FrancophonIA/ELRC3.0 huggingface dataset:
English: Thirty-four of 1619 patients (2.1%) with at least 1 postbaseline ECG assessment were found to have QTcF ≥500 msec, and 79 of 1585 patients (5.0%) with a baseline and at least 1 postbaseline ECG assessment had an increase from baseline QTcF ≥60 msec by automated machine-read evaluation of ECG (see section 4.4).
Danish: 34 ud af 1.619 patienter (2,1%) med mindst 1 ekg-vurdering efter baseline viste sig at have QTcF ≥ 500 ms, og 79 ud af 1.585 patienter (5,0%) med en ekgvurdering ved baseline og mindst 1 efter baseline havde en forlængelse fra baseline i QTcF ≥ 60 ms ved maskinaflæst evaulering af ekg (se pkt.
English: Dizzinessf (26%) Bradycardiag (13%)
Danish: Bradykardi g (13%)
English: XALKORI dose modification - haematological toxicitiesa,b CTCAEc Grade
Danish: XALKORI dosisjustering - hæmatologisk toksicitet a,b
English: N=905e
Danish: N=905
English: • Pain in the abdomen.
Danish: • Smerter i maven
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (e.g., metformin, procainamide).
Danish: Crizotinib kan derfor potentielt øge plasmakoncentrationen af samtidig administrerede lægemidler, som er substrater for OCT1 eller OCT2 (fx metformin, procainamid).
English: • The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
Danish: • 1. linje-behandling af voksne med anaplastisk lymfomkinase-positiv (ALK-positiv) fremskreden ikke-småcellet lungecancer (NSCLC)
English: Across studies in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), 50 (3%) patients treated with crizotinib had any grade all-causality ILD, including 18 (1%) patients with Grade 3 or 4, and 8 (<1%) patients with fatal cases.
Danish: I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N=1.722) havde 50 (3%) af de patienter, der blev behandlet med crizotinib, ILD (uanset kausalitet) af en eller anden grad, herunder 18 (1%) patienter med grad 3 eller 4 og 8 (< 1%) tilfælde med dødelig udgang.
English: Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC, median time to onset of increased Grade 1 or 2 transaminases was 23 days.
Danish: I alle studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC var mediantiden indtil grad 1 eller 2 aminotransferasestigning 23 dage.
English: Following crizotinib 200 mg twice daily dosing, patients with moderate hepatic impairment (N=8) showed higher systemic crizotinib exposure compared to patients with normal hepatic function (N=9) at the same dose level, with geometric mean ratios for AUCdaily and Cmax of 150% and 144%, respectively.
Danish: Efter dosering med crizotinib 200 mg to gange dagligt havde patienter med moderat nedsat leverfunktion (N=8) øget systemisk crizotinib-eksponering sammenlignet med patienter med normal leverfunktion (N=9) ved det samme dosisniveau, med geometriske middelværdier for AUCdaily og Cmax på henholdsvis 150% og 144%.
English: Coadministration of repeated doses of crizotinib (250 mg once daily) with repeated doses of itraconazole (200 mg once daily), a strong CYP3A inhibitor, resulted in increases in crizotinib steady-state AUCtau and Cmax, that were approximately 1.6-fold and 1.3-fold, respectively, those seen when crizotinib was administered alone.
Danish: Administration af gentagne doser crizotinib (250 mg 1 gang dagligt) sammen med gentagne doser itraconazol (200 mg 1 gang daglig), en stærk CYP3A-hæmmer, medførte en stigning i crizotinib steady state AUCtau og Cmax-værdier, der var henholdsvis cirka 1,6 og 1,3 gange større end dem, der ses, når crizotinib administreres alene.
English: The following medicines may reduce the effectiveness of XALKORI:
Danish: Medicinen nævnt herunder kan nedsætte virkningen af XALKORI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER
Danish: YDRE KARTON TIL BLISTER
English: • Clonidine, guanfacine, used to treat hypertension.
Danish: • Clonidin, guanfacin, til behandling af for højt blodtryk.
English: For management of patients who develop symptomatic bradycardia, see Dose Modification and Undesirable Effects sections (see sections 4.2 and 4.8).
Danish: Behandling af patienter, der udvikler symptomatisk bradykardi, fremgår af afsnittene Dosisjustering og Bivirkninger (se pkt.
English: In addition, a decrease in heart rate was found to be associated with increasing crizotinib plasma concentration (see section 4.4), with a maximum mean reduction of 17.8 beats per minute (bpm) after 8 hours on Cycle 2 Day 1.
Danish: 4.4) med en maksimal middelreduktion på 17,8 slag i minuttet (bpm) efter 8 timer på dag 1 i cyklus 2.
English: • Reduced heart rate.
Danish: • Langsom puls.
English: Bradycardia has been reported during clinical studies; therefore, use crizotinib with caution due to the risk of excessive bradycardia when used in combination with other bradycardic agents (e.g., non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, beta-blockers, clonidine, guanfacine, digoxin, mefloquine, anticholinesterases, pilocarpine) (see sections 4.2 and 4.4).
Danish: Derfor bør crizotinib anvendes med forsigtighed på grund af risiko for udtalt bradykadi, når det anvendes sammen med lægemidler, der kan give bradykardi (fx non-dihydropyridin calciumantagonisterså som verapamil og diltiazem, beta-blokkere, clonidin, guanfacin, digoxin, mefloquin, acethylcholinesterase, pilocarpin) (se pkt.
English: There were reports of fatal cases of gastrointestinal perforation during post-marketing use of crizotinib (see section 4.4).
Danish: Efter markedsføringen er der blevet rapporteret om tilfælde af gastrointestinal perforation med dødelig udgang ved brug af crizotinib (se pkt.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered medicinal products that are substrates of P-gp (see section 4.5).
Danish: Dermed kan crizotinib potentielt øge plasmakoncentrationen af lægemidler, som er substrater for P-gp, når disse administreres samtidig (se pkt.4.5).
English: A monitoring of the QT interval should be made in case of combinations of such medicinal products (see sections 4.2 and 4.4).
Danish: QT-intervallet bør måles, når denne kombination anvendes (se pkt.
English: Renal cystn (3%) Blood creatinine increasedo (8%)
Danish: Nyrecyste n (3%) Forhøjet blodkreatinin o (8%)
English: The demographic and disease characteristics of the overall study population were 62% female, median age of 53 years, baseline Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (95%), 51% White and 46% Asian, 4% current smokers, 32% past smokers and 64% never smokers.
Danish: De demografiske og sygdomsrelaterede karakteristika for den samlede studiepopulation var 62% kvinder, medianalder 53 år, Eastern Cooperative Oncology Group (ECOG) -performancestatus ved baseline 0 eller 1 (95%), 51% hvide og 46% asiatere, 4% var nuværende rygere, 32% var tidligere rygere, og 64% havde aldrig røget.
English: All-causality Grade 3 or 4 Electrocardiogram QT prolonged was reported in 27 (1.6%) out of 1722 patients (see sections 4.2, 4.4, 4.5 and 5.2).
Danish: Uanset kausalitet sås der forlænget QT-interval af grad 3 eller 4 hos 27 (1,6%) ud af 1.722 patienter (se pkt.
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume at reduced dosec upon recovery to Grade ≤1 or to heart rate 60 or above
Danish: Hvis der ikke findes samtidigt administrerede lægemidler, der bidrager til bardykardi, eller hvis samtidigt administrerede lægemidler ikke seponeres eller sættes ned i dosis, genoptages behandlingen med nedsat dosis c XALKORI efter forbedring til grad ≤ 1 eller til hjertefrekvens på 60 eller derover
English: Warnings and precautions Talk to your doctor before taking XALKORI:
Danish: Kontakt lægen, før du tager XALKORI:
English: Most of the available information is available in patients with some specific histology type of ALK-positive NSCLC (adenocarcinoma) and limited information is available in the other histologies.
Danish: Der er mest information om patienter med en særlig celletype af ALK-positiv ikke-småcellet lungekræft (adenokarcinom), og der er begrænset information om patienter med andre celletyper.
English: The MAH shall agree the content and format of the educational material with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelsen skal have undervisningsmateriale godkendt af myndighederne i det enkelte medlemsland.
English: In clinical studies, prolonged QT interval was observed with crizotinib.
Danish: Forlænget QT-interval er set i kliniske studier med crizotinib.
English: ROS1-positive advanced NSCLC efficacy results from Study 1001 Efficacy Parameter
Danish: Data for effekt ved ROS1-positiv fremskreden NSCLCfra studie 1001 Effektivitetsparameter
English: Coadministration of repeated doses of crizotinib (250 mg twice daily) with repeated doses of rifampicin (600 mg once daily), a strong CYP3A4 inducer, resulted in 84% and 79% decreases in crizotinib steady-state AUCtau and Cmax, respectively, compared to when crizotinib was given alone.
Danish: Lægemidler, som kan nedsætte plasmakoncentrationen af crizotinib Administration af gentagne doser crizotinib (250 mg 2 gange dagligt) sammen med gentagne doser af rifampicin (600 mg 1 gang dagligt) en kraftig CYP3A4-induktor, medførte et fald i crizotinib steady state AUCtau og Cmax-værdier på henholdsvis 84% og 79%, sammenlignet med når crizotinib administreres alene.
English: In 1722 patients treated with crizotinib with either ALK-positive or ROS1-positive NSCLC across clinical studies, the most frequent adverse reactions (≥3%) associated with dosing interruptions were neutropenia, elevated transaminases, vomiting, and nausea.
Danish: I kliniske studier hos 1.722 patienter behandlet med crizotinib for enten ALK-positiv eller ROS1-positiv NSCLC var de hyppigste bivirkninger (≥ 3%) i forbindelse med afbrydelse af behandlingen neutropeni, aminotransferasestigning, opkastning og kvalme.
English: Treatment with crizotinib should be used with caution in patients with hepatic impairment (see Table 2 and sections 4.4, 4.8 and 5.2).
Danish: Crizotinib skal anvendes med forsigtighed til patienter med nedsat leverfunktion (se skema 2 og pkt.
English: The use of single-agent crizotinib in the treatment of ALK-positive advanced NSCLC was investigated in 2 multinational, single-arm studies (Studies 1001 and 1005).
Danish: Enkeltarmsstudier af ALK-positiv fremskreden NSCLC Crizotinib som monoterapi til behandling af ALK-positiv fremskreden NSCLC er blevet undersøgt i 2 multinationale, enkeltarmede studier (studie 1001 og 1005).
English: Ophthalmological evaluation is recommended if vision disorder persists or worsens in severity (see section 4.8).
Danish: En oftalmologisk undersøgelse anbefales ved vedvarende synsforstyrrelser eller hvis disse progredierer (se pkt.
English: Your doctor may perform electrocardiograms to check there are no problems with your heart during treatment with XALKORI.
Danish: Det kan være nødvendigt, at lægen undersøger dit hjerte ved hjælp af et ekg under behandlingen med XALKORI.
English: Coadministration of a single 150 mg oral dose of crizotinib in the presence of ketoconazole (200 mg twice daily), a strong CYP3A inhibitor, resulted in increases in crizotinib systemic exposure, with crizotinib area-under-the-plasma-concentration versus time curve from time zero to infinity (AUCinf) and maximum observed plasma concentration (Cmax) values that were approximately 3.2-fold and 1.4-fold, respectively, those seen when crizotinib was administered alone.
Danish: Administration af en oral enkeltdosis crizotinib 150 mg under tilstedeværelse af ketoconazol (200 mg 2 gange dagligt), en kraftig CYP3A-hæmmer, medførte en stigning i plasmakoncentrationen af crizotinib med AUC fra starttid til uendelighed (AUCinf) og maksimal plasmakoncentration (Cmax), der var henholdsvis 3,2 og 1,4 gange større end dem, der ses, når crizotinib administreres alene.
English: The most frequent adverse reactions (≥3%, all-causality frequency) associated with dose reductions were elevated transaminases (4%) and neutropenia (3%).
Danish: De hyppigste bivirkninger (≥3%, uanset kausalitet) i forbindelse med dosisreduktion var aminotransferasestigning (4%) og neutropeni (3%).
English: Crizotinib was aneugenic in an in vitro micronucleus assay in Chinese Hamster Ovary cells and in an in vitro human lymphocyte chromosome aberration assay.
Danish: Crizotinib påvirkede antallet af kromosomer i in vitro mikronukleus-test i kinesiske hamsterovarie-celler, og i in vitro human lymfocyt-kromosomafvigelses-test. Der er set små stigninger i strukturelle kromosomafvigelser ved cytotoksiske koncentrationer i humane lymfocytter.
English: OS is based on the data cutoff date of 31 August 2015. a. The median PFS times were 4.2 months (95% CI: 2.8, 5.7) for pemetrexed (HR=0.59; p-value=0.0004 for crizotinib compared with pemetrexed) and 2.6 months (95% CI: 1.6, 4.0) for docetaxel
Danish: * PFS, objektiv responsrate og responsvarighed er baseret på data ved cutoff-dato 30. marts 2012, OS er baseret på data ved cutoff-dato 31. august 2015. a. Mediantiden for PFS var 4,2 måneder (95% CI: 2,8, 5,7) for pemetrexed (HR = 0,59, p = 0,0004 for crizotinib sammenlignet med pemetrexed) og 2,6 måneder (95% CI: 1,6, 4,0) for docetaxel (HR = 0,30, p < 0,0001 for crizotinib sammenlignet med docetaxel).
English: The concurrent use of strong CYP3A inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort, should be avoided (see section 4.4).
Danish: Samtidig behandling med potente CYP3A-induktorer, inklusive (men ikke begrænset til) carbamazepin, phenobarbital, phenytoin, rifampicin og naturlægemidler som indeholder perikon bør undgås (se pkt.
English: Tell your doctor right away if you experience difficulty in breathing, especially if associated with cough or fever.
Danish: • Betændelsesagtig tilstand i lungerne Kontakt straks lægen, hvis du får åndenød især hvis du også har hoste og feber.
English: In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC, Grade 3 or 4 neutropenia has been very commonly (12%) reported.
Danish: I kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC blev grad 3 eller 4 neutropeni indberettet med hyppigheden meget almindelig (12%).
English: If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at previous dose upon recovery to Grade ≤1 or to heart rate 60 or above
Danish: Hvis der findes samtidigt administrerede lægemidler, der bidrager til bradykardi, og disse seponeres, eller deres dosis nedsættes, genoptages behandlingen med den tidligere dosis XALKORI efter forbedring til grad ≤ 1 eller til hjertefrekvens på 60 eller derover
English: In clinical studies of crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, shifts to Grade 3 or 4 decreases in leukocytes and neutrophils were observed at frequencies of 4% and 13%, respectively.
Danish: I de kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC sås nedsat antal leukocytter og neutrofiler af grad 3 eller 4 hos henholdsvis 4% og 13%.
English: • Alteration in sense of taste.
Danish: • Smagsforstyrrelser.
English: Chemotherapy N=174
Danish: Kemoterapi N=174
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine), used to treat migraine.
Danish: • Migrænemidler som ergotamin, dihydroergotamin og lignende.
English: QTc prolongation has been observed in clinical studies in patients treated with crizotinib (see sections 4.8 and 5.2) which may lead to an increased risk for ventricular tachyarrhythmias (e.g., Torsade de Pointes) or sudden death.
Danish: 4.8 og 5.2), hvilket kan medføre øget risiko for ventrikulær takyarytmier (fx torsades de pointes) eller pludselig død.
English: Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are substrates of OCT1 or OCT2 (see section 4.5).
Danish: Crizotinib kan derfor potentielt øge plasmakoncentrationen af samtidig administrerede lægemidler, som er substrater for OCT1 eller OCT2 (se pkt.
English: Local cystic invasion beyond the kidney was observed in some patients.
Danish: Der sås lokal perirenal cysteindvækst hos nogle patienter.
English: Chemotherapy N=171
Danish: Kemoterapi N=171
English: XALKORI 250 mg hard capsules Each hard capsule contains 250 mg of crizotinib.
Danish: XALKORI 250 mg hårde kapsler Hver hård kapsel indeholder 250 mg crizotinib.
English: Keep this leaflet.
Danish: Se desuden pkt.
English: Because of the potential harm to the infant, mothers should be advised to avoid breast-feeding while receiving XALKORI (see section 5.3).
Danish: Da der er risiko for bivirkninger hos det ammede barn, bør amning ophøre under behandling med XALKORI (se pkt.
English: Permanently discontinue if no contributing concomitant medicinal product is identified
Danish: Seponer permanent, hvis der ikke samtidigt er blevet administreret lægemidler, der bidrager til bradykardi.
English: • Procainamide, used to treat cardiac arrhythmia.
Danish: • Procainamid, til behandling af forstyrrelser i hjerterytmen.
English: Efficacy results from randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC* Response Parameter
Danish: Effektdata fra randomiseret fase 3-studie 1007 (samlet analysepopulation) hos patienter med tidligere behandlet ALK-positiv fremskreden NSCLC* Responsparameter
English: XALKORI 250 mg is supplied as hard gelatin capsules with pink cap and body, printed with black ink “Pfizer” on the cap, “CRZ 250” on the body.
Danish: XALKORI 250 mg er en hård gelatinekapsel med pink overdel og underdel, der er mærket med sort blæk “Pfizer” på overdelen og “CRZ 250” på underdelen.
English: Patients could continue treatment as assigned beyond the time of RECIST-defined disease progression at the discretion of the investigator if the patient was perceived to be experiencing clinical benefit.
Danish: Patienterne kunne fortsætte crizotinib-behandlingen efter sygdomsprogression som defineret i RECIST, hvis patienten fortsat havde klinisk gavn af behandlingen, og det var i overensstemmelse med investigators skøn.
English: Efficacy results from randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC* Response Parameter
Danish: Effektdata fra det randomiserede fase 3-studie 1014 (hele analysepopulationen) hos tidligere ubehandlede patienter med ALK-positiv fremskreden NSCLC* Responsparameter
English: The demographic and disease characteristics were 50% female, median age of 51 years, baseline ECOG performance status of 0 (32%) or 1 (55%), 61% White and 30% Asian, less than 1% were current smokers, 27% former smokers, 72% never smokers, 94% metastatic, and 98% of the cancers were classified as adenocarcinoma histology.
Danish: De demografiske og sygdomsrelaterede karakteristika var 50% kvinder, medianalder 51 år, status for ECOG-score ved baseline 0 (32%) eller 1 (55%), 61% hvide og 30% asiatere, færre end 1% var rygere, 27% var tidligere rygere, 72% havde aldrig røget, 94% metastatiske, og 98% af cancertyperne blev histologisk klassificeret som adenokarcinom.
English: The demographic and disease characteristics of the overall study population were 56% female, median age of 50 years, baseline ECOG performance status 0 (39%) or 1 (52%), 52% White and 45% Asian, 4% current smokers, 33% past smokers, and 63% never smokers, 93% metastatic, and 93% of patients' tumours were classified as adenocarcinoma histology.
Danish: De demografiske og sygdomsrelaterede karakteristika for den samlede studiepopulation var 56% kvinder, medianalder 50 år, ECOGperformance status ved baseline 0 (39%) eller 1 (52%), 52% hvide og 45% asiatere, 4% var nuværende rygere, 33% var tidligere rygere, og 63% havde aldrig røget, 93% havde metastaserende sygdom, og 93% af tumorerne var klassificeret som adenokarcinom.
English: • Antipsychotics, used to treat mental illness.
Danish: • Medicin mod psykose, psykisk lidelse.
English: The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had not received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1014.
Danish: Tidligere ubehandlet ALK-positiv fremskreden NSCLC - randomiseret fase 3-studie 1014 Crizotinibs virkning og sikkerhed ved behandling af patienter med ALK-positiv metastaserende NSCLC, som ikke tidligere havde fået systemisk behandling for fremskreden sygdom, blev undersøgt i et globalt, randomiseret åbent studie 1014.
English: An adjustment of the dose of crizotinib is recommended when administering crizotinib to patients with severe renal impairment not requiring peritoneal dialysis or haemodialysis (see sections 4.2 and 4.4).
Danish: Det anbefales at justere crizotinibdosis hos patienter med svært nedsat nyrefunktion, som ikke kræver peritonealdialyse eller hæmodialyse (se pkt.
English: In addition, the population pharmacokinetic analysis using data from Studies 1001, 1005 and 1007 indicated CLcr did not have a clinically meaningful effect on the pharmacokinetics of crizotinib.
Danish: Desuden viste den farmakokinetiske populationsanalyse med data fra studie 1001, 1005 og 1007, at CLcr ikke havde nogen klinisk betydning på crizotinibs farmakokinetik.
English: Based on the population pharmacokinetic analysis of data in Studies 1001, 1005 and 1007, age has no effect on crizotinib pharmacokinetics.
Danish: På basis af den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 har alder ingen effekt på crizotinibs farmakokinetik.
English: How to take XALKORI
Danish: Sådan skal du tage XALKORI
English: Therefore, the concomitant use of strong CYP3A inhibitors (including but not limited to atazanavir, ritonavir, cobicistat, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, and erythromycin) should be avoided.
Danish: Derfor bør samtidig administrering af kraftige CYP3A-hæmmere (herunder men ikke begrænset til atazanavir, ritonavir, cobicistat, itraconazol, ketoconazol, posaconazol, voriconazol, clarithromycin, telithromycin og erythromycin) undgås, medmindre den mulige fordel for patienten opvejer risikoen, i hvilket tilfælde patienten bør overvåges nøje for bivirkninger fra crizotinib (se pkt.
English: The demographic and disease characteristics were 57% female, median age of 53 years, baseline ECOG performance status of 0/1 (82%) or 2/3 (18%), 52% White and 44% Asian, 4% current smokers, 30% former smokers, 66% never smokers, 92% metastatic, and 94% of the cancers were classified as adenocarcinoma histology.
Danish: De demografiske og sygdomsrelaterede karakteristika var 57% kvinder, medianalder 53 år, status for ECOG-score ved baseline 0/1 (82%) eller 2/3 (18%), 52% hvide og 44% asiatere, 4% rygere, 30% tidligere rygere, 66% havde aldrig røget, 92% metastatiske, og 94% af cancertyperne blev histologisk klassificeret som adenokarcinom.
English: Hepatic Impairment
Danish: Akut nyresvigt
English: If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: • Colchicine, used to treat gout.
Danish: • Colchicin, til behandling af urinsyregigt.