FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take Lynparza, take your next normal dose at its scheduled time.
Danish: Hvis du glemmer at tage Lynparza, skal du tage din næste normale dosis på det planlagte tidspunkt.
English: Increase in blood creatinine Uncommon
Danish: Stigning i blodkreatinin Ikke almindelig
English: Depending on the test used and the international classification consensus, the BRCA1/2 mutations have been classified as deleterious/suspected deleterious or pathogenic/likely pathogenic.
Danish: Afhængig af den anvendte test samt international konsensus om klassifikation, er BRCA1/2-mutationerne blevet klassificeret som risikogivende/formodet risikogivende eller patogene/sandsynligvis patogene.
English: Data from a double-blind placebo-controlled study showed median increase up to 23% from baseline remaining consistent over time and returning to baseline after treatment discontinuation, with no apparent clinical sequelae.
Danish: Data fra et dobbeltblindet placebokontrolleret studie viste en middelstigning op til 23 % fra baseline, som forblev konsistent over tid og vendte tilbage til baseline efter seponering af behandlingen, tilsyneladende uden nogen kliniske følger.
English: Paediatric population No studies have been conducted in paediatric patients.
Danish: Pædiatrisk population Der er ikke udført nogen studier med pædiatriske patienter.
English: The duration of therapy with olaparib in patients who developed MDS/AML varied from < 6 months to > 2 years.
Danish: Behandlingsvarigheden med olaparib til patienter, som udviklede MDS/AML, varierede fra < 6 måneder til > 2 år.
English: Therefore, caution should be taken if these medicinal products are co-administered with Lynparza and patients should be closely monitored.
Danish: Derfor bør der udvises forsigtighed, hvis disse lægemidler administreres samtidigt med Lynparza, og patienterne bør følges nøje.
English: Following oral dosing of
Danish: Efter oral dosering af
English: The incidence of anaemia adverse reactions was 22.8% (CTCAE grade ≥3 7.4%).
Danish: Forekomsten af bivirkningen anæmi var 22,8% (CTCAEgrad ≥ 3 7,4%).
English: Table 3 Summary of progression-free survival and overall survival: sBRCA mutated population in Study 19
Danish: Tabel 3 Resumé af progressionsfri overlevelse og samlet overlevelse: sBRCA-muteret population i Study 19
English: In the absence of BRCA1 or BRCA2 mutations, HRR pathway may be compromised by other mechanisms, although the causative aberrancy and penetrance are not fully elucidated.
Danish: I fravær af BRCA1- eller BRCA2-mutationer kan HRR-stien kompromitteres via andre mekanismer, men den tilgrundliggende afvigelse og penetrans er ikke fuldt ud belyst.
English: The duration of therapy with olaparib in patients who developed MDS/AML varied from <6 months to >2 years; data with longer durations of exposure are limited.
Danish: Behandlingsvarigheden med olaparib til patienter, som udviklede MDS/AML, varierede fra < 6 måneder til > 2 år; data med længere eksponeringvarighed er begrænsede.
English: Olaparib does not affect the pharmacokinetics of tamoxifen.
Danish: Olaparib påvirker ikke tamoxifens farmakokinetik.
English: The safety profile is based on pooled data from 1,826 patients with solid tumours treated with Lynparza monotherapy in clinical trials at the recommended dose.
Danish: Sikkerhedsprofilen er baseret på poolede data fra 1.826 patienter med solide tumorer, som blev behandlet med Lynparza-monoterapi i kliniske studier med den anbefalede dosis.
English: PFS (DCO 30 June
Danish: PFS (DCO 30. juni
English: Throw away any Lynparza capsules that have been frozen.
Danish: Kassér Lynparza kapsler, der har været frosset.
English: Lynparza is provided in HDPE plastic bottles containing 112 hard capsules.
Danish: Lynparza leveres i HDPE-plastikflasker indeholdende 112 hårde kapsler.
English: There was no strategy for multiple testing in place for the sub-group analyses.
Danish: Der var ingen strategi for multiple tests for sub-gruppeanalyserne.
English: Very common Dizziness, Headache, Dysgeusia
Danish: Meget almindelig Svimmelhed, hovedpine, dysgeusi
English: Pneumonitis, including events with a fatal outcome, has been reported in <1.0% of patients treated with Lynparza in clinical studies.
Danish: Pneumonitis, herunder hændelser med dødelig udgang, er rapporteret hos <1,0 % af patienterne, behandlet med Lynparza i kliniske studier.
English: In Study 19, 20 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
Danish: I Study 19 blev der identificeret 20 patienter med en somatisk tumor-BRCA-mutation (en mutation i tumoren, men vildtype i germline).
English: Female patients:
Danish: Kvindelige patienter:
English: Very common side effects that may show up in blood tests:
Danish: Meget almindelige bivirkninger, der kan ses i blodprøver:
English: The study demonstrated a clinically relevant and statistically significant improvement in investigator assessed PFS for olaparib compared to placebo.
Danish: Studiet viste en klinisk relevant og statistisk signifikant forbedring af investigatorvurderet PFS for olaparib sammenlignet med placebo.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX46
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX46
English: Rarely, these may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Danish: I sjældne tilfælde kan dette være et tegn på mere alvorlige problemer med knoglemarven, såsom "myelodysplastisk syndrom" (MDS) eller "akut myeloid leukæmi" (AML).
English: Combination with anastrozole, letrozole and tamoxifen A clinical study has been performed to assess the combination of olaparib with anastrozole, letrozole or tamoxifen.
Danish: Kombination med anastrozol, letrozol og tamoxifen Der er blevet udført et klinisk studie til vurdering af kombinationen af olaparib og anastrozol, letrozol eller tamoxifen.
English: Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available.
Danish: Data, der viser klinisk validering af tumor BRCA1/2-test i brystcancer, er ikke tilgængelige på nuværende tidspunkt.
English: There are limited data in patients with somatic BRCA mutated tumours; 10 patients in the olaparib arm and 10 patients in the placebo arm were defined as having somatic BRCA1/2 mutation.
Danish: Der er begrænsede data for patienter med somatiske BRCA-muterede tumorer; 10 patienter i olaparib-armen og 10 patienter i placebo-armen blev defineret som at have somatisk BRCA1/2-mutation.
English: It is also not recommended to consume grapefruit juice while on Lynparza therapy as it is a CYP3A inhibitor.
Danish: Det anbefales også at undlade at indtage grapefrugtjuice under behandling med Lynparza, da det er en CYP3A-inhibitor.
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
Danish: gBRCA1/2-muteret HER2-negativ metastatisk brystcancer OlympiAD (Studie D0819C00003)
English: • feeling tired or weak
Danish: • træthed eller svaghed
English: Uncommon Increase in blood creatinine
Danish: Ikke almindelig Stigning i blodkreatinin
English: • any other anticancer medicines
Danish: • anden medicin mod kræft
English: The safety and efficacy of Lynparza in children and adolescents has not been established.
Danish: Lynparzas sikkerhed og virkning hos børn og unge er ikke klarlagt.
English: Uncommon Hypersensitivity a, Dermatitis
Danish: Ikke almindelig Hypersensitivitet a, dermatitis
English: Therefore, it is recommended that patients take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards (see section 4.2).
Danish: Derfor anbefales det, at patienterne tager Lynparza mindst 1 time efter fødevarer og ikke bør spise i fortrinsvis op til 2 timer derefter (se pkt.
English: Do not switch to Lynparza tablets unless your doctor tells you
Danish: Skift ikke til Lynparza tabletter, medmindre din læge fortæller dig det
English: The secondary endpoints TFST and PFS2 demonstrated a persistent and statistically significant improvement for olaparib compared with placebo (Table 4).
Danish: De sekundære endepunkter TFST og PFS2 viste en vedvarende og statistisk signifikant forbedring for olaparib sammenlignet med placebo (Tabel 4).
English: Up to 20, 37 and 20 metabolites were detected in plasma, urine and faeces respectively, the majority of them representing <1% of the dosed material.
Danish: Op til 20, 37 og 20 metabolitter blev detekteret i henholdsvis plasma, urin og fæces, hvoraf størstedelen af dem repræsenterede < 1 % af det doserede materiale.
English: Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 1.
Danish: Bivirkningerne er opstillet efter MedDRA-systemorganklasse (SOC) og derefter efter den foretrukne MedDRA-term i Tabel 1.
English: No significant interaction was observed with anastrozole or letrozole, whereas tamoxifen decreased exposure to olaparib by 27%.
Danish: Der blev ikke observeret nogen signifikant interaktion med anastrozol eller letrozol, hvorimod tamoxifen reducerede eksponeringen for olaparib med 27 %.
English: The limited data for these somatic tumour BRCA (sBRCA) mutated patients show that fewer patients on olaparib reported progression events or death events compared with placebo (Table 3).
Danish: De begrænsede data for disse somatisk tumor-BRCA (sBRCA)-muterede patienter viser, at færre patienter på olaparib rapporterede progressionshændelser eller dødsfald sammenlignet med placebo (Tabel 3).
English: By central germline testing, deleterious or suspected deleterious mutations were identified in 95.3% (365/383) and 4.7% (18/383) of patients, respectively.
Danish: Via central germline-test blev der identificeret risikogivende eller formodet risikogivende mutationer hos henholdsvis 95,3 % (365/383) og 4,7 % (18/383) af patienterne.
English: It is unknown whether olaparib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om olaparib eller dets metabolitter udskilles i human mælk.
English: In cancers that lack functional components of HRR such as BRCA1 or 2, DNA DSBs cannot be repaired accurately or effectively.
Danish: I cancertyper, der mangler de funktionelle komponenter af HRR såsom BRCA1 eller 2, kan DNADSB'er ikke repareres nøjagtigt eller effektivt.
English: The proportion of patients who progressed within 6 months of the last dose of platinum-based chemotherapy was 3.5% for olaparib and 8.4% for placebo.
Danish: Andelen af patienter, som progredierede inden for 6 måneder efter den sidste dosis af platinbaseret kemoterapi, var 3,5 % for olaparib og 8,4 % for placebo.
English: • dabigatran - used to thin the blood
Danish: • dabigatran - anvendes til at fortynde blodet
English: PARPs are required for the efficient repair of DNA single strand breaks and an important aspect of PARP-induced repair requires that after chromatin modification, PARP auto-modifies itself and dissociates from the DNA to facilitate access for base excision repair (BER) enzymes.
Danish: PARP'er er nødvendige for effektiv reparation af enkeltstrengsbrud på DNA, og et vigtigt aspekt af PARP-induceret reparation kræver, at PARP, efter kromatinmodificering, automodificerer sig selv og skiller sig fra DNA'et for at lette adgang for baseexcisionsreparationsenzymer (BER).
English: Retrospective testing of patients with available tumour samples was performed using central testing and generated successful results in 341 patients, of which 95% had an eligible mutation (known [n=47] or likely pathogenic [n=277]) and 2 gBRCAwt patients were confirmed to have sBRCAm only.
Danish: Retrospektiv test af patienter med tilgængelige tumorprøver blev udført under anvendelse af en central test og genererede vellykkede resultater hos 341 patienter, hvoraf 95 % havde en egnet mutation (kendt [n=47] eller sandsynligvis patogen [n=277]) og 2 gBRCAwt-patienterne blev bekræftet kun at have sBRCAm.
English: Due to the effect of food on olaparib absorption, patients should take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards.
Danish: På grund af indvirkningen af fødevarer på absorptionen af olaparib bør patienterne tage Lynparza mindst 1 time efter indtagelse af fødevarer og undlade at spise i op til 2 timer derefter.
English: Patients were stratified by response to first-line platinum chemotherapy; complete response (CR) or partial response (PR).
Danish: Patienterne blev stratificeret efter respons på platinbaseret førstelinjekemoterapi; komplet respons (CR) eller delvist respons (PR).
English: All patients had potential contributing factors for the development of MDS/AML, having received previous chemotherapy with platinum agents.
Danish: Alle patienterne havde potentielle bidragende faktorer for udvikling af MDS/AML, idet de tidligere havde fået platinholdig kemoterapi.
English: Your doctor has prescribed Lynparza film-coated tablets for you.
Danish: Din læge har udskrevet Lynparza filmovertrukne tabletter til dig.
English: • protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine,
Danish: • proteaseinhibitorer boostet med ritonavir eller cobicistat, boceprevir, telaprevir, nevirapin,
English: Reports of pneumonitis had no consistent clinical pattern and were confounded by a number of pre-disposing factors (cancer and/or metastases in lungs, underlying pulmonary disease, smoking history, and/or previous chemotherapy and radiotherapy).
Danish: Rapporterne om pneumonitis havde intet konsistent klinisk mønster og blev påvirket af en række prædisponerende faktorer (cancer og/eller metastaser i lungerne, underliggende pulmonær sygdom, tidligere rygning og/eller tidligere kemoterapi og strålebehandling).
English: Lynparza may influence your ability to drive and use machines.
Danish: Lynparza kan påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: • if you are allergic to olaparib or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for olaparib eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).
Danish: Olaparib er en type kræftmedicin, der kaldes en PARP-inhibitor (poly [adenosindifosfatribose]polymerase inhibitor).
English: CYP3A4/5 are the isozymes predominantly responsible for the metabolic clearance of olaparib.
Danish: CYP3A4/5 er de isozymer, der hovedsageligt er ansvarlige for den metaboliske clearance af olaparib.
English: If you forget to take Lynparza
Danish: Hvis du har glemt at tage Lynparza
English: • rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
Danish: • rifampicin, rifapentin, rifabutin - anvendes mod bakterieinfektioner, herunder tuberkulose (TB)
English: If the blood parameters remain clinically abnormal after 4 weeks of Lynparza dose interruption, bone marrow analysis and/or blood cytogenetic analysis are recommended.
Danish: Hvis blodparametrene forbliver klinisk unormale efter 4 ugers afbrydelse af behandling med Lynparza, anbefales analyse af knoglemarv og/eller cytogenetisk analyse af blodet.
English: When dosed orally to rats, olaparib induced micronuclei in bone marrow.
Danish: Når der blev givet doser oralt til rotter, inducerede olaparib mikronuclei i knoglemarven.
English: Effect of other medicinal products on olaparib
Danish: Påvirkning fra andre lægemidler på olaparib
English: The potential for olaparib to induce CYP2C9, CYP2C19 and P-gp can also not be excluded.
Danish: Det kan heller ikke udelukkes, at olaparib potentielt kan inducere CYP2C9, CYP2C19 og P-gp.
English: Some of the patients had a history of previous cancer or of bone marrow dysplasia.
Danish: Nogle af patienterne havde en historik med cancer eller knoglemarvsdysplasi.
English: Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients.
Danish: Kvalme medførte dosisafbrydelse og dosisreduktion hos henholdsvis 14 % og 4 % af de olaparibbehandlede patienter.
English: Patients were randomised into the study a median of 40 days after completing their final platinum chemotherapy.
Danish: Patienterne blev randomiseret til studiet gennemsnitligt 40 dage efter at have fuldført deres sidste platinkemoterapi.
English: Exploratory analyses of time to first subsequent therapy or death (TFST) and time to second subsequent therapy or death (TSST- an approximation of PFS2) were also performed.
Danish: Der blev også udført eksplorative analyser af tiden til første efterfølgende behandling eller død (TFST) og tiden til anden efterfølgende behandling eller død (TSST- en tilnærmelse af PFS2).
English: There are no data in patients with severe hepatic impairment (Child-Pugh classification C).
Danish: Der er ingen data for patienter med svært nedsat leverfunktion (Child-Pugh klassifikation C).
English: Dose interruptions and reductions occurred most frequently in the first 3 months of treatment.
Danish: Dosisafbrydelserne og -reduktionerne forekom hyppigst i de første 3 måneder af behandlingen.
English: The most common histological type was serous (> 90%), endometrioid histology was reported in 6% of the patients.
Danish: Den mest almindelige histologiske type var serøs (> 90 %), endometrioid histologi blev rapporteret hos 6 % af patienterne.
English: Patients must have received treatment with an anthracycline unless contraindicated and a taxane in either a (neo)adjuvant or metastatic setting.
Danish: Patienterne skulle have fået behandling med et antracyklin, medmindre det var kontraindiceret, og et taxan i enten (neo)adjuverende eller metastatisk regi.
English: Patients were stratified based on: receipt of prior chemotherapy regimens for metastatic breast cancer (yes/no), hormone receptor (HR) positive vs triple negative (TNBC), prior platinum treatment for breast cancer (yes/no).
Danish: Patienterne blev stratificeret baseret på: modtagelse af tidligere kemoterapibehandlinger for metastatisk brystcancer (ja/nej), hormonreceptor (HR) positiv versus tripel negativ (TNBC), tidligere platinbehandling mod brystcancer (ja/nej).
English: Of patients treated with Lynparza, who entered the study with evidence of disease (target or non-target lesions at baseline), 15.0% experienced complete response compared with 9.1% of patients on placebo.
Danish: Af de patienter, der blev behandlet med Lynparza, som deltog i studiet med tegn på sygdom (mål- eller ikke-mål-læsioner ved baseline), oplevede 15,0 % fuldt respons sammenlignet med 9,1 % af patienterne på placebo.
English: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Danish: Det anbefales, at behandlingen fortsættes indtil progression af den underliggende sygdom eller uacceptabel toksicitet.
English: Vomiting, Diarrhoea, Nausea, Dyspepsia, Upper abdominal pain
Danish: Opkastning, diarré, kvalme, dyspepsi, øvre abdominalsmerter
English: All patients had received first-line platinum-based therapy.
Danish: Alle patienterne havde modtaget platinbaseret førstelinjebehandling.
English: Patients with HR+ (ER and/or PgR positive) tumours must have received and progressed on at least one endocrine therapy (adjuvant or metastatic) or had disease that the treating physician believed to be inappropriate for endocrine therapy.
Danish: Patienter med HR+ (ER og/eller PgR-positive) tumorer skulle have modtaget og have haft sygdomsprogression efter mindst en endokrin behandling (adjuverende eller metastatisk) eller skulle have sygdom, som den behandlende læge mente var uegnet til endokrin behandling.
English: A benefit was also observed in patients with BRCA1/2 wild-type/variants of uncertain significance (BRCA1/2 wt/VUS), although of a lesser magnitude.
Danish: Der blev også observeret en fordel hos patienter med BRCA1/2-vildtype/varianter af usikker betydning (BRCA1/2 wt/VUS), selvom dette var af mindre størrelsesorden.
English: Olaparib inhibited UGT1A1 in vitro, however, PBPK simulations suggest this is not of clinical importance.
Danish: Olaparib hæmmede UGT1A1 in vitro, men PBPK-simulationer tyder på, at dette ikke er af klinisk betydning.
English: gBRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method.
Danish: gBRCA1/2-mutationsstatus skal fastslås af et erfarent laboratorium ved hjælp af en valideret testmetode.
English: Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Danish: Patienter med hormonreceptor (HR)-positiv brystcancer bør også have haft progression på eller efter tidligere endokrin behandling eller anses for værende uegnede til endokrin behandling.
English: Your doctor has prescribed Lynparza capsules for you.
Danish: Din læge har udskrevet Lynparza kapsler til dig.
English: • It is not known whether Lynparza passes into breast milk.
Danish: • Det vides ikke, om Lynparza går over i modermælken.
English: There is no requirement for BRCA1/2 testing prior to using Lynparza for the maintenance treatment of relapsed EOC, FTC or PPC who are in a complete or partial response to platinum-based therapy.
Danish: Der er ikke noget krav om BRCA1/2-test før anvendelse af Lynparza til vedligeholdelsesbehandling af recidiverende EOC, FTC eller PPC til patienter, som udviser helt eller delvist respons på platinbaseret behandling.
English: Studies using human bone marrow cells also showed that direct exposure to olaparib can result in toxicity to bone marrow cells in ex vivo assays.
Danish: Studier med humane knoglemarvsceller viste også, at direkte eksponering for olaparib kan medføre toksicitet overfor knoglemarvsceller i ex vivo-analyser.
English: Treatment was continued until radiological progression of the underlying disease, unacceptable toxicity or for up to 2 years.
Danish: Behandlingen fortsatte indtil radiologisk progression af den underliggende sygdom, uacceptabel toksicitet eller i op til 2 år.
English: • low white blood cell count (lymphopenia) which may decrease your ability to fight infection and may be associated with fever
Danish: • lavt antal hvide blodlegemer (lymfopeni), som kan nedsætte din evne til at bekæmpe infektioner, og som kan være forbundet med feber
English: In a female fertility study where rats were dosed until implantation, although extended oestrus was observed in some animals, mating performance and pregnancy rate was not affected.
Danish: I et fertilitetsstudie med hunrotter fik rotterne doser indtil implantation, og selvom der blev observeret forlænget østral periode hos nogle dyr, sås der ingen påvirkning af parringsaktivitet og drægtighedsrate.
English: Dose interruptions occurred most frequently in the first 3 months and dose reductions in the first 3-6 months of treatment.
Danish: Dosisafbrydelserne forekom hyppigst i de første 3 måneder, og dosisreduktionerne i de første 3-6 måneder af behandlingen.
English: The most common histological type was serous (96%), endometrioid histology was reported in 2% of the patients.
Danish: Den mest almindelige histologiske type var serøs (96 %), og endometrioid histologi blev rapporteret hos 2 % af patienterne.
English: • Your doctor will tell you how many tablets of Lynparza to take.
Danish: • Lægen vil fortælle dig, hvor mange tabletter Lynparza, du skal tage.
English: Patients who take Lynparza may experience fatigue, asthenia or dizziness.
Danish: Patienter, som tager Lynparza, kan opleve træthed, asteni eller svimmelhed.
English: Anaemia and other haematological toxicities were generally low grade (CTCAE grade 1 or 2), however, there were reports of CTCAE grade 3 and higher events.
Danish: Anæmi og anden hæmatologisk toksicitet var generelt af lav grad (CTCAE grad 1 eller 2), men der var rapporter om CTCAE grad 3 og højere forekomster.