiet addizzjonali f'esponimenti ogħla inkludew żieda dipendenti mid-doża f'apoptożi/nekrożi fl-apparat gastrointestinali (GI), fwied u ovarju.
English: Based on a population PK analysis that included 490 patients, where 132 patients had mild renal impairment (60 mL/min ≤ CrCL < 90 mL/min), 33 patients had moderate renal impairment (30 mL/min ≤ CrCL < 60 mL/min), and 1 patient had severe renal impairment (CrCL < 30 mL/min), talazoparib CL/F was decreased by 14% and 37% in patients with mild and moderate renal impairment, respectively, when compared to patients with normal renal function (CrCL ≥ 90 mL/min).
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni li inkludiet 490 pazjent, fejn 132 pazjent kellhom indeboliment tal-kliewi ħafif (60 mL/min ≤ CrCL < 90 mL/min), 33 pazjent kellhom indeboliment talkliewi moderat (30 mL/min ≤ CrCL < 60 mL/min), u pazjent wieħed kellu indeboliment tal-kliewi sever (CrCL < 30 mL/min), is-CL/F ta' talazoparib tnaqqset b'14% u 37% f'pazjenti b'indeboliment tal-kliewi ħafif u moderat, rispettivament, meta mqabbel ma' pazjenti b'funzjoni tal-kliewi normali (CrCL ≥ 90 mL/min).
English: BRCA1-mutation positive
Maltese: Pożittiv għall-mutazzjoni BRCA1
English: The population mean apparent volume of distribution (Vss/F) of talazoparib was 420 L. In vitro, talazoparib is approximately 74% bound to plasma proteins with no concentration dependence over the concentration range of 0.01 µM to 1 µM.
Maltese: In vitro, talazoparib huwa madwar 74% imwaħħal mal-proteini tal-plażma bl-ebda dipendenza talkonċentrazzjoni fuq il-medda tal-konċentrazzjoni ta' 0.01 µM sa 1 µM.
English: Excella GmbH & Co. KG Nürnberger Str. 12
Maltese: Excella GmbH & Co.
English: Talzenna 0.25 mg is available in perforated unit dose blister packs of 30, or 60, or 90 hard capsules and in plastic bottles of 30 hard capsules.
Maltese: Talzenna 0.25 mg jiġi f'pakketti ta' folji ta' unità tad-doża mtaqbba ta' 30, jew 60, jew 90 kapsuli ibsin u fi fliexken tal-plastik ta' 30 kapsula iebsa.
English: Grade 3 and Grade 4 myelosuppression-related events were reported for anaemia 34.8% and 0.4%, neutropenia 15.6% and 1.8%, and thrombocytopenia 12.8% and 4.0%.
Maltese: Ġew irrappurtati avvenimenti relatati ma' majelosoppressjoni ta' Grad 3 u Grad 4 għal anemija 34.8% u 0.4%, newtropenja 15.
English: The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li wasslu għal modifikazzjonijiet fid-doża kienu anemija (33.0%), newtropenja (15.8%), u tromboċitopenja (13.4%).
English: The dose may be lowered to 0.75 mg (taken as three 0.25-mg capsules) once daily, or 0.5 mg (two 0.25-mg capsules) once daily, or 0.25 mg (one 0.25-mg capsule) once daily.
Maltese: Id-doża tista' titbaxxa għal 0.75 mg (li tittieħed bħala tliet kapsuli ta' 0.25 mg) darba kuljum, jew 0.5 mg (żewġ kapsuli ta' 0.25 mg) darba kuljum, jew 0.25 mg (kapsula waħda ta' 0.25 mg) darba kuljum.
English: Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8).
Maltese: Majelosoppressjoni li tikkonsisti minn anemija, lewkopenja/newtropenja, u/jew tromboċitopenja, ġew irrappurtati f'pazjenti kkurati b'talazoparib (ara sezzjoni 4.8).
English: However, based on urinary excretion data the absolute bioavailability is at least 41% with fraction absorbed of at least 69% (see Elimination).
Maltese: Madankollu, abbażi ta' data dwar l-eskrezzjoni mill-awrina, il-bijodisponibbiltà assoluta hija tal-inqas 41% bi frazzjoni assorbita ta' mill-inqas 69% (ara Eliminazzjoni).
English: A total of 431 patients were randomised 2:1 to receive Talzenna 1 mg capsules once daily or chemotherapy at standard doses until progression or unacceptable toxicity.
Maltese: Total ta' 431 pazjent ġew randomizzati 2:1 biex jirċievu Talzenna 1 mg kapsuli darba kuljum jew kimoterapija f'dożi standard sal-progressjoni jew tossiċità mhux aċċettabbli.
English: Permanent discontinuation due to an adverse reaction occurred in 3.6% of patients receiving Talzenna.
Maltese: Twaqqif permanenti minħabba reazzjoni avversa seħħ fi 3.6% tal-pazjenti li kienu qed jirċievu Talzenna.
English: Talazoparib did not have a clinically relevant effect on QTc prolongation at the maximum clinically recommended dose of 1 mg once daily.
Maltese: Talazoparib ma kellux effett klinikament rilevanti fuq it-titwil tal-QTc bid-doża massima klinikament rakkomandata ta' 1 mg darba kuljum.
English: The primary efficacy endpoint was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review (BICR).
Maltese: Il-punt ta' tmiem tal-effikaċja primarja kien is-sopravivenza mingħajr progressjoni (PFS) evalwata skont il-Kriterji ta' Evalwazzjoni tar-Reazzjoni f'Tumuri Solidi (RECIST) verżjoni 1.1. kif ivvalutata minn reviżjoni ċentrali indipendenti blinded (BICR).
English: Hormone receptor status, n (%)
Maltese: Status tar-riċettur tal-ormon, n (%)
English: Red iron oxide (E172)
Maltese: (E171), u red iron oxide (E172)
English: The mean (±standard deviation) terminal plasma half-life of talazoparib was 90 (±58) hours and the population mean (inter-subject variability) apparent oral clearance (CL/F) was 6.5 (31%) L/h in cancer patients.
Maltese: Il-half-life tal-plażma terminali medja (±devjazzjoni standard) ta' talazoparib kienet 90 (±58) siegħa u t-tneħħija orali apparenti (CL/F) medja tal-popolazzjoni (varjabbiltà bejn lindividwi) kienet 6.5 (31%) L/h f'pazjenti bil-kanċer.
English: Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co-administration of multiple daily doses of a P-gp inhibitor, itraconazole 100 mg twice daily with a single 0.5 mg talazoparib dose increased talazoparib total exposure (AUCinf) and peak concentration (Cmax) by approximately 56% and 40%, respectively, relative to a single 0.5 mg talazoparib dose administered alone.
Maltese: Data minn studju ta' interazzjoni mediċinali f'pazjenti b'tumuri solidi avvanzati indikat li l-għoti flimkien ta' ħafna dożi ta' kuljum ta' inibitur ta' P-gp, itraconazole 100 mg darbtejn kuljum ma' doża waħda ta' 0.5 mg talazoparib żied l-esponiment totali ta' talazoparib (AUCinf) u l-konċentrazzjoni massima (Cmax) b'madwar 56% u 40%, rispettivament, relattiv għal doża waħda ta' 0.5 mg talazoparib mogħtija waħidha.
English: Talazoparib is a substrate for drug transporters P-gp and Breast Cancer Resistance Protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.
Maltese: Talazoparib huwa substrat għal trasportaturi tal-mediċina P-gp u Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP, Breast Cancer Resistance Protein) u jiġi eliminat prinċipalment minn tneħħija millkliewi bħala kompost mhux mibdul.
English: 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
Maltese: - 0.25 mg qoxra tal-kapsula: hypromellose (HPMC), yellow iron oxide (E172), u titanium dioxide
English: Forest plot of PFS analyses for key subgroups - EMBRACA study
Maltese: Plott Forest ta' analiżijiet tal-PFS għal sottogruppi ewlenin - l-istudju
English: Anthracycline
Maltese: Antraċiklina
English: Gender, n (%)
Maltese: Sess, n (%)
English: Of the 431 patients randomised in the EMBRACA study, 408 (95%) were centrally confirmed to have a deleterious or suspected deleterious gBRCAm using a clinical trial assay; out of which 354 (82%) were confirmed using the BRACAnalysis CDx®.
Maltese: Mill-431 pazjent randomizzati fl-istudju EMBRACA, 408 (95%) ġew ikkonfermati b'mod ċentrali li kellhom gBRCAm deleteruża jew suspettata deleteruża permezz ta' assaġġ tal-prova klinika; li minnhom 354 (82%) ġew ikkonfermati permezz ta' BRACAnalysis CDx
English: The PK of talazoparib have not been studied in patients with moderate (total bilirubin > 1.5 to 3.0 × ULN and any AST) or severe hepatic impairment (total bilirubin > 3.0 × ULN and any AST) (see section 4.2).
Maltese: Il-PK ta' talazoparib ma ġietx studjata f'pazjenti b'indeboliment tal-fwied moderat (bilirubina totali > 1.5 sa 3.0 × ULN u kwalunkwe AST) jew sever (bilirubina totali > 3.0 × ULN u kwalunkwe AST) (ara sezzjoni 4.2).
English: Abbreviations: aBC=advanced breast cancer; CI=confidence interval; CNS=central nervous system; HR+=hormone receptor-positive; ITT=intent-to-treat; PCT=physician's choice treatment (chemotherapy); PFS=progression-free survival; TNBC=triple-negative breast cancer.
Maltese: ITT=intenzjoni biex jiġi kkurat; PCT=kura tal-għażla tat-tabib (kimoterapija); PFS=sopravivenza mingħajr progressjoni; TNBC=kanċer tas-sider triplu negattiv.
English: Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co-administration of single 1 mg talazoparib dose with multiple daily doses of a P-gp inducer, rifampin 600 mg, with rifampin co-administered 30 minutes before talazoparib on the day of talazoparib dosing, increased talazoparib Cmax by approximately 37% whereas AUCinf was not affected relative to a single 1 mg talazoparib dose administered alone.
Maltese: Data minn studju ta' interazzjoni mediċinali f'pazjenti b'tumuri solidi avvanzati indikat li l-għoti flimkien ta' doża waħda ta' 1 mg talazoparib ma' ħafna dożi ta' kuljum ta' induttur ta' P-gp, rifampin 600 mg, ma' rifampin mogħti flimkien 30 minuta qabel talazoparib fil-jum tad-dożaġġ ta' talazoparib, żied is-Cmax ta' talazoparib b'madwar 37% filwaqt li l-AUCinf ma ġietx affettwata relattiva għal doża waħda ta' 1 mg talazoparib mogħtija waħidha.
English: Other medicines and Talzenna
Maltese: Mediċini oħra u Talzenna
English: The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Maltese: 2%), newtropenja (17.4%), u tromboċitopenja (16.8%).
English: BRCA2-mutation positive
Maltese: Pożittiv għall-mutazzjoni BRCA2
English: Summary of efficacy results - EMBRACA study Talazoparib
Maltese: Sommarju tar-riżulati tal-effikaċja - l-istudju EMBRACA Talazoparib
English: In an embryo-foetal development study in rats, talazoparib resulted in embryo-foetal death, foetal malformation (depressed eye bulge, small eye, split sternebrae, fused cervical vertebral arch) and structural variations in bones at a maternal systemic AUC24 exposure approximately 0.09-fold the relevant human exposure at the recommended dose.
Maltese: Fi studju tal-iżvilupp tal-embrijun-fetu fil-firien, talazoparib irriżulta fil-mewt tal-embrijun-fetu, malformazzjoni tal-fetu (ħruġ ta' għajn dipressat, għajn żgħira, sternebrae maqsumin, arka vertebrali ċervikali fużata) u varjazzjonijiet strutturali fl-għadam f'esponiment ta' AUC24 sistematiku fl-omm ta' madwar 0.09 darbiet tal-esponiment rilevanti fil-bniedem bid-doża rakkomandata.
English: BRCA status by central or local laboratory assessment, n (%)
Maltese: Status tal-BRCA permezz ta' valutazzjoni tallaboratorju ċentrali jew lokali, n (%)
English: Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.
Maltese: Talzenna 1 mg jiġi f'pakketti ta' folji ta' unità tad-doża mtaqba ta' 30 kapsuli ibsin u fi fliexken talplastik ta' 30 kapsula iebsa.
English: The most common (≥ 25%) adverse reactions in patients receiving talazoparib in these clinical studies were fatigue (57.1%), anaemia (49.6%), nausea (44.3%), neutropenia (30.2%), thrombocytopenia (29.6%), and headache (26.5%).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (≥ 25%) f'pazjenti li rċivew talazoparib f'dawn l-istudji kliniċi kienu għeja (57.1%), anemija (49.6%), dardir (44.3%), newtropenja (30.
English: EMBRACA was an open-label, randomised, parallel, 2-arm multicentre study of Talzenna versus chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) in patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease.
Maltese: EMBRACA kien studju open-label, randomizzat, parallel, ta' żewġ fergħat, multiċentriku ta' Talzenna kontra l-kimoterapija (capecitabine, eribulin, gemcitabine, vinorelbine) f'pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku negattiv għall-HER2 b'mutazzjoni BRCA tal-linja ġerminali li rċivew mhux aktar minn 3 korsijiet ta' kimoterapija ċitotossika preċedenti għall-marda metastatika jew lokalment avvanzata tagħhom.
English: St. John's wort (Hypericum perforatum) - a herbal remedy used to treat mild depression and anxiety.
Maltese: - St.John's wort (Hypericum perforatum) - rimedju erbali li jintuża biex jikkura dipressjoni u ansjetà ħfief.
English: Talazoparib undergoes minimal hepatic metabolism in humans.
Maltese: Talazoparib jgħaddi minn metaboliżmu tal-fwied minimu fil-bnedmin.
English: The overall safety profile of Talzenna is based on pooled data from 494 patients who received talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 patients from a randomised Phase 3 study with germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer and 83 patients from a nonrandomised Phase 2 study in patients with germline BRCA-mutated locally advanced or metastatic breast cancer.
Maltese: Il-profil tas-sigurtà globali ta' Talzenna huwa bbażat fuq data miġbura minn 494 pazjent li rċivew talazoparib f'1 mg kuljum fl-istudji kliniċi għal tumuri solidi, inkluż 286 pazjent minn studju randomizzat ta' Fażi 3 b'kanċer tas-sider lokalment avvanzat jew metastatiku negattiv għall-HER2 b'mutazzjoni BRCA tal-linja ġerminali (gBRCAm), u 83 pazjent minn studju mhux randomizzat ta' Fażi
English: 1 mg (one 1 mg capsule) once daily
Maltese: 1 mg (kapsula waħda ta' 1 mg) darba kuljum
English: Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib
Maltese: Talzenna 0.25 mg kapsuli ibsin Talzenna 1 mg kapsuli ibsin talazoparib
English: Based on a population PK analysis that included 490 patients, where 41 patients were Asian and 449 patients were Non-Asian (361 White, 16 Black, 9 Others, and 63 Not reported), talazoparib CL/F was higher in Asian patients compared to Non-Asian patients, leading to 19% lower exposure (AUC) in Asian patients.
Maltese: Abbażi ta' analiżi tal-PK tal-popolazzjoni li inkludiet 490 pazjent, fejn 41 pazjent kienu Asjatiċi u 449 pazjent kienu Mhux Asjatiċi (361 Bojod, 16 Suwed, 9 Oħrajn, u 63 Mhux irrappurtati), is-CL/F ta' talazoparib kienet ogħla f'pazjenti Asjatiċi meta mqabbel ma' pazjenti Mhux Asjatiċi, li twassal għal esponiment (AUC) akar baxx ta' 19% f'pazjenti Asjatiċi.
English: If such events occur, dose modifications (reduction or interruption) are recommended (see section 4.2).
Maltese: Jekk iseħħu tali avvenimenti, huma rakkomandati modifikazzjonijiet fid-doża (tnaqqis jew interruzzjoni) (ara sezzjoni 4.2).
English: A population PK analysis was conducted using data from 490 patients with cancer to evaluate the impact of age (ranging from 18 to 88 years), sex (53 males and 437 females), and body weight (ranging from 35.7 kg to 162 kg) on the PK of talazoparib.
Maltese: Saret analiżi tal-PK tal-popolazzjoni permezz ta' data minn 490 pazjent bil-kanċer biex jiġi evalwat limpatt tal-età (li varjat minn 18 sa 88 sena), tas-sess (53 raġel u 437 mara), u tal-piż tal-ġisem (li varja minn 35.7 kg sa 162 kg) fuq il-PK ta' talazoparib.
English: Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John's wort) may decrease talazoparib exposure.
Maltese: Indutturi oħra ta' P-gp (inkluż iżda mhux limitat għal carbamazepine, phenytoin, u St.
English: Concomitant use of strong BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided.
Maltese: L-użu konkomitanti ta' inibituri qawwija ta' BCRP (inkluż iżda mhux limitat għal kurkumina u cyclosporine) għandu jiġi evitat.
English: Talazoparib exposure generally increased proportionally with dose across the range of 0.025 mg to 2 mg after daily administration of multiple doses.
Maltese: L-esponiment ta' talazoparib ġeneralment żdied proporzjonalment mad-doża fil-medda ta' 0.025 mg sa 2 mg wara għoti kuljum ta' ħafna dożi.
English: High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner.
Maltese: Flixkun tal-polietilene ta' densità għolja (HDPE) u għeluq tal-polypropylene (PP) b'inforra tas-siġill tal-induzzjoni tas-sħana.
English: Pharmacokinetics of talazoparib have not been evaluated in patients < 18 years of age.
Maltese: Il-farmakokinetika ta' talazoparib ma ġietx evalwata f'pazjenti ta' < 18-il sena.
English: Talzenna 1 mg hard capsules
Maltese: Talzenna 1 mg kapsuli ibsin
English: 0.5 mg (two 0.25 mg capsules) once daily
Maltese: 0.5 mg (żewġ kapsuli ta' 0.25 mg) darba kuljum
English: 0.75 mg (three 0.25 mg capsules) once daily
Maltese: 0.75 mg (tliet kapsuli ta' 0.25 mg) darba kuljum
English: Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Maltese: - Talzenna 0.25 mg kapsuli ibsin: kull kapsula fiha talazoparib tosylate ekwivalenti għal 0.25 mg talazoparib.
English: Based on non-clinical findings in testes (partially reversible) and ovary (reversible), Talzenna may impair fertility in males of reproductive potential (see section 5.3).
Maltese: Abbażi ta' sejbiet mhux kliniċi fit-testikoli (parzjalment riversibbli) u fl-ovarji (riversibbli), Talzenna jista' jaffettwa ħażin il-fertilità fi rġiel b'potenzjal riproduttiv (ara sezzjoni 5.3).
English: 1 mg capsule shell
Maltese: 1 mg qoxra tal-kapsula
English: Table 3 summarises adverse reactions based on pooled dataset listed by system organ class, and frequency category.
Maltese: Tabella 3 tiġbor fil-qosor ir-reazzjonijiet avversi abbażi ta' sett ta' data miġbur elenkat skont issistema tal-klassifika tal-organi, u l-kategorija ta' frekwenza.
English: Stomatitis Dyspepsia
Maltese: Popolazzjoni pedjatrika
English: Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo micronucleus assay in rats at exposures similar to clinically relevant doses.
Maltese: Talazoparib kien klastoġeniku f'assaġġ ta' aberrazzjoni kromożika in vitro f'limfoċiti tad-demm periferali tal-bniedem u f'assaġġ tal-mikronukleu in vivo fil-firien f'esponimenti simili għal dożi klinikament rilevanti.
English: 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Maltese: (E171) - 1 mg qoxra tal-kapsula: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide
English: Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day.
Maltese: Ir-reazzjonijiet avversi relatati mal-majelosoppressjoni ta' anemija, newtropenja, u tromboċitopenja ġew irrappurtati b'mod komuni ħafna f'pazjenti kkurati b'talazoparib 1 mg/jum.
English: No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine clearance [CrCl] < 90 mL/min).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal pazjenti b'indeboliment tal-kliewi ħafif (60 mL/min ≤ tneħħija tal-kreatinina [CrCl, creatinine clearance] < 90 mL/min).
English: Talzenna 0.25 mg hard capsules
Maltese: Talzenna 0.25 mg kapsuli ibsin
English: Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
Maltese: F'każijiet rari, għadd baxx taċ-ċelluli tad-demm jista' jkun sinjal ta' problemi aktar serji bil-mudullun bħal sindrome majelodisplastiku (MDS, myelodysplastic syndrome) jew lewkimja majelojde akuta (AML, acute myeloid leukaemia).
English: Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Maltese: - Talzenna 1 mg kapsuli ibsin: kull kapsula fiha talazoparib tosylate ekwivalenti għal 1 mg talazoparib.
English: Pregnant women should be advised of the potential risk to the foetus (see section 4.6).
Maltese: In-nisa tqal għandhom jiġu infurmati dwar ir-riskju potenzjali għall-fetu (ara sezzjoni 4.6).
English: Abbreviations: CI=confidence interval; PFS=progression-free survival.
Maltese: OS=sopravivenza globali; PR=rispons parzjali;
English: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Maltese: Kull kapsula fiha talazoparib tosylate ekwivalenti għal 0.25 mg talazoparib.
English: The safety and efficacy of Talzenna in children and adolescents < 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Talzenna fit-tfal u fl-adolexxenti minn età < 18-il sena ma ġewx determinati s'issa.
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Maltese: 30 mm x 5.32 mm b'kappa tal-ivorju (stampata b'“Pfizer” bliswed) u b'korp abjad (stampat b'“TLZ 0.25” bl-iswed).
English: Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding.
Maltese: Folja b'unità tad-doża mtaqqba tal-polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) b'għatu tal-fojl li jitqaxxar tal-aluminju.
English: In particular, the following may increase the risk of side effects with Talzenna: Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamilgenerally used to treat heart problems.
Maltese: - Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine u verapamil - li ġeneralment jintużaw biex jikkuraw problemi tal-qalb.
English: Headache
Maltese: Stomatite
English: Contact with the capsule content should be avoided.
Maltese: Kuntatt mal-kontenut tal-kapsula għandu jiġi evitat.