FrancophonIA/ELRC3.0 huggingface dataset:
English: The population characteristics across the two arms were: mean age 53 years, age less than 65 (79%), female (57%), Caucasian (54%), Asian (33%), never or former smoker (95%), WHO PS 0 or 1 (93%), adenocarcinoma histology (94%), and metastases to the brain (33%).
Danish: Populationskarakteristika i de to arme var: gennemsnitsalder 53 år, alder under 65 (79 %), kvinder (57 %), kaukasiske (54 %), asiatiske (33 %), aldrig rygere eller tidligere rygere (95 %), WHO PS 0 eller 1 (93 %), adenocarcinom histologi (94 %) og metastaser i hjernen (33 %).
English: Do not chew or crush them.
Danish: De må ikke tygges eller knuses.
English: OS rate at 24 months d, % (95% CI)
Danish: OS-rate ved 24 måneder d, % (95 % CI)
English: Across the seven clinical studies, bradycardia and/or sinus bradycardia (heart rate less than 60 bpm) events (all grade 1) were reported in 2.3% of patients.
Danish: På tværs af de syv kliniske studier blev bradykardi og/eller sinus-bradykardi (hjertefrekvens under 60 bpm, alle af grad 1) rapporteret hos 2,3 % af patienterne.
English: Effects on the thyroid were observed in both rat (mild increases in thyroid stimulating hormone and triiodothyronine/thyroxine T3/T4 concentrations with no microscopic correlate) and monkey (depletion of colloid in males in 4-week study, and one monkey at high dose with diffuse follicular cell hyperplasia and increased thyroid stimulating hormone in 13-week study).
Danish: Der blev observeret påvirkning af thyroidea hos både rotter (let forhøjede thyroideastimulerende hormon- og triiodothyronin/thyroxin T3/T4-koncentrationer uden mikroskopisk korrelat) og aber (forekomst af kolloid hos hanner i et 4-ugers studie og en abe på høj dosis med diffus follikelcellehyperplasi og forhøjet thyroidea-stimulerende hormon i et 13-ugers studie).
English: Patients randomised to the chemotherapy arm could cross-over to receive ceritinib upon RECIST-defined disease progression confirmed by blinded independent review committee (BIRC).
Danish: Patienter, der var randomiseret til kemoterapiarmen kunne krydse over til ceritinib ved RECIST-defineret sygdomsprogression, som var bekræftet af BIRC (blinded independent review committee).
English: CARTON OF UNIT PACK CONTAINING 40 OR 90 HARD CAPSULES
Danish: KARTON TIL ENKELTPAKNING MED 40 ELLER 90 HÅRDE KAPSLER
English: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >5 times upper limit of normal (ULN) with concurrent total bilirubin ≤2 times ULN
Danish: Alaninaminotransferase (ALAT)- eller aspartataminotransferase (ASAT)-stigning >5 gange den øvre normalgrænse (ULN) med samtidig totalbilirubin ≤2 gange ULN
English: Co-administration of ceritinib with strong CYP3A/P-gp inducers decreases ceritinib plasma concentrations.
Danish: Samtidig administration af ceritinib og potente CYP3A/P-gp-induktorer nedsætter plasmakoncentrationen af ceritinib.
English: Log rank p-value = 0.496
Danish: Log rank værdi = 0,496
English: Patients were allowed to continue the assigned study treatment beyond initial progression in case of continued clinical benefit as per the investigator's opinion.
Danish: Patienter kunne fortsætte forsøgsbehandlingen efter initial progression, hvis der ifølge investigators vurdering fortsat var klinisk gavn af behandlingen.
English: None of these events led to discontinuation of ceritinib treatment.
Danish: Ingen af disse bivirkninger førte til seponering af behandling med ceritinib.
English: Pneumonitis (interstitial lung disease, pneumonitis)
Danish: Pneumonitis (interstitiel lungesygdom, pneumonitis)
English: Patients should be monitored and managed using standards of care, including anti-diarrhoeals, anti-emetics or fluid replacement, as clinically indicated.
Danish: Patienter skal monitoreres og behandles med standardpleje, herunder midler mod diarré og kvalme eller væskeerstatning, som klinisk indiceret.
English: chloroquine and halofantrine, medicines used to treat malaria.
Danish: chloroquin og halofantrin, der bruges til behandling af malaria.
English: pravastatine and rosuvastatine, medicines used to reduce cholesterol levels.
Danish: pravastatin og rosuvastatin, der bruges til at sænke kolesterolniveauet.
English: Cardiac electrophysiology
Danish: Kardioelektrofysiologi
English: If you vomit after you swallow the Zykadia capsules, do not take any more capsules until your next scheduled dose.
Danish: Hvis du kaster op efter, at du har sunket Zykadia-kapslerne, må du ikke tage flere kapsler før næste planlagte dosis.
English: Strong CYP3A and P-gp inducers
Danish: Potente CYP3A og P-gb induktorer
English: If ceritinib is administered with medicinal products that inhibit P-gp, an increase in ceritinib concentration is likely.
Danish: Hvis ceritinib administreres sammen med lægemidler, der hæmmer P-gp, vil ceritinib-koncentrationen sandsynligvis stige.
English: If you have any questions contact your doctor right away.
Danish: Kontakt lægen med det samme, hvis du har spørgsmål.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products transported by these proteins.
Danish: Ceritinib kan derfor potentielt øge plasmakoncentrationen af samtidigt administrerede lægemidler, der transporteres af disse proteiner.
English: 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).
Danish: 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.
English: Cellulose, microcrystalline Hydroxypropylcellulose, low-substituted Povidone
Danish: Cellulose, mikrokrystallinsk Hydroxypropylcellulose, lavsubstitueret Povidon
English: Hepatotoxicity events were managed with dose interruptions or reductions in 40.6% of patients.
Danish: Levertoksiske bivirkninger blev håndteret med dosisafbrydelse eller -reduktion hos 40,6 % af patienterne.
English: 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.
Danish: ECOG performance status var 0/1/2 hos henholdsvis 46,3 %/47,6 %/6,1 % af patienterne og 58,0 % havde hjernemetastaser ved baseline.
English: Abnormal liver function test (hepatic function abnormal, hyperbilirubinaemia)
Danish: Unormale resultater af leverfunktionstests (unormal leverfunktion, hyperbilirubinæmi)
English: If you vomit after you swallow the Zykadia tablets, do not take any more tablets until your next scheduled dose.
Danish: Hvis du kaster op efter, at du har sunket Zykadia-tabletterne, må du ikke tage flere tabletter før næste planlagte dosis.
English: OUTER CARTON OF PACK (INCLUDING BLUE BOX) CONTAINING 150 (3 PACKS OF 50) HARD CAPSULES
Danish: YDRE KARTON TIL PAKNING (INKLUSIV BLUE BOX) MED 150 (3 PAKNINGER MED 50) HÅRDE KAPSLER
English: CYP2A6 and CYP2E1 substrates
Danish: CYP2A6- og CYP2E1-substrater
English: severe diarrhoea, nausea or vomiting.
Danish: kraftig diarré, kvalme eller opkastning.
English: medicines used to treat tuberculosis (e.g. rifampicin, rifabutin).
Danish: medicin, der bruges til behandling af tuberkulose (fx rifampicin, rifabutin).
English: 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.
Danish: 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.
English: The majority of patients had adenocarcinoma (97.0%) and had either never smoked or were former smokers (96.1%).
Danish: Størstedelen af patienterne havde adenocarcinom (97,0 %) og havde enten aldrig røget eller var tidligere rygere (96,1 %).
English: medicines used to treat mental health problems (e.g. haloperidol, droperidol, pimozide).
Danish: medicin, der bruges til behandling af psykiske problemer (fx haloperidol, droperidol, pimozid).
English: You must use a highly effective method of birth control during treatment with Zykadia and for 3 months after stopping treatment.
Danish: Du skal bruge yderst sikker prævention under behandlingen med Zykadia og i 3 måneder efter behandlingens ophør.
English: ALT or AST elevation >3 times ULN with concurrent total bilirubin elevation >2 times ULN (in the absence of cholestasis or haemolysis)
Danish: ALAT eller ASAT forhøjet >3 gange ULN med samtidigt forhøjet totalbilirubin >2 gange ULN (i fravær af kolestase eller hæmolyse)
English: 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).
Danish: 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).
English: How Zykadia works
Danish: Hvordan Zykadia virker
English: 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%).
Danish: 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 %).
English: Therefore, ceritinib may have the potential to increase plasma concentrations of co-administered medicinal products that are predominantly metabolised by these enzymes.
Danish: Ceritinib kan derfor potentielt øge plasmakoncentrationerne af samtidigt administrerede lægemidler, der hovedsageligt metaboliseres af disse enzymer.
English: Oesophageal disorder g
Danish: Øsofagussygdom g
English: medicines used to treat stomach problems (e.g. cisapride).
Danish: medicin, der bruges til behandling af maveproblemer (fx cisaprid).
English: 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.
Danish: 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.
English: Caution should be exercised with concomitant use of CYP2A6 and CYP2E1 substrates and ADRs carefully monitored.
Danish: Der skal udvises forsigtighed ved samtidig brug af CYP2A6- og CYP2E1-substrater, og bivirkninger skal monitoreres omhyggeligt.
English: If you accidentally take too many tablets, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Danish: 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.
English: dihydroergotamine and ergotamine, medicines used to treat migraine.
Danish: dihydroergotamin og ergotamin, der bruges til behandling af migræne.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Cardiac disorders Pericarditis b
Danish: Hjerte Perikarditis b
English: Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Danish: Kapsel: gelatine, indigotin (E132) og titandioxid (E171).
English: 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
Danish: 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
English: If you accidentally take too many capsules, or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately.
Danish: 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.
English: medicines used to stop seizures or fits (anti-epileptics such as phenytoin, carbamazepine, or phenobarbital).
Danish: medicin, der bruges til at stoppe krampeanfald (anti-epileptika, som fx phenytoin, carbamazepin eller phenobarbital).
English: Number of events, n (%) Median, months (95% CI) HR (95% CI)
Danish: Antal hændelser, n (%) Median, måneder (95 % CI) HR (95 % CI)
English: No patients required dose reduction or discontinuation of Zykadia due to diarrhoea, nausea or vomiting (see section 4.8).
Danish: Ingen patienter havde behov for dosisreduktion eller behandlingsstop af Zykadia på grund af diarré, kvalme eller opkastning (se pkt.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: Ceritinib 450 mg with food (N=41)
Danish: Ceritinib 450 mg med mad (N=41)
English: Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
Danish: Patienter skal monitoreres for lungesymptomer, der tyder på ILD/pneumonitis.
English: Based on in vitro data, ceritinib is a substrate of the efflux transporter P-glycoprotein (P-gp).
Danish: Baseret på in vitro-data er ceritinib substrat for effluxtransporteren P-glycoprotein (P-gp).
English: Table 2 ADRs in patients treated with Zykadia
Danish: Tabel 2 Bivirkninger hos patienter i behandling med Zykadia
English: 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).
Danish: 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
English: Patients randomised to the chemotherapy arm could further crossover to receive Zykadia upon RECIST-defined disease progression confirmed by BIRC.
Danish: Patienter, der var randomiseret til kemoterapiarmen kunne krydse over til Zykadia ved RECIST-defineret sygdomsprogression, som var bekræftet af BIRC.
English: 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.
Danish: 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.
English: 40 hard capsules 90 hard capsules
Danish: 40 hårde kapsler 90 hårde kapsler
English: Progression-free survival (based on BIRC) Number of events, n (%) Median, months d
Danish: Progressionsfri overlevelse (baseret på BIRC) Antal hændelser, n (%) Median, måneder d
English: 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.
Danish: 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.
English: Based on in vitro data, ceritinib also inhibits CYP2A6 and CYP2E1 at clinically relevant concentrations.
Danish: Baseret på in vitro-data hæmmer ceritinib også CYP2A6 og CYP2E1 i klinisk relevante koncentrationer.
English: Children and adolescents The use of Zykadia in children and adolescents up to 18 years of age is not recommended.
Danish: Børn og unge Børn og unge op til 18 år bør ikke behandles med Zykadia.
English: Chemotherapy (N=116)
Danish: Kemoterapi (N=116)
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Zykadia dosing
Danish: Zykadia-dosering
English: 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).
Danish: Samtidig brug af potente CYP3A-induktorer bør undgås, herunder, men ikke begrænset til, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin og perikum (Hypericum perforatum).
English: Patients with pulmonary symptoms indicative of ILD/pneumonitis should be monitored.
Danish: Patienter, der har symptomer med indikation på ILD/pneumonitis, skal monitoreres.
English: Oral contraceptives If you take Zykadia whilst using oral contraceptives, the oral contraceptives may become ineffective.
Danish: Orale præventionsmidler (p-piller) Hvis du tager Zykadia, mens du bruger p-piller, kan p-pillerne blive virkningsløse.
English: 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.
Danish: Når ceritinib administreres samtidig med andre lægemidler, bør Produktresuméet for det andet lægemiddel konsulteres angående rekommendationer vedrørende samtidig behandling med CYP3A4hæmmere.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: Alveolære skum-makrofager (bekræftet fosfolipidose) sås i lungerne hos rotter, men ikke hos aber, og lymfeknuderne havde makrofag-aggregater hos både rotter og aber.
English: 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)
Danish: 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)
English: 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.
Danish: 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.