natgillin/translations-raw huggingface dataset:
Zykadia filmovertrukne tabletter er lyseblå, runde, bikonvekse med skrå kanter, uden delekærv, præget med ”NVR” på den ene side og ”ZY1” på den anden side. 
What Zykadia looks like and contents of the pack Zykadia film-coated tablets are light blue, round, biconvex with bevelled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side.
I dosis-optimeringsstudiet A2112 (ASCEND-8), for både tidligere behandlede og ubehandlede patienter med ALK-positiv avanceret NSCLC, var den overordnede sikkerhedsprofil af Zykadia ved den anbefalede dosis på 450 mg med mad (N=89) sammenlignelig med Zykadia 750 mg fastende (N=90), bortset fra en reduktion af de gastrointestinale bivirkninger, mens der blev opnået sammenlignelig steady-state optagelse (se pkt. 
In the dose optimisation study A2112 (ASCEND-8) in both previously treated and untreated patients with ALK-positive advanced NSCLC, the overall safety profile of Zykadia at the recommended dose of 450 mg with food (N=89) was consistent with Zykadia 750 mg fasted (N=90), except for a reduction in gastrointestinal adverse drug reactions, while achieving comparable steady-state exposure (see section 5.1 and subsection ‘Gastrointestinal adverse reactions' below).
diclofenac, der bruges til behandling af ledsmerter og betændelse. 
diclofenac, a medicine used to treat joint pain and inflammation.
4.5 vedrørende patienter, der udvikler en samtidig sygdomstilstand og ikke kan tage Zykadia sammen med mad. 
For patients who develop a concurrent medical condition and are unable to take Zykadia with food please refer to section 4.5.
En central tendens-analyse af QTc-data ved gennemsnitlig steady state-koncentration fra Studie A2301 viste, at den øvre grænse for det 2-sidede 90 % CI for QTc-stigning i forhold til baseline var 15,3 msek. 
There were 58 patients (6.3%) with a QTc increase from baseline >60 msec. A central tendency analysis of the QTc data at average steady-state concentration from Study A2301 demonstrated that the upper bound of the 2-sided 90% CI for QTc increase from baseline was 15.3 msec at Zykadia 750 mg fasted.
Patienter skal monitoreres for forhøjet lipase og amylase, før behandling med Zykadia påbegyndes og periodisk derefter som klinisk indiceret (se pkt. 
Patients should be monitored for lipase and amylase elevations prior to the start of Zykadia treatment and periodically thereafter as clinically indicated (see sections 4.2 and 4.8).
Lægemidler, der påvirker pH-værdien i mavesækken Ceritinib udviser pH-afhængig opløselighed og bliver svært opløseligt ved stigning i pH in vitro. 
Ceritinib demonstrates pH-dependent solubility and becomes poorly soluble as pH increases in vitro.
Zykadia indeholder: Aktivt stof: ceritinib. 
What Zykadia contains The active substance of Zykadia is ceritinib.
ændring fra baseline og torsade de pointes eller polymorf ventrikulær takykardi eller tegn/symptomer på alvorlig arytmi 
QTc >500 msec or >60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
Ceritinibs AUCinf-værdier var ca. 58 % og 73 % højere (Cmax ca. 43 % og 41 % højere) for raske forsøgspersoner, når en enkeltdosis 500 mg ceritinib blev administraret med henholdsvis et fedtfattigt måltid (indeholdende ca. 330 kilokalorier og 9 gram fedt) og et fedtholdigt måltid (indeholdende ca. 1000 kilokalorier og 58 g fedt), sammenlignet med fastende. 
Ceritinib AUCinf values were approximately 58% and 73% higher (Cmax approximately 43% and 41% higher) in healthy subjects when a single 500 mg ceritinib dose was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Lægemidler, der kan øge plasmakoncentrationen af ceritinib 
Agents that may increase ceritinib plasma concentrations
Dette genererer et EML4-ALK-fusionsprotein, som indeholder ALK's proteinkinasedomæne fusioneret til den N-terminale del af EML4. 
In the majority of NSCLC cases, EML4 is the translocation partner for ALK; this generates an EML4-ALK fusion protein containing the protein kinase domain of ALK fused to the N-terminal part of EML4.
Dosisafbrydelse og dosisreduktion iværksættes efter behov (se pkt. 
Dose interruption and dose reduction should be employed as necessary (see sections 4.2 and 4.8).
Zykadia hårde kapsler har en hvid, uigennemsigtig underdel og blå, uigennemsigtig overdel, der er præget med ”LDK 150MG” på overdelen og ”NVR” på underdelen. 
What Zykadia looks like and contents of the pack Zykadia hard capsules have a white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body.
domperidon, der bruges til behandling af kvalme og opkastning. 
domperidone, a medicine used to treat nausea and vomiting.
Ceritinib forlængede tid til forværring af de præspecificerede lungecancerspecifikke symptomer hoste, smerter og dyspnø signifikant (sammensat endepunkt LCSS: HR=0,61, 95 % CI: 0,41; 0,90, median tid til forværring [TTD] NE [95 % CI: 20,9; NE] i ceritinib-armen versus 18,4 måneder [13,9; NE] i kemoterapi-armen; LC13: HR=0,48, 95 % CI: 0,34; 0,69, median TTD 23,6 måneder [95 % CI: 20,7; NE] i ceritinib-armen versus 12,6 måneder [95 % CI: 8,9; 14,9] i kemoterapi-armen). 
Ceritinib significantly prolonged time to deterioration for the pre-specified lung cancer specific symptoms of interest of cough, pain and dyspnoea (composite endpoint LCSS: HR=0.61, 95% CI: 0.41, 0.90, median Time to Deterioration [TTD] NE [95% CI: 20.9, NE] in the ceritinib arm versus 18.4 months [13.9, NE] in the chemotherapy arm; LC13: HR=0.48, 95% CI: 0.34, 0.69, median TTD 23.6 months [95% CI: 20.7, NE] in the ceritinib arm versus 12.6 months [95% CI: 8.9, 14.9] in the chemotherapy arm).
Kaplan-Meier-medianer (95 % CI) (måneder) Ceritinib 750 mg: 5,4 (4,1; 6,9) Kemoterapi: 1,6 (1,4; 2,8) 
Kaplan-Meier medians (95% CI) (Months) Ceritinib 750 mg: 5.4 (4.1;6.9) Chemotherapy: 1.6 (1.4;2.8)
Kaplan-Meier-medianer (95 % CI) (måneder) Ceritinib 750 mg: 18,1 (13,4; 23,9) Kemoterapi: 20,1 (11,9; 25,1) 
Kaplan-Meier medians (95% CI) (Months) Ceritinib 750 mg: 18.1 (13.4;23.9) Chemotherapy: 20.1 (11.9;25.1)
Tabel 3 ASCEND-4 (Studie A2301) - Effektresultater hos patienter med tidligere ubehandlet ALK-positiv, fremskreden NSCLC 
Table 3 ASCEND-4 (Study A2301) - Efficacy results in patients with previously untreated ALK-positive advanced NSCLC
Patienter skal monitoreres for unormale resultater af leverlaboratorietests og behandles som anbefalet i pkt. 
Patients should be monitored for liver laboratory test abnormalities and managed as recommended in sections 4.2 and 4.4.
11,3 % af patienterne i ceritinibarmen og 12,1 % af patienterne i kemoterapi-armen blev behandlet med to tidligere kemoterapiregimer for fremskreden sygdom. 
All except one patient received prior chemotherapy (including a platinum doublet) for advanced disease; 11.3% of the patients in the ceritinib arm and 12.1% of the patients in the chemotherapy arm were treated with two prior chemotherapy regimen for advanced disease.
Nyopstået eller forværret hoste med eller uden slim, feber, brystsmerter, vejrtrækningsbesvær eller kortåndethed (mulige tegn på lungeproblemer) Træthed, kløende hud, gulfarvning af huden eller det hvide i øjnene, kvalme eller opkastning, nedsat appetit, smerter i højre side af maven, mørk eller brun urin, blødning eller tendens til blå mærker i højere grad end normalt (mulige tegn eller symptomer på leverproblemer) Kraftig diarré, kvalme eller opkastning 
If you experience any of the following side effects, tell your doctor or pharmacist immediately: Chest pain or discomfort, changes in your heartbeat (fast or slow), light-headedness, fainting, dizziness, blue discoloration of your lips, shortness of breath, swelling of your lower limbs or skin (potential signs or symptoms of heart problems) New or worsening cough with or without mucus, fever, chest pain, trouble breathing or shortness of breath (potential signs of lung problems) Tiredness, itchy skin, yellowing of your skin or the whites of your eyes, nausea (feeling sick) or vomiting, decreased appetite, pain on the right side of your abdomen (belly), dark or brown urine, bleeding or bruising more easily than normal (potential signs or symptoms of liver problems)
Den højeste anbefalede dosis af Zykadia er 450 mg taget en gang daglig sammen med mad (se pkt. 
The maximum recommended dose of Zykadia is 450 mg taken orally once daily with food (see section 4.2).
Hvis den næste dosis er om mindre end 12 timer, skal du ikke tage de glemte kapsler. 
- If your next dose is in less than 12 hours, skip the missed capsules.
Ceritinibs AUCinf-værdier var ca. 39 % og 64 % højere (Cmax ca. 42 % og 58 % højere) for raske forsøgspersoner, når en enkeltdosis 750 mg ceritinib (tablet) blev administreret med henholdsvis et fedtfattigt måltid (indeholdende ca. 330 kilokalorier og 9 gram fedt) og et fedtholdigt måltid (indeholdende ca. 1000 kilokalorier og 58 g fedt), sammenlignet med fastende. 
Ceritinib AUCinf values were approximately 39% and 64% higher (Cmax approximately 42% and 58% higher) in healthy subjects when a single 750 mg ceritinib dose (tablet) was administered with a low fat meal (containing approximately 330 kcalories and 9 grams of fat) and a high fat meal (containing approximately 1000 kcalories and 58 grams of fat), respectively, as compared with the fasted state.
Samtidig administration af en enkeltdosis på 750 mg ceritinib fastende og en protonpumpehæmmer (esomeprazol) 40 mg dagligt i 6 dage hos raske, fastende forsøgspersoner nedsatte AUC og Cmax for ceritinib med henholdsvis 76 % og 79 %. 
Co-administration of a single 750 mg fasted ceritinib dose with a proton pump inhibitor (esomeprazole) 40 mg daily for 6 days in healthy, fasting subjects decreased ceritinib AUC by 76% and Cmax by 79%.
Der skal udvises forsigtighed ved samtidig brug af P-gp-hæmmere, og bivirkninger skal monitoreres omhyggeligt. 
Caution should be exercised with concomitant use of P-gp inhibitors and ADRs carefully monitored.
For de 163 ALK-positive NSCLC-patienter, der havde fået tidligere behandling med en ALK-hæmmer, var medianalderen 52 år (interval: 24-80 år). 
Of the 163 ALK-positive NSCLC patients who had received prior treatment with an ALK inhibitor, the median age was 52 years (range: 24-80 years); 86.5% were younger than 65 years and 54% were female.
Tabel 4 ASCEND-5 (Studie A2303) - Effektresultater hos patienter med tidligere behandlet ALK-positiv, metastatisk/fremskreden NSCLC 
Table 4 ASCEND-5 (Study A2303) - Efficacy results in patients with previously treated ALK-positive metastatic/advanced NSCLC
Der findes ingen effektdata for patienter over 85 år. 
No efficacy data are available in patients over 85 years of age.
Zykadia 150 mg hårde kapsler ceritinib 
Zykadia 150 mg hard capsules ceritinib
Median-alderen var 54 år (interval: 22 til 81 år). 
The median age was 54 years (range: 22 to 81 years); 78.5% of patients were younger than 65 years.
Hvis den næste dosis er om mindre end 12 timer, skal du ikke tage de glemte tabletter. 
- If your next dose is in less than 12 hours, skip the missed tablets.
Figur 1 ASCEND-4 (Studie A2301) - Kaplan-Meier-kurver for progressionsfri overlevelse, vurderet af BIRC 
Figure 1 ASCEND-4 (Study A2301) - Kaplan-Meier curves of progression-free survival as assessed by BIRC
Dosis skal reduceres med ca. en tredjedel, afrundet til den nærmeste dosis, som 150 mg-styrken går op i (se pkt. 
Particular caution should be exercised when treating patients with severe hepatic impairment and the dose should be reduced by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength (see sections 4.4 and 5.2).
Zykadia 150 mg tabletter ceritinib 
Zykadia 150 mg tablets ceritinib
Pausér Zykadia, indtil lipase eller amylase vender tilbage til grad ≤1. 
Withhold Zykadia until lipase or amylase returns to grade ≤1, then reinitiate with dose reduced by 150 mg.
Aktivt stof: ceritinib. 
The active substance of Zykadia is ceritinib.
Figure 3 ASCEND-5 (Studie A2303) - Kaplan-Meier plot af progressionsfri overlevelse, vurderet af BIRC 
Figure 3 ASCEND-5 (Study A2303) - Kaplan-Meier plot of progression-free survival as assessed by BIRC
Genoptag derefter Zykadia med en dosis, der er reduceret med 150 mg. 
Withhold Zykadia until improved, then reinitiate Zykadia with dose reduced by 150 mg.
Disse bivirkninger krævede afbrydelse eller reduktion af dosis hos 0,2 % af patienterne. 
These events required dose reduction or interruption in 0.2% of patients.
Zykadia 150 mg filmovertrukne tabletter 
Zykadia 150 mg film-coated tablets
Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis ceritinib på 450 mg fastende og den potente CYP3A/P-gp-hæmmer ketoconazol (200 mg to gange dagligt i 14 dage), at ceritinibs AUCinf og Cmax steg henholdsvis 2,9 og 1,2 gange sammenlignet med administration af ceritinib alene. 
In healthy subjects, co-administration of a single 450 mg fasted ceritinib dose with ketoconazole (200 mg twice daily for 14 days), a strong CYP3A/P-gp inhibitor, resulted in 2.9-fold and 1.2-fold increase in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Nedsat nyrefunktion (azotæmi, nedsat nyrefunktion) 
Renal impairment (azotaemia, renal impairment)
Cellulose, mikrokrystallinsk Hydroxypropylcellulose, lavsubstitueret Natriumstivelseglycolat (type A) Magnesiumstearat 
Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Sodium starch glycolate (type A) Magnesium stearate
Ingen patienter havde behov for dosisreduktion eller behandlingsstop af studiemedicinen på grund af diarré, kvalme eller opkastning. 
No patients had diarrhoea, nausea, or vomiting that required dose reduction or discontinuation of study drug.
Lægemidler, der kan nedsætte plasmakoncentrationen af ceritinib 
Agents that may decrease ceritinib plasma concentrations
Tabel 1 Anbefalinger vedrørende dosisjustering af Zykadia og behandling af bivirkninger 
Table 1 Zykadia dose adjustment and management recommendations for ADRs
I kliniske studier er der set forhøjet lipase og/eller amylase hos patienter, der blev behandlet med ceritinib. 
Elevations of lipase and/or amylase have occurred in patients treated with ceritinib in clinical studies.
Virkningen og sikkerheden af Zykadia til behandling af patienter med fremskreden ALK-positive NSCLC, som ikke tidligere har fået systemisk anti-cancerbehandling (inklusive ALK-hæmmer) med undtagelse af neo-adjuverende eller adjuverende behandling, blev påvist i et globalt, multicenter-, randomiseret, open-label fase 3-studie; A2301. 
Previously untreated ALK-positive advanced NSCLC - randomised phase 3 Study A2301 (ASCEND-4) The efficacy and safety of Zykadia for the treatment of advanced ALK-positive NSCLC patients who have not received previous systemic treatment anti-cancer therapy (including ALK inhibitor) with the exception of neo-adjuvant or adjuvant therapy, was demonstrated in a global multicentre, randomised, open-label phase 3 Study A2301.
Median-alderen var 54,0 år (interval: 28 til 84 år). 
The median age was 54.0 years (range: 28 to 84 years); 77.1% of patients were younger than 65 years.
Figure 4 ASCEND-5 (Studie A2303) - Kaplan-Meier plot af samlet overlevelse efter behandlingsarm 
Figure 4 ASCEND-5 (Study A2303) - Kaplan-Meier plot of overall survival by treatment arm
Udslæt (udslæt, acneiform dermatitis, maculopapulært udslæt) 
Rash (rash, dermatitis acneiform, rash maculopapular)
Hos raske forsøgspersoner medførte samtidig administration af en enkelt dosis på 750 mg ceritinib fastende og den potente CYP3A/P-gp-induktor rifampicin (600 mg dagligt i 14 dage) at ceritinibs AUCinf og Cmax faldt henholdsvis 70 % og 44 % sammenlignet med administration af ceritinib alene. 
In healthy subjects, co-administration of a single 750 mg fasted ceritinib dose with rifampicin (600 mg daily for 14 days), a strong CYP3A/P-gp inducer, resulted in 70% and 44% decreases in ceritinib AUCinf and Cmax, respectively, compared to when ceritinib was given alone.
Hver tablet indeholder 150 mg ceritinib. 
Each tablet contains 150 mg ceritinib.
Øvrige indholdsstoffer: Tabletkerne: cellulose, mikrokrystalinsk; hydroxypropylcellulose, lavsubstitueret; povidon; croscarmellosenatrium; magnesiumstearat; silica, kolloid vandfri; Filmovertræk: hypromellose; titandioxid (E171); macrogol; talcum; indigotin (E132). 
The other ingredients are: Tablet core: cellulose, microcrystalline; hydroxypropylcellulose, low-substituted; povidone; croscarmellose sodium; magnesium stearate; silica, colloidal anhydrous.
Hver hård kapsel indeholder 150 mg ceritinib. 
Each hard capsule contains 150 mg ceritinib.
Figur 2 ASCEND-4 (Studie A2301) - Kaplan-Meier plot af samlet overlevelse efter behandlingsarm 
Figure 2 ASCEND-4 (Study A2301)- Kaplan-Meier plot of overall survival by treatment arm
Samtidig administration af ceritinib med substrater, som primært metaboliseres via CYP3A eller CYP3A-substrater, der vides at have et snævert terapeutisk indeks (fx alfuzosin, amiodaron, cisaprid, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quetiapin, quinidin, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil og sirolimus), bør undgås. 
Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin,
Tabel 2 Anbefalinger vedrørende dosisjustering af Zykadia og behandling af bivirkninger 
Table 2 Zykadia dose adjustment and management recommendations for ADRs
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion (se pkt. 
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 4.2).
Dette kan være symptomer på fordøjelsesproblemer. 
These may be symptoms of lung problems.
På tværs af de syv kliniske studier havde 9,7 % af patienterne, der blev behandlet med ceritinib QT-forlængelse (alle grader), inkl. 
Across the seven clinical studies, 9.7% of patients treated with ceritinib had events of QT prolongation (any grade), including grade 3 or 4 events in 2.1% of patients.
Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion. 
No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
Hvis der ikke identificeres noget medvirkende lægemiddel, der tages samtidig, eller hvis medvirkende lægemidler, der tages samtidig, ikke seponeres eller dosisreduceres, skal Zykadia genoptages med en dosisreduktion på 150 mg efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover. 
If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, reinitiate Zykadia with dose reduced by 150 mg upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Den samlede intrakranielle responsrate (OIRR) var højere med ceritinib (72,7 %, 95 % CI: 49,8; 89,3) sammenlignet med kemoterapi-armen (27,3%, 95 % CI: 10,7; 50,2). 
(72.7%, 95% CI: 49.8, 89.3) as compared to the chemotherapy arm (27.3%, 95% CI: 10.7, 50.2).
Nedsat nyrefunktion l 
Renal impairment l
Overdreven tørst, hyppigere vandladning (symptomer på for højt blodsukker) Kraftige smerter i den øvre del af maven (tegn på betændelse i bugspytkirtlen, også kaldet pankreatitis) 
Excessive thirst, increased frequency of urination (symptoms of high level of glucose in the blood)
Tid (Måneder) ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Kemoterapi 
ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Chemotherapy 187 172 161 150 146 141 134 124 97 69 49 35 19 10 5 1 0 0
Samtidig administration af ceritinib og substrater, der hovedsageligt metaboliseres via CYP3A eller CYP3Asubstrater, der vides at have et snævert terapeutisk indeks (fx alfuzosin, amiodaron, cisaprid, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quetiapin, quinidin, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil og sirolimus), bør undgås. 
Co-administration of ceritinib with substrates primarily metabolised by CYP3A or CYP3A substrates known to have narrow therapeutic indices (e.g. alfuzosin, amiodarone, cisapride, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quetiapine, quinidine, lovastatin, simvastatin, sildenafil, midazolam, triazolam, tacrolimus, alfentanil and sirolimus) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Tal med din læge, hvis du ikke kan spise mad, når du tager Zykadia. 
If you cannot eat food while taking Zykadia, talk to your doctor.
Hvis et medvirkende lægemiddel, der tages samtidig, identificeres og seponeres, eller dets dosis justeres, skal Zykadia genoptages med den tidligere dosis efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover. 
If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia at the previous dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
alder, køn, race, rygerklasser, ECOG performance status og sygdomsbyrde. 
The PFS benefit of ceritinib was consistent by investigator assessment and across various subgroups including age, gender, race, smoking class, ECOG performance status and disease burden.
Ceritinib forlængede tiden til forværring af de lungecancerspecifikke symptomer hoste, smerter og dyspnø signifikant (sammensat endepunkt LCSS: HR=0,40; 95 % CI: 0,25; 0,65, median tid til forværring [TTD] 18 måneder [95 % CI: 13,4; NE] i ceritinib-armen versus 4,4 måneder [95 % CI: 1,6; 8,6] i kemoterapi-armen; LC13: HR=0,34; 95 % CI: 0,22; 0,52, median TTD 11,1 måneder [95 % CI: 7,1; 14,2] i ceritinib-armen versus 2,1 måneder [95 % CI: 1,0; 5,6] i kemoterapi-armen. 
Ceritinib significantly prolonged time to deterioration for the lung cancer specific symptoms of interest of cough, pain and dyspnoea (composite endpoint LCSS: HR=0.40; 95% CI: 0.25, 0.65, median Time to Deterioration [TTD] 18.0 months [95% CI: 13.4, NE] in the ceritinib arm versus 4.4 months [95% CI: 1.6, 8.6] in the chemotherapy arm; LC13: HR=0.34; 95% CI: 0.22, 0.
QT-forlængelse i EKG 
Electrocardiogram QT prolonged
4.8 og 5.2), hvilket kan medføre øget risiko for ventrikulære takyarytmier (fx torsade de pointes) eller pludselig død. 
QTc prolongation has been observed in clinical studies in patients treated with ceritinib (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.
Pausér Zykadia indtil bedring til baseline ALT/AST niveau eller til ≤3 gange ULN. 
Withhold Zykadia until recovery to baseline ALT/AST levels or to ≤3 times ULN, then reinitiate with dose reduced by 150 mg.
Hver filmovertrukket tablet indeholder 150 mg ceritinib. 
Each film-coated tablet contains 150 mg ceritinib.
Nyrer og urinveje Nyresvigt k 
Renal and urinary disorders Renal failure k
Hvis et medvirkende lægemiddel, der tages samtidig, identificeres og seponeres, eller dets dosis justeres, skal Zykadia genoptages med en dosisreduktion på 150 mg efter bedring til asymptomatisk bradykardi eller til en hjertefrekvens på 60 bpm eller derover og med hyppig monitorering b. 
If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, reinitiate Zykadia with dose reduced by 150 mg upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring b.
Hvis samtidig administration af lægemidler, der er CYP3A-substrater med et snævert terapeutisk indeks, ikke kan undgås, bør der overvejes dosisreduktion af disse. 
If unavoidable, dose reduction for co-administered medicinal products that are CYP3A substrates with narrow therapeutic indices should be considered.