FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to unblinding of the study, tumours of patients were tested for the presence of HRD using an experimental HRD test, which evaluates three indirect measures of tumour genome instability: loss of heterozygosity, telomeric allelic imbalance (TAI), and large-scale state transitions.
Danish: Før afblinding af studiet blev patienternes tumorer testet for forekomst af HRD ved hjælp af en eksperimentel HRD-test, der vurderer 3 indirekte mål for tumorens genomstabilitet: tab af heterozygoti, TAI (telomerisk allel-ubalance) og store statusskift.
English: On the basis of the scientific conclusions for niraparib, the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing niraparib is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for niraparib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder niraparib, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels.
Danish: In vitro hæmmede niraparib dopamintransportøren DAT ved koncentrationsniveauer under humane eksponeringsniveauer.
English: The recommended starting dose is 3 capsules taken together once a day (total daily dose of 300 mg), with or without food.
Danish: Den anbefalede startdosis er 3 kapsler, der tages samlet 1 gang dagligt (samlet daglig dosis på 300 mg) med eller uden mad.
English: Zejula contains lactose
Danish: Zejula indeholder lactose
English: Neither niraparib nor M1 is a CYP3A4 inducer in vitro.
Danish: Hverken niraparib eller M1 er en CYP3A4-inducer in vitro.
English: Women of childbearing potential should not become pregnant while on treatment and should not be pregnant at the beginning of treatment.
Danish: Kvinder i den fødedygtige alder skal undgå at blive gravide, mens de er i behandling, og må ikke være gravide, når de starter behandlingen.
English: Secondary efficacy endpoints included chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), PFS after the first subsequent therapy (PFS2), time to second subsequent therapy (TSST) and OS (overall survival).
Danish: Sekundære effektmål omfattede kemoterapifrit interval (CFI), tid til første efterfølgende behandling (TFST), PFS efter den første efterfølgende behandling (PFS2), tid til anden efterfølgende behandling (TSST) og OS (samlet overlevelse).
English: Dyspnea, cough, nasopharyngitis
Danish: Dyspnø, hoste, nasopharyngitis
English: Animal reproductive and developmental toxicity studies have not been conducted.
Danish: Der er ikke udført dyreforsøg af reproduktions- og udviklingstoksicitet.
English: Febrile neutropenia was reported in 2 out of 367 patients in the NOVA trial leading to the frequency uncommon.
Danish: Febril neutropeni blev indberettet hos 2 ud af 367 patienter i NOVAstudiet, hvilket svarer til hyppigheden 'ikke almindelig'.
English: Effect of other medicinal products on niraparib
Danish: Andre lægemidlers indvirkning på niraparib
English: Brilliant blue FCF (E 133) Erythrosine (E 127) Tartrazine (E 102)
Danish: Brilliant blue FCF (E 133) Erythrosin (E 127) Tartrazin (E 102)
English: The combination of niraparib with vaccines or immunosuppressant agents has not been studied.
Danish: Kombinationen af niraparib og vacciner eller immunsupprimerende midler er ikke undersøgt.
English: Uncommon (may affect up to 1 in 100 people) • Reduction in the number of red blood cells, white blood cells and platelets
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) • Nedsat antal af røde og hvide blodlegemer samt blodplader
English: Frequencies of occurrence of undesirable effects 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 < 1/1,000); very rare (< 1/10,000).
Danish: til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden
English: If adverse reactions are not manageable with this strategy of dose interruption and reduction, it is recommended that Zejula be discontinued.
Danish: Hvis bivirkningerne ikke kan behandles med denne strategi med dosisafbrydelse og -nedsættelse, bør Zejula seponeres.
English: Table 1: Dose modifications for non-haematologic adverse reactions
Danish: Tabel 1: Dosisændringer ved ikke-hæmatologiske bivirkninger
English: Each hard capsule shell also contains the colouring agent tartrazine (E 102) [0.0172 mg].
Danish: Hver hård kapselskal indeholder desuden farvestoffet tartrazin (E 102) [0,0172 mg].
English: If there are other risk factors for bleeding such as co-administration of anticoagulation or antiplatelet medicinal products, consider interrupting these substances and/or transfusion at a higher platelet count.
Danish: Hvis der er andre risikofaktorer for blødning, såsom samtidig administration af antikoagulantia eller trombocythæmmere, skal det overvejes at afbryde disse lægemidler og/eller anvende transfusion for at øge trombocyttallet.
English: A high proportion of patients in both treatment arms in both cohorts had received 3 or more prior lines of chemotherapy, including 49 % and 34 % of niraparib patients in the gBRCAmut and non-gBRCAmut cohorts, respectively.
Danish: En høj patientandel i begge behandlingsarme i begge kohorter havde fået 3 eller flere forudgående kemoterapilinjer, herunder 49 % og 34 % af niraparibpatienterne i hhv. kohorte gBRCAmut og ikke-gBRCAmut.
English: Table 3: Adverse drug reactions: frequencies based on all-causality adverse events* System Organ Class
Danish: Tabel 3: Oversigt over bivirkninger: hyppigheder baseret på bivirkninger, uanset årsag* Organklasse
English: Randomisation within each cohort was stratified by time to progression after the penultimate platinum therapy before study enrollment (6 to < 12 months and ≥ 12 months); use or not of bevacizumab in conjunction with the penultimate or last platinum regimen; and best response during the most recent platinum regimen (complete response and partial response).
Danish: Randomiseringen inden for hver kohorte blev stratificeret efter tid til progression efter den næstsidste platinbehandling før inklusion i studiet (6 til < 12 måneder og ≥ 12 måneder), brug eller ingen brug af bevacizumab sammen med det næstsidste eller sidste platinregime samt bedste respons i det seneste platinregime (komplet respons og delvis respons).
English: What you need to know before you take Zejula Do not take Zejula
Danish: Det skal du vide, før du begynder at tage Zejula Tag ikke Zejula
English: • Sunburn-like reactions following exposure to light
Danish: • Reaktioner ved udsættelse for lys, der ligner solskoldninger
English: Bedtime administration may be a potential method for managing nausea.
Danish: Administration ved sengetid kan være en mulighed for at undertrykke kvalme.
English: Discontinuation due to hypertension occurred in < 1 % of patients.
Danish: Afbrydelse på grund af hypertension forekom hos < 1 % af patienterne.
English: Eligible patients were assigned to one of two cohorts based on the results of a germline BRCA mutation test.
Danish: Egnede patienter kom i en af to kohorter baseret på resultaterne af en test for BRCA-mutation i kimbanen.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Testing for tBRCA mutation and homologous recombination deficiency (HRD) was performed using the HRD test on tumour tissue obtained at the time of initial diagnosis or at the time of recurrence.
Danish: Der blev udført test for tBRCA-mutation og homolog rekombination-defekt (HRD) ved hjælp af HRDtesten på tumorvæv, der var udtaget på tidspunktet for den oprindelige diagnose eller for tilbagefald.
English: Zejula contains the active substance niraparib.
Danish: Zejula indeholder det aktive stof niraparib.
English: In the case that the adverse reaction recurs, it is recommended to reduce the dose.
Danish: Hvis bivirkningen vender tilbage, bør dosis nedsættes.
English: Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Danish: Tegnene kan være feber, kulderystelser, svaghed eller forvirring, hoste, smerter eller en brændende fornemmelse, når du tisser.
English: The data on niraparib in combination with cytotoxic medicinal products are limited.
Danish: Der er begrænsede data om niraparib i kombination med cytotoksiske lægemidler.
English: In the pivotal ENGOT-OV16 study, adverse reactions (ADRs) occurring ≥ 10 % of patients receiving Zejula monotherapy were nausea, thrombocytopenia, fatigue/asthenia, anaemia, constipation, vomiting, abdominal pain, neutropenia, insomnia, headache, decreased appetite, nasopharyngitis, diarrhoea, dyspnea, hypertension, dyspepsia, back pain, dizziness, cough, urinary tract infection, arthralgia, palpitations, and dysgeusia.
Danish: I det pivotale ENGOT-OV16-studie var de bivirkninger, der forekom hos ≥ 10 % af de patienter, som fik Zejula som monoterapi, kvalme, trombocytopeni, træthed/asteni, anæmi, obstipation, opkastning, mavesmerter, neutropeni, insomni, hovedpine, nedsat appetit, nasopharyngitis, diarré, dyspnø, hypertension, dyspepsi, rygsmerter, svimmelhed, hoste, urinvejsinfektion, artralgi, palpitationer og dysgeusi.
English: Population pharmacokinetic analyses indicated that age, weight and race had no significant impact on the pharmacokinetics of niraparib.
Danish: Farmakokinetiske populationsanalyser viste, at alder, vægt og race ikke har nogen signifikant indvirkning på niraparibs farmakokinetik.
English: Within each cohort, patients were randomised using a 2:1 allocation of niraparib and placebo.
Danish: Inden for hver kohorte blev patienterne randomiseret i forholdet 2:1 til niraparib eller placebo.
English: Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/bruising, anaemia).
Danish: Lægen kan anbefale en lavere dosis, hvis du får bivirkninger (såsom kvalme, træthed, unormal blødning, unormale blå mærker, blodmangel).
English: Haematologic adverse reactions have been observed during the treatment with Zejula especially during the initial phase of the treatment.
Danish: Hæmatologiske bivirkninger er observeret under behandling med Zejula, især i behandlingens startfase.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zejula in all subsets of the paediatric population in ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Zejula i alle undergrupper af den pædiatriske population ved ovariecancer (undtagen rhabdomyosarkom og kimcelletumorer).
English: The primary efficacy analysis for PFS was determined by blinded central independent assessment and was prospectively defined and assessed for the gBRCAmut cohort and the non-gBRCAmut cohort separately.
Danish: Den primære effektanalyse for PFS blev bedømt ved en central, blindet og uafhængig vurdering og blev prospektivt defineret og vurderet for gBRCAmut-kohorten og ikke-gBRCAmut-kohorten hver for sig.
English: • Inflammation or swelling of the air passages between the mouth and nose and the lungs,
Danish: • Betændelse eller hævelse i luftvejene mellem mund og næse og lungerne, bronkitis
English: Testing complete blood counts weekly for the first month, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended to monitor for clinically significant changes in any haematologic parameter during treatment (see section 4.2).
Danish: Test af det komplette blodtal ugentligt i den første måned, fulgt af månedlig overvågning under de næste 10 måneders behandling og med jævne mellemrum herefter, anbefales for at overvåge klinisk signifikante ændringer i alle hæmatologiske værdier under behandlingen (se pkt.
English: In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out.
Danish: In vitro er niraparib en svag inducer af CYP1A2 ved høje koncentrationer, og den kliniske relevans af denne virkning kan ikke udelukkes helt.
English: Radioactive recovery in the urine accounted for 47.5 % (range 33.4 % to 60.2 %) and in the feces for 38.8 % (range 28.3 % to 47.0 %) of the dose.
Danish: Den radioaktive udskillelse i urinen og fæces tegnede sig for hhv. 47,5 % (interval 33,4-60,2 %) og 38,8 % (interval 28,3-47,0 %) af dosis.
English: The following adverse reactions have been identified in the ENGOT-OV16 study in patients receiving Zejula monotherapy (see Table 3).
Danish: Følgende bivirkninger er identificeret i ENGOT-OV16-studiet hos patienter, som fik Zejula som monoterapi (se tabel 3).
English: Table 4 shows the results for the PFS primary endpoint for the primary efficacy populations (gBRCAmut cohort and the overall non-gBRCAmut cohort).
Danish: Tabel 4 viser resultaterne for det primære endepunkt PFS for primær effekt-populationerne (gBRCAmut-kohorten og ikke-gBRCAmut-kohorten overordnet set).
English: Therefore, caution should be taken if niraparib is used in combination with vaccines, immunosuppressant agents or with other cytotoxic medicinal products.
Danish: Der skal derfor udvises forsigtighed, hvis niraparib anvendes i kombination med vacciner, immunsupprimerende midler eller med andre cytotoksiske lægemidler.
English: In a population pharmacokinetic analysis of niraparib, the Vd/F was 1,074 L in cancer patients, indicating extensive tissue distribution of niraparib.
Danish: I en farmakokinetisk populationsanalyse af niraparib var Vd/F 1,074 l hos cancerpatienter, hvilket peger på en omfattende vævsfordeling af niraparib.
English: Hazard ratio (95 % CI) *CI denotes confidence interval, gBRCAmut germline BRCA mutation, and NR not reached
Danish: Hazard ratio (95 %-KI) *KI = konfidensinterval, gBRCAmut = BRCA-mutation i kimbanen, og NR = ikke nået
English: In mice, single doses of niraparib increased intracellular levels of dopamine and metabolites in cortex.
Danish: Hos mus øgede enkeltdoser niraparib de intracellulære niveauer af dopamin og metabolitter i cortex.
English: Platelet count < 100,000/μL
Danish: Trombocyttal < 100.000/μl
English: Tartrazine (E 102)
Danish: Tartrazin (E 102)
English: Recommendations for the management of adverse reactions are provided in Table 1.
Danish: Anbefalingerne for behandling af bivirkninger findes i tabel 1.
English: If further dose reduction is needed, a second dose reduction from two hard capsules daily (200 mg) to one capsule daily (100 mg) may be implemented.
Danish: Hvis yderligere dosisnedsættelse er nødvendig, kan endnu en dosisnedsættelse fra 2 hårde kapsler dagligt (200 mg) til 1 kapsel dagligt (100 m) gennemføres.
English: If MDS and/or AML are confirmed while on treatment with Zejula, treatment should be discontinued and the patient treated appropriately.
Danish: Hvis myelodysplastisk syndrom og/eller akut myeloid leukæmi bekræftes, mens patienten behandles med Zejula, skal behandlingen afbrydes, og patienten skal have passende behandling.
English: Zejula hard capsules contain lactose monohydrate.
Danish: Zejula hårde kapsler indeholder lactosemonohydrat.
English: Niraparib is a type of anti-cancer medicine called a PARP inhibitor.
Danish: Niraparib er en type kræftmedicin, der kaldes PARPhæmmere.
English: Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in a small number of patients who received Zejula or placebo.
Danish: Myelodysplastisk syndrom/akut myeloid leukæmi, herunder tilfælde med dødelig udgang, er indberettet hos nogle få patienter, som fik Zejula eller placebo.
English: Overall, MDS/AML has been reported in 7 out of 751 (0.9 %) patients treated with Zejula in clinical studies.
Danish: Der er samlet indberettet myelodysplastisk syndrom/akut myeloid leukæmi hos 7 ud af 751 (0,9 %) patienter, der blev behandlet med Zejula i kliniske studier.
English: Carcinogenicity studies have not been conducted with niraparib.
Danish: Der er ikke udført karcinogenicitetsstudier med niraparib.
English: Paediatric population No studies have been conducted in paediatric patients.
Danish: Der er ikke gennemført studier med pædiatriske patienter.
English: • Feeling of worry, nervousness, or unease
Danish: • Følelse af bekymring, nervøsitet eller utryghed
English: Zejula should not be taken if you are breast-feeding as it is not known if it passes into breast milk.
Danish: Du må ikke tage Zejula, hvis du ammer, da man ikke ved, om det udskilles i mælken.
English: To be eligible for niraparib treatment, the patient should be in response (CR or PR) following completion of last platinum based chemotherapy.
Danish: For at være egnet til niraparibbehandling bør patienten have udvist respons (komplet eller delvis) efter fuldførelse af den sidste platin-baserede kemoterapi.
English: Patient-reported outcome (PRO) data from validated survey tools (FOSI and EQ-5D) indicate that niraparib-treated patients reported no difference from placebo in measures associated with quality of life (QoL).
Danish: Data for patientrapporterede resultater fra validerede undersøgelsesværktøjer (FOSI og EQ-5D) tyder på, at niraparib-behandlede patienter ikke oplevede nogen forskel i forhold til placebo, når de blev adspurgt om forhold vedrørende livskvaliteten.
English: Haematologic adverse reaction requiring transfusion or haematopoietic growth factor support
Danish: Hæmatologisk bivirkning, der kræver støtte i form af transfusion eller hæmatopoietisk vækstfaktor
English: • Permanently discontinue Zejula.
Danish: Seponer Zejula permanent.
English: Missing dose
Danish: Manglende dosis
English: 84 × 1 hard capsules 56 × 1 hard capsules 28 × 1 hard capsules
Danish: 84 × 1 hårde kapsler 56 × 1 hårde kapsler 28 × 1 hårde kapsler
English: In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16.2 L/h in cancer patients.
Danish: I en farmakokinetisk populationsanalyse var niraparibs tilsyneladende totale clearance (CL/F) 16,2 l/h hos cancerpatienter.
English: • Elevated blood tests
Danish: • Forhøjede blodprøveværdier
English: • Fast heart beat may cause dizziness, chest pain or breathlessness
Danish: • Hurtig puls kan medføre svimmelhed, brystsmerter eller åndenød
English: gBRCAmut non-gBRCAmut
Danish: gBRCAmut ikke-gBRCAmut
English: Urinary tract infection, bronchitis
Danish: Urinvejsinfektion, bronkitis
English: Discontinuation due to thrombocytopenia events (thrombocytopenia and platelet count decreased) occurred in approximately 3 % of the patients.
Danish: Afbrydelse på grund af trombocytopeni-hændelser (trombocytopeni og nedsat antal trombocytter) skete hos ca. 3 % af patienterne.
English: A concomitant high-fat meal did not significantly affect the pharmacokinetics of niraparib after administration of 300 mg of niraparib.
Danish: Et samtidigt måltid med højt fedtindhold havde ingen signifikant indvirkning på niraparibs farmakokinetik efter administration af 300 mg niraparib.
English: • Being short of breath, feeling very tired, having pale skin, or fast heartbeat -- these may be signs of a low red blood cell count (anaemia).
Danish: • Åndenød, stor træthed, bleg hud eller hurtig puls - dette kan være tegn på et lavt antal røde blodlegemer (blodmangel (anæmi)).
English: Bronchitis, conjunctivitis
Danish: Bronkitis, konjunktivitis
English: High blood pressure
Danish: Højt blodtryk
English: When you are taking Zejula it may make you feel weak, tired or dizzy and therefore influence your ability to drive and use machines.
Danish: Du kan føle dig svag, træt eller svimmel, når du tager Zejula, og det påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: Headache, dizziness, dysgeusia
Danish: Hovedpine, svimmelhed, dysgeusi
English: Taking Zejula at bedtime may help you to manage nausea.
Danish: Hvis du tager Zejula ved sengetid, kan det hjælpe med til at undertrykke kvalme.
English: Other medicines and Zejula
Danish: Brug af anden medicin sammen med Zejula
English: The secondary endpoints CFI, TFST, and PFS2 demonstrated a statistically significant and persistent treatment effect in favour of the niraparib treatment arm in the gBRCAmut cohort and the overall non-gBRCAmut cohort (Table 5).
Danish: De sekundære endepunkter CFI, TFST og PFS2 viste en statistisk signifikant og vedvarende behandlingseffekt til fordel for niraparib-behandlingsarmen i gBRCAmut-kohorten og ikke-gBRCAmut-kohorten overordnet set (tabel 5).
English: Discontinuation due to neutropenia events occurred in 2 % of patients.
Danish: Afbrydelse på grund af neutropeni skete hos 2 % af patienterne.
English: Caution is recommended when niraparib is combined with active substances that undergo an uptake transport by OCT1 such as metformin.
Danish: Der bør udvises forsigtighed, når niraparib kombineres med aktive stoffer, der er underlagt optagelsestransport via OCT1, f.eks. metformin.
English: Dose reductions may be implemented based on adverse reactions.
Danish: Dosisnedsættelser kan gennemføres i forhold til bivirkninger.
English: Capsule shell Titanium dioxide (E 171) Gelatin
Danish: Titandioxid (E 171) Gelatine
English: Increased niraparib-induced cytotoxicity was observed in tumour cell lines with or without deficiencies in the BReast CAncer (BRCA) 1 and 2 tumour suppressor genes.
Danish: Øget niraparib-induceret cytotoksicitet sås i tumorcellelinjer med eller uden defekter i tumorsuppressorgenerne BReast CAncer (BRCA) 1 og 2.
English: Following multiple oral doses of niraparib from 30 mg to 400 mg once daily, accumulation of niraparib was approximately 2 to 3 folds.
Danish: Efter flere orale doser niraparib på fra 30 mg til 400 mg én gang dagligt var akkumulationen af niraparib ca. 2 til 3 gange så stor.
English: Caution is then recommended when niraparib is combined with substrates of BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin, and methotrexate).
Danish: Forsigtighed tilrådes derfor, når niraparib kombineres med substrater for BCRP (irinotecan, rosuvastatin, simvastatin, atorvastatin og methotrexat).
English: • Bruising or bleeding for longer than usual if you hurt yourself -- these may be signs of a low blood platelet count (thrombocytopenia).
Danish: • Blå mærker eller blødning, der varer længere end normalt, hvis du kommer til skade - dette kan være tegn på et lavt antal blodplader (trombocytopeni).
English: Niraparib is an inhibitor of poly(ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.
Danish: Niraparib er en hæmmer af poly (ADP-ribose) polymerase-/PARP-enzymerne PARP-1 og PARP-2, der spiller en rolle i reparationen af DNA.
English: Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) including clinical diagnoses and/or laboratory findings generally occurred early during niraparib treatment with the incidence decreasing over time.
Danish: Hæmatologiske bivirkninger (trombocytopeni, anæmi, neutropeni), herunder kliniske diagnoser og/eller laboratoriefund, forekom generelt tidligt i niraparib-behandlingen, og incidensen faldt med tiden.
English: Niraparib is not a substrate of bile salt export pump (BSEP).
Danish: Niraparib er ikke et substrat for galdesalteksportpumpen (BSEP).
English: In most cases, hypertension was controlled adequately using standard antihypertensive treatment with or without Zejula dose adjustment (see section 4.2).
Danish: Hypertension var i de fleste tilfælde tilstrækkeligt kontrolleret med gængs antihypertensiv behandling med eller uden dosisjustering af Zejula (se pkt.
English: Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
Danish: Hæmatologiske bivirkninger (trombocytopeni, anæmi, neutropeni) er indberettet hos patienter, der er behandlet med Zejula.
English: P value gBRCAmut non-gBRCAmut
Danish: P-værdi gBRCAmut ikke-gBRCAmut