FrancophonIA/ELRC3.0 huggingface dataset:
English: A ring-opened piperazin-3-ol moiety, and two mono-oxygenated metabolites (each ~10%) were the major circulating components, with one of the mono-oxygenated metabolites also being the major metabolite in the excreta (6% and 5% of the urinary and faecal radioactivity, respectively).
Danish: En piperazin-3-ol-del med åben ring og to monooxygenerede metabolitter (hver ~10 %) var de største cirkulerende dele, hvor den ene monooxygenerede metabolit også var den største metabolit i ekskretet (henholdsvis 6 % og 5 % af radioaktiviteten i urinen og fæces).
English: Enrolment did not require evidence of BRCA1/2 mutation (BRCA mutation status for some patients was determined retrospectively).
Danish: Deltagelse krævede ikke bevis for BRCA1/2-mutation (BRCA-mutationsstatus blev for nogle patienter bestemt retrospektivt).
English: • telithromycin, clarithromycin, erythromycin - used for bacterial infections
Danish: • telithromycin, clarithromycin, erythromycin - anvendes til bakterieinfektioner
English: Missing Number of prior lines of chemotherapy for metastatic breast cancer (%)
Danish: Antal tidligere kemoterapilinjer mod metastatisk brystcancer (%)
English: Interval debulking surgery was performed in 35% of the patients and of these 82% had no macroscopic residual disease reported.
Danish: 35 % af patienterne havde interval debulking kirurgi, og af disse rapporterede 82 % ingen makroskopisk residualsygdom.
English: Lynparza with drink
Danish: Brug af Lynparza sammen med drikke
English: As subsequent therapy, 0.5% and 8% of patients received a PARP inhibitor in the treatment and comparator arms, respectively; 29% and 42% of patients, respectively, received subsequent platinum therapy.
Danish: Som efterfølgende behandling, modtog 0,5 % og 8 % af patienterne en PARP-inhibitor i henholdsvis behandlings- og komparator-armene; henholdsvis 29 % og 42 % af patienterne fik efterfølgende platinbehandling.
English: Induction of CYP1A2, 2B6 and 3A4 has been shown in vitro with CYP2B6 being most likely to be induced to a clinically relevant extent.
Danish: Der er blevet vist induktion af CYP1A2, CYP2B6 og CYP3A4 in vitro, hvor CYP2B6 er den, der mest sandsynligt induceres i klinisk relevant omfang.
English: • The doses of Lynparza capsules and tablets are not the same.
Danish: • Doserne i Lynparza kapsler og tabletter er ikke de samme.
English: Chemotherapy (N = 97) Olaparib 300 mg twice daily (N = 205)
Danish: Kemoterapi (N = 97) Olaparib 300 mg to gange dagligt (N = 205)
English: Very common Cough a, Dyspnoea
Danish: Meget almindelig Hoste a, dyspnø
English: Sixty-three percent (63%) of the patients had upfront debulking surgery and of these the majority (75%) had no macroscopic residual disease.
Danish: 63 % af patienterne havde primær debulking kirurgi, og af disse havde størstedelen (75 %) ingen makroskopisk residualsygdom.
English: No statistically significant differences were observed between olaparib and placebo in patient reported symptoms or HRQoL as measured by improvement and worsening rates in the FACT/NCCN Ovarian Symptom Index (FOSI), Trial Outcome Index (TOI) and Functional Analysis of Cancer TherapyOvarian total score (FACT-O total).
Danish: Der blev ikke observeret nogen statistisk signifikante forskelle mellem olaparib og placebo blandt patientrapporterede symptomer eller helbredsrelateret livskvalitet som målt ved forbedrings- og forværringsrater i FACT/NCCN Ovarian Symptom Index (FOSI), Trial Outcome Index (TOI) og Functional Analysis of Cancer Therapy-Ovarian total score (FACT-O total).
English: Based on its mechanism of action (PARP inhibition), Lynparza could cause foetal harm when administered to a pregnant woman.
Danish: Lynparza kan, baseret på dets virkningsmekanisme (PARP-hæmning), forårsage føtal skade, når det administreres til en gravid kvinde.
English: Number of patients at risk Olaparib 300 mg twice daily tablet
Danish: Antal patienter i risikogruppen Olaparib 300 mg tablet to gange dagligt
English: Ninety three percent (93%) of patients were randomised within 8 weeks of their last dose of platinum-based chemotherapy.
Danish: 93 % af patienterne blev randomiseret inden for 8 uger af deres sidste dosis platinbaserede kemoterapi.
English: • Capsule content: lauroyl macrogol-32 glycerides.
Danish: • Kapselindhold: lauroylmacrogol-32-glycerider.
English: Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1).
Danish: Patienterne skal tidligere have været i behandling med et antracyklin og et taxan til (neo)adjuverende eller metastatisk regi, medmindre patienterne ikke var egnede til disse behandlinger (se pkt.
English: There were 389 patients who were germline BRCA1/2m and 2 who were somatic BRCA1/2m in SOLO1.
Danish: Der var 389 patienter med germline BRCA1/2m og 2 med somatisk BRCA1/2m i SOLO1.
English: Retreatment with olaparib was not permitted following progression on olaparib.
Danish: Gentagen behandling med olaparib var ikke tilladt efter progression på olaparib.
English: There was no evidence of disease at study entry (CR), defined by the investigator as no radiological evidence of disease and cancer antigen 125 (CA-125) within normal range, in 73% and 77% of patients in the olaparib and placebo arms, respectively.
Danish: Der var ingen påvist sygdom ved indtræden i studiet (CR), defineret af investigator som intet radiologisk bevis på sygdom og cancerantigen 125 (CA-125) inden for det normale interval, hos 73 % og 77 % af patienterne i henholdsvis olaparib- og placeboarmene.
English: Consequently, Lynparza may be taken without regard to food (see section 4.2).
Danish: Derfor kan Lynparza tages uden hensyntagen til fødevarer (se pkt.
English: OS analysis in patients with no prior chemotherapy for metastatic breast cancer indicated benefit in these patients with a HR of 0.45 (95% CI 0.27-0.77), while for further lines of therapy HR exceeded 1.
Danish: OS-analyse hos patienter uden forudgående kemoterapi for metastatisk brystcancer indikerede fordele for disse patienter med en HR på 0,45 (95 % CI 0,27-0,77), mens for yderligere behandlingslinjer overskred HR 1.
English: 56 film-coated tablets (7 blisters).
Danish: 56 filmovertrukne tabletter (7 blisterkort).
English: • allergic reactions (e.g. hives, difficulty breathing or swallowing, dizziness which are signs and symptoms of hypersensitivity reactions).
Danish: • allergiske reaktioner (fx nældefeber, vejrtrækningsbesvær eller synkebesvær, svimmelhed, som alle er tegn og symptomer på overfølsomhedsreaktioner).
English: Appropriate clinical monitoring is recommended for patients receiving CYP3A substrates with a narrow therapeutic margin concomitantly with olaparib.
Danish: Det anbefales at udføre passende klinisk monitorering af patienter, der får CYP3A-substrater med en snæver terapeutisk margin samtidig med olaparib.
English: In normal cells, homologous recombination repair (HRR), which requires functional BRCA1 and 2 genes, is effective at repairing these DNA DSBs.
Danish: I normale celler er homolog rekombinationsreparation (HRR), som kræver funktionelle BRCA1- og -2-gener, effektiv til at reparere disse DNA-DSB'er.
English: There are no animal studies on the excretion of olaparib in breast milk.
Danish: Der findes ingen dyrestudier om udskillelse af olaparib i modermælk.
English: In rats, minimal degenerative effects on gastrointestinal tract were also noted.
Danish: Hos rotter blev der også bemærket minimale degenerative virkninger på mave-tarm-kanalen.
English: Following oral administration of olaparib via the capsule formulation, absorption is rapid with peak plasma concentrations typically achieved between 1 to 3 hours after dosing.
Danish: Efter oral administration af olaparib via kapselformuleringen er absorptionen hurtig, typisk med højeste plasmakoncentrationer opnået mellem 1 til 3 timer efter dosering.
English: Patients should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
Danish: Patienterne bør påbegynde behandling med Lynparza senest 8 uger efter afslutning af den sidste dosis af det platinholdige regime.
English: • Your doctor will tell you how many capsules of Lynparza to take.
Danish: • Lægen vil fortælle dig, hvor mange kapsler Lynparza, du skal tage.
English: Secondary efficacy endpoints included PFS2; OS, TDT, TFST, TSST; and HRQoL.
Danish: Sekundære endepunkter omfattede PFS2; OS, TDT, TFST, TSST og HRQoL.
English: Instead, alternative and error-prone pathways are activated, such as the classical non-homologous end joining (NHEJ) pathway, leading to increased genomic instability.
Danish: I stedet for aktiveres alternative og fejlbehæftede reparationsmekanismer, såsom den klassiske ikke-homologe endesammenføjning (NHEJ), hvilket fører til øget genomisk ustabilitet.
English: Ovarian cancer Lynparza is indicated as monotherapy for the:
Danish: Ovariecancer Lynparza er indiceret som monoterapi til:
English: PFS - DCO 30 June 2010
Danish: PFS - DCO 30. juni 2010
English: In the olaparib-treated group, 28.4% of patients remained on treatment for ≥2 years and 14.9% for ≥5 years.
Danish: I den olaparibbehandlede gruppe forblev 28,4 % af patienterne i behandlingen i ≥2 år og 14,9 % i ≥5 år.
English: In the olaparib arm 8% with measurable disease had a complete response versus 1.5% of patients in the comparator arm; 74/167 (44%) of patients in the olaparib arm had a partial response versus 14/66 (21%) of patients in the chemotherapy arm.
Danish: I olaparib-armen havde 8 % med målbar sygdom et komplet respons versus 1,5 % af patienterne i komparator-armen; 74/167 (44 %) af patienterne i olaparib-armen havde et delvist respons versus 14/66 (21 %) af patienterne i kemoterapi-armen.
English: Female partners of male patients must also use highly effective contraception if they are of childbearing potential (see section 4.4).
Danish: Kvindelige partnere til mandlige patienter skal også anvende højeffektiv antikonception, hvis de er i den fertile alder (se pkt.
English: • You must use a condom when having sex with a female partner, even if she is pregnant, while taking Lynparza and for 3 months after taking the last dose.
Danish: • Du skal bruge kondom, når du har sex med en kvindelig partner, også selvom hun er gravid, mens du tager Lynparza og i 3 måneder efter at have taget den sidste dosis.
English: Dyspnoea includes PTs of dyspnoea and dyspnoea exertional; Stomatitis includes PTs of aphthous ulcer, mouth ulceration and stomatitis.
Danish: Dyspnø omfatter de foretrukne termer for dyspnø og funktionsdyspnø; Stomatitis omfatter de foretrukne termer for aftøs ulcus, ulceration i munden og stomatitis.
English: Using the same assay, the fraction bound to alpha-1 acid glycoprotein was 29% at 10 µg/mL with a trend of decreased binding at higher concentrations.
Danish: Ved anvendelse af den samme analyse var den fraktion, der var bundet til surt alfa-1-glykoprotein 29 % ved 10 µg/ml med en tendens til nedsat binding ved højere koncentrationer.
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer:
Danish: gBRCA1/2-muteret HER2-negativ metastatisk brystcancer:
English: In vitro, human plasma protein binding of olaparib was dose-dependent; the fraction bound was approximately 91% at 1 µg/mL, reducing to 82% at 10 µg/mL and to 70% at 40 µg/mL.
Danish: In vitro var den humane plasmaproteinbinding af olaparib dosisafhængig; den bundne fraktion var ca. 91 % ved 1 µg/ml, faldt til 82 % ved 10 µg/ml og til 70 % ved 40 µg/ml.
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common ( 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Danish: Hyppighed for forekomsten af bivirkninger er defineret som: meget almindelig (≥ 1/10); almindelig ( 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Very common Fatigue (including asthenia)
Danish: Meget almindelig Træthed (inklusive asteni)
English: • if you experience any new or worsening symptoms of shortness of breath, coughing or wheezing.
Danish: • hvis du oplever nye eller forværrede symptomer på kortåndethed, hoste eller hvæsen.
English: Large rearrangements in the BRCA1/2 genes were detected in 5.5% (21/383) of the randomised patients.
Danish: Større omarrangeringer i BRCA1/2-generne blev detekteret hos 5,5 % (21/383) af de randomiserede patienter.
English: --------------Placebo bd - - - - - - - - - Olaparib 400 mg bd Number of patients at risk:
Danish: --------------Placebo bd - - - - - - - - - Olaparib 400 mg bd Antal patienter i risiko:
English: Among the patients entering the trial with measurable disease (target lesions at baseline), an objective response rate of 41% was achieved in the Lynparza arm versus 17% on placebo.
Danish: Blandt patienterne, der deltog i studiet med målbar sygdom (mål-læsioner ved baseline) blev der opnået en objektiv responsrate på 41 % i Lynparza-armen versus 17 % på placebo.
English: It is not known whether olaparib or its metabolites are found in seminal fluid.
Danish: Det vides ikke, om olaparib eller dets metabolitter findes i sædvæske.
English: All patients had evidence of gBRCA1/2m at baseline.
Danish: Der var evidens for, at alle patienter ved baseline havde gBRCA1/2m.
English: Lynparza is supplied in packs containing 56 film-coated tablets (7 blisters of 8 tablets each), or multipacks containing 112 (2 packs of 56) film-coated tablets.
Danish: Lynparza leveres i pakninger indeholdende 56 filmovertrukne tabletter (7 blisterkort med 8 tabletter i hver), eller multipakninger indeholdende 112 (2 pakninger a 56) filmovertrukne tabletter.
English: Instead, alternative and error-prone pathways are activated, such as the non-homologous end joining (NHEJ) pathway, leading to increased genomic instability.
Danish: I stedet for aktiveres alternative og fejlbehæftede stier, såsom den ikke-homologe endesammenføjning (NHEJ)-sti, hvilket fører til øget genomisk ustabilitet.
English: Median time to first onset of anaemia was approximately 4 weeks (approximately 7 weeks for CTCAE grade ≥3 events).
Danish: Mediantiden til første forekomst af anæmi var ca. 4 uger (ca. 7 uger for bivirkninger af CTCAE grad ≥ 3).
English: • The doses of Lynparza tablets and capsules are not the same.
Danish: • Doserne i Lynparza tabletter og kapsler er ikke de samme.
English: Common Stomatitis
Danish: Almindelig Stomatitis
English: Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment.
Danish: Lynparza kan administreres til patienter med let nedsat nyrefunktion (kreatininclearance 51 til 80 ml/min) uden dosisjustering.
English: months n-olaparib 74 n-placebo
Danish: Måneder n-olaparib n-placebo
English: Lynparza has moderate influence on the ability to drive and use machines.
Danish: Lynparza påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: • low white blood cell count (leukopenia or neutropenia) which may decrease your ability to fight infection and may be associated with fever.
Danish: • lavt antal hvide blodlegemer (leukopeni eller neutropeni), som kan nedsætte din evne til at bekæmpe infektioner, og som kan være forbundet med feber.
English: Component of a multipack, not to be sold separately.
Danish: Må ikke sælges separat.
English: Secondary endpoints included PFS2, OS, objective response rate (ORR) and HRQoL.
Danish: De sekundære endepunkter omfattede PFS2, OS, objektiv responsrate (ORR) og HRQoL.
English: Myelodysplastic syndrome/Acute myeloid leukaemia The overall incidence of myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML) in patients treated in clinical trials with Lynparza monotherapy, including long-term survival follow-up, was <1.5% and the majority of events had a fatal outcome.
Danish: Den samlede forekomst af myelodysplastisk syndrom/akut myeloid leukæmi (MDS/AML) hos patienter, som blev behandlet alene med Lynparza i kliniske studier, herunder langtidsopfølgning af overlevelse, var <1,5 %, og størstedelen af tilfældene havde dødelig udgang.
English: Lynparza is used for the treatment of a type of ovarian cancer called “BRCA-mutated ovarian cancer”.
Danish: Lynparza anvendes til behandling af en type kræft i æggestokkene, som kaldes “BRCA-muteret ovariecancer”.
English: • feeling short of breath, feeling very tired, pale skin or fast heart beat - these may be symptoms of a decrease in the number of red blood cells (anaemia).
Danish: • en følelse af åndenød, en følelse af ekstrem træthed, bleg hud eller hurtigt puls - dette kan være symptomer på et fald i antallet af røde blodlegemer (anæmi).
English: Median PFS (months)
Danish: Gennemsnit af PFS (måneder)
English: In vitro, CYP3A4/5 were shown to be the enzymes primarily responsible for the metabolism of olaparib (see section 4.5).
Danish: In vitro blev CYP3A4/5 påvist at være de enzymer, som primært var ansvarlige for metabolisme af olaparib (se pkt.
English: C-olaparib to female patients, unchanged olaparib accounted for the majority of the circulating radioactivity in plasma (70%) and was the major component found in both urine and faeces (15% and 6% of the dose, respectively).
Danish: C-olaparib til kvindelige patienter udgjorde uforandret olaparib størstedelen af den radioaktivitet, der var i kredsløb i plasma (70 %) og var den væsentligste komponent, som blev fundet i både urin og fæces (henholdsvis 15 % og 6 % af dosen).
English: If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.
Danish: Hvis pneumonitis bekræftes, bør behandling med Lynparza ophøre, og patienten bør få passende behandling.
English: The incidence of dose interruptions, reductions and discontinuations due to an adverse event was 34.6%, 25.7% and 5.9%, respectively.
Danish: Forekomsten af dosisafbrydelser, -reduktioner og -seponeringer på grund af en bivirkning var henholdsvis 34,6 %, 25,7 % og 5,9 %.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of olaparib in paediatric patients.
Danish: Pædiatrisk population Der er ikke udført nogen studier for at undersøge olaparibs farmakokinetik hos pædiatriske patienter.
English: What Lynparza is used for
Danish: Hvad Lynparza anvendes til
English: Within the BRCA-mutated population the disease control rate at 24 weeks was 57% and 24% for patients in the olaparib and placebo groups, respectively.
Danish: Inden for den BRCA-muterede population var sygdomskontrolraten ved 24 uger henholdsvis 57 % og 24 % for patienter i olaparib- og placebogruppen.
English: Olaparib inhibits CYP3A4 in vitro and is predicted to be a mild CYP3A inhibitor in vivo.
Danish: Olaparib hæmmer CYP3A4 in vitro og forventes at være en svag CYP3A-inhibitor in vivo.
English: In the placebo-treated group, 8.1% of patients remained on treatment for ≥2 years and 1.6% for ≥5 years.
Danish: I den placebobehandlede gruppe forblev 8,1 % af patienterne i behandling i ≥2 år og 1,6 % i ≥5 år.
English: Local or central testing of blood or tumour samples for BRCA1/2 mutations has been used in different studies.
Danish: Lokal eller central test af blod- eller tumorprøver for BRCA1/2-mutationer er blevet anvendt i forskellige studier.
English: PR, defined as the presence of any measurable or non-measurable lesions at baseline or elevated CA-125, was reported in 27% and 23% of patients in the olaparib and placebo arms, respectively.
Danish: PR, defineret som tilstedeværelsen af målbare eller ikkemålbare læsioner ved baseline eller forhøjet CA-125, blev rapporteret hos 27 % og 23 % af patienterne i henholdsvis olaparib og placebo-armene.
English: Co-administration with food slowed the rate (tmax delayed by 2.5 hours and Cmax reduced by approximately 21%) but did not significantly affect the extent of absorption of olaparib (AUC increased 8%).
Danish: Administration samtidig med fødevarer satte hastigheden ned (tmax forsinket med 2,5 timer og Cmax reduceret med ca. 21 %), men påvirkede ikke signifikant omfanget af absorption af olaparib (AUC øget med 8 %).
English: Approximately a quarter of placebo-treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor.
Danish: Omkring en fjerdedel af de placebobehandlede patienter i den BRCA-muterede sub-gruppe (14/62; 22,6 %) fik en efterfølgende PARP-inhibitor.
English: Nausea was generally reported very early, with first onset within the first month of Lynparza treatment in the majority of patients.
Danish: Kvalme blev generelt rapporteret meget tidligt med første opståen inden for den første måned af behandling med Lynparza hos størstedelen af patienterne.
English: It is not known whether Lynparza passes into semen.
Danish: Det vides ikke, om Lynparza overføres til sæd.
English: Ovarian cancer was the primary tumour in >80% of the patients.
Danish: Ovariecancer var den primære tumor hos > 80 % af patienterne.
English: Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on Lynparza and not be pregnant at the beginning of treatment.
Danish: Kvinder i den fertile alder/antikonception hos kvinder Kvinder i den fertile alder bør ikke blive gravide, mens de er i behandling med Lynparza og må ikke være gravide, når behandlingen indledes.
English: (events/patients)
Danish: (hændelser/ patienter) (%)
English: Based on Kaplan-Meier estimates, the proportion of patients that were progression free at 24 and 36 months were 74% and 60% for olaparib versus 35% and 27% for placebo; the median follow-up time was 41 months for both the olaparib and placebo arms.
Danish: Baseret på Kaplan-Meier-estimater var andelen af patienter, som var progressionsfri efter 24 og 36 måneder 74 % og 60 % for olaparib versus 35 % og 27 % for placebo; den mediane opfølgningstid var 41 måneder for både olaparib- og placeboarmen.
English: • phenytoin, carbamazepine, phenobarbital - used as a sedative or to treat fits (seizures) and epilepsy
Danish: • phenytoin, carbamazepin, phenobarbital - anvendes som beroligende middel eller til at behandle kramper (krampeanfald) og epilepsi
English: If a patient develops severe haematological toxicity or blood transfusion dependence, treatment with Lynparza should be interrupted and appropriate haematological testing should be initiated.
Danish: Hvis en patient udvikler svær hæmatologisk toksicitet eller afhængighed af blodtransfusion, bør behandling med Lynparza afbrydes og passende hæmatologiske undersøgelser indledes.
English: In normal cells, homologous recombination repair (HRR) pathway is effective at repairing these DNA DSBs.
Danish: I normale celler er homolog rekombinationsreparation (HRR) effektiv til at reparere disse DNA-DSB'er.
English: Capsule content Lauroyl macrogol-32 glycerides
Danish: Kapselindhold Lauroylmacrogol-32-glycerider
English: Only PSR patients with partially platinum-sensitive disease (platinum-free interval of 6 to 12 months) and patients with platinum-sensitive disease (platinum-free interval of >12 months) who were in response following completion of last platinum-based chemotherapy were enrolled.
Danish: Kun PSR-patienter med delvist platinsensitiv sygdom (platinfrit interval på 6 til 12 måneder) og patienter med platinsensitiv sygdom (platinfrit interval på > 12 måneder), som var i respons efter fuldførelse af sidste platinbaserede kemoterapi, blev indrulleret.
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment and considered regularly throughout treatment.
Danish: Alle kvinder i den fertile alder skal have foretaget en graviditetstest inden behandlingen, og bør overvejes regelmæssigt under behandlingen.
English: Of the 94 patients on the placebo arm who received subsequent therapy, 49 (52%) received a PARP inhibitor.
Danish: Af de 94 patienter i placeboarmen, som fik efterfølgende behandling, fik 49 (52 %) en PARP-hæmmer.