natgillin/translations-raw huggingface dataset:
Er <De> <du> i tvivl, så spørg <lægen> <eller> <,> <apotekspersonalet> <eller sundhedspersonalet>.>
If you have any further questions, ask your <doctor> <,> <or> <pharmacist> <or nurse>.
<Yderligere oplysninger om <{X}> <dette lægemiddel> findes på Lægemiddelstyrelsens hjemmeside HYPERLINK "http://www.laegemiddelstyrelsen" www.dkma.dk.>
<Detailed information on this medicinal product is available on the website of {name of MS Agency (link)}>
<Der foreligger ingen data.>
<Not relevant.>
<{X} indeholder {nævn de(t) hjælpestof(fer), hvor advarsel er påkrævet}>
<X contains {name the excipient(s)}>
<Spørg <lægen> <,> <eller> <apotekspersonalet> <eller sundhedspersonalet>, hvis der er noget, <De> <du> er i tvivl om.>
Check with your <doctor> <or> <,> <pharmacist> <or nurse> if you are not sure.>
{Udseende og pakningsstørrelser
What X looks like and contents of the pack
Sådan skal <De> <du> <tage> <bruge> {X}
How to <take> <use> X
- Øvrige indholdsstoffer <(hjælpestoffer)>: {navne}
The other <ingredient(s)> <(excipient(s))> is (are)...
Opbevares utilgængeligt for børn.
Keep this medicine out of the sight and reach of children.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for ViraferonPeg den 29. maj 2000.
The European Commission granted a marketing authorisation valid throughout the EU for ViraferonPeg on 29 May 2000.
Desuden blokerer de muligvis formeringen af virus.
They may also block the multiplication of viruses.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ViraferonPeg.
This document is a summary of the European Public Assessment Report (EPAR) for ViraferonPeg.
I nogle undersøgelser undersøgte man også tegn på forbedring af leverens tilstand.
Some studies also looked at signs of improvement of the condition of the liver.
Afhængigt af bivirkningernes sværhed kan det være nødvendigt helt at standse behandlingen (herunder boceprevir).
Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).
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 ViraferonPeg.
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 ViraferonPeg.
Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er på mellem 6 måneder og ét år.
The duration of treatment depends on the patient's condition and response to treatment, and ranges from six months to a year.
Hos voksne er de hyppigst forekommende bivirkninger ved ViraferonPeg (set hos flere end 1 ud af 10 patienter) virusinfektion, faryngitis (ondt i halsen), anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofiler, som er en type hvide blodlegemer), appetitløshed, depression, angst, emotionel labilitet (humørsvingninger), nedsat koncentrationsevne, insomni (søvnbesvær), hovedpine, svimmelhed, dyspnø (vejrtrækningsbesvær), hoste, opkastning, kvalme, mavesmerter, diarré, mundtørhed, alopeci (hårtab), kløe, tør hud, udslæt, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på injektionsstedet, betændelse på injektionsstedet, træthed, asteni (svaghed), irritabilitet, kulderystelser, pyreksi (feber), influenzalignende sygdom og vægttab.
In adults, the most common side effects with ViraferonPeg (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Da ViraferonPeg sættes i forbindelse med bivirkninger som depression, skal patienterne overvåges nøje under behandlingen.
Because ViraferonPeg is linked to side effects such as depression, patients must be closely monitored during treatment.
CHMP besluttede, at fordelene ved ViraferonPeg er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for ViraferonPeg.
The CHMP decided that ViraferonPeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette bevirker, at stoffet udskilles langsommere af kroppen, så lægemidlet ikke skal gives så ofte.
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Det vides ikke nøjagtigt, hvordan de virker ved virussygdomme, men de menes at virke immunmodulerende (dvs. de ændrer den måde, kroppens immunsystem virker på).
The exact way that they work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system works).
Den første undersøgelse omfattede tidligere ubehandlede patienter, mens den anden undersøgelse omfattede patienter, hos hvem tidligere behandling havde slået fejl.
The first study involved previously untreated patients while the second study involved patients who had failed previous treatment.
Patienterne kan selv give indsprøjtningerne, hvis de er behørigt instrueret heri.
Patients can inject themselves once they have been trained appropriately.
Begge leveres med et indhold på 50, 80, 100, 120 eller 150 mikrogram peginterferon alfa-2b pr. 0,5 ml.
These contain 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b in 0.5 ml.
Det må ikke anvendes hos patienter, som har haft en alvorlig hjertesygdom eller en autoimmun sygdom (en sygdom, hvor kroppens eget immunforsvar angriber normalt væv), eller hos børn eller unge, som har haft alvorlige psykiske sygdomme, navnlig svær depression, selvmordstanker eller selvmordsforsøg.
It must not be used in patients who have had severe heart disease or an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue), or in children or adolescents who have had severe mental disorders, particularly severe depression, thoughts about committing suicide or suicide attempts.
Hos voksne gives det i kombinationsbehandlinger i en dosis på 1,5 mikrogram pr. kg legemsvægt, eller det anvendes alene i en dosis på 0,5 eller 1,0 mikrogram/kg legemsvægt.
In adults, it is used in combination treatments at a dose of 1.5 micrograms per kilogram body weight, or on its own at 0.5 or 1.0 micrograms/kg.
Hos børn og unge er dosis 60 mikrogram pr. m2 legemsoverfladeareal (beregnet ud fra patientens højde og vægt).
In children and adolescents, the dose is 60 micrograms per square metre body surface area (calculated using the patient's height and weight).
ViraferonPeg sættes ligeledes i forbindelse med vægttab og nedsat vækst hos børn og unge.
ViraferonPeg is also linked to weight loss and reduced growth in children and adolescents.
Behandlingen med ViraferonPeg bør indledes og overvåges af en læge med erfaring i behandling af patienter med hepatitis C. ViraferonPeg gives en gang om ugen som indsprøjtning under huden.
Treatment with ViraferonPeg should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. ViraferonPeg is given once a week as an injection under the skin.
Hos voksne (fra 18 år) kan ViraferonPeg anvendes til ikke tidligere behandlede patienter eller hvor en tidligere behandling har slået fejl.
In adults (aged 18 years and older), ViraferonPeg can be used in patients who have not been treated before or whose previous treatment failed.
Det primære mål for virkningen var indholdet af hepatitis Cvirus i blodet før og efter seks måneders eller et års behandling og ved opfølgningen seks måneder senere.
The main measure of effectiveness was the level of hepatitis C virus circulating in the blood before and after six months or a year of treatment, and at ‘follow-up', six months later.
Dobbeltbehandling med ribavirin anvendes desuden hos tidligere ubehandlede børn og unge (fra 3 til 17 år), så længe deres lever stadig fungerer normalt.
Dual therapy with ribavirin is also used in previously untreated children and adolescents (aged between three and 17 years) as long as their liver is still working normally.
Kombinationen af ViraferonPeg og ribavirin blev også undersøgt i en undersøgelse, der omfattede 1 354 voksne, hvis tidligere behandling var slået fejl, og i en undersøgelse, der omfattede 107 børn og unge mellem tre og 17 år, som ikke var blevet behandlet før.
The combination of ViraferonPeg and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Omkring en fjerdedel af de voksne, hvis tidligere behandling var slået fejl, og omkring to tredjedele af børnene og de unge responderede på behandling med ViraferonPeg og ribavirin.
Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with ViraferonPeg and ribavirin.
Udvalget konstaterede, at den dobbelte kombination med ribavirin var effektiv mod kronisk infektion med hepatitis C-virus hos voksne og børn.
The Committee noted that the dual combination with ribavirin was shown to be effective against longterm hepatitis C virus infection in adults and children.
Interferon alfa-2b i ViraferonPeg fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi": Det fremstilles af en bakterie, der har fået indsat et gen (DNA), som sætter den i stand til at producere interferon alfa-2b.
The interferon alfa-2b in ViraferonPeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
ViraferonPeg må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen interferoner eller andre af indholdsstofferne.
ViraferonPeg must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
ViraferonPeg må ikke anvendes hos patienter med en alvorlig sygdomstilstand, alvorlige leverproblemer, ukontrollerede skjoldbruskkirtelsygdomme, epilepsi eller andre problemer med centralnervesystemet.
ViraferonPeg must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Peginterferon alfa-2b ligner interferon alfa-2b, der allerede har været markedsført i Den Europæiske Union (EU) i en årrække.
Peginterferon alfa-2b is similar to interferon alfa-2b, which has been available in the European Union (EU) for a number of years.
Kombinationen af ViraferonPeg og ribavirin var effektiv hos patienter med cirrose og hos hiv-smittede patienter.
The combination of ViraferonPeg with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Den tredobbelte behandling resulterede i en stigning på cirka 30 % i antallet af tidligere ubehandlede patienter, der reagerede hurtigt på behandlingen og var helbredt efter seks måneder.
Triple therapy led to an increase of about 30% in the number of previously early responders who were cured after six months.
I disse undersøgelser blev effektiviteten hovedsagelig målt på det antal patienter, der ikke havde påviselige hepatitis C-virus i blodet 24 uger efter behandlingens afslutning.
The main measure of effectiveness in these studies was the number of patients who had no detectable hepatitis C virus in their blood 24 weeks after the end of the treatment and could therefore be considered to be cured.
Den fuldstændige liste over alle de indberettede bivirkninger ved ViraferonPeg fremgår af indlægssedlen.
For the full list of all side effects reported with ViraferonPeg, see the package leaflet.
ViraferonPeg kan gives i en tredobbelt kombinationsbehandling sammen med ribavirin og boceprevir til voksne med hepatitis C type 1, hvis lever er beskadiget, men stadig virker normalt (kompenseret leversygdom).
ViraferonPeg can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Hos andre voksne med hepatitis C-virus i blodet, herunder patienter, der desuden er smittet med humant immundefektvirus (hiv), gives ViraferonPeg enten sammen med ribavirin (dobbeltbehandling) eller alene, hvis patienterne ikke må få ribavirin.
In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), ViraferonPeg is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
ViraferonPeg blev - henholdsvis med og uden ribavirin - sammenlignet med interferon alfa-2b i fem hovedundersøgelser, der i alt omfattede over 6 000 ikke tidligere behandlede voksne med hepatitis C, herunder 328 patienter med cirrose og 507 patienter, der også var smittet med hiv.
ViraferonPeg, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
For a full list of restrictions, see the package leaflet.
Hos voksne var ViraferonPeg mere effektivt end interferon alfa-2b til ikke tidligere behandlede patienter, idet ca. en fjerdedel af patienterne responderede på ViraferonPeg alene, og ca. halvdelen responderede på kombinationen af ViraferonPeg og ribavirin.
In adults, ViraferonPeg was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to ViraferonPeg alone and around a half responding to the combination of ViraferonPeg and ribavirin.
Hvilken risiko er der forbundet med ViraferonPeg?
What is the risk associated with ViraferonPeg?
ViraferonPeg er et lægemiddel, der indeholder det aktive stof peginterferon alfa-2b.
ViraferonPeg is a medicine that contains the active substance peginterferon alfa-2b.
Blandt tidligere behandlede patienter var stigningen 40 %.
A 40% increase was seen among patients who had been treated before.
Det aktive stof i ViraferonPeg, peginterferon alfa-2b, tilhører gruppen af "interferoner".
The active substance in ViraferonPeg, peginterferon alfa-2b, belongs to the group ‘interferons'.
Andre oplysninger om ViraferonPeg
Other information about ViraferonPeg:
Det leveres som et pulver med solvens, der blandes til en injektionsvæske (opløsning), og som fyldte engangspenne.
It is available as a powder and solvent that are made up into a solution for injection, and as a single-use prefilled pen.
I ViraferonPeg er interferon alfa-2b blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglycol).
In ViraferonPeg, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
I undersøgelserne med tredobbelt kombinationsbehandling hos patienter med hepatitis C type 1 og kompenseret leversygdom var ViraferonPeg i kombination med ribavirin og boceprevir mere effektivt end den dobbelte kombination af ViraferonPeg og ribavirin alene.
In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, ViraferonPeg in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of ViraferonPeg with ribavirin alone.
Hvorfor blev ViraferonPeg godkendt?
Why has ViraferonPeg been approved?
Den fuldstændige EPAR for ViraferonPeg findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med ViraferonPeg, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
The full EPAR for ViraferonPeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hos børn og unge, der fik ViraferonPeg i kombination med ribavirin, var bivirkningerne de samme som hos voksne.
In children and adolescents receiving ViraferonPeg in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Der var desuden en markant stigning i helbredelsesprocenten hos patienter med kronisk hepatitis C type 1, som fik den tredobbelte behandling bestående af ViraferonPeg i kombination med ribavirin og boceprevir.
There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Det kunstigt fremstillede interferon alfa virker på samme måde som det naturlige.
The replacement acts in the same way as naturally produced interferon alpha.
Hvad er ViraferonPeg?
What is ViraferonPeg?
ViraferonPeg anvendes til behandling af patienter i alderen 3 år og opad med langvarig hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
ViraferonPeg is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Hvad anvendes ViraferonPeg til?
What is ViraferonPeg used for?
I tilfælde af bivirkninger kan det være nødvendigt at justere dosis af ribavirin og ViraferonPeg.
The doses of ribavirin and ViraferonPeg may need to be adjusted for patients who experience side effects.
Hvilken fordel viser undersøgelserne, at der er ved ViraferonPeg?
What benefit has ViraferonPeg shown during the studies?
Hvordan blev ViraferonPeg undersøgt?
How has ViraferonPeg been studied?
Hvordan anvendes ViraferonPeg?
How is ViraferonPeg used?
Hvordan virker ViraferonPeg?
How does ViraferonPeg work?
Der blev udført to hovedundersøgelser med i alt 1 503 voksne patienter med hepatitis C type 1 og kompenseret leversygdom.
Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of ViraferonPeg in a triple therapy combination with ribavirin and boceprevir compared with ViraferonPeg and ribavirin alone.
Hvad er orBec?
What is orBec?
London, den 30. maj 2008 Ref.dok.
London, 30 May 2008 Doc.
EMEA/304437/2008
Ref. EMEA/266786/2008
Ansøgningen var på dag 180, da firmaet trak den tilbage.
The application was at day 180 when the company withdrew.
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for ORBEC
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for ORBEC
Internationalt fællesnavn (INN): beclometasondipropionat
International non-proprietary name (INN): beclomethasone dipropionate
Det virker ved at dæmpe aktiviteten af immunsystemet (kroppens naturlige forsvar) ved at bindes til receptorer i forskellige typer immunceller.
It works by dampening down the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cell.
Hvad forventedes orBec anvendt til?
What was orBec expected to be used for?
Behandlingens virkning blev hovedsagelig bedømt på, hvor lang tid der gik, før behandlingen svigtede i løbet af en behandlingsperiode på 50 dage.
The main measure of effectiveness was how long it took for treatment to fail during the 50 days of treatment.
OrBec blev udpeget som lægemiddel til sjældne sygdomme den 13. marts 2002.
orBec was designated as an orphan medicinal product on 13 March 2002.
Hvilken dokumentation fremlagde firmaet til støtte for ansøgningen til CHMP?
What documentation did the company present to support its application to the CHMP?
I CHMP var der desuden betænkelighed ved, at størstedelen af de patienter, der deltog i undersøgelsen, kom fra kun ét undersøgelsescenter, og at resultaterne derfor ikke var repræsentative for alle patienter.
The CHMP had also concerns that most of the patients who took part in the study came from one study centre, and therefore the results were not representative for the overall population.
OrBec var ikke klart bedre end placebo til at øge den tid, der gik, før sygdommen vendte tilbage i løbet af en behandlingsperiode på 50 dage.
orBec was not significantly better than placebo in increasing the time until the disease came back during the 50-day treatment period.
Transplantat-mod-vært-reaktion kan optræde hos patienter efter organtransplantation, idet cellerne i det transplanterede væv eller organ opfatter patienten som "fremmed" og angriber organismen.
Graft-versus-host disease can occur in patients following tissue or organ transplantation, when the cells in the transplanted tissue or organ recognise the patient as ‘foreign' and attack the body.
Det var hensigten, at det skulle leveres som to forskellige tabletter, der skulle tages samtidig: En tablet med hurtig udløsning (hurtig udløsning betyder, at det aktive stof i tabletterne opløses øjeblikkeligt) og en enterotablet (enterotabletter passerer igennem mavesækken uden at opløses, før de når tarmen).
It was to be available as two separate tablets, to be taken together: one immediate-release tablet (immediate-release means that the tablet has been made to allow the active substance to be released immediately) and one gastro-resistant tablet (gastro-resistant means that the tablet's content passes through the stomach without being broken down until it reaches the intestine).
Dette forventedes at mindske skaden på mavesækken og tarmene.
This was expected to lead to a reduction in damage to the stomach and intestine.
Hvordan forventes orBec at virke?
How is orBec expected to work?
Den 22. maj 2008 meddelte DOR BIOPHARMA UK Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse for orBec til behandling af transplantat-mod-vært-reaktion i mave-tarmsystemet tilbage.
On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease.
Stoffet forventedes at blokere receptorer i mavesækken og tarmene ved lokalt at nedsætte produktionen af stoffer, der medvirker ved genkendelse af fremmede celler og ved betændelsesreaktionen.
It was expected to block receptors in the stomach and intestine, reducing locally the production of substances that are involved in recognising foreign cells and in the inflammation process.
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved orBec ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of orBec had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Efter at CHMP havde vurderet firmaets besvarelse af en række spørgsmål, tilbagestod der fortsat nogle uafklarede punkter.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
I CHMP var der betænkelighed ved, at denne eneste hovedundersøgelse ikke godtgjorde virkningen af orBec.
The CHMP was concerned that the single main study did not demonstrate orBec's effectiveness.