FrancophonIA/ELRC3.0 huggingface dataset:
English: Difficulty in breathing or swallowing
Danish: Problemer med at trække vejret eller synke
English: The median PFS by BIRC using RECIST 1.1 was longer in the ceritinib arm compared to the chemotherapy arm in both subgroups of patients with brain metastases and without brain metastases.
Danish: Den mediane PFS, vurderet af BIRC ved brug af RECIST 1.1, var længere i ceritinib-armen sammenlignet med kemoterapi-armen i begge undergrupper af patienter med hjernemetastaser og uden hjernemetastaser.
English: Ceritinib also has a slight preferential distribution to red blood cells, relative to plasma, with a mean in vitro blood-to-plasma ratio of 1.35.
Danish: Ceritinib har også en let tendens til at foretrække binding til røde blodlegemer i forhold til plasma, med en middel blod/plasmaratio in vitro på 1,35.
English: Systemic exposure of ceritinib was increased when administered with food.
Danish: Systemisk eksponering for ceritinib blev øget, når det blev administreret samtidig med mad.
English: Bradycardia c
Danish: Bradykardi c
English: Study X2101: Responses assessed using RECIST 1.0 Study A2201: Responses assessed using RECIST 1.1 *Includes only patients with confirmed CR, PR
Danish: NE = kan ikke estimeres (not estimable) Studie X2101: Respons vurderet ifølge RECIST 1.0 Studie A2201: Respons vurderet ifølge RECIST 1.1 *Omfatter kun patienter med bekræftet CR, PR
English: Zykadia is a cancer medicine that contains the active substance ceritinib.
Danish: Zykadia er en kræftmedicin, der indeholder det aktive stof ceritinib.
English: There are no data related to brain-to-blood exposure ratio in humans.
Danish: Der er ingen tilgængelige data med hensyn til hjerne/blod-eksponering hos mennesker.
English: Talk to your doctor or pharmacist before taking Zykadia: if you have problems with your liver.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Zykadia: hvis du har leverproblemer.
English: Pharmacotherapeutic group: antineoplasic and immunomodulating agents, ATC code: L01XE28.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske og immunmodulerende stoffer, ATC-kode: L01XE28.
English: In addition, 81 patients (69.8%) in the chemotherapy arm received subsequent Zykadia as first antineoplastic therapy after study treatment discontinuation.
Danish: Desuden fik 81 patienter (69,8 %) i kemoterapi-armen efterfølgende Zykadia som første antineoplastiske behandling efter ophør med forsøgsbehandling.
English: Caution should be used in patients with severe renal impairment, as there is no experience with ceritinib in this population (see section 5.2).
Danish: Der skal udvises forsigtighed hos patienter med svært nedsat nyrefunktion, da der ikke er erfaring med ceritinib hos denne population (se pkt.
English: Lipase and/or amylase elevations
Danish: Forhøjet lipase og/eller amylase
English: Low level of phosphate in the blood (this would be detected during blood tests) High level of enzymes called lipase and/or amylase in the blood (this would be detected during blood tests)
Danish: Lav fosfat-værdi i blodet (dette vil blive opdaget i en blodprøve) Højt niveau af enzymerne lipase og/eller amylase i blodet (dette vil blive opdaget i en blodprøve)
English: It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Danish: Det bruges til at behandle voksne, der har fremskredne stadier af en type lungekræft kaldet ikke-småcellet lungekræft (NSCLC).
English: The median duration of follow-up was 19.7 months (from randomisation to cut-off date).
Danish: Den mediane opfølgningsvarighed var 19,7 måneder (fra randomisering til skæringstidspunktet).
English: Permanently discontinue Zykadia.
Danish: Seponér Zykadia permanent.
English: Based on available data, ceritinib is eliminated primarily via the liver.
Danish: Ifølge de tilgængelige data elimineres ceritinib primært via leveren.
English: The tablets should be swallowed whole with water and should not be chewed or crushed.
Danish: Tabletterne skal synkes hele med vand og må ikke tygges eller knuses.
English: Severe or intolerable nausea, vomiting or diarrhoea despite optimal anti-emetic or anti-diarrhoeal therapy
Danish: Svær eller uudholdelig kvalme, opkastning eller diarré på trods af optimal behandling mod kvalme og diarré.
English: Study A2201 involved 140 patients who had been previously treated with 1-3 lines of cytotoxic chemotherapy followed by treatment with crizotinib, and who had then progressed on crizotinib.
Danish: Studie A2201 involverede 140 patienter, der tidligere var blevet behandlet med 1-3 cytotoksiske kemoterapilinjer efterfulgt af behandling med crizotinib, og som var progredieret på crizotinib.
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blister containing 21 film-coated tablets.
Danish: PVC/PCTFE (polyvinylchlorid/polychlortrifluorethylen) - Aluminiumblister indeholdende 21 filmovertrukne tabletter.
English: A grade 3 event of diarrhoea was reported in one patient (1.1%).
Danish: Grad 3 diarré blev rapporteret for en patient (1,1 %).
English: The absolute bioavailability of ceritinib has not been determined.
Danish: Ceritinibs absolutte biotilgængelighed er ikke bestemt.
English: General disorders and administration site conditions Fatigue m
Danish: Almene symptomer og reaktioner på administrationsstedet Træthed m
English: The liver was also affected in both species, at exposures that approximate clinical exposures at the recommended human dose, and included minimal increases in liver transaminases in a few animals and vacuolation of the intra-hepatic bile duct epithelium.
Danish: Leveren blev også påvirket hos begge arter ved eksponeringer, der svarer til kliniske eksponeringer ved den anbefalede humane dosis, herunder minimale forhøjelser af levertransaminaser hos nogle få dyr og vakuolisering af det intrahepatiske galdegangsepitel.
English: If long-term concomitant treatment with a strong CYP3A inhibitor is necessary and the patient tolerates the reduced dose well, the dose may be increased again with careful monitoring for safety, to avoid potential under-treatment.
Danish: Hvis langvarig samtidig behandling med en potent CYP3A-hæmmer er nødvendig og patienten tolererer den reducerede dosis, kan dosis muligvis øges igen med nøje monitorering for bivirkninger for at undgå potentiel underbehandling.
English: Serial ECGs were collected following a single dose and at steady-state to evaluate the effect of ceritinib on the QT interval in 925 patients treated with Zykadia 750 mg once daily fasted.
Danish: Der blev indsamlet serielle EKG'er efter en enkelt dosis og ved steady state for at evaluere ceritinibs virkning på QT-intervallet hos 925 patienter behandlet med Zykadia 750 mg en gang daglig fastende.
English: An in vivo telemetry study in monkeys showed a modest QT prolongation in 1 of 4 animals after receiving the highest dose of ceritinib.
Danish: Et in vivo telemetrisk studie med aber viste en beskeden QT-forlængelse hos 1 af 4 dyr efter administration af den højeste dosis ceritinib.
English: Eye disorders Vision disorder a
Danish: Øjne Synsforstyrrelser a
English: Ceritinib has been classified in vivo as a strong CYP3A4 inhibitor and has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product.
Danish: Ceritinib er blevet klassificeret som en potent CYP3A4-hæmmer in vivo og kan potentielt interagere med lægemidler, som metaboliseres via CYP3A, hvilket kan føre til øgede serum koncentrationer af det andet lægemiddel.
English: Table 6 ALK-positive advanced NSCLC - overview of efficacy results from Studies X2101 and A2201
Danish: Tabel 6 ALK-positiv fremskreden NSCLC - oversigt over effektresultaterne fra Studie X2101 og A2201
English: Based on the stratified Cox proportional hazards analysis.
Danish: Baseret på den stratificerede Cox-proportionale hazard-analyse.
English: The potential for QT interval prolongation of ceritinib was assessed in seven clinical studies with Zykadia.
Danish: Ceritinibs potentiale for QT-intervalforlængelse blev vurderet i syv kliniske studier med Zykadia.
English: You should take special care when driving and using machines when taking Zykadia as you may experience visual disturbances or tiredness.
Danish: Du skal være meget forsigtig med at køre bil og betjene maskiner, når du tager Zykadia, da du kan opleve synsforstyrrelser eller træthed.
English: Patients who completed 4 cycles of chemotherapy (induction) without progressive disease subsequently received pemetrexed (500 mg/m2) as single-agent maintenance therapy every 21 days.
Danish: Patienter, der færdiggjorde 4 serier med kemoterapi (induktion) uden progressiv sygdom, fik efterfølgende pemetrexed (500 mg/m2) som enkeltstof i vedligeholdelsesbehandling hver 21. dag.
English: Main biotransformation pathways identified in healthy subjects included mono-oxygenation, O-dealkylation, and N-formylation.
Danish: De vigtigste biotransformationsveje, der er identificeret hos raske forsøgspersoner, omfatter mono-oxygenering, O-dealkylering og N-formylering.
English: An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1).
Danish: En præcis og valideret ALK-test er nødvendig for udvælgelsen af ALK-positive NSCLC-patienter (se pkt.
English: Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo.
Danish: Ceritinib hæmmer autofosforylering af ALK, ALK-medieret fosforylering af downstream-signalproteiner og proliferation af ALK-afhængige cancerceller både in vitro og in vivo.
English: The capsules should be administered orally once daily with food at the same time every day.
Danish: Kapslerne skal administreres oralt én gang daglig sammen med mad på samme tidspunkt hver dag.
English: One hundred and five (105) patients out of the 145 patients (72.4%) that discontinued treatment in the chemotherapy arm received subsequent ALK inhibitor as first antineoplastic therapy.
Danish: Ethundredeogfem (105) patienter ud af de 145 patienter (72,4 %), som afbrød behandling i kemoterapi-armen, fik efterfølgende ALK-hæmmer som første anti-neoplastiske behandling.
English: 150 (3 packs of 50) hard capsules.
Danish: 150 (3 pakninger med 50) hårde kapsler.
English: What Zykadia is
Danish: Hvad Zykadia er
English: OS analysis was not adjusted for the potentially confounding effects of cross over.
Danish: OS-analyse var ikke justeret for potentielle konfunderende effekter af overkrydsning.
English: if you have problems with your pancreas.
Danish: hvis du har problemer med bugspytkirtlen.
English: Severe itching of the skin, with a red rash or raised bumps
Danish: Stærk hudkløe med rødt udslæt og knopper
English: Acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) can alter the solubility of ceritinib and reduce its bioavailability.
Danish: Syrereducerende lægemidler (fx protonpumpehæmmere, H2-receptorantagonister, antacida) kan ændre opløseligheden af ceritinib og reducere dets biotilgængelighed.
English: Lipase or amylase elevation grade ≥3
Danish: Forhøjet lipase eller amylase ≥ grad 3
English: Particular caution should be exercised when treating patients with severe hepatic impairment, and the dose should be adjusted (see section 4.2).
Danish: Særlig forsigtighed skal udvises, når patienter med svært nedsat leverfunktion behandles, og dosis skal justeres (se pkt.
English: Carcinogenicity studies have not been performed with ceritinib.
Danish: Der er ikke udført karcinogenicitetsstudier med ceritinib.
English: A pharmacokinetic analysis suggested that ceritinib causes concentration-dependent increases in QTc (see section 4.4).
Danish: En farmakokinetisk analyse tydede på, at ceritinib forårsager koncentrationsafhængige stigninger i QTc (se pkt.
English: If dose reduction is required due to an adverse drug reaction (ADR) not listed in Table 1, then this should be achieved by decrements of 150 mg daily.
Danish: Hvis dosisreduktion er nødvendig på grund af en bivirkning, som ikke er listet i tabel 1, skal dette gøres ved trinvis reduktion á 150 mg daglig.
English: The tablets should be administered orally once daily with food at the same time every day.
Danish: Tabletterne skal administreres oralt én gang daglig sammen med mad på samme tidspunkt hver dag.
English: Permanently discontinue Zykadia if no contributing concomitant medicinal product is identified.
Danish: Seponér Zykadia permanent, hvis der ikke identificeres noget medvirkende lægemiddel, der tages samtidig.
English: The majority of patients were Caucasian (60.0%) or Asian (37.9%).
Danish: Størstedelen af patienterne var kaukasier (60,0 %) eller asiater (37,9 %).
English: Based on in vitro data, ceritinib does not inhibit apical efflux transporter MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Danish: Baseret på in vitro-data hæmmer ceritinib ikke den apikale effluxtransporter MRP2, hepatiske optagstransportere OATP1B1 eller OATP1B3, renale, organisk anion-optagstransportere OAT1 og OAT3 eller organiske kation-optagstransportere OCT1 eller OCT2 i klinisk relevante koncentrationer.
English: The principal toxicity related to ceritinib administration in rats and monkeys was inflammation of the extra-hepatic bile ducts accompanied by increased neutrophil counts in the peripheral blood.
Danish: Den væsentligste toksicitet, der var relateret til administration af ceritinib til rotter og aber, var inflammation i de ekstrahepatiske galdegange ledsaget af forhøjede neutrofiltal i det perifere blod.
English: Following a single oral administration of radioactive ceritinib dose at 750 mg fasted, ceritinib was the main circulating component in human plasma.
Danish: Efter en enkeltdosis oral administration á 750 mg radioaktiv ceritinib fastende var ceritinib den cirkulerende hovedkomponent i human plasma.
English: Respiratory, thoracic and mediastinal disorders Pneumonitis d
Danish: Luftveje, thorax og mediastinum Pneumonitis d
English: Caution is advised with concomitant use of proton pump inhibitors, as exposure of ceritinib may be reduced.
Danish: Det anbefales at udvise forsigtighed ved samtidig behandling med protonpumpehæmmere, da eksponeringen af ceritinib kan blive reduceret.
English: The benefits and potential risks of ceritinib should be considered before beginning therapy in patients who have pre-existing bradycardia (heart rate less than 60 beats per minute [bpm]), patients who have a history of or predisposition for QTc prolongation, patients who are taking anti-arrhythmics or other medicinal products that are known to prolong the QT interval and patients with relevant pre-existing cardiac disease and/or electrolyte disturbances.
Danish: Fordele og potentielle risici bør overvejes før behandling initieres hos patienter med eksisterende bradykardi (hjertefrekvens under 60 slag pr. minut [bpm]), patienter med anamnese eller prædisposition for QT-forlængelse, patienter, der tager antiarytmika eller andre lægemidler, som vides at forlænge QT-intervallet samt patienter med relevant eksisterende hjertesygdom og/eller elektrolytforstyrrelser.
English: Women of childbearing potential should be advised to use a highly effective method of contraception while taking Zykadia and for up to 3 months after discontinuing treatment (see section 4.5).
Danish: Kvinder i den fertile alder bør rådes til at anvende yderst effektiv kontraception mens de tager Zykadia og i op til 3 måneder efter behandlingens ophør (se pkt.
English: Recovery of unchanged ceritinib in the faeces accounts for a mean 68% of an oral dose.
Danish: Genfinding af uændret ceritinib i fæces udgør i gennemsnit 68 % af en oral dosis.
English: Patients receiving ceritinib showed significant improvements over chemotherapy in general Quality of Life and global Health Status measures (LCSS [p<0.001], QLQ-C30, [p<0.001] and EQ-5D-5L index [p<0.001]).
Danish: Patienter, der fik ceritinib, viste signifikante forbedringer over kemoterapi i målinger for generel livskvalitet og global sundhedsstatus (LCSS [p < 0,001], QLQ-C30 [p < 0,001] samt i EQ-5D-5Lindekset [p < 0,001]).
English: The capsules are provided in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules.
Danish: Kapslerne leveres i blisterkort og fås i pakninger, der indeholder 40, 90 eller 150 kapsler (3 pakninger med 50) kapsler.
English: Monitoring of the QT interval is indicated in the event of combinations of such medicinal products (see sections 4.2 and
Danish: Monitorering af QT-intervallet er indiceret ved kombinationsbehandling med denne type lægemidler (se pkt.
English: The primary route of excretion of ceritinib and its metabolites is in the faeces.
Danish: Den primære udskillelsesvej for ceritinib og dets metabolitter er i fæces.
English: Patient reported outcome questionnaires (Lung cancer symptom scale [LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] and EQ-5D-5L) were completed by 80% or more of patients in the ceritinib and chemotherapy arms for all questionnaires at most of the time-points during the course of the study.
Danish: Spørgeskemaer vedrørende patientrapporterede resultater (Lung cancer symptom scale [LCSS], EORTC-QLQ-C30 [C30], EORTC QLQ-LC13 [LC13] og EQ-5D-5L) blev færdiggjort af 80 % eller flere af patienterne i ceritinib- og kemoterapi-armene for alle spørgeskemaer på de fleste tidspunkter i løbet af studiet.
English: The study met its primary objective demonstrating a statistically significant improvement in PFS by BIRC with an estimated 51% risk reduction in the ceritinib arm compared to chemotherapy arm (see Table 4 and Figure 3).
Danish: Studiet mødte sit primære formål og demonstrerede statistisk signifikant forbedring i PFS, vurderet af BIRC, med en estimeret risikoreduktion på 51 % i ceritinib-armen sammenlignet med kemoterapiarmen (se tabel 4 og figur 3).
English: If vomiting occurs during the course of treatment, the patient should not take an additional dose, but should continue with the next scheduled dose.
Danish: Hvis der forekommer opkastning under behandlingen, skal patienten ikke tage en yderligere dosis, men bør fortsætte med den næste planlagte dosis.
English: ALK translocation determines expression of the resulting fusion protein and consequent aberrant ALK signaling in NSCLC.
Danish: ALK-translokation bestemmer ekspressionen af det resulterende fusionsprotein og deraf følgende afvigende ALK-signalering ved NSCLC.
English: The maximum allowable dose under fasted condition is 750 mg (see section 5.2).
Danish: Den maksimale tilladte dosis i faste er 750 mg (se pkt.
English: new or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath.
Danish: nyopstået eller forværret hoste med eller uden slim, feber, brystsmerter, vejrtrækningsbesvær eller kortåndethed.
English: Concurrent elevations of ALT or AST greater than 3× ULN and total bilirubin greater than 2× ULN without elevated alkaline phosphatase have been observed in less than 1% of patients in clinical studies with ceritinib.
Danish: Samtidig forhøjet ALAT eller ASAT på mere end 3× ULN og totalbilirubin på mere end 2× ULN uden forhøjet alkalisk phosphatase blev observeret hos mindre end 1 % af patienterne i kliniske studier med ceritinib.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Zykadia in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Zykadia i alle undergrupper af den pædiatriske population med lungecarcinom (småcellet og ikke-småcellet carcinom) (se pkt.
English: Ceritinib has been classified in vivo as a weak CYP2C9 inhibitor.
Danish: Ceritinib er blevet klassificeret som en svag CYP2C9-hæmmer in vivo.
English: Zykadia should be taken with food.
Danish: Zykadia skal indtages i forbindelse med mad.
English: warfarin and dabigatran, medicines used to prevent blood clots.
Danish: warfarin og dabigatran, der bruges til forebyggelse af blodpropper.
English: Gastrointestinal events were managed primarily with concomitant medicinal products including anti-emetic/anti-diarrhoeal medicinal products.
Danish: Gastrointestinale bivirkninger blev håndteret primært med anden samtidig behandling, som fx antiemetiske lægemidler eller lægemidler mod diarré.
English: In patients who develop transaminase elevations, more frequent monitoring of liver transaminases and total bilirubin should be carried out as clinically indicated (see sections 4.2 and
Danish: Hos patienter, der udvikler transaminasestigninger, skal der udføres hyppigere monitorering af levertransaminaser og totalbilirubin som klinisk indiceret (se pkt.
English: Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies.
Danish: Tilfælde af levertoksicitet forekom hos 1,1 % af de patienter, der fik ceritinib i kliniske studier.
English: Patients should be monitored with liver laboratory tests (including ALT, AST and total bilirubin) prior to the start of treatment, every 2 weeks during the first three months of treatment and monthly thereafter.
Danish: Patienter skal monitoreres med laboratorietests af leverfunktionen (inklusive ALAT, ASAT og totalbilirubin) før behandlingen påbegyndes, hver anden uge i de første tre måneder af behandlingen og månedligt derefter.
English: The efficacy of Zykadia 450 mg with food was evaluated in a multicentre, open-label dose optimisation study A2112 (ASCEND-8).
Danish: Virkningen af Zykadia 450 mg med mad blev evalueret i et multicenter, open-label, dosisoptimeringsstudie A2112 (ASCEND-8).
English: No signs of mutagenicity or clastogenicity were observed in other in vitro and in vivo genotoxicity studies with ceritinib.
Danish: Der blev ikke observeret tegn på mutagenicitet eller klastogenicitet i andre in vitro- og in vivo-genotoksicitetsstudier med ceritinib.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0/1/2 in 37.0%/56.4%/6.4% of patients, and 32.2% had brain metastasis at baseline.
Danish: Eastern Cooperative Oncology Group (ECOG) performance status var 0/1/2 hos 37,0 %/56,4 %/6,4 % af patienterne og 32,2 % havde hjernemetastaser ved baseline.
English: Overall Response Rate (ORR: CR+PR), n (%) (95% CI)
Danish: Responsrate (ORR: CR+PR), n (%) (95% CI)
English: Withhold Zykadia until recovery to asymptomatic (grade ≤1) bradycardia or to a heart rate of 60 beats per minute (bpm) or above.
Danish: Pausér Zykadia indtil bedring til asymptomatisk (grad ≤1) bradykardi eller til en hjertefrekvens på 60 slag pr. minut (bpm) eller derover.
English: Medicines which may increase the risk of side effects with Zykadia: medicines used to treat AIDS/HIV (e.g. ritonavir, saquinavir).
Danish: Medicin, som kan øge risikoen for bivirkninger ved Zykadia: medicin, der bruges til behandling af AIDS/HIV (fx ritonavir, saquinavir).
English: Increases to grade 3 or 4 ALT elevations were observed in 25% of patients.
Danish: ALAT-stigninger til grad 3 eller 4 blev observeret hos 25 % af patienterne.
English: OS data was immature with 48 (41.7%) events in the ceritinib arm and 50 (43.1%) events in the chemotherapy arm, corresponding to approximately 50% of the required events for the final OS analysis.
Danish: OS-data var ikke modne med 48 (41,7 %) hændelser i ceritinib-armen og 50 (43,1 %) hændelser i kemoterapiarmen, svarende til ca. 50 % af de nødvendige hændelser for den endelige OS-analyse.
English: These may be signs or symptoms of heart problems.
Danish: Dette kan være tegn eller symptomer på hjerteproblemer.
English: Asymptomatic cases of bradycardia (heart rate less than 60 bpm) have been observed in 21 out of 925 (2.3%) patients treated with ceritinib in clinical studies.
Danish: Asymptomatiske tilfælde af bradykardi (hjertefrekvens under 60 bpm) er observeret hos 21 ud af 925 (2,3 %) patienter, der blev behandlet med ceritinib i kliniske studier.