FrancophonIA/ELRC3.0 huggingface dataset:
English: COPD is a long-term condition in which the airways and air-sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly get worse.
Danish: KOL er en langvarig sygdom, hvor luftvejene og lungeblærerne i lungerne gradvist blokeres eller beskadiges, hvilket kan medføre vejrtrækningsproblemer, som langsomt bliver værre.
English: The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the dose, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed af inhaleret umeclidiniumbromid var i gennemsnit 13 % af dosis, med et ubetydeligt bidrag fra oral absorption.
English: • Inhale with one long, steady, deep breath in.
Danish: • Inhalér med én lang, stabil, dyb indånding.
English: Don't block the air vent with your fingers.
Danish: Spær ikke for luftkanalerne med dine fingre.
English: See section 4.8 for how to report adverse reactions.
Danish: Se i punkt 4.8, hvordan bivirkninger indberettes.
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og carcinogent potentiale.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: • Take one long, steady, deep breath in.
Danish: • Foretag en lang, jævn, dyb indånding.
English: Cardiac electrophysiology
Danish: Kardiel elektrofysiologi
English: Other special populations
Danish: Andre særlige populationer
English: If you have any of the following symptoms after taking Rolufta Ellipta, stop using this medicine and tell your doctor immediately:
Danish: Hvis du oplever nogle af de følgende symptomer efter at have taget Rolufta Ellipta skal du stoppe med at tage medicinen og straks kontakte din læge:
English: • Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma).
Danish: • nedsat syn eller smerter i øjnene på grund af højt tryk (mulige tegn på glaukom)
English: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control.
Danish: Øget brug af korttidsvirkende bronkodilatatorer til symptomlindring indikerer dårligere sygdomskontrol.
English: Talk to your doctor before using this medicine: if you have asthma (Don't use Rolufta Ellipta to treat asthma)
Danish: Kontakt lægen, før du tager dette lægemiddel: - hvis du har astma (brug ikke Rolufta Ellipta til behandling af astma)
English: The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed from four efficacy studies and the long-term safety study (which involved 1,412 patients who received umeclidinium bromide).
Danish: Hyppigheden af bivirkningerne anført i nedenstående tabel omfatter incidensrater observeret i fire effektstudier og et længerevarende sikkerhedsstudie (som omfattede 1.412 patienter, der fik umeclidiniumbromid).
English: This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Danish: Denne medicin anvendes til behandling af kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: Following repeat doses of umeclidinium 500 micrograms once daily for 10 days, no clinically relevant effect on prolongation of QT interval (corrected using the Fridericia method) or effects on heart rate were observed.
Danish: Efter gentagne doser af umeclidinium 500 mikrogram én gang daglig i 10 dage, blev der ikke observeret nogen klinisk relevant effekt med hensyn til forlængelse af QT-intervallet (korrigeret ved Fridericias metode) eller effekt på hjertefrekvensen.
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Danish: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, Frankrig
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Slide the cover down until you hear a “click”.
Danish: • Træk beskyttelseshætten ned, indtil du hører et "klik".
English: If you think the above applies to you, don't use this medicine until you have checked with your doctor.
Danish: Hvis du tror, at dette gælder for dig, må du ikke tage dette lægemiddel, før du har talt med lægen.
English: No dosage adjustment is required in patients over 65 years (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter over 65 år (se pkt.
English: There is no relevant use of Rolufta Ellipta in the paediatric population (under 18 years of age) in the indication for COPD.
Danish: Der er ikke relevant at anvende Rolufta Ellipta i den pædiatriske population (i alderen under 18 år) til indikationen KOL.
English: Stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.
Danish: Stop med at tage medicinen, og søg omgående lægehjælp, da du kan have en alvorlig tilstand, der kaldes paradoks bronkospasme.
English: Less than 1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral administration.
Danish: Mindre end 1 % af den oralt administrerede dosis (1 % af genfunden radioaktivitet) blev udskilt i urinen, hvilket tyder på ubetydelig absorption efter oral administration.
English: Check with your doctor if you think any of these may apply to you.
Danish: Kontakt lægen, hvis du tror, at noget af ovenstående gælder for dig.
English: There was no attenuation of the bronchodilator effect over time.
Danish: Der var ingen aftagende bronkodilatorisk effekt over tid.
English: It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm.
Danish: Det bør ikke anvendes til lindring af akutte symptomer, dvs. som anfaldsmedicin til behandling af akutte episoder med bronkospasme.
English: Umeclidinium bromide has no or negligible influence on the ability to drive and use machines.
Danish: Umeclidiniumbromid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you want to clean the mouthpiece, use a dry tissue, before you close the cover.
Danish: Hvis du vil rengøre mundstykket, så brug en tør serviet, før du lukker beskyttelseshætten.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Rolufta Ellipta contains lactose') and magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 under ”Rolufta Ellipta indeholder lactose”) og magnesiumstearat.
English: When you take the inhaler out of its tray, it will be in the ‘closed' position.
Danish: Når du tager inhalatoren ud af bakken, vil den være i 'lukket' position.
English: A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium bromide based on the effect of age, race, gender, inhaled corticosteroid use or weight.
Danish: En populationsfarmakokinetisk analyse viste, at dosisjustering ikke er nødvendig for umeclidiniumbromid baseret på effekten af alder, race, køn, forbrug af inhalationssteroider eller vægt.
English: Asthma
Danish: Astma
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Pivotal Efficacy Studies:
Danish: Pivotale studier af virkningen:
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, højdensitetspolyethylen, polyoxymethylen, polybutylenterephthalat, acrylnitril-butadien-styren, polycarbonat og rustfrit stål.
English: The primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with FF/VI.
Danish: Det primære endepunkt var den årlige hyppighed af moderate og svære eksacerbationer under behandling hos forsøgspersoner behandlet med FF/UMEC/VI sammenlignet med FF/VI.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: If you forget to use Rolufta Ellipta Don't inhale an extra dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Rolufta Ellipta Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The mouthpiece should be placed between the lips and the lips should then be closed firmly around it.
Danish: Mundstykket skal anbringes mellem læberne, og læberne skal herefter lukkes godt omkring mundstykket.
English: The active substance is present as a white powder in a blister inside the inhaler.
Danish: Det aktive stof er et hvidt pulver, som ligger i en blister inde i inhalatoren.
English: 1) Read this before you start If you open and close the cover without inhaling the medicine, you will lose the dose.
Danish: Læs dette, inden du starter Hvis du åbner og lukker beskyttelseshætten, uden at inhalere medicinen, så vil dosis gå tabt.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: • Increase of the measured eye pressure
Danish: • stigningn i det målte øjentryk
English: The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who received doses of 55 micrograms or greater for up to one year.
Danish: Sikkerhedsprofilen for umeclidiniumbromid er baseret på data fra 1.663 patienter med KOL, der fik doser på 55 mikrogram eller højere i op til ét år.
English: It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes.
Danish: Det er et quinuclidinderivat, som er en muskarinreceptorantagonist med aktivitet på tværs af flere undertyper af kolinerge muskarinreceptorer.
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLESKRIFT
English: Therefore, umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Danish: Umeclidiniumbromid bør derfor anvendes med forsigtighed hos patienter med svær kardiovaskulær sygdom, særligt hjertearytmier.
English: See package leaflet for further information
Danish: Se indlægssedlen for yderligere oplysninger
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Your medicine is now ready to be inhaled.
Danish: Medicinen er nu klar til at blive inhaleret.
English: There was no evidence for tachyphylaxis in the effect of Rolufta Ellipta over time.
Danish: Der var ingen tegn på takyfylaksi for effekten af Rolufta Ellipta over tid.
English: In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to this medicine for breathing problems, e.g. tiotropium.
Danish: Det er især vigtigt, at du fortæller lægen eller apotekspersonalet, hvis du tager andre langtidsvirkende lægemidler for vejrtrækningsproblemer, som minder om dette lægemiddel, f.eks. tiotropium.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Rolufta Ellipta therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med Rolufta Ellipta skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INHALER LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL INHALATOR
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 medicinen, selvom du bruger inhalatoren korrekt.
English: Adults
Danish: Voksne
English: No dosage adjustment is required in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: • painful and frequent urination (may be signs of a urinary tract infection)
Danish: • smertefuld og hyppig vandladning (kan være tegn på urinvejsinfektion)
English: The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
Danish: Posen med tørremiddel skal kasseres, og må ikke åbnes, spises eller inhaleres.
English: Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Danish: Klinisk signifikante interaktioner, medieret af umeclidiniumbromid ved kliniske doser, anses ikke for at være sandsynlige, på grund af de lave plasmakoncentrationer, der opnås efter dosering via inhalation.
English: In nonclinical studies with umeclidinium bromide, findings were those typically associated with the primary pharmacology of muscarinic receptor antagonists and/or local irritancy.
Danish: I ikkekliniske studier med umeclidiniumbromid var resultaterne i overensstemmelse med dem, der typisk forbindes med den primære farmakologi af muskarinreceptorantagonister, og/eller lokal irritation.
English: Slide the cover down until a “click” is heard.
Danish: Træk beskyttelseshætten ned, indtil der høres et "klik".
English: Antimuscarinic activity
Danish: Antimuskarin aktivitet
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: Following repeat dosing of inhaled umeclidinium bromide, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Danish: Efter gentagen dosering af umeclidiniumbromid som inhalation blev steady state nået inden for 7 til 10 dage med en akkumulation på 1,5 til 1,8 gange.
English: Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray.
Danish: Når bakken er åbnet, kan inhalatoren anvendes i op til 6 uger fra den dag, hvor bakken blev åbnet.
English: Submission of the final clinical study report on a Post-Authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Rolufta Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the PRAC.
Danish: Indsendelse af den endelige rapport for det kliniske observationssikkerhedsstudie (kohorte) efter godkendelsen (PAS - Post-Authorisation Safety), der skal kvantificere incidensen og sammenlignende sikkerhed for udvalgte kardiovaskulære og cerebrovaskulære bivirkninger hos KOL-patienter forbundet med Rolufta Ellipta i sammenligning med tiotropium (studie 201038), i henhold til den protokol, der er aftalt med PRAC.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: BILAG III ETIKETTERING OG INDLÆGSSEDDEL
English: Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles Tachycardia
Danish: Idioventrikulær rytme Supraventrikulær takykardi Supraventrikulære ekstrasystoler Takykardi
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber
English: • Put the mouthpiece between your lips, and close your lips firmly around it.
Danish: • Placér mundstykket mellem læberne, og luk læberne godt sammen omkring mundstykket.
English: The primary metabolic routes for umeclidinium bromide 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: Umeclidiniumbromid metaboliseres primært via oxidation (hydroxylering, O-dealkylering) efterfulgt af konjugering (glucuronidering osv.), hvilket resulterer i en række metabolitter med enten nedsat farmakologisk aktivitet, eller metabolitter hvor den farmakologiske aktivitet ikke er klarlagt.
English: These may affect up to 1 in 10 people:
Danish: Kan forekomme hos op til 1 ud af 10 personer:
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Rolufta Ellipta 55 mcg
Danish: Tabel 1: Trough-FEV1 (ml) ved uge 12 og uge 24 (primært endepunkt) Behandling med Rolufta Ellipta 55 mikrogram
English: Infections and infestations
Danish: Infektioner og parasitære sygdomme
English: Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver afgivet dosis indeholder ca. 12,5 mg lactose (som monohydrat).
English: The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
Danish: En dosis, der er gået tabt, vil blive tilbageholdt i inhalatoren, men den vil ikke længere være tilgængelig til inhalation.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv
English: Rolufta Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Rolufta Ellipta er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Special populations
Danish: Særlige populationer
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger.
English: OTHER
Danish: ANDET
English: There are no data from the use of umeclidinium bromide in pregnant women.
Danish: Der er ingen data fra anvendelse af umeclidiniumbromid til gravide kvinder.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB07
Danish: Farmakoterapeutisk klassifikation: Andre midler mod obstruktiv lungesygdom, inhalation, anticholinergica, ATC-kode: R03BB07.
English: Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.
Danish: Selvom der ikke er udført formelle interaktionsstudier in vivo, er inhaleret umeclidiniumbromid blevet anvendt samtidigt med andre lægemidler mod KOL, herunder korttidsvirkende og langtidsvirkende sympatomimetiske bronkodilatatorer og inhalationssteroider, uden klinisk evidens for interaktion.
English: Immediate breathing difficulties
Danish: Akutte vejrtrækningsproblemer
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og administration
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Danish: • Hvis dosistælleren ikke tæller nedad, når du hører "klikket", vil inhalatoren ikke afgive medicin.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: 30 doses
Danish: 30 doser
English: Slide the cover upwards as far as it will go, to cover the mouthpiece.
Danish: Skub beskyttelseshætten så langt tilbage som muligt, så den dækker for mundstykket.
English: The Ellipta inhaler contains pre-dispensed doses and is ready to use.
Danish: Ellipta inhalatoren indeholder afdelte doser og er klar til brug.
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 dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: a) Prepare a dose
Danish: a) Klargøring af en dosis
English: These may affect up to 1 in 100 people:
Danish: Kan forekomme hos op til 1 ud af 100 personer:
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium bromide was assessed in healthy volunteers.
Danish: Effekten af den moderate P-gp-hæmmer verapamil (240 mg én gang daglig) på farmakokinetikken af umeclidiniumbromid ved steady state blev bestemt hos raske personer.
English: An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia).
Danish: En overdosis af umeclidiniumbromid vil sandsynligvis medføre tegn og symptomer, der stemmer overens med de kendte bivirkninger ved inhalerede muskarinantagonister (f.eks. mundtørhed, visuelle akkommodationsforstyrrelser og takykardi).
English: The probability of having an exacerbation in patients receiving Rolufta Ellipta at week 24 was 8.9% compared with 13.7% for placebo.
Danish: Sandsynligheden for at få en eksacerbation hos patienter, der fik Rolufta Ellipta ved uge 24, var 8,9 % sammenlignet med 13,7 % for placebo.
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Rolufta Ellipta inhaler:
Danish: Hvis du får trykken for brystet, hoste, hvæsende vejrtrækning eller åndenød, umiddelbart efter at du har brugt din Rolufta Ellipta inhalator:
English: Umeclidinium bromide is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic).
Danish: Umeclidiniumbromid er en langtidsvirkende muskarinreceptorantagonist (også kaldet et antikolinergikum).
English: Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 15 minutes.
Danish: Efter administration af umeclidiniumbromid som inhalation hos raske personer indtraf Cmax efter 5 til 15 minutter.
English: • taste disturbance.
Danish: • smagsforstyrrelser.
English: 12-Week Study Treatment difference1 95% Confidence interval p-value
Danish: Studie af 12 ugers varighed Behandlingsforskel1 95 % konfidensinterval p-værdi
English: Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle.
Danish: Umeclidiniumbromid udøver sin bronkodilaterende aktivitet ved kompetitivt at hæmme binding af acetylcholin til kolinerge muskarinreceptorer på luftvejenes glatte muskulatur.