FrancophonIA/ELRC3.0 huggingface dataset:
English: 8 Repeat steps 4 to 7 to treat the other nostril.
Danish: 4-7 i det andet næsebor.
English: • The usual starting dose is 2 sprays in each nostril once every day.
Danish: • Sædvanlig startdosis er 2 pust i hvert næsebor 1 gang daglig.
English: However the dose of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.
Danish: Men intranasal fluticasonfuroat skal altid reduceres til den mindste dosis, hvor symptomerne er under kontrol.
English: Fluticasone furoate undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone furoate in patients with severe liver disease is likely to be increased.
Danish: Der sker en betragtelig first pass-metabolisme af fluticasonfuroat, og det er derfor sandsynligt, at den systemiske påvirkning øges hos patienter med svær leverinsufficiens (se pkt.
English: There are no data in patients with severe hepatic impairment (see section 4.4 and 5.2).
Danish: Der findes ingen oplysninger om patienter med svær leverinsufficiens (se pkt.
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Danish: Systemisk påvirkning kan opstå efter nasalsteroider, især ved høje doser givet over længere tid.
English: • The usual starting dose is 1 spray in each nostril once a day.
Danish: • Sædvanlig startdosis er 1 pust i hvert næsebor 1 gang daglig.
English: The medicinal product is available in three pack sizes: 30, 60 and 120 sprays.
Danish: Der er tre pakningsstørrelser: 30, 60 og 120 pust.
English: If you have any liver problems, tell your doctor or pharmacist.
Danish: Hvis du har en leversygdom, skal du informere din læge om dette.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Omrystes
English: Caution is advised when treating these patients.
Danish: Dette kan resultere i hyppigere systemiske bivirkninger, og forsigtighed tilrådes ved behandling af disse patienter.
English: 2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefingersee picture e.
Danish: Fjern hætten ved at klemme hårdt om siderne på den med tommel- og pegefinger - se billede e.
English: Renal Impaired Patients: No dose adjustment is required in this population (see section 5.2).
Danish: Patienter med nedsat nyrefunktion: Der er ikke behov for dosisændringer til denne patientgruppe (se pkt.
English: Adults and children 12 years and over
Danish: Voksne og unge fra 12 år
English: Preparing the nasal spray for use You must prepare the nasal spray:
Danish: Klargøring af næsesprayen Du skal klargøre næsesprayen:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INTRANASAL SPRAY/DEVICE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: What Alisade is and what it is used for Before you use Alisade How to use Alisade
Danish: Det skal du vide, før du begynder at bruge Alisade Sådan skal du bruge Alisade Bivirkninger
English: The plastic device contains the nasal spray suspension within a Type I amber bottle (glass) fitted with a metering spray pump.
Danish: Plastkapppen omslutter næsesprayen i brun glasflaske (type 1) med doseringspumpe.
English: 3 Hold the nasal spray upright, then tilt and point the nozzle away from you.
Danish: Hold næsesprayen, så næsestudsen peger væk fra dig.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Hvis det er tæt på næste dosis, skal du blot vente og tage den. Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Alisade 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Danish: Alisade 27,5 mikrogram/pust, næsespray, suspension Fluticasonfuroat
English: Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds.
Danish: De kan også opstå året rundt på grund af allergi over for dyr, husstøvmider eller skimmelsvamp.
English: Each spray delivers 27.5 micrograms of fluticasone furoate.
Danish: Et pust giver ca. 27,5 mikrogram fluticasonfuroat.
English: Alisade nasal spray is a predominantly off-white plastic device with a dose indicator window, light blue side actuated lever and lid which contains a stopper.
Danish: ALISADE næsespray, suspension, består af en plastkappe med vindue, lyseblå dosisknap og tætsluttende hætte.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each spray delivers 27.5 micrograms of fluticasone furoate
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et pust afgiver 27,5 mikrogram fluticasonfuroat
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Danish: anafylaktisk chok, angioødem, udslæt og urticaria
English: Driving and using machines Alisade is unlikely to affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt, at Alisade påvirker arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: 1 Shake the nasal spray vigorously with the cap on for about 10 seconds.
Danish: Ryst næsesprayen grundigt i ca. 10 sekunder med hætten på.
English: Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall response to therapy compared to placebo in three studies.
Danish: Allergisk helårsrhinitis hos voksne og unge (fra 12 år) Fluticasonfuroat næsespray 110 mikrogram 1 gang daglig forbedrede signifikant nasalsymptomerne og patienternes opfattelse af det samlede behandlingsrespons sammenlignet med placebo i tre kliniske forsøg.
English: PSURs
Danish: EXP
English: What Alisade contains
Danish: Alisade indeholder:
English: NAME OF THE MEDICINAL PRODUCT ALISADE 27.5 micrograms/spray nasal spray suspension
Danish: LÆGEMIDLETS NAVN ALISADE 27,5 mikrogram/pust næsespray, suspension
English: What Alisade looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Danish: Medicinen er en hvid suspension i brun glasflaske med pumpefunktion.
English: BEFORE YOU USE ALISADE
Danish: Hvis du har glemt at bruge Alisade
English: Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged periods.
Danish: Intranasale kortikosteroider kan give systemiske bivirkninger, specielt ved høje doser i længere tid.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Alisade, skal du henvende dig til den lokale repræsentant:
English: In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation.
Danish: I dyreforsøg er der påvist abnormiteter som ganespalte og IUGR.
English: Fluticasone furoate 110 micrograms once daily was not associated with hypothalamicpituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects.
Danish: Hverken hos voksne, unge eller børn førte 110 mikrogram fluticasonfuroat 1 gang daglig til suppression af hypothalamus-hypofyse-binyrebarkfunktionen (HPA).
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: Indehaver af markedsføringstilladelsen og fremstiller
English: Renal Impairment:
Danish: Nedsat nyrefunktion:
English: HOW TO USE ALISADE
Danish: SÅDAN SKAL DU BRUGE ALISADE
English: Take special care with Alisade:
Danish: Vær ekstra forsigtig med at bruge Alisade
English: If you have any further questions on the use of this product, or if you have any discomfort using the nasal spray ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om, eller hvis det er ubehageligt at bruge næsesprayen.
English: Taking nasal glucocorticoids (such as Alisade):
Danish: Behandling med binyrebarkhormoner i næsen (fx Alisade)
English: NAME OF THE MEDICINAL PRODUCT Alisade 27.5 micrograms/spray nasal spray suspension Fluticasone furoate
Danish: LÆGEMIDLETS NAVN Alisade 27,5 mikrogram/pust Fluticasonfuroat
English: For a full list of excipients, see section 6.1.
Danish:  Se brugsanvisningen efter punkt 6.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: If any of the side effects gets serious or troublesome, or if you notice any side effects not listed in this leaflet: Tell your doctor or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver generende eller værre, eller du får bivirkninger, som ikke er nævnt her.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Alisade 27.5 micrograms/spray nasal spray suspension Fluticasone fuorate
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Alisade 27,5 mikrogram/pust
English: Very common
Danish: Ikke relevant
English: Tell your doctor if you are taking, or have recently taken, any other medicines, including those bought without a prescription.
Danish: Brug af anden medicin Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: 7 If your dose is two sprays in each nostril repeat steps 4 to 6.
Danish: 4-6, hvis du skal have to pust i hvert næsebor.
English: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info.lt@gsk.com
Danish: GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00
English: It may cause irritation of the nasal mucosa.
Danish: Det kan forårsage irritation i næseslimhinden.
English: 30 sprays 60 sprays 120 sprays
Danish: 120 pust
English: Nasal use
Danish: Næsestuds
English: Nasal ulceration
Danish: Fluticasonfuroat
English: BATCH NUMBER LOT {Number}
Danish: BATCHNUMMER
English: If you use more Alisade than you should
Danish: Hvis du har taget for meget Alisade
English: • Check the nasal spray for damage
Danish: Undersøg om næsesprayen er ødelagt.
English: Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily.
Danish: Effekten af fluticasonfuroat næsespray 110 mikrogram 1 gang daglig blev bekræftet i en post hoc-analyse over 6 og 12 uger i det samme kliniske forsøg samt i et 6 ugers HPA-aksesikkerhedsforsøg.
English: Hepatic Impairment:
Danish: Nedsat leverfunktion:
English: contact your doctor as soon as possible.
Danish: Kontakt lægen så hurtigt som muligt.
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 15 January 2019
Danish: Dato for første markedsføringstilladelse: 8. maj 2014 Dato for seneste fornyelse: 15 januar 2019
English: The following statements reflect studies conducted on the individual components.
Danish: De følgende redegørelser er baseret på studier udført med enkeltkomponenterne.
English: Once daily
Danish: En gang daglig.
English: These belong to a group of medicines called bronchodilators.
Danish: Disse tilhører en gruppe af lægemidler, der kaldes bronkodilatatorer.
English: Characteristics in specific groups of healthy volunteers or patients
Danish: Karakteristika hos specifikke grupper af raske personer eller patienter
English: n/e
Danish: n/a
English: Frequency cannot be estimated from the available data: • dizziness.
Danish: Hyppigheden kan ikke beregnes ud fra tilgængelige data: • svimmelhed.
English: Barnard Castle, County Durham DL12 8DT United Kingdom
Danish: Barnard Castle, County Durham DL12 8DT Storbritannien
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Danish: Reduktionen af serumkalium er normalt forbigående og kræver ikke supplering.
English: No dose adjustment is required in patients over 65 years.
Danish: Dosisjustering er ikke nødvendig hos patienter over 65 år.
English: Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies.
Danish: Patienter med klinisk signifikant ukontrolleret kardiovaskulær sygdom blev udelukket fra de kliniske studier.
English: For pharmacokinetic purposes each component can therefore be considered separately.
Danish: Derfor kan hvert stof farmakokinetisk betragtes hver for sig.
English: ANORO ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation.
Danish: Anoro Ellipta skal administreres på samme tidspunkt hver dag for at opretholde bronkodilatation.
English: • increase of the measured eye pressure
Danish: • stigning i det målte øjentryk
English: When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life.
Danish: Når medicinen tages regelmæssigt, kan den hjælpe med at holde dine vejrtrækningsproblemer under kontrol og mindske påvirkningen af KOL i din dagligdag.
English: Concurrent use of either non-selective or selective beta-adrenergic blockers should be avoided unless there are compelling reasons for their use.
Danish: Samtidig brug af både ikke-selektive og selektive beta-adrenerge blokkere bør undgås, medmindre der er tvingende grunde hertil.
English: These studies were not specifically designed to evaluate the effect of treatments on COPD exacerbations and patients were withdrawn from the study if an exacerbation occurred.
Danish: Disse studier var ikke specifikt designet til at evaluere effekten af behandling på KOL-eksacerbationer og patienter blev trukket ud af studiet, hvis en eksacerbation opstod.
English: Treatment difference1 (95% confidence intervals, p-value) Trough FEV1 (ml)
Danish: Behandlingsforskel1 (95 % konfidensinterval, p-værdi) Trough FEV1 (ml)
English: N=number in Intent-to-treat population mcg = micrograms n/e = not evaluated
Danish: N = antal i Intend-to-treat population n/a = Ikke evalueret
English: This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.
Danish: Denne medicin modvirker stramning af musklerne i lungerne, så luften lettere kan komme ind og ud.
English: - if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for umeclidinium, vilanterol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: You may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache.
Danish: Du kan opleve, at dit hjerte slår hurtigere end normalt, at du ryster, får synsforstyrrelser, får tør mund, eller at du får hovedpine.
English: It is a quinuclidine derivative with activity across multiple muscarinic receptor subtypes.
Danish: Det er et quinuclidinderivat med aktivitet på tværs af flere undertyper af muskarinreceptorer.
English: Improvement in EET compared with placebo was seen at Day 2 and was sustained at Week 6 and Week 12.
Danish: Der blev set forbedring i EET sammenlignet med placebo på dag 2, og den var fastholdt ved uge 6 og uge 12.
English: Difference in the mean number of puffs per day over Weeks 1-24
Danish: Forskel i gennemsnitligt antal pust om dagen i uge 1-24.
English: It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor.
Danish: Det er meget vigtigt, at du tager Anoro Ellipta hver dag nøjagtigt efter lægens anvisning.
English: 1) Read this before you start If you open and close the cover without inhaling the medicine, you will lose the dose.
Danish: 1) Læs dette, inden du starter Hvis du åbner og lukker beskyttelseshætten uden at inhalere medicinen, vil dosis gå tabt.
English: Talk to your doctor before using this medicine: - if you have asthma (Don't use ANORO ELLIPTA to treat asthma)
Danish: Kontakt lægen, før du tager dette lægemiddel: hvis du har astma (brug ikke Anoro Ellipta til behandling af astma)
English: Pooled data from Study DB2113360 and Study DB2113374
Danish: Poolede data fra studie DB2113360 og studie DB2113374.
English: There is no relevant use of ANORO ELLIPTA in the paediatric population (under 18 years of age) for the indication of COPD.
Danish: Det er ikke relevant at anvende Anoro Ellipta i den pædiatriske population (i alderen under 18 år) til indikationen KOL.
English: Don't use ANORO ELLIPTA if you already use these medicines.
Danish: Du må ikke bruge Anoro Ellipta, hvis du allerede tager nogen af disse lægemidler.
English: Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Danish: Umeclidinium/vilanterol bør kun anvendes under graviditet, hvis den forventede fordel for moderen opvejer den potentielle risiko for fostret.
English: In COPD the muscles around the airways tighten.
Danish: Ved KOL strammes musklerne omkring luftvejene.
English: A dose-dependent increase in heart rate was also observed.
Danish: Der blev desuden observeret en dosisafhængig øgning af hjertefrekvensen.
English: Summary of the safety profile The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%).
Danish: Sammendrag af sikkerhedsprofilen Den hyppigst rapporterede bivirkning ved umeclidinium/vilanterol var nasopharyngitis (9 %).
English: Vilanterol was not teratogenic in rats.
Danish: Vilanterol var ikke teratogent i rotter.
English: The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates observed in the integration of five 24-week studies and in the 12-month safety study.
Danish: Hyppigheden for bivirkningerne klassificeret i nedenstående tabel omfatter incidensrater observeret ved sammenlægning af fem studier af 24 ugers varighed og i sikkerhedsstudiet af 12 måneders varighed.
English: COPD is a long-term condition characterised by breathing difficulties that slowly get worse.
Danish: KOL er en langvarig sygdom, hvor vejrtrækningsproblemer langsomt bliver værre.
English: The active substances are present as a white powder in separate blisters inside the inhaler.
Danish: De aktive stoffer er et hvidt pulver, som ligger i separate blistere inde i inhalatoren.
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: Umeclidinium was not teratogenic in rats or rabbits.
Danish: Umeclidinium var ikke teratogent i rotter eller kaniner.
English: Following oral inhalation both compounds act locally on airways to produce bronchodilation by separate mechanisms.
Danish: Efter oral inhalation virker begge stoffer lokalt på luftvejene og giver bronkodilatation via forskellige mekanismer.
English: It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Anoro Ellipta vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Following oral administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in faeces.
Danish: Efter oral administration af radioaktivt mærket vilanterol viste massebalancen 70 % af radioaktivitet i urinen og 30 % i fæces.
English: Genotoxicity and carcinogenicity
Danish: Genotoksicitet og carcinogent potentiale
English: • suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness)
Danish: • pludselig svaghedsfornemmelse eller svimmelhed (kan føre til besvimelse eller bevidstløshed).
English: Other antimuscarinics and sympathomimetics
Danish: Andre antimuskarinika og sympatomimetika
English: Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be lifethreatening.
Danish: Administration af umeclidinium/vilanterol kan forårsage paradoks bronkospasme, der kan være livstruende.
English: Immediate breathing difficulties after using ANORO ELLIPTA are rare.
Danish: Akutte vejrtrækningsproblemer efter brug af Anoro Ellipta er sjældne.
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 personer):
English: If you have any of the following symptoms after taking ANORO ELLIPTA stop using this medicine and tell your doctor immediately.
Danish: Hvis du oplever nogle af de følgende symptomer, efter du har taget Anoro Ellipta, skal du stoppe med at tage medicinen og straks kontakte lægen.
English: Atrial fibrillation Supraventricular tachycardia Rhythm idioventricular Tachycardia
Danish: Supraventrikulær takykardi Idioventrikulær rhythm Takykardi
English: A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium or vilanterol based on the effect of age, race, gender, inhaled corticosteroid use, or weight.
Danish: En populationsfarmakokinetisk analyse viste, at dosisjustering ikke er nødvendigt for umeclidinium eller vilanterol baseret på effekten af alder, race, køn, forbrug af inhalationssteroider eller vægt.
English: However, other beta2-adrenergic agonists are detected in human milk.
Danish: Andre beta2-agonister kan dog spores i human mælk.
English: EU/1/14/898/001 1 inhaler of 7 doses EU/1/14/898/002 1 inhaler of 30 doses
Danish: EU/1/14/898/001 1 inhalator med 7 doser EU/1/14/898/002 1 inhalator med 30 doser
English: Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet ved eksponeringer, der ikke er klinisk relevante, efter administration af vilanterol (se pkt.
English: Step-by-step instructions What is the inhaler?
Danish: Brugervejledning Hvad er en inhalator?
English: The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Danish: Sikkerhedsprofilen for Anoro Ellipta er baseret på sikkerhedserfaringer med umeclidinium/vilanterol og de to komponenter individuelt fra det kliniske udviklingsprogram, der omfattede 6.855 patienter med KOL, og fra spontan indrapportering.
English: If you forget to use ANORO ELLIPTA Don't inhale an extra dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Anoro Ellipta Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Danish: Den absolutte biotilgængelighed af inhaleret vilanterol var 27 %, med et ubetydeligt bidrag fra oral absorption.
English: The tray can be discarded after first opening.
Danish: Bakken kan kasseres efter åbning.
English: The other ingredients are lactose monohydrate (see section 2 under ‘ANORO ELLIPTA contains lactose') and magnesium stearate.
Danish: Øvrige indholdsstoffer: lactosemonohydrat (se punkt 2 ”Anoro Ellipta indeholder lactose” og magnesiumstearat.
English: Verapamil, a moderate CYP3A4 inhibitor, did not significantly affect the pharmacokinetics of vilanterol.
Danish: Verapamil, en moderat CYP3A4-hæmmer, påvirkede ikke signifikant farmakokinetikken af vilanterol.
English: Improvements in TDI focal score compared with each monotherapy component and tiotropium were not statistically significant (see Table 1).
Danish: Forbedringer i TDI fokal score sammenlignet med hver monoterapikomponent og tiotropium var ikke statistisk signifikant (se tabel 1).
English: Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol.
Danish: Lægemidler, der indeholder beta-adrenerge blokkere, kan svække eller antagonisere virkningen af beta2adrenerge agonister, såsom vilanterol.
English: Supraventricular extrasystoles Palpitations
Danish: Supraventrikulære ekstrasystoler Palpitationer