FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on preclinical data, alectinib is not a substrate of p-glycoprotein or BCRP, which are both efflux transporters in the blood brain barrier, and is therefore able to distribute into and be retained within the central nervous system.
Danish: Baseret på prækliniske data er alectinib ikke substrat for p-glykoprotein eller BCRP, der begge er efflux-transportører i blod-hjerne-barrieren, og kan derfor passere til og tilbageholdes i centralnervesystemet.
English: If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Danish: Hvis du har spørgsmål til, hvordan Alecensa virker, eller hvorfor lægen har ordineret denne medicin, skal du spørge lægen, sygeplejersken eller apotekspersonalet.
English: The ADRs 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 <1/1000), very rare (<1/10,000).
Danish: Bivirkningerne i tabel 3 præsenteres efter systemorganklasse og hyppighed, defineret på følgende måde: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100),
English: Grade 2 or Grade 3 (symptomatic, may be severe and medically significant, medical intervention indicated)
Danish: Bradykardia grad 2 eller 3 (symptomatisk, kan være svær og klinisk signifikant; intervention indiceret)
English: M4 has shown similar in vitro potency and activity against ALK.
Danish: M4 har udvist samme in vitro potens og aktivitet mod ALK.
English: In addition, one patient experienced a Grade 4 adverse event of drug-induced liver injury.
Danish: Yderligere oplevede en patient en bivirkning af grad 4 i form af lægemiddelinduceret leverskade.
English: The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity), and not a clastogenic effect on chromosomes.
Danish: Mekanismen bag mikronukleus-induktionen var abnorm kromosomsegregering (aneugenicitet) og ikke en klastogen påvirkning af kromosomer.
English: Based on in vitro data, alectinib is not a substrate of P-gp.
Danish: Baseret på in vitro-data er alectinib ikke et P-gp-substrat.
English: Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
Danish: Obstipation (35%), kvalme (19%), diarré (16%) og opkastning (11%) var de hyppigst rapporterede gastrointestinale bivirkninger.
English: ● The active substance is alectinib.
Danish: ● Aktivt stof: alectinib.
English: Based on a population PK analysis, the apparent clearance (CL/F) of alectinib was 81.9 L/hour.
Danish: Baseret på en farmakokinetisk populationsanalyse var alectinibs tilsyneladende clearance (CL/F) 81,9 l/time.
English: Name and address of the manufacturer(s) responsible for batch release Roche Pharma AG
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Roche Pharma AG
English: These include:
Danish: Det drejer sig om:
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products.
Danish: Evaluér samtidig behandling med lægemidler, der vides at forårsage bradykardi, samt antihypertensiva.
English: The limited data on the safety and efficacy of Alecensa 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 vedrørende Alecensas sikkerhed og virkning hos patienter på 65 år og derover tyder ikke på, at dosisjustering er nødvendig hos ældre patienter (se pkt.
English: There were no fatal cases of ILD in any of the clinical trials.
Danish: Der var ingen dødelige tilfælde af interstitiel lungesygdom i de kliniske studier.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan påvirke op til 1 ud af 10 patienter)
English: HDPE bottle with a child-resistant closure and an integrated desiccant.
Danish: HDPE beholder med børnesikret lukning og et integreret tørremiddel.
English: Carcinogenicity Carcinogenicity studies have not been performed to establish the carcinogenic potential of Alecensa.
Danish: Der er ikke gennemført karcinogenicitetsstudier med henblik på at undersøge Alecensas karcinogene potentiale.
English: Glyceryl monooleate
Danish: Glycerylmonooleat
English: The demographic characteristics of the overall study population were 67% Caucasian, 26% Asian, 56% females, and the median age was 52 years.
Danish: De demografiske karakteristika for den samlede studiepopulation var 67% kaukasere, 26% asiater og 56% kvinder; medianalderen var 52 år.
English: No fertility studies in animals have been performed to evaluate the effect of Alecensa.
Danish: Der er ikke udført fertilitetsstudier hos dyr med henblik på at evaluere effekten af Alecensa.
English: They must be taken with food (see section 5.2).
Danish: De skal tages i forbindelse med et måltid (se pkt.
English: Multiple doses of 600 mg alectinib had no influence on the exposure of midazolam (2 mg), a sensitive CYP3A substrate.
Danish: Gentagne doser af alectinib 600 mg påvirkede ikke eksponeringen af midazolam (2 mg), et følsomt CYP3A-substrat.
English: Metabolite M1b was detected as a minor metabolite from in vitro and in human plasma in healthy subjects.
Danish: Metabolitten M1b er detekteret som en mindre væsentlig metabolit in vitro og i plasma hos raske frivillige.
English: Liver function, including ALT, AST, and total bilirubin should be monitored at baseline and then every 2 weeks during the first 3 months of treatment.
Danish: Leverfunktion, inklusive ALAT, ASAT og total-bilirubin, bør bestemmes ved baseline og monitoreres hver 2. uge i løbet af de første 3 behandlingsmåneder.
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, proteinkinasehæmmere; ATC-kode: L01XE36.
English: You should use caution when drinking grapefruit juice or eating grapefruit or Seville oranges while on treatment with Alecensa as they may change the amount of Alecensa in your body.
Danish: Du skal være forsigtig med at drikke grapefrugtjuice eller spise grapefrugt eller pomerans, mens du er i behandlig med Alecensa, eftersom disse fødevarer kan påvirke mængden af Alecensa i din krop.
English: Patients should be monitored for pulmonary symptoms indicative of pneumonitis.
Danish: Patienterne skal monitoreres for pulmonale symptomer, der er indikative for pneumonitis.
English: Formation of metabolite M1b and its minor isomer M1a is likely to be catalyzed by a combination of CYP isozymes (including isozymes other than CYP3A) and aldehyde dehydrogenase (ALDH) enzymes.
Danish: Dannelse af M1b-metabolitten og dens mindre væsentlige M1a-isomer katalyseres sandsynligvis af en kombination af CYP-isozymer (også andre isozymer end CYP3A) og aldehyddehydrogenase (ALDH)-enzymer.
English: (range 0.3 - 27.0)
Danish: (interval 0,3 - 27,0)
English: Do not give this medicine to children or adolescents under the age of 18 years.
Danish: Børn og unge under 18 år må ikke få dette lægemiddel.
English: INFORMATION IN BRAILLE alecensa
Danish: INFORMATION I BRAILLESKRIFT alecensa
English: A risk for induction of CYP2B6 and PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Danish: Risiko for induktion af CYP2B6 og pregnan X-receptor (PXR)-regulerede enzymer ud over CYP3A4 kan ikke fuldstændigt udelukkes.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: Severe myalgia has not been reported in the clinical trial BO28984.
Danish: Svær myalgi er ikke rapporteret i det kliniske studie BO28984.
English: ● If you become pregnant when taking the medicine or during the 3 months after taking your last dose, tell your doctor straight away.
Danish: ● Hvis du bliver gravid, mens du tager dette lægemiddel eller inden for 3 måneder efter, du har afsluttet behandlingen, skal du straks kontakte lægen.
English: ● everolimus, a medicine used to treat certain types of cancer or used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Danish: ● everolimus, medicin mod bestemte typer kræft eller for at forebygge, at kroppens immunsystem afstøder en transplanteret nyre, hjerte eller lever
English: Patients should also be advised to use a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sun screen and lip balm (SPF ≥50) to help protect against potential sunburn.
Danish: Patienterne skal også opfordres til at bruge bredspektret UVA/UVB (ultraviolet A/ultraviolet B) solfaktor og læbepomade (SPF ≥50) for at beskytte mod solskoldning.
English: These patients were treated with the recommended dose of 600 mg twice daily.
Danish: Patienterne blev behandlet med den anbefalede dosis på 600 mg to gange dagligt.
English: In addition to crizotinib, patients may have received previous treatment with chemotherapy.
Danish: Udover crizotinib kunne patienterne tidligere have været behandlet med kemoterapi.
English: The signs may be similar to those from your lung cancer.
Danish: Symptomerne kan være de samme som for lungekræften.
English: Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Danish: Alectinib absorberer UV-lys mellem 200 og 400 nm og har udvist fototoksisk potentiale i en in vitro lyssikkerhedstest efter UVA-bestråling af dyrkede musefibroblaster.
English: Management of adverse events may require dose reduction, temporary interruption, or discontinuation of treatment with Alecensa.
Danish: Håndtering af bivirkninger kan nødvendiggøre dosisreduktion, midlertidig behandlingsafbrydelse eller seponering af Alecensa.
English: Alectinib and its major metabolite M4 are highly bound to human plasma proteins (>99%), independent of active substance concentration.
Danish: Alectinib og den vigtigste metabolit M4 bindes i udstrakt grad til humane plasmaproteiner (>99%), uafhængigt af koncentrationen af det aktive stof.
English: Patients should be advised to report any unexplained muscle pain, tenderness, or weakness.
Danish: Patienterne bør informeres om, at de skal rapportere enhver form for uforklarlige muskelsmerter, muskelømhed eller muskelsvaghed.
English: Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Danish: Dosisjustering er derfor ikke nødvendig, når Alecensa administreres sammen med protonpumpehæmmere eller andre lægemidler, som øger gastrisk pH (fx H2-receptorantagonister eller antacida).
English: In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
Danish: I prækliniske studier har hæmning af ALK-tyrosinkinase-aktivitet medført blokering af de efterfølgende signalveje, inklusive STAT 3 og PI3K/AKT og induktion af tumorcelledød (apoptose).
English: ● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
Danish: ● besvimelse, svimmelhed og lavt blodtryk (kan være tegn på langsom hjerterytme)
English: ● blurred vision, loss of sight, black dots or white spots in your vision, and seeing double (problems with your eyes)
Danish: ● sløret syn, synstab, sorte eller hvide pletter for øjnene og dobbeltsyn (øjenproblemer)
English: Baseline demographic and disease characteristics for Alecensa were median age 58 years (54 years for crizotinib), 55% female (58% for crizotinib), 55% non-Asian (54% for crizotinib), 61% with no smoking history (65% for crizotinib), 93% ECOG PS of 0 or 1 (93% for crizotinib), 97% Stage IV disease (96% for crizotinib), 90% adenocarcinoma histology (94% for crizotinib), 40% CNS metastases at baseline (38% for crizotinib) and 17% having received prior CNS radiation (14% for crizotinib).
Danish: Baseline-demografi og sygdomskarakteristika for Alecensa var medianalder på 58 år (54 år for crizotinib), 55% kvinder (58% for crizotinib), 55% ikke-asiatiske (54% for crizotinib), 61% der aldrig havde røget (65% for crizotinib), 93% med ECOG PS 0 eller 1 (93% for crizotinib), 97% med stadie IV-sygdom (96% for crizotinib), 90% med adenocarcinomhistologi (94% for crizotinib), 40% med CNS-metastaser ved baseline (38% for crizotinib) og 17% som tidligere havde fået CNS-strålebehandling (14% for crizotinib).
English: These studies were conducted in rats and monkeys at exposures equal to or greater than 2.6- and 0.5-fold, respectively, of the human exposure, measured by AUC, at the recommended dose of 600 mg twice daily.
Danish: Disse studier er udført med rotter og aber eksponeret for doser svarende til eller højere end henholdsvis 2,6 og 0,5 gange den humane eksponering, målt ved AUC, ved den anbefalede dosis på 600 mg 2 gange dagligt.
English: (range 1 - 30)
Danish: (interval 1-30)
English: System organ class ADRs (MedDRA)
Danish: Systemorganklasse Bivirkninger (MedDRA)
English: Results from the human mass balance study demonstrated that alectinib and M4 were the main circulating moieties in plasma with 76% of the total radioactivity in plasma.
Danish: Resultater fra et humant massebalancestudie har vist, at alectinib og M4 er de vigtigste cirkulerende lægemiddeldele i plasma; de redegør for ca. 76% af den totale radioaktivitet i plasma.
English: CPK levels should be assessed every two weeks for the first month of treatment and as clinically indicated in patients reporting symptoms.
Danish: Kreatinkinase bør monitoreres hver 2. uge under den første måneds behandling og derefter som klinisk indiceret hos patienter, der rapporterer symptomer.
English: The events declined in frequency after the first month of treatment.
Danish: Frekvensen af disse bivirkninger faldt efter den første måneds behandling.
English: Study NP28761
Danish: Studie NP28761
English: Immediately interrupt and permanently discontinue Alecensa if no other potential causes of ILD/pneumonitis have been identified.
Danish: Afbryd straks behandlingen og seponér Alecensa permanent, hvis der ikke identificeres anden potentiel årsag til ILD/pneumonitis.
English: A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
Danish: En let hypotensiv effekt er observeret hos aber ved eksponeringer nogenlunde svarende til den klinisk relevante eksponering.
English: Alectinib demonstrated in vitro and in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.
Danish: Alectinib har udvist in vitro og in vivo aktivitet mod muterede former af ALK-enzymet, inklusive de mutationer, der forårsager resistens over for crizotinib.
English: This is because it is not known if Alecensa can pass over into breast milk and could therefore harm your baby.
Danish: Det vides ikke, om Alecensa udskilles i mælken og derfor kan skade barnet.
English: Dose modification is not required in case of asymptomatic bradycardia (see section 4.2).
Danish: Dosisjustering er ikke nødvendig ved asymptomatisk bradykardi (se pkt.
English: Efficacy data are summarised in Table 4 and the Kaplan-Meier curve for investigator assessed PFS is shown in Figure 1.
Danish: Effektdata opsummeres i Tabel 4 og Kaplan-Meier-kurven for progressionsfri overlevelse vurderet af investigator er vist i Figur
English: Alectinib and M4 are not substrates of BCRP or organic anion-transporting polypeptide (OATP) 1B1/B3.
Danish: Alectinib og M4 er ikke BCRP-substrater eller substrater for organisk anion-transporterende polypeptid (OATP) 1B1/B3.
English: This is because Alecensa can affect the way some other medicines work.
Danish: Det er vigtigt, fordi Alecensa kan påvirke andre lægemidlers virkning, og fordi andre lægemidler kan påvirke, hvordan Alecensa virker.
English: Female patients, who become pregnant while taking Alecensa or during the 3 months following the last dose of Alecensa must contact their doctor and should be advised of the potential harm to the foetus.
Danish: Kvindelige patienter, som bliver gravide under behandling med Alecensa eller inden for 3 måneder efter sidste dosis Alecensa, skal kontakte lægen og bør informeres om den potentielle risiko for fostret.
English: Alecensa contains lactose (a type of sugar).
Danish: Alecensa indeholder lactose (en sukkerart).
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid medicinen nøjagtigt efter lægens eller apotekspersonalet anvisning.
English: ECOG PS (0/1 vs. 2), race (Asian vs. non-Asian), and CNS metastases at baseline (yes vs. no) were stratification factors for randomisation.
Danish: Stratifikationsfaktorer for randomisering var ECOG PS (0/1 vs. 2), race (asiatisk vs. ikke-asiatisk) og CNS-metastaser ved baseline (ja vs. nej).
English: The ECOG (Eastern Cooperative Oncology Group) performance status at baseline was 0 or 1 in 90.6% of patients and 2 in 9.4% of patients.
Danish: Patienternes ECOG- performancestatus (Eastern Cooperative Oncology Group) ved baseline var 0 eller 1 hos 90,6% af patienterne og 2 hos 9,4% af patienterne.
English: Alecensa may cause foetal harm when administered to a pregnant woman.
Danish: Alecensa kan skade fostret, hvis det administreres til en gravid kvinde.
English: The geometric mean volume of distribution at steady state (Vss) of alectinib following IV administration was 475 L, indicating extensive distribution into tissues.
Danish: Det geometrisk gennemsnitlige fordelingsvolumen ved steady state (Vss) for alectinib efter i.v.administration er 475 l, hvilket indikerer udtalt vævsfordeling.
English: ● Do not breast-feed while taking this medicine.
Danish: ● Du må ikke amme, mens du tager dette lægemiddel.
English: ● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
Danish: ● unormale resultater af blodprøver til vurdering af leverfunktionen (højt niveau af alanin aminotransferase, aspartat-aminotransferase og bilirubin)
English: What Alecensa is Alecensa is a cancer medicine that contains the active substance alectinib.
Danish: Alecensa er medicin mod kræft og indeholder det aktive indholdsstof alectinib.
English: 56 hard capsules
Danish: 56 hårde kapsler.
English: ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Danish: De objektive responsrater i studierne NP28673 og NP28761 var konsistente på tværs af subgrupper med hensyn til patienternes baseline-karakteristika som alder, køn, race, ECOG-performancestatus, metastaser i centralnervesystemet (CNS) og tidligere behandling med kemoterapi, særligt når man tager det lille antal patienter i nogle subgrupper i betragtning.
English: This is to check you do not have any liver or muscle problems while taking Alecensa.
Danish: Det er for at kontrollere, at du ikke får lever- eller muskelproblemer, mens du tager Alecensa.
English: The ECOG performance status at baseline was 0 or 1 in 89.7% of patients and 2 in 10.3% of patients.
Danish: Patienternes ECOG- performancestatus ved baseline var 0 eller 1 hos 89,7% af patienterne og 2 hos 10,3% af patienterne.
English: This medicinal product contains 48 mg sodium per daily dose (1200 mg), equivalent to 2.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 48 mg natrium per daglig dosis (1200 mg), svarende til 2,4% af den anbefalede WHO maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana anti-ALK (D5F3) immunohistochemistry (IHC) was required before randomisation into the study.
Danish: Patienterne skulle have positiv central vævsprøvetest for ALK-proteinekspression ved Ventana anti-ALK (D5F3) immunhistokemi (IHC), inden de kunne randomiseres i studiet.
English: ● This means you take a total of 8 capsules (1200 mg) each day.
Danish: ● Det betyder, at du i alt skal tage 8 kapsler (1200 mg) hver dag.
English: The events generally occurred during the first 3 months of treatment, were usually transient and resolved upon temporary interruption of Alecensa treatment (reported for 1.5% and 3.0% of the patients, respectively) or dose reduction (2.2% and 1.2%, respectively).
Danish: Bivirkningerne opstod som regel inden for de første 3 behandlingsmåneder, var oftest forbigående og forsvandt ved midlertidig afbrydelse af Alecensa-behandlingen (rapporteret for henholdsvis 1,5% og 3,0% af patienterne) eller dosisreduktion
English: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CPK = creatine phosphokinase; CTCAE = NCI Common Terminology Criteria for Adverse Events; ILD = interstitial lung disease; ULN = upper limit of normal a
Danish: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CK = kreatinkinase; CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events; ILD = interstitiel lungesygdom.
English: The mean in vitro human blood-to-plasma concentration ratios of alectinib and M4 are 2.64 and 2.50, respectively, at clinically relevant concentrations.
Danish: Gennemsnitlig in vitro humant blod:plasmakoncentrationsratio for alectinib og M4 er henholdsvis 2,64 og 2,50 ved klinisk relevante koncentrationer.
English: 224 (4 packs of 56) hard capsules
Danish: 224 (4 pakker a 56) hårde kapsler
English: Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.
Danish: Alecensa skal seponeres permanent, hvis patienten ikke tåler en dosis på 300 mg 2 gange dagligt.
English: The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability.
Danish: Alecensa-dosis reduceres i trin af 150 mg 2 gange dagligt afhængigt af tolerabilitet.
English: The absolute bioavailability of alectinib capsules was 36.9% (90% CI: 33.9%, 40.3%) under fed conditions in healthy subjects.
Danish: Den absolutte biotilgængelighed af alectinib-kapsler, taget i forbindelse med et måltid, var 36,9% (90% konfidensinterval: 33,9%; 40,3%) hos raske frivillige.
English: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på En hård kapsel indeholder 33,7 mg lactose (som monohydrat) og 6 mg natrium (som natriumlaurilsulfat).
English: ● Do not take this medicine after the expiry date which is stated on the carton and either the blister or the bottle after EXP.
Danish: ● Brug ikke lægemidlet efter den udløbsdato, der står på ydre emballage og enten på blisterkort eller beholder efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Population PK analysis supports dose proportionality for alectinib across the dose range of 300 to 900 mg under fed conditions.
Danish: En farmakokinetisk populationsanalyse understøtter dosisproportionalitet for alectinib ved doser på 300-900 mg administreret i forbindelse med et måltid.
English: Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
Danish: Du skal være særlig opmærksom, når du fører motorkøretøj eller bruger maskiner, da du kan få problemer med synet eller langsom hjerterytme eller lavt blodtryk, der kan være forbundet med besvimelse eller svimmelhed, mens du er i behandling med Alecensa.