natgillin/translations-raw huggingface dataset:
Raptiva er et pulver og en opløsningsvæske, der bruges til at fremstille en injektionsvæske (opløsning). 
Raptiva is a powder and solvent that are made up into a solution for injection.
Resultaterne var de samme, uanset om patienterne tidligere havde fået systemisk behandling for psori 
The results were similar in those who had and those who had not taken systemic treatments for psoriasis
Behandling med Raptiva bør iværksættes af en speciallæge i hudsygdomme. 
Raptiva treatment should be initiated by a doctor who specialises in dermatology (the treatment of skin conditions).
Behandlingen bør kun fortsætte, hvis den virker. 
Therapy should only be continued in patients who have responded to treatment.
Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten. 
It must not be used in women who are more than three months pregnant.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exforge HCT den 16. oktober 2009. 
The European Commission granted a marketing authorisation valid throughout the European Union for Exforge HCT on 16 October 2009.
Den fuldstændige EPAR for Exforge HCT findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Exforge HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Exforge HCT. 
This is a summary of the European public assessment report (EPAR) for Exforge HCT.
amlodipin / valsartan/ hydrochlorothiazid 
amlodipine / valsartan / hydrochlorothiazide
Amlodipin er en ‘calciumkanalblokker'. 
Amlodipine is a ‘calcium channel blocker'.
Exforge HCT indtages gennem munden, og dosis er en tablet dagligt på samme tidspunkt hver dag og helst om morgenen. 
Exforge HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Exforge HCT. 
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 Exforge HCT.
Kombinationen af de tre aktive stoffer har en additiv virkning og sænker blodtrykket mere end de enkelte lægemidler alene. 
The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone.
Hvis du ønsker yderligere oplysninger om behandling med Exforge HCT, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Exforge HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Patienterne fik enten Exforge HCT eller en af de tre kombinationer, som kun indeholdt to af de aktive stoffer, i otte uger. 
Patients received either Exforge HCT or one of the three combinations containing only two of the active substances for eight weeks.
Da kombinationen af de tre aktive stoffer har været anvendt i en række år, fremlagde virksomheden undersøgelser, der viste, at tabletten, som indeholdt alle tre stoffer, optages af kroppen på samme måde som de særskilte tabletter. 
Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
Det primære mål for virkning var den gennemsnitlige ændring i blodtrykket. 
The main measure of effectiveness was the average change in the blood pressure.
Valsartan er en ”angiotensin II-receptorantagonist”, hvilket betyder, at det blokerer virkningen af et hormon i kroppen, som kaldes angiotensin II. 
Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II.
Det fås som tabletter indeholdende amlodipin, valsartan og hydrochlorthiazid i følgende mængder: 5/160/12,5 mg, 10/160/12,5 mg, 5/160/25 mg, 10/160/25 mg og 10/320/25 mg. 
It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg.
Hovedundersøgelsen påviste den gavnlige virkning af den højeste styrke af Exforge HCT til nedsættelse af blodtrykket. 
The main study showed the benefit of the highest strength of Exforge HCT in lowering the blood pressure.
De tre aktive stoffer i Exforge HCT er lægemidler mod forhøjet blodtryk, som allerede anvendes i Den Europæiske Union (EU). 
The three active substances in Exforge HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Den dosis af Exforge HCT, som skal anvendes, er den samme som doserne af tre individuelt aktive stoffer, som patienten fik tidligere. 
The dose of Exforge HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at der var større sandsynlighed for, at patienter, der allerede fik de tre aktive stoffer, ville overholde behandlingen, hvis de fik ordineret Exforge HCT, hvor de tre stoffer er kombineret i en enkelt tablet. 
The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Exforge HCT which combines the three substances in a single tablet.
Behandling med den højeste styrke af Exforge HCT var mere effektiv til at behandle hypertension end tokombinationsbehandlinger, der hver indeholdt to aktive stoffer. 
Treatment with the highest strength of Exforge HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Exforge HCT anvendes til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne, hvis blodtryk allerede er tilstrækkeligt kontrolleret med en kombination af amlopidin, valsartan og hydrochlorthiazid. 
Exforge HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Exforge HCT er et lægemiddel, der indeholder de tre aktive stoffer amlodipin, valsartan og hydrochlorthiazid. 
Exforge HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
CHMP besluttede, at fordelene ved Exforge HCT opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Exforge HCT. 
The CHMP therefore decided that Exforge HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Den gennemsnitlige reduktion af blodtrykket var ca. 39,7/24,7 mmHg hos patienter, der fik Exforge HCT, sammenlignet med 32/19,7 mmHg, 33,5/21,5 mmHg og 31,5/19,5 mmHg hos patienter, der henholdsvis fik kombinationerne valsartan/hydrochlorthiazid, valsartan/amlodipin og hydrochlorthiazid/amlodipin. 
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Exforge HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer valsartan hormonet i at virke og gør det derved muligt for blodkarrene at udvide sig, således at blodtrykket falder. 
By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.
Andre oplysninger om Exforge HCT 
Other information about Exforge HCT
Exforge HCT må ikke anvendes af personer, der er overfølsomme (allergiske) over for de aktive stoffer, andre sulfonamider, dihydropyridinderivater eller andre af indholdsstofferne i Exforge HCT. 
Exforge HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Exforge HCT.
Det virker ved at øge urinproduktionen, hvorved væskemængden i blodet reduceres og blodtrykket nedsættes. 
It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
De hyppigste bivirkninger ved Exforge HCT (som optræder hos mellem 1 og 10 patienter ud af 100) er hypokaliæmi (lavt kaliumindhold i blodet)), svimmelhed, hovedpine, hypotension (for lavt blodtryk), dyspepsi (halsbrand), pollakisuri (hyppig vandladning), træthed og ødem (væskeansamling). 
The most common side effects with Exforge HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Den daglige dosis af Exforge HCT må ikke overskride 10 mg amlodipin, 320 mg valsartan og 25 mg hydrochlorthiazid. 
The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Derudover blev der gennemført en hovedundersøgelse af 2 271 patienter med moderat til svær hypertension, som blev behandlet med den højeste styrke af Exforge HCT (320 mg valsartan, 10 mg amlodipin og 25 mg hydrochlorthiazid). 
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Den fuldstændige liste over de indberettede bivirkninger ved Exforge HCT fremgår af indlægssedlen. 
For the full list of all side effects reported with Exforge HCT, see the package leaflet.
Exforge HCT opfyldte endvidere i samtlige doser kravet om at dokumentere, at lægemidlet var sammenligneligt med kombinationerne af de individuelt aktive stoffer indtaget separat. 
For all doses, Exforge HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken seperately.
Det må heller ikke anvendes hos patienter, som har leverproblemer eller galdeproblemer (f.eks. gulsot), alvorlige nyreproblemer, anuri (en sygdom, hvor patienten har manglende urinproduktion eller evne til at tømme blæren), eller hos patienter i dialyse (en blodrensningsteknik). 
It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).
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. 
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.
Hvilken risiko er der forbundet med Exforge HCT? 
What is the risk associated with Exforge HCT?
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. 
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.
Hvorfor blev Exforge HCT godkendt? 
Why has Exforge HCT been approved?
Hvordan blev Exforge HCT undersøgt? 
How has Exforge HCT been studied?
Hvad anvendes Exforge HCT til? 
What is Exforge HCT used for?
Hvad er Exforge HCT? 
What is Exforge HCT?
Hvilken fordel viser undersøgelserne, at der er ved Exforge HCT? 
What benefit has Exforge HCT shown during the studies?
Hvordan anvendes Exforge HCT? 
How is Exforge HCT used?
Amlodipin mindsker indstrømningen af calcium i cellerne, så de ikke kan trække sig sammen. 
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.
Det er et "hybridt lægemiddel". 
It is a hybrid medicine.
Tabletterne tages som 2 til 4 delte doser. 
The tablets are taken in 2 to 4 divided doses.
Cuprior skal tages på tom mave mindst én time før eller to timer efter et måltid. 
Cuprior should be taken on an empty stomach, at least one hour before or two hours after meals.
Den anbefalede totale daglige dosis er 3 til 6,5 tabletter til voksne og 1,5 til 4 tabletter til børn. 
In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cuprior. 
This is a summary of the European public assessment report (EPAR) for Cuprior.
For at tage højde for denne forskel anvendes Cuprior i lavere doser. 
To take account of this difference, Cuprior is used at lower doses.
Det betyder, at det svarer til et "referencelægemiddel" (i dette tilfælde Trientine Dihydrochloride 300 mg kapsler), som også indeholder trientin. 
This means that it is similar to a ‘reference medicine' (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine.
Cuprior fås som 150-mg-tabletter. 
Cuprior is available as 150 mg tablets.
Den fuldstændige EPAR for Cuprior findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Cuprior can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Cuprior 
Other information about Cuprior
Cuprior trientin 
Cuprior trientine
CHMP bemærkede, at trientin er blevet anvendt til behandling af patienter med Wilsons sygdom i over 30 år. 
The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson's disease.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cuprior? 
What measures are being taken to ensure the safe and effective use of Cuprior?
Virksomheden fremlagde data fra offentliggjort litteratur, der viser, at trientin i væsentlig grad øger kobberudskillelsen i urinen. 
The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Cuprior opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Det virker ved at binde sig til kobber i kroppen og danne et kompleks, som herefter udskilles i urinen. 
It works by attaching to copper in the body and forming a complex that is then eliminated in the urine.
Hvilke fordele og risici er der forbundet med Cuprior? 
What are the benefits and risks of Cuprior?
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. 
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.
Forskellen på Cuprior og referencelægemidlet er, at Cuprior indeholder en anden form for trientin (trientintetrahydrochlorid) og ikke skal opbevares i køleskab. 
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.
Cuprior anvendes til patienter, der ikke kan tage D-penicillamin, som er et andet lægemiddel mod denne tilstand. 
Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition.
Resultaterne viste, at Cuprior danner et højere niveau af det aktive stof i blodet end referencelægemidlet. 
Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine.
Cuprior udleveres kun efter recept, og behandlingen bør indledes af en speciallæge med erfaring i behandling af Wilsons sygdom. 
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.
Da Cuprior er et hybridt lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Hvorfor blev Cuprior godkendt? 
Why is Cuprior approved?
Cuprior indeholder det aktive stof trientin. 
Cuprior contains the active substance trientine.
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. 
For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det er ikke en praktisk vejledning i, hvordan Cuprior bør anvendes. 
It is not intended to provide practical advice on how to use Cuprior.
Virksomheden foretog også en undersøgelse for at sammenligne niveauet af trientin i blodet efter indtagelse af Cuprior med niveauet for referencelægemidlet. 
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.
Det aktive stof i Cuprior, trientin, er et chelatdannende stof. 
The active substance in Cuprior, trientine, is a chelating agent.
Hvad er Cuprior, og hvad anvendes det til? 
What is Cuprior and what is it used for?
patientens respons og kobberniveauet i kroppen. 
Doses are adjusted according to patient response and levels of copper in the body.
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. 
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.
Hvordan er Cuprior blevet undersøgt? 
How has Cuprior been studied?
Hvis du ønsker praktisk vejledning om anvendelsen af Cuprior, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Cuprior, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Cuprior? 
How is Cuprior used?
Det er en genetisk tilstand, hvor kobber optaget fra maden ophobes i kroppen, navnlig i leveren og hjernen, og medfører skader. 
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.
Hvordan virker Cuprior? 
How does Cuprior work?
Medlemsstaterne skal sikre sig, at alle betingelser eller restriktioner med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet, som beskrevet nedenfor, bliver implementeret. 
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:
Information om Pharmacovigilance Monitoring Programme omkring potentielle risiko for klinisk relevant hypotension og relaterede problemer i forbindelse med brug af DCF. 
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.
Information om skift fra 50 ml hætteglas til 20 ml hætteglas Revatio 0,8 mg/ml injektionsvæske 
- Information on the switch from the 50 ml vial to the 20 ml vial for Revatio 0.8 mg/ml solution
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 
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
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. 
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.
Det skal du vide, før du begynder at bruge [produktnavn] 
What you need to know before you use [product name]
Hypoparatyroidismeh 
Hypoparathyroidismh
Graviditet og amning <Produktnavn> kan om nødvendigt anvendes under graviditet. 
If necessary, <Product name> can be used during pregnancy.
Vedtaget på PRAC's møde den 12.-15. marts 2019 
Adopted at the 12-15 March 2019 PRAC
Det skal du vide, før du begynder at bruge OPDIVO Advarsler og forsigtighedsregler 
What you need to know before you use OPDIVO Warnings and precautions
Kontakt <lægen><jordemoderen>, hvis smerterne og/eller feberen ikke mindskes, eller hvis du har brug for at tage lægemidlet oftere. 
Contact your <doctor><midwife> if the pain and/or fever are not reduced or if you need to take the medicine more often.
Nivolumab - hypoparatyroidisme (EPITT nr. 19310) 
Nivolumab - Hypoparathyroidism (EPITT no 19310)
Epidemiologiske studier af den neurologiske udvikling hos børn, der eksponeres for paracetamol i uterus, viser inkonklusive resultater. 
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.
Der foreligger ikke konventionelle studier, hvor man har anvendt aktuelt anerkendte standarder for evaluering af reproduktions- og udviklingstoksicitet. 
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.