FrancophonIA/ELRC3.0 huggingface dataset:
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment (see section 4.4).
Slovenian: Pri vseh ženskah v rodni dobi je treba pred zdravljenjem opraviti test nosečnosti (glejte poglavje 4.4).
English: You should not use Talzenna if you are pregnant.
Slovenian: - Zdravila Talzenna ne smete jemati, če ste noseči.
English: Talzenna 1 mg hard capsules EU/1/19/1377/005
Slovenian: Talzenna 1 mg trde kapsule EU/1/19/1377/005
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.
Slovenian: Okrajšave: aBC = napredovali rak dojk (advanced breast cancer); IZ = interval zaupanja; OŽ = osrednje živčevje; HR+ = pozitivno na hormonske receptorje; ITT = populacija z namenom zdravljenja (intent-to-treat); PCT = zdravljenje po zdravnikovi izbiri (physician's choice treatment) (kemoterapija); PFS = preživetje brez napredovanja bolezni (progression-free survival); TNBC = trojno negativni rak dojk (triple-negative breast cancer).
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.
Slovenian: V študiji razvoja zarodka/ploda pri podganah je talazoparib povzročil smrt zarodka/ploda, malformacije ploda (zmanjšano izbočenje očesa, majhno oko, nezrasla prsnica, zraščen cervikalni vretenčni lok) in strukturne spremembe kosti pri sistemskih izpostavljenostih AUC24 pri materi, ki so bile približno 0,09-krat večje od ustrezne izpostavljenosti pri ljudeh pri priporočenem odmerku.
English: Agents that may affect talazoparib plasma concentrations
Slovenian: Učinkovine, ki lahko vplivajo na koncentracije talazopariba v plazmi
English: Your doctor may want to test your bone marrow to check for these problems.
Slovenian: Zdravnik bo morda želel preveriti prisotnost teh težav s preiskavo kostnega mozga.
English: 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).
Slovenian: Ker uporaba hormonske kontracepcije pri bolnicah z rakom dojk ni priporočljiva, je treba uporabiti dve nehormonski in komplementarni metodi kontracepcije (glejte poglavje 4.6).
English: Low blood cell counts
Slovenian: Zmanjšanje števila krvnih celic
English: Consider resuming Talzenna at next lower dose or discontinue
Slovenian: Razmislite o nadaljevanju zdravljenja z zdravilom Talzenna z naslednjim manjšim odmerkom ali prekinite zdravljenje.
English: Following a single oral dose of talazoparib with high-fat, high-calorie food (approximately 827 calories, 57% fat), the mean Cmax of talazoparib was decreased by approximately 46%, the median Tmax was delayed from 1 to 4 hours, while the AUCinf was not affected.
Slovenian: Po enkratnem peroralnem odmerku talazopariba, ki so ga dali z visokokalorično hrano z visoko vsebnostjo maščob (približno 827 kalorij, 57 % maščob), se je srednja vrednost Cmax talazopariba znižala za približno 46 %, mediani tmax se je podaljšal z 1 na 4 ure, vpliva na vrednost AUCinf pa ni bilo.
English: d. Includes preferred terms of leucopenia and white blood cell count decreased.
Slovenian: Vključuje priporočena izraza levkopenija in zmanjšanje števila belih krvnih celic.
English: 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.
Slovenian: Populacijska FK analiza kaže, da sočasno dajanje zdravil za zmanjševanje kisline, vključno z zaviralci protonske črpalke in antagonisti histaminskih receptorjev H2 ali drugimi zdravili za zmanjševanje kisline, ne vpliva pomembno na absorpcijo talazopariba.
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.
Slovenian: Srednji navidezni volumen porazdelitve talazopariba v populaciji (Vss/F)je bil 420 l. In vitro se na beljakovine v plazmi veže približno 74 % talazopariba, pri čemer vezava v razponu koncentracij od 0,01 µM do 1 µM ni odvisna od koncentracije.
English: Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, and verapamil) should be avoided.
Slovenian: Sočasni uporabi močnih zaviralcev P-gp (med drugim amjodarona, karvedilola, klaritromicina, kobicistata, darunavirja, dronedarona, eritromicina, indinavirja, itrakonazola, ketokonazola, lapatiniba, lopinavirja, propafenona, kinidina, ranolazina, ritonavirja, sakvinavirja, telaprevirja, tipranavirja in verapamila) se je treba izogibati.
English: 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.
Slovenian: Zdravljenje rakavih celičnih linij, ki imajo poškodovane gene za popravljanje DNK, s talazoparibom kot samostojno učinkovino privede do povečanih ravni γH2AX, označevalca prelomov dvojnovijačne DNK, ter do zmanjšane celične proliferacije in povečane apoptoze.
English: However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Slovenian: Učinka drugih induktorjev P-gp na izpostavljenost talazoparibu niso preučevali.
English: Talzenna may only be used in patients with severe renal impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for renal function and adverse events (see section 5.2).
Slovenian: Zdravilo Talzenna lahko uporabljamo pri bolnikih s hudo okvaro ledvic samo, če korist odtehta morebitno tveganje, bolnika pa je treba skrbno spremljati glede delovanja ledvic in neželenih učinkov (glejte poglavje 5.2).
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Slovenian: Pri vseh ženskah v rodni dobi je treba pred zdravljenjem opraviti test nosečnosti.
English: Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters.
Slovenian: Velikosti pakiranj: škatle s 30 × 1 kapsulo, 60 × 1 kapsulo ali 90 × 1 kapsulo v pretisnih omotih za enkratni odmerek.
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).
Slovenian: Podatkov o plodnosti pri bolnikih ni. Glede na predklinične ugotovitve na modih (delno reverzibilne spremembe) in jajčnikih (reverzibilne spremembe), lahko zdravilo Talzenna oslabi plodnost pri moških s sposobnostjo razmnoževanja (glejte poglavje 5.3).
English: Effect of acid-reducing agents
Slovenian: Učinek zdravil za zmanjševanje kisline
English: To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and clinical presentation should be considered (Table 2).
Slovenian: Za obvladovanje neželenih učinkov zdravila je treba glede na resnost in klinično sliko razmisliti o prekinitvi zdravljenja ali zmanjšanju odmerka (preglednica 2).
English: If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see section 4.2).
Slovenian: Če se sočasnemu dajanju z močnim zaviralcem P-gp ni mogoče izogniti, je treba zmanjšati odmerek zdravila Talzenna (glejte poglavje 4.2).
English: EU/1/19/1377/002 (30 hard capsules) EU/1/19/1377/003 (60 hard capsules) EU/1/19/1377/004 (90 hard capsules)
Slovenian: EU/1/19/1377/002 (30 trdih kapsul) EU/1/19/1377/003 (60 trdih kapsul) EU/1/19/1377/004 (90 trdih kapsul)
English: Myelosuppression-related adverse events associated with dose modifications were reported for up to approximately 30% of patients in the talazoparib 1 mg/day population and those associated with permanent study drug discontinuation were reported for less than 1% of patients.
Slovenian: O neželenih učinkih, povezanih z mielosupresijo, ki so se pojavili v povezavi s prilagajanjem odmerka, so poročali pri do približno 30 % bolnikov iz populacije, ki je prejemala talazoparib 1 mg/dan, o neželenih učinkih, povezanih z mielosupresijo, ki so se pojavili v povezavi s trajno prekinitvijo jemanja preiskovanega zdravila, pa pri manj kot 1 % bolnikov.
English: Additional findings at higher exposures included dose-dependent increase in apoptosis/necrosis in the gastrointestinal (GI) tract, liver and ovary.
Slovenian: Dodatne ugotovitve pri večjih izpostavljenostih so vključevale od odmerka odvisno povečanje apoptoze/nekroze v prebavilih, jetrih in jajčnikih.
English: 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.
Slovenian: Protitumorsko aktivnost talazopariba so opazili tudi pri modelu heterolognega presadka raka dojk z mutacijami gena BRCA, ki so ga pridobili od bolnika (PDX - patient-derived xenograft), pri katerem so bolnika predhodno zdravili s shemo na osnovi platine.
English: Neutrophil count < 1,000/μL ≥ 1,500/µL Non-haematologic adverse reaction Grade 3 or Grade 4
Slovenian: ≥ 1.500/µl nehematološki neželeni učinek stopnje 3 ali stopnje 4
English: h. Includes preferred terms of fatigue and asthenia.
Slovenian: Vključuje priporočena izraza utrujenost in astenija.
English: f. Includes preferred terms of abdominal pain, abdominal pain upper, abdominal discomfort and abdominal pain lower.
Slovenian: Vključuje priporočene izraze bolečina v trebuhu, bolečina v zgornjem delu trebuha, nelagodje v trebuhu in bolečina v spodnjem delu trebuha.
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%.
Slovenian: Poročali so o z mielosupresijo povezanih učinkih stopnje 3 in stopnje 4, in sicer o anemiji s pogostnostjo 34,8 % oziroma 0,4 %, o nevtropeniji s pogostnostjo 15,6 % oziroma 1,8 % in o trombocitopeniji s pogostnostjo 12,8 % oziroma 4,0 %.
English: Developmental toxicology
Slovenian: Razvojna toksičnost
English: Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted.
Slovenian: Sistemska hormonska kontracepcija Študij medsebojnega delovanja zdravil med talazoparibom in peroralno kontracepcijo niso opravili.
English: 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.
Slovenian: In vitro talazoparib v klinično pomembnih koncentracijah ni zaviral nobene pomembnejše izooblike uridin-difosfat-glukuronoziltransferaze (UGT - uridine-diphosphate glucuronosyltransferase) (1A1, 1A4, 1A6, 1A9, 2B7 in 2B15).
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®.
Slovenian: Od 431 randomiziranih bolnikov v študiji EMBRACA, so pri 408 (95 %) z uporabo preskusa za klinično preskušanje centralno potrdili škodljive ali domnevno škodljive mutacije gena BRCA, med katerimi so pri 354 (82 %) mutacije potrdili s preskusom BRACAnalysis CDx
English: Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.
Slovenian: Zdravilo Talzenna je indicirano kot monoterapija za zdravljenje odraslih bolnikov z germinalnimi mutacijami genov BRCA1 ali BRCA2, ki imajo lokalno napredovalega ali metastatskega HER2 negativnega raka dojk.
English: Talk to your healthcare provider about birth control methods that may be right for you.
Slovenian: Z zdravnikom se posvetujte o metodah kontracepcije, ki so primerne za vas.
English: Talazoparib did not have a clinically relevant effect on QTc prolongation at the maximum clinically recommended dose of 1 mg once daily.
Slovenian: Talazoparib pri največjem klinično priporočenem odmerku 1 mg enkrat na dan ni imel klinično pomembnega učinka na podaljšanje intervala QTc.
English: Common (may affect up to 1 in 10 people) Alteration in taste (dysgeusia) Indigestion
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - sprememba okušanja (disgevzija) - prebavne motnje - vnetje ust
English: Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John's wort) may decrease talazoparib exposure.
Slovenian: Drugi induktorji P-gp (med drugim karbamazepin, fenitoin in šentjanževka) lahko zmanjšajo izpostavljenost talazoparibu.
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).
Slovenian: Na podlagi populacijske FK analize, ki je vključevala 490 bolnikov, pri čemer je imelo 132 bolnikov blago okvaro ledvic (60 ml/min ≤ CrCL < 90 ml/min), 33 bolnikov zmerno okvaro ledvic (30 ml/min ≤ CrCL < 60 ml/min) in 1 bolnik hudo okvaro ledvic (CrCL < 30 ml/min), je bila vrednost CL/F talazopariba pri bolnikih z blago in zmerno okvaro ledvic manjša za 14 % oziroma 37 % v primerjavi z bolniki z normalnim delovanjem ledvic (CrCL ≥ 90 ml/min).
English: 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.
Slovenian: Po ponavljajočem se vsakodnevnem dajanju 1 mg talazopariba je bila pri bolnikih geometrična sredina (% koeficienta variance [KV%]) površine pod krivuljo koncentracije talazopariba v plazmi v odvisnosti od časa (AUC) v stanju dinamičnega ravnovesja v razponu od 126 (107) ng•hr/ml do 208 (37) ng•hr/ml, največja plazemska koncentracija (Cmax) talazopariba v stanju dinamičnega ravnovesja pa v razponu od 11 (90) ng/ml do 19 (27) ng/ml.
English: Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used.
Slovenian: Ker uporaba hormonske kontracepcije pri bolnicah z rakom dojk ni priporočljiva, je treba uporabiti dve nehormonski in komplementarni metodi kontracepcije.
English: How to store Talzenna 6.
Slovenian: Kako jemati zdravilo Talzenna 4.
English: 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.
Slovenian: In vitro talazoparib v klinično pomembnih koncentracijah ni bil niti zaviralec citokromov (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4/5 niti induktor CYP1A2, CYP2B6 ali CYP3A4.
English: 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.
Slovenian: Zdravilo Talzenna uporabljamo za zdravljenje odraslih z vrsto raka dojk, poznano kot HER-2 negativno, ki imajo nenormalen podedovan gen BRCA.
English: Thrombocytopenia: Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count
Slovenian: - trombocitopenija: podplutbe ali krvavitve, ki trajajo dlje kot običajno, kadar se poškodujete to so lahko znaki zmanjšanja števila krvnih ploščic.
English: ECOG performance status, n (%)
Slovenian: Stanje zmogljivosti po ECOG, n (%)
English: Forest plot of PFS analyses for key subgroups - EMBRACA study
Slovenian: Slika 2.Drevesni diagram analiz PFS pri ključnih podskupinah - študija EMBRACA
English: Talzenna 0.25 mg hard capsules EU/1/19/1377/001
Slovenian: Talzenna 0,25 mg trde kapsule EU/1/19/1377/001
English: Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant and/or metastatic setting.
Slovenian: Bolniki so se morali predhodno že zdraviti z antraciklinom in/ali taksanom (razen če je bilo to kontraindicirano) v okviru neoadjuvantnega ali adjuvantnega zdravljenja in/ali v okviru zdravljenja metastatske bolezni.
English: Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods.
Slovenian: Ker uporaba hormonske kontracepcije pri bolnicah z rakom dojk ni priporočljiva, morate uporabiti dve nehormonski metodi kontracepcije.
English: Talzenna is not recommended for use in patients with severe renal impairment or requiring haemodialysis (see section 5.2).
Slovenian: Zdravila Talzenna ni priporočljivo uporabljati pri bolnikih s hudo okvaro ledvic ali bolnikih, ki potrebujejo hemodializo (glejte poglavje 5.2).
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.
Slovenian: Celokupen varnostni profil zdravila Talzenna temelji na združenih podatkih 494 bolnikov, ki so v kliničnih študijah pri bolnikih s čvrstimi tumorji prejemali 1 mg talazopariba na dan, vključno z 286 bolniki iz randomizirane študije 3. faze pri bolnikih s HER2-negativnim, lokalno napredovalim ali metastatskim rakom dojk z germinalnimi mutacijami gena BRCA (gBRCAm) in 83 bolniki iz nerandomizirane študije 2. faze pri bolnikih z lokalno napredovalim ali metastatskim rakom dojk z germinalnimi mutacijami gena BRCA.
English: Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Slovenian: Tiskarsko črnilo: šelak (E904), propilenglikol (E1520), amonijev hidroksid (E527), črni železov oksid (E172) in kalijev hidroksid (E525).
English: Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.
Slovenian: Zdravilo Talzenna 1 mg je na voljo v perforiranih pretisnih omotih za enkratni odmerek s 30 trdimi kapsulami ter v plastenkah s 30 trdimi kapsulami.
English: Talzenna lowers your blood cell counts, such as your red blood cell count (anaemia), white blood cell count (neutropenia), or blood platelet count (thrombocytopenia).
Slovenian: Zdravilo Talzenna povzroči zmanjšanje števila krvnih celic, na primer števila rdečih krvnih celic (anemijo), števila belih krvnih celic (nevtropenijo) ali števila krvnih ploščic (trombocitopenijo).
English: In vitro, talazoparib did not inhibit any of the major intestinal, hepatic or renal membrane transporters (P-gp, BCRP, organic anion transporting polypeptide [OATP]1B1, OATP1B3, organic cationic transporter [OCT]1, OCT2, organic anion transporter [OAT]1, OAT3, bile salt export pump [BSEP], multidrug and toxin extrusion [MATE]1 and MATE2-K) at clinically relevant concentrations.
Slovenian: In vitro talazoparib v klinično pomembnih koncentracijah ni zaviral pomembnejših membranskih prenašalcev v črevesju, jetrih ali ledvicah (P-gp, BCRP, polipeptidnega prenašalca organskih anionov [OATP - organic anion transporting polypeptide]1B1, OATP1B3, prenašalca organskih kationov [OCT - organic cationic transporter]1, OCT2, prenašalca organskih anionov [OAT - organic anion transporter]1, OAT3, črpalke žolčnih soli [BSEP - bile salt export pump] ter beljakovin za ekstruzijo več zdravil in toksinov [MATE - multidrug and toxin extrusion]1 in MATE2-K).
English: c. Includes preferred terms of neutropenia and neutrophil count decreased.
Slovenian: Vključuje priporočena izraza nevtropenija in zmanjšanje števila nevtrofilcev.
English: Talazoparib undergoes minimal hepatic metabolism in humans.
Slovenian: Talazoparib se pri ljudeh minimalno presnavlja v jetrih.
English: Talzenna is for oral use.
Slovenian: Zdravilo Talzenna je za peroralno uporabo.
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.
Slovenian: Pri bolnikih z rakom je bil srednji (± standardni odklon) končni razpolovni čas talazopariba v plazmi 90 (± 58) ur, srednji navidezni peroralni očistek (CL/F) v populaciji (variabilnost med preskušanci) pa 6,5 (31 %) l/h.
English: 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.
Slovenian: Na podlagi populacijske FK analize, ki je vključevala 490 bolnikov, pri čemer je imelo 118 bolnikov blago okvaro jeter (celokupni bilirubin ≤ 1,0 × ZMN in AST > ZMN ali celokupni bilirubin > 1,0 do 1,5 × ZMN in katerakoli vrednost AST), blaga okvara jeter ni imela nobenega učinka na FK talazopariba.
English: 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.
Slovenian: Ženske v rodni dobi morajo pred začetkom zdravljenja s talazoparibom, med zdravljenjem in še 7 mesecev po prekinitvi zdravljenja s talazoparibom uporabljati visoko učinkovite oblike kontracepcije (glejte poglavje 4.4).
English: Neutropenia: Infection, developing chills or shivering, or fever - these may be signs of a low white blood cell count
Slovenian: - nevtropenija: okužba, pojav mrzlice ali drgetanja ali vročine - to so lahko znaki zmanjšanja števila belih krvnih celic.
English: What Talzenna is and what it is used for
Slovenian: Kaj je zdravilo Talzenna in za kaj ga uporabljamo
English: The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo.
Slovenian: Učinka zaviralcev BCRP na FK talazopariba in vivo niso preučevali.
English: Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).
Slovenian: 6.1 Seznam pomožnih snovi vsebina kapsule silificirana mikrokristalna celuloza (sMCC) (mikrokristalna celuloza in silicijev dioksid)
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.
Slovenian: Študija EMBRACA je bila odprta, randomizirana, multicentrična študija z 2 vzporednima skupinama, v kateri so zdravilo Talzenna primerjali s kemoterapijo (kapecitabin, eribulin, gemcitabin, vinorelbin) pri bolnikih s HER2-negativnim lokalno napredovalim ali metastatskim rakom dojk z germinalnimi mutacijami gena BRCA, ki za zdravljenje metastatske ali lokalno napredovale bolezni predhodno niso prejeli več kot 3 sheme citotoksične kemoterapije.