natgillin/translations-raw huggingface dataset:
Til forebyggelse af kardiovaskulære problemer svarede virkningen af Pritor til virkningen af ramipril, idet ca. 17 % af patienterne døde, blev hospitalsindlagt som følge af kardiovaskulære problemer eller fik et hjerteanfald eller slagtilfælde.
In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Den fuldstændige liste over indberettede bivirkninger ved Pritor fremgår af indlægssedlen.
For the full list of all side effects reported with Pritor, see the package leaflet.
Hvilken fordel viser undersøgelserne, at der er ved Pritor?
What benefit has Pritor shown during the studies?
Hvordan blev Pritor undersøgt?
How has Pritor been studied?
Den fuldstændige EPAR for Pritor findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Hvis du ønsker yderligere oplysninger om behandling med Pritor, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
The full EPAR for Pritor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Hvad anvendes Pritor til?
What is Pritor used for?
Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer telmisartan hormonet i at have nogen effekt, hvorved blodkarrene udvider sig.
By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Hvordan anvendes Pritor?
How is Pritor used?
Hvad er Winfuran?
What is Winfuran?
Virkningerne af Winfuran blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Winfuran were first tested in experimental models before being studied in humans.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Winfuran (nalfurafin) EMA/33514/2014
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Behandlingens virkning blev hovedsagelig bedømt på ændringen i symptomer, såsom kløeintensitet og søvnforstyrrelse, efter fire ugers behandling, baseret på et standardscoresystem.
The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Den 24. januar 2014 EMA/33514/2014
EMA/33514/2014
Winfuran er et lægemiddel, der indeholder det aktive stof nalfurafin.
Winfuran is a medicine that contains the active substance nalfurafine.
Hvad forventedes Winfuran anvendt til?
What was Winfuran expected to be used for?
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Winfuran (nalfurafin)
Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Det kunne ikke påvises i hovedundersøgelsen, at Winfuran var mere effektivt end placebo til at lindre kløen.
The main study failed to show that Winfuran was more effective than placebo at relieving itching.
Den nøjagtige årsag til uræmisk pruritus kendes ikke, men kløen menes at hænge sammen med for stor aktivitet af visse receptorer, my-opioidreceptorer, i hjernen og i huden.
Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin.
En supplerende analyse viste en beskeden fordel hos en undergruppe af patienter med en svær form for uræmisk pruritus, men CHMP fandt ikke, at den kliniske betydning heraf var påvist.
Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Den 17. januar 2014 meddelte Toray International U.K. Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Winfuran til behandling af kløe (svær uræmisk pruritus) hos dialysepatienter med nyresygdom i slutstadiet.
On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Winfuran blev sammenlignet med placebo (en virkningsløs behandling) i én hovedundersøgelse med deltagelse af 339 patienter, der havde uræmisk pruritus og var i regelmæssig dialysebehandling.
The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Winfuran aktiverer nogle andre receptorer, kappa-receptorerne, som blokerer aktiviteten af my-opioidreceptorerne og derved lindrer kløen hos patienter med uræmisk pruritus.
Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Uræmisk pruritus er vedvarende kløe, der optræder hos nogle patienter, hvis nyrer ikke fungerer korrekt.
Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly.
CHMP's hovedbetænkelighed var, at fordelene ved Winfuran til behandling af uræmisk pruritus ikke var tilstrækkelig påvist.
The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Winfuran ikke opvejede risiciene, og konkluderede, at lægemidlet ikke kunne være blevet godkendt på baggrund af de oplysninger, som virksomheden havde fremlagt.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.
Hvordan forventes Winfuran at virke?
How is Winfuran expected to work?
Winfuran blev udpeget som “lægemiddel til sjældne sygdomme” den 11. september 2002 til uræmisk pruritus.
Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Virksomheden har meddelt CHMP, at der ikke er nogen igangværende kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Winfuran.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.
På baggrund af gennemgangen af dataene havde CHMP afgivet en negativ udtalelse og anbefalet afslag på udstedelse af markedsføringstilladelse for Winfuran til behandling af svær uræmisk pruritus.
Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi CHMP fandt, at de forelagte data ikke gjorde det muligt for udvalget at vurdere benefit/risk-forholdet som positivt.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Winfuran skulle anvendes hos patienter, hvis nyrer var holdt helt op med at virke (nyresygdom i slutstadiet), og som fik dialyse for at få fjernet affaldsstoffer fra blodet.
Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Det skulle have været leveret som koncentrat til infusionsvæske, opløsning, i en vene.
It was to be available as a concentrate for solution for infusion into a vein.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Winfuran eller i programmer for anvendelse af Winfuran med særlig udleveringstilladelse?
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Winfuran forventedes anvendt til behandling af svær uræmisk pruritus.
Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus.
Olysio leveres som 150 mg kapsler.
Olysio is available as 150 mg capsules.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Olysio.
This is a summary of the European public assessment report (EPAR) for Olysio.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Olysio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Olysio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den normale dosis er én kapsel én gang dagligt, der tages sammen med mad, i 12 eller 24 uger.
The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Hvad er Olysio, og hvad anvendes det til?
What is Olysio and what is it used for?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Olysio?
What measures are being taken to ensure the safe and effective use of Olysio?
Agenturet var desuden af den opfattelse, at de tilgængelige data understøtter anvendelsen af Olysio in kombination med sofosbuvir.
The Agency also considered that the data available support the use of Olysio in combination with sofosbuvir.
Olysio anvendes i kombination med andre
Olysio is used in combination with other medicines.
Denne undersøgelse gennemføres på baggrund af data, der indikerer, at patienter, som behandles med disse lægemidler, og som har haft leverkræft, kan risikere, at deres kræft vender hurtigt tilbage.
This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Olysio opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The European Medicines Agency decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvad sikkerheden angår, tåltes Olysio godt, og bivirkningerne kunne behandles.
Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Det er ikke en praktisk vejledning i, hvordan Olysio bør anvendes.
It is not intended to provide practical advice on how to use Olysio.
Hvilke risici er der forbundet med Olysio?
What are the risks associated with Olysio?
Olysio udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
Olysio can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Virksomheden, der markedsfører Olysio, vil gennemføre en undersøgelse blandt patienter, der tidligere har haft leverkræft, for at vurdere risikoen for, at leverkræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Olysio.
The company that markets Olysio will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Olysio.
Hvordan virker Olysio?
How does Olysio work?
Den fuldstændige liste over bivirkninger og begrænsninger
For the full list of side effects and restrictions, see the package leaflet.
Olysio er et lægemiddel mod virus (et antiviralt lægemiddel), der indeholder det aktive stof simeprevir.
Olysio is an antiviral medicine that contains the active substance simeprevir.
En analyse af disse undersøgelser viste, at Olysio var mindre effektivt hos den undergruppe, der var smittet med hepatitis C-virus af genotype 1a med Q80K-mutationen.
An analysis of these studies showed that Olysio was less effective in a sub-group of patients infected with hepatitis C virus genotype 1a that has the Q80K mutation.
De hyppigste bivirkninger ved Olysio (som optræder hos mere end 1 ud af 10 patienter) er kvalme, udslæt, kløe og vejrtrækningsbesvær.
The most common side effects during treatment with Olysio (which may affect more than 1 in 10 people) are nausea (feeling sick), rash, pruritus (itching) and dyspnoea (difficulty breathing).
Olysio skal anvendes i kombination med andre lægemidler til behandling af kronisk hepatitis C, såsom peginterferon alfa og ribavirin eller sofosbuvir.
Olysio must be used in combination with other medicines used to treat chronic hepatitis C, such as with peginterferon alfa and ribavirin or with sofosbuvir.
Det anvendes til behandling af voksne med kronisk hepatitis C, der er en smitsom sygdom, som angriber leveren og forårsages af hepatitis C-virus.
It is used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Eliminationen nåede op på over 90 %, når behandlingen blev forlænget til 24 uger.
Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Tre hovedundersøgelser med 1 178 patienter, som havde hepatitis C-virus af genotype 1, så nærmere på kombinationen med peginterferon alfa og ribavirin.
Three main studies involving 1,178 patients with hepatitis C virus of genotype 1 investigated the combination with peginterferon alfa and ribavirin.
Før behandlingen med Olysio påbegyndes, bør patienter med genotype 1a have taget en blodprøve for at se, om den virus, de er smittet med, indeholder en forandring (mutation) kaldet Q80K, da Olysio vides at være mindre effektivt hos disse patienter.
Before starting treatment with Olysio, patients with genotypes 1a should have a blood test to check whether the virus they are infected with has a mutation (a change in the genetic material of the virus) called Q80K, as Olysio is known to be less effective in these patients.
I undersøgelsen deltog patienter med og uden skrumpelever og patienter, hos hvem den tidligere behandling ikke
The study included patients with and without cirrhosis as well as patients who had not responded to previous therapy.
Hvis du ønsker yderligere oplysninger om behandling med Olysio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Olysio, read the package leaflet (also part of the EPAR) or contact
En række undersøgelser viser, at Olysio i kombination med peginterferon alfa og ribavirin eller med sofosbuvir var effektivt til at eliminere hepatitis C-virusset fra blodet efter 12 eller 24 ugers
Several studies show that Olysio in combination with peginterferon alfa and ribavirin or with sofosbuvir is effective in clearing the hepatitis C virus from the blood after 12 or 24 weeks of treatment.
Det aktive stof i Olysio, simeprevir, blokerer virkningen af enzymet NS3/4A serinprotease i hepatitis Cvirusset.
The active substance in Olysio, simeprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Yderligere undersøgelser med kombinationen af peginterferon alfa og ribavirin hos patienter med hepatitis C-virus af genotype 4 og patienter, der desuden var smittet med hiv, gav de lignende resultater som hos patienter med
Additional studies of the combination with peginterferon alfa and ribavirin involving patients with hepatitis C virus of genotype 4 and patients with HIV co-infection showed results consistent with those in patients with genotype 1.
Hvilke fordele viser undersøgelserne, at der er ved Olysio?
What benefits of Olysio have been shown in studies?
I to yderligere undersøgelser med 413 patienter, som fik simeprevir i kombination med sofosbuvir, var eliminationen hos patienterne uden skrumpelever, som fik Olysio sammen med sofosbuvir, 97 % efter 12 uger, mens eliminationen hos patienterne med skrumpelever var 83 % efter 12 uger.
In two additional studies of simeprevir in combination with sofosbuvir in 413 patients, patients without cirrhosis who were taking Olysio together with sofosbuvir had a clearance rate at 12 weeks of 97%, while patients with cirrhosis had a 12 weeks clearance rate of 83%.
En undersøgelse med 167 patienter så nærmere på kombinationen af Olysio og sofosbuvir, og resultaterne viste, at denne kombination (med eller uden ribavirin) har elimineret infektionen med hepatitis C af genotype 1 hos over 90 % af patienterne 12 uger efter afslutningen af behandlingen.
Olysio taken together with sofosbuvir was investigated in a study involving 167 patients, which showed that the combination (with or without ribavirin) cleared infection with hepatitis C genotype 1 in around 90% of patients 12 weeks after the end of treatment.
I den tredje undersøgelse med patienter, hvis infektion var vendt tilbage efter interferonbaseret behandling, var omkring 80 % (206 ud af 260) af de patienter, der fik Olysio, hepatitis C-negative 12 uger efter afslutningen af behandlingen sammenlignet med 37 % (49 ud 133) af dem, der fik placebo.
In the third study, involving patients whose infections had come back following treatment with interferon-based therapy, around 80% (206 out of 260) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with around 37% (49 out of 133) of
I to undersøgelser med ikke tidligere behandlede patienter var omkring 80 % (419 ud af 521) af de patienter, der fik Olysio, hepatitis Cnegative 12 uger efter afslutningen af behandlingen sammenlignet med 50 % (132 ud 264) af dem,
In two of the studies, which involved previously untreated patients, around 80% (419 out of 521) of patients taking Olysio tested negative for hepatitis C 12 weeks after the end of treatment, compared with 50% (132 out of 264) of patients on placebo.
Hvis du ønsker praktisk vejledning om anvendelsen af Olysio, kan du læse indlægssedlen eller
For practical information about using Olysio, patients should read the package leaflet or contact their
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Olysio.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olysio have also been included in the summary of product characteristics and the
Agenturet konkluderede, at betydeligt flere patienter var uden tegn på infektion, når de fik Olysio som tillægsbehandling til peginterferon alfa og ribavirin, og at dette gælder både tidligere ubehandlede og tidligere behandlede patienter.
The Agency concluded that, in both previously untreated patients and patients who had already been treated, adding Olysio to treatment with peginterferon alfa and ribavirin considerably increased the number of patients showing no sign of infection.
Olysio anbefales til patienter med virus af genotype 1 og 4.
Several varieties (genotypes) of hepatitis C virus exist and Olysio is recommended for patients with virus of genotypes 1 and 4.
Den nødvendige dosis bestemmes ved hjælp af følgende formel:
The required dose is determined using the following formula:
Dato for første markedsføringstilladelse: 04 januar 2017
Date of first authorisation: 04 January 2017
Din læge vil oplyse dig om de tidlige tegn på allergiske reaktioner.
Your doctor should inform you of the early signs of allergic reactions.
Regimet kan justeres ud fra patientens respons.
The regimen may be adjusted based on patient response.
Ud fra en mikrobiologisk betragtning skal lægemidlet anvendes straks.
From a microbiological point of view, the product should be used immediately.
Pædiatrisk population <12 år
Paediatric population <12 years of age
Med henblik på forbedring af sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede produkt angives tydeligt.
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Ældre Kliniske studier med AFSTYLA har ikke inkluderet personer over 65 år.
Elderly Clinical studies of AFSTYLA did not include subjects over 65 years of age.
ATC-kode: B02BD02
ATC code: B02BD02
• hvor alvorlig din sygdom er
• the severity of your disease
VWF stabiliserer faktor VIII og beskytter den mod nedbrydning.
VWF stabilizes factor VIII and protects it from degradation.
Hvor meget AFSTYLA, du skal have, samt behandlingens varighed afhænger af:
The amount of AFSTYLA you need to take and the duration of treatment depend on:
Dette kan enten gøres ved at lade hætteglassene stå ved stuetemperatur i en times tid eller ved at holde dem i hænderne i nogle få minutter.
This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Faktor VIII bør derfor kun anvendes under graviditet og amning, hvis det er klart indiceret.
Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Osmolalitet: 500-600 mOsm/kg
Osmolality: 500 - 600 mOsm/kg
Præparatet indeholder spor af hamsterproteiner (se også afsnittet "Brug ikke AFSTYLA").
The product contain traces of hamster proteins (see also “Do not use AFSTYLA”).
AFSTYLA kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, AFSTYLA can cause side effects, although not everybody gets them.
Hyppigere eller højere doser kan være nødvendige hos børn <12 år for at opveje den højere clearance i denne aldersgruppe.
More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
Der blev ikke inkluderet nogen pædiatriske patienter < 18 år i kirurgi-populationen.
No paediatric subjects <18 years of age were included in the surgery population.
Monitorering ved hjælp af laboratorieprøver
Monitoring laboratory tests
Injektion gentages hver 12. til 24. time.
Repeat injection every 12 to 24 hours.
Dosering baseret på kropsvægt kan nødvendiggøre justering hos under- og overvægtige patienter.
Dose based on bodyweight may require adjustment in underweight or overweight patients.
Efter rekonstitution er der påvist kemisk og fysisk i-brug-stabilitet på 48 timer ved stuetemperatur (under 25 °C).
After reconstitution the chemical and physical in-use stability has been demonstrated for 48 hours at room temperature (below 25 °C).
Den specifikke aktivitet af AFSTYLA er 7.400-16.000 IE/mg protein.
The specific activity of AFSTYLA is 7400 - 16000 IU/mg protein.
Brug ikke AFSTYLA
Do not use AFSTYLA
Det noteres at den årlige blødningsrate (ABR) ikke kan sammenlignes mellem forskellige faktorkoncentrater eller mellem kliniske studier.
Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Ingen patienter udviklede inhibitorer eller oplevede anafylaktiske reaktioner.
No patient developed an inhibitor or experienced an anaphylactic reaction.
Mangel på denne faktor betyder, at blodet ikke koagulerer så hurtigt, som det bør, hvorved tendensen til blødninger øges.
Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
AFSTYLA kan bruges til alle aldersgrupper.
AFSTYLA can be used for all age groups.
Udsæt ikke hætteglassene for direkte varme.
Do not expose the vials to direct heat.
• smerter på injektionsstedet
• pain at the injection site