FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: EMBRACA var et open-label, randomiseret, parallelt, 2-armet multicenterstudie af Talzenna sammenlignet med kemoterapi (capecitabin, eribulin, gemcitabin, vinorelbin) hos patienter med germline BRCA-muteret, lokalt fremskreden eller metastatisk HER2-negativ brystkræft, som ikke havde fået mere end 3 forudgående cytotoksiske behandlinger med kemoterapi mod deres metastatiske eller lokalt fremskredne sygdom.
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.
Danish: Der skal træffes foranstaltninger til rutinemæssig monitorering af hæmatologiske parametre og symptomer forbundet med anæmi, leukopeni/neutropeni og/eller trombocytopeni hos patienter, der får talazoparib.
English: 1 mg capsule shell
Danish: 1 mg kapselskal
English: Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day.
Danish: Bivirkninger relateret til myelosuppression, anæmi, neutropeni og thrombocytopeni blev meget ofte indberettet for patienter, der blev behandlet med talazoparib 1 mg/dag.
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).
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer) - være forpustet, føle sig træt, bleg hud eller hurtigt hjerterytme - det kan være tegn på et lavt antal røde blodlegemer (anæmi).
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.
Danish: Farmakokinetisk populationsanalyse tyder på, at samtidig brug af syrenedsættende midler, herunder protonpumpehæmmere og H2-receptor antagonister eller andre syrenedsættende midler, ikke havde en signifikant indvirkning på absorptionen af talazoparib.
English: Kaplan-Meier curves of PFS - EMBRACA study
Danish: Kaplan-Meier-kurver for PFS - EMBRACA-studiet tid (måneder)
English: Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).
Danish: Øvrige indholdsstoffer: - Kapselindhold: silikonificeret mikrokrystalinsk cellulose (sMCC) (mikrokrystalinsk cellulose og siliciumdioxid).
English: If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see section 4.2).
Danish: Hvis samtidig administration med en kraftig P-gp-hæmmer ikke kan undgås, skal dosis af Talzenna reduceres (se pkt.
English: Platelet count < 50,000/μL
Danish: Trombocyttælling < 50.000/μl
English: Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted.
Danish: Systemisk hormonal kontraception Der er ikke udført interaktionsstudier med talazoparib og orale kontraceptiva.
English: 1 mg (one 1 mg capsule) once daily
Danish: 1 mg (en 1 mg kapsel) 1 gang dagligt
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKEANVENDT LÆGEMIDDEL ELLER AFFALD HERAF
English: High-density polyethylene (HDPE) bottle and polypropylene (PP) closure with heat induction seal liner.
Danish: Beholder i højdensitets polyethylen (HDPE) og lukning i polypropylen (PP) med varmeinduceret forsegling.
English: BRCA mutation status (breast cancer susceptibility gene 1 [BRCA1] positive or breast cancer susceptibility gene 2 [BRCA2] positive) was similar across both treatment arms.
Danish: Status for BRCA-mutationer (gen 1 for forhøjet risiko for brystkræft (BRCA1) eller gen 2 for forhøjet risiko for brystkræft (BRCA2)) var ens i begge behandlingsarme.
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)
Danish: EU/1/19/1377/002 (30 hårde kapsler) EU/1/19/1377/003 (60 hårde kapsler) EU/1/19/1377/004 (90 hårde kapsler)
English: If you take more Talzenna than you should
Danish: Hvis du har taget for meget Talzenna
English: Developmental toxicology
Danish: Udviklingsmæssig toksikologi
English: Women who can become pregnant and men with partners who are or can become pregnant should use effective contraception.
Danish: Fertile kvinder og mænd med gravide eller fertile partnere skal bruge en sikker form for prævention.
English: Since the use of hormonal contraception is not recommended if you have breast cancer, you should use two non-hormonal contraception methods.
Danish: Da prævention, der indeholder hormoner ikke kan anbefales, hvis du har brystkræft, skal du anvende to ikke-hormonholdige præventionsmåder.
English: Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir - used to treat HIV infections/AIDS.
Danish: - cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir og tipranavir bruges til behandling af hiv-infektioner/aids.
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.
Danish: Talazoparib hæmmer ikke nogen af de større uridindiphosphat-glukuronosyltransferase (UGT) isoformer (1A1, 1A4, 1A6, 1A9, 2B7 og 2B15) in vitro ved klinisk relevante koncentrationer.
English: Resume Talzenna at next lower dose
Danish: Genoptag Talzenna ved næste reducerede dosis
English: Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John's wort) may decrease talazoparib exposure.
Danish: Andre P-gp-induktorer (herunder blandt andet carbamazepin, phenytoin og prikbladet perikon) kan nedsætte eksponeringen for talazoparib.
English: BRCA status by central or local laboratory assessment, n (%)
Danish: Hormonreceptorpositiv (ER-positiv eller PgR-positiv) BRCA-status ud fra vurdering af centralt eller lokalt laboratorium, n (%)
English: 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.
Danish: Virkningen af talazoparib på repolarisering af hjertet hos 37 patienter med fremskredne solide tumorer blev undersøgt med tidsbestemte elektrokardiogrammer (EKG'er) for at vurdere forholdet mellem ændringer i QT-intervallet korrigeret for hjertefrekvens (QTc) fra baseline og de tilhørende plasmatalazoparib-koncentrationer.
English: Talk to your healthcare provider about birth control methods that may be right for you.
Danish: Tal med din læge om, hvilken prævention der kan være den rigtige for dig.
English: The active substance is talazoparib.
Danish: Aktivt stof: talazoparib.
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.
Danish: Talzenna 0,25 mg fås i perforerede blisterpakninger med 30, 60 eller 90 hårde kapsler og i plastbeholdere med 30 hårde kapsler.
English: c. Includes preferred terms of neutropenia and neutrophil count decreased.
Danish: Omfatter de foretrukne termer for neutropeni og nedsat neutrofiltal.
English: Studies in animals have shown embryo-foetal toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: What you need to know before you take Talzenna
Danish: Det skal du vide, før du begynder at tage Talzenna
English: Talzenna 0.25 mg hard capsules EU/1/19/1377/001
Danish: Talzenna 0,25 mg hårde kapsler EU/1/19/1377/001
English: If you are breast-feeding.
Danish: - Hvis du ammer.
English: Chemotherapy Median PFS=5.6 months 95% CI (4.2, 6.7)
Danish: Median PFS=5,6 måneder 95% CI (4,2; 6,7)
English: BRCA2-mutation positive
Danish: BRCA2-positiv
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).
Danish: Talzenna nedsætter antallet af blodlegemer som f. eks. antallet af røde blodlegemer (blodmangel eller anæmi), antallet af hvide blodlegemer (neutropeni) eller antallet af blodplader (trombocytopeni).
English: The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo.
Danish: Virkningen af BCRP-hæmmere på talazoparibs farmakokinetik er ikke blevet undersøgt in vivo.
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.
Danish: Data fra et interaktionsstudie af lægemidler hos patienter med fremskredne, solide tumorer indikerede, at samtidig administration af 1 enkelt dosis 1 mg talazoparib med flere daglige doser af P-gpinduktoren rifampin 600 mg, hvor rifampin blev administreret 30 minutter før talazoparib på dagen, hvor talazoparib blev doseret, øgede talazoparib Cmax med ca. 37%, hvorimod AUCinf ikke blev påvirket i forhold til 1 enkelt dosis 1 mg talazoparib administreret alene.
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.
Danish: Talazoparib hæmmer ikke cytokrom (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4/5 eller CYP1A2, CYP2B6 eller CYP3A4 in vitro ved klinisk relevante koncentrationer.
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).
Danish: Der kræves ingen dosisjustering for patienter med let nedsat leverfunktion (total bilirubin ≤ 1 × øvre normalgrænse (ULN) og aspartataminotransferase (ASAT) > ULN eller total bilirubin > 1,0-1,5 × ULN og enhver ASAT).
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.
Danish: C)talazoparib til mennesker blev der ikke fundet større cirkulerende metabolitter i plasmaet, og talazoparib var eneste cirkulerende lægemiddelrelaterede stof.
English: Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure.
Danish: Samtidig administration af talazoparib og BCRP-hæmmere kan øge eksponeringen for talazoparib.
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.
Danish: Data fra et interaktionsstudie af lægemidler hos patienter med fremskredne, solide tumorer indikerede, at samtidig administration af flere daglige doser af P-gp-hæmmeren itraconazol 100 mg 2 gange dagligt med en enkelt dosis 0,5 mg talazoparib, øgede den samlede eksponering af talazoparib (AUCinf) og den maksimale koncentration (Cmax) med henholdsvis ca. 56 % og 40 % sammenlignet med en enkelt dosis på 0,5 mg talazoparib administreret alene.
English: The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (35.2%), neutropenia (17.4%), and thrombocytopenia (16.8%).
Danish: De mest almindelige (≥ 10 %) grad ≥ 3 bivirkninger af talazoparib var anæmi (35,2%), neutropeni (17,4%) og thrombocytopeni (16,8%).
English: h. Includes preferred terms of fatigue and asthenia.
Danish: Omfatter de foretrukne termer for træthed og asteni.
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.
Danish: Den generelle sikkerhedsprofil for Talzenna bygger på poolede data fra 494 patienter, der fik talazoparib 1 mg dagligt i kliniske studier af solide tumorer, herunder 286 patienter fra et randomiseret fase 3-studie med germline BRCA-muteret (gBRCAm), lokalt fremskreden eller metastatisk HER2
English: Talzenna 1 mg is available in perforated unit dose blister packs of 30 hard capsules and in plastic bottles of 30 hard capsules.
Danish: Talzenna 1 mg fås i perforerede blisterpakninger med 30 hårde kapsler og plastbeholdere med 30 hårde kapsler.
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).
Danish: Talzenna må kun bruges til patienter med kraftigt nedsat nyrefunktion, hvis fordelene opvejer de mulige risici, og patienten skal nøje monitoreres med hensyn til nyrefunktion og bivirkninger (se pkt.
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment (see section 4.4).
Danish: Der skal foretages en graviditetstest af alle fertile kvinder forud for behandling (se pkt.
English: However, the effect of other P-gp inducers on talazoparib exposure has not been studied.
Danish: Virkningen på eksponeringen for talazoparib af andre P-gp-induktorer er dog ikke undersøgt.
English: Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Danish: Printblæk: Shellak (E904), propylenglycol (E1520), ammoniumhydroxid (E527), sort jernoxid (E172) og kaliumhydroxid (E525).
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.
Danish: Baseret på en farmakokinetisk analyse, der omfattede 490 patienter, hvoraf 118 patienter havde let nedsat leverfunktion (total bilirubin ≤ 1,0× ULN og ASAT > ULN, eller total bilirubin > 1,01,5 × ULN og enhver ASAT), havde en let nedsat leverfunktion ingen virkning på farmakokinetikken for talazoparib.
English: BRCA1-mutation positive
Danish: BRCA1-positiv
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.
Danish: Talazoparib hæmmer ikke nogen af de større intestinale, hepatiske eller renale membrantransportproteiner (P-gp, BCRP, organisk anion-transporterende polypeptid (OATP)1B1, OATP1B3, organisk kationtransportør (OCT)1, OCT2, organisk aniontransportør (OAT)1, OAT3, galde-salt-eksportpumpe (BSEP), multidrug og toksinekstrudering (MATE)1 og MATE2-K) in vitro ved klinisk relevante koncentrationer.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle or blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Asian
Danish: Asiatisk
English: All grades* n (%)
Danish: Alle grader* n (%)
English: Infection, developing chills or shivering, or fever or feeling hot - these may be signs of a low white blood cell count (neutropenia).
Danish: - infektion, kuldegysninger eller rysten, feber eller føle sig varm - det kan være tegn på et lavt antal hvide blodlegemer (neutropeni).
English: Excella GmbH & Co. KG Nürnberger Str. 12
Danish: KG Nürnberger Str. 12
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.
Danish: Da brugen af hormonal kontraception ikke kan anbefales til patienter med brystkræft, skal der anvendes 2 ikke-hormonale svangerskabsforebyggende metoder.
English: d. Includes preferred terms of leucopenia and white blood cell count decreased.
Danish: Omfatter de foretrukne termer for leukopeni og nedsat antal hvide blodlegemer.
English: ORR (%, 95% CI) Odds ratio (95% CI) 2-sided p-valuef p<0.0001
Danish: ORR (%, 95 % CI) Odds ratio (95 % CI) 2-sidet p-værdi p < 0,0001
English: P-gp is likely involved in talazoparib active renal secretion.
Danish: P-gp er sandsynligvis involveret i aktiv udskillelse af talazoparib via nyrerne.
English: Platinum
Danish: Platin
English: Polyvinyl chloride/polyvinylidene chloride (PVC/PVdC) perforated unit dose blister with an aluminum peel off foil lidding.
Danish: Enkeltdoser i perforeret blister i polyvinylklorid/polyvinylidenklorid (PVC/PVdC) med aluminiumsfolie til at trække af.
English: a. Includes preferred terms of thrombocytopenia and platelet count decreased.
Danish: Omfatter de foretrukne termer for thrombocytopeni og nedsat trombocyttal.
English: Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count (thrombocytopenia).
Danish: - blå mærker eller du bløder længere end normalt, hvis du får et sår - det kan være tegn på et lavt antal blodplader (trombocytopeni).
English: Male and female contraception
Danish: Fertile kvinder/kontraception til mænd og kvinder
English: The most common adverse reactions leading to dose modifications were anaemia (33.0%), neutropenia (15.8%), and thrombocytopenia (13.4%).
Danish: De mest almindelige bivirkninger, der førte til dosisændring, var anæmi (33,0%), neutropeni (15,8%) og thrombocytopeni (13,4%).
English: Talzenna is not recommended during pregnancy or for women of childbearing potential not using contraception (see section 4.4).
Danish: Talzenna bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender kontraception (se pkt.
English: Events, number (%) Median (95% CI), months Hazard ratio (95% CI) 2-sided p-valueb p=0.1053
Danish: Hændelser, antal (%) Median (95 % CI), måneder Hazard ratio (95 % CI) 2-sidet p-værdi p= 0,1053
English: Thrombocytopenia: Bruising or bleeding for longer than usual if you hurt yourself - these may be signs of a low blood platelet count
Danish: - Trombocytopeni: blå mærker eller at du bløder længere tid end normalt, hvis du får et sår - det kan være tegn på et lavt antal blodplader.
English: Myelosuppression consisting of anaemia, leucopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8).
Danish: Myelosuppression bestående af anæmi, leukopeni/neutropeni og/eller thrombocytopeni er blevet indberettet hos patienter, der er blevet behandlet med talazoparib (se pkt.
English: Talzenna has not been studied in patients with severe renal impairment (CrCl < 30 mL/min) or patients requiring haemodialysis.
Danish: Talzenna er ikke undersøgt hos patienter med kraftigt nedsat nyrefunktion (CrCl < 30 ml/min.)
English: Talzenna 1 mg hard capsules
Danish: Talzenna 1 mg hårde kapsler
English: Neutropenia: Infection, developing chills or shivering, or fever - these may be signs of a low white blood cell count
Danish: - Neutropeni: infektion, får kuldegysninger eller rysten eller feber - det kan være tegn på et lavt antal hvide blodlegemer.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: Pack size: cartons of 30 capsules in a HDPE bottle.
Danish: Pakningsstørrelse: Kartoner med 30 kapsler i en HDPE-beholder.
English: 30 × 1 capsules
Danish: Hård kapsel 30 × 1 kapsler
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).
Danish: Da brugen af hormonal kontraception ikke kan anbefales til patienter med brystkræft, skal der anvendes 2 ikke-hormonale svangerskabsforebyggende metoder (se pkt.
English: e. Includes preferred terms of lymphocyte count decreased and lymphopenia.
Danish: Omfatter de foretrukne termer for nedsat lymfocyttal og lymfopeni.
English: Anthracycline
Danish: Antracyklin
English: 0.75 mg (three 0.25 mg capsules) once daily
Danish: 0,75 mg (tre 0,25 mg kapsler) 1 gang dagligt
English: St. John's wort (Hypericum perforatum) - a herbal remedy used to treat mild depression and anxiety.
Danish: - Johannesurt/perikon (Hypericum perforatum), et naturlægemiddel, der bruges til nedtrykthed,
English: Renal elimination of unchanged drug (passive filtration and active secretion) is the major route of talazoparib elimination.
Danish: Den vigtigste udskillelsesvej for talazoparib er renal udskillelse af uomdannet lægemiddel (passiv filtrering og aktiv udskillelse).
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Danish: De kan tages med eller uden mad og drikke (se pkt.
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.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Danish: Pakningsstørrelse: Karton med 30 × 1 kapsler i blister med enhedsdoser.
English: No dose adjustment is required for patients with mild renal impairment (60 mL/min ≤ creatinine clearance [CrCl] < 90 mL/min).
Danish: Der kræves ingen dosisjustering for patienter med let nedsat nyrefunktion (60 ml/min.
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.
Danish: Kvinder, der kan blive gravide, skal bruge en sikker form for prævention, mens de bliver behandlet med Talzenna og i mindst 7 måneder efter sidste dosis Talzenna.
English: Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 0.25 mg capsule shell
Danish: Silicificeret mikrokrystalinsk cellulose (sMCC) (mikrokrystallinsk cellulose og siliciumdioxid)
English: Effect of acid-reducing agents
Danish: Virkningen af syrenedsættende stoffer
English: The PK of talazoparib have not been studied in patients requiring haemodialysis (see section 4.2).
Danish: Farmakokinetikken for talazoparib er ikke undersøgt for patienter, der har brug for hæmodialyse (se pkt.
English: 30 capsules
Danish: Hård kapsel 30 kapsler
English: Talzenna 0.25 mg hard capsules
Danish: Talzenna 0,25 mg hårde kapsler
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.
Danish: 4) før, de indleder behandling med talazoparib, under behandlingen og 7 måneder efter seponering af behandling med talazoparib.