FrancophonIA/ELRC3.0 huggingface dataset:
English: This will allow the general public to access information in the database in all languages and it will include more information 9 The Agency will continue to develop the EudraVigilance database and will add a new component on suspected unexpected serious adverse reactions 9 EMEA will also prepare and design a database of manufacturing authorisations and good manufacturing practice certificates required under the new Directive on human medicines
Danish: EMEA ligeledes udarbejde og udforme en database over fremstillingsgodkendelser og certifikater for god fremstillingspraksis, der kræves i henhold til det nye direktiv om humanmedicinske lægemidler
English: The performance indicator for this objective is the percentage of products evaluated within the regulatory timeline of 210 days.
Danish: Præstationsindikatoren for denne målsætning er procenten af produkter, der vurderes inden for
English: Sara Mendosa, Head of Sector for infrastructure services, b. 23 January 1950, n. British
Danish: Sara Mendosa, leder af sektionen for infrastrukturtjenester,
English: CHMP Guideline on handling direct healthcare professional communication for medicinal products for human use
Danish: CHMP Guideline on Risk Assessment of Medicinal Products on Human
English: To be released for consultation in 2Q 2005
Danish: Sendes til høring i 2. kv.
English: Joint CHMP/CVMP Quality Working Party Working party on Environmental Risk Assessment Scientific advisory group on Antimicrobials Scientific Advice Working Party
Danish: Arbejdsgruppen vedrørende lægemiddelovervågning Arbejdsgruppen vedrørende bioteknologi Fælles CHMP/CVMP-arbejdsgruppe vedrørende kvalitet
English: Medicines for human use
Danish: Human Use
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Danish: Martin HARVEY ALLCHURCH Tlf.: (direkte nummer) (44-20) 74 18 84 27
English: Total Title 2
Danish: Status specifications trin 2
English: For matters relating to pharmacovigilance for
Danish: Pharmacovigilance for Vaccines
English: Education: Business studies and languages at Loughborough Polytechnic Career to date: From 1975 to 1990, Mrs Mendosa held a number of posts at the European Commission in Luxembourg, including the Conference Service, the Office for Official Publications and the Statistical Office.
Danish: Karriereforløb: Fra 1975 til 1990 beklædte Sara Mendosa en række stillinger i Europa
English: Position paper to be developed
Danish: Konceptdokument udvikles
English: medicinal products for veterinary use
Danish: af veterinærlægemidler
English: He was re-elected chairman of the CHMP in 2004.
Danish: Han blev genvalgt som formand i 2004.
English: To be released for consultation in 2/3Q 2005
Danish: Sendes til høring i 2./3.
English: Revision of the current procedural framework for the evaluation of medicines, quality assurance and increased level of scientific support by the Agency
Danish: Gennemgang af de eksisterende proceduremæssige rammer for vurdering af lægemidler,
English: Management and organisation of the CVMP
Danish: Policy for the transmission of PhVWP
English: Guideline on the clinical investigation To be released for consultation in
Danish: Note for guidance on the clinical investigation of recombinant Factor
English: EU Comments in preparation of ICH Guideline
Danish: EU-kommentarer til forberedelse af
English: To provide timely information on MRLs to the public in accordance with agreed timelines
Danish: Målet er, at 100 % af ansøgningerne skal være evalueret inden for denne frist At tilvejebringe rettidig information til offentligheden om maksimale grænseværdier i overensstemmelse med aftalte frister
English: To be finalised in 2/3Q 2005
Danish: Afsluttes i 2./3.
English: To be finalised in 3Q 2005
Danish: Afsluttes i 3. kv.
English: Contents
Danish: Indhold
English: Completion of the internal evaluation work with new Member States in the context of the Canadian mutual recognition agreement
Danish: At færdiggøre optagelsen af de nye medlemsstater i MRA (EF-Canada)
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 15 January 2019
Danish: Dato for første markedsføringstilladelse: 23. september 2014 Dato for seneste fornyelse: 15. januar 2019
English: There is no relevant use of Ulunar Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Danish: Der er ingen relevant brug af Ulunar Breezhaler i den pædiatriske population (under 18 år) ved indikationen KOL.
English: Please read the full Instructions for Use before using the Ulunar Breezhaler.
Danish: Læs venligst den fulde anvisning for brug inden du bruger Ulunar Breezhaler.
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Ulunar Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Danish: Øvrige mest almindelige bivirkninger relateret til lægemidlet (mindst 3 % af patienterne på Ulunar Breezhaler og også højere end for placebo) var hoste, nasopfaryngitis og hovedpine.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Ulunar Breezhaler inhaler.
Danish: Den anbefalede dosis er inhalation af indholdet i en kapsel én gang dagligt ved hjælp af Ulunar Breezhaler-inhalatoren.
English: The presentation of the safety profile is based on the experience with Ulunar Breezhaler and the individual active substances.
Danish: Oplysningerne om sikkerhedsprofilen er baseret på erfaringerne med Ulunar Breezhaler og de individuelle aktive stoffer.
English: Therefore Ulunar Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Danish: Ulunar Breezhaler bør derfor ikke gives sammen med beta-adrenerge blokkere (herunder øjendråber), medmindre der er tvingende årsager hertil.
English: Following inhalation of Ulunar Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Danish: Efter inhalation af Ulunar Breezhaler er den absolutte biotilgængelighed af indacaterol blevet estimeret til at være fra 61 til 85 % af leveret dosis, og for glycopyrronium var den omkring 47 % af leveret dosis.
English: You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit, or you may notice visual disturbances, feel constipated or have difficulty when passing urine.
Danish: Du kan muligvis opleve, at dit hjerte slår hurtigere end normalt, eller du kan have hovedpine, føle dig døsig, have kvalme eller blive nødt til at kaste op. Du kan også opleve synsforstyrrelser, føle dig forstoppet eller have problemer med at lade vandet.
English: Talk to your doctor, pharmacist or nurse before using Ulunar Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Ulunar Breezhaler hvis noget af følgende passer på dig: - hvis du har astma - denne medicin må ikke bruges til behandling af astma.
English: The effect was significantly greater for Ulunar Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Danish: Virkningen var signifikant højere for Ulunar Breezhaler sammenlignet med indacaterol, glycopyrronium eller tiotropium alene (forskel på 110 ml for hver sammenligning).
English: General disorders and administration site conditions Pyrexia1
Danish: Almene symptomer og reaktioner på administrationsstedet Pyreksi1
English: Ulunar Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Danish: Ulunar Breezhaler kan bruges ved den anbefalede dosis til ældre patienter (75 år eller ældre).
English: Ulunar Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Danish: Ulunar Breezhaler må ikke anvendes til behandling af astma, da der ikke foreligger data for denne indikation.
English: - When you start a new pack, use the new Ulunar Breezhaler inhaler that is supplied in the pack.
Danish: - Når du starter på en ny pakning, skal du bruge den nye Ulunar Breezhaler-inhalator, som er vedlagt pakningen.
English: Administration of Ulunar Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Danish: Anvendelse af Ulunar Breezhaler kan medføre paradoks bronkospasme, hvilket kan være livstruende.
English: The components of Ulunar Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Danish: Komponenterne i Ulunar Breezhaler er ikke kendt for at have et QT-forlængende potentiale ved kliniske dosisniveauer.
English: Do not use Ulunar Breezhaler - if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ulunar Breezhaler - hvis du er allergisk over for indacaterol eller glycopyrronium eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: During long-term clinical studies, more patients on Ulunar Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Danish: Kliniske langtidsstudier har vist, at flere patienter på Ulunar Breezhaler har oplevet klinisk betydningsfulde ændringer i blodglukose (4,9 %) ved den anbefalede dosis end ved placebo (2,7 %).
English: No specific interaction studies were conducted with Ulunar Breezhaler.
Danish: Der er ikke udført specifikke interaktionsstudier med Ulunar Breezhaler.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ulunar Breezhaler contains lactose”).
Danish: - Øvrige indholdsstoffer i inhalationspulveret: lactosemonohydrat og magnesiumstearat (se afsnit 2 under ”Ulunar Breezhaler indeholder lactose”).
English: If you use more Ulunar Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Danish: Hvis du har inhaleret for meget af dette lægemiddel, eller hvis andre personer ved et uheld bruger dine kapsler, skal du øjeblikkeligt fortælle det til din læge eller henvende dig til den nærmeste skadestue.
English: Indacaterol administered to dogs alone or in Ulunar Breezhaler was associated with a similar incidence and severity of myocardial lesions.
Danish: Indacaterol administreret til hunde alene eller i Ulunar Breezhaler var forbundet med sammenlignelig forekomst og sværhedsgrad af myokardielæsioner.
English: In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Ulunar Breezhaler (contain similar active substances).
Danish: Fortæl det især til lægen, hvis du tager: medicin som kan være tilsvarende Ulunar Breezhaler (indeholder lignende aktive stoffer).
English: Show the pack of Ulunar Breezhaler.
Danish: Vis dem pakken med Ulunar Breezhaler.
English: If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Danish: Hvis der opstår symptomer, som antyder allergiske reaktioner, specielt angioødem (vejrtræknings- eller synkebesvær, hævet tunge, læber og ansigt), urticaria eller hududslæt, skal behandlingen seponeres med det samme og alternativ terapi startes.
English: Upon initiation of treatment with Ulunar Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Danish: Ved påbegyndelse af behandling med Ulunar Breezhaler skal plasmaglukose monitoreres tættere hos diabetespatienter.
English: Not for acute use Ulunar Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Danish: Ikke til akut brug Ulunar Breezhaler er ikke indiceret til behandling af akutte tilfælde af bronkospasmer.
English: The use of Ulunar Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Danish: Anvendelsen af Ulunar Breezehaler hos ammende kvinder bør kun overvejes, hvis den forventede fordel for kvinden er større end den potentielle risiko for spædbarnet (se pkt.
English: The safety experience with Ulunar Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Danish: Erfaringer vedrørende sikkerhed af Ulunar Breezhaler er baseret på data fra op til 15 måneders eksponering ved den anbefalede terapeutiske dosis.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ulunar Breezhaler should any of these signs or symptoms develop.
Danish: Patienter skal informeres om tegn og symptomer på akut snævervinklet glaukom og skal informeres om øjeblikkelig seponering af Ulunar Breezhaler, hvis patienten udvikler nogle af disse tegn eller symptomer.
English: Indacaterol, one of the active substances in Ulunar Breezhaler, may prevent labour due to its effect on the uterus.
Danish: Indacaterol, et af de aktive stoffer i Ulunar Breezhaler, kan muligvis forhindre veer på grund af effekten på livmoderen.
English: There are no data from the use of Ulunar Breezhaler in pregnant women available.
Danish: Der er utilstrækkelige data fra anvendelse af Ulunar Breezhaler til gravide kvinder.
English: Ulunar Breezhaler should be used with caution in these patient groups.
Danish: Ulunar Breezhaler bør anvendes med forsigtighed til disse patientgrupper.
English: Following inhalation of Ulunar Breezhaler, the median time to reach peak plasma concentrations of indacaterol and glycopyrronium was approximately 15 minutes and 5 minutes, respectively.
Danish: Efter inhalation af Ulunar Breezhaler var mediantiden for opnåelse af maksimal plasmakoncentration af glycopyrronium og indacaterol henholdsvis ca. 15 minutter og 5 minutter.
English: What Ulunar Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Danish: Ulunar Breezhaler indeholder - Aktive stoffer: indacaterol (som maleat) og glycopyrroniumbromid.
English: Ulunar Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Danish: Indgift af Ulunar Breezhaler om morgenen reducerede dynamisk hyperinflation og forøgede tiden hvor fysisk aktivitet kunne opretholdes fra første dosis.
English: When indacaterol and glycopyrronium are administered together in Ulunar Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Danish: Når indacaterol og glycopyrronium gives samtidig i Ulunar Breezhaler, udøver de en additiv virkning grundet deres forskellige virkningsmekanisme, der er målrettet forskellige receptorer og signalveje til at opnå afslappelse af den glatte muskulatur.
English: • Ulunar Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Danish: • Ulunar Breezhaler kapsler skal altid opbevares i den originale blister og må først tages ud umiddelbart inden anvendelse.
English: During treatment with Ulunar Breezhaler - Stop using this medicine and seek medical help immediately if you experience any of the following: eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of an acute attack of narrow-angle glaucoma.
Danish: Under behandling med Ulunar Breezhaler - Stop med at tage medicinen og søg lægehjælp øjeblikkeligt, hvis du oplever en af følgende tilstande: øjensmerter eller -ubehag, midlertidig sløring af synet, visuelle ringe eller farvet syn i forbindelse med røde øjne.
English: There was no evidence for tachyphylaxis to the effect of Ulunar Breezhaler over time when compared to placebo or its monotherapy components.
Danish: Der var ikke tegn på takyfylaksi over for virkningen af Ulunar Breezhaler over tid ved sammenligning med placebo eller dets monoterapikomponenter.
English: There were no relevant effects of Ulunar Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Danish: Der var ingen relevante virkninger af Ulunar Breezhaler på den gennemsnitlige hjertefrekvens i løbet af 24 timer og på hjertefrekvensen målt efter 30 minutter, 4 timer og 24 timer.
English: There is no information on clinically relevant overdosing with Ulunar Breezhaler.
Danish: Der er ingen information vedrørende klinisk relevant overdosering med Ulunar Breezhaler.
English: Ulunar Breezhaler showed clinically meaningful improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) in a number of clinical studies.
Danish: Ulunar Breezhaler viste klinisk relevant forbedring af lungefunktionen (målt ved forceret ekspiration i et sekund, FEV1) i en række kliniske studier.
English: • Do not use the Ulunar Breezhaler capsules with any other inhaler.
Danish: • Brug ikke Ulunar Breezhaler kapsler med nogen anden inhalator.
English: Ulunar Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Danish: Ulunar Breezhaler skal anvendes med forsigtighed hos patienter med kardiovaskulære sygdomme (koronar hjertesygdom, akut myokardieinfarkt, hjertearytmier, hypertension)
English: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are the active substances of Ulunar Breezhaler.
Danish: Der er rapporteret øjeblikkelige overfølsomhedsreaktioner efter administration af indacaterol eller glycopyrronium, som er de aktive stoffer i Ulunar Breezhaler.
English: Therefore, Ulunar Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Danish: Derfor må Ulunar Breezhaler kun anvendes under graviditet, hvis den forventede fordel opvejer den potentielle risiko for fosteret.
English: Ulunar Breezhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Danish: Ulunar Breezhaler skal anvendes med forsigtighed hos patienter med konvulsive sygdomme eller tyrotoksikose og hos patienter, som er usædvanlig responsive over for beta2-adrenerge agonister.
English: This will also help you to remember to use it. You can inhale Ulunar Breezhaler any time before or after food or drink.
Danish: Du kan inhalere Ulunar Breezhaler på hvilket som helst tidspunkt før og efter indtagelse af mad og drikke.
English: The combination of indacaterol and glycopyrronium in Ulunar Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Danish: Kombinationen af indacaterol og glycopyrronium i Ulunar Breezhaler viste en hurtigt indsættende virkning inden for 5 minutter efter dosering.
English: Increased heart rates were apparent in dogs at all doses of Ulunar Breezhaler and each monotherapy component.
Danish: Der var tydeligt øget hjertefrekvens hos hunde ved alle doser Ulunar Breezhaler og hver monoterapikomponent.
English: Ulunar Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Danish: Ulunar Breezhaler er indiceret som bronkodilaterende vedligeholdelsesbehandling til symptomlindring hos voksne patienter med kronisk obstruktiv lungesygdom (KOL).
English: Ulunar Breezhaler is recommended to be administered at the same time of the day each day.
Danish: Det anbefales at tage Ulunar Breezhaler på samme tidspunkt hver dag.
English: The Ulunar Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Danish: Det kliniske Fase III-udviklingsprogram for Ulunar Breezhaler omfattede seks studier, der inkluderede mere end 8.000 patienter: 1) et 26-ugers placebo- og aktiv-kontrolleret studie (indacaterol én gang dagligt, glycopyrronium én gang dagligt, open-label tiotropium én gang dagligt); 2) et 26-ugers aktivkontrolleret studie (fluticason/salmeterol to gange dagligt); 3) et 64-ugers aktivkontrolleret studie (glycopyrronium én gang dagligt, open-label tiotropium én gang dagligt); 4) et 52-ugers placebokontrolleret studie; 5) et 3-ugers placebo- og aktiv-kontrolleret (tiotropium én gang dagligt) arbejdstolerance-studie og 6) et 52-ugers aktiv-kontrolleret studie (fluticason/salmeterol to gange dagligt).
English: Based on the in vitro performance data, the dose of indacaterol delivered to the lung is expected to be similar for Ulunar Breezhaler and indacaterol monotherapy product.
Danish: På grundlag af in vitro performancedata forventes dosis af indacaterol leveret til lungerne at være den samme for Ulunar Breezhaler og indacaterol monoterapiproduktet.
English: The highest dose level of 464 micrograms/86 micrograms Ulunar Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Danish: Det højeste doseringsniveau på 464 mikrogram/86 mikrogram Ulunar Breezhaler viste også en højere andel af absolutte QTcF-værdier >450 ms (12,2 % versus 5,7 % for placebo).
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Ulunar Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Danish: En farmakokinetisk populationsanalyse af data fra KOL-patienter efter inhalation af Ulunar Breezhaler viste ingen signifikant virkning af alder, køn og (fedt-fri) legemsvægt på systemisk eksponering af indacaterol og glycopyrronium.
English: The effects on heart rate for Ulunar Breezhaler increased in magnitude and duration when compared with the changes observed for each component alone consistent with an additive response.
Danish: Ulunar Breezhaler havde en både kraftigere og længere varende virkning på hjertefrekvensen sammenlignet med ændringerne observeret for hver af komponenterne alene, hvilket er i overensstemmelse med en additiv virkning.
English: Ulunar Breezhaler is used as an ongoing treatment for your COPD.
Danish: Ulunar Breezhaler anvendes som en vedvarende behandling af din KOL.
English: Time to first pneumonia was prolonged with Ulunar Breezhaler compared to fluticasone/salmeterol (p=0.013).
Danish: Tid til første pneumoni blev forlænget med Ulunar Breezhaler sammenlignet med fluticason/salmeterol (p=0,013).
English: The co-administration of Ulunar Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Danish: Brug af Ulunar Breezhaler sammen med andre lægemidler indeholdende antikolinergika er ikke undersøgt og kan derfor ikke anbefales (se pkt.
English: Ulunar Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Ulunar Breezhaler belong (see section 4.5).
Danish: Ulunar Breezhaler bør ikke anvendes sammen med lægemidler indeholdende andre langtidsvirkende beta-adrenerge agonister eller langtidsvirkende muskarine antagonister, der er de farmakoterapeutiske grupper, som komponenterne i Ulunar Breezhaler tilhører (se pkt.