FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may interfere with the interpretation of the images.
Danish: Fortæl det altid til nuklearmedicineren, hvis De bruger anden medicin eller har gjort det for nylig.
English: For repeated use, see section 4.4.
Danish: For gentagen brug henvises til pkt.
English: Adrenal
Danish: Amning
English: GERMANY
Danish: Administration
English: Trace a starting line 2.5 cm from the bottom of the paper strip.
Danish: (ITLC-SG ) eller for papirkromatografi (RBM-1).Tegn en startlinje 2,5 cm fra bunden af papirstrimlen.
English: Colon
Danish: Milt
English: Renal impairment / Hepatic impairment
Danish: Nedsat nyrefunktion/nedsat leverfunktion
English: Whole body
Danish: aktivitet totale
English: Breast
Danish: Bryster
English: In general, patients were monitored for about 27 months, during which they took the medicine for about 24 months on average.
Danish: Generelt blev patienterne overvåget i ca. 27 måneder, i løbet af hvilke de i gennemsnit fik lægemidlet i ca. 24 måneder.
English: Other information about Neparvis
Danish: Andre oplysninger om Neparvis
English: The full EPAR for Neparvis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Neparvis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Neparvis tablets are taken twice a day.
Danish: Neparvis-tabletter tages to gange dagligt.
English: Why is Neparvis approved?
Danish: Hvorfor er Neparvis blevet godkendt?
English: This is a summary of the European public assessment report (EPAR) for Neparvis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neparvis.
English: A risk management plan has been developed to ensure that Neparvis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Neparvis anvendes så sikkert som muligt.
English: What is Neparvis and what is it used for?
Danish: Hvad er Neparvis, og hvad anvendes det til?
English: This medicine is the same as Entresto, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Entresto, som allerede er godkendt i Den Europæiske Union (EU).
English: The study was stopped early because there was compelling evidence that Neparvis was more effective than enalapril.
Danish: Undersøgelsen blev standset tidligt, fordi der var overbevisende dokumentation for, at Neparvis var mere effektivt end enalapril.
English: In the group treated with Neparvis, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril.
Danish: I den gruppe, der blev behandlet med Neparvis, afgik 21,8 % (914 af 4 187) ved døden på grund af hjerte- og kredsløbsproblemer eller blev indlagt med hjertesvigt, sammenholdt med 26,5 % (1 117 af 4 212) af dem, der blev behandlet med enalapril.
English: The company that makes Entresto has agreed that its scientific data can be used for Neparvis (‘informed consent').
Danish: Virksomheden, som fremstiller Entresto, har indvilget i, at dens videnskabelige oplysninger må anvendes for Neparvis (informeret samtykke).
English: The recommended starting dose is one tablet of Neparvis 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Danish: Den anbefalede startdosis er 1 tablet af Neparvis 49 mg/51 mg to gange dagligt, som efter 2-4 uger fordobles til 97 mg/103 mg to gange dagligt.
English: Neparvis can only be obtained with a prescription.
Danish: Neparvis udleveres kun efter recept.
English: What are the risks associated with Neparvis?
Danish: Hvilke risici er der forbundet med Neparvis?
English: Neparvis is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Danish: Neparvis fås som tabletter (24 mg sacubitril/26 mg valsartan, 49 mg sacubitril/51 mg valsartan og 97 mg sacubitril/103 mg valsartan).
English: What measures are being taken to ensure the safe and effective use of Neparvis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Neparvis?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Neparvis are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Neparvis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Neparvis.
Danish: Det er ikke en praktisk vejledning i, hvordan Neparvis bør anvendes.
English: It must not be taken by patients who have suffered angioedema, those who have severe liver disease or by women who are pregnant.
Danish: Det må ikke anvendes af patienter, der har haft angioødem eller har svær leversygdom, eller af gravide.
English: Valsartan is an ‘angiotensin-II-receptor antagonist', which means that it blocks the action of a hormone called angiotensin II.
Danish: Valsartan er en "angiotensin-II-receptor-antagonist", hvilket betyder, at den blokerer virkningen af hormonet angiotensin II.
English: Sacubitril blocks the breakdown of natriuretic peptides produced in the body.
Danish: Sacubitril blokerer nedbrydningen af natriuretiske peptider, der produceres i kroppen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neparvis, 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 Neparvis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The two active substances in Neparvis, sacubitril and valsartan, work in different ways.
Danish: De to aktive stoffer i Neparvis, sacubitril og valsartan, virker på forskellig måde.
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone's harmful effects on the heart and it also reduces blood pressure by allowing blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder til, standser valsartan hormonets skadelige virkninger på hjertet og nedsætter også blodtrykket ved at lade karrene udvide sig.
English: The most common side effects with Neparvis (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Danish: De hyppigste bivirkninger ved Neparvis (som kan optræde hos mere end 1 ud af 10 personer) er højt kaliumindhold i blodet, lavt blodtryk og nedsat nyrefunktion.
English: Patients in the study had long-term heart failure with symptoms of the disease and reduced ejection fraction (the proportion of blood leaving the heart).
Danish: Patienterne i undersøgelsen havde langvarigt hjertesvigt med symptomer på sygdommen, herunder nedsat uddrivningsfraktion (den andel af blodet, der forlader hjertet).
English: The serious side effects of Neparvis in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Danish: De alvorlige bivirkninger ved Neparvis i hovedundersøgelsen svarede til bivirkningerne ved enalapril, som allerede er godkendt til anvendelse ved hjertesvigt.
English: How is Neparvis used?
Danish: Hvordan anvendes Neparvis?
English: Neparvis must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Danish: Neparvis må ikke tages sammen med lægemidler af typen ACE-hæmmere (som anvendes til behandling af hjertesvigt og højt blodtryk).
English: For more information about treatment with Neparvis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Neparvis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the study, Neparvis was compared to enalapril, another medicine used for heart failure.
Danish: I undersøgelsen blev Neparvis sammenlignet med enalapril, et andet lægemiddel, der anvendes ved hjertesvigt.
English: Neparvis is a heart medicine that contains the active substances sacubitril and valsartan.
Danish: Neparvis er et hjertelægemiddel, der indeholder de to aktive stoffer sacubitril og valsartan.
English: Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissue) that occurs in heart failure.
Danish: Natriuretiske peptider nedsætter også blodtrykket og beskytter hjertet mod den udvikling af arvæv (fibrose), som optræder ved hjertesvigt.
English: The main study found that Neparvis reduced deaths from heart and circulation problems or hospital admissions for heart failure.
Danish: Hovedundersøgelsen viste, at Neparvis nedsatte dødeligheden ved hjerte- og kredsløbsproblemer og omfanget af indlæggelser for hjertesvigt.
English: For practical information about using Neparvis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Neparvis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Neparvis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Neparvis?
English: For the full list of all side effects reported with Neparvis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Neparvis fremgår af indlægssedlen.
English: Neparvis has been shown to be effective in treating heart failure in one main study.
Danish: En hovedundersøgelse har vist, at Neparvis er effektivt til at behandle hjertesvigt.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: How does Neparvis work?
Danish: Hvordan virker Neparvis?
English: 1 pump
Danish: 1 pumpe
English: Cutaneous use Multidose container with airless pump (PP/TPO/HDPE)
Danish: Flerdosisbeholder med ikke-ventileret pumpe (PP/TPO/HDPE)
English: 3 inhalers with 60 actuations
Danish: 3 inhalatorer, som hver har 60 doser
English: Abilify has been authorised since June 2004.
Danish: Abilify har været godkendt siden juni 2004.
English: 17 December 2009 EMA/809491/2009 EMEA/H/C/471
Danish: EMEA/H/C/471
English: The study lasted up to a year and involved 1,076 patients, some of whom had completed one of the three short-term studies.
Danish: Undersøgelsen varede i op til et år og omfattede 1 076 patienter, hvoraf nogle havde gennemført en af de tre korttidsundersøgelser.
English: What is Abilify?
Danish: Hvad er Abilify?
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Danish: Dets nøjagtige virkningsmåde kendes ikke, men man ved, at det bindes til flere forskellige receptorer på overfladen af nervecellerne i hjernen.
English: The main measure of effectiveness was the change in symptoms over the six weeks of dual treatment.
Danish: Det primære effektmål var en forandring i symptomerne i løbet af de seks uger med kombinationsbehandling.
English: Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Abilify (aripiprazole)
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om ændring af markedsføringstilladelsen for Abilify (aripiprazol)
English: At the start of the study, the patients were put on an eight-week course of an antidepressant (escitalopram, sertraline, venlafaxine, fluoxetine or paroxetine).
Danish: I starten af undersøgelsen gennemgik patienterne et 8-ugers forløb med et antidepressivt middel (escitalopram, sertralin, venlafaxin, fluoxetin eller paroxetin).
English: Abilify was not compared with any other treatments in this study and the patients knew which medicines they were taking.
Danish: Abilify blev ikke sammenlignet med nogen andre behandlinger i denne undersøgelse, og patienterne vidste, hvilke lægemidler de tog.
English: There are no consequences on the use of Abilify in its authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Abilify til de godkendte indikationer, for hvilke benefit/riskforholdet forbliver uændret.
English: The 1,090 patients who did not respond to this antidepressant then added either Abilify or placebo (a dummy treatment).
Danish: De 1 090 patienter, som ikke responderede på dette antidepressive middel, supplerede det herefter med enten Abilify eller placebo (en virkningsløs behandling).
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Danish: Det aktive stof i Abilify, aripiprazol, er et antipsykotisk lægemiddel.
English: What was Abilify expected to be used for?
Danish: Hvad forventedes Abilify anvendt til?
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af "neurotransmittere", dvs. kemiske stoffer, som nervecellerne bruger til at kommunikere indbyrdes.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth), an oral solution and a solution for injection.
Danish: Det fås som tabletter, smeltetabletter (tabletter, der opløses i munden), oral opløsning og injektionsvæske, opløsning.
English: On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.
Danish: Den 17. november 2009 meddelte Otsuka Pharmaceutical Europe Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om en ny indikation for Abilify til behandling af resistente større depressive episoder.
English: Abilify is a medicine that contains the active substance aripiprazole.
Danish: Abilify er et lægemiddel, der indeholder det aktive stof aripiprazol.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Danish: Aripiprazol menes at virke hovedsagelig som "partiel agonist" for receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin).
English: Each patient received an antidepressant that they had not previously taken for the current depressive episode.
Danish: Alle patienter fik et antidepressivt middel, som de ikke tidligere havde taget for den aktuelle depressive episode.
English: The short-term studies were ‘double-blind', which means that neither the patients nor the investigators knew which patients were receiving Abilify and which were receiving placebo.
Danish: Korttidsundersøgelserne var "dobbeltblindede", hvilket betyder, at hverken patienterne eller investigatorerne vidste, hvilke patienter der fik Abilify, og hvilke patienter der fik placebo.
English: Since dopamine and 5-hydroxytryptamine are involved in major depression, Abilify is expected to help to normalise the activity of the brain when it is added to antidepressants, reducing the symptoms of major depressive episodes.
Danish: Da dopamin og 5-hydroxytryptamin er involveret ved svær depression, forventes Abilify at være med til at normalisere hjerneaktiviteten, når det anvendes som supplement til antidepressiva, så symptomerne på større depressive episoder reduceres.
English: The company presented the results of three short-term and one long-term study to support its application.
Danish: Til støtte for sin ansøgning fremlagde virksomheden resultaterne af tre korttids- og en langtidsundersøgelse.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Danish: Det betyder, at aripiprazol virker som dopamin og 5-hydroxytryptamin, idet det aktiverer disse receptorer, dog i mindre grad end neurotransmitterne.
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækningen af ansøgningen, kan ses her.
English: How is Abilify expected to work?
Danish: Hvordan forventes Abilify at virke?
English: The full European Public Assessment Report for Abilify is available here.
Danish: Den fuldstændige EPAR for Abilify findes her.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Abilify could not have been approved for the treatment of resistant major depressive episodes.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Abilify ikke kunne have været godkendt til behandling af større depressive episoder.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Abilify in the treatment of major depressive episodes did not outweigh its risks.
Danish: På tilbagetrækningstidspunktet var CHMP således af den opfattelse, at fordelene ved Abilify til behandling af større depressive episoder ikke opvejer risiciene.
English: The CHMP was concerned over the patients included in the studies, as it was not clear whether they all had resistant depression, defined as failure to respond to at least two previous antidepressants.
Danish: CHMP havde betænkeligheder med hensyn til de patienter, der deltog i undersøgelserne, eftersom det ikke fremgik klart, om de alle led af resistent depression, der defineres som manglende respons på mindst to tidligere antidepressiva.
English: It is already used to treat schizophrenia, and to treat and prevent manic episodes (periods of extremely high mood) in patients with bipolar I disorder.
Danish: Det anvendes allerede til behandling af skizofreni og til behandling og forebyggelse af maniske episoder (perioder med ekstremt højt humør) hos patienter med bipolar lidelse type 1.
English: What is happening with Abilify for the treatment of schizophrenia and the treatment and prevention of manic episodes in bipolar I disorder?
Danish: Hvad sker der med Abilify til behandling af skizofreni og til behandling og forebyggelse af maniske episoder ved bipolar lidelse type 1?
English: The Committee was also concerned that there was no long-term information from ‘double-blind' studies looking at the maintenance of Abilify's effects and its ability to prevent depression coming back.
Danish: CHMP havde ligeledes betænkeligheder med hensyn til, at der ikke var nogen langtidsinformation fra "dobbeltblindede" undersøgelser, hvor man undersøgte fastholdelsen af Abilifys virkning og dets evne til at forebygge tilbagevendende depression.
English: Abilify was also expected to be used, in addition to antidepressants, to treat major depressive episodes in patients who had not responded adequately to previous antidepressant treatment.
Danish: Abilify forventedes anvendt som supplement til antidepressiva til behandling af større depressive episoder hos patienter, der ikke havde responderet tilstrækkeligt på tidligere antidepressiv behandling.
English: The short-term studies involved patients with major depressive episodes that had not responded to up to three previous antidepressant treatments.
Danish: Korttidsundersøgelserne omfattede patienter med større depressive episoder, der ikke havde responderet på højst tre tidligere antidepressive behandlinger.
English: The long-term study looked at the maintenance of Abilify's effects when added to an antidepressant.
Danish: I langtidsundersøgelsen undersøgte man fastholdelsen af Abilifys virkning, når det anvendes som supplement til et antidepressivt middel.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Abilify?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Abilify eller i programmer for anvendelse af Abilify med særlig udleveringstilladelse?
English: Major depressive episodes are periods of depressed mood or loss of interest in everyday activities that last for at least two weeks in patients with major depression.
Danish: Større depressive episoder er perioder, som varer mindst to uger, hvor patienter med svær depression lider af dårligt humør eller manglende interesse i hverdagsaktiviteter.
English: The company informed the CHMP that there are no consequences for patients currently in clinical trials or compassionate use programmes using Abilify.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Abilify eller i programmer for anvendelse af Abilify med særlig udleveringstilladelse.
English: The evaluation was withdrawn after ‘day 90'.
Danish: Ansøgningsproceduren var ved dag 90, da virksomheden trak sin ansøgning tilbage.
English: The final agreed wording was:
Danish: Den vedtagne endelige ordlyd var:
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • udvalget behandlede henvisningen i henhold til artikel 30 i direktiv 2001/83/EF,
English: Overall summary of the scientific evaluation of EMLA cream and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af EMLA creme og relaterede navne (se bilag I)
English: • Adults
Danish: • Voksne
English: EMLA was first approved in Sweden in 1984 and is currently nationally approved in 22 countries of the European Economic Area (EEA): Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Danish: EMLA blev først godkendt i Sverige i 1984 og er på nuværende tidspunkt nationalt godkendt i 22 lande i Det Europæiske Økonomiske Samarbejdsområde (EØS): Østrig, Belgien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Letland, Luxembourg, Malta, Nederlandene, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige samt Island og Norge.
English: In the majority of the countries the following age ranges are approved: neonates 0-2 months, infants 3-11 months and children 1-11 years.
Danish: I de fleste lande er følgende aldersgrupper godkendt: nyfødte 0-2 måneder, småbørn 3-11 måneder og børn 1-11 år.
English: • Mechanical cleansing/debridement
Danish: • Mekanisk rensning/debridering
English: A similar restriction (with caveats) for children 3 months and above was also considered necessary.
Danish: En tilsvarende begrænsning (med cave) for børn over tre måneder fandtes ligeledes nødvendig.
English: This information explains the time-course of the dynamic effects and how health care professionals can adapt to facilitate the procedures.
Danish: Disse oplysninger forklarer tidsforløbet af de dynamiske effekter, og hvordan sundhedspersoner kan tilpasse sig derefter for at lette indgrebene.