natgillin/translations-raw huggingface dataset:
Bivirkningerne omfattede svær og langvarig knoglemarvssuppression med deraf følgende lavt antal hvide blodceller og blodplader, leverproblemer og bivirkninger i forbindelse med infusionen såsom kuldegysninger, feber og lavt blodtryk.
These included severe and long-lasting bone marrow suppression causing low levels of white blood cells and platelets, liver problems, and side effects related to the infusion, such as chills, fever and low blood pressure.
Hvad er Mylotarg?
What is Mylotarg?
Virkningerne af Mylotarg blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Mylotarg were first tested in experimental models before being studied in humans.
Det var dog vanskeligt at sammenligne virkningen af Mylotarg med andre behandlingsformer, der anvendes ved denne sygdom, med hensyn til, hvor længe bedringen ville vare, hvor lang tid der ville gå, før sygdommen forværredes, eller hvilken virkning lægemidlet ville have på overlevelsen.
However, it was difficult to compare the effectiveness of Mylotarg and other treatments used for this disease, in terms of how long remission would last, how long it would take until the disease got worse, or what the medicines' effects would be on survival.
Mylotarg blev ikke sammenlignet med andre behandlinger i nogen af undersøgelserne.
Mylotarg was not compared to any other treatment in any of the studies.
Calicheamicinen ødelægger derefter leukæmicellernes dna og dræber således cellerne.
The calicheamicin then breaks up the leukaemia cells' DNA, eventually killing the cells.
I alle tre undersøgelser var det primære mål for virkningen andelen af patienter, som var i fuldstændig bedring efter syv måneders behandling.
In all three studies, the main measure of effectiveness was the proportion of patients who achieved ‘complete remission' after a seven-month course of treatment.
Hvad forventedes Mylotarg anvendt til?
What was Mylotarg expected to be used for?
Det indeholder det aktive stof gemtuzumab ozogamicin.
It contains the active substance gemtuzumab ozogamicin.
Virksomheden oplyste også, at den fortsat vil udlevere Mylotarg til igangværende, løbende kliniske undersøgelser.
The company also stated that it will continue to supply Mylotarg for use in existing, ongoing clinical trials.
Virkningerne af Mylotarg blev undersøgt i tre hovedundersøgelser, hvori der i alt deltog 277 patienter med CD33-positiv akut myeloid leukæmi, hvis sygdom var vendt tilbage efter ét tidligere behandlingsforløb.
The effects of Mylotarg were studied in three main studies involving a total of 277 patients with CD33-positive acute myeloid leukaemia, whose disease had come back after one previous course of treatment.
Den 20. september 2007 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvori udvalget anbefaler afslag på ansøgningen om markedsføringstilladelse for lægemidlet Mylotarg 5 mg pulver til opløsning til infusion til behandling af akut myeloid leukæmi.
On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia.
Mylotarg skulle anvendes til behandling af patienter, hvis sygdom var vendt tilbage efter ét tidligere behandlingsforløb, og som ikke var egnede til andre typer intensiv kemoterapi såsom højdosis-cytarabin, der er et andet lægemiddel mod kræft.
Mylotarg was to be used to treat patients whose disease had come back after one previous course of treatment, and who were not suitable for other types of intensive chemotherapy such as highdose cytarabine (another anticancer medicine).
Virksomheden har informeret CHMP om, at patienter, der for øjeblikket deltager i programmer for anvendelse af Mylotarg med særlig udleveringstilladelse, fortsat vil få Mylotarg, indtil de har afsluttet deres behandlingsforløb.
The company informed the CHMP that patients currently included in compassionate use programmes will continue to receive Mylotarg until they have finished their course of treatment.
Inden i cellerne frigives det cytotoksiske stof, der kaldes calicheamicin.
Inside the cells, the cytotoxic substance, which is called calicheamicin, is released.
Mylotarg blev udpeget som lægemiddel til sjældne sygdomme den 18. oktober 2000 for akut myeloid leukæmi.
Mylotarg was designated as an orphan medicinal product on 18 October 2000 for acute myeloid leukaemia.
Det skulle gives til patienter, som var såkaldt CD33-positive, hvilket betyder, at der er et protein kaldet CD33 på overfladen af de kræftramte hvide blodceller.
It was to be used in patients who were ‘CD33-positive', meaning that their cancerous white blood cells had a protein called CD33 on their surface.
Mylotarg forventedes anvendt til behandling af akut myeloid leukæmi, der er en type kræft i de hvide blodceller.
Mylotarg was expected to be used to treat acute myeloid leukaemia, a type of cancer of the white blood cells.
Hvordan forventes Mylotarg at virke?
How is Mylotarg expected to work?
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Mylotarg eller i programmer for anvendelse af Mylotarg med særlig udleveringstilladelse?
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Mylotarg?
På daværende tidspunkt var CHMP af den opfattelse, at der ikke forelå tilstrækkelig dokumentation til at kunne bedømme Mylotargs virkning ved behandling af akut myeloid leukæmi, og at fordelene ved Mylotarg derfor ikke opvejede risiciene.
At that point in time, the CHMP was of the opinion that there was insufficient evidence to establish the effectiveness of Mylotarg in the treatment of acute myeloid leukaemia, and therefore that the medicine's benefits did not outweigh its risks.
Når antistoffet binder sig til CD33, absorberer cellen både antistoffet og det cytotoksiske stof, som antistoffet er bundet til.
When the antibody attaches to CD33, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to.
CHMP var betænkelig ved, at undersøgelserne af Mylotarg ikke viste nogen gavnlig virkning ved lægemidlet på grund af undersøgelsens udformning.
The CHMP was concerned that the studies of Mylotarg had not shown a benefit of the medicine, because of the way they were designed.
Mylotarg er et pulver, der anvendes til at lave en opløsning til infusion (drop i en vene).
Mylotarg is a powder that is made up into a solution for infusion (drip into a vein).
Udvalget noterede sig bivirkningerne ved Mylotarg.
The Committee noted that there were side effects associated with Mylotarg.
Det monoklonale antistof, der er en del af det aktive stof (gemtuzumab), er i stand til at binde sig til CD33, der er et antigen, som findes på overfladen af akut myeloid leukæmi-cellerne hos ca. 80 % af patienterne.
The monoclonal antibody part of the active substance (gemtuzumab) has been designed to bind to CD33, an antigen which is found on the surface of acute myeloid leukaemia cells in about 80% of patients.
Det aktive stof i Mylotarg, gemtuzumab ozogamicin, er et stof, der er giftigt for celler (cytotoksisk), og som er bundet til et monoklonalt antistof.
The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic (cell-killing) substance that is linked to a monoclonal antibody.
Fuldstændig bedring er, når der ikke længere kan påvises leukæmiceller i blodet, og når knoglemarven kun indeholder et meget
Complete remission is when the leukaemia cells can no longer be detected in the blood and are at very low levels in the bone marrow.
CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Mylotarg.
Hence, the CHMP recommended that Mylotarg be refused marketing authorisation.
Studiet blev derefter forlænget til fire år.
The study was then extended to four years.
Alle patienter bør vurderes mindst én gang hvert andet år.
All patients should be assessed at least once every two years.
Rebif fik en markedsføringstilladelse med gyldighed i hele EU den 4. maj 1998.
Rebif received a marketing authorisation valid throughout the EU on 4 May 1998.
Andre oplysninger om Rebif
Other information about Rebif
Yderligere information om Rebif findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/rebif.
Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Som for alle lægemidler bliver data vedrørende brug af Rebif løbende overvåget.
As for all medicines, data on the use of Rebif are continuously monitored.
Hvad er Rebif, og hvad anvendes det til?
What is Rebif and what is it used for?
Patienterne havde haft mindst to tilbagefald i de foregående to år.
The patients had experienced at least two relapses in the previous two years.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rebif?
What measures are being taken to ensure the safe and effective use of Rebif?
Det anbefales at give en dosis på 22 mikrogram til patienter, som ikke kan tåle den højere dosis.
A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Hvorfor er Rebif godkendt i EU?
Why is Rebif authorised in the EU?
En oversigt over Rebif, og hvorfor det er godkendt i EU
An overview of Rebif and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Rebif opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Rebif's benefits are greater than its risks and it can be authorised for use in the EU.
De indberettede bivirkninger ved Rebif vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Når behandlingen med Rebif indledes, bør dosen øges langsomt fra en startdosis på 8,8 mikrogram tre gange om ugen for at undgå bivirkninger.
When first starting treatment with Rebif, the dose should be slowly increased from a starting dose of 8.8 micrograms three times a week to avoid side effects.
Patienterne kan godt selv indsprøjte Rebif, når de er blevet instrueret i det.
The patients can inject Rebif themselves once they have been trained.
Der sås en vis virkning på forværringen af invaliditeten, men kun hos de patienter, der havde haft tilbagefald i de to år inden forsøgets start.
Some effect on progression of disability could be seen, but only in the patients who had relapses in the two years before the start of the study.
Den anbefalede dosis af Rebif er 44 mikrogram givet tre gange om ugen ved injektion under huden.
The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Hvilke risici er der forbundet med Rebif?
What are the risks associated with Rebif?
Lægen kan råde patienten til at tage feberreducerende smertestillende medicin før hver injektion og i 24 timer efter injektionen for at reducere de influenzalignende symptomer, der kan optræde som bivirkning ved behandlingen.
The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the influenza (flu)-like symptoms that may occur as a side effect of treatment.
Sandsynligheden for forværring af multipel sklerose over en periode på 24 måneder var 62,5 % for de patienter, der fik Rebif tre gange om ugen, og 75,5 % for de patienter, der fik Rebif én gang om ugen, sammenlignet med 85,8 % for de patienter, der fik placebo.
The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Hvis du ønsker mere information om anvendelsen af Rebif, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Rebif, see the package leaflet or contact your doctor or pharmacist.
Rebif (44 mikrogram givet én eller tre gange om ugen) blev også sammenlignet med placebo hos 515 patienter, som havde haft et enkelt attak af demyelinisering.
Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Rebif må ikke anvendes til patienter med svær depression eller selvmordstanker.
Rebif must not be used in patients who have severe depression or have thoughts of suicide.
Patienterne fik enten Rebif (22 eller 44 mikrogram) eller placebo (en uvirksom behandling) i to år.
Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
De hyppigste bivirkninger ved Rebif (som kan forekomme hos mere end 1 ud af 10 personer) er influenzalignende symptomer, neutropeni, lymfopeni og leukopeni (lavt antal hvide blodlegemer), trombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), hovedpine, betændelse og andre reaktioner på injektionsstedet samt stigninger i leverenzymerne (transaminaser).
The most common side effects with Rebif (which may affect more than 1 in 10 people) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Rebif kan også anvendes til patienter, der har haft et enkelt attak af demyelinisering ledsaget af betændelse.
Rebif can also be used in patients who have had a single attack of demyelination accompanied by inflammation.
Det aktive stof i Rebif er proteininterferonet beta-1a, der tilhører en gruppe interferoner, som kan dannes naturligt i kroppen for at hjælpe den med at bekæmpe virus og andre angreb.
The active substance in Rebif is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Den fuldstændige liste over bivirkninger og begrænsninger ved Rebif fremgår af indlægssedlen.
For the full list of side effects and restrictions with Rebif, see the package leaflet.
Rebif indeholder det aktive stof interferon beta-1a.
Rebif contains the active substance interferon beta-1a.
Hvordan anvendes Rebif?
How is Rebif used?
Det vides endnu ikke med sikkerhed, hvordan Rebif virker ved multipel sklerose, men det aktive stof, interferon beta-1a, synes at berolige immunsystemet og forebygger tilbagefald af multipel sklerose.
The exact way that Rebif works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Tilbagefaldene blev reduceret med ca. 30 % over to år for både 22 og 44 mikrogram Rebif sammenlignet med placebo, og med 22 % (22 mikrogram Rebif) og med 29 % (44 mikrogram Rebif) over fire år.
Rebif was more effective than placebo in reducing the number of relapses in relapsing MS. Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Hvilke fordele viser studierne, at der er ved Rebif?
What benefits of Rebif have been shown in studies?
Rebif fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af multipel sklerose.
Rebif can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Rebif fås som en injektionsvæske, opløsning, i fyldte sprøjter, fyldte penne og cylinderampuller til brug i en elektronisk injektionsanordning.
Rebif is available as a solution for injection in prefilled syringes, prefilled pens and cartridges for use in an electronic injection device.
Rebif er et lægemiddel til behandling af patienter med recidiverende multipel sklerose.
Rebif is a medicine used to treat patients with relapsing multiple sclerosis (MS).
Rebifs virkning er ikke påvist hos patienter med sekundær progressiv multipel sklerose (den type multipel sklerose, der kommer efter recidiverende multipel sklerose), som ikke giver tilbagefald.
Rebif's effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.
Rebif blev undersøgt hos 560 patienter med tilbagefald af multipel sklerose.
Rebif has been studied in 560 patients with relapsing MS.
Ved recidiverende multipel sklerose oplever patienten attakker (tilbagefald) mellem perioder uden symptomer.
Relapsing MS is the type of MS where the patient has attacks (relapses) between periods with no symptoms.
Hvordan virker Rebif?
How does Rebif work?
Multipel sklerose er en sygdom, hvor betændelse beskadiger nerverne og det beskyttende lag omkring dem (demyelinisering).
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rebif.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rebif have been included in the summary of product characteristics and the package leaflet.
Før anvendelse af Rebif skal lægen udelukke andre årsager til symptomerne.
It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.
Rebif havde ikke nogen nævneværdig virkning på forværringen af invaliditeten, men tilbagefaldsraten blev reduceret med ca. 30 %.
Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
3 x 30 tabletter (multipakni ng)
3 x 30 tablets (multipack)
(Særnavn) Navn Styrke Lægemiddelfor m
MA (EU) number (Invented) name Strength Pharmaceutical Form
Administration Indhold (Koncentra tion)
Route of Administration
Progressiv betyder, at symptomerne bliver stadig værre over tid.
Progressive means that symptoms get steadily worse over time.
Desuden var udvalget af den holdning, at det var nødvendigt med yderligere oplysninger om, hvordan lægemidlet absorberes, modificeres og fjernes fra kroppen.
In addition, the Committee was of the opinion that more information was needed about how the medicine is absorbed, modified and removed from the body.
Qizenday er et lægemiddel, der indeholder det aktive stof biotin.
Qizenday is a medicine that contains the active substance biotin.
Det skulle have været leveret som kapsler, der tages gennem munden.
It was to be available as capsules to be taken by mouth.
Det primære mål for virkningen var forbedring af synet.
The main measure of effectiveness was improvement in vision.
Hvad er Qizenday?
What is Qizenday?
I den første undersøgelse deltog 154 patienter med spinal progressiv multipel
The first study involved 154 patients with spinal progressive multiple sclerosis.
Tre af disse enzymer er involveret i energiproduktionen, mens et fjerde menes at være involveret i dannelsen af skeder omkring nervecellerne.
Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Hvad forventedes Qizenday anvendt til?
What was Qizenday expected to be used for?
sklerose.
The main
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Qizenday (biotin)
Withdrawal of the marketing authorisation application for Qizenday (biotin)
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Qizenday (biotin) EMA/821654/2017
Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Det primære mål for virkningen var antallet af patienter, hvis samlede invaliditet faldt, og hvis gangevne blev forbedret.
measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved.
Virksomheden fremlagde data fra to hovedundersøgelser, der sammenlignede Qizenday med placebo (ikke-aktivt stof).
The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
CHMP fandt, at dataene for lægemidlets virkning ikke var solide nok, og at der var usikkerhed med hensyn til sikkerheden ved lægemidlet på grund af det lille antal patienter, der var behandlet med Qizenday.
The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday.
Symptomerne omfatter svaghed, gangbesvær og synsforstyrrelser.
Symptoms include weakness, difficulty walking and problems with vision.
Den anden undersøgelse omfattede 93 patienter med multipel sklerose, der havde synstab på grund af betændelse i den optiske nerve.
The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
Den 13. november 2017 meddelte Medday Pharmaceuticals officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Qizenday til behandling af progressiv multipel sklerose.
On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Qizenday forventedes anvendt til behandling af voksne med den progressive form af multipel sklerose, der er en sygdom, hvor den beskyttende skede omkring nervecellerne i hjernen og rygmarven er beskadiget, og nerverne progressivt degenerer.
Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Qizenday ikke opvejede risiciene.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks.
Efter CHMP's vurdering af virksomhedens svar på den sidste spørgsmålsrunde, var der fortsat visse uafklarede punkter.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
På baggrund af gennemgangen af dataene og virksomhedens svar på CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Qizenday ikke kunne være blevet godkendt til behandling af progressiv multipel sklerose.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Hvordan virker Qizenday?
How does Qizenday work?
Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser eller i programmer for anvendelse af Qizenday med særlig udleveringstilladelse.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday.
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at baggrunden for tilbagetrækningen er CHMP's udtalelse om, at de fremlagte kliniske data ikke sætter udvalget i stand til at konkludere, at benefit/risk-forholdet for Qizenday er positivt.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.