FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no ROS1-positive patients >85 years old in Study 1001.
Danish: Der var ingen ROS1-positive patienter >85 år i studie 1001.
English: • If your next dose is in 6 hours or more, take the missed capsule as soon as you remember.
Danish: • Hvis du skal tage den næste dosis om 6 timer eller mere, skal du tage den glemte kapsel lige så snart, du kommer i tanke om det.
English: Periodic monitoring with imaging and urinalysis should be considered in patients who develop renal cysts.
Danish: Periodisk monitorering med billeddiagnostik og urinanalyse bør overvejes hos patienter, der udvikler nyrecyster.
English: For most patients, ROS1-positive NSCLC was identified by FISH.
Danish: For de fleste patienters vedkommende blev ROS1-positiv NSCLC identificeret ved FISH.
English: Following oral single dose administration in the fasted state, crizotinib is absorbed with median time to achieve peak concentrations of 4 to 6 hours.
Danish: Efter oral administration af en enkelt dosis taget fastende, absorberes crizotinib med peakkoncentration efter gennemsnitlig 4 til 6 timer.
English: The disease characteristics were 94% metastatic, 96% adenocarcinoma histology, and 13% with no prior systemic therapy for metastatic disease.
Danish: Sygdomskarakteristika var 94% metastatisk, 96% adenokarcinomhistologi, og 13%, der ikke tidligere havde fået systemisk behandling for metastatisk sygdom.
English: The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (1/10); common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: De bivirkninger, der er anført i skema 3, er angivet efter systemorganklasse og følgende hyppigheder: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Crizotinib should be discontinued in patients who develop gastrointestinal perforation.
Danish: Crizotinib bør seponeres hos patienter, der udvikler gastrointestinal perforation.
English: XALKORI may increase side effects associated with the following medicines:
Danish: XALKORI kan øge bivirkninger i forbindelse med følgende lægemidler:
English: Serial ECGs in triplicate were collected following a single dose and at steady state to evaluate the effect of crizotinib on QT intervals.
Danish: Der blev indsamlet serielle ekg'er i tre eksemplarer efter en enkelt dosis og ved steady state for at evaluere crizotinibs indvirkning på QT-intervallet.
English: • Anticholinesterases, used to restore muscle function.
Danish: • Antikolinerge midler, til at genoprette muskelfunktion.
English: Crizotinib is also an inhibitor of the Hepatocyte Growth Factor Receptor (HGFR, c-Met) RTK, ROS1 (c-ros) and Recepteur d'Origine Nantais (RON) RTK.
Danish: Crizotinib er også en hæmmer af receptor for hepatocytvækstfaktor (HGFR, c-Met) RTK, ROS1 (c-ros) og Recepteur d'Origine Nantais (RON) RTK.
English: The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites.
Danish: Den primære metabolisering hos mennesker er oxidation af piperidin-ringen til crizotinib-laktam og O-dealkylering med efterfølgende fase 2 konjugering af O-dealkylerede metabolitter.
English: Adverse reactions reported in crizotinib clinical studies (N=1722) System organ class
Danish: Bivirkninger indberettet i kliniske crizotinibstudier (N=1.722) Systemorganklasse
English: Some lung problems may get worse during treatment with XALKORI, as XALKORI may cause inflammation of the lungs during treatment.
Danish: Nogle lungeproblemer bliver værre under behandlingen med XALKORI fordi XALKORI kan give en betændelseslignende tilstand i lungerne under behandlingen.
English: XALKORI can be prescribed to you if your disease is at an advanced stage and previous treatment has not helped to stop your disease.
Danish: XALKORI kan ordineres til dig, hvis din sygdom er i et fremskredent stadium og hvis tidligere behandling ikke har virket.
English: Pre-existing ophthalmic abnormalities and concomitant medical conditions which could be contributory to ocular findings were noted in many patients, and no conclusive causal relationship to crizotinib could be determined.
Danish: Præeksisterende okulære abnormiteter og samtidige medicinske tilstande, som kunne bidrage til de okulære fund, blev bemærket hos mange patienter, og en afgørende årsagssammenhæng med crizotinib kunne ikke konstateres.
English: Most events were mild in severity.
Danish: De fleste tilfælde var lette i sværhedsgrad.
English: The NOAEL for aneugenicity was approximately 1.8-fold human clinical exposure based on AUC.
Danish: NOAEL for kromosomtalspåvirking var ca. 1,8 gange human klinisk eksponering baseret på AUC.
English: • If your next dose is in less than 6 hours, skip the missed capsule.
Danish: • Hvis du skal tage den næste dosis om mindre end 6 timer, skal du springe den glemte kapsel over.
English: Tell your doctor right away if you have any new or worsening symptoms including difficulty in breathing, shortness of breath, or cough with or without mucous, or fever.
Danish: Fortæl det straks til lægen, hvis du får nye forværrede symptomer herunder besvær med at trække vejret, åndenød, hoste med eller uden slim eller feber.
English: ALK and ROS1 testing
Danish: ALK- og ROS1-analyse
English: • Cisapride, used to treat stomach problems.
Danish: • Cisaprid, til behandling af maveproblemer.
English: Your doctor may stop XALKORI treatment and refer you to an ophthalmologist.
Danish: Din læge vil måske standse behandlingen med XALKORI og henvise dig til en øjenlæge.
English: Study 1001 N=53a
Danish: Studie 1001 N=53
English: XALKORI treatment
Danish: XALKORI-behandling
English: q. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism).
Danish: q) Nedsat testosteron i blodet (nedsat testosteron i blodet, hypogonadisme, sekundær hypogonadisme).
English: Assessment should be performed by laboratories with demonstrated proficiency in the specific technology being utilised (see section 4.4).
Danish: Vurderingen bør udføres af laboratorier med tilstrækkelig kompetence inden for den anvendte analyse (se pkt.
English: Median time to onset of any grade leukopenia was 85 days.
Danish: Mediantiden til leukopeni af en eller anden grad var 85 dage.
English: Withhold until recovery to Grade ≤2, then resume at the same dose schedule
Danish: Hold pause indtil forbedring til grad ≤ 2, herefter genoptages samme doseringsplan
English: Seven (0.4%) patients had temporary treatment discontinuation and 2 (0.1%) patients had a dose reduction associated with vision disorder.
Danish: 7 (0,4%) patienter afbrød behandlingen midlertidigt, og 2 (0,1%) patienter fik nedsat dosis i forbindelse med synsforstyrrelser.
English: Crizotinib treatment should be withheld if ILD/pneumonitis is suspected.
Danish: Behandlingen med crizotinib skal afbrydes, hvis der er mistanke om ILD/pneumonitis.
English: Either ALK-positive or ROS1-positive NSCLC status should be established prior to initiation of crizotinib therapy.
Danish: Enten ALK-positiv eller ROS1-positiv NSCLC-status skal konstateres, inden behandling med crizotinib indledes.
English: • Pimozide, used to treat mental illness.
Danish: • Pimozid, til behandling af psykisk sygdom.
English: No visual disturbances associated with crizotinib appeared to be related to changes in best corrected visual acuity, the vitreous, the retina, or the optic nerve.
Danish: Ingen synsforstyrrelser i forbindelse med crizotinib syntes at være relateret til forandringer i bedst muligt korrigeret synsskarphed, i glaslegemet, i retina eller i synsnerven.
English: In vitro, crizotinib did not inhibit the human hepatic uptake transport proteins organic anion transporting polypeptide (OATP)1B1 or OATP1B3 or the renal uptake transport proteins organic anion transporter (OAT)1 or OAT3 at clinically relevant concentrations.
Danish: In vitro hæmmer crizotinib ikke de humane hepatiske transportproteiner organisk anion-transportpolypeptid (OATP) 1B1 og OATP1B3 eller de renale transportproteiner organisk anion-transporter (OAT) 1 eller OAT3 ved klinisk relevante koncentrationer.
English: • If you have ever had stomach or intestine problems such as holes (perforation), or if you have conditions causing inflammation inside the abdomen (diverticulitis), or if you have spread of cancer inside the abdomen (metastasis).
Danish: • Hvis du på noget tidspunkt har haft mave- eller tarmproblemer som f.eks. huller (perforering), eller hvis du har lidelser, der giver betændelse i maven (divertikulitis), eller hvis du har kræft, der har bredt sig i maven (metastase).
English: Limited data are available in this subgroup of patients (see sections 4.2 and 5.1).
Danish: Der er begrænsede data tilgængelige i denne subgruppe af patienter (se pkt.
English: b. Based on the Cox proportional hazards stratified analysis.
Danish: b. Baseret på den stratificerede analyse efter Cox' proportionale risikomodel.
English: • Partial or complete loss of vision in one or both eyes Tell your doctor right away if you experience any loss of vision or any change in vision such as difficulty seeing out of one or both eyes.
Danish: • Delvist eller fuldstændigt synstab på et eller begge øjne Kontakt straks lægen, hvis du får synstab eller synsændringer såsom problemer med at se med et eller begge øjne.
English: Other findings included an effect on the liver (elevation of liver transaminases) and retinal function, and potential for phospholipidosis in multiple organs without correlative toxicities.
Danish: Andre fund inkluderer leverpåvirkning (stigning i levertransaminase), påvirkning af retinafunktion samt risiko for phospholipidose i flere organer uden korrelerende toksicitet.
English: Median time to onset of increased Grade 3 or 4 transaminases was 43 days.
Danish: Mediantiden indtil grad 3 eller 4 aminotransferasestigninger var 43 dage.
English: Electrolyte disturbances, dehydration and bradycardia may further increase the risk of QTc prolongation and thus, periodic monitoring of ECG and electrolyte levels is recommended in patients with GI toxicity (see section 4.4).
Danish: Elektrolytforstyrrelser, dehydrering og bradykardi kan yderligere øge risikoen for QTc-forlængelse og derfor anbefales periodisk monitorering af ekg og elektrolytniveauer hos patienter med gastrointestinal tokcisitet (se pkt.
English: The No Observed Adverse Effect Levels (NOAEL) for these findings were either subtherapeutic or up to 2.6-fold human clinical exposure based on AUC.
Danish: Niveauet for antallet af observerede bivirkninger (NOAEL - No Observed Adverse Effect Levels) var enten sub-terapeutisk eller op til 2,6 gange human klinisk eksponering baseret på AUC.
English: k. Oesophagitis (Oesophagitis, Oesophageal ulcer).
Danish: k) Øsofagitis(øsofagitis, øsofageal ulcus).
English: Seventeen (1%) patients required permanent discontinuation from treatment.
Danish: Der var 17 (1%) patienter, hvor behandlingen måtte afbrydes permanent.
English: • Clarithromycin, telithromycin, erythromycin, antibiotics used to treat bacterial infections.
Danish: • Clarithromycin, telithromycin, erythromycin, antibiotika til behandling af infektioner med bakterier.
English: Intracranial Disease Control Rate (IC-DCR) at 12 weeks was 65% and 46% for crizotinib and chemotherapy-treated patients, respectively.
Danish: Den intrakranielle sygdomskontrolrate (Intracranial Disease Control Rate - IC-DCR) efter 12 uger var 65% og 46% for patienterne i henholdsvis crizotinib- og kemoterapi-armen.
English: • If you have vision disorders (seeing flashes of light, blurred vision, and double vision).
Danish: • Hvis du har synsforstyrrelser (ser lysglimt, har sløret syn eller dobbeltsyn).
English: In Study 1007, the median duration of study treatment was 48 weeks for patients in the crizotinib arm (N=172).
Danish: I studie 1007 var den mediane behandlingsvarighed 48 uger for patienter i crizotinib-armen (N=172).
English: Time to Deterioration (TTD) was prespecified as the first occurrence of a ≥10-point increase in scores from baseline in symptoms of pain in chest, cough, or dyspnoea as assessed by EORTC QLQ-LC13.
Danish: Tid indtil forværring (TTD) var specificeret på forhånd som første forekomst af en stigning på ≥10 point i scorerne fra baseline for symptomer på smerter i brystet, hoste eller dyspnø ifølge EORTC QLQ-LC13.
English: • Decreased levels of testosterone, a male sex hormone.
Danish: • Nedsat niveau af testosteron i blodet, et mandligt kønshormon.
English: Median time to onset of any grade neutropenia was 89 days.
Danish: Mediantid til neutropeni af en eller anden grad var 89 dage.
English: • Medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol.
Danish: • Medicin mod forhøjet blodtryk, der kaldes beta-blokkere, fx atenolol, propranolol og labetolol.
English: Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted area under the plasma concentration-time curve at steady-state (AUCss) (95% CI) was 23%-37% higher in Asian patients (N=523) than in non-Asian patients (N=691).
Danish: Baseret på den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 var det forventede areal under plasmakoncentrations-tids-kurven (AUCss) ved steady state (95% CI) 23%37% højere hos asiatiske patienter (N=523) end hos ikke-asiatiske patienter (N=691).
English: Based on nonclinical safety findings, male and female fertility may be compromised by treatment with XALKORI (see section 5.3).
Danish: På baggrund af ikke-kliniske sikkerhedsdata kan mænds og kvinders fertilitet påvirkes af behandling med XALKORI (se pkt.
English: Crizotinib dose adjustment according to Child-Pugh classification has not been studied in patients with hepatic impairment.
Danish: Dosisjustering af crizotinib ifølge Child-Pugh klassifikation er ikke undersøgt hos patienter med nedsat leverfunktion.
English: The most common findings concerned slit lamp biomicroscopy (21.1%), fundoscopy (15.8%) and visual acuity (13.2%).
Danish: De mest almindelige fund vedrørte biomikroskopi med spaltelampe (21,1%), fundoskopi (15,8%) og synsskarphed (13,2%).
English: Tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual.
Danish: Fortæl det straks til lægen, hvis du føler dig mere træt end normalt, får gulfarvning af hud eller øjne, mørkfarvning af urinen (tefarvet), kvalme, opkastning eller nedsat appetit eller smerter i højre side af maven, kløe eller hvis du lettere får blå mærker end du plejer.
English: c. Based on the stratified log-rank test (1-sided).
Danish: c. Baseret på den stratificerede log-rank-test (1-sidet).
English: g. Bradycardia (Bradycardia, Heart rate decreased, Sinus bradycardia).
Danish: g) Bradykardi (bradykardi, nedsat hjertefrekvens, sinus bradykardi).
English: Patients with pulmonary symptoms indicative of ILD/pneumonitis should be monitored.
Danish: Patienter med lungesymptomer, der kan tyde på ILD/pneumonitis, skal observeres.
English: Seventeen (1%) patients required permanent discontinuation from treatment associated with elevated transaminases, suggesting that these events were generally manageable by dosing modifications as defined in Table 2 (see section 4.2).
Danish: Hos 17 (1%) af patienterne måtte behandlingen afbrydes permanent i forbindelse med forhøjede aminotransferaser, hvilket tyder på, at disse tilfælde generelt kunne håndteres gennem dosisændringer som angivet i skema 2 (se pkt.
English: • If you are experiencing severe stomach or abdominal pain, fever, chills, shortness of breath, fast heartbeat, partial or complete loss of vision (in one or both eyes) or changes in bowel habits.
Danish: • Hvis du oplever stærke smerter i maven eller underlivet, feber, kulderystelser, åndenød, hjertebanken, delvist eller fuldstændigt synstab (på et eller begge øjne) eller ændringer i afføringsmønstret.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos 1 ud af 10 personer)
English: Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and 2, respectively.
Danish: Effektdata fra det randomiserede fase 3-studie 1014 er sammenfattet i skema 4, og Kaplan-Meier-kurverne for PFS og OS er vist i henholdsvis figur 1 og 2.
English: Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in faeces and urine, respectively.
Danish: Uomdannet crizotinib repræsenterede henholdsvis 53% og 2,3% af den administrede dosis i fæces og urin.
English: Of note, no patients with SCC histology were randomised in the crizotinib arm in Study 1007 and no patients with SCC were enrolled in Study 1014 due to pemetrexed-based regimen being used as a comparator.
Danish: Det bør bemærkes, at ingen patienter med SCC-histologi blev randomiseret til crizotinib-armen i studie 1007, og ingen patienter med SCC indgik i studie 1014 på grund af det pemtrexedbaserede regime, der blev brugt som komparator.
English: Vomiting (51%) Diarrhoea (54%) Nausea (57%) Constipation (43%) Abdominal painj
Danish: Opkastning (51%) Diarré (54%) Kvalme (57%) Obstipation (43%) Abdominalsmerter
English: In patients with new onset of severe visual loss (best corrected visual acuity less than 6/60 in one or both eyes), crizotinib treatment should be discontinued (see section 4.2).
Danish: Hos patienter med nyligt opstået alvorligt synstab (bedst korrigeret synsskarphed på mindre end 6/60 på et eller begge øjne) skal behandlingen med crizotinib seponeres (se pkt.
English: Patients should not take 2 doses at the same time to make up for a missed dose.
Danish: Der må ikke indtages 2 doser på en gang for at kompensere for den glemte dosis.
English: Leukopenia was associated with a dose reduction for <0.5% of patients, and no patients permanently discontinued crizotinib treatment associated with leukopenia.
Danish: Dosis blev reduceret på grund af leukopeni hos <0,5% af patienterne, og ingen patienter afbrød crizotinibbehandlingen permanent på grund af leukopeni.
English: • Moxifloxacine, used to treat bacterial infections.
Danish: • Moxifloxacin, til behandling af bakterieinfektioner.
English: Caution should be exercised in administering crizotinib in combination with medicinal products that are predominantly metabolised by these enzymes.
Danish: Der bør udvises forsigtighed, når crizotinib administreres samtidig med lægemidler, som metaboliseres af disse enzymer.
English: One hundred seventy-three (173) patients were randomised to crizotinib and 174 patients were randomised to chemotherapy (either pemetrexed or docetaxel).
Danish: 173 patienter blev randomiseret til crizotinib, og 174 patienter til kemoterapi (enten pemetrexed eller docetaxel).
English: Physiologically-based pharmacokinetic (PBPK) simulations predicted a 17% increase in crizotinib steady-state AUC after treatment with the moderate CYP3A inhibitors, diltiazem or verapamil.
Danish: Simulering af fysiologisk baseret farmakokinetik forudsiger en 17 % stigning i crizotinib steady state AUC efter behandling med moderate CYP3A-hæmmere som diltiazem eller verapamil.
English: Talk to your doctor right away after having taken XALKORI:
Danish: Kontakt straks lægen, når du har taget XALKORI:
English: • Ketoconazole, itraconazole, posaconazole, voriconazole, used to treat fungal infections.
Danish: • Ketoconazol, itraconazol, posaconazol, voriconazol, bruges til behandling af svampeinfektion.
English: Patients with mild (60≤ CLcr <90 mL/min) and moderate (30≤ CLcr <60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Danish: Patienter med let (60 ≤ CLcr <90 ml/min) og moderat (30 ≤ CLcr <60 ml/min) nedsat nyrefunktion blev indrulleret i enkeltarmsstudierne 1001 og 1005.
English: Crizotinib can be administered with or without food (see section 4.2).
Danish: Crizotinib kan administreres med eller uden føde (se Pkt.
English: In vitro studies demonstrated that CYP3A4/5 were the major enzymes involved in the metabolic clearance of crizotinib.
Danish: In vitro studier viser, at det er CYP3A4/5-enzymer, der hovedsageligt er involveret i den metaboliske clearance af crizotinib.
English: No safety and efficacy data are available on re-treatment with crizotinib of patients who received crizotinib in previous lines of therapy.
Danish: Der findes ingen tilgængelige data for virkning og sikkerhed ved genbehandling med crizotinib hos patienter, der fik crizotinib i tidligere behandlingsregimer.
English: • Bupropion, used to treat depression and smoking cessation.
Danish: • Bupropion, til behandling af depression samt til rygeafvænning.
English: Grade 3 or 4 leukopenia has been commonly (3%) reported (see section 4.8).
Danish: Grad 3 eller 4 leukopeni er blevet indberettet som almindelig (3%) (se pkt.
English: Abbreviations: CI=confidence interval; N/n=number of patients.
Danish: Forkortelser: CI = konfidensinterval, N/n = antal patienter.
English: If necessary, your doctor may decide to reduce the dose to 200 mg to be taken orally twice daily (total amount 400 mg) and if further dose reduction is necessary, to reduce it to 250 mg to be taken orally once daily.
Danish: Lægen kan om nødvendigt nedsætte dosis til 200 mg 2 gange dagligt (i alt 400 mg), og hvis yderligere dosisnedsættelse er nødvendig, kan dosis nedsættes til 250 mg 1 gang daglig.
English: • Rifabutin, rifampicin, used to treat tuberculosis.
Danish: • Rifabutin, rifampicin, bruges til behandling af tuberkulose.
English: Your doctor may decide to permanently discontinue your treatment if you are unable to tolerate XALKORI 250 mg taken orally once daily.
Danish: Lægen kan beslutte at afbryde din behandling permanent, hvis du ikke kan tåle at få XALKORI 250 mg oralt (gennem munden) 1 gang dagligt.
English: Other side effects of XALKORI may include:
Danish: Andre bivirkninger af XALKORI kan være:
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving XALKORI.
Danish: Kvinder i den fødedygtige alder bør rådes til at undgå at blive gravid under behandling med XALKORI.
English: No patients in the crizotinib arm of randomised Phase 3 Studies 1007 and 1014, and single arm Study 1005 were >85 years.
Danish: Ingen patienter i crizotinib-armen i det randomiserede fase 3-studie 1007 og 1014 og enkeltarmsstudiet 1005 var >85 år.
English: XALKORI can be prescribed to you for the initial treatment if your disease is at an advanced stage of lung cancer.
Danish: XALKORI kan ordineres til dig til den indledende behandling, hvis din lungekræft er i et fremskredent stadium.
English: It is recommended that women avoid becoming pregnant and that men do not father children during treatment with XALKORI because this medicine could harm the baby.
Danish: Kvinder bør ikke blive gravide og mænd bør ikke blive fædre under behandlingen med XALKORI, da lægemidlet kan skade fostret.
English: Withhold until recovery to Grade ≤1 or to heart rate 60 or above
Danish: Hold pause indtil forbedring til grad ≤ 1 eller til hjertefrekvens på 60 eller derover
English: Patient brochure including a Patient Alert Card (text as agreed by the CHMP).
Danish: Produktresumé og indlægsseddel Patientinformation inklusive et patientinformationskort (med tekst som vedtaget af CHMP)