FrancophonIA/ELRC3.0 huggingface dataset:
English: Translarna works in these patients by enabling the protein-making apparatus in cells to move past the defect, allowing the cells to produce a functional dystrophin protein.
Danish: Hos sådanne patienter virker Translarna ved at gøre cellernes proteinopbyggende apparat i stand til at bevæge sig forbi defekten og producere et dystrofin, der fungerer.
English: Patients with Duchenne muscular dystrophy lack normal dystrophin, a protein found in muscles.
Danish: Patienter med Duchennes muskeldystrofi mangler det normale protein dystrofin i musklerne.
English: What benefits of Translarna have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Translarna?
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene which prematurely stop the production of a normal dystrophin protein, leading to a shortened dystrophin protein that does not function properly.
Danish: Translarna er beregnet til patienter, hos hvem sygdommen er forårsaget af visse defekter (nonsensmutationer) i genet for dystrofin, som blokerer den normale opbygning af dystrofin, så proteinet bliver for kort og ikke fungerer som det skal.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Translarna 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 Translarna.
English: How does Translarna work?
Danish: Hvordan virker Translarna?
English: The effect was more pronounced in a subgroup of patients whose ability to walk was worsening, where patients taking 40 mg/kg daily Translarna could walk on average 50 metres more than those taking placebo.
Danish: Patienter, der fik 40 mg/kg Translarna dagligt kunne i gennemsnit gå 50 meter længere end de, der fik placebo.
English: Because this protein helps to protect muscles from injury as muscles contract and relax, in patients with Duchenne muscular dystrophy the muscles become damaged and eventually stop working.
Danish: Dette protein beskytter musklerne efter de læsioner, der opstår, når de trækker sig sammen og afslappes,
English: In one main study, involving 174 patients aged 5 to 20 years with Duchenne muscular dystrophy who were able to walk, two doses of Translarna (40 mg/kg daily and 80 mg/kg daily) were compared with placebo (a dummy treatment).
Danish: Der blev anvendt to forskellige doser af Translarna (40 mg/kg dagligt og 80 mg/kg dagligt), som blev sammenlignet med virkningsløs behandling (placebo).
English: The maximum single dose is 200 mg.
Danish: Den maksimale enkeltdosis er 200 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Raptiva to Serono Europe Ltd. on 20 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Raptiva til Serono Europe Ltd. den 20. september 2004.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RAPTIVA
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) RAPTIVA
English: How has Raptiva been studied?
Danish: Hvordan blev Raptiva undersøgt?
English: The Committee recommended that Raptiva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Raptiva.
English: Raptiva is given by injection under the skin.
Danish: Raptiva gives ved indsprøjtning under huden.
English: It is given as a 12-week course, with a first dose of 0.7 mg per kilogram body weight followed by weekly injections of 1.0 mg/kg.
Danish: Det gives som en 12 ugers kur, der begynder med en dosis på 0,7 mg pr. kg legemsvægt, efterfulgt af indsprøjtninger hver uge i en dosis af 1,0 mg/kg.
English: Raptiva was more effective than placebo at improving the symptoms of psoriasis.
Danish: Raptiva var mere effektivt end placebo til at bedre symptomerne på psoriasis.
English: The active substance in Raptiva, efalizumab, is a monoclonal antibody.
Danish: Det aktive stof i Raptiva, efalizumab, er et monoklonalt antistof.
English: The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘high-need' patients, and that the effectiveness of Raptiva is relevant for these patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konstaterede, at patienter med "stort behov" havde psoriasis i sværere grad, og at virkningen af Raptiva er relevant for sådanne patienter.
English: In all studies, the effectiveness of Raptiva was compared with that of placebo (a dummy treatment).
Danish: I alle undersøgelserne blev virkningen af Raptiva sammenlignet med virkningen af placebo (virkningsløs behandling).
English: In the fifth study, 526 of the 793 patients were ‘high need', since they had failed to respond to or could not take other systemic treatments.
Danish: havde 526 af de 793 deltagende patienter "stort behov", da anden systemisk behandling ikke virkede eller ikke kunne anvendes.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse de faglige drøftelser
English: The most common side effects with Raptiva (seen in more than 1 patient in 10) are mild to moderate flu-like symptoms including headache, fever, chills, nausea (feeling sick), myalgia (muscle pain), and leucocytosis and lymphocytosis (increased white blood cell counts).
Danish: De almindeligste bivirkninger af Raptiva (som ses hos flere end 1 ud af 10 patienter) er lette til moderate influenzalignende symptomer som hovedpine, feber, kulderystelser, kvalme, muskelsmerter samt leukocytose og lymfocytose (forhøjet antal hvide blodlegemer).
English: In the fifth study, overall, 166 (31%) of the 529 patients receiving Raptiva responded to treatment, compared with 11 (4%) of the 264 receiving placebo.
Danish: I den femte undersøgelse reagerede 166 (31 %) af de 529 patienter, der fik Raptiva, positivt på behandlingen, sammenholdt med 11 (4 %) af de 264, der fik placebo.
English: Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
Danish: Raptiva var genstand for fem undersøgelser, der omfattede næsten 3 000 patienter med moderat til svær plaque psoriasis.
English: As LFA-1 is important in helping the lymphocytes to stick to cells in the skin, efalizumab reduces the inflammation in the skin that causes psoriasis.
Danish: Da LFA-1 er nødvendigt for, at lymfocytterne kan bindes til cellerne i huden, dæmper efalizumab den betændelsesreaktion i huden, som er årsag til psoriasis.
English: Looking only at the ‘high need' patients in this study, 30% of those receiving Raptiva responded to treatment, compared with 3% of those receiving
Danish: Hvis man alene ser på patienter med "stort behov" i denne undersøgelse, virkede behandlingen hos 30 % af de patienter, der fik Raptiva, sammenholdt med 3 % af dem, der fik placebo.
English: Raptiva should not be used in people who may be hypersensitive (allergic) to efalizumab or any of the other ingredients.
Danish: Raptiva bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for efalizumab eller andre af indholdsstofferne.
English: Looking at the results of the first four studies taken together, 320 (26%) of the 1,213 patients receiving 1.0 mg/kg Raptiva per week responded to treatment, compared with 25 (4%) of the 715 receiving placebo.
Danish: Hvis man ser på resultaterne af de fire første undersøgelser sammenlagt, virkede behandlingen hos 320 (26 %) af de 1 213 patienter, der fik Raptiva, 1,0 mg/kg pr. uge, sammenholdt med 25 (4 %) af de 715, der fik placebo.
English: It should also not be used in patients who have had cancer, who have active tuberculosis or another severe infection, who have other types of psoriasis, or who have low levels of
Danish: Det bør desuden ikke anvendes hos patienter, som har haft kræft eller har aktiv tuberkulose, andre alvorlige infektioner, andre former for psoriasis eller svækket immunfor
English: Raptiva is used for the treatment of adults with moderate to severe chronic (long-term) plaque psoriasis (a disease causing red, scaly patches on the skin).
Danish: Raptiva anvendes hos voksne med moderat til svær kronisk plaque psoriasis (en sygdom, der giver røde, skællende områder på huden).
English: This improves
Danish: Derved mindskes symptomer
English: The main measure of effectiveness was the proportion of patients who ‘responded' to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hos hvem behandlingen efter 12 uger havde virket, dvs. hos hvem symptomscore var blevet mindst 75 % bedre.
English: Efalizumab has been designed to bind to part of a protein called LFA-1 on the surface of lymphocytes, a type of white blood cell that is involved in the inflammation process.
Danish: Efalizumab er udformet, så det bindes til et afsnit af proteinet LFA-1 på overfladen af lymfocytterne, der er en type hvide blodlegemer, som medvirker ved betændelsesprocesser.
English: The studies included patients who had not taken other treatments for psoriasis in the past, as well as those who had taken other treatments.
Danish: Undersøgelserne omfattede dels patienter, der ikke tidligere havde fået anden medicin mod psoriasis, dels patienter, der tidligere havde fået sådan medicin.
English: What benefit has Raptiva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Raptiva?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on the surface of cells in the body.
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det binder sig til en bestemt struktur, der kaldes et antigen og findes på overfladen af visse celler i organismen.
English: For the full list of all side effects reported with Raptiva, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Raptiva fremgår af indlægssedlen.
English: It is used in patients who have failed to respond to or cannot take other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Danish: Det anvendes hos patienter, hos hvem systemisk behandling (helkropsbehandling) af psoriasis ikke virker eller ikke tåles, herunder ciclosporin, methotrexat og PUVA (psoralen ultraviolet-A).
English: Therefore, the Committee decided that Raptiva's benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Danish: Udvalget besluttede derfor, at fordelene ved Raptiva er større end risiciene til behandling af voksne patienter med moderat til svær kronisk plaque psoriasis, hos hvilke anden systemisk behandling, herunder ciclosporin, methotrexat og PUVA, enten ikke virker, er kontraindiceret eller ikke tåles.
English: Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.
Danish: Hvis lægen finder det hensigtsmæssigt, kan patienterne selv give indsprøjtningerne efter at have fået tilstrækkelig oplæring.
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet
Danish: PUVA er en behandlingsform, hvor patienten får medicin indeholdende stoffet psoralen, efterfulgt af behandling med ultraviolet lys.
English: Raptiva should be used with caution in patients who have problems with their liver or
Danish: Raptiva bør anvendes med forsigtighed hos patienter med lever- eller nyreproblemer.
English: Raptiva is a powder and solvent that are made up into a solution for injection.
Danish: Raptiva er et pulver og en opløsningsvæske, der bruges til at fremstille en injektionsvæske (opløsning).
English: The results were similar in those who had and those who had not taken systemic treatments for psoriasis
Danish: Resultaterne var de samme, uanset om patienterne tidligere havde fået systemisk behandling for psori
English: Raptiva treatment should be initiated by a doctor who specialises in dermatology (the treatment of skin conditions).
Danish: Behandling med Raptiva bør iværksættes af en speciallæge i hudsygdomme.
English: Therapy should only be continued in patients who have responded to treatment.
Danish: Behandlingen bør kun fortsætte, hvis den virker.
English: It must not be used in women who are more than three months pregnant.
Danish: Det må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exforge HCT on 16 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exforge HCT den 16. oktober 2009.
English: 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.
Danish: Den fuldstændige EPAR for Exforge HCT findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Exforge HCT.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Exforge HCT.
English: amlodipine / valsartan / hydrochlorothiazide
Danish: amlodipin / valsartan/ hydrochlorothiazid
English: Amlodipine is a ‘calcium channel blocker'.
Danish: Amlodipin er en ‘calciumkanalblokker'.
English: Exforge HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Danish: Exforge HCT indtages gennem munden, og dosis er en tablet dagligt på samme tidspunkt hver dag og helst om morgenen.
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 Exforge HCT.
Danish: 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.
English: The combination of the three active substances has an additive effect, reducing the blood pressure more than the individual medicines alone.
Danish: Kombinationen af de tre aktive stoffer har en additiv virkning og sænker blodtrykket mere end de enkelte lægemidler alene.
English: For more information about treatment with Exforge HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: Patients received either Exforge HCT or one of the three combinations containing only two of the active substances for eight weeks.
Danish: Patienterne fik enten Exforge HCT eller en af de tre kombinationer, som kun indeholdt to af de aktive stoffer, i otte uger.
English: 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.
Danish: 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.
English: The main measure of effectiveness was the average change in the blood pressure.
Danish: Det primære mål for virkning var den gennemsnitlige ændring i blodtrykket.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II.
Danish: Valsartan er en ”angiotensin II-receptorantagonist”, hvilket betyder, at det blokerer virkningen af et hormon i kroppen, som kaldes angiotensin II.
English: 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.
Danish: 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.
English: The main study showed the benefit of the highest strength of Exforge HCT in lowering the blood pressure.
Danish: Hovedundersøgelsen påviste den gavnlige virkning af den højeste styrke af Exforge HCT til nedsættelse af blodtrykket.
English: The three active substances in Exforge HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Danish: De tre aktive stoffer i Exforge HCT er lægemidler mod forhøjet blodtryk, som allerede anvendes i Den Europæiske Union (EU).
English: 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.
Danish: Den dosis af Exforge HCT, som skal anvendes, er den samme som doserne af tre individuelt aktive stoffer, som patienten fik tidligere.
English: 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.
Danish: 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.
English: Treatment with the highest strength of Exforge HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Danish: Behandling med den højeste styrke af Exforge HCT var mere effektiv til at behandle hypertension end tokombinationsbehandlinger, der hver indeholdt to aktive stoffer.
English: 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.
Danish: 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.
English: Exforge HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Danish: Exforge HCT er et lægemiddel, der indeholder de tre aktive stoffer amlodipin, valsartan og hydrochlorthiazid.
English: The CHMP therefore decided that Exforge HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Exforge HCT opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Exforge HCT.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Other information about Exforge HCT
Danish: Andre oplysninger om Exforge HCT
English: 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.
Danish: 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.
English: It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
Danish: Det virker ved at øge urinproduktionen, hvorved væskemængden i blodet reduceres og blodtrykket nedsættes.
English: 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).
Danish: 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).
English: The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Danish: Den daglige dosis af Exforge HCT må ikke overskride 10 mg amlodipin, 320 mg valsartan og 25 mg hydrochlorthiazid.
English: 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).
Danish: 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).
English: For the full list of all side effects reported with Exforge HCT, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Exforge HCT fremgår af indlægssedlen.
English: For all doses, Exforge HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken seperately.
Danish: Exforge HCT opfyldte endvidere i samtlige doser kravet om at dokumentere, at lægemidlet var sammenligneligt med kombinationerne af de individuelt aktive stoffer indtaget separat.
English: 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).
Danish: 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).