FrancophonIA/ELRC3.0 huggingface dataset:
English: ORR (%, 95% CI) Odds ratio (95% CI) 2-sided p-valuef p<0.0001
Slovenian: ORR (%; 95 % IZ) razmerje obetov (95 % IZ) 2-stranska vrednost p p < 0,0001
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.
Slovenian: Zdravilo Talzenna 0,25 mg je na voljo v perforiranih pretisnih omotih za enkratni odmerek s 30, 60 ali 90 trdimi kapsulami ter v plastenkah s 30 trdimi kapsulami.
English: Pack size: cartons of 30 capsules in a HDPE bottle.
Slovenian: Velikost pakiranja: škatle s 30 kapsulami v plastenki iz HDPE.
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.
Slovenian: Skupno so na prejemanje zdravila Talzenna 1 mg kapsule enkrat na dan ali kemoterapije v standardnih odmerkih do napredovanja bolezni ali pojava nesprejemljive toksičnosti v razmerju 2 : 1 randomizirali 431 bolnikov.
English: The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2).
Slovenian: FK talazopariba pri bolnikih, ki potrebujejo hemodializo, niso preučevali (glejte poglavje 4.2).
English: Dose adjustments for toxicities Dose level
Slovenian: Prilagajanje odmerkov pri toksičnostih Odmerna raven priporočeni začetni odmerek
English: Excella GmbH & Co. KG Nürnberger Str. 12
Slovenian: KG Nürnberger Str. 12
English: The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Slovenian: Najpogostejši (≥ 10 %) neželeni učinki talazopariba stopnje ≥ 3 so bili anemija (35,2 %), nevtropenija (17,4 %) in trombocitopenija (16,8 %).
English: Progression-free survival by BICR
Slovenian: Preživetje brez napredovanja bolezni glede na BICR
English: High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z zaporko iz polipropilena (PP) s toplotno zavarjeno tesnilno oblogo.
English: Demographic, baseline, and disease characteristics - EMBRACA study Talazoparib
Slovenian: Demografske značilnosti, izhodiščne značilnosti in značilnosti bolezni - študija EMBRACA
English: 30 capsules
Slovenian: trda kapsula 30 kapsul
English: Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding.
Slovenian: Perforirani pretisni omot za enkratni odmerek iz polivinilklorida/poliviniliden klorida (PVC/PVdC) z odlepno prekrivno aluminijasto folijo.
English: * There were no Grade 5 adverse drug reactions.
Slovenian: Neželenih učinkov stopnje 5 ni bilo.
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.
Slovenian: Podatki iz študije medsebojnega delovanja pri bolnikih z napredovalimi čvrstimi tumorji so pokazali, da je sočasno dajanje enkratnega odmerka 1 mg talazopariba z večkratnimi dnevnimi odmerki induktorja P-gp, rifampicina 600 mg, pri čemer so rifampicin dajali 30 minut pred talazoparibom na dan odmerjanja talazopariba, povečalo vrednost Cmax talazopariba za približno 37 %, na vrednost AUCinf pa ni vplivalo glede na enkratni odmerek 1 mg talazopariba, ki so ga dali samostojno.
English: Objective response by investigatord,e
Slovenian: Objektivni odziv po oceni raziskovalca d,e n = 219
English: Renal elimination of unchanged drug (passive filtration and active secretion) is the major route of talazoparib elimination.
Slovenian: Glavna pot izločanja talazopariba je izločanje nespremenjenega zdravila skozi ledvice (pasivna filtracija in aktivna sekrecija).
English: Hormone receptor-positive (ER positive or
Slovenian: Status hormonskih receptorjev, n (%) HER2-pozitiven trojno negativen pozitiven na hormonske receptorje (ER-pozitiven ali PgR-pozitiven)
English: 1 mg (one 1 mg capsule) once daily
Slovenian: 1 mg (ena 1 mg kapsula) enkrat na dan prvo zmanjšanje odmerka
English: You should not breast-feed while taking Talzenna and for at least 1 month after the last dose.
Slovenian: Med jemanjem zdravila Talzenna in še najmanj 1 mesec po zadnjemu odmerku zdravila ne smete dojiti.
English: Permanent discontinuation due to an adverse reaction occurred in 3.6% of patients receiving Talzenna.
Slovenian: Pri 3,6 % bolnikov, ki so prejemali zdravilo Talzenna, so zaradi neželenega učinka trajno prekinili zdravljenje.
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.
Slovenian: Podatki iz študije medsebojnega delovanja zdravil pri bolnikih z napredovalimi čvrstimi tumorji so pokazali, da je sočasno dajanje večkratnih dnevnih odmerkov zaviralca P-gp, itrakonazola 100 mg dvakrat na dan, z enkratnim odmerkom 0,5 mg talazopariba, povečalo skupno izpostavljenost talazoparibu (AUCinf) za približno 56 %, največjo koncentracijo (Cmax) pa za približno 40 % v primerjavi z enkratnim odmerkom 0,5 mg talazopariba, ki so ga dali samostojno.
English: There is limited experience of overdose with talazoparib.
Slovenian: Izkušnje s prevelikim odmerjanjem talazopariba so omejene.
English: Talzenna is not recommended during pregnancy or for women of childbearing potential not using contraception (see section 4.4).
Slovenian: Zdravila Talzenna ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (poglavje 4.4).
English: 0.25 mg (one 0.25 mg capsule) once daily Complete blood count should be obtained prior to starting Talzenna therapy and monitored monthly and as clinically indicated (see Table 2 and section 4.4).
Slovenian: Pred začetkom zdravljenja z zdravilom Talzenna je treba pregledati celotno krvno sliko ter jo nato spremljati mesečno in kot je klinično indicirano (glejte preglednico 2 in poglavje 4.4).
English: Events, number (%) Median (95% CI), months Hazard ratio (95% CI) 2-sided p-valueb p=0.1053
Slovenian: dogodki, število (%) mediana (95 % IZ), meseci razmerje ogroženosti (95 % IZ) 2-stranska vrednost p p = 0,1053
English: No metabolites that individually represented more than 10% of the administered dose were recovered in the urine or faeces.
Slovenian: V urinu ali blatu niso našli presnovkov, ki bi posamično predstavljali več kot 10 % danega odmerka.
English: The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Slovenian: Najpogostejši neželeni učinki, ki so privedli do prilagajanja odmerka, so bili anemija (33,0 %), nevtropenija (15,8 %) in trombocitopenija (13,4 %).
English: Resume Talzenna at next lower dose
Slovenian: Nadaljujte zdravljenje z zdravilom Talzenna z naslednjim manjšim odmerkom.
English: How to take Talzenna
Slovenian: Kako jemati zdravilo Talzenna
English: Stomatitis Dyspepsia
Slovenian: Okvara ledvic
English: What Talzenna is used for
Slovenian: Za kaj uporabljamo zdravilo Talzenna
English: A highly effective method of contraception is required for female patients during treatment with Talzenna, and for at least 7 months after completing therapy.
Slovenian: Bolnice morajo med zdravljenjem z zdravilom Talzenna in še vsaj 7 mesecev po koncu zdravljenja uporabljati visokoučinkovito metodo kontracepcije.
English: No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine clearance [CrCl] < 90 mL/min).
Slovenian: Pri bolnikih z blago okvaro ledvic (60 ml/min ≤ očistek kreatinina [CrCl - creatinine clearance] < 90 ml/min) prilagajanje odmerka ni potrebno.
English: 30 × 1 capsules
Slovenian: trda kapsula 30 × 1 kapsula
English: Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure.
Slovenian: Sočasno dajanje talazopariba z zaviralci BCRP lahko poveča izpostavljenost talazoparibu.
English: 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).
Slovenian: Pri bolnikih z blago okvaro jeter (celokupni bilirubin ≤ 1 × zgornja meja normale [ZMN] in vrednost aspartat-aminotransferaze (AST) > ZMN ali celokupni bilirubin > 1,0 do 1,5 × ZMN in katerakoli vrednost AST) prilagajanje odmerka ni potrebno.
English: Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib.
Slovenian: Pri bolnikih, ki so prejemali zaviralce poli-(adenozin-difosfat-riboza) polimeraze (PARP), vključno s talazoparibom, so poročali o mielodisplastičnem sindromu/akutni mieloični levkemiji (MDS/AML).
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.
Slovenian: Talazoparib je bil klastogen in vitro v preskusu kromosomskih aberacij na limfocitih iz humane periferne krvi in in vivo v mikronukleusnem testu pri podganah pri izpostavljenostih, podobnih tistim pri klinično pomembnih odmerkih.
English: Chemotherapy
Slovenian: kemoterapija
English: Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leucopenia/neutropenia, and/or thrombocytopenia in patients receiving talazoparib.
Slovenian: Pri bolnikih, ki prejemajo talazoparib, je treba sprejeti previdnostne ukrepe za rutinsko spremljanje hematoloških parametrov ter znakov in simptomov, povezanih z anemijo, levkopenijo/nevtropenijo in/ali trombocitopenijo.
English: b. Includes preferred terms of anaemia, haematocrit decreased and haemoglobin decreased.
Slovenian: Vključuje priporočene izraze anemija, zmanjšanje vrednosti hematokrita in zmanjšanje vrednosti hemoglobina.
English: 0.5 mg (two 0.25 mg capsules) once daily
Slovenian: 0,25 mg (ena 0,25 mg kapsula) enkrat na dan
English: Concomitant use of strong P-gp inhibitors during treatment with talazoparib should be avoided.
Slovenian: Med zdravljenjem s talazoparibom se je treba izogibati sočasni uporabi močnih zaviralcev P-gp.
English: BCRP inhibitors
Slovenian: Zaviralci BCRP
English: Talzenna 1 mg hard capsules
Slovenian: Talzenna 1 mg trde kapsule
English: All grades* n (%)
Slovenian: Vse stopnje n (%)
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).
Slovenian: Zdravila Talzenna niso preučevali pri bolnikih z zmerno (celokupni bilirubin > 1,5 do 3,0 × ZMN in katerakoli vrednost AST) ali hudo okvaro jeter (celokupni bilirubin > 3,0 × ZMN in katerakoli vrednost AST) (glejte poglavje 5.2).
English: Haemoglobin < 8 g/dL
Slovenian: Nadaljujte zdravljenje z zdravilom Talzenna hemoglobin < 8 g/dl
English: 4.7 Effects on ability to drive and use machines Talzenna may have a minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev
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.
Slovenian: Na podlagi populacijske FK analize, ki je vključevala 490 bolnikov, med katerimi je bilo 41 Azijcev in 449 neazijcev (361 belopoltih, 16 temnopoltih, 9 druge rase in 63 brez navedbe), je bila vrednost CL/F
English: Twenty-eight percent (28%) of the patients in the pivotal study were taking acid-reducing agents, mainly proton pump inhibitors.
Slovenian: V ključni študiji je zdravila za zmanjševanje kisline, večinoma zaviralce protonske črpalke, jemalo osemindvajset odstotkov (28 %) bolnikov.
English: P-gp is likely involved in talazoparib active renal secretion.
Slovenian: Pri aktivni ledvični sekreciji talazopariba verjetno sodeluje P-gp.
English: Events, number (%) Median (95% CI), months Hazard ratioa (95% CI) 2-sided p-valueb p<0.0001
Slovenian: dogodki, število (%) mediana (95 % IZ), meseci razmerje ogroženosti a (95 % IZ) 2-stranska vrednost p p < 0,0001
English: 1 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), titanium dioxide (E171), and red iron oxide (E172)
Slovenian: ovojnica 1 mg kapsule hipromeloza (HPMC) rdeči železov oksid (E172) rumeni železov oksid (E172) titanov dioksid (E171)
English: 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).
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - zasoplost, občutek izjemne utrujenosti, bleda koža ali hiter srčni utrip - to so lahko znaki zmanjšanja števila rdečih krvnih celic (anemije) - okužba, pojav mrzlice ali drgetanja ali vročine ali če vam je vroče - to so lahko znaki zmanjšanja števila belih krvnih celic (nevtropenije) - podplutbe ali krvavitve, ki trajajo dlje kot običajno, kadar se poškodujete - to so lahko znaki zmanjšanja števila krvnih ploščic (trombocitopenije)
English: No adverse reactions were reported in one patient who accidentally self-administered thirty 1-mg capsules of talazoparib on Day 1 and was immediately treated with gastric decontamination.
Slovenian: Pri 1 bolniku, ki je 1. dan pomotoma vzel 30 kapsul talazopariba 1 mg in so ga nemudoma zdravili z izpiranjem želodca, niso poročali o neželenih učinkih.
English: Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy) during treatment with Talzenna, and for at least 4 months after the final dose (see section 4.4).
Slovenian: Bolnikom s partnerkami v rodni dobi ali nosečimi partnerkami je treba svetovati, naj med zdravljenjem z zdravilom Talzenna in še vsaj 4 mesece po zadnjem odmerku uporabljajo učinkovito kontracepcijo (tudi če so imeli vazektomijo) (glejte poglavje 4.4).
English: Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s talazoparibom, so poročali o mielosupresiji, ki je zajemala anemijo, levkopenijo/nevtropenijo in/ali trombocitopenijo (glejte poglavje 4.8).
English: e. Includes preferred terms of lymphocyte count decreased and lymphopenia.
Slovenian: Vključuje priporočena izraza zmanjšanje števila limfocitov in limfopenija.
English: (stratification factors: number of prior cytotoxic chemotherapy regimens, triple-negative status, history of central nervous system metastasis) and was relative to overall chemotherapy with < 1 favouring talazoparib.
Slovenian: Razmerje ogroženosti je temeljilo na stratificiranem Coxovem regresijskem modelu z zdravljenjem kot edino sočasno spremenljivko (stratifikacijski dejavniki: število predhodnih shem citotoksične kemoterapije, trojno negativni status, anamneza metastaz v osrednjem živčevju) in so ga primerjali s celotno kemoterapijo, z vrednostjo < 1 v korist talazopariba.
English: Following oral administration of a single 1 mg dose of [14C]talazoparib to humans, no major circulating metabolites were identified in plasma, and talazoparib was the only circulating drug-derived entity identified.
Slovenian: C] talazopariba ljudem niso ugotovili pomembnejših presnovkov v obtoku v plazmi; edina ugotovljena spojina v plazmi, ki izhaja iz zdravila, je bil talazoparib.
English: 0.75 mg (three 0.25 mg capsules) once daily
Slovenian: 0,75 mg (tri 0,25 mg kapsule) enkrat na dan drugo zmanjšanje odmerka
English: No talazoparib dose adjustments are required when co-administered with rifampin.
Slovenian: Pri sočasnem dajanju z rifampicinom prilagajanje odmerka talazopariba ni potrebno.
English: Missing dose
Slovenian: Izpuščeni odmerek
English: Women who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after the last dose of Talzenna.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Talzenna in še vsaj 7 mesecev po zadnjem odmerku zdravila Talzenna uporabljati učinkovito metodo kontracepcije.
English: 0.25 mg capsule shell: hypromellose (HPMC), yellow iron oxide (E172), and titanium dioxide (E171)
Slovenian: ovojnica 0,25 mg kapsule hipromeloza (HPMC) rumeni železov oksid (E172) titanov dioksid (E171)
English: 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.
Slovenian: V preskusu kromosomskih aberacij in vitro na limfocitih iz humane periferne krvi in mikronukleusnem preskusu in vivo na kostnem mozgu pri podganah je bil talazoparib klastogen, v Amesovem testu pa ni bil mutagen (glejte poglavje 5.3).
English: Talzenna contains the active substance talazoparib.
Slovenian: Zdravilo Talzenna vsebuje zdravilno učinkovino talazoparib.
English: BRCA2-mutation positive
Slovenian: Status mutacij gena
English: Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy), during treatment with Talzenna and for at least 4 months after the final dose.
Slovenian: Bolnikom s partnerkami v rodni dobi ali nosečimi partnerkami je treba svetovati, naj med zdravljenjem z zdravilom Talzenna in še vsaj 4 mesece po zadnjem odmerku uporabljajo učinkovito kontracepcijo (tudi če so imeli vazektomijo).
English: Talzenna 0.25 mg hard capsules
Slovenian: Talzenna 0,25 mg trde kapsule
English: Red iron oxide (E172)
Slovenian: (E171) in rdeči železov oksid (E172)
English: Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules talazoparib
Slovenian: Talzenna 0,25 mg trde kapsule Talzenna 1 mg trde kapsule talazoparib
English: Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Slovenian: Velikost pakiranja: škatle s 30 × 1 kapsulo v pretisnih omotih za enkratni odmerek.
English: You should not become pregnant while taking Talzenna.
Slovenian: - Med jemanjem zdravila Talzenna ne smete zanositi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON
Slovenian: ZUNANJA ŠKATLA ZA PRETISNE OMOTE
English: Very common (may affect more than 1 in 10 people) Low counts of white blood cells, red blood cells, and blood platelets Decreased appetite
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - majhno število belih krvnih celic, rdečih krvnih celic in krvnih ploščic - pomanjkanje apetita - občutek omotice - glavobol - občutek siljenja na bruhanje (navzea) - bruhanje - driska - bolečina v trebuhu - izguba las in dlak
English: Of the 431 patients randomised onto EMBRACA, 287 were randomised to the Talzenna arm and 144 to the chemotherapy arm. Randomisation was stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non-TNBC), and history of central nervous system metastasis (yes versus no).
Slovenian: Stratifikacijo ob randomizaciji so opravili glede na predhodno uporabo kemoterapije zaradi metastatske bolezni (0 v primerjavi z 1, 2 ali 3), glede na trojno negativni status bolezni (trojno negativni rak dojk [TNBC - triple-negative breast cancer] v primerjavi z ne-TNBC) in glede na metastaze v osrednjem živčevju v anamnezi (da v primerjavi z ne).
English: The complete response rate was 5.5% for talazoparib compared to 0% for the chemotherapy arm. e. Per RECIST 1.1, confirmation of CR/PR was not required.
Slovenian: Stopnja popolnega odziva je bila 5,5 % v skupini, ki je prejemala talazoparib, in 0 % v skupini, ki je prejemala kemoterapijo.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules
Slovenian: Talzenna 0,25 mg trde kapsule Talzenna 1 mg trde kapsule
English: Anaemia: Being short of breath, feeling very tired, pale skin, or fast heartbeat - these may be signs of a low red blood cell count
Slovenian: Znaki in simptomi, na katere morate biti pozorni, vključujejo: - anemija: zasoplost, občutek izjemne utrujenosti, bleda koža ali hiter srčni utrip - to so lahko znaki zmanjšanja števila rdečih krvnih celic.
English: Strong inhibitors of P-gp may lead to increased talazoparib exposure.
Slovenian: Sočasno zdravljenje z zaviralci P-glikoproteina (P-gp) Močni zaviralci P-gp lahko privedejo do povečane izpostavljenosti talazoparibu.
English: Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Slovenian: Ena trda kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza 0,25 mg talazopariba.
English: How to store Talzenna
Slovenian: Shranjevanje zdravila Talzenna
English: (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 5.2).
Slovenian: FK talazopariba pri bolnikih z zmerno (celokupni bilirubin > 1,5 do 3,0 × ZMN in katerakoli vrednost AST) ali hudo okvaro jeter (celokupni bilirubin > 3,0 × ZMN in katerakoli vrednost AST) niso preučevali (glejte poglavje 4.2).
English: Men with female partners who are pregnant or able to become pregnant should use effective birth control (contraception), even after a vasectomy, during treatment with Talzenna and for at least 4 months after the last dose.
Slovenian: Moški z nosečimi partnerkami ali partnerkami v rodni dobi morajo med zdravljenjem z zdravilom Talzenna in še vsaj 4 mesece po zadnjem odmerku uporabljati učinkovito metodo kontracepcije, tudi če so imeli vazektomijo.
English: Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Slovenian: Ena trda kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza 1 mg talazopariba.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg capsules talazoparib
Slovenian: Talzenna 0,25 mg kapsule talazoparib
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: Curcumin (e.g. found in turmeric root) in some medicines (see also section Talzenna with food and drink below).
Slovenian: Zdravilo Talzenna skupaj s hrano in pijačo spodaj).
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Slovenian: Neprozorna trda kapsula, velika približno 14,30 mm × 5,32 mm, s svetlo rdečim pokrovčkom (s črno natisnjeno oznako ''Pfizer'') in belim telesom (s črno natisnjeno oznako ''TLZ 1'').
English: What Talzenna looks like and contents of the pack Talzenna 0.25 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules, with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Slovenian: Zdravilo Talzenna 0,25 mg je na voljo v obliki neprozornih trdih kapsul, velikih približno 14,30 mm × 5,32 mm, s pokrovčkom slonokoščene barve (s črno natisnjeno oznako ''Pfizer'') in belim telesom (s črno natisnjeno oznako ''TLZ 0.25'').