FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories are defined as: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Danish: Hyppigheden er inddelt i følgende kategorier: Meget almindelig (≥ 1/10) og almindelig (≥ 1/100 til < 1/10).
English: Adverse reactions based on pooled dataset from 5 studies (N=494) System organ class Frequency Preferred term
Danish: Bivirkninger baseret på poolede datasæt fra 5 studier (N = 494) Systemorganklasse Hyppighed Foretrukken term
English: If you have any questions about how Talzenna works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Talzenna virker, eller hvorfor denne medicin er ordineret til dig, skal du spørge din læge.
English: What Talzenna is and how it works
Danish: Hvad er Talzenna, og hvordan virker det
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-liste), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: d. Conducted in ITT with measurable disease population who had an objective response.
Danish: Udført i ITT med målbar sygdomspopulation med en objektiv reaktion.
English: * There were no Grade 5 adverse drug reactions.
Danish: * Der var ingen grad 5-bivirkninger.
English: Your doctor will perform a pregnancy test prior to starting Talzenna.
Danish: Din læge vil foretage en graviditetstest, før du starter på Talzenna.
English: Children and adolescents Talzenna is not to be used in children or adolescents (under 18 years of age).
Danish: Børn og unge Talzenna må ikke bruge til børn eller unge (under 18 år).
English: If you get certain side effects while you are taking Talzenna (see section 4), your doctor may lower your dose or stop treatment, either temporarily or permanently.
Danish: Hvis du får bivirkninger, mens du tager Talzenna (se afsnit 4), vil din læge muligvis nedsætte din dosis eller stoppe behandlingen, enten midlertidigt eller permanent.
English: Take the carton and this leaflet so that the doctor knows what you have been taking.
Danish: Tag æsken og denne indlægsseddel med dig, så lægen ved, hvad du har taget.
English: If the patient vomits or misses a dose, an additional dose should not be taken.
Danish: Hvis patienten kaster op eller springer en dosis over, må der ikke tages en ekstra dosis.
English: Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Talzenna skal påbegyndes og overvåges af en læge med erfaring i administration af lægemidler mod cancer.
English: Talzenna with food and drink
Danish: Brug af Talzenna sammen med mad og drikke
English: Complete blood counts should be obtained at baseline and monitored monthly for signs of haematologic toxicity during treatment.
Danish: Fuldstændige blodtællinger skal indhentes ved baseline og monitoreres månedligt for tegn på hæmatologisk toksicitet under behandlingen.
English: Please see section “Male and female contraception” below.
Danish: Se afsnittet ”Prævention for mænd og kvinder” herunder.
English: Randomised Phase 3 study EMBRACA
Danish: Randomiseret fase 3-studie EMBRACA
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via the det nationale rapporteringssystem anført i V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: This is because Talzenna can affect the way some other medicines work.
Danish: Det er fordi, Talzenna kan påvirke den måde, anden medicin virker på.
English: Following repeated daily dosing, plasma talazoparib concentrations reached steady-state within 2 to 3 weeks.
Danish: Efter gentagen daglig dosering nåede plasma-talazoparibkoncentrationerne steady-state i løbet af 2-3 uger.
English: If you feel dizzy, weak, or tired (these are very common side effects of Talzenna), you should not drive or use machines.
Danish: Hvis du føler dig svimmel, svag eller træt (meget almindelige bivirkninger ved Talzenna), skal du undgå at køre bil eller betjene maskiner.
English: Food intake decreased the rate but not the extent of talazoparib absorption.
Danish: Fødeindtagelse nedsatte hastigheden, men ikke omfanget af talazoparibabsorption.
English: The safety and efficacy of Talzenna in children and adolescents < 18 years of age have not been established.
Danish: Talzennas sikkerhed og virkning hos børn og unge i alderen < 18 år er ikke klarlagt.
English: Do not use curcumin in food supplements while you are taking Talzenna as it may increase Talzenna's side effects.
Danish: Anvend ikke kurkumin kosttilskud, mens du tager Talzenna, da det kan øge bivirkninger af Talzenna.
English: Talzenna is for oral use.
Danish: Talzenna er til oral anvendelse.
English: Your healthcare provider will perform a test to make sure that Talzenna is right for you.
Danish: Sundhedspersonalet vil foretage en test for at sikre sig, at Talzenna er det rigtige for dig.
English: However, based on urinary excretion data the absolute bioavailability is at least 41% with fraction absorbed of at least 69% (see Elimination).
Danish: Ud fra data om udskillelse i urinen er fuldstændig biotilgængelighed mindst 41 % med en absorberet fraktion på mindst 69 % (se Udskillelse).
English: The median duration of exposure was 5.4 months (range 0.03-61.1).
Danish: Middelvarigheden af eksponeringen var 5,4 måneder (interval 0,03-61,1).
English: Abbreviations: CI=confidence interval; PFS=progression-free survival.
Danish: Forkortelser: CI=konfidensinterval; PFS=progressionsfri overlevelse.
English: If you forget to take Talzenna
Danish: Hvis du har glemt at tage Talzenna
English: You will have regular blood tests during treatment with Talzenna to check your blood cells (white blood cells, red blood cells, and platelets).
Danish: Du vil få taget regelmæssige blodprøver under behandlingen med Talzenna for at kontrollere dine blodlegemer (hvide blodlegemer, røde blodlegemer og blodplader).
English: The study demonstrated a statistically significant improvement in PFS for Talzenna compared with chemotherapy (see Table 5).
Danish: Studiet viste signifikant forbedring af PFS for Talzenna sammenlignet med kemoterapi (se tabel 5).
English: Talzenna hard capsules come in different strengths.
Danish: Talzenna hårde kapsler fås i forskellige styrker.
English: What Talzenna contains
Danish: Talzenna indeholder
English: Consistent with the overall results, a reduction in the risk of disease progression or death in favour of the talazoparib arm was observed in all individual patient subgroups (Figure 2).
Danish: I overensstemmelse med det samlede resultat blev der observeret en reduktion af risikoen for sygdomsprogression eller dødsfald til fordel for talazoparib-armen hos alle individuelle patientundergrupper (figur 2).
English: Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.
Danish: Understøttende behandling med eller uden blod- og/eller trombocyttransfusion og/eller administration af kolonistimulerende faktorer kan anvendes efter behov.
English: Time from initial diagnosis of breast cancer to diagnosis of advanced breast cancer (years) n
Danish: Tid fra første diagnose med brystkræft til diagnose med fremskreden brystkræft (år)
English: Talazoparib undergoes minimal hepatic metabolism in humans.
Danish: Talazoparib undergår minimal hepatisk metabolisme hos mennesker.
English: This is probably the net effect of both P-gp induction and inhibition by rifampin under the tested conditions in the drug-drug interaction study.
Danish: Dette er sandsynligvis nettoeffekten af både P-gp induktion og hæmning af rifampicin under de undersøgte forhold i interaktionsstudiet.
English: f. Stratified CMH test.
Danish: Stratificeret CMH-test.
English: g. For talazoparib Grade 1 is 21% and Grade 2 is 2%.
Danish: For talazoparib er grad 1 21% og grad 2 2%.
English: A series of prespecified subgroup PFS analyses was performed based on prognostic factors and baseline characteristics to investigate the internal consistency of treatment effect.
Danish: Der blev udført en række præspecificerede PFS-analyser i undergruppen baseret på prognostiske faktorer og baseline-egenskaber for at undersøge intern overensstemmelse af behandlingseffekten.
English: Efficacy data for EMBRACA based on the primary analysis as assessed by the independent review and investigator are summarised in Table 5.
Danish: Virkningsdata for EMBRACA ud fra den første analyse ifølge den uafhængige gennemgang og investigator er opsummeret i tabel 5.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX60
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, ATC-kode: L01XX60
English: Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2.
Danish: Talazoparib er en hæmmer af PARP-enzymerne, PARP1 og PARP2.
English: This includes any possible side effects not listed in this leaflet.
Danish: herunder bivirkninger, som ikke er nævnt her.
English: Talazoparib did not have a clinically relevant effect on QTc prolongation at the maximum clinically recommended dose of 1 mg once daily.
Danish: Talazoparib havde ikke nogen klinisk relevant virkning på QTcforlængelsen ved den maksimalt klinisk anbefalede dosis på 1 mg én gang dagligt.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Danish: Tag ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at den har været åbnet.
English: If MDS/AML is confirmed, talazoparib should be discontinued.
Danish: Hvis MDS/AML bekræftes, skal talazoparib seponeres.
English: Permanent discontinuation due to an adverse reaction occurred in 3.6% of patients receiving Talzenna.
Danish: Permanent seponering som følge af bivirkninger forekom hos 3,6% af de patienter, der fik Talzenna.
English: What you need to know before you take Talzenna 3.
Danish: Det skal du vide, før du begynder at tage Talzenna 3.
English: Talzenna may have a minor influence on the ability to drive and use machines.
Danish: Talzenna kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: f. Includes preferred terms of abdominal pain, abdominal pain upper, abdominal discomfort and abdominal pain lower.
Danish: Omfatter de foretrukne termer for abdominalsmerter, øvre abdominalsmerter, abdominalt ubehag og nedre abdominalsmerter.
English: Do not take a double dose to make up for the forgotten or vomited capsules.
Danish: Du må ikke tage en dobbeltdosis som erstatning for de glemte kapsler eller kapsler, du har kastet op.
English: No prior treatment with a PARP inhibitor was permitted.
Danish: Tidligere behandling med PARP-hæmmere var ikke tilladt.
English: It is unknown whether talazoparib is excreted in human breast milk.
Danish: Det er ukendt, om talazoparib udskilles i human mælk.
English: Serious problems with the bone marrow
Danish: Alvorlige problemer med knoglemarven
English: Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Danish: Patienter med hormonreceptor (HR)-positiv brystkræft skal tidligere have været behandlet med endokrin terapi eller anses for uegnede til endokrin terapi.
English: Figure 1 shows the Kaplan-Meier curve for the EMBRACA study.
Danish: Figur 1 viser Kaplan-Meier-kurven for EMBRACA-studiet.
English: You should not become pregnant while taking Talzenna.
Danish: - du skal må ikke blive gravid, mens du tager Talzenna.
English: Number of patients who received following prior therapies, n (%) Taxane
Danish: Antal patienter, der tidligere havde fået følgende behandlinger, n (%) Taxan
English: Progression-free survival by BICR
Danish: Progressionsfri overlevelse (PFS) ifølge BICR
English: Patients with changes (mutations) in genes called BRCA are at risk of developing some forms of cancer.
Danish: Patienter med ændringer (mutationer) i generne, der kaldes BRCA (brystkræftgen), kan udvikle visse former for kræft.
English: Myelodysplastic syndrome/Acute myeloid leukaemia
Danish: Myelodysplastisk syndrom/akut myeloid leukæmi
English: The secondary objectives were objective response rate (ORR), overall survival (OS), safety, and PK.
Danish: De sekundære formål var objektiv responsrate (ORR), samlet overlevelse (OS), sikkerhed og farmokinetisk analyse.
English: Rarely, low blood cell counts may be a sign of more serious problems with the bone marrow such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
Danish: Et lavt blodtal kan i sjældne tilfælde være tegn på mere alvorlige problemer med knoglemarven som f.eks. myelodysplastisk syndrom (MDS) eller akut myeloid leukæmi (AML).
English: You should not use Talzenna if you are pregnant.
Danish: - du må ikke bruge Talzenna, hvis du er gravid.
English: The absolute bioavailability study has not been conducted in humans.
Danish: Der er ikke udført human-studier af fuldstændig biotilgængelighed.
English: Following oral administration of talazoparib, the median time to Cmax (Tmax) was generally between 1 to 2 hours after dosing.
Danish: Efter oral administration af talazoparib var mediantid til Cmax (Tmax) generelt mellem 1 og 2 timer efter dosering.
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.
Danish: I alt 431 patienter blev randomiseret 2:1 til Talzenna 1 mg kapsel én gang dagligt eller kemoterapi i standarddoser indtil progression eller uacceptabel toksicitet.
English: The median accumulation ratio of talazoparib following repeated oral administration of 1 mg once daily was in the range of 2.3 to 5.2.
Danish: Middel akkumuleringsraten for talazoparib efter gentagne oral administration af 1 mg én gang dagligt var mellem 2,3 og 5,2.
English: Insufficient data are available to estimate the impact of severe renal impairment on talazoparib CL/F in this patient population.
Danish: Der er utilstrækkelige data til at vurdere indvirkningen af svært nedsat nyrefunktion på CL/F for talazoparib for denne patientpopulation.
English: Curcumin is found in turmeric root and you should not use large amounts of turmeric root, but using spices in food is not likely to cause a problem.
Danish: Kurkumin findes i gurkemeje, og du må ikke bruge gurkemeje i større mængder; brug af krydderier i maden anses dog ikke for at udgøre en risiko.
English: Talazoparib should not be started until patients have recovered from haematological toxicity caused by previous therapy (≤ Grade 1).
Danish: Der må ikke startes med talazoparib, før patienterne er kommet sig over hæmatologisk toksicitet forårsaget af forudgående behandling (≤ grad 1).
English: HER2-positive
Danish: HER2-positiv
English: Pharmacokinetics of talazoparib have not been evaluated in patients < 18 years of age.
Danish: Farmakokinetikken for talazoparib er ikke blevet vurderet for patienter < 18 år.
English: It is not known if Talzenna passes into breast milk.
Danish: Det vides ikke, om Talzenna går over i modermælken.
English: The results have shown that age, sex, and body weight had no clinically relevant effect on the PK of talazoparib.
Danish: Resultaterne har vist, at alder, køn og kropsvægt ikke havde nogen klinisk relevant virkning på farmakokinetikken for talazoparib.
English: Based on these results, Talzenna can be administered with or without food (see section 4.2).
Danish: Baseret på disse resultater kan Talzenna tages med og uden mad (se pkt.
English: There is limited experience of overdose with talazoparib.
Danish: Der er begrænset erfaring med overdosering af talazoparib.
English: Curcumin (e.g. found in turmeric root) in some medicines (see also section Talzenna with food and drink below).
Danish: - Kumarin (findes f. eks. i gurkemeje) i lægemidler (se også afsnit Brug af Talzenna sammen med mad og drikke herunder.)
English: The recommended dose is 1 mg talazoparib once daily.
Danish: Den anbefalede dosis er 1 mg talazoparib én gang dagligt.
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).
Danish: Ud fra ikke-kliniske fund i testikler (delvist reversible) og ovarier (reversible) kan Talzenna forringe fertiliteten hos fertile mænd (se pkt.
English: Haemoglobin < 8 g/dL
Danish: Hæmoglobin < 8 g/dl
English: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method.
Danish: Patienterne skal udvælges til behandling med Talzenna mod brystkræft ud fra tilstedeværelsen af risikogivende eller formodede risikogivende germline BRCA-mutationer bestemt af et erfarent laboratorium ved hjælp af en valideret testmetode.
English: You can take Talzenna with food or between meals.
Danish: Du kan tage Talzenna med eller uden mad.
English: b. Stratified Log-rank test. c. 51% of the projected final number of OS events occurred (163 of 321 deaths).
Danish: 51% af det forventede endelige antal OS-hændelser indtraf (163 ud af 321 dødsfald).
English: Lapatinib - used to treat patients with certain types of breast cancer.
Danish: - Lapatinib bruges til behandling af patienter med visse former for brystkræft.
English: Fertility Talazoparib may reduce fertility in men.
Danish: Fertilitet Talazoparib kan nedsætte mænds fertilitet.
English: Talk to your doctor, pharmacist or nurse before taking Talzenna and during your treatment if you experience signs or symptoms described in this section.
Danish: Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet før du tager Talzenna og under behandlingen, hvis du oplever nogen af de symptomer, der er beskrevet i dette afsnit.
English: No metabolites that individually represented more than 10% of the administered dose were recovered in the urine or faeces.
Danish: Der blev ikke fundet metabolitter, som udgjorde mere end 10 % af den administrerede dosis i urin eller fæces.
English: Common (may affect up to 1 in 10 people) Alteration in taste (dysgeusia) Indigestion
Danish: Almindelig (kan påvirke 1 ud af 10 personer) - smagsforstyrrelser (dysgeusi) - dårlig fordøjelse - mundbetændelse
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.
Danish: Patienterne skulle have modtaget behandling med et antracyklin og/eller et taxan (medmindre det var kontraindiceret) i en neoadjuvant, adjuvant og/eller metastatisk sammenhæng.
English: Clarithromycin and erythromycin antibiotics - used to treat bacterial infections.
Danish: - Antibiotika: clarithromycin og erythromycin, som anvendes til behandling af infektioner med bakterier.
English: No dose adjustment is necessary in elderly (≥ 65 years of age) patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (≥ 65 år) (se pkt.
English: Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumour patients treated with talazoparib in clinical studies.
Danish: Der er indberettet i alt 2 tilfælde af MDS/AML ud af 584 (0,3%) patienter med solide tumorer, der blev behandlet med talazoparib i kliniske studier.
English: Low blood cell counts
Danish: Lavt antal blodlegemer
English: Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 62.3% of patients receiving Talzenna.
Danish: Dosisændringer (reduktion eller afbrydelse af dosis) som følge af bivirkninger forekom hos 62,3% af de patienter, der fik Talzenna.
English: Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable.
Danish: Der skal eventuelt ydes genetisk rådgivning til patienter med BRCA-mutationer i henhold til lokale retningslinjer.
English: This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of talazoparib, indicating the potential for genotoxicity in humans.
Danish: Denne clastogenicitet stemmer overens med genomets manglende stabilitet som følge af den primære farmakologi for talazoparib, hvilket tyder på risikoen for genotoksicitet hos mennesker.
English: Talzenna may cause foetal harm when administered to a pregnant woman.
Danish: Talzenna kan medføre fosterskader, hvis det administreres til gravide kvinder.
English: If such events occur, dose modifications (reduction or interruption) are recommended (see section 4.2).
Danish: I tilfælde af at disse symptomer opstår anbefales dosisændring (reduktion eller afbrydelse) (se pkt.
English: Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments (see section 5.1).
Danish: Patienterne skal have været behandlet tidligere med antracyklin og/eller et taxan som (neo)adjuvant behandling eller behandling mod lokalt fremskreden cancer eller metastaser, medmindre patienterne ikke var egnede til disse behandlinger (se pkt 5.1).
English: Itraconazole and ketoconazole - used to treat fungal infections.
Danish: - Itraconazol og ketoconazol bruges til behandling af svampeinfektioner.
English: Dose adjustments for toxicities Dose level
Danish: Dosisjustering ved toksicitet Dosisniveau
English: Forest plot of PFS analyses for key subgroups - EMBRACA study
Danish: Forest-diagram over PFS-analyser for primære undergrupper - EMBRACA-studiet
English: Patients with prior platinum therapy for advanced disease were required to have no evidence of disease progression during platinum therapy.
Danish: For patienter, der havde platinbehandling mod fremskreden sygdom i anamnesen, var det et krav, at der ikke måtte være tegn på sygdomsprogression under platinbehandlingen.
English:  Grade 1
Danish:  grad 1
English: Talazoparib exposure generally increased proportionally with dose across the range of 0.025 mg to 2 mg after daily administration of multiple doses.
Danish: Generelt steg eksponering for talazoparib proportionalt med dosis i intervallet 0,025 mg til 2 mg efter daglig administration af flere doser.
English: Carcinogenicity studies have not been conducted with talazoparib.
Danish: Der er ikke udført karcinogenicitetsstudier med talazoparib.
English: Fatigue/asthenia or dizziness may occur following administration of talazoparib.
Danish: Der kan forekomme træthed/asteni eller svimmelhed efter administration af talazoparib.
English: Concomitant use of strong BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided.
Danish: Samtidig brug af kraftige BCRP-hæmmere (herunder blandt andet curcumin og cyklosporin) skal undgås.
English: Potential contributing factors for the development of MDS/AML include previous platinum-containing chemotherapy, other DNA damaging agents or radiotherapy.
Danish: Faktorer, der eventuelt kan bidrage til udviklingen af MDS/AML, omfatter forudgående platinholdig kemoterapi, andre stoffer, der kan skade DNA, eller strålebehandling.
English: Patient demographic, baseline, and disease characteristics were generally similar between the study treatment arms (see Table 4).
Danish: Patientdemografien, baseline og sygdomskarakteristika var generelt ens i begge behandlingsarme (se tabel 4).