natgillin/translations-raw huggingface dataset:
Opkastning medførte afbrydelse hos 10 % af de olaparibbehandlede patienter; ingen olaparibbehandlede patienter oplevede opkastning, som medførte dosisreduktion. 
Vomiting events led to interruption in 10% of olaparib-treated patients; no olaparib-treated patients experienced a vomiting event leading to dose reduction.
Incidensen af MDS/AML-tilfælde var sammenlignelig hos patienter med gBRCA1m og gBRCA2m (henholdsvis 1,7 % og 1,4 %). 
The incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.7% and 1.4%, respectively).
På tidspunktet for PFSanalysen havde 1 patient et bekræftet delvist respons med en responsvarighed på 9,7 måneder i olaparib-armen. 
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.
Lynparza er til oral anvendelse. 
Lynparza is for oral use.
Der er imidlertid ikke behov for dosisjustering på baggrund af etnicitet (se pkt. 
However, no dose adjustment is required on the basis of ethnicity (see section 5.2).
Der var ingen strategi for multiple tests for subgruppeanalyserne eller for alle patienterne TFST. 
There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST.
Median opfølgningstid hos censurerede patienter var 25,3 måneder for olaparib versus 26,3 måneder for komparator. 
The median follow-up time in censored patients was 25.3 months for olaparib versus 26.3 months for comparator.
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). 
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).
HDPE-plastikflaske med børnesikret lukning indeholdende 112 hårde kapsler. 
HDPE plastic bottle with a child-resistant closure containing 112 hard capsules.
• Én dosis (8 kapsler) Lynparza synkes med vand, én gang om morgenen og én gang om aftenen. 
• Take one dose (8 capsules) of Lynparza by mouth with water, once in the morning and once in the evening.
Olaparib udviste intet mutagent potentiale, men var klastogent i pattedyrsceller in vitro. 
Olaparib showed no mutagenic potential, but was clastogenic in mammalian cells in vitro.
Den anbefalede Lynparza-monoterapidosis er ikke egnet til kombination med myelosuppressive anticancerlægemidler. 
The recommended Lynparza monotherapy dose is not suitable for combination with myelosuppressive anticancer medicinal products.
I dyrestudier blev der ikke observeret nogen effekt på konception, men der er bivirkninger på embryoføtal overlevelse (se pkt. 
In animal studies, no effect on conception was observed but there are adverse effects on embryofoetal survival (see section 5.3).
Det vides ikke, om Lynparza kan påvirke effekten af visse hormonelle præventionsmidler. 
It is not known whether Lynparza may affect the effectiveness of some hormonal contraceptives.
Lynparza anvendes til behandling af: 
Lynparza is used for the treatment of:
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. 
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.
Ved multipel dosering blev der observeret en AUC-akkumulationsratio på 1,8, og PK viste sig at være tidsafhængig i en lav grad. 
On multiple dosing, an AUC accumulation ratio of 1.8 was observed and PK appeared to be time-dependent to a small extent.
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. 
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.
Derfor kan olaparib ved samtidig administration reducere eksponeringen for substrater for disse metaboliske enzymer og transportprotein. 
Therefore, olaparib upon co-administration may reduce the exposure to substrates of these metabolic enzymes and transport protein.
• du har visse bivirkninger, mens du tager Lynparza (se punkt 4). 
• you have certain side effects while you are taking Lynparza (see section 4).
Efter 2 år forblev 43 % olaparibbehandlede patienter progressionsfrie i sammenligning med kun 15 % placebobehandlede patienter. 
At 2 years, 43% olaparib-treated patients remained progression free compared with only 15% placebo-treated patients.
Der blev observeret konsistente resultater i subgruppen af patienter mht. påvist sygdom ved indtræden i studiet. 
Consistent results were observed in the subgroups of patients by evidence of the disease at study entry.
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. 
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.
Anæmi var den mest almindelige CTCAE grad ≥ 3 bivirkning, som blev rapporteret i kliniske studier. 
Anaemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies.
Der er påvist et eksponerings-respons-forhold mellem olaparib og fald i hæmoglobin. 
An exposure-response relationship between olaparib and decreases in haemoglobin has been demonstrated.
Graviditet/antikonception 
Pregnancy/contraception
Hvis du glemmer at tage Lynparza, skal du tage din næste normale dosis på det planlagte tidspunkt. 
If you forget to take Lynparza, take your next normal dose at its scheduled time.
Stigning i blodkreatinin Ikke almindelig 
Increase in blood creatinine Uncommon
Afhængig af den anvendte test samt international konsensus om klassifikation, er BRCA1/2-mutationerne blevet klassificeret som risikogivende/formodet risikogivende eller patogene/sandsynligvis patogene. 
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.
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. 
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.
Pædiatrisk population Der er ikke udført nogen studier med pædiatriske patienter. 
Paediatric population No studies have been conducted in paediatric patients.
Behandlingsvarigheden med olaparib til patienter, som udviklede MDS/AML, varierede fra < 6 måneder til > 2 år. 
The duration of therapy with olaparib in patients who developed MDS/AML varied from < 6 months to > 2 years.
Derfor bør der udvises forsigtighed, hvis disse lægemidler administreres samtidigt med Lynparza, og patienterne bør følges nøje. 
Therefore, caution should be taken if these medicinal products are co-administered with Lynparza and patients should be closely monitored.
Efter oral dosering af 
Following oral dosing of
Forekomsten af bivirkningen anæmi var 22,8% (CTCAEgrad ≥ 3 7,4%). 
The incidence of anaemia adverse reactions was 22.8% (CTCAE grade ≥3 7.4%).
Tabel 3 Resumé af progressionsfri overlevelse og samlet overlevelse: sBRCA-muteret population i Study 19 
Table 3 Summary of progression-free survival and overall survival: sBRCA mutated population in Study 19
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. 
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.
Behandlingsvarigheden med olaparib til patienter, som udviklede MDS/AML, varierede fra < 6 måneder til > 2 år; data med længere eksponeringvarighed er begrænsede. 
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.
Olaparib påvirker ikke tamoxifens farmakokinetik. 
Olaparib does not affect the pharmacokinetics of tamoxifen.
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. 
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.
PFS (DCO 30. juni 
PFS (DCO 30 June
Kassér Lynparza kapsler, der har været frosset. 
Throw away any Lynparza capsules that have been frozen.
Lynparza leveres i HDPE-plastikflasker indeholdende 112 hårde kapsler. 
Lynparza is provided in HDPE plastic bottles containing 112 hard capsules.
Der var ingen strategi for multiple tests for sub-gruppeanalyserne. 
There was no strategy for multiple testing in place for the sub-group analyses.
Meget almindelig Svimmelhed, hovedpine, dysgeusi 
Very common Dizziness, Headache, Dysgeusia
Pneumonitis, herunder hændelser med dødelig udgang, er rapporteret hos <1,0 % af patienterne, behandlet med Lynparza i kliniske studier. 
Pneumonitis, including events with a fatal outcome, has been reported in <1.0% of patients treated with Lynparza in clinical studies.
I Study 19 blev der identificeret 20 patienter med en somatisk tumor-BRCA-mutation (en mutation i tumoren, men vildtype i germline). 
In Study 19, 20 patients were identified with a somatic tumour BRCA mutation (a mutation in the tumour but wildtype in the germline).
Kvindelige patienter: 
Female patients:
Meget almindelige bivirkninger, der kan ses i blodprøver: 
Very common side effects that may show up in blood tests:
Studiet viste en klinisk relevant og statistisk signifikant forbedring af investigatorvurderet PFS for olaparib sammenlignet med placebo. 
The study demonstrated a clinically relevant and statistically significant improvement in investigator assessed PFS for olaparib compared to placebo.
Farmakoterapeutisk klassifikation: antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX46 
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX46
I sjældne tilfælde kan dette være et tegn på mere alvorlige problemer med knoglemarven, såsom "myelodysplastisk syndrom" (MDS) eller "akut myeloid leukæmi" (AML). 
Rarely, these may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Kombination med anastrozol, letrozol og tamoxifen Der er blevet udført et klinisk studie til vurdering af kombinationen af olaparib og anastrozol, letrozol eller tamoxifen. 
Combination with anastrozole, letrozole and tamoxifen A clinical study has been performed to assess the combination of olaparib with anastrozole, letrozole or tamoxifen.
Data, der viser klinisk validering af tumor BRCA1/2-test i brystcancer, er ikke tilgængelige på nuværende tidspunkt. 
Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available.
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. 
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.
Det anbefales også at undlade at indtage grapefrugtjuice under behandling med Lynparza, da det er en CYP3A-inhibitor. 
It is also not recommended to consume grapefruit juice while on Lynparza therapy as it is a CYP3A inhibitor.
gBRCA1/2-muteret HER2-negativ metastatisk brystcancer OlympiAD (Studie D0819C00003) 
gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
• træthed eller svaghed 
• feeling tired or weak
Ikke almindelig Stigning i blodkreatinin 
Uncommon Increase in blood creatinine
• anden medicin mod kræft 
• any other anticancer medicines
Lynparzas sikkerhed og virkning hos børn og unge er ikke klarlagt. 
The safety and efficacy of Lynparza in children and adolescents has not been established.
Ikke almindelig Hypersensitivitet a, dermatitis 
Uncommon Hypersensitivity a, Dermatitis
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. 
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).
Skift ikke til Lynparza tabletter, medmindre din læge fortæller dig det 
Do not switch to Lynparza tablets unless your doctor tells you
De sekundære endepunkter TFST og PFS2 viste en vedvarende og statistisk signifikant forbedring for olaparib sammenlignet med placebo (Tabel 4). 
The secondary endpoints TFST and PFS2 demonstrated a persistent and statistically significant improvement for olaparib compared with placebo (Table 4).
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. 
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.
Bivirkningerne er opstillet efter MedDRA-systemorganklasse (SOC) og derefter efter den foretrukne MedDRA-term i Tabel 1. 
Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 1.
Der blev ikke observeret nogen signifikant interaktion med anastrozol eller letrozol, hvorimod tamoxifen reducerede eksponeringen for olaparib med 27 %. 
No significant interaction was observed with anastrozole or letrozole, whereas tamoxifen decreased exposure to olaparib by 27%.
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). 
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).
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. 
By central germline testing, deleterious or suspected deleterious mutations were identified in 95.3% (365/383) and 4.7% (18/383) of patients, respectively.
Det er ukendt, om olaparib eller dets metabolitter udskilles i human mælk. 
It is unknown whether olaparib or its metabolites are excreted in human milk.
I cancertyper, der mangler de funktionelle komponenter af HRR såsom BRCA1 eller 2, kan DNADSB'er ikke repareres nøjagtigt eller effektivt. 
In cancers that lack functional components of HRR such as BRCA1 or 2, DNA DSBs cannot be repaired accurately or effectively.
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. 
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.
• dabigatran - anvendes til at fortynde blodet 
• dabigatran - used to thin the blood
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). 
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.
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. 
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.
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. 
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.
Patienterne blev stratificeret efter respons på platinbaseret førstelinjekemoterapi; komplet respons (CR) eller delvist respons (PR). 
Patients were stratified by response to first-line platinum chemotherapy; complete response (CR) or partial response (PR).
Alle patienterne havde potentielle bidragende faktorer for udvikling af MDS/AML, idet de tidligere havde fået platinholdig kemoterapi. 
All patients had potential contributing factors for the development of MDS/AML, having received previous chemotherapy with platinum agents.
Din læge har udskrevet Lynparza filmovertrukne tabletter til dig. 
Your doctor has prescribed Lynparza film-coated tablets for you.
• proteaseinhibitorer boostet med ritonavir eller cobicistat, boceprevir, telaprevir, nevirapin, 
• protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine,
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). 
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).
Lynparza kan påvirke din evne til at føre motorkøretøj og betjene maskiner. 
Lynparza may influence your ability to drive and use machines.
• hvis du er allergisk over for olaparib eller et af de øvrige indholdsstoffer i dette lægemiddel 
• if you are allergic to olaparib or any of the other ingredients of this medicine (listed in section 6)
Olaparib er en type kræftmedicin, der kaldes en PARP-inhibitor (poly [adenosindifosfatribose]polymerase inhibitor). 
Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).
CYP3A4/5 er de isozymer, der hovedsageligt er ansvarlige for den metaboliske clearance af olaparib. 
CYP3A4/5 are the isozymes predominantly responsible for the metabolic clearance of olaparib.
Hvis du har glemt at tage Lynparza 
If you forget to take Lynparza
• rifampicin, rifapentin, rifabutin - anvendes mod bakterieinfektioner, herunder tuberkulose (TB) 
• rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
Hvis blodparametrene forbliver klinisk unormale efter 4 ugers afbrydelse af behandling med Lynparza, anbefales analyse af knoglemarv og/eller cytogenetisk analyse af blodet. 
If the blood parameters remain clinically abnormal after 4 weeks of Lynparza dose interruption, bone marrow analysis and/or blood cytogenetic analysis are recommended.
Når der blev givet doser oralt til rotter, inducerede olaparib mikronuclei i knoglemarven. 
When dosed orally to rats, olaparib induced micronuclei in bone marrow.
Påvirkning fra andre lægemidler på olaparib 
Effect of other medicinal products on olaparib
Det kan heller ikke udelukkes, at olaparib potentielt kan inducere CYP2C9, CYP2C19 og P-gp. 
The potential for olaparib to induce CYP2C9, CYP2C19 and P-gp can also not be excluded.
Nogle af patienterne havde en historik med cancer eller knoglemarvsdysplasi. 
Some of the patients had a history of previous cancer or of bone marrow dysplasia.
Kvalme medførte dosisafbrydelse og dosisreduktion hos henholdsvis 14 % og 4 % af de olaparibbehandlede patienter. 
Nausea events led to dose interruption and dose reductions in 14% and 4%, respectively, of olaparib-treated patients.
Patienterne blev randomiseret til studiet gennemsnitligt 40 dage efter at have fuldført deres sidste platinkemoterapi. 
Patients were randomised into the study a median of 40 days after completing their final platinum chemotherapy.
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). 
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.
Der er ingen data for patienter med svært nedsat leverfunktion (Child-Pugh klassifikation C). 
There are no data in patients with severe hepatic impairment (Child-Pugh classification C).
Dosisafbrydelserne og -reduktionerne forekom hyppigst i de første 3 måneder af behandlingen. 
Dose interruptions and reductions occurred most frequently in the first 3 months of treatment.
Den mest almindelige histologiske type var serøs (> 90 %), endometrioid histologi blev rapporteret hos 6 % af patienterne. 
The most common histological type was serous (> 90%), endometrioid histology was reported in 6% of the patients.
Patienterne skulle have fået behandling med et antracyklin, medmindre det var kontraindiceret, og et taxan i enten (neo)adjuverende eller metastatisk regi. 
Patients must have received treatment with an anthracycline unless contraindicated and a taxane in either a (neo)adjuvant or metastatic setting.
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). 
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).
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. 
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.
Det anbefales, at behandlingen fortsættes indtil progression af den underliggende sygdom eller uacceptabel toksicitet. 
It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity.
Opkastning, diarré, kvalme, dyspepsi, øvre abdominalsmerter 
Vomiting, Diarrhoea, Nausea, Dyspepsia, Upper abdominal pain
Alle patienterne havde modtaget platinbaseret førstelinjebehandling. 
All patients had received first-line platinum-based therapy.