FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver function tests including ALT, AST, and total bilirubin should be monitored once a week during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3 or 4 elevations.
Danish: Leverfunktionsundersøgelse, herunder test for ALAT, ASAT- og bilirubinstigninger, skal udføres hver uge de første 2 behandlingsmåneder, og derefter 1 gang om måneden samt hvis det er klinisk nødvendigt, med hyppigere undersøgelser ved grad 2, 3 eller 4 stigninger.
English: In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations.
Danish: In vitro er crizotinib ikke en hæmmer af galdesalt-eksportpumpen (BSEP) ved klinisk relevante koncentrationer.
English: An accurate and validated assay for either ALK or ROS1 is necessary for the selection of patients for treatment with XALKORI (see section 5.1 for information on assays used in the trials).
Danish: En præcis og valideret test for enten ALK eller ROS1 er vigtig for selektion af patienter til XALKORI-behandling (se pkt.
English: Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Danish: De patientrapporterede symptomer og den generelle livskvalitet (QoL) blev indsamlet ved hjælp af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13).
English: All upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec.
Danish: Alle øvre grænser for 90% CI for LS middelændring af QTcF fra baseline på alle tidspunkter på dag 1 i cyklus 2 var <20 ms.
English: Withhold if ILD/pneumonitis is suspected, and permanently discontinue if treatment-related ILD/pneumonitis is diagnosedd
Danish: Hold pause ved mistanke om ILD/pneumonitis, og seponer permanent, hvis behandlingsrelateret ILD/pneumonitis diagnosticeres
English: In patients with new onset of Grade 4 visual loss, crizotinib treatment should be discontinued and ophthalmological evaluation should be performed.
Danish: Hos patienter med nyligt opstået grad 4 synstab bør behandlingen med crizotinib seponeres, og der skal udføres en oftalmologisk undersøgelse.
English: Drug-induced ILD/pneumonitis should be considered in the differential diagnosis of patients with ILD-like conditions such as: pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome (ARDS), alveolitis, lung infiltration, pneumonia, pulmonary oedema, chronic obstructive pulmonary disease, pleural effusion, aspiration pneumonia, bronchitis, obliterative bronchiolitis, and bronchiectasis.
Danish: Lægemiddelinduceret ILD/pneumonitis bør overvejes som differentialdiagnose hos patienter med ILD-lignende tilstande såsom pneumonitis, strålepneumonitis, allergisk alveolitis, interstitiel pneumonitis, lungefibrose, akut respiratorisk distress-syndrom (ARDS), alveolitis, lungeinfiltration, pneumoni, lungeødemer, kronisk obstruktiv lungesygdom, pleuraeffusion, aspirationspneumoni, bronkitis, bronchiolitis obliterans og bronkiektase.
English: Crizotinib should be used with caution in patients at risk for gastrointestinal perforation (e.g., history of diverticulitis, metastases to the gastrointestinal tract, concomitant use of medicinal products with a recognized risk of gastrointestinal perforation).
Danish: Crizotinib bør anvendes med forsigtighed hos patienter, der har risiko for gastrointestinal perforation (fx divertikulitis i anamnesen, metastaser i mave-tarm-kanalen, samtidig brug af lægemidler med en kendt risiko for gastrointestinal perforation).
English: The antitumour efficacy of crizotinib was dose-dependent and correlated to pharmacodynamic inhibition of phosphorylation of ALK fusion proteins (including EML4-ALK and NPM-ALK) in tumours in vivo.
Danish: Anti-tumorvirkningen af crizotinib er dosisafhængig og korrelerer til farmakodynamisk hæmning af fosforyleringen af ALK-fusionsproteiner (herunder EML4-ALK og NPM-ALK) i tumorer in vivo.
English: QT prolongation may clinically manifest as bradycardia, dizziness, and syncope.
Danish: QT-forlængelse kan manifestere sig klinisk som bradykardi, svimmelhed og synkope.
English: b. Three patients were not evaluable for response in Study 1001, and 42 patients were not evaluable for response in Study 1005. c. Estimated using the Kaplan-Meier method.
Danish: Tre patienter kunne ikke evalueres med hensyn til respons i studie 1001, og 42 patienter kunne ikke evalueres med hensyn til respons i studie 1005.
English: Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
Danish: Symptomatisk, kan være alvorlig og klinisk signifikant, medicinsk intervention er indiceret
English: The central tendency analysis indicated that all upper limits of the 90% CI for the LS mean change from Baseline in QTcF at all Cycle 2 Day 1 time points were <20 msec. A pharmacokinetic/pharmacodynamic analysis suggested a relationship between crizotinib plasma concentration and QTc.
Danish: Den centrale tendensanalyse indikerede, at alle øvre grænser for 90% CI for middelændringen (beregnet efter mindste kvadraters metode LS) i QTcF fra baseline ved alle målepunkter på dag 1 i cyklus 2 var <20 ms. En farmakokinetisk/farmakodynamisk analyse antyder en sammenhæng mellem crizotinibs plasmakoncentration og QTc.
English: g. Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
Danish: g. Baseret på den stratificerede Cochran-Mantel-Haenszel-test (2-sidet).
English: • Phenytoin, carbamazepine or phenobarbital, anti-epileptics used to treat seizures or fits.
Danish: • Phenytoin, carbamazepin eller phenobarbital, medicin mod epileptiske kramper eller anfald.
English: • Efavirenz, raltegravir, used to treat HIV infection.
Danish: • Efavirenz, raltegravir til behandling af hiv-infektion.
English: Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and <1% of patients, respectively.
Danish: Dosis blev reduceret, eller behandlingen seponeret permanent på grund af neutropeni hos henholdsvis 3% og <1% af patienterne.
English: e. Vision disorder (Diplopia, Halo vision, Photophobia, Photopsia, Vision blurred, Visual acuity reduced, Visual brightness, Visual impairment, Visual perseveration, Vitreous floaters).
Danish: e) Synsforstyrrelser (diplopi, halo-syn, fotofobi, fotopsi, sløret syn, nedsat synsskarphed, visuel lysintensitet, nedsat syn, visuel perseveration, ”flyvende fluer”).
English: The antitumour efficacy of crizotinib was dose-dependent and demonstrated a correlation with inhibition of ROS1 phosphorylation in vivo.
Danish: Crizotinibs antitumoreffektivitet var dosisafhængig og udviste korrelation med in vivo hæmning af ROS1-fosforylering.
English: • Alfentanil and other short acting opiates such as fentanyl (painkillers used for surgical procedures).
Danish: • Alfentanil og anden korttidsvirkende stærk smertestillende medicin som fx fentanyl (anvendes under operation).
English: Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Danish: Andre mulige årsager til ILD/pneumonitis skal udelukkes, og crizotinib skal seponeres permanent hos patienter, som diagnosticeres med behandlingsrelateret ILD/pneumonitis (se pkt.
English: Each carton contains 60 hard capsules.
Danish: Hver æske indeholder 60 hårde kapsler.
English: According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 (<1%) patients with fatal cases.
Danish: Ifølge en uafhængig undersøgelseskomités (IRC) vurdering af patienter med ALK-positiv NSCLC (N=1.669) havde 20 (1,2%) af patienterne ILD/pneumonitis, herunder 10 (<1%) med dødelig udgang.
English: Crizotinib is an inhibitor of P-glycoprotein (P-gp) in vitro.
Danish: Crizotinib hæmmer P-glykoprotein (P-gp) in vitro.
English: N=154e
Danish: N=154
English: Crizotinib demonstrated antitumour efficacy, including marked cytoreductive antitumour activity, in mice bearing tumour xenografts that expressed ALK fusion proteins.
Danish: Crizotinib viser antitumoreffekt, inklusive udpræget cytoreduktiv antitumor-aktivitet, i mus som er bærere af tumor-xenografter, som udtrykker ALK-fusionsproteiner.
English: • Methadone, used to treat pain and for the treatment of opioid dependence.
Danish: • Methadon, til behandling af smerter og til behandling af misbrug.
English: There was one ALK-positive patient >85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
Danish: Der var én ALK-positiv patient >85 år ud af 154 patienter i enkeltarmsstudiet 1001 (se også pkt.
English: The crizotinib starting dose should be adjusted to 250 mg taken orally once daily in patients with severe renal impairment not requiring peritoneal dialysis or haemodialysis.
Danish: Startdosis bør justeres til 250 mg oralt 1 gang dagligt hos patienter med svært nedsat nyrefunktion, som ikke kræver peritonealdialyse eller hæmodialyse.
English: Following the administration of a single 250 mg radiolabeled crizotinib dose to healthy subjects, 63% and 22% of the administered dose was recovered in faeces and urine, respectively.
Danish: Efter administration af en radioaktivt mærket enkeltdosis på 250 mg crizotinib til raske forsøgspersoner, blev der genfundet henholdsvis 63% og 22% af den administrerede dosis i fæces og i urin.
English: • Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
Danish: • Forhøjede indhold af enzymet alkalisk fosfatase i blodet (det kan tyde på et dårligt fungerende eller beskadiget organ, såsom lever, bugspytkirtel, knogle, skjoldbruskkirtel eller galdeblære).
English: In rat and dog repeat-dose toxicity studies up to 3-month duration, the primary target organ effects were related to the gastrointestinal (emesis, faecal changes, congestion), haematopoietic (bone marrow hypocellularity), cardiovascular (mixed ion channel blocker, decreased heart rate and blood pressure, increased LVEDP, QRS and PR intervals, and decreased myocardial contractility), or reproductive (testicular pachytene spermatocyte degeneration, single-cell necrosis of ovarian follicles) systems.
Danish: I repeat-dose toksicitetsstudier i rotter og hunde af op til 3 måneders varighed var de primært påvirkede organer relateret til følgende organsystemer mave-tarmkanal (kvalme, fæcesændringer, obstipation), hæmatopoietisk (knoglemarvshypocellularitet), kardiovaskulær (blandede ionkanalblokkere, nedsat hjerterytme og blodtryk, forøgede LVEDP, QRS og PR-intervaller og nedsat myokardiekontraktion), eller reproduktive (degenerering af spermatocytter i testis, enkeltcellenekrose i ovariefollikler).
English: No starting dose adjustment is recommended for patients with mild hepatic impairment.
Danish: Det er ikke nødvendigt at justere startdosis hos patienter med let nedsat leverfunktion.
English: Objective Response Rate (Based on IRR) Objective Response Rate % (95% CI)
Danish: Objektiv responsrate (baseret på IRR) Objektiv response rate % (95% CI)
English: In Study 1014, the median duration of study treatment was 47 weeks for patients in the crizotinib arm (N=171); the median duration of treatment was 23 weeks for patients who crossed over from the chemotherapy arm to receive crizotinib treatment (N=109).
Danish: I studie 1014 var den mediane varighed af studiebehandlingen 47 uger for patienter i crizotinib-armen (N=171); den mediane behandlingsvarighed var 23 uger for patienter, der overgik fra kemoterapi-armen til at få crizotinibbehandling (N=109).
English: If you stop taking XALKORI
Danish: Hvis du holder op med at tage XALKORI
English: The median duration of treatment was 22.4 months (95% CI: 15.0, 35.9).
Danish: Den mediane behandlingsvarighed var 22,4 måneder (95% CI: 15,0; 35,9).
English: Blood creatinine increase and creatinine clearance decreased were observed in patients in clinical studies with crizotinib.
Danish: Der blev observeret stigning af blod-kreatinin og nedsat kreatininclearance hos patienter i kliniske studier med crizotinib.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om XALKORI findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: For ROS1-positive NSCLC patients in Study 1001 (N=53), the median duration of treatment was 101 weeks.
Danish: For ROS1-positive NSCLC-patienter i studie 1001 (N=53) var den mediane behandlingstid 101 uger.
English: The safety and efficacy of crizotinib in paediatric patients has not been established.
Danish: Pædiatrisk population Crizotinibs sikkerhed og virkning er ikke klarlagt.
English: Efficacy data from Studies 1001 and 1005 are provided in Table 6.
Danish: Effektdata fra studie 1001 og 1005 ses i skema 6.
English: Efficacy data from Study 1007 are summarised in Table 5, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Danish: Effektdata fra det randomiserede fase 3-studie 1007 er sammenfattet i skema 5, og Kaplan-Meierkurverne for PFS og samlet (OS) er vist i henholdsvis figur 4 og 5.
English: Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13) at baseline (Day 1 Cycle 1) and Day 1 of each subsequent treatment cycle.
Danish: De patientrapporterede symptomer og den generelle livskvalitet blev indsamlet ved hjælp af EORTC QLQ-C30 og dets lungecancermodul (EORTC QLQ-LC13) ved baseline (dag 1, cyklus 1) og dag 1 i hver af de efterfølgende behandlingscyklusser.
English: Patients received crizotinib 250 mg orally twice daily.
Danish: Patienterne fik crizotinib 250 mg oralt to gange dagligt.
English: If you experience any side effects, talk to your doctor, pharmacist, or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma.
Danish: Den geometriske gennemsnitsværdi af distributionsvolumen ved steady state (Vdss) er 1772 liter ved infusion af en dosis på 50 mg, hvilket tyder på udtalt fordeling fra plasma in i vævene.
English: Capsule content: colloidal anhydrous silica, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate.
Danish: Kapselindhold: kolloid vandfri silica, mikrokrystallinsk cellulose, vandfrit calciumhydrogenphosphat, natriumstivelsesglycolat (type A), magnesiumstearat.
English: Renal failure and acute renal failure were reported in patients treated with crizotinib in clinical trials and during post marketing.
Danish: Der blev indberettet nyresvigt og akut nyresvigt hos patienter, som blev behandlet med crizotinib i kliniske studier og efter markedsføring.
English: Grade 4 Ocular Disorder (Visual Loss)
Danish: Grad 4 Øjne (synstab)
English: The median OS at the time of data cutoff was 51.4 months (95% CI: 29.3, NR).
Danish: Median OS på tidspunktet for data cutoff var 51,4 måneder (95% CI: 29,3; NR).
English: In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
Danish: In vitro studier tyder på at crizotinib er substrat for P-glykoprotein (P-gp).
English: Patients could continue crizotinib treatment beyond the time of Response Evaluation Criteria in Solid Tumours (RECIST)-defined disease progression at the discretion of the investigator if the patient was still experiencing clinical benefit.
Danish: Patienterne kunne fortsætte crizotinibbehandlingen efter sygdomsprogression som defineret i Response Evaluation Criteria in Solid Tumours (RECIST), hvis patienten fortsat havde klinisk gavn af behandlingen, og det var i overensstemmelse med investigators skøn.
English: b. Anaemia (Anaemia, Haemoglobin decreased, Hypochromic anaemia).
Danish: b) Anæmi (anæmi, nedsat hæmoglobin, hypokrom anæmi).
English: When using crizotinib, ECG and electrolytes (e.g., calcium, magnesium, potassium) should be obtained as close as possible prior to the first dose and periodic monitoring with ECGs and electrolytes is recommended, especially at the beginning of treatment in case of vomiting, diarrhoea, dehydration or impaired renal function.
Danish: Det anbefales, at patienterne får taget ekg og målt elektrolytter (fx calcium, magnesium og kalium) så sent som muligt inden den første dosis og periodisk monitoreres for elektrolytter og får taget ekg især i starten af behandlingen i tilfælde af opkastning, diarré, dehydrering eller nedsat nyrefunktion.
English: Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Danish: Hos 14 (36,8%) af de 30 patienter blev der rapporteret en okulær abnormitet af en eller anden type, og hos 16 (42,1%) patienter var der ingen okulære fund.
English: Crizotinib significantly prolonged PFS, the primary objective of the study, compared to chemotherapy as assessed by IRR.
Danish: Crizotinib forlængede PFS signifikant, som var det primære studieendepunkt, sammenlignet med kemoterapi efter vurdering ved IRR.
English: Progression-Free Survival (Based on IRR) Number with event, n (%) Type of event, n (%) Progressive Disease Death without objective progression Median PFS in months (95% CI)
Danish: Progressionsfri overlevelse (baseret på IRR) Antal med hændelse, n (%) Hændelsestype, n (%) Progredierende sygdom Dødsfald uden objektiv progression Median PFS i måneder (95% CI)
English: Titanium dioxide (E171) Red iron oxide (E172)
Danish: Titadioxid (E171) Rød jernoxid (E172)
English: Therefore, clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the hepatic or renal uptake of medicinal products that are substrates for these transporters.
Danish: Det er derfor ikke sandsynligt, at der vil være kliniske interaktioner som følge af crizotinib-medieret hæmning af leverens eller nyrernes elimination af lægemidler, som er substrat for disse transportproteiner.
English: If you accidentally take too many capsules, tell your doctor or pharmacist right away.
Danish: Hvis du har taget for mange kapsler, skal du omgående kontakte lægen eller skadestuen.
English: The dose may be increased to 200 mg twice daily based on individual safety and tolerability after at least 4 weeks of treatment (see sections 4.4 and 5.2).
Danish: Afhængigt af individuel sikkerhed og tolerabilitet kan dosis eventuelt øges til 200 mg 2 gange dagligt efter mindst 4 ugers behandling (se pkt.
English: Therefore, administration of crizotinib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.
Danish: Derfor kan samtidig administration af crizotinib og lægemidler, som er substrat for P-pg (fx digoxin, dabigatran, colchicin, pravastatin), medføre øget virkning og øgede bivirkninger af disse lægemidler.
English: Post-implantation loss was increased at doses ≥50 mg/kg/day (approximately 0.4 times the AUC at the recommended human dose) in rats, and reduced fetal body weights were considered adverse effects in the rat and rabbit at 200 and 60 mg/kg/day, respectively (approximately 1.2-fold human clinical exposure based on AUC).
Danish: Der er set et forøget postimplantationstab ved doser ≥50 mg/kg/dag (ca. 0,4 gange AUC ved anbefalede humane doser) i rotter og nedsat føtalvægt som bivirkning i rotter og kaniner ved henholdsvis 200 og 60 mg/kg/dag (ca. 1,2 gange human klinisk eksponering baseret på AUC).
English: • Reduction in the number of red blood cells (anaemia).
Danish: • Blodmangel (nedsat antal røde blodlegemer).
English: The concomitant use of crizotinib with CYP3A4 substrates with narrow therapeutic indices should be avoided (see section 4.5).
Danish: Administration af crizotinib sammen med CYP3A4-substrater med lille terapeutisk indeks bør undgås (se pkt.
English: All-causality adverse events associated with permanent treatment discontinuation occurred in 302 (18%) patients of which the most frequent (≥1%) were interstitial lung disease (1%) and elevated transaminases (1%).
Danish: Permanent seponering på grund af bivirkninger uanset kausalitet forekom hos 302 (18%) patienter, hvoraf de hyppigste (≥1%) var interstitiel lungesygdom (1%) og aminotransferasestigning (1%).
English: • First dose reduction: XALKORI 200 mg taken orally twice daily
Danish: • Første dosisreduktion: XALKORI 200 mg oralt 2 gange dagligt
English: Administration of a single 250 mg crizotinib dose following treatment with esomeprazole 40 mg once daily for 5 days resulted in an approximately 10% decrease in crizotinib total exposure (AUCinf) and no change in peak exposure (Cmax); the extent of the change in total exposure was not clinically meaningful.
Danish: Administration af en enkelt dosis på 250 mg crizotinib efter behandling med 40 mg esomeprazol en gang dagligt i 5 dage resulterede i et fald på ca. 10% i den samlede crizotinib-eksponering (AUCinf) og ingen ændring i den maksimale eksponering (Cmax).
English: Avoid using crizotinib in combination with other bradycardic agents (e.g., beta-blockers, non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, clonidine, digoxin) to the extent possible, due to the increased risk of symptomatic bradycardia.
Danish: Undgå så vidt det er muligt at bruge crizotinib i kombination med andre lægemidler, der kan give bradykardi (fx beta-blokkere, non-dihydropyridin calciumantagonister såsom verapamil og diltiazem, clonidin, digoxin), på grund af den øgede risiko for symptomatisk bradykardi.
English: • The recommended dose is one capsule of 250 mg taken orally twice daily (total amount
Danish: • Den anbefalede dosis er 1 kapsel på 250 mg, som synkes 2 gange dagligt (i alt 500 mg).
English: The full analysis population included 347 patients with ALK-positive advanced NSCLC as identified by FISH prior to randomisation.
Danish: I den samlede analysepopulation indgik 347 patienter med ALK-positiv fremskreden NSCLC, som var diagnosticeret med FISH inden randomiseringen.
English: A total of 934 patients with ALK-positive advanced NSCLC were treated with crizotinib in Study 1005 at the time of data cutoff for PFS and ORR analysis.
Danish: I alt 934 patienter med ALK-positiv fremskreden NSCLC var blevet behandlet med crizotinib i studie 1005 på det tidspunkt, hvor data blev opgjort for PFS- og ORR-analysen.
English: In particular, the following medicines may increase the risk of side effects with XALKORI:
Danish: Medicinen nævnt herunder kan især øge risikoen for at få bivirkninger af XALKORI:
English: In vitro studies in human hepatocytes indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated induction of the metabolism of medicinal products that are substrates for CYP1A2.
Danish: In vitro studier i humane hepatocytter antyder, at kliniske lægemiddelinteraktioner som følge af crizotinib-medieret induktion af metaboliseringen af lægemidler, som er substrater for CYP1A2, ikke er sandsynlige.
English: Findings observed in the female reproductive tract included single-cell necrosis of ovarian follicles of a rat given 500 mg/kg/day for 3 days.
Danish: Fund i reproduktionsvejene hos hunrotter er enkeltcellenekrose i ovariefolikler ved doser på 500 mg/kg/dag for 3 dage.
English: h. Cardiac failure (Cardiac failure, Cardiac failure congestive, Ejection fraction decreased, Left ventricular failure, Pulmonary oedema).
Danish: h) Hjertesvigt (hjertesvigt, kronisk venstresidig hjerteinsufficiens, nedsat uddrivningsfraktion, venstre ventrikelsvigt, lungeødem).