natgillin/translations-raw huggingface dataset:
pravastatin og rosuvastatin, der bruges til at sænke kolesterolniveauet.
pravastatine and rosuvastatine, medicines used to reduce cholesterol levels.
Kardioelektrofysiologi
Cardiac electrophysiology
Hvis du kaster op efter, at du har sunket Zykadia-kapslerne, må du ikke tage flere kapsler før næste planlagte dosis.
If you vomit after you swallow the Zykadia capsules, do not take any more capsules until your next scheduled dose.
Potente CYP3A og P-gb induktorer
Strong CYP3A and P-gp inducers
Hvis ceritinib administreres sammen med lægemidler, der hæmmer P-gp, vil ceritinib-koncentrationen sandsynligvis stige.
If ceritinib is administered with medicinal products that inhibit P-gp, an increase in ceritinib concentration is likely.
Kontakt lægen med det samme, hvis du har spørgsmål.
If you have any questions contact your doctor right away.
Brug af Zykadia i kombination med andre lægemidler, der vides at forårsage bradykardi (fx betablokkere, non-dihydropyridin-calciumkanalblokkere, klonidin og digoxin), skal så vidt muligt undgås.
Use of Zykadia in combination with other agents known to cause bradycardia (e.g. beta blockers, non-dihydropyridine calcium channel blockers, clonidine and digoxin) should be avoided as far as possible.
I modsætning til dette var AUC (90 % CI) og Cmax (90 % CI) i armen for 600 mg taget med mad (N=30) øget med henholdsvis 24 % (3 %, 49 %) og 25 % (4 %, 49 %) sammenlignet med armen for 750 mg fastende.
In contrast, the steady-state AUC (90% CI) and Cmax (90% CI) for the 600 mg with food arm (N=30) increased by 24% (3%, 49%) and 25% (4%, 49%), respectively, compared to the 750 mg fasted arm.
Ceritinib kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede lægemidler, der transporteres af disse proteiner.
Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products transported by these proteins.
Andre potentielle årsager til ILD/pneumonitis skal udelukkes, og Zykadia skal seponeres permanent hos patienter, der får konstateret enhver grad af behandlingsrelateret ILD/pneumonitis (se pkt.
Other potential causes of ILD/pneumonitis should be excluded, and Zykadia permanently discontinued in patients diagnosed with any grade treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Cellulose, mikrokrystallinsk Hydroxypropylcellulose, lavsubstitueret Povidon
Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Povidone
Levertoksiske bivirkninger blev håndteret med dosisafbrydelse eller -reduktion hos 40,6 % af patienterne.
Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
ECOG performance status var 0/1/2 hos henholdsvis 46,3 %/47,6 %/6,1 % af patienterne og 58,0 % havde hjernemetastaser ved baseline.
The ECOG performance status was 0/1/2 in 46.3%/47.6%/6.1% of patients respectively, and 58.0% had brain metastasis at baseline.
Unormale resultater af leverfunktionstests (unormal leverfunktion, hyperbilirubinæmi)
Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia)
Hvis du kaster op efter, at du har sunket Zykadia-tabletterne, må du ikke tage flere tabletter før næste planlagte dosis.
If you vomit after you swallow the Zykadia tablets, do not take any more tablets until your next scheduled dose.
YDRE KARTON TIL PAKNING (INKLUSIV BLUE BOX) MED 150 (3 PAKNINGER MED 50) HÅRDE KAPSLER
OUTER CARTON OF PACK (INCLUDING BLUE BOX) CONTAINING 150 (3 PACKS OF 50) HARD CAPSULES
CYP2A6- og CYP2E1-substrater
CYP2A6 and CYP2E1 substrates
kraftig diarré, kvalme eller opkastning.
severe diarrhoea, nausea or vomiting.
medicin, der bruges til behandling af tuberkulose (fx rifampicin, rifabutin).
medicines used to treat tuberculosis (e.g. rifampicin, rifabutin).
Den geometriske, gennemsnitlige tilsyneladende clearance (CL/F) af ceritinib var lavere ved steady state (33,2 liter/time) efter 750 mg daglig oral dosering end efter en enkelt oral dosis på 750 mg (88,5 liter/timer), hvilket tyder på, at ceritinib udviser non-lineær farmakokinetik over tid.
The geometric mean apparent clearance (CL/F) of ceritinib was lower at steady-state (33.2 litres/hour) after 750 mg daily oral dosing than after a single 750 mg oral dose (88.5 litres/hour), suggesting that ceritinib demonstrates non-linear pharmacokinetics over time.
Størstedelen af patienterne havde adenocarcinom (97,0 %) og havde enten aldrig røget eller var tidligere rygere (96,1 %).
The majority of patients had adenocarcinoma (97.0%) and had either never smoked or were former smokers (96.1%).
medicin, der bruges til behandling af psykiske problemer (fx haloperidol, droperidol, pimozid).
medicines used to treat mental health problems (e.g. haloperidol, droperidol, pimozide).
Du skal bruge yderst sikker prævention under behandlingen med Zykadia og i 3 måneder efter behandlingens ophør.
You must use a highly effective method of birth control during treatment with Zykadia and for 3 months after stopping treatment.
ALAT eller ASAT forhøjet >3 gange ULN med samtidigt forhøjet totalbilirubin >2 gange ULN (i fravær af kolestase eller hæmolyse)
ALT or AST elevation >3 times ULN with concurrent total bilirubin elevation >2 times ULN (in the absence of cholestasis or haemolysis)
I alt 81 tidligere ubehandlede patienter med ALKpositiv lokalt avanceret eller metastatisk NSCLC blev randomiseret til at få Zykadia 450 mg en gang daglig med mad (N=41) eller Zykadia 750 mg en gang daglig fastende (N=40).
A total of 81 previously untreated patients with ALK-positive locally advanced or metastatic NSCLC were randomised to receive Zykadia 450 mg once daily with food (N=41) or Zykadia 750 mg once daily under fasted conditions (N=40).
Hvordan Zykadia virker
How Zykadia works
Diarré, kvalme eller opkastning forekom hos 74,2 % af 89 patienter behandlet med Zykadia ved den anbefalede dosis på 450 mg taget sammen med mad i et dosis-optimeringsforsøg og var hovedsageligt grad 1 hændelser (49,4 %).
Diarrhoea, nausea, or vomiting occurred in 74.2% of 89 patients treated with Zykadia at the recommended dose of 450 mg taken with food in a dose optimisation study and were mainly grade 1 events (49.4%).
Ceritinib kan derfor potentielt øge plasmakoncentrationerne af samtidigt administrerede lægemidler, der hovedsageligt metaboliseres af disse enzymer.
Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products that are predominantly metabolised by these enzymes.
Øsofagussygdom g
Oesophageal disorder g
medicin, der bruges til behandling af maveproblemer (fx cisaprid).
medicines used to treat stomach problems (e.g. cisapride).
Steady state AUC for ceritinib ved reducerede doser efter samtidig behandling med ketoconazol 200 mg 2 gange dagligt i 14 dage blev ved simuleringer bestemt til at være svarende til steady state AUC for ceritinib alene.
The steady-state AUC of ceritinib at reduced doses after co-administration with ketoconazole 200 mg twice daily for 14 days was predicted by simulations to be similar to the steady-state AUC of ceritinib alone.
Der skal udvises forsigtighed ved samtidig brug af CYP2A6- og CYP2E1-substrater, og bivirkninger skal monitoreres omhyggeligt.
Caution should be exercised with concomitant use of CYP2A6 and CYP2E1 substrates and ADRs carefully monitored.
Hvis du ved et uheld har taget for mange tabletter, eller hvis nogen ved et uheld har taget din medicin, skal du straks kontakte en læge eller et hospital.
If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
dihydroergotamin og ergotamin, der bruges til behandling af migræne.
dihydroergotamine and ergotamine, medicines used to treat migraine.
Effektdata fra studie A2303 er opsummeret i tabel 4 og Kaplan-Meier-kurver for henholdsvis PFS og OS er vist i figur 3 og 4.
Efficacy data from Study A2303 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Dosis skal justeres korrekt, dvs. hos patienter, der behandles med 450 mg eller 300 mg sammen med mad, skal dosis øges til henholdsvis 750 mg eller 450 mg, taget på tom mave (se pkt.
Dose must be adjusted properly, i.e for patients treated with 450 mg or 300 mg with food, the dose should be increased to 750 mg or 450 mg taken on an empty stomach, respectively (see section 5.2) and for patients treated with 150 mg with food treatment should be discontinued.
Hjerte Perikarditis b
Cardiac disorders Pericarditis b
Kapsel: gelatine, indigotin (E132) og titandioxid (E171).
Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Unormale blodprøveresultater ved måling af din nyrefunktion (høj kreatinin-værdi) Halsbrand (muligt tegn på forstyrrelser i fordøjelseskanalen) Fald i antallet af røde blodceller kaldet anæmi
Abnormal results of blood tests to check kidney function (high level of creatinine) Heartburn (potential sign of a disorder of the digestive tract) Reduction in the number of red blood cells, known as anaemia
Hvis du ved et uheld har taget for mange kapsler, eller hvis nogen ved et uheld har taget din medicin, skal du straks kontakte en læge eller et hospital.
If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
medicin, der bruges til at stoppe krampeanfald (anti-epileptika, som fx phenytoin, carbamazepin eller phenobarbital).
medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital).
Antal hændelser, n (%) Median, måneder (95 % CI) HR (95 % CI)
Number of events, n (%) Median, months (95% CI) HR (95% CI)
Ingen patienter havde behov for dosisreduktion eller behandlingsstop af Zykadia på grund af diarré, kvalme eller opkastning (se pkt.
No patients required dose reduction or discontinuation of Zykadia due to diarrhoea, nausea or vomiting (see section 4.8).
Det skal besluttes, om amning eller behandling med Zykadia skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen (se pkt.
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Zykadia therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Samtidig administration af ceritinib med substrater, der hovedsageligt metaboliseres af CYP2C9 eller CYP2C9-substrater, der vides at have et snævert terapeutisk indeks (fx phenytoin og warfarin) bør undgås.
Co-administration of ceritinib with substrates primarily metabolised by CYP2C9 or CYP2C9 substrates known to have narrow therapeutic indices (e.g. phenytoin and warfarin) should be avoided.
Ceritinib 450 mg med mad (N=41)
Ceritinib 450 mg with food (N=41)
Patienter skal monitoreres for lungesymptomer, der tyder på ILD/pneumonitis.
Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
Baseret på in vitro-data er ceritinib substrat for effluxtransporteren P-glycoprotein (P-gp).
Based on in vitro data, ceritinib is a substrate of the efflux transporter P-glycoprotein (P-gp).
Tabel 2 Bivirkninger hos patienter i behandling med Zykadia
Table 2 ADRs in patients treated with Zykadia
I alt blev 376 patienter randomiseret i en 1:1-ratio (stratificeret for WHO performance status, tidligere adjuverende/neoadjuverende kemoterapi og tilstedeværelse/fravær af hjernemetastaser ved screening) til enten ceritinib (750 mg daglig, fastende) eller kemoterapi (baseret på investigators valg: pemetrexed [500 mg/m2] plus cisplatin [75 mg/m2] eller carboplatin [AUC 5-6], administreret hver
A total of 376 patients were randomised in a 1:1 ratio (stratified by WHO performance status, prior adjuvant/neoadjuvant chemotherapy and presence/absence of brain metastasis at screening) to receive either ceritinib (750 mg daily, fasted) or chemotherapy (based on investigator's choice - pemetrexed [500 mg/m2] plus cisplatin [75 mg/m2] or carboplatin [AUC 5-6], administered every 21 days).
Patienter, der var randomiseret til kemoterapiarmen kunne krydse over til Zykadia ved RECIST-defineret sygdomsprogression, som var bekræftet af BIRC.
Patients randomised to the chemotherapy arm could further crossover to receive Zykadia upon RECIST-defined disease progression confirmed by BIRC.
Tabel 2 viser frekvenskategorier for bivirkninger indberettet for Zykadia hos patienter, der blev behandlet med en startdosis på 750 mg fastende (N=925) fra syv kliniske studier.
Table 2 shows the frequency category of ADRs reported for Zykadia in patients treated at a dose of 750 mg fasted (N=925) in seven clinical studies.
40 hårde kapsler 90 hårde kapsler
40 hard capsules 90 hard capsules
Progressionsfri overlevelse (baseret på BIRC) Antal hændelser, n (%) Median, måneder d
Progression-free survival (based on BIRC) Number of events, n (%) Median, months d
Der blev observeret gastrointestinal toksicitet hos begge arter, karakteriseret ved vægttab, nedsat fødeindtagelse, emesis (abe), diarré og ved høje doser histopatologiske læsioner, herunder erosion, slimhindebetændelse og skum-makrofager i den duodenale krypt og submucosa.
Gastrointestinal toxicity was observed in both species characterised by body weight loss, decreased food consumption, emesis (monkey), diarrhoea and, at high doses, by histopathological lesions including erosion, mucosal inflammation and foamy macrophages in the duodenal crypts and submucosa.
Baseret på in vitro-data hæmmer ceritinib også CYP2A6 og CYP2E1 i klinisk relevante koncentrationer.
Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Børn og unge Børn og unge op til 18 år bør ikke behandles med Zykadia.
Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Kemoterapi (N=116)
Chemotherapy (N=116)
I studie X2101 blev i alt 246 ALK-positive NSCLC-patienter behandlet med en Zykadia-dosis på 750 mg fastende: 163 havde tidligere fået behandling med en ALK-hæmmer og 83 var ALK-hæmmer behandlingsnaive.
In study X2101 a total of 246 ALK-positive NSCLC patients were treated at a Zykadia dose of 750 mg once daily fasted: 163 who had received prior treatment with an ALK inhibitor and 83 who were ALK inhibitor naïve.
Baseret på en farmakokinetisk populationsanalyse af 345 patienter med let nedsat nyrefunktion (CLcr 60 til <90 ml/min), 82 patienter med moderat nedsat nyrefunktion (CLcr 30 til <60 ml/min) og 546 patienter med normal nyrefunktion (≥90 ml/min) var eksponeringen for ceritinib tilsvarende hos patienter med let til moderat nedsat nyrefunktion og normal nyrefunktion, hvilket tyder på, at dosisjustering ikke er nødvendigt hos patienter med let til moderat nedsat nyrefunktion.
Based on a population pharmacokinetic analysis of 345 patients with mild renal impairment (CLcr 60 to <90 ml/min), 82 patients with moderate renal impairment (CLcr 30 to <60 ml/min) and 546 patients with normal renal function (≥90 ml/min), ceritinib exposures were similar in patients with mild and moderate renal impairment and normal renal function, suggesting that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Zykadia-dosering
Zykadia dosing
Samtidig brug af potente CYP3A-induktorer bør undgås, herunder, men ikke begrænset til, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikum (Hypericum perforatum).
Concomitant use of strong CYP3A inducers should be avoided; this includes, but is not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum).
Patienter, der har symptomer med indikation på ILD/pneumonitis, skal monitoreres.
Patients with pulmonary symptoms indicative of ILD/pneumonitis should be monitored.
Orale præventionsmidler (p-piller) Hvis du tager Zykadia, mens du bruger p-piller, kan p-pillerne blive virkningsløse.
Oral contraceptives If you take Zykadia whilst using oral contraceptives, the oral contraceptives may become ineffective.
Når ceritinib administreres samtidig med andre lægemidler, bør Produktresuméet for det andet lægemiddel konsulteres angående rekommendationer vedrørende samtidig behandling med CYP3A4hæmmere.
When ceritinib is co-administered with other medicinal products, the Summary of Product Characteristics (SmPC) for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors.
Effektdata fra studie A2301 er opsummeret i tabel 3 og Kaplan-Meier-kurver for PFS og OS er vist i henholdsvis figur 1 og figur 2.
Efficacy data from Study A2301 are summarised in Table 3, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and Figure 2, respectively.
I studie A2303 blev 133 patienter med hjernemetastaser ved baseline (66 patienter i Zykadia-armen og 67 patienter i kemoterapi-armen) vurderet for intrakranielt respons af en BIRC neuroradiolog ifølge modificeret RECIST 1.1 (dvs. op til 5 læsioner i hjernen).
In Study A2303, 133 patients with baseline brain metastasis (66 patients in the Zykadia arm and 67 patients in the chemotherapy arm) were assessed for intracranial response by BIRC neuroradiologist (per modified RECIST 1.1 (i.e. up to 5 lesions in the brain).
Alveolære skum-makrofager (bekræftet fosfolipidose) sås i lungerne hos rotter, men ikke hos aber, og lymfeknuderne havde makrofag-aggregater hos både rotter og aber.
Alveolar foamy macrophages (confirmed phospholipidosis) were seen in the lungs of rats, but not in monkeys, and the lymph nodes of rats and monkeys had macrophage aggregates.
Samlet responsrate Investigator (95 % CI) BIRC (95 % CI) Responsvarighed* Investigator (måneder, 95 % CI) BIRC (måneder, 95 % CI) Progressionsfri overlevelse Investigator (måneder, 95 % CI) BIRC (måneder, 95 % CI) Samlet overlevelse (OS) (måneder, 95 % CI)
Duration of follow-up Median (months) (min - max) Overall response rate Investigator (95% CI) BIRC (95% CI) Duration of response* Investigator (months, 95% CI) BIRC (months, 95% CI) Progression-free survival Investigator (months, 95% CI) BIRC (months, 95% CI) Overall survival (months, 95% CI)
Der bør udvises forsigtighed ved samtidig brug af BCRP-substrater (fx rosuvastatin, topotecan, sulfasalazin) og P-gp-substrater (digoxin, dabigatran, colchicin, pravastatin) og der skal monitoreres for bivirkninger.
Caution should be exercised with concomitant use of BCRP substrates (e.g. rosuvastatin, topotecan, sulfasalazine) and P-gp substrates (digoxin, dabigatran, colchicine, pravastatin) and ADRs carefully monitored.
Effekten af nedsat leverfunktion på enkeltdosis-farmakokinetikken for ceritinib (750 mg fastende) blev vurderet for forsøgspersoner med let (Child-Pugh klasse A, N=8), moderat (Child-Pugh klasse B, N=7) eller svært (Child-Pugh klasse C, N=7) nedsat leverfunktion og hos 8 raske forsøgspersoner med normal leverfunktion.
The effect of hepatic impairment on the single-dose pharmacokinetics of ceritinib (750 mg under fasted conditions) was evaluated in subjects with mild (Child-Pugh class A; N=8), moderate (ChildPugh class B; N=7), or severe (Child-Pugh class C; N=7) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Patienter skal monitoreres for QT-forlængelse og behandles som anbefalet i pkt.
Patients should be monitored for QT prolongation and managed as recommended in sections 4.2 and
Hvis du holder op med at tage Zykadia
If you stop taking Zykadia
Nedenstående bivirkninger afspejler eksponering af Zykadia 750 mg dagligt fastende hos 925 patienter med ALK-positiv fremskreden NSCLC i syv kliniske studier inklusive to randomiserede, kontrollerede fase 3-studier (studierne A2301 og A2303).
Adverse drug reactions (ADRs) described below reflect exposure to Zykadia 750 mg once daily fasted in 925 patients with ALK-positive advanced NSCLC across a pool of seven clinical studies including two randomised, active-controlled, phase 3 studies (studies A2301 and A2303).
Hypromellose Titandioxid (E171) Macrogol Talcum
Titanium dioxide (E171) Macrogol
Trykfarve: Shellac-glasur (bleget, afvokset) 45 %, sort jernoxid (E172), propylenglycol og ammoniumhydroxid 28 %.
Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Efter en enkelt oral administration af ceritinib til patienter steg plasmaeksponeringen for ceritinib, repræsenteret ved Cmax og AUClast, dosisproportionalt over dosisområdet 50 til 750 mg fastende.
After single oral administration of ceritinib in patients, plasma exposure to ceritinib, as represented by Cmax and AUClast, increased dose-proportionally over the 50 to 750 mg dose range under fasted conditions.
Zykadia kan øge de bivirkninger, der er forbundet med følgende medicin: medicin, der bruges til behandling af uregelmæssig hjerterytme eller andre hjerteproblemer (fx amiodaron, disopyramid, procainamid, quinidin, sotalol, dofetilid, ibutilid og digoxin).
Zykadia may increase the side effects associated with the following medicines: medicines used to treat irregular heartbeat or other heart problems (e.g. amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide and digoxin).
Frekvensen af disse udvalgte bivirkninger (diarré, kvalme og opkastning) er baseret på patienter, som er behandlet med den anbefalede dosis ceritinib på 450 mg taget med mad (N=89) i studiet A2112 (ASCEND-8) (se afsnittet ”Gastrointestinale bivirkninger” nedenfor)
The frequency of these selected gastrointestinal ADRs (diarrhoea, nausea and vomiting) is based on patients treated with the recommended dose of ceritinib 450 mg with food (N=89) in the study A2112 (ASCEND-8) (see subsection ‘Gastrointestinal adverse reactions' below)
Hvor længe skal du tage Zykadia
How long to take Zykadia
Efter orale enkeltdoser af ceritinib fastende lå ceritinibs geometriske, gennemsnitlige tilsyneladende plasmahalveringstid (T½) på mellem 31 og 41 timer hos patienter i dosisområdet 400 til 750 mg.
Following single oral doses of ceritinib under fasted conditions, the geometric mean apparent plasma terminal half-life (T½) of ceritinib ranged from 31 to 41 hours in patients over the 400 to 750 mg dose range.
50 hårde kapsler.
50 hard capsules.
Synsforstyrrelser (nedsat syn, sløret syn, fotopsi, mouches volantes, nedsat synsskarphed, akkomodationslidelse, presbyopi)
Vision disorder (vision impairment, vision blurred, photopsia, vitreous floaters, visual acuity reduced, accommodation disorder, presbyopia)
Andre potentielle årsager til ILD/pneumonitis bør udelukkes (se pkt.
Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Pakninger bestående af 40, 90 eller 150 (3 pakninger med 50) hårde kapsler.
Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.
Behandling med ceritinib anbefales ikke til patienter med medfødt lang QT-syndrom eller patienter, der tager lægemidler, der vides at forlænge QT-intervallet (se pkt.
Treatment with ceritinib is not recommended in patients who have congenital long QT syndrome or who are taking medicinal products known to prolong the QTc interval (see sections 4.4 and 4.5).
medicin, der bruges til behandling af infektioner, herunder medicin til behandling af svampeinfektioner (midler mod svamp, som fx ketoconazol, itraconazol, voriconazol, posaconazol) og medicin til behandling af visse typer bakterieinfektioner (antibiotika, som fx telithromycin).
These include medicines that treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines that treat certain types of bacterial infection (antibiotics such as telithromycin).
Hud og subkutane væv Udslæt j
Skin and subcutaneous tissue disorders Rash j
Baseret på in vitro-data er ceritinib kompetitiv hæmmer af metabolismen af CYP3A-substratet midazolam og CYP2C9-substratet diclofenac.
Based on in vitro data, ceritinib competitively inhibits the metabolism of a CYP3A substrate, midazolam, and a CYP2C9 substrate, diclofenac.