FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the change in the blood levels of LDL cholesterol after 12 weeks.
Danish: Det primære mål for virkningen var ændringen i blodets indhold af LDL-kolesterol efter 12 uger.
English: Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Danish: Primær hyperkolesterolæmi er, når blodets kolesterolindhold er højt.
English: Pelzont 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: Pelzont anvendes normalt sammen med et statin (standard kolesterolsænkende lægemiddel), når virkningen af et statin alene er utilstrækkelig.
English: When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors.
Danish: Når patienten tager tabletten, frigives laropiprant først til blodbanen og blokerer PGD2-receptorerne.
English: Primary means that the hypercholesterolaemia does not have any identifiable cause.
Danish: Primær betyder, at der ikke kan påvises en årsag til hyperkolesterolæmien.
English: Flushing was measured using the flushing symptom questionnaire.
Danish: Flushing blev målt ved hjælp af spørgeskemaet om flushing-symptomer.
English: Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘prostaglandin D2' (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin.
Danish: Flushing fremkaldt af nikotinsyre menes at opstå som følge af frigivelsen af et stof kaldet "prostaglandin D2" (PGD2) fra hudcellerne, hvilket udvider blodkarrene i huden.
English: In Pelzont tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Danish: I Pelzont-tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
English: Patients with combined mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Danish: Patienter med kombineret blandet dyslipidæmi har et højt blodindhold af det "dårlige" LDL-kolesterol og triglycerider (en type fedt) og et lavt indhold af det "gode" HDL-kolesterol.
English: The second study showed that the LDL cholesterol levels were further reduced when Pelzont was taken with simvastatin (48% reduction), compared with Pelzont alone (17% reduction) or simvastatin alone (37% reduction).
Danish: Den anden undersøgelse viste, at indholdet af LDL-kolesterol blev yderligere sænket, når Pelzont blev givet sammen med simvastatin (48 % reduktion) sammenlignet med Pelzont alene (17 % reduktion) eller simvastatin alene (37 % reduktion).
English: Pelzont was effective in reducing the blood levels of LDL cholesterol.
Danish: Pelzont var effektivt til at sænke blodets indhold af LDL-kolesterol.
English: The second study compared the combination of Pelzont and simvastatin (a statin) with Pelzont alone or simvastatin alone in 1,398 patients.
Danish: Den anden undersøgelse sammenlignede kombinationen af Pelzont og simvastatin (et statin) med Pelzont alene eller simvastatin alene hos 1 398 patienter.
English: Pelzont is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Danish: Pelzont er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3-vitamin) og laropiprant.
English: Pelzont was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Danish: Pelzont blev undersøgt i fire hovedundersøgelser af patienter med hyperkolesterolæmi eller blandet dyslipidæmi.
English: In the first study, LDL cholesterol levels were reduced by 19% in patients taking Pelzont, compared with 1% in those taking placebo.
Danish: I den første undersøgelse blev indholdet af LDL-kolesterol reduceret med 19 % hos patienter, der fik Pelzont, sammenlignet med 1 % hos dem, der fik placebo.
English: It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery.
Danish: Det bør heller ikke anvendes hos patienter med leverinsufficiens, aktivt mavesår eller arterieblødninger.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont'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 Pelzont er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
English: It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Danish: Lægemidlet bør anvendes med forsigtighed hos patienter med nyreinsufficiens og bør ikke anvendes hos patienter med leverinsufficiens.
English: For the full list of all side effects reported with Pelzont, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Pelzont fremgår af indlægssedlen.
English: Pelzont should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Danish: Pelzont 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 Pelzont in modifying blood fat levels.
Danish: To undersøgelser så nærmere på Pelzonts virkning med hensyn til sænkning af blodets fedtindhold.
English: Pelzont 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: Pelzont anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
English: In the fourth study, flushing was seen on fewer days in patients taking Pelzont than in those taking nicotinic acid alone.
Danish: I den fjerde undersøgelse optrådte flushing færre dage hos patienter, som fik Pelzont, end hos dem, der fik nikotinsyre alene.
English: Adding laropiprant to nicotinic acid reduced the symptoms of flushing caused by nicotinic acid.
Danish: Når laropiprant blev givet sammen med nikotinsyre, reduceredes symptomerne på flushing fremkaldt af nikotinsyre.
English: In the first and third studies, fewer patients taking Pelzont 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 Pelzont, moderat, svær eller ekstrem flushing, end det var tilfældet hos patienter, der fik nikotinsyre alene.
English: The third and fourth studies looked at the effectiveness of laropiprant in reducing the flushing caused by nicotinic acid.
Danish: Den tredje og fjerde undersøgelse så nærmere på laropiprants virkning med hensyn til at reducere flushing fremkaldt af nikotinsyre.
English: What is Pelzont?
Danish: Hvad er Pelzont?
English: Why has Pelzont been approved?
Danish: Hvorfor blev Pelzont godkendt?
English: What is Pelzont used for?
Danish: Hvad anvendes Pelzont til?
English: How has Pelzont been studied?
Danish: Hvordan blev Pelzont undersøgt?
English: The nicotinic acid is released more slowly from the other layer and has its effect as a fatmodifying agent.
Danish: Nikotinsyren frigives langsommere fra det andet lag og ændrer fedtindholdet i blodet.
English: What benefit has Pelzont shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pelzont?
English: The first study compared the effectiveness of Pelzont 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 Pelzont med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL-kolesterol.
English: How is Pelzont used?
Danish: Hvordan anvendes Pelzont?
English: How does Pelzont work?
Danish: Hvordan virker Pelzont?
English: be approved for use in the EU.
Danish: godkendes til anvendelse i EU.
English: is a ‘generic medicine'.
Danish: er et "generisk lægemiddel".
English: may be given to adults or children from 3 years of age and weighing at least 15 kg.
Danish: kan gives til voksne eller børn i alderen tre år og opefter, som vejer mindst 15 kg.
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: is available as tablets.
Danish: fås som tabletter.
English: is always given with ritonavir.
Danish: gives altid sammen med ritonavir.
English: This allows effective treatment while avoiding a higher dose of darunavir.
Danish: Dette bevirker effektiv behandling, samtidig med at en højere dosis af darunavir undgås.
English: contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Danish: indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Prezista.
English: does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: helbreder ikke hivinfektion eller aids, men hivbehandling kan forsinke den beskadigelse af immunsystemet og den udvikling af infektioner og sygdomme, der er forbundet med aids.
English: is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: er et antiviralt lægemiddel, der anvendes sammen med andre hivlægemidler til behandling af patienter med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: It blocks protease, an enzyme involved in the reproduction of HIV.
Danish: Det blokerer protease, som er et enzym, der medvirker ved formeringen af hiv.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også en undersøgelse, der viste, at lægemidlet var "bioækvivalent" med referencelægemidlet.
English: approved?
Danish: godkendt?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka d.d.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Darunavir Krka d.d.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka d.d.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Prezista, og det er ikke nødvendigt at gentage disse med Darunavir Krka d.d.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body.
Danish: Når enzymet blokeres, formerer virussen sig ikke normalt, og formeringen af den i kroppen bliver langsommere.
English: contains the active substance darunavir.
Danish: indeholder det aktive stof darunavir.
English: As for every medicine, the company provided studies on the quality of Darunavir Krka d.d.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Darunavir Krka d.d.
English: Therefore, the Agency's view was that, as for Prezista, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Prezista.
English: has been shown to have comparable quality and to be bioequivalent to Prezista.
Danish: er af sammenlignelig kvalitet og er bioækvivalent med Prezista.
English: can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Danish: udleveres kun efter recept, og behandlingen bør iværksættes af en sundhedsperson med erfaring i behandling af hivinfektion.
English: Ritonavir reduces the breakdown of darunavir, increasing the levels of darunavir in the blood.
Danish: Ritonavir reducerer nedbrydningen af darunavir og øger dermed koncentrationen af darunavir i blodet.
English: It is given with low-dose ritonavir or, in adults, with cobicistat.
Danish: Det gives sammen med lavdosis-ritonavir eller, hos voksne, sammen med cobicistat.
English: For more information about treatment with Darunavir Krka d.d., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Darunavir Krka d.d., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Darunavir Krka d.d.
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Darunavir Krka d.d.
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information on generic medicines, see the questionand-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar her.
English: This is a summary of the European public assessment report (EPAR) for Darunavir Krka d.d.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Darunavir Krka d.d.
English: The active substance in Darunavir Krka d.d., darunavir, is a protease inhibitor.
Danish: Det aktive stof i Darunavir Krka d.d., darunavir, er en proteasehæmmer.
English: The medicine is to be taken with low-dose ritonavir or, as an alternative in adults, with cobicistat and with other HIV medicines, and should be taken with food.
Danish: Lægemidlet tages med lavdosis-ritonavir eller, alternativt hos voksne, med cobicistat og andre hivlægemidler, og det bør tages sammen med mad.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka d.d.
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 Darunavir Krka d.d.
English: For practical information about using Darunavir Krka d.d., patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Darunavir Krka d.d., kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Darunavir Krka d.d.
Danish: Hvilken fordel og risiko er der forbundet med Darunavir Krka d.d.
English: on 18 January 2018.
Danish: EMA/23187/2018
English: Darunavir Krka d.d., taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: tages i kombination med andre hivlægemidler, nedsættes mængden af hiv i blodet, og den holdes på et lavt niveau.
English: been studied?
Danish: undersøgt?
English: Other information about Darunavir Krka d.d.
Danish: Andre oplysninger om Darunavir Krka d.d.
English: It is not intended to provide practical advice on how to use Darunavir Krka d.d.
Danish: Det er ikke en praktisk vejledning i, hvordan Darunavir Krka d.d.
English: The full EPAR for Darunavir Krka d.d.
Danish: Den fuldstændige EPAR for Darunavir Krka d.d.
English: The Agency recommended that Darunavir Krka d.d.
Danish: Agenturet anbefalede, at Darunavir Krka d.d.
English: This means that Darunavir Krka d.d.
Danish: Det betyder, at Darunavir Krka d.d.
English: and what is it used for?
Danish: bør anvendes.
English: How does Darunavir Krka d.d.
Danish: Hvordan blev Darunavir Krka d.d.
English: Why is Darunavir Krka d.d.
Danish: Hvorfor blev Darunavir Krka d.d.
English: Because Darunavir Krka d.d.
Danish: Når Darunavir Krka d.d.
English: How is Darunavir Krka d.d.
Danish: Hvordan virker Darunavir Krka d.d.
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: Italy
Danish: Ansøger
English: Spain
Danish: Navn
English: Didanosine 400 mg gastroresistant capsules, hard
Danish: Styrke Lægemiddelform Indgivelsesvej
English: United Kingdom
Danish: Medlemsstat EU/EAA
English: The recommended dose is 150 mg twice a day.
Danish: Den anbefalede dosis er 150 mg to gange dagligt.
English: Further information on Verzenios can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Verzenios findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Verzenios
Danish: Andre oplysninger om Verzenios
English: If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
Danish: Hvis patienten oplever visse bivirkninger, kan det være nødvendigt at afbryde eller stoppe behandlingen eller nedsætte dosis.
English: As for all medicines, data on the use of Verzenios are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Verzenios løbende overvåget.
English: Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Danish: Behandlingen bør fortsætte så længe, som patienten har gavn af den og kan tåle bivirkningerne.
English: What measures are being taken to ensure the safe and effective use of Verzenios?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Verzenios?
English: Verzenios contains the active substance abemaciclib.
Danish: Verzenios indeholder det aktive stof abemaciclib.
English: The dose should be reduced if the patient is also taking certain medicines called ‘CYP3A4 inhibitors'.
Danish: Dosen bør reduceres, hvis patienten også får en type medicin, der kaldes CYP3A4-hæmmere.
English: Regarding safety, the main risk is diarrhoea, which is considered manageable with dose reduction.
Danish: Hvad angår sikkerheden, er den primære bivirkning diarré, der vurderes at kunne håndteres ved at reducere dosen.
English: Data were considered sufficient to conclude that Verzenios can be of benefit also in women who have not yet been through the menopause.
Danish: Dataene blev vurderet at være tilstrækkelige til at konkludere, at Verzenios også kan være gavnligt hos kvinder, der endnu ikke har været gennem overgangsalderen.
English: Verzenios is available as tablets (50 mg, 100 mg and 150 mg).
Danish: Verzenios fås som tabletter i styrkerne 50 mg, 100 mg og 150 mg.
English: An overview of Verzenios and why it is authorised in the EU
Danish: En oversigt over Verzenios, og hvorfor det er godkendt i EU
English: Side effects reported with Verzenios are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Verzenios vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Verzenios, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Verzenios, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that the benefits of Verzenios are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Verzenios opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Verzenios can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Verzenios udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: The most common side effects with Verzenios (which may affect more than 1 in 10 people) are diarrhoea, infections, neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), tiredness, nausea (feeling sick), vomiting and decreased appetite.
Danish: De hyppigste bivirkninger ved Verzenios (der kan forekomme hos mere end 1 ud af 10 patienter) er diarré, infektioner, neutropeni (lavt antal neutrofiler, en type hvide blodlegemer), anæmi (lavt antal røde blodlegemer), træthed, kvalme, opkastning og nedsat appetit.
English: Verzenios is a cancer medicine used to treat women with breast cancer that is advanced or has spread to other parts of the body.
Danish: Verzenios er et kræftlægemiddel til behandling af kvinder med brystkræft, der er fremskreden eller har spredt sig til andre dele af kroppen.
English: The active substance in Verzenios, abemaciclib, blocks the activity of enzymes known as cyclindependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Danish: Det aktive stof i Verzenios, abemaciclib, blokerer aktiviteten af en række enzymer, der kaldes cyklinafhængige kinaser (CDK4 og CDK6), og som spiller en vigtig rolle i reguleringen af den måde, som celler vokser og deler sig på.
English: What is Verzenios and what is it used for?
Danish: Hvad er Verzenios, og hvad anvendes det til?
English: Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).
Danish: Verzenios kan kun anvendes, når kræftcellerne har en bestemt type receptorer (hormonreceptorer) på deres overflade (HR-positiv brystkræft) og ikke producerer unormalt store mængder af de såkaldte HER2-receptorer (HER2-negativ brystkræft).
English: Why is Verzenios authorised in the EU?
Danish: Hvorfor blev Verzenios godkendt i EU?
English: Grapefruit juice should be avoided during treatment with Verzenios as it may affect the way the medicine is absorbed and broken down in the body.
Danish: Grapefrugtjuice bør undgås under behandling med Verzenios, da grapefrugtjuice kan påvirke lægemidlets optagelse og nedbrydning i kroppen.
English: It is used together with a hormonal medicine, either an aromatase inhibitor or fulvestrant.
Danish: Verzenios anvendes sammen med et hormonpræparat, enten en aromatase-hæmmer eller fulvestrant.
English: What are the risks associated with Verzenios?
Danish: Hvilke risici er der forbundet med Verzenios?
English: For the full list of side effects and restrictions of Verzenios, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Verzenios fremgår af indlægssedlen.