natgillin/translations-raw huggingface dataset:
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.
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.
Hvordan virker Translarna?
How does Translarna work?
Patienter, der fik 40 mg/kg Translarna dagligt kunne i gennemsnit gå 50 meter længere end de, der fik placebo.
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.
Dette protein beskytter musklerne efter de læsioner, der opstår, når de trækker sig sammen og afslappes,
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.
Der blev anvendt to forskellige doser af Translarna (40 mg/kg dagligt og 80 mg/kg dagligt), som blev sammenlignet med virkningsløs behandling (placebo).
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).
Den maksimale enkeltdosis er 200 mg.
The maximum single dose is 200 mg.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Raptiva til Serono Europe Ltd. den 20. september 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Raptiva to Serono Europe Ltd. on 20 September 2004.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) RAPTIVA
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RAPTIVA
Hvordan blev Raptiva undersøgt?
How has Raptiva been studied?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Raptiva.
The Committee recommended that Raptiva be given marketing authorisation.
Raptiva gives ved indsprøjtning under huden.
Raptiva is given by injection under the skin.
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.
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.
Raptiva var mere effektivt end placebo til at bedre symptomerne på psoriasis.
Raptiva was more effective than placebo at improving the symptoms of psoriasis.
Det aktive stof i Raptiva, efalizumab, er et monoklonalt antistof.
The active substance in Raptiva, efalizumab, is a monoclonal antibody.
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.
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.
I alle undersøgelserne blev virkningen af Raptiva sammenlignet med virkningen af placebo (virkningsløs behandling).
In all studies, the effectiveness of Raptiva was compared with that of placebo (a dummy treatment).
havde 526 af de 793 deltagende patienter "stort behov", da anden systemisk behandling ikke virkede eller ikke kunne anvendes.
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.
Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse de faglige drøftelser
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
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).
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).
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.
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.
Raptiva var genstand for fem undersøgelser, der omfattede næsten 3 000 patienter med moderat til svær plaque psoriasis.
Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
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.
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.
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.
Looking only at the ‘high need' patients in this study, 30% of those receiving Raptiva responded to treatment, compared with 3% of those receiving
Raptiva bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for efalizumab eller andre af indholdsstofferne.
Raptiva should not be used in people who may be hypersensitive (allergic) to efalizumab or any of the other ingredients.
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.
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.
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
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
Raptiva anvendes hos voksne med moderat til svær kronisk plaque psoriasis (en sygdom, der giver røde, skællende områder på huden).
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).
Derved mindskes symptomer
This improves
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.
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.
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.
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.
Undersøgelserne omfattede dels patienter, der ikke tidligere havde fået anden medicin mod psoriasis, dels patienter, der tidligere havde fået sådan medicin.
The studies included patients who had not taken other treatments for psoriasis in the past, as well as those who had taken other treatments.
Hvilken fordel viser undersøgelserne, at der er ved Raptiva?
What benefit has Raptiva shown during the studies?
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.
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.
Den fuldstændige liste over de indberettede bivirkninger ved Raptiva fremgår af indlægssedlen.
For the full list of all side effects reported with Raptiva, see the Package Leaflet.
Det anvendes hos patienter, hos hvem systemisk behandling (helkropsbehandling) af psoriasis ikke virker eller ikke tåles, herunder ciclosporin, methotrexat og PUVA (psoralen ultraviolet-A).
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).
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.
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.
Hvis lægen finder det hensigtsmæssigt, kan patienterne selv give indsprøjtningerne efter at have fået tilstrækkelig oplæring.
Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.
PUVA er en behandlingsform, hvor patienten får medicin indeholdende stoffet psoralen, efterfulgt af behandling med ultraviolet lys.
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet
Raptiva bør anvendes med forsigtighed hos patienter med lever- eller nyreproblemer.
Raptiva should be used with caution in patients who have problems with their liver or
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.