FrancophonIA/ELRC3.0 huggingface dataset:
English: No dosage adjustment is required in patients with mild, moderate or severe hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat leverfunktion.
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 bruge dette lægemiddel, og søg straks lægehjælp, da dette kan være tegn på et akut anfald af snævervinklet glaukom.
English: Plasma metabolic profiles following oral administration of vilanterol in a human radiolabel study were consistent with high first-pass metabolism.
Danish: De metaboliske plasmaprofiler efter oral administration af vilanterol i et studie af radioaktivt mærkede stoffer i mennesker svarede til høj førstepassage-metabolisme.
English: Your inhaler is now empty.
Danish: Din inhalator er nu tom.
English: Don't use more than your doctor tells you to use.
Danish: Brug ikke mere, end lægen siger.
English: At study entry, the most common COPD medications reported in the FULFIL and IMPACT studies were ICS +LABA+LAMA (28%, 34% respectively), ICS+LABA (29%, 26% respectively), LAMA+LABA (10%, 8% respectively) and LAMA (9%, 7% respectively).
Danish: Ved indtrædelse i studiet var de mest almindelige KOL-lægemidler, der blev indberettet i FULFIL- og IMPACT-studierne, ICS + LABA + LAMA (henholdsvis 28 % og 34 %), ICS + LABA (henholdsvis 29 % og 26 %), LAMA + LABA (henholdsvis 10 % og 8 %) og LAMA (henholdsvis 9 % og 7 %).
English: In terms of other patient characteristics, a study in CYP2D6 poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.
Danish: Med hensyn til andre patientkarakteristika viste et studie af personer med nedsat CYP2D6-stofskifte ingen tegn på en klinisk signifikant effekt af genetisk CYP2D6-polymorfi på systemisk eksponering for umeclidinium.
English: Once the tray is opened Trelegy Ellipta is ready to use.
Danish: Når bakken er åbnet er Trelegy Ellipta klar til brug.
English: Significant reductions were observed over all other timepoints for UMEC/VI (p<0.001) and for the all but two of the of timepoints for FF/VI (p≤0.021).
Danish: Der blev observeret signifikante reduktioner ved alle andre tidspunkter for UMEC/VI (p < 0,001) og ved alle bortset fra to af tidspunkterne for FF/VI (p ≤ 0,021).
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:
Danish: Hvis dine KOL-symptomer (åndenød, hvæsende vejrtrækning, hoste) ikke aftager, hvis de bliver værre, eller hvis du oftere inhalerer et lægemiddel med hurtig virkning:
English: Pneumonia which required hospitalisation occurred in 1% of patients receiving Trelegy Ellipta and <1% of patients receiving budesonide/formoterol up to 24 weeks.
Danish: Der opstod pneumoni, som krævede hospitalsindlæggelse, hos 1 % af de patienter, der fik Trelegy Ellipta, og hos < 1 % af de patienter, der fik budesonid/formoterol op til 24 uger.
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Danish: De farmakologiske effekter af beta2-adrenerge agonister, herunder vilanterol, kan i det mindste delvist tilskrives stimulering af intracellulær adenylatcyklase, som er det enzym, der katalyserer omdannelsen af adenosintrifosfat (ATP) til cyklisk 3',5'-adenosinmonofosfat (cyklisk AMP).
English: Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL and week 52 in IMPACT (a subset of patients, n=5,058).
Danish: Åndenød blev målt ved hjælp af TDI-fokalscore (Transition Dyspnoe Index) i uge 24 i FULFIL og uge 52 i IMPACT (en undergruppe af patienter, n = 5.058).
English: The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Danish: De primære metaboliske ruter for umeclidinium er oxidative (hydroxylering, O-dealkylering) efterfulgt af konjugering (glukuronidering osv.), hvilket giver en række forskellige metabolitter enten med reduceret farmakologisk aktivitet, eller hvor den farmakologiske aktivitet ikke er fastsat.
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium and vilanterol was assessed in healthy volunteers.
Danish: Virkningen af den moderate P-gp-hæmmer verapamil (240 mg én gang dagligt) på farmakokinetikken af umeclidinium og vilanterol ved steady-state er blevet vurderet hos frivillige raske forsøgspersoner.
English: Fluticasone furoate is a corticosteroid with potent anti-inflammatory activity.
Danish: Fluticasonfuroat er et kortikosteroid med potent antiinflammatorisk effekt.
English: Anticholinergic activity
Danish: Antikolinergiske aktiviteter
English: Fluticasone furoate, umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Danish: Fluticasonfuroat, umeclidinium og vilanterol er substrater for P-glykoproteintransporteren (P-gp).
English: Umeclidinium 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: Umeclidiniums plasmahalveringstiden efter inhalation i 10 dage var 19 timer i gennemsnit, og 3-4 % af det aktive stof blev udskilt i uændret form i urinen ved steady-state.
English: Trelegy Ellipta is for inhalation use only.
Danish: Trelegy Ellipta er kun beregnet til inhalation.
English: Don't use Trelegy Ellipta if you already use these medicines.
Danish: Du må ikke bruge Trelegy Ellipta, hvis du allerede bruger et eller flere af disse lægemidler.
English: Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme CYP3A4.
Danish: Fluticasonfuroat og vilanterol elimineres hurtigt via omfattende førstepassage-metabolisme medieret af enzymet CYP3A4.
English: Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Danish: Undlad at bruge lægemidlet, hvis du er gravid, medmindre lægen siger, at du kan bruge det.
English: In vitro protein binding studies between subjects with severe renal impairment and healthy volunteers were conducted, and no clinically significant evidence of altered protein binding was seen.
Danish: Der er foretaget in vitro-proteinbindingsstudier hos forsøgspersoner med svært nedsat nyrefunktion og frivillige raske forsøgspersoner, og der blev ikke registreret klinisk signifikant evidens for ændret proteinbinding.
English: Interaction with CYP3A4 inhibitor
Danish: Interaktion med CYP3A4-hæmmere
English: In Study 200812, Trelegy Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two inhalers, in the improvement from baseline in trough FEV1 at week 24.
Danish: I studie 200812 var Trelegy Ellipta non-inferior sammenlignet med FF/VI + UMEC, som blev administreret samtidig i to inhalatorer, i forbedringen fra FEV1-baseline i uge 24.
English: You may not be able to taste or feel the medicine, even when you are using the inhaler correctly.
Danish: Det er ikke sikkert, at du kan smage eller mærke lægemidlet, selvom du bruger inhalatoren korrekt.
English: • Slide the cover down until you hear a “click”.
Danish: • Træk beskyttelseshætten ned, indtil du hører et klik.
English: Following oral inhalation, umeclidinium and vilanterol act locally on airways to produce bronchodilation by separate mechanisms and fluticasone furoate reduces inflammation.
Danish: Efter oral inhalation virker umeclidinium og vilanterol lokalt i luftvejene ved at producere bronkodilatation via separate mekanismer, og fluticasonfuroat reducerer inflammation.
English: Take it back to your pharmacist for advice.
Danish: Returner den til apoteket, og bed om hjælp.
English: The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day.
Danish: Den anbefalede og maksimale dosis er én inhalation med Trelegy Ellipta 92/55/22 mikrogram én gang dagligt på samme tidspunkt hver dag.
English: Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors on airway smooth muscle.
Danish: Umeclidinium udøver sin bronkodilaterende aktivitet ved at hæmme bindingen af acetylkolin kompetitivt med muskarine receptorer på luftvejenes glatte muskulatur.
English: However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk.
Danish: Der er dog påvist andre kortikosteroider, muskarine antagonister og beta2-adrenerge agonister i human mælk.
English: The fluticasone furoate/vilanterol component of Trelegy Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Danish: Fluticasonfuroat/vilanterol-komponenten i Trelegy Ellipta er blevet vurderet hos patienter med alle sværhedsgrader af nedsat leverfunktion (Child-Pugh A, B eller C).
English: Your lips fit over the contoured shape of the mouthpiece for inhaling.
Danish: Dine læber passer om den afrundede form på inhaleringsmundstykket.
English: Lung function endpoint in FULFIL
Danish: Endepunkt for lungefunktion i FULFIL
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while using Trelegy Ellipta - these could be symptoms of a lung infection:
Danish: Lungebetændelse (pneumoni) hos KOL-patienter (almindelig bivirkning) Kontakt lægen, hvis du får et eller flere af følgende symptomer, mens du bruger Trelegy Ellipta - det kan være symptomer på lungebetændelse:
English: 2) Prepare a dose
Danish: 2) Klargøring af dosis
English: Umeclidinium has not been evaluated in patients with severe hepatic impairment.
Danish: Umeclidinium er ikke blevet evalueret hos patienter med svært nedsat leverfunktion.
English: Patients should not stop therapy with Trelegy Ellipta without physician supervision since symptoms may recur after discontinuation.
Danish: Patienten bør ikke stoppe behandlingen med Trelegy Ellipta uden samråd med lægen, da symptomerne kan vende tilbage efter seponering.
English: The primary metabolic route for fluticasone furoate is hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Danish: Den primære metaboliske rute for fluticasonfuroat er hydrolyse af S-fluoromethylcarbothioatgruppen til metabolitter med signifikant reduceret kortikosteroidaktivitet.
English: Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and faeces.
Danish: Den primære elimination af vilanterol skete via metabolisering efterfulgt af udskilning af metabolitter i urin og fæces.
English: In FULFIL, bronchodilatory effects with Trelegy Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Danish: I FULFIL var de bronkodilatoriske virkninger med Trelegy Ellipta evidente på den første behandlingsdag og blev opretholdt i løbet af behandlingsperioden på 24 uger (ændringerne i forhold til baseline i FEV1 var 90-222 ml på dag 1 og 160-339 ml i uge 24).
English: The efficacy of Trelegy Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Danish: Virkningen af Trelegy Ellipta (92/55/22 mikrogram), der administreres én gang dagligt, er blevet evalueret hos patienter med en klinisk KOL-diagnose i to studier med aktiv kontrol og i et enkelt, noninferiorstudie.
English: Umeclidinium was not teratogenic in rats or rabbits.
Danish: Umeclidinium var ikke teratogent hos rotter eller kaniner.
English: Dry mouth
Danish: Tør mund
English: Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone furoate and vilanterol, which could lead to an increased potential for adverse reactions.
Danish: Der bør udvises forsigtighed ved samtidig administration af potente CYP3A4-hæmmere (f.eks. produkter, der indeholder ketoconazol, ritonavir eller cobicistat), da der er mulighed for øget systemisk eksponering for både fluticasonfuroat og vilanterol, hvilket kan føre til øget risiko for bivirkninger.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics including triple combinations with corticosteroids, ATC code: R03AL08.
Danish: Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, adrenergika i kombination med antikolinergika herunder trestof-behandling med kortikosteroider, ATC-kode: R03AL08.
English: When fewer than 10 doses are left, half of the dose counter shows red.
Danish: Når der er under 10 doser tilbage, vises halvdelen af dosistælleren i rødt.
English: Following intravenous administration, approximately 58% of the administered radiolabelled dose was excreted in faeces and approximately 22% of the administered radiolabelled dose was excreted in urine.
Danish: Efter intravenøs administration blev ca. 58 % af den administrerede radioaktivt mærkede dosis udskilt med fæces, og ca. 22 % af den administrerede radioaktivt mærkede dosis blev udskilt i urinen.
English: Trelegy Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Trelegy Ellipta bruges til at behandle kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Danish: Efter åbning skal posen med tørremiddel kasseres og må ikke åbnes, spises eller inhaleres.
English: Patients with moderate hepatic impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC).
Danish: Patienter med moderat nedsat leverfunktion viste ikke nogen tegn på stigning i den systemiske eksponering for hverken umeclidinium eller vilanterol (Cmax og AUC).
English: In the event of deterioration of COPD during treatment with Trelegy Ellipta, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Danish: Hvis KOL-tilstanden forværres under behandling med Trelegy Ellipta, skal der foretages en ny vurdering af patienten og af KOL-behandlingsmetoden.
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Danish: Inhalatoren består af flere komponenter i polypropylen, polyethylen med høj densitet, polyoxymethylen, polybutylenterephthalat, acrylonitrilbutadienstyren, polycarbonat og rustfrit stål.
English: For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left, and then will show half red with the number 0 after the last dose is used.
Danish: På inhalatoren med 14 doser vises halvdelen af dosistælleren i rødt når der er under 10 doser tilbage, og vil når den sidste dose er brugt, igen vise halvdelen i rødt, og tallet 0.
English: Nasopharyngitis Candidiasis of mouth and throat Urinary tract infection
Danish: Nasopharyngitis Candidiasis i mund og svælg Urinvejsinfektion
English: Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been conducted.
Danish: Der er ikke udført kliniske farmakologiske studier med en specifik P-gp-hæmmer og fluticasonfuroat.
English: Vilanterol was not teratogenic in rats.
Danish: Vilanterol var ikke teratogent hos rotter.
English: Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with an immediate wheezing and shortness of breath after dosing and may be life-threatening.
Danish: Administration af fluticasonfuroat/umeclidinium/vilanterol kan forårsage paradoks bronkospasme med akut hvæsen og åndenød efter indtagelse af dosis, hvilket kan være livstruende.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING)
English: In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Danish: I FULFIL forbedrede Trelegy Ellipta daglige symptomer på KOL som vurderet ved E-RS: Samlet KOL score sammenlignet med BUD/FOR (fald på ≥ 2 enheder fra baseline).
English: There have been reports of increases in blood glucose levels in diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol and this should be considered when prescribing to patients with a history of diabetes mellitus.
Danish: Der er rapporter om øget blodglucoseniveau hos diabetespatienter, der er blevet behandlet med fluticasonfuroat/umeclidinium/vilanterol, og dette skal indgå i vurderingen, når der ordineres til patienter med diabetes mellitus i anamnesen.
English: Each inhaler contains either 14 or 30 doses (14 or 30 day supply).
Danish: Hver inhalator indeholder enten 14 eller 30 doser (til 14 eller 30 dages forbrug).
English: The absolute bioavailability of fluticasone furoate when administrated as fluticasone furoate/vilanterol by inhalation was 15.2%, primarily due to absorption of the inhaled portion of the dose delivered to the lung, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed for fluticasonfuroat ved administration som inhalation af fluticasonfuroat/vilanterol var 15,2 %, primært på grund af absorption af den inhalerede del af dosis, der leveres til lungerne, med en ubetydelig andel fra oral absorption.
English: In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects.
Danish: Hos 113 østasiatiske forsøgspersoner med KOL (japansk og østasiatisk herkomst), som fik FF/UMEC/VI fra en enkelt inhalator (27 % af forsøgspersonerne), lå estimaterne for fluticasonfuroat AUC(ss) i gennemsnit 30 % højere end hos kaukasiske forsøgspersoner.
English: Slide the cover down fully until a “click” is heard.
Danish: Træk beskyttelseshætten ned, indtil du hører et ”klik”.
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution should be exercised (see section 4.4).
Danish: Samtidig hypokalæmisk behandling med methylxanthinderivativer, steroider eller ikkekaliumbesparende diuretika kan forstærke den mulige hypokalæmiske virkning af beta2-adrenerge agonister og der bør derfor udvises forsigtighed (se pkt.
English: If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
Danish: Hvis du vil rengøre mundstykket, skal du bruge en tør serviet, før du lukker beskyttelseshætten.
English: Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual single inhalers (FF, UMEC and VI).
Danish: De systemiske niveauer (Cmax ved steady-state og AUC) af FF, UMEC og VI efter FF/UMEC/VI i en enkelt inhalator (tredobbelt kombination) var inden for intervallet af de niveauer, der blev observeret efter FF/VI + UMEC som to inhalatorer, dobbelte kombinationer (FF/VI og UMEC/VI), samt efter individuelle enkeltinhalatorer (FF, UMEC og VI).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trelegy 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 Trelegy Ellipta i alle undergrupper af den pædiatriske population ved KOL (se pkt.
English: Fluticasone furoate has a low association with red blood cells.
Danish: Fluticasonfuroat har lav association med røde blodlegemer.
English: An overdose will likely produce signs, symptoms or adverse effects associated with the individual components' pharmacological actions (e.g. Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Danish: Overdosering vil sandsynligvis medføre tegn, symptomer eller bivirkninger som følge af de enkelte indholdsstoffers farmakologiske virkninger (f.eks. Cushing's syndrom, cushingoide træk, binyrebarksuppression, nedsat knoglemineraltæthed, mundtørhed, visuelle akkommodationsforstyrrelser, takykardi, arytmi, rysten, hovedpine, hjertebanken, kvalme, hyperglykæmi og hypokalæmi).
English: Talk to your doctor before using Trelegy Ellipta - if you have asthma (Don't use Trelegy Ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (TB) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances
Danish: Kontakt lægen, før du bruger Trelegy Ellipta - hvis du har astma (Trelegy Ellipta må ikke bruges til at behandle astma) - hvis du har hjerteproblemer eller højt blodtryk - hvis du har leverproblemer - hvis du har lungetuberkulose (TB) eller langvarige eller ubehandlede infektioner - hvis du har et problem med øjnene kaldet snævervinklet glaukom - hvis du har forstørret prostata, besvær med at tisse eller en blokering i blæren - hvis du lider af epilepsi - hvis du har problemer med skjoldbruskkirtlen - hvis du har lavt kaliumindhold i blodet - hvis du har diabetes - hvis du oplever sløret syn eller andre synsforstyrrelser.
English: Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use.
Danish: Opbevar inhalatoren i den forseglede bakke for at beskytte mod fugt, og tag den først ud umiddelbart før første brug.
English: Supraventricular tachyarrhythmia Tachycardia
Danish: Supraventrikulær takyarytmi Takykardi
English: Cardiovascular effects
Danish: Kardiovaskulære effekter
English: The increase in fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum cortisol.
Danish: Den øgede eksponering for fluticasonfuroat var forbundet med en reduktion på 27 % i vægtet gennemsnit af serumkortisol i løbet af de første 24 timer.
English: Trelegy Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52.
Danish: Trelegy Ellipta medførte en signifikant forbedring (p < 0,001) i lungefunktionen (defineret ved en gennemsnitlig ændring fra FEV1-baseline i uge 24) (se tabel 1), og forbedringen blev opretholdt i undergruppen af patienter, der fortsatte behandlingen til uge 52.