FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies have also shown that giving Fulphila produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at indgivelse af Fulphila danner samme niveau af det aktive stof i kroppen som indgivelse af Neulasta.
English: For the full list of side effects and restrictions with Fulphila, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Fulphila fremgår af indlægssedlen.
English: In Fulphila, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Fulphila er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Danish: Filgrastim får knoglemarven til at danne flere hvide blodlegemer, og stigningen i hvide blodlegemer modvirker neutropeni.
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Det fås som en fyldt sprøjte med injektionsvæske, opløsning, til indsprøjtning under huden.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.
Danish: Desuden har studier med brystkræftpatienter i behandling med kemoterapi vist, at Fulphila er lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: I laboratoriestudier, hvor Fulphila er blevet sammenlignet med Neulasta, er det påvist, at det aktive stof i Fulphila svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: How is Fulphila used?
Danish: Hvordan anvendes Fulphila?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulphila have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fulphila.
English: What benefits of Fulphila have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Fulphila?
English: How does Fulphila work?
Danish: Hvordan virker Fulphila?
English: Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Fulphila er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: It is available as tablets (75 mg).
Danish: Det fås som tabletter (75 mg).
English: The full EPAR for Clopidogrel Apotex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Clopidogrel Apotex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan Pharma on 16 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Clopidogrel Mylan Pharma den 16. oktober 2009.
English: The name of the medicine was changed to Clopidogrel Apotex on 20 January 2010.
Danish: Lægemidlets navn blev ændret til Clopidogrel Apotex den 20. januar 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Apotex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel Apotex.
English: For more information about treatment with Clopidogrel Apotex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel Apotex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Clopidogrel Apotex.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel Apotex.
English: This means that Clopidogrel Apotex is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Apotex er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: The standard dose of Clopidogrel Apotex is one 75-mg tablet once a day.
Danish: Standarddosis af Clopidogrel Apotex er en tablet a 75 mg en gang dagligt.
English: Clopidogrel Apotex is used to prevent problems caused by blood clots in adults who have:
Danish: Clopidogrel Apotex anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne, som
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Danish: • har atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre), når det skal gives sammen med aspirin.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Apotex has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel Apotex er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Danish: Det anvendes til patienter, som har mindst en risikofaktor for vaskulære hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin Kantagonister (andre lægemidler, der forebygger blodpropper), og som har en lille blødningsrisiko Lægemidlet udleveres kun efter recept.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Danish: Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på fire tabletter a 75 mg.
English: Clopidogrel Apotex can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel Apotex kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
Danish: Nogle af disse patienter kan have fået en stent (et kort rør) anbragt i en arterie for at forhindre denne i at indsnævre sig.
English: Clopidogrel Apotex is a ‘generic medicine'.
Danish: Clopidogrel Apotex er et ‘generisk lægemiddel'.
English: Because Clopidogrel Apotex is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Apotex er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Apotex can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel Apotex kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter,
English: Other information about Clopidogrel Apotex:
Danish: Andre oplysninger om Clopidogrel Apotex:
English: The Committee recommended that Clopidogrel Apotex be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Apotex.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Plavix.
English: Because Clopidogrel Apotex is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Apotex er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Clopidogrel Apotex is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Apotex er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: What are the benefits and risks of Clopidogrel Apotex?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Apotex?
English: The active substance in Clopidogrel Apotex, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Apotex, clopidogrel, er en trombocytfunktionshæmmer.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Apotex is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Clopidogrel Apotex sammen med aspirin.
English: Clopidogrel Apotex clopidogrel
Danish: Clopidogrel Apotex
English: Why has Clopidogrel Apotex been approved?
Danish: Hvorfor blev Clopidogrel Apotex godkendt?
English: include heart attacks and unstable angina (a severe type of chest pain).
Danish: Akut koronart syndrom er en samlebetegnelse for Tidligere kendt som Clopidogrel Mylan Pharma hjerteproblemer, som omfatter hjerteanfald og ustabil angina (en svær form for brystsmerter).
English: How has Clopidogrel Apotex been studied?
Danish: Hvordan blev Clopidogrel Apotex undersøgt?
English: What is Clopidogrel Apotex?
Danish: Hvad er Clopidogrel Apotex?
English: How is Clopidogrel Apotex used?
Danish: Hvordan anvendes Clopidogrel Apotex?
English: What is Clopidogrel Apotex used for?
Danish: Hvad anvendes Clopidogrel Apotex til?
English: How does Clopidogrel Apotex work?
Danish: Hvordan virker Clopidogrel Apotex?
English: 1 cartridge
Danish: 1 Cylinderampul
English: These enzymes are needed for the production of serotonin.
Danish: Disse enzymer er nødvendige for produktionen af serotonin.
English: This is a summary of the European public assessment report (EPAR) for Xermelo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xermelo.
English: Doses may need to be reduced in patients with mildly or moderately reduced liver function.
Danish: Det kan være nødvendigt at reducere dosis hos patienter med let eller moderat nedsat leverfunktion.
English: The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Danish: De bivirkninger, der sås, og som hovedsagelig berørte maven, gav ikke større problemer og vurderedes at være milde og håndterbare.
English: The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Xermelo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The effects of Xermelo were seen from about 3 weeks after starting treatment.
Danish: Virkningen af Xermelo sås fra ca. 3 uger efter behandlingsstart.
English: Other information about Xermelo
Danish: Andre oplysninger om Xermelo
English: Carcinoid syndrome occurs when certain tumours produce and release too much of a substance called serotonin into the blood.
Danish: Karcinoidt syndrom opstår, når visse tumorer producerer og frigiver for meget af et stof, der hedder serotonin, i blodet.
English: What measures are being taken to ensure the safe and effective use of Xermelo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xermelo?
English: Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Danish: Da antallet af patienter med karcinoidt syndrom er lavt, betragtes sygdommen som "sjælden", og Xermelo blev udpeget som "lægemiddel til sjældne sygdomme" den 8. oktober 2009.
English: Xermelo contains the active substance telotristat.
Danish: Xermelo indeholder det aktive stof telotristat.
English: Xermelo can only be obtained with a prescription.
Danish: Xermelo udleveres kun efter recept.
English: Why is Xermelo approved?
Danish: Hvorfor blev Xermelo godkendt?
English: What is Xermelo and what is it used for?
Danish: Hvad er Xermelo, og hvad anvendes det til?
English: It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Danish: Xermelo fås som tabletter, der indeholder 250 mg telotristat, og den anbefalede dosis er én tablet tre gange dagligt.
English: Doctors may consider stopping treatment if patients do not benefit after 12 weeks.
Danish: hvis patienten ikke har opnået en positiv effekt efter 12 uger.
English: The full EPAR for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Xermelo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The excess serotonin can cause severe diarrhoea as well as other symptoms such as flushing of the face and cramps.
Danish: Den forhøjede forekomst af serotonin kan forårsage svær diarré og andre symptomer som f.eks. ansigtsrødme og kramper.
English: It is not intended to provide practical advice on how to use Xermelo.
Danish: Det er ikke en praktisk vejledning i, hvordan Xermelo bør anvendes.
English: Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Danish: Xermelo anvendes sammen med andre lægemidler, der kaldes somatostatin-analoger, når disse lægemidler ikke er nok i sig selv til at kontrollere diarréen.
English: By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Danish: Ved at hæmme disse enzymer reducerer telotristat produktionen af serotonin hos patienter med karcinoidt syndrom, hvorved sygdommens symptomer lindres.
English: For more information about treatment with Xermelo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xermelo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xermelo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Xermelo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Danish: Xermelo er et lægemiddel til behandling af voksne med svær diarré forbundet med en tilstand, der kaldes karcinoidt syndrom.
English: The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Danish: De hyppigste bivirkninger ved Xermelo (kan forekomme hos mere end 1 ud af 10 personer) er mavesmerter, forhøjet gammaglutamyltransferase (et leverenzym) og træthed; disse bivirkninger er typisk milde til moderate.
English: The commonest side effect severe enough to cause treatment to be stopped is abdominal pain.
Danish: Blandt de bivirkninger, der kan være så svære, at behandlingen skal standses, er den hyppigste mavesmerter.
English: The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Danish: Fordelene ved at tilføje Xermelo til behandlingen er påvist i en hovedundersøgelse af 135 patienter med karcinoidt syndrom, hvis diarré ikke var fuldt kontrolleret med somatostatin-analoger alene.
English: What are the risks associated with Xermelo?
Danish: Hvilke risici er der forbundet med Xermelo?
English: The active substance in Xermelo, telotristat, blocks the action of enzymes called L-tryptophan hydroxylases.
Danish: Det aktive stof i Xermelo, telotristat, hæmmer virkningen af de såkaldte L-tryptophanhydroxylaseenzymer.
English: Although small, this reduction was considered significant given that patients view the frequency of bowel movements as a symptom with an important impact on their quality of life.
Danish: Selvom der ikke er tale om en stor reduktion, vurderes den at være væsentlig, fordi patienterne oplever et øget antal afføringer som et symptom, der går ud over deres livskvalitet.
English: Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Danish: Xermelo blev sammenlignet med placebo (ikke-aktivt stof), og det primære mål for virkning var ændringen i, hvor mange gange om dagen i gennemsnit, den enkelte patient havde afføring i løbet af undersøgelsens varighed på 12 uger.
English: For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Xermelo, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xermelo fremgår af indlægssedlen.
English: At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Danish: Ved behandlingsstart havde de patienter, der fik Xermelo, afføring 6,1 gange om dagen i gennemsnit, idet dette tal i løbet af de 12 uger faldt til 4,7 gange om dagen i gennemsnit, svarende til en reduktion på 1,4 gange.
English: Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Danish: Det er påvist, at Xermelo reducerer antallet af afføringer hos patienter med karcinoidt syndrom, der ikke er fuldt kontrolleret med anden medicin.
English: Patients taking placebo were having an average of 5.2 bowel movements daily at the start, which fell to an average of 4.6 movements daily, a fall of 0.6 movements.
Danish: De patienter, der fik placebo, havde i begyndelsen afføring 5,2 gange om dagen i gennemsnit, og dette tal faldt til 4,6 gange om dagen i gennemsnit, svarende til en reduktion på 0,6 gange.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xermelo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xermelo.
English: How is Xermelo used?
Danish: Hvordan anvendes Xermelo?
English: What benefits of Xermelo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Xermelo?
English: How does Xermelo work?
Danish: Hvordan virker Xermelo?
English: 29 May 2019
Danish: 29. maj 2019
English: Doctors use this scale to rate how well patients can talk, breath, eat and perform other normal activities.
Danish: Lægerne bruger denne skala til at vurdere, hvor godt patienterne kan tale, trække vejret, spise og udføre andre almindelige aktiviteter.
English: What was Radicava expected to be used for?
Danish: Hvad forventedes Radicava anvendt til?
English: What is Radicava?
Danish: Hvad er Radicava?
English: Withdrawal of the marketing authorisation application for Radicava (edaravone)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Radicava (edaravon)
English: Radicava is a medicine that contains the active substance edaravone.
Danish: Radicava er et lægemiddel, der indeholder det aktive stof edaravon.
English: However, the study involved only a small number of patients and there was not enough evidence of improvements in other important measures, such as those related to survival, breathing and muscle strength.
Danish: Studiet omfattede imidlertid kun et lille antal patienter, og der var ikke tilstrækkeligt belæg for forbedringer inden for andre vigtige områder som f.eks. overlevelse, vejrtrækning og muskelstyrke.
English: Radicava was expected to be used to slow down the worsening of the disease in patients who can still perform normal daily activities.
Danish: Radicava forventedes anvendt til at bremse forværringen af sygdommen hos patienter, der stadig kan udføre normale daglige aktiviteter.
English: The Committee considered the merits of such a study but had some objections, including the fact that the treatment for ALS had changed significantly over the past few years, rendering comparisons difficult.
Danish: Udvalget vurderede fordelene ved en sådan undersøgelse, men havde en række indsigelser, herunder det forhold, at behandlingen af ALS havde ændret sig betydeligt i løbet af de seneste år, hvilket gjorde det vanskeligt at foretage sammenligninger.
English: On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).
Danish: Den 24. maj 2019 meddelte Mitsubishi Tanabe Pharma GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Radicava til behandling af amyotrofisk lateral sklerose (ALS).
English: Given the clear need for further evidence of Radicava's effectiveness, the Committee considered the possibility of a conditional approval, which would allow the company to provide more data at a later stage.
Danish: I betragtning af det klare behov for yderligere dokumentation for Radicavas effektivitet overvejede udvalget muligheden for en betinget godkendelse, som ville give virksomheden mulighed for at fremlægge flere oplysninger på et senere tidspunkt.
English: When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Danish: Når patienter i placebogruppen senere skiftede til Radicava, var der ingen mærkbar effekt.
English: Furthermore, the CHMP noted important differences between the two groups which could have influenced the final results - such as the fact that a higher number of patients in the Radicava group had less severe disease.
Danish: Desuden noterede CHMP sig betydelige forskelle mellem de to grupper, som kan have påvirket de endelige resultater - f.eks. det forhold, at et større antal patienter i Radicava-gruppen havde mindre alvorlige sygdomme.
English: The company informed the CHMP that the withdrawal does not have any impact on ongoing clinical trials.
Danish: Virksomheden oplyste til CHMP, at tilbagetrækningen ikke vil have nogen betydning for igangværende kliniske undersøgelser.