FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 11 metabolites were found circulating in plasma at low levels with mean contribution to the radioactivity AUC of ≤2.3% for each metabolite.
Danish: Der blev fundet i alt 11 cirkulerende metabolitter i plasma i lave koncentrationer med et middelbidrag til radioaktivitet AUC på ≤2,3 % for hver metabolit.
English: In the ceritinib arm, 115 patients were treated with 750 mg once daily fasted.
Danish: I ceritinib-armen fik 115 patienter behandling med 750 mg en gang daglig fastende.
English: Do not take Zykadia: if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Zykadia: hvis du er allergisk over for ceritinib eller et af de øvrige indholdsstoffer i Zykadia (angivet i punkt 6).
English: Your doctor may need to adjust your treatment or stop Zykadia temporarily or permanently.
Danish: Din læge vil måske justere din behandling eller afbryde behandlingen med Zykadia midlertidigt eller permanent.
English: Blood tests during treatment with Zykadia
Danish: Blodprøver under behandlingen med Zykadia
English: Nausea e
Danish: Kvalme e
English: Increasing the frequency of international normalised ratio (INR) monitoring may be considered if co-administration with warfarin is unavoidable.
Danish: En øget monitoreringsfrekvens for international normaliseret ratio (INR) bør overvejes, såfremt samtidig behandling med warfarin ikke kan undgås.
English: Secondary biotransformation pathways involving the primary biotransformation products included glucuronidation and dehydrogenation.
Danish: De sekundære biotransformationveje, der involverer de primære biotransformationsprodukter, omfatter glucuronidering og dehydrogenering.
English: You and your doctor will decide together whether you should breast-feed or take Zykadia.
Danish: Du og din læge vil sammen beslutte, om du skal amme eller tage Zykadia.
English: Ceritinib is an orally highly selective and potent ALK inhibitor.
Danish: Ceritinib er en oral, stærkt selektiv og potent ALK-hæmmer.
English: Persistent hyperglycaemia greater than 250 mg/dl despite optimal anti-hyperglycaemic therapy
Danish: Vedvarende hyperglykæmi på mere end 250 mg/dl på trods af optimal antihyperglykæmisk behandling
English: The safety profile in patients aged 65 years or older was similar to that in patients less than 65 years of age (see section 4.2).
Danish: Sikkerhedsprofilen hos patienter i alderen 65 år eller derover lignede sikkerhedsprofilen hos patienter på under 65 år (se pkt.
English: Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Danish: Brug ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget på nogen måde, eller hvis der er tegn på, at den har været åbnet.
English: Food can range from a light to a full meal (see section 5.2).
Danish: Mad kan variere fra et let til et fuldt måltid (se pkt.
English: Seven patients (7.9%) required study drug interruption due to diarrhoea or nausea.
Danish: Syv patienter (7,9 %) havde behov for midlertidig afbrydelse af studiemedicinen på grund af diarré eller kvalme.
English: Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the baby.
Danish: Zykadia bør ikke anvendes under graviditet, medmindre den mulige gavnlige virkning opvejer den mulige risiko for barnet.
English: Limited efficacy data are available in elderly patients.
Danish: Der er begrænsede data tilgængelig vedrørende effekt hos ældre patienter.
English: ALK-positive NSCLC status should be established prior to initiation of Zykadia therapy.
Danish: ALK-positiv NSCLC-status skal fastslås før initiering af Zykadia-behandling.
English: Significantly decreased urine flow (potential sign of a kidney problem)
Danish: Væsentligt nedsat urinmængde (muligt tegn på et nyreproblem)
English: Most of these severe/life-threatening cases improved or resolved with interruption of treatment.
Danish: I de fleste af disse alvorlige/livstruende tilfælde bedredes eller forsvandt symptomerne ved afbrydelse af behandlingen.
English: Non-adenocarcinoma histology
Danish: Ikke-adenocarcinom-histologi
English: Peak plasma levels (Cmax) of ceritinib are achieved approximately 4 to 6 hours after a single oral administration in patients.
Danish: Peak-plasmakoncentrationer (Cmax) af ceritinib opnås ca. 4 til 6 timer efter en enkelt oral administration til patienter.
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Danish: Hvis du tager et eller flere af dem, vil din læge muligvis ordinere et andet lægemiddel til dig.
English: excessive thirst or increased frequency of urination.
Danish: overdreven tørst eller hyppigere vandladning.
English: ciclosporin, sirolimus and tacrolimus, medicines used in organ transplantation to prevent transplant organ rejection.
Danish: ciclosporin, sirolimus og tacrolimus, der bruges ved organtransplantation til at forebygge, at det transplanterede organ afstødes.
English: Significant improvements were reported for the majority of lung cancer specific symptoms for Zykadia compared to chemotherapy (four out of six LCSS and 10 out of 12 QLQ-LC13 symptom scores).
Danish: Der blev rapporteret signifikante forbedringer af størstedelen af lungecancerspecifikke symptomer for Zykadia sammenlignet med kemoterapi (fire ud af seks LCSS- og 10 ud af 12 QLQ-LC13-symptomscorer).
English: The median duration of follow-up was 16.5 months (from randomisation to data cut-off date).
Danish: Den mediane opfølgningsvarighed var 16,5 måneder (fra randomisering til dataskæringsdatoen).
English: Food/drink interactions
Danish: Interaktion med mad og drikkevarer
English: Therefore, clinical drug-drug interactions as a result of ceritinib-mediated inhibition of substrates for these transporters are unlikely to occur.
Danish: Forekomst af kliniske lægemiddelinteraktioner som følge af ceritinib-medieret hæmning af substrater for disse transportere er derfor ikke sandsynlig.
English: methadone, a medicine used to treat pain and for the treatment of opioid dependence.
Danish: methadon, der bruges til behandling af smerter og til behandling af opioid-afhængighed.
English: Bradycardia (bradycardia, sinus bradycardia)
Danish: Bradykardi (bradykardi, sinusbradykardi)
English: Bradycardia a
Danish: Bradykardi a
English: Complete Response (CR), Partial Response (PR) confirmed by repeat assessments performed not less than 4 weeks after response criteria were first met Overall response rate determined based on BIRC assessment per RECIST 1.1 Exact binomial 95% confidence interval
Danish: Komplet respons (CR), partielt respons (PR) bekræftet ved gentaget vurdering udført ikke mindre end 4 uger efter responskriteriet blev mødt første gang Responsrate er bestemt ved hjælp af BIRC vurdering i henhold til RECIST 1.1 Det nøjagtige binomiale 95% konfidensinterval
English: 93.3% had adenocarcinoma and 96.9% had either never been or were former smokers.
Danish: 93,3 % havde adenocarcinom og 96,9 % havde enten aldrig været eller var tidligere rygere.
English: The potential for Zykadia to cause infertility in male and female patients is unknown (see section 5.3).
Danish: Zykadias potentiale for at forårsage infertilitet hos mandlige og kvindelige patienter er ukendt (se pkt.
English: In Studies X2101 and A2201, brain metastases were seen in 60.1% and 71.4% of patients, respectively.
Danish: I Studie X2101 og A2201 sås hjernemetastaser hos henholdsvis 60,1 % og 71,4 % af patienterne.
English: Time-dependent inhibition of CYP3A was also observed.
Danish: Tidsafhængig hæmning af CYP3A blev også observeret.
English: Based on available data, ceritinib elimination via the kidney is negligible (1.3% of a single oral administered dose).
Danish: Baseret på de tilgængelige data er elimination af ceritinib via nyrerne ubetydelig (1,3 % efter administration af en enkelt oral dosis).
English: if you have problems with your lungs or problems breathing.
Danish: hvis du har lungeproblemer eller vejrtrækningsproblemer.
English: Population pharmacokinetic analyses showed that age, gender and race had no clinically meaningful influence on ceritinib exposure.
Danish: Farmakokinetiske populationsanalyser har vist, at alder, køn og race ikke har nogen klinisk relevant indflydelse på eksponeringen for ceritinib.
English: 59.5% of patients with brain metastasis at baseline received no prior radiotherapy to the brain.
Danish: 59,5 % af patienterne med hjernemetastaser ved baseline havde ikke tidligere fået strålebehandling i hjernen.
English: In rats, ceritinib crosses the intact blood brain barrier with a brain-to-blood exposure (AUCinf) ratio of about 15%.
Danish: Hos rotter krydser ceritinib den intakte blod-hjernebarriere med en hjerne/blod-eksponeringsratio (AUCinf) på ca. 15 %.
English: midazolam, a medicine used to treat acute seizures or as a sedative before or during surgery or medical procedures.
Danish: midazolam, der bruges til behandling af akutte krampeanfald eller som beroligende medicin før eller under operationer eller medicinske indgreb.
English: Event-free probability estimate at 9 months d
Danish: Hændelsesfri sandsynlighed ved 9 måneder d
English: The safety and efficacy of ceritinib in children and adolescents aged up to 18 years have not been established.
Danish: Ceritinibs sikkerhed og virkning hos børn og unge i alderen op til 18 år er ikke klarlagt.
English: Talk to your doctor about the birth control methods that may be right for you.
Danish: Tal med din læge om, hvilken præventionsform der er den rigtige for dig.
English: Early identification and management of ADRs with standard supportive care measures should be considered.
Danish: Tidlig identifikation og behandling af bivirkninger med understøttende standardplejeforanstaltninger bør overvejes.
English: Agents that are substrates of transporters
Danish: Lægemidler, der er substrater for transportproteiner
English: The study met its primary objective demonstrating a statistically significant improvement in progression free survival (PFS) by BIRC (see Table 3 and Figure 1).
Danish: Studiet mødte sit primære formål og demonstrerede statistisk signifikant forbedring i progressionsfri overlevelse (PFS), vurderet af BIRC (se tabel 3 og figur 1).
English: Women of childbearing potential/Contraception
Danish: Kvinder i den fertile alder/Kontraception
English: Use of Zykadia in patients with congenital long QT syndrome should be avoided.
Danish: Brug af Zykadia hos patienter med medfødt lang QT-syndrom skal undgås.
English: In vitro studies suggest that ceritinib is a substrate for P-glycoprotein (P-gp), but not of breast cancer resistance protein (BCRP) or multi-resistance protein 2 (MRP2).
Danish: In vitro-studier tyder på, at ceritinib er et substrat for P-glycoprotein (P-gp), men ikke for breast cancer resistance protein (BCRP) eller multi-resistance protein 2 (MRP2).
English: Binding of ceritinib to human plasma proteins in vitro is approximately 97% in a concentration independent manner, from 50 ng/ml to 10,000 ng/ml.
Danish: Binding af ceritinib til humane plasmaproteiner in vitro er ca. 97 % og sker på en koncentrationsafhængig måde fra 50 ng/ml til 10.000 ng/ml.
English: Log rank p-value = <0.001
Danish: Log rank p-værdi = <0,001
English: Particular care should be exercised when administering ceritinib to patients with an increased risk of experiencing torsade de pointes during treatment with a QTc-prolonging medicinal product.
Danish: Der skal udvises særlig forsigtighed når ceritinib administreres til patienter med øget risiko for at opleve torsade de pointes i løbet af behandlingen med et QTc-forlængende lægemiddel.
English: Patients with severe renal impairment (CLcr <30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
Danish: Patienter med svært nedsat nyrefunktion (CLcr <30 ml/min) blev ikke inkluderet i de kliniske studier af Zykadia (se pkt.
English: Seventy-three (73) patients received docetaxel and 40 received pemetrexed.
Danish: Treoghalvfjerds (73) patienter fik docetaxel og 40 fik pemetrexed.
English: You should also tell your doctor if you are already taking Zykadia and you are prescribed a new medicine that you have not already taken at the same time as Zykadia.
Danish: Du skal også fortælle det til lægen, hvis du allerede tager Zykadia, og du får ordineret et nyt lægemiddel, som du ikke tidligere har taget sammen med Zykadia.
English: alfentanil and fentanyl, medicines used to treat severe pain.
Danish: alfentanil og fentanyl, der bruges til behandling af stærke smerter.
English: The limited data on the safety and efficacy of ceritinib in patients aged 65 years and older do not suggest that a dose adjustment is required in elderly patients (see section 5.2).
Danish: De begrænsede data om ceritinibs sikkerhed og virkning hos patienter i alderen 65 år og derover tyder ikke på, at dosisjustering er nødvendig hos ældre patienter (se pkt.
English: For patients who develop a concurrent medical condition and are unable to take Zykadia with food, Zykadia can be taken on an empty stomach as the alternate continued treatment regimen, in which no food should be eaten for at least two hours before and one hour after the dose.
Danish: Hos patienter, der udvikler en samtidig medicinsk tilstand og ikke kan tage Zykadia sammen med mad, kan Zykadia tages på tom mave som alternativt kontinuerende behandlingsregime, hvor mad ikke må indtages i mindst to timer før og en time efter dosis.
English: The use of concomitant medicinal products associated with bradycardia should be carefully evaluated.
Danish: Samtidig behandling med lægemidler der associeres med bradykardi skal evalueres nøje.
English: Formal non-clinical studies on the potential effects of ceritinib on fertility have not been conducted.
Danish: Der er ikke udført formelle non-kliniske studier af ceritinibs potentielle virkning på fertilitet.
English: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of ceritinib.
Danish: In vitro-studier har vist, at CYP3A er det vigtigste enzym involveret i den metaboliske clearance af ceritinib.
English: The bioavailability of ceritinib is increased in the presence of food.
Danish: Ceritinibs biotilgængelighed stiger i tilstedeværelse af mad.
English: The tablets are provided in blisters and are available in a pack containing 84 tablets (4 blisters of 21 tablets).
Danish: Tabletterne leveres i blisterkort og fås i en pakning, der indeholder 84 tabletter (4 blisterkort med 21 tabletter).
English: In vitro data show that the IC50 for the inhibitory effect of ceritinib on the hERG potassium channel was 0.4 micromolar.
Danish: In vitro-data viste, at IC50 for ceritinibs hæmmende virkning på hERG-kaliumkanalen var 0,4 mikromolær.
English: A total of 57.4% of patients were female.
Danish: I alt var 57,4 % af patienterne kvinder.
English: A total of 55.8% of patients were female.
Danish: I alt var 55,8 % af patienterne kvinder.
English: The median duration of exposure to Zykadia 750 mg fasted was 44.9 weeks (range: 0.1 to 200.1 weeks).
Danish: Den mediane varighed af eksponeringen for Zykadia 750 mg fastende var 44,9 uger (interval: 0,1 til 200,1 uger).
English: The risk of hyperglycaemia was higher in patients with diabetes mellitus and/or concurrent steroid use.
Danish: Risikoen for hyperglykæmi var højere hos patienter med diabetes mellitus og/eller ved samtidig brug af steroider.
English: If you have any questions about how Zykadia works or why this medicine has been prescribed for you, ask your doctor or pharmacist.
Danish: Hvis du har spørgsmål til, hvordan Zykadia virker, eller hvorfor det er ordineret til dig, skal du spørge lægen eller apotekspersonalet.
English: moxifloxacin and clarithromycin, medicines used to treat bacterial infections.
Danish: moxifloxacin og clarithromycin, der bruges til behandling af bakterieinfektioner.
English: However, the risk for a clinically relevant decrease in bioavailability of ceritinib is possibly lower with concomitant use of H2 blockers if they are administered 10 hours before or 2 hours after the ceritinib dose, and with antacids if they are administered 2 hours before or 2 hours after the ceritinib dose.
Danish: Dog er risikoen for klinisk relevant nedsat biotilgængelighed af ceritinib muligvis mindre ved samtidig behandling med H2-blokkere, hvis de administreres 10 timer før eller 2 timer efter ceritinib, og med antacida, hvis de administreres 2 timer før eller 2 timer efter ceritinib.
English: Your doctor should also perform blood tests to check the functioning of your pancreas and the level of sugar in your blood before you start treatment with Zykadia and regularly during treatment.
Danish: Din læge vil også tage blodprøver for at kontrollere dit blodsukker, og hvordan din bugspytkirtel fungerer, før du begynder på behandlingen med Zykadia og regelmæssigt under behandlingen.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): Synsproblemer
English: Across seven clinical studies, 168 out of 925 patients (18.2%) treated with Zykadia were aged 65 years or older.
Danish: På tværs af syv kliniske studier var 168 ud af 925 patienter (18,2 %), som blev behandlet med Zykadia, 65 år eller ældre.
English: Table 1 summarises recommendations for dose interruption, reduction or discontinuation of Zykadia in the management of selected ADRs.
Danish: Tabel 1 opsummerer anbefalinger for dosisafbrydelse, -reduktion eller seponering af Zykadia ved behandling af udvalgte bivirkninger.
English: Your doctor should perform blood tests before you start treatment, every 2 weeks during the first three months of treatment and monthly therafter.
Danish: Din læge vil tage blodprøver, før du begynder på behandlingen, hver anden uge i de første tre måneder af behandlingen og derefter månedligt.
English: Periodic monitoring with ECGs and periodic monitoring of electrolytes (e.g. potassium) is recommended in these patients.
Danish: Periodisk monitorering med EKG'er og periodisk monitorering af elektrolytter (fx kalium) anbefales hos disse patienter.
English: Daily oral dosing of ceritinib results in achievement of steady-state by approximately 15 days and remains stable afterwards, with a geometric mean accumulation ratio of 6.2 after 3 weeks of daily dosing.
Danish: Daglig oral dosering med ceritinib medførte opnåelse af steady state efter ca. 15 dage og forbliver stabil derefter med en geometrisk, gennemsnitlig akkumuleringsratio på 6,2 efter 3 ugers daglig dosering.
English: Patient reported outcome questionnaires were collected using the EORTC QLQ C30/LC13, LCSS and EQ-5D-5L.
Danish: Spørgeskemaer vedrørende patientrapporterede resultater blev indsamlet ved brug af EORTC QLQ C30/LC13, LCSS og EQ-5D-5L.
English: If you have questions about how long to take Zykadia, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Zykadia, skal du tale med din læge eller apotekspersonalet.
English: In patients treated with Zykadia 450 mg with food, 10% of patients had an adverse event that required at least one dose reduction and 42% of patients had an adverse event that required at least one dose interruption.
Danish: Hos patienter behandlet med Zykadia 450 mg taget sammen med mad, oplevede 10 % af patienterne bivirkninger, som nødvendiggjorde mindst én dosisreduktion, og 42 % af patienterne oplevede bivirkninger, som nødvendiggjorde mindst én afbrydelse af behandlingen.
English: OS analysis was not adjusted for the effects of cross-over.
Danish: OS-analyse var ikke justeret for effekterne af overkrydsning.
English: Limited information is available in ALK-positive NSCLC patients with non-adenocarcinoma histology.
Danish: Der er begrænset information tilgængelig om ALK-positive NSCLC-patienter med ikke-adenocarcinom-histologi.
English: Zykadia should be discontinued in patients unable to tolerate 150 mg daily taken with food.
Danish: Zykadia skal seponeres hos patienter, der ikke tolererer en dosis på 150 mg daglig taget sammen med mad.
English: In the event of vomiting, diarrhoea, dehydration or impaired renal function, correct electrolytes as clinically indicated.
Danish: I tilfælde af opkastning, diarré, dehydrering eller nedsat nyrefunktion skal elektrolytter korrigeres som klinisk indiceret.
English: If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours.
Danish: Hvis en dosis glemmes, skal patienten tage den, med mindre den næste dosis skal tages inden for 12 timer.
English: Ceritinib was demonstrated to be effective against EML4-ALK activity in a NSCLC cell line (H2228), resulting in inhibition of cell proliferation in vitro and regression of tumours in H2228-derived xenografts in mouse and rat.
Danish: Det blev påvist, at ceritinib var effektiv mod EML4-ALK-aktivitet i en NSCLC-cellelinje (H2228), hvilket medførte hæmning af celleproliferation in vitro og regression af tumorer i H2228-afledte xenografter hos mus og rotter.
English: Mixed cell/neutrophilic inflammation of the extra-hepatic ducts extended to the pancreas and/or duodenum at higher doses.
Danish: Blandet celle-/neutrofilinflammation i de ekstrahepatiske galdegange bredte sig til pankreas og/eller duodenum ved højere doser.
English: Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase).
Danish: Zykadia gives kun til patienter, hvis sygdom skyldes en defekt i et gen kaldet ALK (anaplastisk lymfomkinase).
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blisters containing 10 hard capsules.
Danish: PVC/PCTFE (polyvinylchlorid/polychlortrifluorethylen) - Aluminiumblister indeholdende 10 hårde kapsler.
English: Pack containing 84 film-coated tablets (4 blisters per pack).
Danish: Pakninger bestående af 84 filmovertrukne tabletter (4 blistere pr. pakning).
English: INTERMEDIATE CARTON OF PACK (WITHOUT BLUE BOX) CONTAINING 50 HARD CAPSULES
Danish: KARTON TIL DELPAKNING (UDEN BLUE BOX) MED 50 HÅRDE KAPSLER
English: 64.5% of the study population were Caucasian, 29.4% Asian, 0.4% Black and 2.6% other races.
Danish: 64,5 % af studiepopulationen var kaukasiske, 29,4 % asiatiske, 0,4 % sorte og 2,6 % andre racer.
English: Number of events, n (%) Median, months d
Danish: Antal hændelser, n (%) Median, måneder d
English: The majority of patients were Caucasian (66.3%) or Asian (28.8%).
Danish: Størstedelen af patienterne var kaukasier (66,3 %) eller asiater (28,8 %).
English: Patients should be instructed to avoid grapefruit and grapefruit juice as they may inhibit CYP3A in the gut wall and may increase the bioavailability of ceritinib.
Danish: Patienterne skal instrueres i at undgå grapefrugt og grapefrugtjuice, da det kan hæmme CYP3A i tarmvæggen og dermed øge ceritinibs biotilgængelighed.
English: These may be symptoms of a high level of sugar in the blood.
Danish: Dette kan være symptomer på for højt blodsukker.
English: One hundred fifteen (115) patients were randomised to Zykadia and one hundred sixteen (116) were randomised to chemotherapy (either pemetrexed or docetaxel).
Danish: Ethundredeogfemten (115) patienter blev randomiseret til Zykadia og ethundredeogseksten (116) blev randomiseret til kemoterapi (enten pemetrexed eller docetaxel).
English: Safety pharmacology studies indicate that ceritinib is unlikely to interfere with vital functions of the respiratory and central nervous systems.
Danish: Sikkerhedsfarmakologiske studier indikerede, at ceritinib sandsynligvis ikke påvirker vitale funktioner i respirations- og centralnervesystemet.
English: Zykadia blocks the action of this abnormal protein and thus slows down the growth and spread of NSCLC.
Danish: Zykadia blokerer virkningen af det unormale protein og nedsætter dermed hastigheden af vækst og spredning af NSCLC.
English: The capsules should be swallowed whole with water and should not be chewed or crushed.
Danish: Kapslerne skal synkes hele med vand og må ikke tygges eller knuses.
English: ECG studies in monkeys after 4- or 13-weeks of dosing with ceritinib have not shown QT prolongation or abnormal ECGs.
Danish: EKG-studier med aber efter 4 eller 13-ugers dosering med ceritinib har ikke vist QT-forlængelse eller unormale EKG'er.