FrancophonIA/ELRC3.0 huggingface dataset:
English: Cialis is a medicine containing the active substance tadalafil.
Danish: Cialis er et lægemiddel, der indeholder det aktive stof tadalafil.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dagligt, afhængigt af hvor godt det tolereres.
English: Cialis must not be used where sexual activity is inadvisable (e.g. in men with heart disease).
Danish: Cialis må ikke anvendes, når seksuel aktivitet er frarådet (f.eks. hos mænd med hjertesygdom).
English: It must also not be taken by 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, NAION).
Danish: Det må heller ikke indtages af patienter, som på noget tidspunkt har haft synstab forårsaget af et problem med blodtilførslen til nerven i øjet (non-arteritis anterior iskæmisk opticusneuropati (NAION)).
English: Cialis is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Cialis anvendes til behandling af mænd med erektil dysfunktion (undertiden kaldet impotens), hvilket er manglende evne til at opnå eller opretholde en hård penis (erektion), som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: Once-a-day dosing of Cialis was studied in three further studies lasting 12 to 24 weeks and involving a total of 853 patients.
Danish: Den daglige enkeltdosering med Cialis blev undersøgt i tre yderligere undersøgelser over en periode på 12 til 24 uger med i alt 853 patienter.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cialis, 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 Cialis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance of Cialis, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'.
Danish: Det aktive stof i Cialis, tadalafil, tilhører en gruppe af lægemidler kaldet "phosphodiesterase type 5 (PDE5)-hæmmere".
English: The CHMP decided that Cialis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Cialis opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Cialis.
English: Cialis was significantly more effective than placebo in all studies in erectile dysfunction.
Danish: Cialis var væsentligt mere effektivt end placebo i alle undersøgelserne af erektil dysfunktion.
English: By blocking the breakdown of cGMP, Cialis restores erectile function.
Danish: Ved at hæmme nedbrydningen af cGMP genopretter Cialis den erektile funktion.
English: Cialis must not be taken with nitrates (a type of medicine used for angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension).
Danish: Cialis må ikke tages sammen med nitrater (en gruppe af lægemidler der anvendes til behandling af angina) eller lægemidler i klassen "guanylatcyklase-stimulatorer", såsom riociguat (et lægemiddel til behandling af højt blodtryk i de kar, der forsyner lungerne, kendt som pulmonal hypertension).
English: What is the risk associated with Cialis?
Danish: Hvilken risiko er der forbundet med Cialis?
English: For treating erectile dysfunction, the recommended dose of Cialis is 10 mg taken ‘on demand' at least 30 minutes before sexual activity.
Danish: Den anbefalede dosis Cialis til behandling af erektil dysfunktion er 10 mg, som indtages efter behov mindst 30 minutter inden seksuel aktivitet.
English: Cialis can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor's judgement.
Danish: Cialis kan, med udgangspunkt i lægens vurdering, indtages ved en lavere dosis én gang dagligt af mænd, som ønsker at bruge lægemidlet ofte (to gange om ugen eller mere).
English: Patients taking Cialis once a day at doses of 2.5 or 5 mg also reported improved erections compared with those taking placebo.
Danish: Patienter, der tog tadalafil en gang dagligt i en dosis på 2,5 eller 5 mg indberettede også om forbedrede erektioner sammenlignet med dem, der tog placebo.
English: By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Cialis also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Danish: Ved at blokere phosphodiesteraseenzymet og forhindre nedbrydningen af cGMP forbedrer Cialis endvidere blodstrømningen til blærehalskirtlen, og blæren og får musklerne heri til at slappe af.
English: The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated.
Danish: Dosis er 5 mg én gang dagligt, men kan sænkes til 2,5 mg én gang
English: In all studies, the effects of Cialis were compared with those of placebo (a dummy treatment), and the main measure of effectiveness was the ability to get and maintain an erection.
Danish: I samtlige undersøgelser blev virkningen af Cialis sammenlignet med placebo (en virkningsløs behandling), og virkningen blev hovedsageligt målt på evnen til at opnå og opretholde erektion.
English: The most common side effects with Cialis are headache, dyspepsia (indigestion), back pain and myalgia (muscle pain), which are more common at higher doses.
Danish: De hyppigste bivirkninger ved Cialis er hovedpine, dyspepsi (fordøjelsesbesvær), rygsmerter og muskelsmerter, som er mere almindelige ved højere doser.
English: Cialis given at a dose of 5 mg was also more effective than placebo in all the studies in patients with benign prostatic hyperplasia, with the results showing a significant improvement in symptoms after 12 weeks compared with placebo.
Danish: Cialis givet i dosis på 5 mg var også mere effektivt end placebo i alle undersøgelserne med patienter med godartet forstørret blærehalskirtel, hvor resultaterne viste en væsentlig forbedring i symptomerne efter 12 uger sammenlignet med placebo.
English: For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Danish: Til behandling af mænd med godartet forstørret blærehalskirtel eller mænd med både godartet forstørret blærehalskirtel og erektil dysfunktion er den anbefalede dosis 5 mg én gang dagligt.
English: Because Cialis has not been studied in patients who have had a heart attack within the last three months or a stroke within the last six months, or those who have high blood pressure or heart disorders (irregular heart beat), these men should not use the medicine.
Danish: Cialis må ikke anvendes til mænd, som har haft et hjertetilfælde inden for de seneste tre måneder eller et slagtilfælde inden for de seneste seks måneder, eller hos patienter med forhøjet blodtryk eller hjerteforstyrrelser (uregelmæssig hjerterytme), da Cialis ikke er blevet undersøgt hos disse patienter.
English: What is Cialis?
Danish: Hvad er Cialis?
English: For the full list of all side effects reported with Cialis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Cialis fremgår af indlægssedlen.
English: Cialis can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous), which involve problems with the flow of urine.
Danish: Cialis kan også anvendes til behandling af tegn og symptomer på godartet forstørret blærehalskirtel (benign prostatahyperplasi), som omfatter problemer med urinstrømmen.
English: Why has Cialis been approved?
Danish: Hvorfor blev Cialis godkendt
English: Four main studies comparing Cialis with placebo were carried out in 1,500 patients with the condition, including some who also had erectile dysfunction.
Danish: Cialis blev sammenlignet med placebo i fire hovedundersøgelser, som omfattede 1 500 patienter med denne tilstand, herunder nogle, som også havde erektil dysfunktion.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Danish: Stoffet cGMP produceres i penis ved seksuel stimulering og medfører en afslapning af musklerne i svulmelegemet (corpora cavernosa), hvorved blodstrømningen til corpora øges, og der således fremkaldes en erektion.
English: What is Cialis used for?
Danish: Hvad anvendes Cialis til?
English: For one of the questionnaires, where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded scores of 22.6 or 25 after receiving Cialis 10 mg or 20 mg, respectively.
Danish: I en af spørgeskemaundersøgelserne, hvor pointskalaen var 30, nåede patienter, der havde opnået 15 point inden behandlingen, op på 22,6 eller 25 point efter at have fået henholdsvis Cialis 10 mg eller 20 mg. I undersøgelserne blandt den almindelige befolkning som helhed oplyste 81 % af patienterne, at tadalafil efter behov havde forbedret deres erektion, mens tallet for placebo kun lå på 35 %.
English: Cialis has also been studied in patients with benign prostatic hyperplasia.
Danish: Cialis er også blevet undersøgt hos patienter med godartet forstørret blærehalskirtel.
English: How has Cialis been studied?
Danish: Hvordan blev Cialis undersøgt?
English: What benefit has Cialis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cialis?
English: How is Cialis used?
Danish: Hvordan anvendes Cialis?
English: Cialis, when taken ‘on demand' before sexual activity, has been studied in six main studies including 1,328 patients with erectile dysfunction.
Danish: Cialis blev undersøgt i seks hovedundersøgelser, der omfattede 1 328 patienter med erektil dysfunktion, hvor det blev indtaget efter behov inden seksuel aktivitet.
English: How does Cialis work?
Danish: Hvordan virker Cialis?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trevaclyn to Merck Sharp & Dohme Ltd. on 3 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trevaclyn til Merck Sharp & Dohme Ltd. den 3. juli 2008.
English: The Committee recommended that Trevaclyn be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Trevaclyn.
English: Other information about Trevaclyn:
Danish: Andre oplysninger om Trevaclyn:
English: The starting dose of Trevaclyn is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Danish: Startdosis for Trevaclyn er én tablet én gang dagligt i fire uger, hvorefter dosis øges til to tabletter én gang dagligt.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREVACLYN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TREVACLYN EPAR - sammendrag for offentligheden
English: The effects of Trevaclyn were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Trevaclyn blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Trevaclyn is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Danish: Trevaclyn anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning hos denne aldersgruppe.
English: Trevaclyn is used on its own only in patients who cannot take statins.
Danish: Trevaclyn anvendes alene hos patienter, der ikke tåler statiner.
English: The full EPAR for Trevaclyn can be found here.
Danish: Den fuldstændige EPAR for Trevaclyn findes her.
English: The most common side effect with Trevaclyn (seen in more than 1 patient in 10) is flushing.
Danish: Den mest almindelige bivirkning ved Trevaclyn (som optræder hos flere end 1 ud af 10 patienter) er flushing.
English: They included a total of 2,349 patients who were taking either Trevaclyn or nicotinic acid.
Danish: De omfattede i alt 2 349 patienter, som tog enten Trevaclyn eller nikotinsyre.
English: The two active substances in Trevaclyn, nicotinic acid and laropiprant, have different modes of action.
Danish: De to aktive stoffer i Trevaclyn, nikotinsyre og laropiprant, har forskellige virkemåder.
English: The second study showed that the LDL cholesterol levels were further reduced when Trevaclyn was taken with simvastatin (48% reduction), compared with Trevaclyn alone (17% reduction) or simvastatin alone (37% reduction).
Danish: Den anden undersøgelse viste, at indholdet af LDL-kolesterol blev yderligere sænket, når Trevaclyn blev givet sammen med simvastatin (48 % reduktion) sammenlignet med Trevaclyn alene (17 % reduktion) eller simvastatin alene (37 % reduktion).
English: Trevaclyn is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Danish: Trevaclyn anvendes normalt sammen med et statin (standard kolesterolsænkende lægemiddel), når virkningen af et statin alene er utilstrækkelig.
English: What is the risk associated with Trevaclyn?
Danish: Hvilken risiko er der forbundet med Trevaclyn?
English: The second study compared the combination of Trevaclyn and simvastatin (a statin) with Trevaclyn alone or simvastatin alone in 1,398 patients.
Danish: Den anden undersøgelse sammenlignede kombinationen af Trevaclyn og simvastatin (et statin) med Trevaclyn alene eller simvastatin alene hos 1 398 patienter.
English: In Trevaclyn tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Danish: I Trevaclyn-tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
English: For the full list of all side effects reported with Trevaclyn, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Trevaclyn fremgår af indlægssedlen.
English: Trevaclyn is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Danish: Trevaclyn er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3-vitamin) og laropiprant.
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Trevaclyn, compared with 1% in those taking placebo.
Danish: I den første undersøgelse blev indholdet af LDL-kolesterol reduceret med 19 % hos patienter, der fik Trevaclyn, sammenlignet med 1 % hos dem, der fik placebo.
English: Why has Trevaclyn been approved?
Danish: Hvorfor blev Trevaclyn godkendt?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn's benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Trevaclyn er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
English: Trevaclyn was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Danish: Trevaclyn blev undersøgt i fire hovedundersøgelser af patienter med hyperkolesterolæmi eller blandet dyslipidæmi.
English: Trevaclyn was effective in reducing the blood levels of LDL cholesterol.
Danish: Trevaclyn var effektivt til at sænke blodets indhold af LDL-kolesterol.
English: Trevaclyn should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Danish: Trevaclyn bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nikotinsyre, laropiprant eller andre af indholdsstofferne.
English: Two studies looked at the effectiveness of Trevaclyn in modifying blood fat levels.
Danish: To undersøgelser så nærmere på Trevaclyns virkning med hensyn til sænkning af blodets fedtindhold.
English: Trevaclyn is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘combined mixed dyslipidaemia' and ‘primary hypercholesterolaemia'.
Danish: Trevaclyn anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
English: What is Trevaclyn?
Danish: Hvad er Trevaclyn?
English: In the fourth study, flushing was seen on fewer days in patients taking Trevaclyn than in those taking nicotinic acid alone.
Danish: I den fjerde undersøgelse optrådte flushing færre dage hos patienter, som fik Trevaclyn, end hos dem, der fik nikotinsyre alene.
English: In the first and third studies, fewer patients taking Trevaclyn reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Danish: I den første og den tredje undersøgelse oplevede færre patienter, der fik Trevaclyn, moderat, svær eller ekstrem flushing, end det var tilfældet hos patienter, der fik nikotinsyre alene.
English: What is Trevaclyn used for?
Danish: Hvad anvendes Trevaclyn til?
English: How has Trevaclyn been studied?
Danish: Hvordan blev Trevaclyn undersøgt?
English: What benefit has Trevaclyn shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Trevaclyn?
English: The nicotinic acid is released more slowly from the other layer and has its effect as a fat-modifying agent.
Danish: Nikotinsyren frigives langsommere fra det andet lag og ændrer fedtindholdet i blodet.
English: The first study compared the effectiveness of Trevaclyn with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Danish: Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Trevaclyn med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL-kolesterol.
English: How is Trevaclyn used?
Danish: Hvordan anvendes Trevaclyn?
English: How does Trevaclyn work?
Danish: Hvordan virker Trevaclyn?
English: Previously known as Arcalyst.
Danish: Tidligere kendt under navnet Arcalyst.
English: It must not be used in patients with an active, severe infection.
Danish: Det må ikke anvendes til patienter, som har en aktiv svær infektion.
English: Severe disabilities such as deafness and loss of vision may also occur.
Danish: Svær invaliditet såsom døvhed og tab af syn kan også forekomme.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arcalyst to Regeneron UK Limited on 23 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Arcalyst til Regeneron UK Limited den 23. oktober 2009.
English: It contains the active substance rilonacept (80 mg/ml).
Danish: Det indeholder det aktive stof rilonacept (80 mg/ml).
English: Patients may inject themselves once they have been trained if their doctor believes it is appropriate.
Danish: Patienterne kan give sig selv indsprøjtningen, når de har lært teknikken, hvis lægen mener, at det er hensigtsmæssigt.
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Danish: CAPS er en gruppe af sygdomme, hvor patienter har en fejl i det gen, der danner et protein, som kaldes kryopyrin.
English: The full EPAR for Rilonacept Regeneron can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rilonacept Regeneron findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The name of the medicine was changed to Rilonacept Regeneron on 23 July 2010.
Danish: Lægemidlets navn blev ændret til Rilonacept Regeneron den 23. juli 2010.
English: The main measure of effectiveness was how much their symptoms reduced after the six-week treatment and how much the improvements were maintained after the nine-week treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor meget symptomerne var mindsket efter seks ugers behandling, og hvor længe bedringerne blev fastholdt efter ni ugers behandling.
English: This document is a summary of the European public assessment report (EPAR) for Rilonacept Regeneron.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rilonacept Regeneron.
English: This means that because the diseases are rare, it has not been possible to obtain complete information about Rilonacept Regeneron.
Danish: Det betyder, at sygdommene er så sjældne, at der ikke har kunnet skaffes fuldstændige oplysninger om Rilonacept Regeneron.
English: Because the number of patients with CAPS is low, the diseases are considered ‘rare', and Rilonacept Regeneron was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Danish: Da antallet af patienter med CAPS er lavt, betragtes sygdommene som ”sjældne”, og Rilonacept Regeneron blev udpeget som ”lægemiddel til sjældne sygdomme” den 10. juli 2007.
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain, and tiredness.
Danish: Dette fører til betændelse i mange dele af kroppen med symptomer såsom feber, udslæt, ledsmerter og træthed.
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 Rilonacept Regeneron.
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 Rilonacept Regeneron.
English: Rilonacept Regeneron has been authorised under ‘exceptional circumstances'.
Danish: Rilonacept Regeneron er godkendt under "særlige omstændigheder".
English: Adults should be given a starting dose of two injections of 160 mg each in two different parts of the body on the same day.
Danish: Startdosis til voksne er to injektioner på hver 160 mg, som gives på to forskellige steder af kroppen på samme dag.
English: It works by attaching to chemical messengers in the body called interleukin-1beta and interleukin-1 alpha. One of these messengers, interleukin-1 beta, is produced at high levels in patients with CAPS, causing inflammation.
Danish: Det virker ved at binde sig til kemiske signalstoffer i kroppen kaldet interleukin-1 beta og interleukin-1 alpha. Et af disse signalstoffer, interleukin-1 beta, dannes i store mængder hos patienter med CAPS, hvilket er årsag til betændelse.
English: Rilonacept Regeneron was more effective than placebo at treating symptoms of CAPS.
Danish: Rilonacept Regeneron var mere effektivt end placebo til at behandle symptomer på CAPS.
English: For more information about treatment with Rilonacept Regeneron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rilonacept Regeneron, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Rilonacept Regeneron is used to treat cryopyrin-associated periodic syndromes (CAPS).
Danish: Rilonacept Regeneron anvendes til behandling af kryopyrin-associerede periodiske syndromer (CAPS).