FrancophonIA/ELRC3.0 huggingface dataset:
English: Duloxetine Lilly must also not be used in patients with reduced liver function or patients with severely reduced kidney function.
Danish: Duloxetin Lilly må heller ikke anvendes hos patienter med nedsat leverfunktion eller svært nedsat nyrefunktion.
English: Duloxetine Lilly is available as gastroresistant capsules (30 mg and 60 mg).
Danish: Duloxetin Lilly fås som enterokapsler (30 og 60 mg).
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i dette lægemiddel, duloxetin, hæmmer genoptagelsen af serotonin og noradrenalin.
English: For more information about treatment with Duloxetine Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Duloxetin Lilly, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Danish: Hos patienter, der responderer på Duloxetin Lilly, bør behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage, eller længere hos patienter, der tidligere gentagne gange har haft perioder med depression.
English: The other two studies looked at how long it took for symptoms to return in patients who had initially responded to Duloxetine Lilly, including 288 patients with a history of repeated episodes of depression for up to five years.
Danish: I de to andre undersøgelser blev det registreret, hvor lang tid det tog for symptomerne at vende tilbage hos patienter, der i begyndelsen havde haft virkning af Duloxetin Lilly, herunder 288 patienter med tidligere gentagne episoder med depression i op til fem år.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Lilly?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duloxetin Lilly?
English: Duloxetine Lilly was shown to be more effective than placebo at treating the disorder and preventing symptoms returning.
Danish: Duloxetin Lilly var mere effektivt end placebo til at behandle sygdommen og forebygge tilbagevenden af symptomerne.
English: For neuropathic pain, Duloxetine Lilly has been compared with placebo in two 12-week studies in 809 diabetic adults.
Danish: Mod neuropatiske smerter er Duloxetin Lilly blevet sammenlignet med placebo i to 12-ugers undersøgelser hos 809 voksne diabetespatienter.
English: What is Duloxetine Lilly and what is it used for?
Danish: Hvad er Duloxetin Lilly, og hvad anvendes det til?
English: Other information about Duloxetine Lilly
Danish: Andre oplysninger om Duloxetin Lilly
English: In the two studies where the approved dose of Duloxetine Lilly was compared with placebo, Duloxetine Lilly was more effective.
Danish: I de to undersøgelser, hvor den godkendte dosis af Duloxetin Lilly blev sammenlignet med placebo, var Duloxetin Lilly mere effektivt.
English: Duloxetine Lilly duloxetine
Danish: Duloxetin Lilly duloxetin
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Danish: • smerter ved diabetesbetingede nervelidelser som følge beskadigelse af nerverne i arme og ben (perifer neuropati)
English: Why is Duloxetine Lilly approved?
Danish: Hvorfor blev Duloxetin Lilly godkendt?
English: For practical information about using Duloxetine Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Duloxetin Lilly, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In patients who respond to Duloxetine Lilly, treatment should continue for several months, to prevent the disorder coming back.
Danish: Hos patienter, hos hvem Duloxetin Lilly virker, skal behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage.
English: What are the risks associated with Duloxetine Lilly?
Danish: Hvilke risici er der forbundet med Duloxetin Lilly?
English: These studies showed that Duloxetine Lilly was more effective at reducing pain than placebo.
Danish: Disse undersøgelser viste, at Duloxetin Lilly var mere effektivt til at nedsætte smerterne end placebo.
English: It is not intended to provide practical advice on how to use Duloxetine Lilly.
Danish: Det er ikke en praktisk vejledning i, hvordan Duloxetin Lilly bør anvendes.
English: For generalised anxiety disorder, Duloxetine Lilly has been compared with placebo in five studies involving a total of 2,337 patients.
Danish: Mod generaliseret angst er Duloxetin Lilly blevet sammenlignet med placebo i fem undersøgelser med i alt 2 337 patienter.
English: For major depression, Duloxetine Lilly has been compared with placebo (a dummy treatment) in eight main studies involving a total of 2,544 patients.
Danish: Virkningen af Duloxetin Lilly ved svær depression er blevet sammenlignet med virkningsløs behandling (placebo) i otte hovedundersøgelser med tilsammen 2 544 patienter.
English: Although the results of the depression studies varied, Duloxetine Lilly was more effective than placebo in four of the studies.
Danish: Resultaterne af undersøgelserne vedrørende depression varierede, men i fire af undersøgelserne var Duloxetin Lilly mere effektivt end placebo.
English: For the full list of all side effects reported with Duloxetine Lilly, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Duloxetin Lilly fremgår af indlægssedlen.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Danish: Når deres genoptagelse i nervecellerne blokeres, opnår man derfor en bedring i depressionssymptomer og angst og i neuropatiske smerter.
English: How is Duloxetine Lilly used?
Danish: Hvordan anvendes Duloxetin Lilly?
English: How does Duloxetine Lilly work?
Danish: Hvordan virker Duloxetin Lilly?
English: The dose of Duloxetine Lilly should be reduced gradually when stopping treatment.
Danish: Når behandlingen ophører, bør det ske ved gradvis nedsættelse af dosis af Duloxetin Lilly.
English: What benefits of Duloxetine Lilly have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Duloxetin Lilly?
English: The patients were treated for eight weeks.
Danish: Patienterne var i behandling i otte uger.
English: It should not be taken together with grapefruit juice.
Danish: Den bør ikke tages sammen med grapefrugtsaft.
English: 'Essential' means that the hypertension has no obvious cause.
Danish: "Essentiel" betyder, at hypertensionen ikke har nogen klar årsag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasitrio on 22 November 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rasitrio den 22. november 2011.
English: It is available as tablets in the following strengths: 150 /5/12.5 mg; 300/5/12.5 mg; 300/5/25 mg; 300/10/12.5 mg; and 300/10/25 mg.
Danish: Det fås som tabletter i følgende styrker: 150/5/12,5 mg; 300/5/12,5 mg; 300/5/25 mg; 300/10/12,5 mg og 300/10/25 mg.
English: This is a summary of the European public assessment report (EPAR) for Rasitrio.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rasitrio.
English: The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Danish: Patienten skal tage en tablet en gang om dagen sammen med et let måltid, helst på samme tid hver dag.
English: The full EPAR for Rasitrio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rasitrio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The tablet should be swallowed whole with water.
Danish: Tabletten sluges hel med vand.
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 Rasitrio.
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 anvendelsesbetingelserne for Rasitrio.
English: The CHMP noted that taking the three active substances in one tablet, as opposed to taking separate tablets, may lead to better compliance with treatment.
Danish: CHMP bemærkede, at indtagelse af de tre aktive stoffer i én tablet i stedet for i separate tabletter kan føre til en bedre overholdelse af behandlingen.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Danish: Det blokerer særlige kanaler på celleoverfladen kaldet calciumkanaler, som calciumpartiklerne normalt kommer ind igennem.
English: Amlodipine is a calcium channel blocker.
Danish: Amlodipin er en calciumkanalblokker.
English: For more information about treatment with Rasitrio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rasitrio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Hydrochlorothiazide is a diuretic.
Danish: Hydrochlorthiazid er et diuretikum.
English: The main measure of effectiveness was the reduction in the average systolic blood pressure (blood pressure when the heart is contracting) measured when the patients were seated.
Danish: Det primære effektmål var sænkningen af det gennemsnitlige systoliske blodtryk (blodtrykket, når hjertet trækker sig sammen), målt hos patienter i siddende stilling.
English: After eight weeks, patients treated with Rasitrio had an average reduction in sitting systolic blood pressure of 37.4 mmHg.
Danish: Efter otte uger var det systoliske blodtryk i siddende stilling hos patienter, der blev behandlet med Rasitrio, gennemsnitligt faldet 37,4 mmHg.
English: Patients should be switched to the fixed combination tablet of Rasitrio that contains the same component doses as previously used individually.
Danish: Patienterne skal gå over til den faste kombinationstablet af Rasitrio, der indeholder de samme doser, som tidligere blev anvendt individuelt.
English: The Committee therefore decided that Rasitrio's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Rasitrio opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rasitrio.
English: The company also presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
Danish: Virksomheden fremlagde også resultaterne af undersøgelser, som viste, at tabletten, der indeholder alle tre stoffer, absorberes på samme måde i kroppen som de separate tabletter.
English: The most frequent adverse reactions for Rasitrio are hypotension and dizziness.
Danish: De hyppigste bivirkninger ved Rasitrio er hypotension og svimmelhed.
English: Studies also showed that the active substances in Rasitrio are absorbed in the body in the same way as the active substances when given as separate tablets.
Danish: Undersøgelser har også vist, at de aktive stoffer i Rasitrio optages i kroppen på samme måde, som når de aktive stoffer gives som separate tabletter.
English: Other information about Rasitrio
Danish: Andre oplysninger om Rasitrio:
English: By blocking the activity of renin, levels of both, angiotensin I and angiotensin II, fall.
Danish: Når renins aktivitet blokeres, mindskes niveauerne af både angiotensin I og angiotensin II.
English: It works by increasing urine production, reducing the volume of fluid in the blood and lowering the blood pressure.
Danish: Det virker ved at øge urinproduktionen, reducere mængden af væske i blodet og sænke blodtrykket.
English: The main study showed a greater reduction in blood pressure with Rasitrio than with combinations of two active substances.
Danish: Hovedundersøgelsen viste en større sænkning af blodtrykket med Rasitrio end med kombinationerne af to aktive stoffer.
English: This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
Danish: Dette fremkalder vasodilatation (udvidelse af blodkarrene), så blodtrykket falder.
English: The combination of these three active substances reduces blood pressure more than either medicine acting alone.
Danish: Kombinationen af disse tre aktive stoffer sænker blodtrykket mere end de enkelte lægemidler taget separat.
English: For the full list of all side effects reported with Rasitrio, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Rasitrio fremgår af indlægssedlen.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når calciumionerne kommer ind i muskelcellerne i blodkarvæggene, forårsager det en sammentrækning.
English: EPAR summary for the public aliskiren / amlodipine / hydrochlorothiazide
Danish: EPAR - sammendrag for offentligheden aliskiren / amlodipin / hydrochlorthiazid
English: Reductions of 28.2 mmHg, 30.6 mmHg and 30.8 mmHg were seen for aliskiren plus hydrochlorothiazide, aliskiren plus amlodipine and amlodipine plus hydrochlorothiazide respectively.
Danish: Der blev konstateret et fald på 28,2 mmHg, 30,6 mmHg og 30,8 mmHg for henholdsvis aliskiren plus hydrochlorthiazid, aliskiren plus amlodipin og amlodipin plus hydrochlorthiazid.
English: By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.
Danish: Ved at reducere mængden af calcium til cellerne forhindrer amlodipin blodkarvæggene i at trække sig sammen, hvorved blodtrykket sænkes.
English: What is the risk associated with Rasitrio?
Danish: Hvilken risiko er der forbundet med Rasitrio?
English: Rasitrio is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose.
Danish: Rasitrio anvendes til behandling af essentiel hypertension (højt blodtryk) hos voksne, hvis blodtryk allerede kontrolleres tilstrækkeligt med en kombination af aliskiren, amlodipin og hydrochlorthiazid, der gives samtidig i den samme dosis.
English: In a main study in 1,191 patients with moderate or severe hypertension, Rasitrio combinations containing the three active substances were compared with combinations containing only two active substances: aliskiren plus amlodipine, amlodipine plus hydrochlorothiazide, and aliskiren plus hydrochlorothiazide.
Danish: I en hovedundersøgelse af 1 191 patienter med moderat til svær hypertension blev Rasitriokombinationerne indeholdende de tre aktive stoffer sammenlignet med kombinationer indeholdende kun to aktive stoffer: aliskiren plus amlodipin, amlodipin plus hydrochlorthiazid og aliskiren plus hydrochlorthiazid.
English: Aliskiren is a renin inhibitor.
Danish: Aliskiren er en reninhæmmer.
English: Rasitrio must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, or hydrochlorothiazide, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine) or sulphonamide (includes hydrochlorothiazide).
Danish: Rasitrio må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren, amlodipin, hydrochlorthiazid, andre af indholdsstofferne i lægemidlet eller andre stoffer afledt af dihydropyridin (en gruppe, der omfatter amlodipin) eller sulfonamid (herunder hydrochlorthiazid).
English: Why has Rasitrio been approved?
Danish: Hvorfor blev Rasitrio godkendt?
English: The strength of the Rasitrio tablet that the patient takes depends on the doses of aliskiren, amlodipine and hydrochlorothiazide that they received previously.
Danish: Styrken af den Rasitrio-tablet, patienten tager, afhænger af de doser aliskiren, amlodipin eller hydrochlorthiazid, som patienten har taget tidligere.
English: Rasitrio is a medicine that contains the active substances aliskiren, amlodipine and hydrochlorothiazide.
Danish: Rasitrio er et lægemiddel, der indeholder de aktive stoffer aliskiren, amlodipin og hydrochlorthiazid.
English: What is Rasitrio?
Danish: Hvad er Rasitrio?
English: The Rasitrio combination was more effective than the double combinations at reducing systolic blood pressure.
Danish: Rasitrio-kombinationen var mere effektiv til sænkning af det systoliske blodtryk end kombinationerne med to aktive stoffer.
English: Rasitrio contains three active substances, aliskiren, amlodipine, and hydrochlorothiazide.
Danish: Rasitrio indeholder tre aktive stoffer: aliskiren, amlodipin og hydrochlorthiazid.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: Det blokerer virkningen af et enzym kaldet renin, der i kroppen medvirker ved dannelsen af stoffet angiotensin I. Angiotensin I omdannes til hormonet angiotensin II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: How has Rasitrio been studied?
Danish: Hvordan blev Rasitrio undersøgt?
English: What is Rasitrio used for?
Danish: Hvad anvendes Rasitrio til?
English: What benefit has Rasitrio shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rasitrio?
English: How is Rasitrio used?
Danish: Hvordan anvendes Rasitrio?
English: How does Rasitrio work?
Danish: Hvordan virker Rasitrio?
English: Consequently, the study results could not be considered reliable and could not be used for the evaluation of the vaccine.
Danish: Derfor kunne forsøgsresultaterne ikke betragtes som pålidelige og kunne ikke anvendes til evalueringen af vaccinen.
English: On 13 June 2008, Novartis Vaccines and Diagnostics S.r.l.
Danish: Novartis Vaccines and Diagnostics S.r.l.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for flere oplysninger om din behandling, kan du kontakte din behandlende læge.
English: The CHMP was concerned over the way the main clinical study was carried out.
Danish: CHMP var bekymret over den måde, hvorpå det vigtigste kliniske forsøg blev gennemført.
English: The virus used in the vaccine was first inactivated (killed) so that it does not cause any disease.
Danish: Den virus, der er anvendt i vaccinen, blev først inaktiveret (dræbt), så den ikke er sygdomsfremkaldende.
English: An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘good clinical practice' (GCP).
Danish: En inspektion af nogle af forsøgslokaliteterne viste, at forsøget ikke var blevet gennemført i overensstemmelse med "god klinisk praksis" (GCP).
English: The effects of Aflunov were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Aflunov er først blevet testet i forsøgsmodeller, inden det blev undersøgt hos mennesker.
English: The application was at day 190 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 190, da virksomheden trak sin ansøgning tilbage.
English: The main clinical study of Aflunov involved over 4,000 adults.
Danish: Det vigtigste kliniske forsøg med Aflunov omfattede over 4 000 voksne.
English: As a result, the size of the clinical database for the assessment of the vaccine's safety was not sufficient to fulfil the requirements of the EMEA's guidelines on prepandemic vaccines.
Danish: Som følge heraf var den kliniske database for vurdering af vaccinens sikkerhed ikke tilstrækkelig til at opfylde kravene i EMEA's retningslinjer om præpandemiske vacciner.
English: What is Aflunov?
Danish: Hvad er Aflunov?
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: Udbrud af en influenzapandemi forekommer, når der opstår en ny stamme af en influenzavirus, der let smitter fra menneske til menneske, fordi mennesker ikke er immune over for den. En pandemi kan berøre de fleste lande og regioner i hele verden.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Aflunov?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med Aflunov?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/VietNam/1194/2004)
Danish: SPØRGSMÅL OG SVAR I FORBINDELSE MED TILBAGETRÆKNING AF MARKEDSFØRINGSANSØGNINGEN for AFLUNOV Fællesnavn: Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) (A/VietNam/1194/2004)
English: Aflunov also contains an ‘adjuvant' (a compound containing oil), which is expected to stimulate a better response.
Danish: Aflunov indeholder desuden et "adjuvans" (et olieholdigt stof), der forventes at forstærke immunresponsen.
English: Aflunov is a vaccine.
Danish: Aflunov er en vaccine.
English: Aflunov was expected to provide protection against this strain, so that it could be used before or during a flu pandemic.
Danish: Man havde forventet, at Aflunov skulle yde beskyttelse mod denne stamme, så det kunne anvendes før eller under en pandemi.
English: What was Aflunov expected to be used for?
Danish: Hvad forventedes Aflunov anvendt til?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Danish: Baseret på gennemgang af data og virksomhedens svar på CHMP's liste over spørgsmål på tidspunktet for tilbagetrækning havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Aflunov ikke kunne være blevet godkendt til profylakse af H5N1 fugleinfluenza.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Danish: Når CHMP har fremsat en udtalelse, går der som regel cirka to måneder, før Europa-Kommissionen udsteder en markedsføringstilladelse.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Danish: Det er en særlig vaccinetype, som skal beskytte mod en influenzastamme, der eventuelt vil forårsage en influenzapandemi i fremtiden.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Da CHMP havde vurderet virksomhedens svar på en liste med spørgsmål, var der stadig nogle udestående spørgsmål, man ikke havde fået afklaring på.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod sygdommen.
English: What were the reasons given by the company to withdraw the application?
Danish: Hvilke begrundelser gav virksomheden for sin tilbagetrækning af ansøgningen?
English: Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Danish: Sundhedseksperter er bekymrede for, at den næste influenzapandemi kan forårsages af H5N1-stammen af virussen.