FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor straight away if you notice any of the following SERIOUS side effects - you may need urgent medical treatment:
Danish: Kontakt straks lægen, hvis du får nogen af følgende ALVORLIGE bivirkninger, da du kan have behov for akut behandling:
English: Clinic visits occurred each cycle (4 weeks ± 3 days).
Danish: Der var klinikbesøg i hver cyklus (4 uger ± 3 dage).
English: *CTCAE=Common Terminology Criteria for Adverse Events
Danish: *CTCAE = Common Terminology Criteria for Adverse Events (fælles terminologiske kriterier for bivirkninger).
English: Hazard ratio (95 % CI) Time to first subsequent treatment
Danish: Hazard ratio (95 %-KI) Tid til første efterfølgende behandling
English: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established.
Danish: Niraparibs sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Patients who experience these symptoms should observe caution when driving or using machines.
Danish: Patienter, som oplever disse symptomer, skal udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
English: Your doctor will check you on a regular basis, and you will normally continue to take Zejula as long as you experience benefit, and do not suffer unacceptable side effects.
Danish: Lægen kontrollerer dig med jævne mellemrum, og du vil normalt kunne fortsætte med at tage Zejula, så længe du har fordel af det og ikke har uacceptable bivirkninger.
English: However, due to its high permeability and bioavailability, the risk of clinically relevant interactions with medicinal products that inhibit these transporters is unlikely.
Danish: På grund af dets høje permeabilitet og biotilgængelighed er risikoen for klinisk relevante interaktioner med lægemidler, der hæmmer disse transportører, usandsynlig.
English: Following a signal regarding sepsis with niraparib, a number of relevant cases were identified.
Danish: Efter et signal vedrørende sepsis relateret til niraparib er der identificeret en række relevante tilfælde.
English: These findings occurred at exposure levels below those seen clinically, and were largely reversible within 4 weeks of cessation of dosing.
Danish: Disse fund forekom ved eksponeringsniveauer, der er under dem, der ses klinisk, og var stort set reversible i løbet af 4 uger efter doseringens ophør.
English: Hypertension, including hypertensive crisis
Danish: Hypertension, herunder hypertensiv krise
English: Median ages ranged from 57 to 63 years across treatments and cohorts.
Danish: Medianaldre gik fra 57 til 63 år på tværs af behandlinger og kohorter.
English: Overall, the PRAC considered that the preferred term febrile neutropenia was adequate to describe the cases reviewed within this PSUSA.
Danish: PRAC er samlet set af den opfattelse, at den foretrukne term febril neutropeni er hensigtsmæssig til at beskrive de tilfælde, der er gennemgået i forbindelse med denne PSUSA.
English: Reduced locomotor activity was seen in one of two single dose studies in mice.
Danish: Reduceret lokomotorisk aktivitet blev observeret i et ud af to enkeltdosisstudier hos mus.
English: This medicinal product contains tartrazine (E 102), which may cause allergic reactions.
Danish: Dette lægemiddel indeholder tartrazin (E 102), der kan medføre allergiske reaktioner.
English: • Swelling in the feet, ankles, legs, and/or hands
Danish: • Hævelse i fødder, ankler, ben og/eller hænder
English: The capsules should not be chewed or crushed.
Danish: Kapslerne bør ikke tygges eller knuses.
English: This medicine contains lactose and tartrazine - see section 2 for more information.
Danish: Dette lægemiddel indeholder lactose og tartrazin - se punkt 2 for yderligere oplysninger.
English: This results in tumour cell death, helping to control the cancer.
Danish: Dette medfører tumorcelledød, der hjælper med at behandle kræften.
English: Progression-free survival was determined per RECIST (Response Evaluation Criteria in Solid Tumors, version 1.1) or clinical signs and symptoms and increased CA-125.
Danish: Progressionsfri overlevelse blev fastslået i henhold til RECIST-kriterierne (Response Evaluation Criteria in Solid Tumors, version 1.1) eller kliniske tegn og symptomer samt forhøjet CA-125.
English: Neutrophil < 1,000/µL or Haemoglobin < 8 g/dL
Danish: Neutrofiltal < 1.000/µl eller hæmoglobin < 8 g/dl
English: All patients had received multiple platinum-containing chemotherapy regimens and many had also received other DNA damaging agents and radiotherapy.
Danish: Alle patienter havde fået flere platinholdige kemobehandlingsregimer, og mange havde også fået andre DNA-skadelige stoffer og røntgenbehandling.
English: Overall, in almost half of the presented cases, the causality could not be excluded or was related to the study drug.
Danish: Samlet set kunne der i næsten halvdelen af tilfældene generelt konstateres eller ikke afvises en årsagssammenhæng med studielægemidlet.
English: Take your next dose at its scheduled time.
Danish: Tag din næste dosis på det normalt planlagte tidspunkt.
English: The most commonly used dose in niraparib-treated patients in the NOVA study was 200 mg.
Danish: Den mest almindeligt anvendte dosis til niraparib-behandlede patienter i NOVA-studiet var 200 mg.
English: Most patients were age 18 to 64 years (78 %), Caucasian (86 %) and had an ECOG performance status of 0 (68 %).
Danish: De fleste patienter var i alderen 18-64 år (78 %), var kaukasiske (86 %) og havde en ECOG-performancestatus på 0 (68 %).
English: PARP helps cells repair damaged DNA so blocking it means that the DNA of cancer cells cannot be repaired.
Danish: PARP hjælper cellerne med at reparere beskadiget DNA, så når enzymet blokeres, kan kræftcellernes DNA ikke blive repareret.
English: If patients miss a dose, they should take their next dose at its regularly scheduled time.
Danish: Hvis patienterne springer en dosis over, skal de tage deres næste dosis på det normalt planlagte tidspunkt.
English: It is unknown whether niraparib or its metabolites are excreted in human milk.
Danish: Det er ukendt, om niraparib eller dets metabolitter udskilles i human mælk.
English: Pre-existing hypertension should be adequately controlled before starting Zejula treatment.
Danish: Eksisterende hypertension skal være tilstrækkeligt kontrolleret før start på Zejula-behandling.
English: The CA-125 levels should be normal (or a > 90 % decrease in CA-125 from baseline) following their last platinum treatment, and be stable for at least 7 days.
Danish: CA-125-niveauet bør være normalt (eller udvise et fald på > 90 % fra baseline) efter den sidste platin-behandling og bør være stabilt i mindst 7 dage.
English: Approximately 25 % of patients in the NOVA study weighed less than 58 kg, and approximately 25 % of patients weighed more than 77 kg.
Danish: Omtrent 25 % af patienterne i NOVA-studiet vejede mindre end 58 kg, og ca. 25 % af patienterne vejede mere end 77 kg.
English: The major primary target organ for toxicity in both species was the bone marrow, with associated changes in peripheral haematology parameters.
Danish: Det vigtige primære målorgan for toksicitet hos begge arter var knoglemarv med relaterede ændringer i perifere hæmatologiske parametre.
English: Discontinue treatment.
Danish: Seponer behandling.
English: Increased plasma concentrations of co-administered medicinal products that are substrates of these transporters (e.g. metformin) cannot be excluded.
Danish: Øgede plasmakoncentrationer af samtidigt administrerede lægemidler, som er substrater for disse transportere (f.eks. metformin), kan ikke udelukkes.
English: Approximately 47 % of patients restarted at a reduced dose in Cycle 2.
Danish: Ca. 47 % af patienterne startede igen på en nedsat dosis i cyklus 2.
English: There are no or limited amount of data from the use of niraparib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af niraparib til gravide kvinder.
English: Oxidative metabolism of niraparib is minimal in vivo.
Danish: Den oxidative metabolisering af niraparib er minimal in vivo.
English: • Low potassium levels in the blood
Danish: • Lavt kaliumniveau i blodet
English: The recommended dose modifications for adverse reactions are listed in Tables 1 and 2.
Danish: De anbefalede dosisændringer ved bivirkninger er anført i tabel 1 og 2.
English: He or she may also give you medicine to treat high blood pressure and adjust your Zejula dose, if necessary.
Danish: Han/hun kan også give dig medicin mod højt blodtryk og eventuelt justere din Zejula-dosis.
English: Your doctor will ask you to confirm that you are not pregnant with a pregnancy test before starting your treatment.
Danish: Lægen vil bede dig bekræfte, at du ikke er gravid, og du vil få taget en graviditetstest, før du starter behandlingen.
English: Induction of CYPs (CYP1A2 and CYP3A4)
Danish: Induktion af CYP'er (CYP1A2 og CYP3A4)
English: No effect on behavioural and/or neurological parameters have been observed in repeat-dose toxicity studies in rats and dogs at estimated CNS exposure levels similar to or below expected therapeutic exposure levels.
Danish: Der er ikke observeret nogen indvirkning på adfærdsmæssige og/eller neurologiske parametre i undersøgelser af toksicitet ved gentagne doser hos rotter og hunde ved skønnede CNS-eksponeringsniveauer svarende til eller under de forventede terapeutiske eksponeringsniveauer.
English: It is used after the cancer has responded to previous treatment with standard platinum-based chemotherapy.
Danish: Det anvendes, efter at kræften har reageret på tidligere behandling med standardkemoterapi baseret på platin.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX54.
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske midler, ATC-kode: L01XX54.
English: Frequency of all CTCAE grades
Danish: Hyppighed af alle CTCAEgrader
English: The experimental test was not able to discriminate which patients would or would not benefit from niraparib maintenance therapy.
Danish: Den eksperimentelle test kunne ikke skelne mellem, hvilke patienter der ville eller ikke ville have gavn af vedligeholdelsesbehandling med niraparib.
English: Niraparib was moderately protein bound in human plasma (83.0 %), mainly with serum albumin.
Danish: Niraparib var moderat proteinbundet i humant plasma (83,0 %), hovedsagelig med serumalbumin.
English: In addition, Granulocyte-Colony Stimulating Factor (G-CSF) was administered to approximately 6 % of patients treated with niraparib as concomitant therapy for neutropenia.
Danish: Derudover blev granulocytkolonistimulerende faktor (G-CSF) administreret til ca. 6 % af de patienter, der fik niraparib, som samtidig behandling for neutropeni.
English: The capsules contain a white to off-white powder.
Danish: Kapslerne indeholder et hvidt til råhvidt pulver.
English: Hypertension of any grade occurred in 19.3 % of patients treated with Zejula.
Danish: Hypertension af alle grader forekom hos 19,3 % af de patienter, som blev behandlet med Zejula.
English: • Resume Zejula at same or reduced dose based on clinical evaluation.
Danish: Genoptag Zejula i samme eller nedsat dosis baseret på en klinisk vurdering.
English: Women of childbearing potential/contraception in females
Danish: Kvinder i den fødedygtige alder/prævention hos kvinder
English: Only 13 % of low body weight patients remained at a dose of 300 mg beyond Cycle 3.
Danish: Kun 13 % af patienterne med en lav kropsvægt fik stadig en dosis på 300 mg efter 3. cyklus.
English: In repeat-dose oral toxicity studies, niraparib was administered daily for up to 3 months' duration in rats and dogs.
Danish: I toksicitetsstudier af gentagen oral dosering blev niraparib administreret dagligt i op til 3 måneder hos rotter og hunde.
English: Zejula should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.
Danish: Zejula skal afbrydes i tilfælde af hypertensiv krise, eller hvis medicinsk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med antihypertensiv behandling.
English: • if you are allergic to niraparib or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for niraparib eller et af de øvrige indholdsstoffer i Zejula (angivet i punkt 6).
English: Zejula should not be used during pregnancy.
Danish: Zejula må ikke anvendes under graviditet.
English: Your doctor may want to test your bone marrow to check for these problems.
Danish: Lægen vil måske teste din knoglemarv for at undersøge, om det er tilfældet.
English: Your doctor will test your blood regularly throughout your treatment.
Danish: Lægen vil teste dit blod med jævne mellemrum under hele behandlingen.
English: Therefore, a clinically meaningful interaction related to an inhibition of these efflux transporters although unlikely, cannot be excluded.
Danish: Derfor kan en klinisk relevant interaktion, der er relateret til en hæmning af disse effluxtransportører, ikke udelukkes, selvom det er usandsynligt.
English: Hazard ratio (95 % CI) Progression-free survival 2
Danish: Hazard ratio (95 %-KI) Progressionsfri overlevelse 2
English: M1 is not a CYP1A2 inducer.
Danish: M1 er ikke en CYP1A2-inducer.
English: A possible cause for sepsis is a low neutrophil count and there is a potential association between niraparib and developing sepsis.
Danish: En mulig årsag til sepsis er et lavt antal neutrofiler, og der er en mulig sammenhæng mellem niraparib og udvikling af sepsis.
English: Patients with ECOG performance status 2 to 4 Clinical data are not available in patients with ECOG performance status 2 to 4.
Danish: Patienter med ECOG-funktionsstatus 2-4 Der foreligger ingen kliniske data om patienter med ECOG-funktionsstatus 2-4.
English: Zejula should not be taken during pregnancy as it could harm your baby.
Danish: Zejula må ikke tages under graviditet, da det kan skade barnet.
English: Effect of niraparib on other medicinal products
Danish: Niraparibs indvirkning på andre lægemidler
English: Contact your doctor straightaway if you become pregnant while you are taking Zejula.
Danish: Kontakt straks lægen, hvis du bliver gravid, mens du tager Zejula.
English: In the clinical programme, blood pressure measurements were obtained on Day 1 of each 28-day cycle while the patient remained on Zejula.
Danish: I det kliniske program blev blodtrykket målt på dag 1 i hver 28-dages cyklus, mens patienten blev behandlet med Zejula.
English: PARP inhibitors block an enzyme called poly [adenosine diphosphate-ribose] polymerase (PARP).
Danish: PARP-hæmmere blokerer et enzym, der kaldes poly[adenosindiphosphat-ribose]polymerase (PARP).
English: In the NOVA study, 48 % of patients had a dose interruption in Cycle 1.
Danish: I NOVA-studiet havde 48 % af patienterne en dosisafbrydelse i cyklus 1.
English: Do not chew or crush the capsules.
Danish: Du må ikke tygge eller knuse kapslerne.
English: Pancytopenia has been observed in < 1 % of patients receiving niraparib.
Danish: Pancytopeni er set hos < 1 % af de patienter, som fik niraparib.
English: However, based on its mechanism of action, niraparib could cause embryonic or foetal harm, including embryo-lethal and teratogenic effects, when administered to a pregnant woman.
Danish: Men ud fra niraparibs virkningsmekanisme kan det muligvis forårsage skade på embryo eller foster, herunder dødelig og teratogen virkning på embryo, når det gives til en gravid kvinde.
English: Patients were assigned to the gBRCAmut cohort based on blood samples for gBRCA analysis that were taken prior to randomisation.
Danish: Patienterne blev placeret i gBRCAmut-kohorten baseret på blodprøver for gBRCA-analyse, der blev taget før randomisering.
English: Patients could not have received prior PARP inhibitor therapy, including Zejula.
Danish: Patienterne måtte ikke tidligere have fået behandling med PARP-hæmmere, herunder Zejula.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for niraparib, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for niraparib er CHMP nået frem til følgende videnskabelige konklusioner:
English: In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death.
Danish: In vitro-studier har vist, at niraparib-induceret cytotoksicitet kan omfatte hæmning af PARP-enzymatisk aktivitet og øget dannelse af PARP-DNA-komplekser med deraf følgende DNA-skader, apoptose og celledød.
English: A pregnancy test should be performed on all women of childbearing potential prior to treatment.
Danish: Der skal tages en graviditetstest af alle kvinder i den fødedygtige alder før behandlingen.
English: Table 4: Summary of primary objective outcomes in the ENGOT-OV16 study gBRCAmut cohort
Danish: Tabel 4: Sammendrag af resultaterne for det primære formål i ENGOT-OV16-studiet gBRCAmut-kohorte
English: A reversible reduction of spermatogenesis was observed in rats and dogs (see section 5.3).
Danish: Der er observeret en reversibel reduktion af spermatogenesen hos rotter og hunde (se pkt.
English: • Fever or infection - low white blood cell count (neutropenia) can increase your risk for infection.
Danish: • Feber eller infektion - et lavt antal hvide blodlegemer (neutropeni) kan medføre øget risiko for infektioner.
English: If you forget to take Zejula
Danish: Hvis du har glemt at tage Zejula
English: Aclar/PVC/aluminium foil perforated unit dose blisters in cartons of 84 × 1, 56 × 1 and 28 × 1 hard capsules.
Danish: Perforerede enkeltdosisblistre af aclar/PVC/aluminiumsfolie i kartoner af 84 × 1, 56 × 1 og 28 × 1 hårde kapsler.
English: Do not take an additional dose if you miss a dose or vomit after taking Zejula.
Danish: Du må ikke tage en ekstra dosis, hvis du glemmer en dosis eller kaster op, efter at du har taget Zejula.
English: Talk to your doctor, pharmacist or nurse before or while taking this medicine if any of the following could apply to you:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før eller mens du tager dette lægemiddel, hvis noget af følgende gælder dig:
English: Patients who take Zejula may experience asthenia, fatigue and dizziness.
Danish: Patienter, som tager Zejula, kan opleve asteni, træthed og svimmelhed.
English: In pooled samples collected over 6 days, 40.0 % of the dose was recovered in the urine primarily as metabolites and 31.6 % of the dose was recovered in the feces primarily as unchanged niraparib.
Danish: I puljede prøver indsamlet over 6 dage blev 40,0 % af dosis udskilt i urinen primært som metabolitter, og 31,6 % af dosis blev udskilt i fæces primært som uændret niraparib.
English: Observe caution when driving or using machines.
Danish: Udvis forsigtighed, når du fører motorkøretøj eller betjener maskiner.
English: Package leaflet: Information for the patient Zejula 100 mg hard capsules niraparib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Zejula 100 mg, hårde kapsler niraparib Dette lægemiddel er underlagt supplerende overvågning.
English: The incidence of Grade 3 or 4 ADRs was greater among low body weight patients (78 %) than high body weight patients (53 %).
Danish: Forekomsten af bivirkninger af grad 3 eller 4 var højere hos patienter med en lav legemsvægt (78 %) end hos patienter med en høj legemsvægt (53 %).
English: Anaemia of any grade might persist during Zejula treatment.
Danish: Anæmi af alle grader kan vare ved under Zejula-behandlingen.
English: Blood pressure should be monitored monthly for the first year and periodically thereafter during treatment with Zejula.
Danish: Blodtrykket skal overvåges månedligt i det første år og med jævne mellemrum derefter under behandling med Zejula.
English: The most common serious adverse reactions > 1 % (treatment-emergent frequencies) were thrombocytopenia and anaemia.
Danish: De mest almindelige alvorlige bivirkninger hos > 1 % (hyppigheder under behandling) var trombocytopeni og anæmi.
English: Grade 3/4 hypertension occurred in 8.2 % of patients.
Danish: Hypertension af grad 3/4 forekom hos 8,2 % af patienterne.
English: Zejula has moderate influence on the ability to drive or use machines.
Danish: Zejula påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Non-gBRCAmut cohort niraparib (N = 138)
Danish: Ikke-gBRCAmut-kohorte niraparib (N = 138)
English: Patients treated with Zejula who develop thrombocytopenia might have an increased risk of haemorrhage.
Danish: Patienter, som behandles med Zejula og udvikler trombocytopeni, kan have en forhøjet blødningsrisiko.
English: Patients began treatment on Cycle 1/Day 1 (C1/D1) with niraparib 300 mg or matched placebo administered QD in continuous 28-day cycles.
Danish: Patienterne begyndte behandling i cyklus 1/dag 1 (C1/D1) med niraparib 300 mg eller tilsvarende placebo administreret dagligt i fortløbende cyklusser på 28 dage.
English: In the clinical programme, hypertension was readily managed with anti-hypertensive medicinal products.
Danish: I det kliniske program blev hypertension nemt behandlet med antihypertensiva.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Niraparib can cause haematological toxicity that includes febrile neutropenia.
Danish: Niraparib kan medføre hæmatologisk toksicitet, som omfatter febril neutropeni.
English: • For patients with platelet count ≤ 10,000/μL, platelet transfusion should be considered.
Danish: Hos patienter med et trombocyttal på ≤ 10.000/μl bør trombocyttransfusion overvejes.
English: Contents of the pack and other information What Zejula contains
Danish: Pakningsstørrelser og yderligere oplysninger Zejula indeholder
English: The duration of Zejula treatment in patients prior to developing MDS/AML varied from 1 month to > 2 years.
Danish: Varigheden af Zejula-behandlingen hos patienter, før de udviklede myelodysplastisk syndrom/akut myeloid leukæmi, varierede fra 1 måned til > 2 år.
English: Your doctor will measure your blood pressure regularly throughout your treatment.
Danish: Lægen måler dit blodtryk med jævne mellemrum under hele din behandling.
English: Even though inhibition of CYP3A4 in the liver is not expected, the potential to inhibit CYP3A4 at the intestinal level has not been established at relevant niraparib concentrations.
Danish: Selvom der ikke forventes nogen hæmning af CYP3A4 i leveren, er muligheden for hæmning af CYP3A4 i tarmen ikke klarlagt ved relevante niraparib-koncentrationer.
English: This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of niraparib and indicates potential for genotoxicity in humans.
Danish: Denne klastogenicitet er forenelig med genominstabilitet, der skyldes niraparibs primære farmakologi, og tyder på et potentiale for genotoksicitet hos mennesker.
English: Signs and symptoms you need to look out for include fever or infection, and abnormal bruising or bleeding (see section 4 for more information).
Danish: De tegn og symptomer, du skal holde øje med, er bl.a. feber eller infektion samt unormale blå mærker eller blødning (læs mere i punkt 4).