natgillin/translations-raw huggingface dataset:
Patient demographic, baseline, and disease characteristics were generally similar between the study treatment arms (see Table 4). 
Općenito su demografske karakteristike, početne karakteristike i karakteristike bolesti bolesnika bile slične među liječenim skupinama u ispitivanju (vidjeti tablicu 4).
Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods. 
Budući se ne preporučuje primjena hormonske kontracepcije ako imate rak dojke, trebate koristiti dvije nehormonalne kontracepcije.
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. 
Doza se može smanjiti na 0,75 mg (uzimaju se tri kapsule od 0,25 mg) jednom na dan ili na 0,5 mg (uzimaju se dvije kapsule od 0,25 mg) jednom na dan ili na 0,25 mg (uzima se jedna kapsula od 0,25 mg) jednom na dan.
St. John's wort (Hypericum perforatum) - a herbal remedy used to treat mild depression and anxiety. 
- Gospina trava (Hypericum perforatum) - biljni lijek koji se koristi u liječenju blage depresije i tjeskobe.
A risk to breast-fed children cannot be excluded and therefore breast-feeding is not recommended during treatment with Talzenna and for at least 1 month after the final dose. 
Rizik za dojenčad ne može se isključiti te se stoga dojenje ne preporučuje tijekom liječenja lijekom Talzenna i tijekom najmanje 1 mjesec nakon zadnje doze.
Common (may affect up to 1 in 10 people) Alteration in taste (dysgeusia) Indigestion 
Često (mogu se javiti u manje od 1 na 10 osoba) - Promjena okusa (disgeuzija) - Loša probava
Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant and/or metastatic setting. 
Bolesnici su trebali primiti liječenje antraciklinom i/ili taksanom (osim ako je kontraindiciran) u neoadjuvantnom, adjuvantnom i/ili metastatskom okruženju.
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. 
Posebice, sljedeći lijekovi mogu povećati rizik od nuspojava s lijekom Talzenna: - Amiodaron, karvedilol, dronedaron, propafenon, kvinidin, ranolazin i verapamil - uglavnom se koriste za liječenje srčanih problema.
Talzenna 1 mg hard capsules EU/1/19/1377/005 
Talzenna 1 mg tvrde kapsule EU/1/19/1377/005
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%). 
Najčešće (≥ 25 %) nuspojave u bolesnika koji su primali talazoparib u ovim kliničkim ispitivanjima bile su: umor (57,1 %), anemija (49,6 %), mučnina (44,3 %), neutropenija (30,2 %), trombocitopenija (29,6 %) i glavobolja (26,5 %).
Insufficient data are available to estimate the impact of severe renal impairment on talazoparib CL/F in this patient population. 
Nema dovoljno podataka da bi se procijenio utjecaj teškog oštećenja funkcije bubrega na prividni peroralni klirens talazopariba u ovoj populaciji bolesnika.
Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany 
KG Nürnberger Strasse 12 90537 Feucht Njemačka
Concomitant use of strong P-gp inhibitors during treatment with talazoparib should be avoided. 
Treba izbjegavati istodobnu primjenu jakih inhibitora P-gp-a tijekom liječenja talazoparibom.
Talzenna may have a minor influence on the ability to drive and use machines. 
Lijek Talzenna može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used (see section 4.6). 
Budući da se ne preporučuje upotreba hormonske kontracepcije u bolesnica s rakom dojke, trebale bi se koristiti dvije nehormonalne i komplementarne metode kontracepcije (vidjeti dio 4.6).
Abbreviations: BICR=blinded independent central review; CI=confidence interval; CMH=CochranMantel-Haenszel; CR=complete response; IQR=interquartile range; ITT=intent-to-treat; ORR=objective response rate; OS=overall survival; PR=partial response; RECIST 1.1=Response Evaluation Criteria in Solid Tumors version 1.1. a. Hazard ratio was based on stratified Cox regression model with treatment as the only covariate 
Kratice: BICR=slijepa neovisna centralna procjena (engl. blinded independent central review); CI=interval pouzdanosti (engl. confidence interval); CMH=Cochran-Mantel-Haenszel; CR=potpuni odgovor (engl. complete response); IQR=interkvartilni raspon (engl. interquartile range); ITT=populacija predviđena za liječenje (engl. intent-to-treat); ORR=stopa objektivnog odgovora (engl. objective response rate); OS=ukupno preživljenje (engl. overall survival); PR=djelomičan odgovor (engl. partial response); RECIST 1.1=Kriteriji za procjenu odgovora kod solidnih tumora, verzija 1.1. (engl.
Following repeated daily dosing of 1 mg talazoparib to patients, the geometric mean (% coefficient of variation [CV%]) area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of talazoparib at steady-state was in the range of 126 (107) ng•hr/mL to 208 (37) ng•hr/mL and 11 (90) ng/mL to 19 (27) ng/mL, respectively. 
Nakon što je u bolesnika primijenjena ponavljana dnevna doza od 1 mg talazopariba, geometrijska srednja vrijednost (% koeficijent varijacije) područja ispod krivulje koncentracija u plazmi-vrijeme (AUC) i maksimalne zabilježene koncentracije talazopariba u plazmi (Cmax) u stanju dinamičke ravnoteže kretala se u rasponu od 126 (107) ng•h/ml do 208 (37) ng•h/ml, odnosno od 11 (90) ng/ml do 19 (27) ng/ml.
Population PK analysis indicates that co-administration of acid-reducing agents including proton pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid-reducing agents had no significant impact on the absorption of talazoparib. 
Analiza populacijske farmakokinetike pokazuje da istodobna primjena lijekova koji smanjuju kiselinu, uključujući inhibitore protonske pumpe i antagoniste histaminskih receptora tipa 2 (H2RA) ili druge lijekove koji smanjuju kiselinu, nije imala značajan utjecaj na apsorpciju talazopariba.
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. 
U ispitivanju embrio-fetalnog razvoja u štakora talazoparib je doveo do embrio-fetalne smrti, malformacija fetusa (uvučena očna jabučica, malo oko, razdvojene sternebre, srašten luk kralješka vrata) i strukturne varijacije u kostima pri majčinoj sistemskoj izloženosti AUC24 približno 0,09 puta većoj od značajne izloženosti ljudi pri preporučenoj dozi.
Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding. 
Polivinilkloridni/poliviniliden kloridni (PVC/PVdC) perforirani blister s jediničnim dozama zatvoren s aluminijskom folijom na otvoru koja se može odlijepiti.
1 mg (one 1 mg capsule) once daily 
1 mg (jedna kapsula od 1 mg) jednom na dan
The effect of talazoparib on cardiac repolarisation was evaluated using time-matched electrocardiograms (ECGs) in assessing the relationship between the change of the QT interval corrected for heart rate (QTc) from baseline and the corresponding plasma talazoparib concentrations in 37 patients with advanced solid tumours. 
Učinak talazopariba na repolarizaciju srca procijenjen je primjenom s vremenom povezanih promjena EKG-a pri utvrđivanju veze između promjene QT-intervala korigiranog prema srčanoj frekvenciji (QTc) na početku liječenja i odgovarajućih koncentracija talazopariba u plazmi u 37 bolesnika s uznapredovalim solidnim tumorima.
Treatment of cancer cell lines that are harbouring defects in DNA repair genes with talazoparib single agent leads to increased levels of γH2AX, a marker of double stranded DNA breaks, and results in decreased cell proliferation and increased apoptosis. 
Liječenje staničnih linija raka koje imaju anomalije u genima za popravak DNK samo talazoparibom dovodi do povećanih razina γH2AX, pokazatelja lomova dvolančane DNK, i uzrokuje smanjenu staničnu proliferaciju i povećanu apoptozu.
No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine clearance [CrCl] < 90 mL/min). 
Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (60 ml/min ≤ klirens kreatinina [CrCl] < 90 ml/min).
Kaplan-Meier curves of PFS - EMBRACA study 
Kaplan-Meierove krivulje PFS-a - ispitivanje EMBRACA
Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters. 
Veličine pakiranja: kutije s 30 × 1 kapsulom ili 60 × 1 kapsulom ili 90 × 1 kapsulom u blisterima s jediničnim dozama.
Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone. 
Analiza populacijske farmakokinetike isto je tako pokazala da je istodobna primjena jakih inhibitora P-gp-a povećala izloženost talazoparibu za 45 %, u usporedbi s talazoparibom kada se primjenjuje sam.
Talzenna has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or patients requiring haemodialysis. 
Lijek Talzenna nije ispitivan u bolesnika s teškim oštećenjem bubrega (CrCl < 30 ml/min) ili u bolesnika kojima je potrebna hemodijaliza.
In vitro, talazoparib did not inhibit any of the major uridine-diphosphate glucuronosyltransferase (UGT) isoforms (1A1, 1A4, 1A6, 1A9, 2B7, and 2B15) at clinically relevant concentrations. 
In vitro, talazoparib nije inhibirao niti jedan od glavnih izoformi uridin-difosfatglukuronoziltransferaze (UGT) (1A1, 1A4, 1A6, 1A9, 2B7 i 2B15) pri klinički značajnim koncentracijama.
Median PFS=8.6 months 95% CI (7.2, 9.3) 
Medijan PFS-a=8,6 mjeseci 95% CI (7,2; 9,3)
Talzenna may cause foetal harm when administered to a pregnant woman. 
Lijek Talzenna može izazvati oštećenja fetusa kada se daje trudnici.
Talzenna may only be used in patients with moderate or severe hepatic impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for hepatic function and adverse events. 
Lijek Talzenna smije se primjenjivati u bolesnika s umjerenim ili teškim oštećenjem jetre samo ako korist nadmašuje mogući rizik, dok je potrebno pozorno pratiti funkciju jetre i moguću pojavu štetnih događaja u bolesnika.
Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used. 
Budući da se ne preporučuje upotreba hormonske kontracepcije u bolesnica s rakom dojke, trebale bi se koristiti dvije nehormonalne i komplementarne metode kontracepcije.
You will have regular blood tests during treatment with Talzenna to check your blood cells (white blood cells, red blood cells, and platelets). 
Tijekom terapije lijekom Talzenna podvrgnut ćete se redovitim krvnim pretragama kako bi se provjerile Vaše krvne stanice (leukociti, eritrociti i trombociti).
Agents that may affect talazoparib plasma concentrations 
Lijekovi koji mogu utjecati na koncentracije talazopariba u plazmi
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. 
Srednja vrijednost (± standardna devijacija) terminalnog poluvijeka talazopariba u plazmi iznosila je 90 (± 58) sati, a srednja vrijednost populacijskog (interindividualna varijabilnost) prividnog peroralnog klirensa iznosila je 6,5 (31 %) l/h u bolesnika koji boluju od raka.
Talzenna is not recommended during pregnancy or for women of childbearing potential not using contraception (see section 4.4). 
Ne preporučuje se koristiti lijek Talzenna tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju (vidjeti dio 4.4).
Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats but not mutagenic in Ames assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman. 
Talazoparib je bio klastogen u in vitro testu aberacije kromosoma u humanim limfocitima periferne krvi i u in vivo mikronukleus testu koštane srži u štakora, ali nije bio mutagen u Amesovom testu (vidjeti dio 5.3), te može izazvati oštećenja fetusa kada se daje trudnici.
In vitro, talazoparib was not an inhibitor of cytochrome (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 or inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations. 
In vitro, talazoparib nije bio inhibitor citokroma (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4/5 niti induktor CYP1A2, CYP2B6 ili CYP3A4 pri klinički značajnim koncentracijama.
What Talzenna is and what it is used for 
Što je Talzenna i za što se koristi
Women of childbearing potential must use highly effective forms of contraception (see section 4.4) prior to starting treatment with talazoparib, during treatment, and for 7 months after stopping treatment with talazoparib. 
Žene reproduktivne dobi moraju koristiti visokoučinkovite oblike kontracepcije (vidjeti dio 4.4) prije početka liječenja, tijekom liječenja i tijekom 7 mjeseci nakon završetka liječenja talazoparibom.
It is unknown whether talazoparib is excreted in human breast milk. 
Nije poznato izlučuje li se talazoparib u majčino mlijeko.
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®. 
Za 408 (95 %) od 431 bolesnika randomiziranog u ispitivanje EMBRACA bilo je centralno potvrđeno da imaju štetan ili sumnju na štetan gBRCAm primjenom testa kliničkog ispitivanja, dok je za 354 (82 %) njih isto bilo potvrđeno primjenom testa BRACAnalysis CDx
Randomised Phase 3 study EMBRACA 
Faza 3 randomiziranog ispitivanja EMBRACA
A pregnancy test should be performed on all women of childbearing potential prior to treatment (see section 4.4). 
Sve žene reproduktivne dobi moraju napraviti test na trudnoću prije liječenja (vidjeti dio 4.4).
Talazoparib Chemotherapy 
Talazoparib Kemoterapija
Contraception in women of childbearing potential 
Kontracepcija u žena reproduktivne dobi
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%. 
Događaji stupnja 3 i stupnja 4 povezani s mijelosupresijom zabilježeni su za anemiju (34,8 % i 0,4 %), neutropeniju (15,6 % i 1,8 %) i trombocitopeniju (12,8 % i 4,0 %).
d. Includes preferred terms of leucopenia and white blood cell count decreased. 
Uključuje preporučene pojmove: leukopenija i smanjen broj bijelih krvnih stanica.
Consider resuming Talzenna at next lower dose or discontinue 
Razmotrite nastavak primjene sljedeće niže doze lijeka Talzenna ili prekid primjene lijeka Talzenna
No dose adjustment is required for patients with mild hepatic impairment (total bilirubin ≤ 1 × upper limit of normal [ULN] and aspartate aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST). 
Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem jetre (ukupni bilirubin ≤ 1 × gornja granica normale [GGN] i aspartat aminotransferaza (AST) > GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN i bilo koji AST).
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. 
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih je 41 bolesnik bio azijskog porijekla, a 449 bolesnika nisu bili azijskog porijekla (361 pripadnik bijele rase, 16 pripadnika crne rase, 9 ostalih, dok 63 bolesnika nisu prijavila rasu), prividni peroralni klirens talazopariba bio je veći u bolesnika azijskog porijekla, u usporedbi s bolesnicima koji nisu bili azijskog porijekla, što vodi 19 % nižoj izloženosti (AUC) u bolesnika azijskog porijekla.
Very common (may affect more than 1 in 10 people) Being short of breath, feeling very tired, having pale skin, or fast heartbeat - these may be signs of a low red blood cell count (anaemia). 
Vrlo često (mogu se javiti kod više od 1 na 10 osoba) - Nedostatak zraka, osjećaj velikog umora, blijeda koža ili brzi otkucaji srca - to mogu biti znakovi niskog broja eritrocita (anemija).
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. 
EMBRACA je bilo otvoreno, randomizirano, paralelno, multicentrično ispitivanje na dvije skupine lijeka Talzenna u odnosu na kemoterapiju (kapecitabin, eribulin, gemcitabin, vinorelbin) u bolesnika s lokalno uznapredovalim ili metastatskim HER2-negativnim rakom dojke s mutiranim BRCA genom u zametnim stanicama koji prethodno nisu primili više od 3 režima citotoksične kemoterapije za svoju metastatsku ili lokalno uznapredovalu bolest.
Infection, developing chills or shivering, or fever or feeling hot - these may be signs of a low white blood cell count (neutropenia). 
- Infekcija, pojavljivanje zimica ili drhtanja, ili vrućica ili se osjećate vruće - to mogu biti znakovi niskog broja leukocita (neutropenija).
Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules. 
Talzenna od 1 mg dostupna je u perforiranim blister pakiranjima s jediničnim dozama, koja sadrže 30 tvrdih kapsula, i u plastičnim bočicama s 30 tvrdih kapsula.
Talazoparib anti-tumour activity was also observed in a patient-derived xenograft (PDX) BRCA mutant breast cancer model where the patient was previously treated with a platinum-based regimen. 
Antitumorska aktivnost talazopariba zabilježena je i u modelu ksenografta bolesnika s rakom dojke s mutacijom gena BRCA kod kojeg je bolesnik prethodno bio liječen režimom na bazi platine.
Chemotherapy Median PFS=5.6 months 95% CI (4.2, 6.7) 
Medijan PFS-a=5,6 mjeseci 95% CI (4,2; 6,7)
Platelet count < 50,000/μL 
Broj trombocita < 50 000/μl
Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia). 
- Dobivanje modrica ili krvarenje koje traje duže nego je to uobičajeno kada se ozlijedite - to mogu biti znakovi niskog broja trombocita (trombocitopenija).
Talzenna 0.25 mg hard capsules EU/1/19/1377/001 
Talzenna 0,25 mg tvrde kapsule EU/1/19/1377/001
Do not open, crush or chew the capsules. 
Kapsule nemojte otvarati, lomiti niti žvakati.
Asian 
Azijska
c. Includes preferred terms of neutropenia and neutrophil count decreased. 
Uključuje preporučene pojmove: neutropenija i smanjen broj neutrofila.
The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2). 
Farmakokinetika talazopariba nije ispitivana u bolesnika kojima je potrebna hemodijaliza (vidjeti dio 4.2).
Talzenna is used to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene. 
Talzenna se koristi za liječenje odraslih s tipom raka dojke poznatim kao rak dojke negativan na receptor HER2, koji ima naslijeđeni abnormalni BRCA genom.
EU/1/19/1377/002 (30 hard capsules) EU/1/19/1377/003 (60 hard capsules) EU/1/19/1377/004 (90 hard capsules) 
EU/1/19/1377/002 (30 tvrdih kapsula) EU/1/19/1377/003 (60 tvrdih kapsula) EU/1/19/1377/004 (90 tvrdih kapsula)
If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced to 0.75 mg once daily. 
P-gp-a ne može izbjeći, potrebno je smanjiti dozu lijeka Talzenna na 0,75 mg jednom na dan.
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). 
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih su 132 bolesnika imala blago oštećenje funkcije bubrega (60 ml/min ≤ CrCL < 90 ml/min), 33 bolesnika umjereno oštećenje funkcije bubrega (30 ml/min ≤ CrCL < 60 ml/min), a 1 bolesnik teško oštećenje funkcije bubrega (CrCL < 30 ml/min), prividni peroralni klirens talazopariba smanjio se za 14 %, odnosno 37 % u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega, u usporedbi s bolesnicima s normalnom funkcijom bubrega (CrCL ≥ 90 ml/min).
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. 
Talzenna od 0,25 mg dostupna je u perforiranim blister pakiranjima s jediničnim dozama, koja sadrže 30, 60 ili 90 tvrdih kapsula, i u plastičnim bočicama s 30 tvrdih kapsula.
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. 
CNS=središnji živčani sustav (engl. central nervous system); HR+=s pozitivnim hormonskim receptorima; ITT=populacija predviđena za liječenje; PCT=liječnikov odabir liječenja (kemoterapija); PFS=preživljenje bez progresije bolesti; TNBC=trostruko negativni rak dojke (engl. triple-negative breast cancer).
If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor. 
Ako imate bilo kakvih pitanja u vezi djelovanja lijeka Talzenna ili razloga zašto
The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo. 
Učinak inhibitora BCRP-a na farmakokinetiku talazopariba nije ispitivan in vivo.
Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure. 
Istodobna primjena talazopariba s inhibitorima BCRP-a može povećati izloženost talazoparibu.
Based on a population PK analysis that included 490 patients, where 118 patients had mild hepatic impairment (total bilirubin ≤ 1.0 × ULN and AST > ULN, or total bilirubin > 1.0 to 1.5 × ULN and any AST), mild hepatic impairment had no effect on the PK of talazoparib. 
Na temelju analize populacijske farmakokinetike koja je uključivala 490 bolesnika, od kojih je 118 bolesnika imalo blago oštećenje funkcije jetre (ukupni bilirubin ≤ 1,0 × GGN i AST > GGN ili ukupni bilirubin > 1,0 do 1,5 × GGN i bilo koji AST), blago oštećenje funkcije jetre nije imalo učinka na farmakokinetiku talazopariba.
Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia). 
Talzenna smanjuje broj Vaših krvnih stanica, poput broja eritrocita (anemija), leukocita (neutropenija) ili broja trombocita (trombocitopenija).
Hormone receptor status, n (%) 
Nedostaje Status hormonskih receptora, n (%) HER2-pozitivan