FrancophonIA/ELRC3.0 huggingface dataset:
English: Alu/Alu non-perforated blister containing 8 film-coated tablets.
Danish: Alu/Alu ikke-perforeret blister indeholdende 8 filmovertrukne tabletter.
English: On multiple dosing there is no marked accumulation, with steady state exposures achieved within ~3 to 4 days.
Danish: Ved multipel dosering er der ingen udpræget akkumulering, og steady state-eksponering opnås inden for ~3 til 4 dage.
English: Exploratory analyses of TFST and TSST were also performed.
Danish: Der blev også udført eksplorative analyser af TFST og TSST.
English: • pain in the stomach area under the ribs (upper abdominal pain)
Danish: • smerter i maveområdet under ribbenene (øvre abdominalsmerter)
English: After this period, throw away any capsules that have not been used.
Danish: Efter denne periode kasséres eventuelle kapsler, der ikke er blevet brugt.
English: If your blood count falls to a low level, you may need to have a blood transfusion (where you are given new blood or blood-based products from a donor).
Danish: Hvis dit blodtal falder til et lavt niveau, kan du have behov for at få en blodtransfusion (hvor du vil få nyt blod eller blodbaserede produkter fra en donor).
English: These findings occurred at exposures below those seen clinically.
Danish: Disse fund forekom ved eksponeringer, som var under dem, der blev set klinisk.
English: The medicines listed here may not be the only ones that could affect Lynparza.
Danish: De ovennævnte typer medicin er måske ikke de eneste, der kan påvirke Lynparza.
English: • Take Lynparza once in the morning and once in the evening.
Danish: • Tag Lynparza én gang om morgenen og én gang om aftenen.
English: Gender (%) Female Male
Danish: Køn (%) Kvinder Mænd
English: Chemotherapy n=97
Danish: Kemoterapi n=97
English: • Swallow Lynparza tablets whole, with or without food.
Danish: • Synk Lynparza tabletter hele, med eller uden mad.
English: Lynparza should not be used during pregnancy.
Danish: Lynparza må ikke anvendes under graviditet.
English: • changes in taste of foods (dysgeusia)
Danish: • ændring af hvordan mad smager (dysgeusi)
English: Confirmed responses (by BICR) were defined as a recorded response of either CR/PR, confirmed by repeat imaging not less than 4 weeks after the visit when the response was first observed.
Danish: Bekræftet respons (af BICR) var defineret som et registreret respons af enten CR/PR, bekræftet ved gentagen scanning ikke mindre end 4 uger efter besøget, hvor responset blev observeret første gang.
English: There are limited clinical data available in non-Caucasian patients.
Danish: Der er begrænsede kliniske data tilgængelige for ikke-kaukasiske patienter.
English: • Take Lynparza at least one hour after eating food.
Danish: • Tag Lynparza mindst 1 time efter et måltid.
English: Hard capsule 112 capsules
Danish: Hårde kapsler 112 kapsler
English: Age - year (median)
Danish: Alder - år (median)
English: • if you are breast-feeding (see section 2 below for more information).
Danish: • hvis du ammer (se punkt 2 nedenfor for yderligere oplysninger).
English: Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med Lynparza bør indledes og overvåges af en læge med erfaring i anvendelse af anticancerlægemidler.
English: In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically.
Danish: I tilfælde af overdosering bør lægerne følge almene understøttende forholdsregler og behandle patienten symptomatisk.
English: Lynparza tablets should be swallowed whole and not chewed, crushed, dissolved or divided.
Danish: Lynparza tabletter skal synkes hele og ikke tygges, knuses, opløses eller deles.
English: Any capsules that have been frozen must be discarded.
Danish: Kapsler, der har været frosset, skal destrueres.
English: Seven male patients were randomised (5 olaparib and 2 comparator).
Danish: Syv mandlige patienter blev randomiseret (5 olaparib og 2 komparator).
English: Appropriate clinical monitoring is recommended for patients receiving this type of medicinal product concomitantly.
Danish: Passende klinisk monitorering anbefales til patienter, der får denne type lægemiddel samtidig.
English: The gBRCAm status of patients enrolled via local testing was confirmed retrospectively by central testing.
Danish: gBRCAm-statussen af patienter, som blev inkluderet via lokal test, blev bekræftet retrospektivt via central test.
English: (See previous paragraph: “Women of childbearing potential/contraception in females” for further information about birth control and pregnancy testing.)
Danish: (Se forrige afsnit ”Kvinder i den fertile alder/antikonception hos kvinder” for yderligere oplysninger om antikonception og graviditetsundersøgelser.)
English: Do not take Lynparza:
Danish: Tag ikke Lynparza:
English: Patients could have received prior bevacizumab, except in the regimen immediately prior to randomisation.
Danish: Patienterne kunne tidligere have modtaget bevacizumab, undtagen i regimet umiddelbart inden randomisering.
English: The metabolism of olaparib is extensive.
Danish: Metabolismen af olaparib er omfattende.
English: Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness.
Danish: Inden for hver SOC er de foretrukne termer opstillet efter faldende hyppighed og derefter efter hvor alvorlige de er.
English: In particular, caution should be exercised if olaparib is administered in combination with any statin.
Danish: Der bør især udvises forsigtighed, hvis olaparib administreres i kombination med statiner.
English: Lynparza tablets may be taken without regard to meals.
Danish: Lynparza tabletter kan tages uden hensyntagen til måltider.
English: Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous treatment, can be treated beyond 2 years.
Danish: Patienter med påvist sygdom efter 2 år, som efter den behandlende læges skøn kan få yderligere fordel af fortsat behandling, kan behandles ud over de 2 år.
English: Overall disease classification Metastatic
Danish: Samlet sygdomsklassifikation Metastatisk
English: There is limited experience of overdose with olaparib.
Danish: Der er begrænset erfaring med overdosering af olaparib.
English: Since it cannot be excluded that olaparib may reduce exposure to substrates of CYP2C9 through enzyme induction, the efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib.
Danish: Da det ikke kan udelukkes, at olaparib kan reducere eksponeringen af substrater for CYP2C9 via enzyminduktion, kan effektiviteten af nogle hormonelle antikonceptiva være nedsat ved samtidig administration af olaparib.
English: Patients had tumour assessments at baseline and every 12 weeks for 3 years, and then every 24 weeks relative to date of randomisation, until objective radiological disease progression.
Danish: Patienterne fik tumorvurdering ved baseline og hver 12. uge i 3 år og derefter hver 24. uge i forhold til randomiseringsdatoen, indtil objektiv radiologisk sygdomsprogression.
English: PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage.
Danish: PARP-inhibitorer kan ødelægge kræftceller, der ikke er gode til at reparere DNA-skader.
English: Other special populations Limited safety data are available in elderly (age  75 years) and non-Caucasian patients.
Danish: Andre særlige populationer Der er begrænsede sikkerhedsdata tilgængelige for ældre (alder  75 år) og ikke-kaukasiske patienter.
English: • decrease in the number of platelets in blood (thrombocytopenia) - you may notice the following symptoms:
Danish: • fald i antallet af blodplader i blodet (trombocytopeni) - du kan få følgende symptomer:
English: In repeat-dose toxicity studies of up to 6 months duration in rats and dogs, daily oral doses of olaparib were well-tolerated.
Danish: I toksicitetsstudier med gentagne doser af op til 6 måneders varighed med rotter og hunde var daglige orale doser af olaparib veltolererede.
English: events/patients
Danish: hændelser/patienter
English: If preferred, you can keep Lynparza capsules out of the refrigerator (below 30°C) for up to 3 months.
Danish: Hvis du foretrækker det, kan du opbevare Lynparza kapsler udenfor køleskabet (under 30°C) i op til 3 måneder.
English: Please tell your doctor if you are taking a hormonal contraceptive, as your doctor may recommend the addition of a non-hormonal contraceptive method.
Danish: Fortæl det til lægen, hvis du tager et hormonelt præventionsmiddel, da din læge kan anbefale at supplere med en ikke-hormonel beskyttelse mod graviditet.
English: • You should not take Lynparza if you are pregnant or might become pregnant.
Danish: • Du bør ikke tage Lynparza, hvis du er gravid eller måske bliver gravid.
English: Frequency of CTCAE grade 3 and above
Danish: Frekvens af CTCAE grad 3 og derover
English: Patients in the olaparib group continued to receive treatment longer than those in the placebo group.
Danish: Patienterne i olaparibgruppen fortsatte med at få behandling i længere tid end patienterne i placebogruppen.
English: The majority of the metabolism was attributable to oxidation reactions with a number of the components produced undergoing subsequent glucuronide or sulfate conjugation.
Danish: Størstedelen af metabolismen skyldtes oxideringsreaktioner, hvor en række af de producerede komponenter gennemgik efterfølgende glucuronid- eller sulfatkonjugering.
English: See section 4 for more information about these side effects, including the signs and symptoms you need to look out for (for example, fever or infection, bruising or bleeding).
Danish: Se punkt 4 for mere information om disse bivirkninger, herunder tegn og symptomer, som du skal holde øje med (for eksempel feber eller infektion, blå mærker eller blødning).
English: Clinical studies of olaparib in combination with other anticancer medicinal products, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
Danish: Kliniske undersøgelser af olaparib i kombination med andre anticancerlægemidler, herunder DNA-beskadigende lægemidler, indikerer en potensering og forlængelse af myelosuppressiv toksicitet.
English: No adjustment in starting dose is required for elderly patients.
Danish: Det er ikke nødvendigt at justere startdosis hos ældre patienter.
English: Carcinogenicity Carcinogenicity studies have not been conducted with olaparib.
Danish: Karcinogenicitet Der er ikke udført karcinogenicitetsstudier med olaparib.
English: What Lynparza is and how it works
Danish: Hvad Lynparza er, og hvordan det virker
English: Symptoms of overdose are not established and there is no specific treatment in the event of Lynparza overdose.
Danish: Symptomerne på overdosering er ikke fastslået, og der findes ingen specifik behandling i tilfælde af overdosering med Lynparza.
English: Frequency of All CTCAE grades
Danish: Frekvens af alle CTCAE grader
English: No unexpected adverse reactions were reported in a small number of patients who took a daily dose of up to 900 mg of olaparib tablets over two days.
Danish: Der er ikke rapporteret nogen uventede bivirkninger blandt et lille antal patienter, som tog en daglig dosis på op til 900 mg olaparib tabletter over to dage.
English: Do not eat preferably for up to 2 hours after taking Lynparza.
Danish: Du må helst ikke spise i op til 2 timer efter, du har taget Lynparza.
English: Do not drink grapefruit juice while you are being treated with Lynparza.
Danish: Du må ikke drikke grapefrugtjuice, mens du er i behandling med Lynparza.
English: Efficacy results are presented in Table 2 and Figures 1 and 2.
Danish: Effektresultater er præsenteret i tabel 2 og figur 1 og 2.
English: The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters.
Danish: Det væsentligste primære målorgan for toksicitet for begge arter var knoglemarven med associerede forandringer i perifere hæmatologiske parametre.
English: OUTER CARTON MULTIPACK -including the blue box
Danish: YDRE ÆSKE MULTIPAKNING - med blue box
English: There are very limited data in patients with a somatic BRCA mutation.
Danish: Der er meget begrænsede data hos patienter med somatisk BRCA-mutation.
English: Absence of fully functional HRR pathway is one of the key determinants of platinum sensitivity in ovarian and other cancers.
Danish: En ikke fuldt funktionel HRR-mekanisme er en af de vigtigste determinanter for platinsensitivitet i ovariecancer og andre cancertyper.
English: Previous anthracycline and taxane treatment
Danish: Tidligere behandling med antracyklin og taxan
English: • if you have low blood cell counts on testing.
Danish: • hvis du har lavt antal blodlegemer i en blodprøve.
English: This clastogenicity is consistent with the known pharmacology of olaparib and indicates potential for genotoxicity in man.
Danish: Denne klastogenicitet er i overensstemmelse med den kendte farmakologi af olaparib og indikerer potentiale for genotoksicitet hos mennesker.
English: When olaparib is bound to the active site of DNA-associated PARP it prevents the dissociation of PARP and traps it on the DNA, thus blocking repair.
Danish: Når olaparib bindes til det aktive site af DNA-associeret PARP, forhindrer det, at PARP dissocierer og indfanger det på DNA'et, hvorved der blokeres for reparation.
English: • you are taking certain medicines that may affect Lynparza (see section 2).
Danish: • du tager visse lægemidler, der kan påvirke Lynparza (se punkt 2).
English: No previous treatment with a PARP inhibitor, including olaparib, was permitted.
Danish: Ingen tidligere behandling med en PARP-inhibitor, herunder olaparib, var tilladt.
English: • a certain type of breast cancer (BRCA-mutated, HER2-negative) which has spread beyond the original tumour.
Danish: • en bestemt type brystkræft (BRCA-muteret, HER2-negativ), som har spredt sig ud over den oprindelige tumor.
English: The incidence of elevations in mean corpuscular volume from low or normal at baseline to above the ULN was approximately 55%.
Danish: Forekomsten af stigninger i middelcellevolumen fra lav eller normal ved baseline til over ULN var ca. 55 %.
English: Therefore, an additional non-hormonal contraceptive method should be considered during treatment (see section 4.5).
Danish: Derfor bør det overvejes at anvende en yderligere ikke-hormonel antikonceptionsmetode under behandlingen (se pkt.
English: These may be low counts for red or white blood cells or low platelet counts.
Danish: Dette kan være lavt antal røde eller hvide blodlegemer eller lavt antal blodplader.
English: Genetic testing should be conducted by an experienced laboratory using a validated test.
Danish: Genetisk test skal udføres af et erfarent laboratorium ved hjælp af en valideret test.
English: A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis).
Danish: Et lille antal patienter, som blev behandlet med Lynparza, rapporterede om lungebetændelse (pneumonitis).
English: New metastatic breast cancer (%) Hormone receptor status (%) HR+
Danish: Lokalt fremskreden Ny metastatisk brystcancer (%) Hormonreceptorstatus (%) HR+
English: Combination of olaparib with vaccines or immunosuppressant agents has not been studied.
Danish: Kombinationen af olaparib og vacciner eller immunsuppressive lægemidler er ikke undersøgt.
English: The clinical study report should be submitted by:
Danish: Den kliniske forsøgsrapport skal indsendes senest:
English: C-olaparib, ~86% of the dosed radioactivity was recovered within a 7-day collection period, ~44% via the urine and ~42% via the faeces.
Danish: C-olaparib blev ~86 % af den doserede radioaktivitet genfundet inden for en opsamlingsperiode på 7 dage, ~44 % via urinen og ~42 % via fæces.
English: Do not switch to Lynparza capsules unless your doctor tells you
Danish: Skift ikke til Lynparza kapsler, medmindre din læge fortæller dig det
English: efavirenz - used for viral infections, including HIV
Danish: efavirenz - anvendes mod virusinfektioner, herunder hiv
English: If you take more Lynparza than your normal dose, contact your doctor or nearest hospital straight away.
Danish: Hvis du tager mere Lynparza end din normale dosis, skal du straks kontakte din læge eller det nærmeste hospital.
English: In solutions of purified proteins, the olaparib fraction bound to albumin was approximately 56%, which was independent of olaparib concentrations.
Danish: I opløsninger af rensede proteiner var olaparibfraktionen, der var bundet til albumin, ca. 56 %, som var uafhængig af olaparibkoncentrationerne.
English: Tests and checks Your doctor will check your blood before and during treatment with Lynparza.
Danish: Tests og undersøgelser Din læge vil undersøge dit blod inden og under behandlingen med Lynparza.
English: * (2-sided)
Danish: * (2-sidet)
English: 90% of patients had creatinine values of CTCAE grade 0 at baseline and 10% were CTCAE grade 1 at baseline.
Danish: 90 % af patienterne havde kreatininværdier på CTCAE grad 0 ved baseline, og 10 % var CTCAE grad 1 ved baseline.
English: For patients who remained in complete clinical response (i.e. no radiological evidence of disease), the maximum duration of treatment was 2 years; however, patients who had evidence of disease that remained stable (i.e. no evidence of disease progression) could continue to receive Lynparza beyond 2 years.
Danish: For patienter, som forblev i komplet klinisk respons (dvs. uden radiologisk påvist sygdom), var den maksimale varighed 2 år, men patienter, hvor det var påvist, at sygdommen forblev stabil (dvs. uden påvist sygdomsprogression) kunne fortsætte med at få Lynparza ud over de 2 år.
English: Effect of olaparib on other medicinal products
Danish: Påvirkning fra olaparib på andre lægemidler
English: Vomiting events led to interruption in 10% of olaparib-treated patients; no olaparib-treated patients experienced a vomiting event leading to dose reduction.
Danish: Opkastning medførte afbrydelse hos 10 % af de olaparibbehandlede patienter; ingen olaparibbehandlede patienter oplevede opkastning, som medførte dosisreduktion.
English: The incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.7% and 1.4%, respectively).
Danish: Incidensen af MDS/AML-tilfælde var sammenlignelig hos patienter med gBRCA1m og gBRCA2m (henholdsvis 1,7 % og 1,4 %).
English: At the time of the PFS analysis, 1 patient had a confirmed partial response with a duration of response of 9.7 months in the olaparib arm.
Danish: På tidspunktet for PFSanalysen havde 1 patient et bekræftet delvist respons med en responsvarighed på 9,7 måneder i olaparib-armen.
English: Lynparza is for oral use.
Danish: Lynparza er til oral anvendelse.
English: However, no dose adjustment is required on the basis of ethnicity (see section 5.2).
Danish: Der er imidlertid ikke behov for dosisjustering på baggrund af etnicitet (se pkt.
English: There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST.
Danish: Der var ingen strategi for multiple tests for subgruppeanalyserne eller for alle patienterne TFST.
English: The median follow-up time in censored patients was 25.3 months for olaparib versus 26.3 months for comparator.
Danish: Median opfølgningstid hos censurerede patienter var 25,3 måneder for olaparib versus 26,3 måneder for komparator.
English: A statistically significant improvement in PFS, the primary efficacy outcome, was demonstrated for olaparib-treated patients compared with those in the comparator arm (see Table 8 and Figure 6).
Danish: En statistisk signifikant forbedring af PFS, det primære effektresultat, blev påvist for olaparibbehandlede patienter sammenlignet med patienterne i komparator-armen (se tabel 8 og figur 6).
English: HDPE plastic bottle with a child-resistant closure containing 112 hard capsules.
Danish: HDPE-plastikflaske med børnesikret lukning indeholdende 112 hårde kapsler.
English: • Take one dose (8 capsules) of Lynparza by mouth with water, once in the morning and once in the evening.
Danish: • Én dosis (8 kapsler) Lynparza synkes med vand, én gang om morgenen og én gang om aftenen.
English: Olaparib showed no mutagenic potential, but was clastogenic in mammalian cells in vitro.
Danish: Olaparib udviste intet mutagent potentiale, men var klastogent i pattedyrsceller in vitro.
English: The recommended Lynparza monotherapy dose is not suitable for combination with myelosuppressive anticancer medicinal products.
Danish: Den anbefalede Lynparza-monoterapidosis er ikke egnet til kombination med myelosuppressive anticancerlægemidler.
English: In animal studies, no effect on conception was observed but there are adverse effects on embryofoetal survival (see section 5.3).
Danish: I dyrestudier blev der ikke observeret nogen effekt på konception, men der er bivirkninger på embryoføtal overlevelse (se pkt.
English: It is not known whether Lynparza may affect the effectiveness of some hormonal contraceptives.
Danish: Det vides ikke, om Lynparza kan påvirke effekten af visse hormonelle præventionsmidler.
English: Lynparza is used for the treatment of:
Danish: Lynparza anvendes til behandling af:
English: Both nausea and vomiting were reported to be intermittent for the majority of patients and can be managed by dose interruption, dose reduction and/or antiemetic therapy.
Danish: Både kvalme og opkastning blev rapporteret at være intermitterende for størstedelen af patienterne og kan håndteres ved afbrydelse af doseringen, dosisreduktion og/eller behandling med antiemetika.
English: On multiple dosing, an AUC accumulation ratio of 1.8 was observed and PK appeared to be time-dependent to a small extent.
Danish: Ved multipel dosering blev der observeret en AUC-akkumulationsratio på 1,8, og PK viste sig at være tidsafhængig i en lav grad.
English: In patients with mutations (changes) in certain genes called BRCA (breast cancer gene), who are at risk of developing some forms of cancer, PARP inhibitors are able to trigger the death of cancer cells by blocking an enzyme that helps repair DNA.
Danish: Hos patienter med mutationer (forandringer) i visse gener, der kaldes BRCA (brystcancergen), som har risiko for at udvikle visse typer kræft, kan PARP-inhibitorer slå kræftcellerne ihjel ved at blokere et enzym, der er med til at reparere DNA.
English: Therefore, olaparib upon co-administration may reduce the exposure to substrates of these metabolic enzymes and transport protein.
Danish: Derfor kan olaparib ved samtidig administration reducere eksponeringen for substrater for disse metaboliske enzymer og transportprotein.
English: • you have certain side effects while you are taking Lynparza (see section 4).
Danish: • du har visse bivirkninger, mens du tager Lynparza (se punkt 4).
English: At 2 years, 43% olaparib-treated patients remained progression free compared with only 15% placebo-treated patients.
Danish: Efter 2 år forblev 43 % olaparibbehandlede patienter progressionsfrie i sammenligning med kun 15 % placebobehandlede patienter.
English: Consistent results were observed in the subgroups of patients by evidence of the disease at study entry.
Danish: Der blev observeret konsistente resultater i subgruppen af patienter mht. påvist sygdom ved indtræden i studiet.
English: Lynparza 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.
Danish: Lynparza bør udelukkende anvendes til patienter med svært nedsat nyrefunktion, hvis fordelene opvejer den potentielle risiko, og patienten bør overvåges omhyggeligt for nyrefunktion og bivirkninger.
English: Anaemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies.
Danish: Anæmi var den mest almindelige CTCAE grad ≥ 3 bivirkning, som blev rapporteret i kliniske studier.
English: An exposure-response relationship between olaparib and decreases in haemoglobin has been demonstrated.
Danish: Der er påvist et eksponerings-respons-forhold mellem olaparib og fald i hæmoglobin.
English: Pregnancy/contraception
Danish: Graviditet/antikonception