FrancophonIA/ELRC3.0 huggingface dataset:
English: The reduction in the rate of exacerbations was 10 to 12% higher with Ultibro Breezhaler than with tiotropium and glycopyrronium.
Danish: Faldet i andelen af tilbagefald var 10-12 % større med Ultibro Breezhaler end med tiotropium og glycopyrronium.
English: Regarding its safety, Ultibro Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Danish: Vedrørende sikkerheden er Ultibro Breezhaler sammenligneligt med indacaterol og glycopyrronium, når disse anvendes hver for sig.
English: In both studies, the main measure of effectiveness was how Ultibro Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Danish: I begge undersøgelser blev virkningen hovedsagelig bedømt på, hvordan 26 ugers behandling med Ultibro Breezhaler forbedrede patienternes forcerede udåndingsvolumen (FEV1, der er den maksimale mængde luft, en person kan udånde på et sekund).
English: Ultibro Breezhaler is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Danish: Ultibro Breezhaler leveres som inhalationspulver i kapsler og udleveres kun efter recept.
English: It is taken at the same time each day using the Ultibro Breezhaler device.
Danish: Det skal tages på samme klokkeslæt hver dag ved hjælp af Ultibro Breezhaler-inhalatoren.
English: The active substances in Ultibro Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Danish: Begge aktive stoffer i Ultibro Breezhaler, indacaterol og glycopyrronium, udvider luftvejene og forbedrer vejrtrækningen ved KOL, men de virker på forskellige måder.
English: It is not intended to provide practical advice on how to use Ultibro Breezhaler.
Danish: Det er ikke en praktisk vejledning i, hvordan Ultibro Breezhaler bør anvendes.
English: Other information about Ultibro Breezhaler
Danish: Andre oplysninger om Ultibro Breezhaler
English: In the second study the average increase in FEV1 was 140 ml more with Ultibro Breezhaler treatment than with treatment with fluticasone and salmeterol.
Danish: I den anden undersøgelse var den gennemsnitlige stigning i FEV1 140 ml større med Ultibro Breezhaler end med fluticason og salmeterol.
English: Why is Ultibro Breezhaler approved?
Danish: Hvorfor er Ultibro Breezhaler blevet godkendt?
English: What is Ultibro Breezhaler and what is it used for?
Danish: Hvad er Ultibro Breezhaler, og hvad anvendes det til?
English: What are the risks associated with Ultibro Breezhaler?
Danish: Hvilke risici er der forbundet med Ultibro Breezhaler?
English: For practical information about using Ultibro Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ultibro Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Ultibro Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ultibro Breezhaler fremgår af indlægssedlen.
English: A third study studied the effects of Ultibro Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Danish: En tredje undersøgelse vedrørte virkningerne af 64 ugers behandling med Ultibro Breezhaler på andelen af tilbagefald, sammenlignet med glycopyrronium eller tiotropium (andre midler mod KOL).
English: How is Ultibro Breezhaler used?
Danish: Hvordan anvendes Ultibro Breezhaler?
English: What benefits of Ultibro Breezhaler have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ultibro Breezhaler?
English: How does Ultibro Breezhaler work?
Danish: Hvordan virker Ultibro Breezhaler?
English: While one study compared the effects of Ultibro Breezhaler with those of placebo (a dummy inhalation), or indacaterol or glycopyrronium alone, the other study compared Ultibro Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Danish: Den ene undersøgelse sammenlignede virkningerne af Ultibro Breezhaler med virkningerne af placebo (en virkningsløs inhalator) eller med indacaterol eller glycopyrronium alene.
English: The
Danish: ACOMPLIA
English: The European Commission granted a marketing authorisation valid throughout the European Union for ACOMPLIA to sanofi-aventis on 19 June 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ACOMPLIA til sanofi-aventis den 19. juni 2006.
English: Medicinal product no longer authorised©EMEA 2007
Danish: Lægemidlet er ikke længere autoriseret til salg©EMEA 2007
English: Other information about ACOMPLIA:
Danish: Andre oplysninger om ACOMPLIA:
English: The effects of ACOMPLIA were first tested in experimental models before being studied in humans.
Danish: Virkningerne af ACOMPLIA blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The full EPAR for ACOMPLIA can be found here.
Danish: Den fuldstændige EPAR om ACOMPLIA findes her.
English: ACOMPLIA is taken as one tablet once a day, before breakfast.
Danish: Doseringen af ACOMPLIA er én tablet dagligt, som tages inden morgenmaden.
English: The Committee recommended that ACOMPLIA be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for ACOMPLIA.
English: It acts by blocking a specific type of receptor, the cannabinoid type 1 (CB1) receptors.
Danish: Det virker ved at blokere en bestemt type receptorer, der kaldes cannabinoid-receptorer type 1 (CB1).
English: ACOMPLIA is a medicine containing the active substance rimonabant.
Danish: ACOMPLIA er et lægemiddel, som indeholder det aktive stof rimonabant.
English: The company will use specific databases to monitor ACOMPLIA's side effects, especially those linked to the nervous system.
Danish: Firmaet anvender specifikke databaser til overvågning af bivirkninger ved ACOMPLIA, navnlig bivirkninger forbundet med nervesystemet.
English: The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist.
Danish: Det aktive stof i ACOMPLIA, rimonabant, er en cannabinoid-receptorantagonist.
English: The studies in smoking cessation did not show consistent results, and the effect of ACOMPLIA in this area was difficult to estimate.
Danish: Undersøgelserne med hensyn til opnåelse af rygestop gav ikke ensartede resultater, og det var vanskeligt at vurdere virkningen af ACOMPLIA på dette område.
English: Caution should be used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Danish: ACOMPLIA bør anvendes med forsigtighed i kombination med visse lægemidler, f.eks. ketoconazol eller itraconazol (lægemidler mod svamp), ritonavir (anvendes ved hiv-infektion), telithromycin eller clarithromycin (antibiotika).
English: ACOMPLIA is used together with diet and exercise to treat adult patients:
Danish: ACOMPLIA anvendes som supplement til diæt og motion til behandling af voksne patienter:
English: Therefore, ACOMPLIA is not recommended as an aid for smoking cessation
Danish: Det anbefales således ikke at anvende ACOMPLIA som hjælp til at stoppe rygning.
English: The company that makes ACOMPLIA will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
Danish: Firmaet, som fremstiller ACOMPLIA, iværksætter et program, der skal sikre, at lægemidlet anvendes til patienter til sundhedsmæssige formål frem for af kosmetiske årsager (ved at give uddannelsespakker til patienter og læger), og føre tilsyn med, hvordan lægemidlet anvendes.
English: What is the risk associated with ACOMPLIA?
Danish: Hvilken risiko er der forbundet med ACOMPLIA?
English: Which measures are being taken to ensure the safe use of ACOMPLIA?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af ACOMPLIA?
English: It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Danish: ACOMPLIA bør heller ikke anvendes til patienter med svær depression, eller som behandles med antidepressive midler, da det kan øge risikoen for depression, herunder selvmordstanker hos et mindre antal patienter.
English: Four studies of ACOMPLIA in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg. One study looked more particularly at patients with abnormal levels of blood fat, and one at patients with type 2 diabetes.
Danish: Der er foretaget fire undersøgelser af ACOMPLIA hos næsten 7 000 overvægtige og svært overvægtige patienter, hvis vægt i starten af undersøgelsen gennemsnitligt lå på mellem 94 og 104 kg. En af undersøgelserne så især nærmere på patienter med unormalt højt fedtindhold i blodet, og en anden så nærmere på patienter med type 2-diabetes.
English: Why has ACOMPLIA been approved?
Danish: Hvorfor blev ACOMPLIA godkendt?
English: The Committee for Medicinal products for Human Use (CHMP) concluded that ACOMPLIA had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at ACOMPLIA har vist sig effektivt til opnåelse af vægttab hos overvægtige eller svært overvægtige patienter med tilknyttede risikofaktorer.
English: During the studies, the most common side effects with ACOMPLIA (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Danish: I løbet af undersøgelserne var de hyppigste bivirkninger ved ACOMPLIA (som ses hos flere end 1 ud af 10 patienter) kvalme og infektioner i det øvre åndedrætssystem.
English: The Committee decided that ACOMPLIA's benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
Danish: Udvalget besluttede, at fordelene ved ACOMPLIA er større end risiciene ved anvendelse som supplement til diæt og motion til behandling af svært overvægtige patienter og overvægtige patienter med risikofaktorer såsom type 2-diabetes eller dyslipidæmi.
English: After one year, all patients who received ACOMPLIA lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
Danish: Efter et år havde alle patienter, der fik ACOMPLIA, opnået et større vægttab end dem, der fik placebo: de tabte gennemsnitligt 4,9 kg mere end patienterne i placebo-gruppen, undtagen i undersøgelsen af sukkersygepatienter, hvor forskellen i vægttabet var 3,9 kg. Lægemidlet nedsatte desuden risikoen for fornyet vægtøgning.
English: ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
Danish: ACOMPLIA bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for rimonabant eller andre af indholdsstofferne, eller af patienter, som ammer.
English: Four studies of ACOMPLIA as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
Danish: Undersøgelserne, der omfattede over 7 000 patienter, sammenlignede lægemidlet med placebo og målte virkningen af behandlinger på 10 uger (et år i en af undersøgelserne) med hensyn til opnåelse af rygestop og tilbagefald det følgende år.
English: What is ACOMPLIA?
Danish: Hvad er ACOMPLIA?
English: For the full list of all side effects reported with ACOMPLIA, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved ACOMPLIA fremgår af indlægssedlen.
English: What benefit has ACOMPLIA shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ACOMPLIA?
English: studies compared the effect of ACOMPLIA with that of a placebo (a dummy treatment) on weight loss over one to two years.
Danish: med placebo (en uvirksom behandling) med hensyn til vægttab over et til to år.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ACOMPLIA EPAR summary for the public
Danish: EPAR - sammendrag for offentligheden
English: What is ACOMPLIA used for?
Danish: Hvad anvendes ACOMPLIA til?
English: How is ACOMPLIA used?
Danish: Hvordan anvendes ACOMPLIA?
English: How has ACOMPLIA been studied?
Danish: Hvordan blev ACOMPLIA undersøgt?
English: How does ACOMPLIA work?
Danish: Hvordan virker ACOMPLIA?
English: The studies lasted 12 weeks.
Danish: Undersøgelserne varede 12 uger.
English: Other information about Levitra:
Danish: Andre oplysninger om Levitra:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levitra den 6. marts 2003.
English: This document is a summary of the European public assessment report (EPAR) for Levitra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levitra.
English: The full EPAR for Levitra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levitra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • patients who have had a stroke or a heart attack within the last six months;
Danish: • patienter, som har haft et hjerte- eller slagtilfælde inden for de seneste seks måneder
English: In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection.
Danish: I alle undersøgelserne var det primære effektmål evnen til at opnå og opretholde en erektion.
English: A risk management plan has been developed to ensure that Levitra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Levitra anvendes så sikkert som muligt.
English: Because Levitra has not been studied in the following group patients, they must not use the medicine:
Danish: Da Levitra ikke er blevet undersøgt hos de nedenstående patientgrupper, bør disse grupper ikke anvende lægemidlet:
English: The most common side effect with Levitra (seen in more than 1 patient in 10) is headache.
Danish: Den hyppigste bivirkning ved brug af Levitra (som ses hos flere end 1 ud af 10 patienter) er hovedpine.
English: What measures are being taken to ensure the safe and effective use of Levitra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levitra?
English: What is the risk associated with Levitra?
Danish: Hvilken risiko er der forbundet med Levitra?
English: • patients who have hypotension (low blood pressure);
Danish: • patienter med hypotension (for lavt blodtryk)
English: The recommended dose of Levitra is 10 mg, taken about 25 to 60 minutes before sexual activity.
Danish: Den anbefalede dosis Levitra er 10 mg, der indtages cirka 25 til 60 minutter inden seksuel aktivitet.
English: Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.
Danish: Levitra-tabletter og -smeltetabletter var betydeligt mere virkningsfulde end placebo i alle målinger i samtlige undersøgelser.
English: Levitra is a medicine that contains the active substance vardenafil.
Danish: Levitra er et lægemiddel, der indeholder det aktive stof vardenafil.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levitra.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Levitra skal anvendes.
English: For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levitra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why has Levitra been approved?
Danish: Hvorfor er Levitra blevet godkendt?
English: By blocking the breakdown of cGMP, Levitra restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Levitra den erektile funktion.
English: • patients with unstable angina and hereditary eye problems known as ‘retinal degenerative disorders'.
Danish: • patienter med ustabil angina eller arvelige øjenproblemer kaldet ”retinale degenerative sygdomme”.
English: Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years
Danish: I to yderligere hovedundersøgelser blev smeltetabletterne sammenlignet med placebo hos 701 mænd i alderen 21 til 84 år.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levitra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Levitra, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.
Danish: Dosen af filmovertrukne tabletter kan øges til maksimalt 20 mg eller nedsættes til 5 mg, afhængig af behandlingens virkning og eventuelle bivirkninger.
English: The CHMP decided that Levitra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Levitra opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Levitra.
English: Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Levitra anvendes til behandling af voksne mænd (over 18 år) med erektil dysfunktion (undertiden kaldet impotens), hvilket er manglende evne til at opnå eller opretholde en tilstrækkelig hård penis (erektion) til at kunne gennemføre tilfredsstillende seksuel aktivitet.
English: The maximum recommended dosing frequency is one film-coated tablet or orodispersible tablet per day.
Danish: Den maksimalt anbefalede dosishyppighed er én filmovertrukken tablet eller smeltetablet dagligt.
English: It must also not be used in patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Danish: Det må heller ikke indtages af patienter, som på noget tidspunkt har haft nedsat syn forårsaget af et problem med blodtilførslen til nerven i øjet (non-arteritis anterior iskæmisk opticusneuropati eller NAION).
English: If Levitra film-coated tablets are taken with a high fat meal, the onset of activity may be delayed.
Danish: Hvis filmovertrukne Levitra-tabletter indtages samtidig med et måltid med højt fedtindhold, kan virkningens indtræden forsinkes.
English: The active ingredient of Levitra, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive indholdsstof i Levitra, vardenafil, tilhører en gruppe af lægemidler, som kaldes hæmmere af fosfodiesterase type 5 (PDE5).
English: What is Levitra?
Danish: Hvad er Levitra?
English: One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed.
Danish: I én af disse undersøgelser indgik mænd med sukkersyge, og i en anden indgik mænd, som havde fået deres prostatakirtel fjernet.
English: It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere fosfodiesteraseenzymet, som normalt nedbryder et stof, der kaldes cyklisk guanosinmonofosfat (cGMP).
English: Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years.
Danish: Levitra-tabletter blev sammenlignet med placebo (en virkningsløs behandling) i fire hovedundersøgelser af 2 431 mænd med erektil dysfunktion i alderen 20 til 83 år.
English: Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with medicines called ‘HIV protease inhibitors' such as ritonavir or indinavir (used to treat HIV infection).
Danish: Levitra må ikke gives sammen med ketoconazol og itraconazol (til behandling af svampeinfektioner) til mænd over 75 år eller sammen med lægemidler kaldet ”hiv-proteasehæmmere” som f.eks. ritonavir og indinavir (til behandling af hiv-infektion).
English: Levitra must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients.
Danish: Levitra må ikke anvendes til patienter, der er overfølsomme (allergiske) over for vardenafil eller andre af indholdsstofferne.
English: • patients with severe liver disease or end-stage kidney disease requiring dialysis;
Danish: • patienter med svær lever- eller nyresygdom i slutstadiet, som kræver dialyse
English: In addition, Levitra must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Danish: Ydermere må Levitra ikke gives sammen med lægemidler af typen guanylatcyclasestimulatorer, herunder riociguat (til behandling af pulmonal hypertension [forhøjet blodtryk i lungerne]).
English: Levitra must not be taken with nitrates (medicines used to treat angina).
Danish: Levitra må ikke indtages sammen med nitrater (lægemidler, der anvendes til behandling af hjertekrampe (angina)).
English: For the full list of all side effects reported with Levitra, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Levitra fremgår af indlægssedlen.
English: What benefit has Levitra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Levitra?
English: What is Levitra used for?
Danish: Hvad anvendes Levitra til?
English: How has Levitra been studied?
Danish: Hvordan er Levitra blevet undersøgt?
English: For Levitra to be effective, sexual stimulation is required.
Danish: Seksuel stimulering er nødvendig for, at Levitra kan virke.
English: How is Levitra used?
Danish: Hvordan anvendes Levitra?
English: The dose may need to be adjusted in patients taking other medicines that block enzymes that break down Levitra.
Danish: For patienter med milde til moderate leverproblemer eller svære nyreproblemer anbefales en startdosis på 5 mg. Dosen skal muligvis justeres hos patienter, som tager andre lægemidler, der blokerer de enzymer, som nedbryder Levitra.
English: How does Levitra work?
Danish: Hvordan virker Levitra?
English: Crospovidone, type A
Danish: Crospovidon, type A
English: Some side effects can be serious (frequency not known):
Danish: Nogle bivirkninger kan være alvorlige (hyppighed ikke kendt):
English: Rasilez with food and drink
Danish: Brug af Rasilez sammen med mad og drikke