natgillin/translations-raw huggingface dataset:
Asymptomatiske tilfælde af PML kan påvises ved MRI-skanning, og eksperter inden for MRI og multipel sklerose er enige om, at PML-forandringerne kan identificeres med forenklede MRI-protokoller (som giver mulighed for kortere procedurer og desuden er mindre belastende for de patienter, der skannes).
Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
• Efter 2 års behandling bør patienterne på ny informeres om risikoen for PML med Tysabri.
• After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
• Den alvorlige hjerneinfektion PML (progressiv multifokal leukoencefalopati) er kendt som en ikke almindelig risiko ved lægemidlet Tysabri, der anvendes mod multipel sklerose.
• Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
• Før påbegyndelse af behandlingen bør der foreligge en baseline-MRI (sædvanligvis inden for 3 måneder) som reference, og der bør foretages en baseline-anti-JCV antistoftest for at underbygge risikostratificeringen for PML.
• Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
• Din risiko for PML afhænger af en række faktorer, såsom om du har haft antistoffer mod JC-virus i blodet (som tegn på, at du har været udsat for det virus, der forårsager PML) og i hvilken koncentration, hvor længe du har fået Tysabri, og om du har fået lægemidler, der undertrykker immunsystemet, før du begyndte behandlingen med Tysabri.
• Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
• Symptomerne på PML kan svare til symptomerne på et anfald af multipel sklerose og kan bestå i tiltagende svaghed, tale- og kommunikationsbesvær, synsvanskeligheder og undertiden ændringer i humør og adfærd.
• Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Der er beskrevet tilfælde af asymptomatisk PML baseret på MRI og positiv JC-virus-DNA-test i cerebrospinalvæske.
Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
For patienter med højere risiko bør hyppigere MRI-skanning overvejes
More frequent MRI scans should be considered for patients at higher risk
• For patienter med højere risiko for PML bør der overvejes hyppigere MRI-skanning (f.eks. hver 3.6. måned) med brug af en forkortet protokol (f.eks.
• For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
De ajourførte risikoberegninger viser, at ved antistof-indeksværdier på 0,9 eller derunder er risikoen for at udvikle PML lille og lavere end tidligere beregnet, og at risikoen øges væsentligt ved indeks over 1,5 og behandling med Tysabri længere end 2 år.
The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Kendte risikofaktorer for at udvikle PML ved behandling med Tysabri er tilstedeværelse af antistoffer mod JC-virus, behandling med Tysabri længere end to år, samt forudgående brug af immunosuppressiva.
Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som vedtog udvalgets endelige udtalelse.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Yderligere stratificering af PMLrisikoen efter anti-JC virus-antistofindeks for patienter, der ikke tidligere havde brugt immunosuppressiva, blev foretaget ved kombination af den samlede årlige risiko med fordelingen af antistofindeks.
Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
• Spørg lægen, sygeplejersken eller apotekspersonalet, hvis der er mere, du vil vide.
• If you have any questions or concerns, speak to your doctor, nurse or pharmacist.
• enten har fået et immundæmpende middel før de begyndte at få Tysabri eller har højt JC-virusantistofindeks uden at have fået immundæmpende midler.
• either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Hvis der konstateres forandringer tydende på PML, bør MRI-protokollen udvides til at omfatte "kontrastforstærket T1-vægtet MRI", og det bør overvejes at undersøge spinalvæsken for JC-virus.
If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Nyere undersøgelser viser, at udfaldet for patienterne kan forbedres ved tidlig opdagelse og behandling af PML, mens sygdommen endnu er i de indledende stadier og er uden symptomer (asymptomatisk).
Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Dette virus er meget udbredt hos den almindelige befolkning og er normalt harmløst.
This virus is very common in the general population and is normally harmless; however, it can lead to PML in persons whose immune system is weakened.
Det aktive stof i Tysabri, natalizumab, er et protein af typen monoklonalt antistof.
The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
• Ved mistanke om PML bør MRI-protokollen udvides til at omfatte kontrastforstærket T1-vægtet billeddannelse, og det bør overvejes at undersøge cerebrospinalvæsken for JC-virus-DNA ved hjælp af ultrafølsom PCR.
• If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket.
If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Poolede data fra store kliniske undersøgelser tyder på, at der for patienter, der ikke tidligere har fået immunosuppressiva, er sammenhæng mellem niveauet af anti-JC-virus antistofrespons (-indeks) og risikoen for PML.
Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
• Ved mistanke om PML vil lægen standse behandlingen med Tysabri, indtil PML kan udelukkes.
• If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
• Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket.
• If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
På grundlag af disse data foreligger der ajourførte beregninger af risikoen for PML2 ved behandling af JC-virus-antistof-positive patienter med Tysabri, som vist i tabel 1 nedenfor: Tabel 1: Risiko for PML (pr. 1 000 patienter) for anti-JC-virus-antistofpositive patienter* Varighed af anvendelse af Tysabri
Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use
Nye data fra store kliniske undersøgelser tyder desuden på, at der er sammenhæng mellem blodets indhold af JC-virus-antistoffer ("antistofindeks") og risikoen for PML for patienter, der ikke har været i behandling med immundæmpende lægemidler (immunosuppressiva) før påbegyndelse af behandlingen med Tysabri.
New data from large clinical studies also suggest that, in patients who have not been treated with immunosuppressants (medicines that reduce the activity of the immune system) before starting Tysabri, the blood level of antibodies against JC virus (‘antibody index') relates to the level of risk for PML.
London, den 19. marts 2008 Doc.
London, 19 March 2008 Doc.
Dette forventes at være med til at forhindre beskadigelse af organerne.
This is expected to help to prevent organ damage.
Det skulle leveres som kapsler.
It was to be available as capsules.
Internationalt fællesnavn (INN): natriumeprodisat
International non-proprietary name (INN): eprodisate sodium
Hvad er Kiacta?
What is Kiacta?
Firmaet havde anmodet om, at den negative udtalelse blev taget op til fornyet overvejelse, men denne var endnu ikke afsluttet, da firmaet trak ansøgningen tilbage.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Det er en sjælden, livstruende sygdom, som opstår hos patienter med længerevarende betændelse, som oftest skyldes rheumatoid arthritis (leddegigt).
This is a rare, life-threatening disease that occurs in patients with long-lasting inflammation, most commonly due to rheumatoid arthritis.
Virkningerne af Kiacta blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Kiacta were first tested in experimental models before being studied in humans.
Kiacta blev udpeget som lægemiddel til sjældne sygdomme den 31. juli 2001.
Kiacta was designated an orphan medicinal product on 31 July 2001.
Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, hos hvem nyrefunktionen blev betydeligt forværret eller som døde i løbet af de to års behandling.
The main measure of effectiveness was the number of patients whose kidney function got significantly worse or who died over two years of treatment.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Kiacta?
What are the consequences of the withdrawal for patients in clinical trials with Kiacta?
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for KIACTA
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for KIACTA
Selvom det blev antydet, at Kiacta muligvis er virksomt, konkluderede udvalget, at det var nødvendigt med en anden undersøgelse for at påvise lægemidlets virkning.
Although there was a suggestion that Kiacta may be active, the Committee concluded that another study would be needed to demonstrate the medicine's effectiveness.
Kiacta er et lægemiddel, der indeholder det aktive stof dinatriumeprodisat.
Kiacta is a medicine containing the active substance eprodisate disodium.
Den 13. marts 2008 meddelte Neurochem Luxco II SARL officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Kiacta til behandling af A- amyloidose (AA-amyloidose).
On 13 March 2008, Neurochem Luxco II SARL officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kiacta for the treatment of amyloid A amyloidosis.
Virksomheden underrettede CHMP om, at den igangværende kliniske undersøgelse med Kiacta bliver afbrudt, så der kan udføres en anden undersøgelse for at sammenligne Kiacta med placebo.
The company informed the CHMP that the ongoing clinical trial with Kiacta is being stopped, so that it can carry out a second study to compare Kiacta with placebo.
Hvad forventedes Kiacta anvendt til?
What was Kiacta expected to be used for?
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Kiacta ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Kiacta had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Kiacta til behandling af AA amyloidose.
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Kiacta for the treatment of AA amyloidosis.
Efter en inspektion af stedet, hvor oplysningerne fra undersøgelsen var blevet analyseret, sætte udvalget spørgsmålstegn ved, om undersøgelsens resultater var pålidelige på grund af den måde analysen var blevet gennemført på.
In addition, following an inspection of the site where the data from the study were analysed, the CHMP had concerns over the reliability of the study's findings because of the way the analysis was carried out.
Det aktive stof i Kiacta, dinatriumeprodisat, forventes at virke ved at påvirke dannelsen af AA-fibriller og dermed forhindre, at de aflejrer sig i organerne.
The active substance in Kiacta, eprodisate disodium, is expected to work by interfering with the formation of fibrils of AA, preventing the deposits from building up in the organs.
Amyloid A-amyloidose skyldes, at der ophober sig uopløselige “fibriller” (fine tråde) af et protein kaldet ‘amyloid A' (AA) i kroppens organer.
Amyloid A amyloidosis is caused by the build-up of insoluble ‘fibrils' (fine threads) of a protein called ‘amyloid A' (AA) in the organs of the body.
Hvordan forventes Kiacta at virke?
How is Kiacta expected to work?
CHMP gav udtryk for betænkeligheder ved, at virkningen af Kiacta til behandling af AA-amyloidose ikke var blevet påvist i tilstrækkelig grad i den eneste hovedundersøgelse, som var blevet gennemført.
The CHMP was concerned that the effectiveness of Kiacta in treating AA amyloidosis had not been demonstrated sufficiently in the single main study.
AA fremstilles i kroppen af et protein kaldet ‘serumamyloid A', der frigives af leverceller som reaktion på betændelse.
AA is produced in the body from a protein called ‘serum amyloid A', which is released by liver cells in response to inflammation.
Kiacta forventedes anvendt til behandling af AA-amyloidose.
Kiacta was expected to be used to treat amyloid A amyloidosis.
De alvorligste symptomer på sygdommen skyldes, at amyloid A aflejres i nyrerne og beskadiger dem.
The most serious symptoms of the disease are caused by AA deposits building up in the kidneys and damaging them.
Kiactas virkning blev undersøgt i en hovedundersøgelse af 183 patienter med AA amyloidose.
The effectiveness of Kiacta was studied in one main study involving 183 patients with AA amyloidosis, in which Kiacta was compared with placebo (a dummy treatment).
Pilisborosjenő 2097 Ungarn
Pilisborosjenő 2097 Hungary
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Indehaver af markedsføringstilla delse
Marketing Authorisation Holder
Der kan også være episoder med depression.
They may also have episodes of depression.
Behandlingen må ikke vare længere end 12 uger.
Treatment must not last longer than 12 weeks.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Aripiprazole Accord 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 Aripiprazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Til forebyggelse af maniske episoder hos voksne bør der fortsættes med samme dosis.
To prevent manic episodes in adults, the same dose should be continued.
Aripiprazole Accord fås som tabletter (5, 10, 15 og 30 mg) og udleveres kun efter recept.
Aripiprazole Accord is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aripiprazole Accord.
This is a summary of the European public assessment report (EPAR) for Aripiprazole Accord.
Udvalget anbefalede, at Aripiprazole Accord godkendes til anvendelse i EU.
The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Der er udarbejdet en risikostyringsplan for at sikre, at Aripiprazole Accord anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Det betyder, at Aripiprazole Accord svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Abilify.
This means that Aripiprazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Virksomheden, der markedsfører Aripiprazole Accord, skal desuden udlevere oplysningsmateriale til patienterne eller deres omsorgsgivere og til lægerne, hvor det forklares, hvordan lægemidlet anvendes sikkert hos patienter mellem 13 og 17 år.
In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Andre oplysninger om Aripiprazole Accord
Other information about Aripiprazole Accord
Dosis bør tilpasses, hvis patienten får visse andre lægemidler, som påvirker nedbrydningen af Aripiprazole Accord i kroppen.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Accord is broken down in the body.
Aripiprazol menes hovedsagelig at virke ved delvis stimulation (dvs. som en “partiel agonist”) af receptorerne for neurotransmitterne dopamin og 5-hydroxytryptamin (også kaldet serotonin).
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Hvilke fordele og risici er der forbundet med Aripiprazole Accord?
What are the benefits and risks of Aripiprazole Accord?
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Aripiprazole Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Aripiprazole Accord anvendes hos voksne til behandling af moderate til svære maniske episoder og forebyggelse af nye maniske episoder hos voksne, hos hvem lægemidlet tidligere har virket.
Aripiprazole Accord is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aripiprazole Accord?
What measures are being taken to ensure the safe and effective use of Aripiprazole Accord?
Det aktive stof i Aripiprazole Accord, aripiprazol, er et antipsykotisk lægemiddel.
The active substance in Aripiprazole Accord, aripiprazole, is an antipsychotic medicine.
• skizofreni, der er en psykisk sygdom, som giver forskellige symptomer, bl.a. i form af tanke- og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
• bipolar lidelse type I, en psykisk sygdom med skiftende episoder med abnormt højt humør (maniske episoder) og perioder med normalt humør.
• bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Abilify.
Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Aripiprazole Accord i overensstemmelse med EU's krav er af sammenlignelig kvalitet og er bioækvivalent med Abilify.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Aripiprazole Accord aripiprazol
Aripiprazole Accord aripiprazole
Det betyder, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne.
This means that aripiprazole acts like dopamine and 5hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Aripiprazole Accord er et lægemiddel, der anvendes ved følgende psykiske sygdomme:
Aripiprazole Accord is a medicine used in patients with the following mental illnesses:
Hvis du ønsker yderligere oplysninger om behandling med Aripiprazole Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Aripiprazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da Aripiprazole Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Aripiprazole Accord anvendes til patienter over 15 år
Aripiprazole Accord is used in patients aged 15 years or over;
Det er ikke en praktisk vejledning i, hvordan Aripiprazole Accord bør anvendes.
It is not intended to provide practical advice on how to use Aripiprazole Accord.
Hvad er Aripiprazole Accord, og hvad anvendes det til?
What is Aripiprazole Accord and what is it used for?
Da Aripiprazole Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Abilify.
Because Aripiprazole Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Ved skizofreni er den anbefalede startdosis til voksne 10 eller 15 mg dagligt, efterfulgt af en vedligeholdelsesdosis på 15 mg én gang dagligt.
For schizophrenia, the recommended starting dose is 10 or 15 mg per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.