natgillin/translations-raw huggingface dataset:
Patienter, der udvikler symptomatisk bradykardi, bør behandles efter anbefalingerne i afsnittene Dosisjustering og Advarsler og forsigtighedsregler (se pkt.
Patients who develop symptomatic bradycardia should be managed as recommended in the Dose Modification and Warnings and Precautions sections (see sections 4.2, 4.4 and 4.5).
f. ORR var 29% (95% CI: 21, 39) for pemetrexed (p < 0,0001 sammenlignet med crizotinib) og 7% (95% CI: 2,
f. ORRs were 29% (95% CI: 21, 39) for pemetrexed (p-value <0.0001 compared with crizotinib) and 7% (95%
livskvalitet (QoL) i crizitonib-armen sammenlignet med kemoterapi-armen (samlet forskel i ændring fra baseline var 13,8; p <0,0001).
Significantly greater improvement in global QOL was observed in the crizotinib arm compared to the chemotherapy arm (overall difference in change from baseline scores 13.8; p-value <0.0001).
Patienter, som blev behandlet med 250 mg 1 gang dagligt, eller hvis dosis blev nedsat til 250 mg 1 gang dagligt, skal have behandlingen seponeret under evalueringen.
e. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Fordelen ved crizotinib med hensyn til PFS var konsistent på tværs af undergrupperne, baseret på patientkarakteristika ved baseline som alder, køn, race, rygestatus, forløbet tid siden diagnosticering, status for ECOG, tilstedeværelse af hjernemetastaser og tidligere behandling med EGFR tyrosinkinasehæmmer.
The PFS benefit of crizotinib was consistent across subgroups of baseline patient characteristics such as age, gender, race, smoking class, time since diagnosis, ECOG performance status, presence of brain metastases and prior EGFR TKI therapy.
Potentiel forlængelse af QT-intervallet pga. crizotinib er undersøgt hos patienter med enten ALKpositiv eller ROS1-positiv NSCLC behandlet med crizotinib 250 mg 2 gange dagligt.
The QT interval prolongation potential of crizotinib was assessed in patients with either ALK-positive or ROS1-positive NSCLC who received crizotinib 250 mg twice daily.
Tag ikke XALKORI:
Do not take XALKORI
In vitro studier antyder, at crizotinib er en svag hæmmer af uridindiphosphat-glukuronosyltransferase (UGT)1A1 og UGT2B7.
In vitro studies indicated that crizotinib is a weak inhibitor of uridine diphosphate glucuronosyltransferase (UGT)1A1 and UGT2B7.
Crizotinib gav symptomatiske fordele gennem en signifikant forlængelse af tiden indtil forværring (median 4,5 måneder mod 1,4 måneder) hos patienter, som rapporterede symptomer på smerter i brystet, dyspnø eller hoste sammenlignet med kemoterapi (HR 0,50, 95% CI: 0,37; 0,66, Hochbergjusteret log-rank 2-sidet p < 0,0001).
Crizotinib resulted in symptoms benefit by significantly prolonging time to deterioration (median 4.5 months versus 1.4 months) in patients who reported symptoms of pain in chest, dyspnoea, or cough, compared to chemotherapy (HR 0.50; 95% CI: 0.37, 0.66; Hochberg adjusted log-rank p< 0.0001).
• Pravastatin, til behandling af for højt kolesterol.
• Pravastatin, used to reduce cholesterol levels.
XALKORI findes i blisterpakninger med 60 hårde kapsler og i en plastikbeholder med 60 hårde kapsler.
It is available in blister packs of 60 hard capsules and in plastic bottles of 60 hard capsules.
Hos patienter med tidligere behandlede hjernemetastaser ved baseline var mediantiden til intrakraniel progression (IC-TTP) 15,7 måneder i crizotinib-armen (N=39) og 12,5 måneder i kemoterapi-armen (N=40) (HR=0,45 [95% CI: 0,19, 1,07]; 1-sidet p-værdi = 0,0315).
For patients with previously treated baseline brain metastases, the median intracranial time to progression (IC-TTP) was 15.7 months in the crizotinib arm (N=39) and 12.5 months in the chemotherapy arm (N=40) (HR=0.45 [95% CI: 0.19, 1.07]; 1-sided p-value=0.0315).
I studie 1005 var den korrigerede geometriske Ctrough, ss-middelværdi af crizotinib hos grupperne med let (N=191) og moderat (N=65) nedsat nyrefunktion henholdsvis 9,1% og 15% højere end hos patienter med normal nyrefunktion.
In Study 1005, the adjusted geometric mean Ctrough, ss of crizotinib in mild (N=191) and moderate (N=65) renal impairment groups were 9.1% and 15% higher, respectively, than those in patients with normal renal function.
I det randomiserede fase 3-studie 1007 sås grad 3 eller 4 ALAT- eller ASAT-stigning hos 18% og 9% af de patienter, der fik crizotinib, og 5% og < 1% af de patienter, der fik kemoterapi.
In randomised Phase 3 Study 1007, increases to Grade 3 or 4 ALT or AST elevations were observed in 18% and 9% of patients receiving crizotinib and 5% and <1% of patients receiving chemotherapy.
Interaktion med føde Grapefrugt eller grapefrugtjuice skal undgås under behandling med crizotinib (se pkt.
Grapefruit or grapefruit juice should be avoided during treatment with crizotinib (see sections 4.2 and
Undgå at bruge crizotinib i kombination med andre lægemidler, der kan give bradykardi eller forlænge QT-intervallet, og/eller antiarytmika (se Forlængelse af QT-intervallet og Bradykardi under pkt.
Avoid using crizotinib in combination with other bradycardic agents, medicinal products that are known to prolong QT interval and/or antiarrhythmics (see section 4.4 QT interval prolongation, Bradycardia, and section 4.5).
Forkortelser: CI=konfidensinterval, N=antal patienter, NR=ikke nået, OS=samlet overlevelse.
Abbreviations: CI=confidence interval; N=number of patients; NR=not reached; OS=overall survival.
I alt 149 patienter med ALK-positiv fremskreden NSCLC, herunder 125 patienter med tidligere behandlet ALK-positiv fremskreden NSCLC, blev inkluderet i studie 1001 på det tidspunkt, hvor data blev opgjort for PFS-og ORR-analysen.
A total of 149 ALK-positive advanced NSCLC patients, including 125 patients with previously treated ALK-positive advanced NSCLC, were enrolled into Study 1001 at the time of data cutoff for PFS and ORR analysis.
GENEREL KLASSIFIKATION FOR UDLEVERING
GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE
Crizotinib udviste koncentrationsafhængig hæmning af kinaseaktivitet af ALK, ROS1 og c-Met i biokemiske test og hæmmede fosforylering og modulerede kinaseafhængige fænotyper i cellebaserede test. Crizotinib viser potent og selektiv væksthæmmende aktivitet og inducerer apoptose i tumorcellelinjer med ALK-fusionshændelser (inklusive echinoderm microtubule-associated proteinlike 4 [EML4]-ALK og nucleophosmin [NPM]-ALK), ROS1-fusionshændelser eller amplifikation af ALK- eller MET-genlokus.
Crizotinib demonstrated potent and selective growth inhibitory activity and induced apoptosis in tumour cell lines exhibiting ALK fusion events (including echinoderm microtubule-associated protein-like 4 [EML4]-ALK and nucleophosmin [NPM]-ALK), ROS1 fusion events, or exhibiting amplification of the ALK or MET gene locus.
I kliniske studier med patienter (n=1.722), som blev behandlet med crizotinib, havde i alt 19 (1,1%) patienter hjertesvigt af enhver grad, 8 (0,5%) patienter havde grad 3 eller 4 hjertesvigt, og 3 (0,2%) patienter fik hjertesvigt med dødelig udgang.
Across clinical studies (n=1722), 19 (1.1%) patients treated with crizotinib had any grade cardiac failure, 8 (0.5%) patients had Grade 3 or 4, and 3 (0.2%) patients had fatal outcome.
Fund i reproduktionsvejene hos hanrotter er degenerering af spermatocytter i testis ved doser på ≥50 mg/kg/dag i 28 dage (ca. 1,1 gange human klinisk eksponering baseret på AUC).
Findings observed in the male reproductive tract included testicular pachytene spermatocyte degeneration in rats given ≥50 mg/kg/day for 28 days (approximately 1.1-fold human clinical exposure based on AUC).
Estimeret ved Kaplan-Meier-metoden.
g. Estimated using the Kaplan-Meier method.
Et ekg-understudie med blindede, manuelle ekg-målinger blev gennemført hos 52 ALK-positive NSCLC-patienter, som fik crizotinib 250 mg to gange dagligt.
An ECG substudy using blinded manual ECG measurements was conducted in 52 ALK-positive NSCLC patients who received crizotinib 250 mg twice daily.
Hvad du skal gøre, hvis du har glemt at tage en dosis afhænger af, hvor lang tid der er, til du skal tage den næste dosis:
If you forget to take XALKORI What to do if you forget to take a capsule depends on how long it is until your next dose.
Printblæk: shellac, propylenglycol, kaliumhydroxid og sort jernoxid (E172).
Printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
De patienter, der var randomiseret til kemoterapi, kunne overgå til crizotinibbehandling efter sygdomsprogression som defineret i RECIST og bekræftet ved IRR.
Patients randomised to chemotherapy could crossover to receive crizotinib upon RECIST-defined disease progression confirmed by IRR.
Brug af anden medicin sammen med XALKORI
Other medicines and XALKORI
Det skal du vide, før du begynder at tage XALKORI
What you need to know before you take XALKORI
Derfor bør samtidig administration af crizotinib med CYP3A-substrater med smalt terapeutisk indeks, herunder (men ikke begrænset til) alfentanil, cisaprid, cyclosporin, ergotaminderivater, fentanyl, pimozid, chinidin, sirolimus og tacrolimus undgås (se pkt.
Therefore, coadministration of crizotinib with CYP3A substrates with narrow therapeutic indices, including but not limited to alfentanil, cisapride, cyclosporine, ergot derivatives, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus should be avoided (see section 4.4).
p-værdi
p-valuef
Patienterne skal monitoreres for hepatotoksicitet og behandles i henhold til anbefalingerne i pkt.
Patients should be monitored for hepatotoxicity and managed as recommended in sections 4.2 and 4.4.
f) Svimmelhed (balanceforstyrrelse, svimmelhed, postural svimmelhed, nærsynkope).
f. Dizziness (Balance disorder, Dizziness, Dizziness postural, Presyncope).
In vitro studier antyder, at crizotinib er en CYP2B6-hæmmer.
In vitro studies indicated that crizotinib is an inhibitor of CYP2B6.
Synsforstyrrelser, hyppigst nedsat syn, fotopsi, sløret syn og ”flyvende fluer” blev set hos 1.084 (63%) af 1.722 patienter, der blev behandlet med crizotinib (alle typer kausalitet og alle grader).
All-causality, all grade, vision disorder, most commonly visual impairment, photopsia, vision blurred, and vitreous floaters, was experienced by 1084 (63%) of 1722 patients treated with crizotinib.
Brugen af crizotinib som enkeltstof til behandling af ROS1-positiv fremskreden NSCLC blev undersøgt i etmultinationalt multicenterstudie med en enkelt arm 1001.
The use of single-agent crizotinib in the treatment of ROS1-positive advanced NSCLC was investigated in multicenter, multinational, single-arm Study 1001.
Crizotinib resulterede i signifikant mindre forværring fra baseline i perifer neuropati (cyklus 6 til 20, p < 0,05), dysfagi (cyklus 5 til 11, p < 0,05) og øm mund (cyklus 2 til 20, pi < 0,05) sammenlignet med kemoterapi.
Crizotinib resulted in a significantly lower deterioration from baseline in peripheral neuropathy (Cycles 6 to 20; p-value <0.05), dysphagia (Cycles 5 to 11; p-value <0.05) and sore mouth (Cycle 2 to 20; p-value <0.05) compared to chemotherapy.
Kolloid vandfri siliciumioxid Mikrokrystallinsk cellulose Vandfrit calciumhydrogenphosphat Natriumstivelsesglycolat Magnesiumstearat
Colloidal anhydrous silica Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Sodium starch glycolate (Type A) Magnesium stearate
Der blev udført et oftalmologisk understudie med specifikke okulære vurderinger på nærmere angivne tidspunkter hos 54 patienter med NSCLC, der fik 250 mg crizotinib 2 gange dagligt.
An ophthalmology substudy using specific ophthalmic assessments at specified time points was conducted in 54 patients with NSCLC who received crizotinib 250 mg twice daily.
p-værdi Responsvarighed Median e, måneder (95% CI)
p-valueg Duration of Response Mediane, Months (95% CI)
Til patienter med moderat nedsat leverfunktion (enhver ASAT og total bilirubin > 1,5 × ULN og  3 × ULN) anbefales en startdosis på 200 mg to gange dagligt.
The starting crizotinib dose for patients with moderate hepatic impairment (any AST and total bilirubin >1.5 × ULN and 3 × ULN) is recommended to be 200 mg twice daily.
• Behandling af voksne med tidligere behandlet anaplastisk lymfomkinase-positiv (ALK-positiv) fremskreden ikke-småcellet lungecancer (NSCLC)
• The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicine obtained over the counter.
Den systemiske crizotinib-eksponering hos patienter med moderat leverfunktion ved dosen på 200 mg to gange dagligt var imidlertid sammenlignelig med, hvad man observerede hos patienter med normal leverfunktion ved en dosis på 250 mg to gange dagligt, med geometriske middelværdier for AUCdaily og Cmax på henholdsvis 114% og 109%.
However, the systemic crizotinib exposure in patients with moderate hepatic impairment at the dose of 200 mg twice daily was comparable to that observed from patients with normal hepatic function at a dose of 250 mg twice daily, with geometric mean ratios for AUCdaily and Cmax of 114% and 109%, respectively.
• Anden dosisreduktion: XALKORI 250 mg oralt 1 gang dagligt
• Second dose reduction: XALKORI 250 mg taken orally once daily
Under de enkelte hyppigheder er de alvorligste bivirkninger nævnt først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Påvirkning af synet
Visual effects
Den mediane DR var 24,7 måneder (95% CI: 15,2 ; 45,3).
The median DR was 24.7 months (95% CI: 15.2, 45.3).
• For lidt fosfor i blodet, hvilket kan gøre dig forvirret eller give muskelsvaghed (hypofosfatæmi).
• Hypophosphataemia (low blood phosphate levels that can cause confusion or muscle weakness).
De hyppigste bivirkninger (≥ 3%) i forbindelse med dosisnedsættelse var aminotransferasestigning og neutropeni.
The most frequent adverse reactions (≥3%) associated with dose reductions were elevated transaminases and neutropenia.
• Metformin, til behandling af sukkersyge (diabetes mellitus).
• Metformin, used to treat diabetes.
Neuropati d (25%) Smagsforstyrrelser
Neuropathyd (25%) Dysgeusia (21%)
65 af 89 patienter (73%) i crizotinib-armen og 11 af 132 (8,3%) patienter i kemoterapi-armen, fortsatte med behandlingen i mindst 3 uger efter objektiv sygdomsprogression.
Sixty-five of 89 (73%) patients treated with crizotinib and 11 of 132 (8.3%) patients treated with chemotherapy continued treatment for at least 3 weeks after objective disease progression.
Grapefrugtjuice kan øge plasmakoncentrationen af crizotinib og bør derfor undgås (se pkt.
Grapefruit or grapefruit juice may also increase plasma concentrations of crizotinib and should be avoided (see sections 4.2 and 4.4).
Der er set lægemiddelinduceret levertoksicitet (herunder dødelige tilfælde) hos patienter, der blev behandlet med crizotinib i kliniske studier (se pkt.
Drug-induced hepatotoxicity (including cases with fatal outcome) has been reported in patients treated with crizotinib across clinical trials (see section 4.8).
Nedsat testosteron i blodet q (2%)
Blood testosterone decreasedq (2%)
Nyresvigt (<1%)
Acute renal failure (<1%) Renal failure
rapporterede synsforstyrrelser, som opstod med en frekvens på 4 til 7 dage hver uge, varede i op til 1 minut og havde let eller ingen indvirkning (score på 0 til 3 af en maksimal score på 10) på de daglige aktiviteter i henhold til de indhentede oplysninger fra spørgeskemaet VSAQ-ALK.
The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 (>50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Til patienter med svært nedsat leverfunktion (enhver ASAT og total bilirubin > 3 × ULN) anbefales en startdosis på 250 mg en gang dagligt (se pkt.
The starting crizotinib dose for patients with severe hepatic impairment (any AST and total bilirubin >3 × ULN) is recommended to be 250 mg once daily (see section 5.2).
Crizotinib førte til symptomfordele gennem signifikant forlængelse af TTD sammenlignet med kemoterapi (median 2,1 måneder versus 0,5 måneder; HR = 0,59; 95% CI: 0,45-0,77; Hochbergjusteret log-rank 2-sidet p = 0,0005).
Crizotinib resulted in symptom benefits by significantly prolonging TTD compared to chemotherapy (median 2.1 months versus 0.5 months; HR=0.59; 95% CI: 0.45, 0.77; Hochberg-adjusted log-rank 2-sided p-value =0.0005).
• Morphin, til behandling af stærke smerter.
• Morphine, used to treat acute and cancer pain.
In vitro studier antyder dog, at det ikke er sandsynligt, at der vil forekomme klinisk interaktion som følge af crizotinib-medieret hæmning af metaboliseringen af lægemidler, som er substrater for UGT1A1, UGT1A4, UGT1A6, UGT1A9 eller UGT2B7.
However, in vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of drugs that are substrates for UGT1A4, UGT1A6, or UGT1A9.
In vitro studier viser, at crizotinib er en svag hæmmer af UGT1A1 og UGT2B7 (se pkt.
In vitro studies showed that crizotinib is a weak inhibitor of UGT1A1 and UGT2B7 (see section 4.5).
Skema 3 viser bivirkninger, der er set hos 1.722 patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC, der fik crizotinib i både 2 randomiserede fase 3-studier (1007 og 1014) og 2 kliniske enkeltarmsstudier (1001 og 1005) (se pkt.
Table 3 presents adverse reactions reported in 1722 patients with either ALK-positive or ROS1-positive advanced NSCLC who received crizotinib across 2 randomised Phase 3 studies (1007 and 1014) and 2 single-arm clinical studies (1001 and 1005) (see section 5.1).
Elleve (21%) patienter havde en stigning i baseline-QTcF ≥30 på <60 ms og en patient (2%) havde en stigning fra baseline-QTcF på ≥60 ms. Ingen patienter havde maksimum QTcF ≥480 ms.
Eleven (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
- Aktivt stof: crizotinib.
The active substance in XALKORI is crizotinib.
Der skal udvises forsigtighed ved bilkørsel eller betjening af maskiner, hvis patienten oplever symptomatisk bradykardi (fx synkope, svimmelhed eller hypotension), synsforstyrrelser, eller træthed under behandling med XALKORI (se pkt.
Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension), vision disorder, or fatigue while taking XALKORI (see sections 4.2, 4.4 and 4.8).
Dermed kan crizotinib potentielt øge plasmakoncentrationen af samtidig administrerede lægemidler, som metaboliseres af CYP2B6 (fx bupropion, efavirenz).
Therefore, crizotinib may have the potential to increase plasma concentrations of coadministered drugs that are metabolized by CYP2B6 (e.g., bupropion, efavirenz).
Der bør derfor udvises forsigtighed ved samtidig administration af crizotinib og moderate CYP3Ahæmmere.
Caution is therefore recommended in case of coadministration of crizotinib with moderate CYP3A inhibitors.
Median PFS på data cutoff var 19,3 måneder (95% CI: 15,2;
The median PFS at the time of data cutoff was 19.3 months (95% CI: 15.2, 39.1).
• Permanent seponering, hvis XALKORI 250 mg oralt 1 gang dagligt ikke tolereres
• Permanently discontinue if unable to tolerate XALKORI 250 mg taken orally once daily
Baseret på in vitro studier forventes det, at crizotinib kan hæmme P-gp i tarmen.
Based on an in vitro study, crizotinib is predicted to inhibit intestinal P-gp.
Justering af crizotinib-dosis er nødvendig ved administration af crizotinib til patienter med moderat eller svært nedsat leverfunktion (se pkt.
An adjustment of the dose of crizotinib is recommended when administering crizotinib to patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
I studie 1001 var den korrigerede geometriske middelværdi i plasma Ctrough, ss henholdsvis 5,1% og 11% højere hos patienter med let (N=35) og moderat (N=8) nedsat nyrefunktion end hos patienter med normal nyrefunktion.
In Study 1001, the adjusted geometric mean of plasma Ctrough, ss in mild (N=35) and moderate (N=8) renal impairment patients were 5.1% and 11% higher, respectively, than those in patients with normal renal function.
• Hvis du har alvorligt nedsat nyrefunktion.
• If you have reduced heart rate.
XALKORI indeholder:
What XALKORI contains
Samtidig administration af lægemidler, der øger gastrisk pH Crizotinibs vandopløselighed er pH-afhængig, og lav (sur) pH giver højere opløselighed.
The aqueous solubility of crizotinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Forlænget QTinterval (4%) Synkope (3%)
Cardiac failureh (1%) Electrocardiogram QT prolonged (4%) Syncope (3%)
Synsforstyrrelserne indtraf generelt inden for den første behandlingsuge.
The onset of vision disorders generally started within the first week of drug administration.
Efter dosering med crizotinib 250 mg to gange dagligt viste patienter med let nedsat leverfunktion (N=10) den samme systemiske crizotinib-eksponering ved steady state som patienter med normal leverfunktion (N=8), med geometriske middelværdier for arealet under plasmakoncentrationstidskurven ved daglig eksponering i steady state (AUCdaily) og Cmax på henholdsvis 91,1% og 91,2%.
Following crizotinib 250 mg twice daily dosing, patients with mild hepatic impairment (N=10) showed similar systemic crizotinib exposure at steady state compared to patients with normal hepatic function (N=8), with geometric mean ratios for area under the plasma concentration-time curve as daily exposure at steady state (AUCdaily) and Cmax of 91.1% and 91.2%, respectively.
De demografiske karakteristika var 57% kvinder; medianalder 55 år; ECOG-performancestatus 0 eller 1 (98%) eller 2 (2%) ved baseline, 57% hvide og 40% asiater; 25% tidligere rygere, og 75% havde aldrig røget.
The demographic characteristics were 57% female; median age 55 years; baseline ECOG performance status of 0 or 1 (98%) or 2 (2%), 57% White and 40% Asian; 25% former smokers, and 75% never smokers.
Grad 4 bradykardi d,e,f
Grade 4 Bradycardiad,e,f Life-threatening consequences, urgent intervention indicated
Hvis der findes samtidigt administrerede lægemidler, der bidrager til bradykardi, og disse seponeres, eller deres dosis nedsættes, genoptages behandlingen med 250 mg en gang dagligt c efter forbedring til grad ≤ 1 eller til hjertefrekvens på 60 eller derover med hyppig monitorering
If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at 250 mg once dailyc upon recovery to Grade ≤1 or to heart rate 60 or above, with frequent monitoring
Opdatering baseret på endelig analyse af OS. Analyse af OS var ikke justeret for den mulige konfunderende effekt ved overkrydsning (144 (84%) af patienterne i kemoterapi-armen modtog efterfølgende crizotinibbehandling).
OS analysis was not adjusted for the potentially confounding effects of cross over (144 [84%] patients in the chemotherapy arm received subsequent crizotinib treatment).
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
This leaflet was last revised in {MM/YYYY}.
Crizotinib gav ifølge IRR-vurderingen en signifikant forlænget progressionsfri overlevelse (PFS), som var det primære studieendepunkt, sammenlignet med kemoterapi.
Crizotinib significantly prolonged progression-free survival (PFS), the primary objective of the study, compared to chemotherapy as assessed by IRR.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2012