FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, Exforge HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Danish: Endelig må Exforge HCT ikke anvendes hos patienter med hypokaliæmi (lavt kaliumindhold i blodet), hyponatriæmi (lavt saltindhold i blodet) og hypercalcæmi (forhøjet calciumniveau i blodet), som ikke reagerer på behandling, og hos patienter med hyperurikæmi (forhøjet urinsyre i blodet), der udløser symptomer.
English: What is the risk associated with Exforge HCT?
Danish: Hvilken risiko er der forbundet med Exforge HCT?
English: Exforge HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Exforge HCT i kombination med lægemidler, der indeholder aliskiren (som anvendes til behandling af essentiel hypertension), må ikke anvendes til patienter med diabetes eller moderat eller alvorlig nyresygdom.
English: Why has Exforge HCT been approved?
Danish: Hvorfor blev Exforge HCT godkendt?
English: How has Exforge HCT been studied?
Danish: Hvordan blev Exforge HCT undersøgt?
English: What is Exforge HCT used for?
Danish: Hvad anvendes Exforge HCT til?
English: What is Exforge HCT?
Danish: Hvad er Exforge HCT?
English: What benefit has Exforge HCT shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Exforge HCT?
English: How is Exforge HCT used?
Danish: Hvordan anvendes Exforge HCT?
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and helps the blood vessel walls to relax and widen, thereby reducing blood pressure.
Danish: Amlodipin mindsker indstrømningen af calcium i cellerne, så de ikke kan trække sig sammen.
English: It is a hybrid medicine.
Danish: Det er et "hybridt lægemiddel".
English: The tablets are taken in 2 to 4 divided doses.
Danish: Tabletterne tages som 2 til 4 delte doser.
English: Cuprior should be taken on an empty stomach, at least one hour before or two hours after meals.
Danish: Cuprior skal tages på tom mave mindst én time før eller to timer efter et måltid.
English: In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets.
Danish: Den anbefalede totale daglige dosis er 3 til 6,5 tabletter til voksne og 1,5 til 4 tabletter til børn.
English: This is a summary of the European public assessment report (EPAR) for Cuprior.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cuprior.
English: To take account of this difference, Cuprior is used at lower doses.
Danish: For at tage højde for denne forskel anvendes Cuprior i lavere doser.
English: This means that it is similar to a ‘reference medicine' (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine.
Danish: Det betyder, at det svarer til et "referencelægemiddel" (i dette tilfælde Trientine Dihydrochloride 300 mg kapsler), som også indeholder trientin.
English: Cuprior is available as 150 mg tablets.
Danish: Cuprior fås som 150-mg-tabletter.
English: The full EPAR for Cuprior can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cuprior findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Cuprior
Danish: Andre oplysninger om Cuprior
English: Cuprior trientine
Danish: Cuprior trientin
English: The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson's disease.
Danish: CHMP bemærkede, at trientin er blevet anvendt til behandling af patienter med Wilsons sygdom i over 30 år.
English: What measures are being taken to ensure the safe and effective use of Cuprior?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cuprior?
English: The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine.
Danish: Virksomheden fremlagde data fra offentliggjort litteratur, der viser, at trientin i væsentlig grad øger kobberudskillelsen i urinen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior's benefits 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 Cuprior opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It works by attaching to copper in the body and forming a complex that is then eliminated in the urine.
Danish: Det virker ved at binde sig til kobber i kroppen og danne et kompleks, som herefter udskilles i urinen.
English: What are the benefits and risks of Cuprior?
Danish: Hvilke fordele og risici er der forbundet med Cuprior?
English: Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body.
Danish: Selv om Cuprior frigiver mere trientin i kroppen end referencelægemidlet, kan denne forskel udlignes ved at nedsætte dosis, som under alle omstændigheder justeres efter patientens respons og kobberniveauet i kroppen.
English: The difference between Cuprior and the reference medicine is that Cuprior contains another form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator.
Danish: Forskellen på Cuprior og referencelægemidlet er, at Cuprior indeholder en anden form for trientin (trientintetrahydrochlorid) og ikke skal opbevares i køleskab.
English: Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition.
Danish: Cuprior anvendes til patienter, der ikke kan tage D-penicillamin, som er et andet lægemiddel mod denne tilstand.
English: Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine.
Danish: Resultaterne viste, at Cuprior danner et højere niveau af det aktive stof i blodet end referencelægemidlet.
English: Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Danish: Cuprior udleveres kun efter recept, og behandlingen bør indledes af en speciallæge med erfaring i behandling af Wilsons sygdom.
English: Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Cuprior er et hybridt lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why is Cuprior approved?
Danish: Hvorfor blev Cuprior godkendt?
English: Cuprior contains the active substance trientine.
Danish: Cuprior indeholder det aktive stof trientin.
English: For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cuprior, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Cuprior.
Danish: Det er ikke en praktisk vejledning i, hvordan Cuprior bør anvendes.
English: The company also carried out a study to compare the levels of trientine in the blood after having taken Cuprior with those for the reference medicine.
Danish: Virksomheden foretog også en undersøgelse for at sammenligne niveauet af trientin i blodet efter indtagelse af Cuprior med niveauet for referencelægemidlet.
English: The active substance in Cuprior, trientine, is a chelating agent.
Danish: Det aktive stof i Cuprior, trientin, er et chelatdannende stof.
English: What is Cuprior and what is it used for?
Danish: Hvad er Cuprior, og hvad anvendes det til?
English: Doses are adjusted according to patient response and levels of copper in the body.
Danish: patientens respons og kobberniveauet i kroppen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cuprior 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 Cuprior.
English: How has Cuprior been studied?
Danish: Hvordan er Cuprior blevet undersøgt?
English: For practical information about using Cuprior, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cuprior, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Cuprior used?
Danish: Hvordan anvendes Cuprior?
English: Cuprior is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Danish: Det er en genetisk tilstand, hvor kobber optaget fra maden ophobes i kroppen, navnlig i leveren og hjernen, og medfører skader.
English: How does Cuprior work?
Danish: Hvordan virker Cuprior?
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre sig, at alle betingelser eller restriktioner med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet, som beskrevet nedenfor, bliver implementeret.
English: The Information for Healthcare professionals should contain the following key elements: - Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
Danish: Information om Pharmacovigilance Monitoring Programme omkring potentielle risiko for klinisk relevant hypotension og relaterede problemer i forbindelse med brug af DCF.
English: - Information on the switch from the 50 ml vial to the 20 ml vial for Revatio 0.8 mg/ml solution
Danish: Information om skift fra 50 ml hætteglas til 20 ml hætteglas Revatio 0,8 mg/ml injektionsvæske
English: The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided the following: - Information for Healthcare professionals - Copy of the Summary of Product Characteristics (SPC) - Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems
Danish: Indehaveren af markedsføringstilladelsen skal med de nationale myndigheder sikre, at der etableres et kontrolleret nationalt distributionssystem for 20 ml hætteglas med Revatio 0,8 mg/ml injektionsvæske, opløsning for at sikre, at sundhedspersonale, der vil udskrive og/eller anvende Revatio 0,8 mg/ml injektionsvæske, opløsning forud for ordination får udleveret følgende: Information til sundhedspersonale Kopi af produktresumé (SPC) En særlig Data Capture Form (DCF), der er udformet til at lette rapportering af tilfælde af hypotension og relaterede problemer
English: The Marketing Authorisation Holder shall agree the information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Danish: Indehaveren af markedsføringstilladelsen skal inden markedsføring af 20 ml hætteglas med Revatio 0,8 mg/ml injektionsvæske i det pågældende medlemsland i samarbejde med nationale myndigheder i hvert medlemsland blive enige om indholdet af informationen til sundhedspersonalet samt hvilken gruppe af sundhedspersonale, der er relevant.
English: What you need to know before you use [product name]
Danish: Det skal du vide, før du begynder at bruge [produktnavn]
English: Hypoparathyroidismh
Danish: Hypoparatyroidismeh
English: If necessary, <Product name> can be used during pregnancy.
Danish: Graviditet og amning <Produktnavn> kan om nødvendigt anvendes under graviditet.
English: Adopted at the 12-15 March 2019 PRAC
Danish: Vedtaget på PRAC's møde den 12.-15. marts 2019
English: What you need to know before you use OPDIVO Warnings and precautions
Danish: Det skal du vide, før du begynder at bruge OPDIVO Advarsler og forsigtighedsregler
English: Contact your <doctor><midwife> if the pain and/or fever are not reduced or if you need to take the medicine more often.
Danish: Kontakt <lægen><jordemoderen>, hvis smerterne og/eller feberen ikke mindskes, eller hvis du har brug for at tage lægemidlet oftere.
English: Nivolumab - Hypoparathyroidism (EPITT no 19310)
Danish: Nivolumab - hypoparatyroidisme (EPITT nr. 19310)
English: Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.
Danish: Epidemiologiske studier af den neurologiske udvikling hos børn, der eksponeres for paracetamol i uterus, viser inkonklusive resultater.
English: Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
Danish: Der foreligger ikke konventionelle studier, hvor man har anvendt aktuelt anerkendte standarder for evaluering af reproduktions- og udviklingstoksicitet.
English: If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Danish: Paracetamol kan anvendes under graviditet, hvis det er klinisk indiceret, men bør tages i den laveste effektive dosis, så kort tid som muligt og med lavest mulige hyppighed.
English: You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.
Danish: Du bør tage den lavest mulige dosis, der mindsker smerterne og/eller feberen, og bruge lægemidlet så kort tid som muligt.
English: A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity.
Danish: En stor mængde data for gravide kvinder peger hverken på risiko for misdannelser eller toksicitet hos fosteret/den nyfødte.
English: Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache, decreased blood levels of calcium and visual disturbances.
Danish: Tegn og symptomer på, at disse kirtler ikke virker korrekt, kan være voldsom træthed, vægtændringer, hovedpine, nedsat mængde kalcium i blodet og synsforstyrrelser.
English: Frequency: Not known for nivolumab monotherapy / nivolumab in combination with ipilimumab [Table key: h Post-marketing event (also see section 4.4)]
Danish: Hyppighed: Ikke kendt for nivolumab-monoterapi/nivolumab i kombination med ipilimumab [tabelnøgle: h Bivirkning efter markedsføring (se også pkt.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/157160/2019
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/189299/2019
English: • Decreased function of the parathyroid gland
Danish: • Nedsat funktion af biskjoldbruskkirtlerne
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Danish: Problemer med hormonproducerende kirtler (herunder hypofysen, skjoldbruskkirtlen, biskjoldbruskkirtlerne og binyrerne), som kan påvirke, hvordan disse kirtler fungerer.
English: Other immune-related adverse reactions: […] Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported post-marketing (see section 4.8).
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Andre immunrelaterede bivirkninger: […] Tilfælde af Vogt-Koyanagi-Haradas syndrom og hypoparatyroidisme er rapporteret efter markedsføring (se pkt.
English: Paracetamol - Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus (EPITT no 17796)
Danish: Paracetamol - anvendelse af paracetamol under graviditet, indvirkning på den neurologiske udvikling hos børn og indvirkning på det urogenitale system (EPITT nr.
English: The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009.
Danish: Denne tilladelse blev fornyet den 13. april 2004 og 13. april 2009.
English: The remains of the tumour should be removed whenever this is possible, usually after several weeks.
Danish: Resterne af svulsten fjernes, når det bliver muligt, sædvanligvis efter flere ugers forløb.
English: It contains the active substance tasonermin.
Danish: Det indeholder det aktive stof tasonermin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Beromun to Boehringer Ingelheim International GmbH on 13 April 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Beromun til Boehringer Ingelheim International GmbH den 13. april 1999.
English: Other information about Beromun:
Danish: Andre oplysninger om Beromun:
English: Beromun is usually only used once, but a second perfusion can be considered six to eight weeks after the first.
Danish: Beromun anvendes sædvanligvis kun én gang, men det kan overvejes at give endnu en perfusion seks til otte uger efter den første.
English: The replacement TNFα acts in same way as the naturally produced protein.
Danish: Det kunstigt fremstillede TNFα virker på samme måde som det naturligt producerede protein.
English: Beromun is not recommended for patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Danish: Beromun anbefales ikke til børn under 18 år på grund af manglende data om sikkerhed og effekt hos denne aldersgruppe
English: Sixty-two of the patients also received interferon-gamma (another anticancer medicine).
Danish: 62 af patienterne fik desuden interferon gamma (et andet kræftmiddel).
English: The Committee recommended that Beromun be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Beromun.
English: The full EPAR for Beromun can be found here.
Danish: Den fuldstændige EPAR for Beromun findes her.
English: There were too few patients also receiving interferon-gamma to determine whether this improved the patients' outcome further.
Danish: De patienter, der desuden fik interferon gamma, var for få til, at det kunne fastslås, om udfaldet for patienterne derved blev endnu bedre.
English: Melphalan is given during the same operation over 60 minutes, beginning 30 minutes after the start of the Beromun perfusion, when the temperature should be increased to 39 to 40°C.
Danish: Melfalan gives under samme indgreb i løbet af 60 minutter, begyndende 30 minutter efter starten af perfusionen med Beromun, når temperaturen er blevet øget til 39-40 °C.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BEROMUN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) BEROMUN EPAR - sammendrag for offentligheden
English: Beromun has been studied in four main studies involving a total of 188 patients, in which it was given in combination with melphalan.
Danish: Der blev udført fire hovedundersøgelser af Beromun hos i alt 188 patienter, hos hvem det blev givet i kombination med melfalan.
English: A review of the studies by three independent experts found that only 145 of these patients were candidates for amputation or surgical removal of the tumour that would have resulted in significant loss of function (disability).
Danish: Ved en gennemgang af undersøgelserne foretaget af tre uafhængige eksperter fandtes kun 145 af disse patienter at behøve amputation eller operativ fjernelse af svulsten, hvilket ville have medført en betydelig grad af funktionstab (invaliditet).
English: Therefore, the main measure of effectiveness was based on the experts' assessment of the outcome of these 145 patients, in comparison with the outcome that would be expected without using Beromun.
Danish: Behandlingens virkning blev derfor hovedsagelig bedømt på grundlag af eksperternes vurdering af resultatet for disse 145 patienter, sammenlignet med det forventede resultat uden brug af Beromun.
English: Most patients taking Beromun experience fever, which is usually mild to moderate.
Danish: Hos de fleste patienter giver Beromun feber, der sædvanligvis er let til moderat.
English: The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNFα).
Danish: Det aktive stof i Beromun, tasonermin, er en kopi af det menneskelige protein tumornekrosefaktor alfa-1a (TNFα).
English: What is the risk associated with Beromun?
Danish: Hvilken risiko er der forbundet med Beromun?
English: Why has Beromun been approved?
Danish: Hvorfor blev Beromun godkendt?
English: The active substance in Beromun, tasonermin, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce TNFα.
Danish: Det aktive stof i Beromun, tasonermin, fremstilles ved "rekombinant dna-teknologi": Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere TNFα.
English: The exact way that TNFα works against certain types of cancer is not fully understood, but it is thought that it can kill tumour cells directly, as well as destroy the blood vessels supplying tumours and stimulate the immune system to attack them.
Danish: Hvordan TNFα virker mod visse kræfttyper, vides ikke nøjagtigt, men det menes at kunne dræbe svulstceller direkte og desuden ødelægge de kar, der forsyner svulsterne, og stimulere immunsystemet til at angribe dem.
English: This leads to the tumour dying back and getting smaller, particularly when the medicine is combined with other cytotoxic (cellkilling) medicines and raised temperature.
Danish: Dette bevirker, at svulstvævet visner og svinder, navnlig når lægemidlet anvendes i kombination med andre cytotoksiske (celledræbende) lægemidler og forhøjet temperatur.
English: It can be used before surgery to reduce the size of a tumour, or instead of surgery when the tumour cannot be removed by surgery alone.
Danish: Det kan anvendes før en operation for at få svulsten til at svinde, eller i stedet for operation, når svulsten ikke kan fjernes ved operation alene.
English: It must also not be used in patients who cannot receive vasopressors (medicines to increase the blood pressure), anticoagulants (medicines to prevent blood clotting) or medicines that can harm the heart.
Danish: Det må heller ikke anvendes hos patienter, som ikke må få blodtryksforhøjende medicin, antikoagulerende midler (medicin, der forebygger blodpropper) eller medicin, der kan skade hjertet.
English: Some side effects of Beromun are serious and could require a patient to spend time in an intensive care unit after treatment.
Danish: Nogle af bivirkningerne af Beromun er alvorlige og kan kræve indlæggelse på intensivafdeling efter behandlingen.
English: Beromun must not be used in patients who cannot receive melphalan or who cannot undergo ILP.
Danish: Beromun må ikke anvendes hos patienter, der ikke må få melfalan, eller hos patienter, der ikke må få ILP-behandling.