FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget annden medicin eller planlægger at tage anden medicin.
English: METHOD OF ADMINISTRATION
Danish: ADMINISTRATIONSMETODE
English: The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a placeboand moxifloxacin-controlled QT trial of 103 healthy volunteers.
Danish: Effekten af umeclidinium 500 mikrogram (afdelt) på QT-intervallet blev vurderet i et placebo- og moxifloxacin-kontrolleret QT-studie hos 103 raske personer.
English: In the event of deterioration of COPD during treatment with umeclidinium bromide, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Forværres KOL under behandlingen med umeclidiniumbromid, skal der foretages en revurdering af patienten og af KOL behandlingsregimet.
English: If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost.
Danish: Hvis inhalatorens beskyttelseshætte åbnes og lukkes, uden at medicinen inhaleres, så vil dosis gå tabt.
English: Use Rolufta Ellipta regularly
Danish: Tag Rolufta Ellipta regelmæssigt
English: Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter.
Danish: Umeclidiniumbromid er et substrat for transportproteinet P-glykoprotein (P-gp).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: 7 doses 30 doses
Danish: 7 doser 30 doser
English: Patients receiving Rolufta Ellipta had a higher percentage of days when no rescue medication was needed (on average 31.1%) compared with placebo (on average 21.7%).
Danish: Patienter, der fik Rolufta Ellipta, havde en højere procentdel af dage uden behov for anfaldsmedicin (gennemsnitligt 31,1 %) sammenlignet med placebo (gennemsnitligt 21,7 %).
English: It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models.
Danish: Umeclidiniumbromid udviser langsom reversibilitet ved undertypen af humane muskarinreceptorer, M3, in vitro og har en langvarig virkning in vivo, når det administreres direkte til lungerne i prækliniske modeller.
English: Pharmacodynamic effects
Danish: Farmakodynamisk virkning
English: If you are not sure what your medicine contains talk to your doctor or pharmacist.
Danish: Hvis du ikke er sikker på, hvad din medicin indeholder, så tal med lægen eller apotekspersonalet.
English: Other medicinal products for COPD
Danish: Andre lægemidler mod KOL
English: Open the cover when ready to take a dose.
Danish: Åbn beskyttelseshætten, når du er klar til at tage en dosis.
English: Each inhaler contains either 7 or 30 doses.
Danish: Hver inhalator indeholder enten 7 eller 30 doser.
English: Reproductive toxicity
Danish: Reproduktionstoksicitet
English: The inhaler is packaged in a tray.
Danish: Inhalatoren er pakket i en bakke.
English: Do not open the tray until you are ready to start using your new inhaler.
Danish: Du må ikke åbne bakken, før du er klar til at begynde at bruge din nye inhalator.
English: Following oral administration to healthy male subjects, total radioactivity was excreted primarily in faeces (92% of the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose.
Danish: Efter oral administration til raske mænd blev den samlede radioaktivitet primært udskilt i fæces (92 % af den administrerede radioaktivt mærkede dosis eller 99 % af genfunden radioaktivitet) 168 timer efter dosering.
English: See ‘Step-by-step instructions for use' in this leaflet for full information.
Danish: Se 'Brugervejledning' i denne indlægsseddel for yderligere oplysninger.
English: Intraocular pressure increased Eye pain
Danish: Øget intraokulært tryk Øjensmerter
English: The tray can be discarded after first opening.
Danish: Bakken kan smides ud efter åbning.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: If possible, show them the inhaler, the package or this leaflet.
Danish: Tag inhalatoren, pakningen eller denne indlægsseddel med, hvis det er muligt.
English: Rolufta Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing.
Danish: Rolufta Ellipta må ikke anvendes til lindring af pludselige anfald af åndenød eller hvæsende vejrtrækning.
English: Eye problems during treatment with Rolufta Ellipta
Danish: Øjenproblemer under behandling med Rolufta Ellipta
English: The European Medicines Agency has waived the obligation to submit the results of studies with Rolufta Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Rolufta Ellipta i alle undergrupper af den pædiatriske population ved indikationen KOL (se pkt.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel til dig personligt.
English: Umeclidinium bromide plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state.
Danish: Halveringstiden for elimination af umeclidiniumbromid i plasma efter dosering via inhalation i 10 dage var i gennemsnit 19 timer hos raske personer, med 3-4 % aktivt stof udskilt uomdannet i urinen ved steady state.
English: Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
Danish: BERLIN-CHEMIE AG Tel: +49 (0) 3067070
English: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Danish: Umeclidiniumbromid er et substrat for cytochrom P450 2D6 (CYP2D6).
English: The short duration of these two studies and limited number of exacerbation events, preclude any conclusion regarding additional effect of Rolufta Ellipta on COPD exacerbation rate.
Danish: Grundet det korte forløb af disse to studier og det begrænsede antal eksacerbationer var det ikke muligt at konkludere, om Rolufta Ellipta havde en additiv effekt på hyppigheden af KOL-eksacerbationer.
English: In vitro studies showed that umeclidinium bromide is principally metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Danish: In vitro-studier viste, at umeclidiniumbromid primært metaboliseres via cytochrom P450 2D6 (CYP2D6) og er et substrat for transportproteinet P-glykoprotein (P-gp).
English: 24-Week Study Treatment difference1 95% Confidence interval p-value
Danish: Studie af 24 ugers varighed Behandlingsforskel1 95 % konfidensinterval p-værdi
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide.
Danish: Der kan ses kardiovaskulære virkninger, såsom hjertearytmier, f.eks. atrieflimren og takykardi, efter administration af muskarinreceptorantagonister, herunder umeclidiniumbromid.
English: Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists or medicinal products containing this active substance has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.
Danish: Samtidig administration af umeclidiniumbromid med andre langtidsvirkende muskarinantagonister eller lægemidler, der indeholder dette aktive stof, er ikke undersøgt og anbefales ikke, da det kan forstærke kendte bivirkninger ved inhalerede muskarinantagonister.
English: Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be lifethreatening.
Danish: Som med andre inhalationsbehandlinger kan administration af umeclidiniumbromid forårsage paradoks bronkospasme, der kan være livstruende.
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered radioactivity) was excreted in faeces by 192 hours post-dose.
Danish: Efter intravenøs administration var ca. 58 % af den administrerede radioaktivt mærkede dosis (eller 73 % af genfunden radioaktivitet) udskilt i fæces 192 timer efter dosering.
English: In a pre- and post-natal study, subcutaneous administration of umeclidinium bromide to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Danish: I et studie af præ- og postnatal udvikling resulterede subkutan administration af umeclidiniumbromid til rotter i lavere vægtstigning og nedsat fødeindtagelse hos moderen, og i let nedsatte kropsvægte hos afkommet inden fravænning ved en dosis på 180 mikrogram/kg/dag (ca. 80 gange human klinisk eksponering over for umeclidinium 55 mikrogram, baseret på AUC).
English: The bronchodilatory effects with Rolufta Ellipta compared with placebo were evident after the first day of treatment in both studies and were maintained over the 12-week and 24-week treatment periods.
Danish: I begge studier var de bronkodilaterende effekter af Rolufta Ellipta sammenlignet med placebo evidente efter den første dag med behandling og blev opretholdt over behandlingsperioderne på 12 uger og 24 uger.
English: Stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma.
Danish: Stop med at tage medicinen og søg omgående lægehjælp, da dette kan være tegn på et akut anfald af snævervinklet grøn stær.
English: A study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium bromide.
Danish: Et studie med personer, der er dårlige til at metabolisere på grund af manglende CYP2D6-aktivitet, viste, at der ikke var en klinisk signifikant effekt af genetisk CYP2D6-polymorfisme på den systemiske eksponering over for umeclidiniumbromid.
English: To use Rolufta Ellipta, you breathe it into your lungs through your mouth using the Ellipta inhaler.
Danish: Rolufta Ellipta tages ved at indånde medicinen ned i dine lunger gennem munden ved hjælp af Ellipta-inhalatoren.
English: Umeclidinium bromide is intended for the maintenance treatment of COPD.
Danish: Umeclidiniumbromid er beregnet til vedligeholdelsesbehandling af KOL.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: Bivirkningernes hyppighed er defineret efter følgende konvention: 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 (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses called sinusitis)
Danish: • følelse af trykken eller smerter i kinderne og panden (kan være tegn på betændelse i bihulerne, kaldet sinuitis)
English: • Difficulty and pain when passing urine - these may be signs of a bladder obstruction or urinary retention
Danish: • besværet og smertefuld vandladning - dette kan være tegn på tilstopning i blæren eller urinretention
English: It is not known whether the ingredients of Rolufta Ellipta can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Rolufta Ellipta går over i modermælken.
English: The excretion of the drug-related material in the faeces following intravenous dosing indicated secretion into the bile.
Danish: Udskillelsen af det lægemiddelrelaterede materiale i fæces efter intravenøs dosering indikerede udskillelse i galden.
English: Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken, bakken og inhalatoren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Frequency
Danish: Hyppighed
English: Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.
Danish: Umeclidiniumbromid bør i overensstemmelse med dets antimuskarine aktivitet anvendes med forsigtighed hos patienter med urinretention eller med snævervinklet glaukom.
English: A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium bromide are similar between COPD patients 65 years and older and those younger than 65 years of age.
Danish: En populationsfarmakokinetisk analyse viste, at farmakokinetikken af umeclidiniumbromid hos KOLpatienter på 65 år og derover svarer til farmakokinetikken hos KOL-patienter under 65 år.
English: Cardiovascular effects
Danish: Kardiovaskulær virkning
English: Inhalation use.
Danish: Til inhalation.
English: No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose.
Danish: Der blev ikke observeret nogen effekt på AUC eller Cmax af umeclidinium ved en dosis, der var 4 gange højere end den terapeutiske dosis.
English: Don't open the inhaler until you are ready to inhale a dose of medicine.
Danish: Åbn ikke inhalatoren, før du er klar til at inhalere en dosis af medicinen.
English: Mechanism of action
Danish: Virkningsmekanisme
English: The maximum dose is one inhalation of umeclidinium bromide once daily.
Danish: Den maksimale dosis er én inhalation af umeclidiniumbromid én gang daglig.
English: United Kingdom or
Danish: Storbritannien eller
English: Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air.
Danish: Stramning af musklerne omkring luftvejene giver yderligere vejrtrækningsproblemer, idet luftvejene indsnævres og luftgennemstrømning derved mindskes.
English: Multipack: 90 (3 inhalers of 30) doses
Danish: Multipakning: 90 (3 pakninger med 30) doser
English: It is unknown whether umeclidinium bromide is excreted in human milk.
Danish: Det vides ikke, om umeclidiniumbromid udskilles i human mælk.
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
Danish: I et randomiseret, dobbeltblindet 52-ugers studie (CTT116855, IMPACT) med 10.355 voksne patienter med symptomatisk KOL med 1 eller flere moderate eller svære eksacerbationer i anamnesen inden for de forudgående 12 måneder, blev behandling med fluticasonfuroat/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 mikrogram) administreret én gang dagligt som en enkelt inhalator sammenlignet med fluticasonfuroat/vilanterol (FF/VI 99/22 mikrogram) administreret én gang dagligt som en enkelt inhalator.
English: The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
Danish: Nedenstående brugervejledning for inhalator med 30 doser (30 dages forbrug) gælder også for inhalator med 7 doser (7 dages forbrug).
English: The mean annual rate of exacerbations was 0.91 and 1.07 for FF/UMEC/VI and FF/VI respectively (Rate Ratio: 0.85; 95% CI: 0.80, 0.90; p<0.001).
Danish: Den gennemsnitlige årlige hyppighed af eksacerbationer var 0,91 og 1,07 for henholdsvis FF/UMEC/VI og FF/VI (rate ratio: 0,85; 95 % CI: 0,80, 0,90; p < 0,001).
English: The inhaler contains one aluminium foil laminate blister of 7 or 30 doses.
Danish: Inhalatoren indeholder én lamineret aluminiumsfolieblister med enten 7 eller 30 doser.
English: Inhalation powder, pre-dispensed (inhalation powder).
Danish: Inhalationspulver, afdelt (inhalationspulver).
English: 7 doses
Danish: 7 doser
English: When you are ready to use your inhaler, peel back the lid to open the tray.
Danish: Når du er klar til at bruge din inhalator, træk da låget af for at åbne bakken.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale yderpakning for at beskytte mod fugt.
English: Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use.
Danish: Inhalatoren skal opbevares i den forseglede bakke for at beskytte mod fugt, og skal først tages ud umiddelbart før første brug.
English: The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
Danish: Inhalatorens mundstykke kan rengøres med en tør serviet, før beskyttelseshætten lukkes.
English: If you are breast-feeding, you must check with your doctor before you use Rolufta Ellipta.
Danish: Hvis du ammer, skal du tale med lægen, før du begynder at tage Rolufta Ellipta.
English: Excipients: lactose and magnesium stearate.
Danish: Hjælpestoffer: lactose og magnesiumstearat.
English: The inhaler should not be shaken.
Danish: Inhalatoren må ikke omrystes.
English: The inhaler will be in the ‘closed' position when it is first taken out of its sealed tray.
Danish: Inhalatoren vil være i 'lukket' position, når den tages ud af den forseglede bakke.
English: If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often: contact your doctor as soon as possible.
Danish: Hvis dine KOL-symptomer (åndenød, hvæsende vejrtrækning, hoste) ikke aftager, eller hvis de bliver værre, eller hvis du oftere inhalerer et lægemiddel med hurtig virkning:
English: The active substance is umeclidinium bromide.
Danish: Aktivt stof: umeclidiniumbromid.
English: To be used within 6 weeks of first opening of the tray.
Danish: Skal anvendes inden for 6 uger efter anbrud af bakken.
English: Inhaler
Danish: Inhalator
English: What you need to know before you use Rolufta Ellipta 3.
Danish: Det skal du vide, før du begynder at tage Rolufta Ellipta 3.
English: An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8fold higher dose with no effect on umeclidinium bromide Cmax.
Danish: AUC for umeclidiniumbromid blev øget ca. 1,3 gange ved en 8 gange højere dosis, uden at der blev set nogen effekt på Cmax for umeclidiniumbromid.
English: The date should be added as soon as the inhaler has been removed from the tray.
Danish: Datoen skal noteres, så snart inhalatoren er taget ud af bakken.
English: Rolufta Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section
Danish: Anvendelse af Rolufta Ellipta er ikke undersøgt hos patienter med svært nedsat leverfunktion og skal derfor anvendes med forsigtighed til disse patienter (se pkt.
English: The recommended dose is one inhalation of umeclidinium bromide once daily.
Danish: Den anbefalede dosis er én inhalation af umeclidiniumbromid én gang daglig.
English: Instructions for use:
Danish: Brugervejledning:
English: EXP In use shelf-life: 6 weeks.
Danish: EXP Holdbarhed efter anbrud: 6 uger.
English: Effects on lung function
Danish: Effekt på lungefunktion
English: Throw this desiccant sachet away - don't open, eat or inhale it.
Danish: Smid posen med tørremiddel ud - du må ikke åbne, spise eller inhalere posen med tørremiddel.
English: Step-by-step instructions for use What is the inhaler?
Danish: Brugervejledning Hvad er en inhalator?
English: If you get 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 instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30 day supply) or the 7-dose inhaler (7 day supply).
Danish: Nedenstående brugervejledning til Ellipta inhalatoren kan både bruges til inhalator med 30 doser (30 dages forbrug) og inhalator med 7 doser (7 dages forbrug).
English: Always use this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: Clinical efficacy
Danish: Klinisk virkning
English: Subjects with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with moderate hepatic impairment and healthy volunteers.
Danish: Patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) viste ingen tegn på øget systemisk eksponering over for umeclidiniumbromid (Cmax og AUC), og der var ingen tegn på ændret proteinbinding mellem patienter med moderat nedsat leverfunktion og raske personer.
English: Distribution
Danish: Fordeling
English: If you become wheezy or breathless, use your quick-acting inhaler (such as salbutamol), then seek medical advice.
Danish: Hvis du får hvæsende vejrtrækning eller åndenød, skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol) og herefter søge lægehjælp.
English: Fertility
Danish: Fertilitet
English: The clinical efficacy of Rolufta Ellipta administered once daily was evaluated in 904 adult patients who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373).
Danish: Den kliniske virkning af Rolufta Ellipta administreret én gang daglig blev vurderet i to pivotale kliniske fase III-studier, hvor 904 voksne patienter med en klinisk diagnose på KOL fik umeclidiniumbromid eller placebo; et studie var af 12 ugers varighed (AC4115408) og et studie af 24 ugers varighed (DB2113373).
English: Take it back to your pharmacist for advice.
Danish: Returnér den til apoteket og bed om hjælp.
English: The medicine may not be tasted or felt, even when using the inhaler correctly.
Danish: Det er ikke sikkert, at medicinen kan smages eller mærkes, selvom inhalatoren anvendes korrekt.
English: Nasopharyngitis Upper respiratory tract infection Urinary tract infection Sinusitis
Danish: Nasopharyngitis Infektion i øvre luftveje Urinvejsinfektion Sinuitis
English: Nervous system disorders
Danish: Nervesystemet
English: Medicinal product subject to medical prescription.
Danish: Lægemidlet er receptpligtigt.
English: Contents of the pack and other information Step-by-step instructions for use
Danish: Pakningsstørrelser og yderligere oplysninger Brugervejledning
English: The steady-state pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers).
Danish: Farmakokinetikken af umeclidiniumbromid ved steady state blev bestemt hos raske personer, der manglede CYP2D6 (personer med nedsat metabolisme).
English: Other side effects
Danish: Andre bivirkninger
English: If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol).
Danish: Hvis du får et anfald af denne type, skal du inhalere et lægemiddel med hurtig virkning (f.eks. salbutamol).
English: In the 24-week placebo-controlled study in patients with symptomatic COPD, Rolufta Ellipta reduced the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0, p=0.035*).
Danish: I det 24 ugers placebo kontrollerede studie hos patienter med symptomatisk KOL, reducerede Rolufta Ellipta risikoen for moderat/svær KOL-eksacerbation med 40% sammenlignet med placebo (analyse af tiden til første eksacerbation; hazard ratio 0,6; 95% CI: 0,4, 1,0, p = 0,035*).
English: Don't use more than your doctor tells you to use.
Danish: Du må ikke tage mere, end lægen har foreskrevet.