FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Nimvastid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (this means that the two medicines produce the same levels of the active substance in the body).
Danish: Da Nimvastid er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængde af det aktive stof i kroppen).
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Nimvastid by the patient.
Danish: Behandling bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt overvåger patientens indtagelse af Nimvastid.
English: Treatment with Nimvastid should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandling med Nimvastid bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom og demens hos patienter med Parkinsons sygdom.
English: What is Nimvastid?
Danish: Hvad er Nimvastid?
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain,
Danish: Hos patienter med Alzheimers sygdom eller med demens som følge af Parkinsons sygdom vil visse hjerneceller dø.
English: The active substance in Nimvastid, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Nimvastid, rivastigmin, er et middel til behandling af demens.
English: Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Exelon.
English: resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Danish: Det medfører for lavt indhold af neurotransmitteren acetylcholin (et signalstof, som anvendes af nervecellerne til indbyrdes kommunikation).
English: Nimvastid orodispersible tablets should be placed on the tongue, where they disintegrate quickly in the saliva before being swallowed.
Danish: Nimvastid-smeltetabletter tages ved, at de lægges under tungen, hvor de hurtigt opløses af spyttet, før de sluges.
English: Because Nimvastid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Nimvastid er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Nimvastid been approved?
Danish: Hvorfor blev Nimvastid godkendt?
English: What is Nimvastid used for?
Danish: Hvad anvendes Nimvastid til?
English: It is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Det kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: Orodispersible means that the tablets dissolve in the mouth.
Danish: Smeltetabletter er tabletter, som opløser sig i munden.
English: How has Nimvastid been studied?
Danish: Hvordan blev Nimvastid undersøgt?
English: How is Nimvastid used?
Danish: Hvordan anvendes Nimvastid?
English: By blocking these enzymes, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Nimvastid hjernens indhold af acetylcholin.
English: How does Nimvastid work?
Danish: Hvordan virker Nimvastid?
English: This summary was last updated in 09-2011.
Danish: Dette sammendrag blev sidst ajourført i 09-2011.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 May 2008.
Danish: Efter at virksomheden havde forelagt de supplerende oplysninger, det var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 22. maj 2008.
English: However, the time taken for the disease to get worse after treatment was the same in both groups (about 10
Danish: Den tid, der gik efter behandlingen til sygdommen forværredes, var imidlertid den samme i de to grupper (ca. ti måneder).
English: The full EPAR for Zevalin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Zevalin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zevalin on 16 January 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zevalin den 16. januar 2004.
English: • patients who have gone into remission (reduction in the number of cancerous cells) after their first
Danish: • patienter, der er i remission (dvs. hvor antallet af kræftceller er faldet) efter deres første
English: Zevalin is used in the following groups of patients:
Danish: Zevalin anvendes til følgende patientgruppe:
English: This is a summary of the European public assessment report (EPAR) for Zevalin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zevalin.
English: Zevalin was originally authorised under ‘exceptional circumstances' because it had not been possible to obtain complete information about Zevalin.
Danish: Zevalin blev oprindeligt godkendt under "særlige omstændigheder", da det ikke havde været muligt at indhente fyldestgørende oplysninger om produktet.
English: 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 Zevalin.
Danish: 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 Zevalin.
English: In both studies, the main measure of effectiveness was the number of patients whose disease responded partially or completely to treatment.
Danish: I begge undersøgelserne var det vigtigste mål for virkningen antallet af patienter, der responderede helt eller delvis på behandlingen.
English: Zevalin is given as
Danish: Zevalin gives som
English: For more information about treatment with Zevalin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zevalin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Zevalin must be given as a slow infusion lasting 10 minutes.
Danish: Zevalin skal gives ved langsom intravenøs infusion, der varer 10 minutter.
English: The doctor who prescribes it must ensure that the risks linked to the exposure to the radioactivity are lower than the risks from the disease itself.
Danish: Den ordinerende læge skal sikre, at risikoen ved udsættelse for radioaktiviteten er mindre end risikoen ved selve sygdommen.
English: EPAR summary for the public ibritumomab tiuxetan
Danish: EPAR - sammendrag for offentligheden ibritumomab tiuxetan
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur, der kaldes et antigen og som findes i visse celler i kroppen.
English: The main measure of effectiveness was the length of time the patients survived without their disease getting worse.
Danish: Det vigtigste mål for virkningen var, hvor længe patienterne overlevede, uden at sygdommen forværredes.
English: Zevalin is not used directly, but it must be radiolabelled before use.
Danish: Zevalin anvendes ikke direkte, men skal mærkes radioaktivt før brug.
English: Radiolabelled Zevalin treatment should only be handled and given by someone who is authorised to use radioactive medicines.
Danish: Radiomærket Zevalin må kun håndteres og gives af personer, som er autoriserede til at anvende radioaktive lægemidler.
English: Zevalin must not be used in patients who are pregnant or breast feeding.
Danish: Zevalin må ikke anvendes til patienter, der er gravide eller ammer.
English: The Committee recommended that Zevalin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zevalin.
English: Other information about Zevalin
Danish: Andre oplysninger om Zevalin:
English: Radiolabelled Zevalin is radioactive and its use may carry a risk of cancer and hereditary defects.
Danish: Radiomærket Zevalin er radioaktivt, og anvendelsen heraf kan medføre risiko for kræft og arvelige defekter.
English: This is followed, seven to nine days later, by a second infusion of rituximab and an injection of radiolabelled Zevalin.
Danish: Syv til ni dage senere får patienten endnu en infusion af rituximab og en indsprøjtning af radiomærket Zevalin.
English: ‘induction treatment' (initial chemotherapy treatment) for lymphoma.
Danish: ”induktionsbehandling” (førstebehandling med kemoterapi) mod lymfomer.
English: Zevalin should not be used in people who may be hypersensitive (allergic) to ibritumomab, yttrium chloride, mouse proteins or any of the other ingredients.
Danish: Zevalin bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for ibritumomab, yttriumchlorid, museproteiner eller andre af indholdsstofferne.
English: The main study compared the effectiveness of Zevalin with that of rituximab in 143 patients.
Danish: I hovedundersøgelsen blev virkningen af Zevalin sammenlignet med virkningen af rituximab hos 143 patienter.
English: In patients who were not responding to other treatments or whose disease had come back after previous treatment, Zevalin was more effective than rituximab: 80% of the patients receiving radiolabelled Zevalin responded, compared with 56% of the patients receiving rituximab.
Danish: Hos patienter, som ikke responderede på andre behandlinger eller hos hvem sygdommen var vendt tilbage efter tidligere behandling, var Zevalin mere effektivt end rituximab, idet 80 % af patienterne responderede på behandlingen med radiomærket Zevalin sammenlignet med 56 % af de patienter, som fik rituximab.
English: What is the risk associated with Zevalin?
Danish: Hvilken risiko er der forbundet med Zevalin?
English: The most common side effects with Zevalin (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), leucocytopenia and neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), asthenia (weakness), pyrexia (fever), rigors (stiffness) and nausea (feeling sick).
Danish: De mest almindelige bivirkninger ved Zevalin (der ses hos flere end 1 ud af 10 patienter), er anæmi (for lavt antal røde blodlegemer), leukocytopeni og neutropeni (for lavt antal hvide blodlegemer), trombocytopeni (for lavt antal blodplader), kraftesløshed, feber, stivhed og kvalme.
English: However, there were too few patients who had received rituximab as part of their induction treatment to determine whether there would be a benefit of using Zevalin as consolidation treatment in these patients.
Danish: Antallet af patienter, som havde fået rituximab som en del af deres induktionsbehandling, var imidlertid for lavt til at afgøre, om det ville have været en fordel at anvende Zevalin som konsoliderende behandling hos disse patienter.
English: The dose of Zevalin is calculated to give the appropriate amount of radioactivity for the patient's condition, based on the blood cell count.
Danish: Den anvendte dosis Zevalin beregnes, så der tilføres en passende mængde radioaktivitet i forhold til patientens tilstand, baseret på antallet af blodlegemer.
English: For the full list of all side effects reported with Zevalin, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Zevalin fremgår af indlægssedlen.
English: Patients receiving radiolabelled Zevalin survived for an average of 37 months until their disease got worse, compared with 14 months in those who did not receive any further treatment.
Danish: Patienterne, der fik radioaktivt mærket Zevalin, overlevede gennemsnitligt i 37 måneder, inden deres sygdom forværredes, sammenlignet med 14 måneder for dem, som ikke fik nogen supplerende behandling.
English: Why has Zevalin been approved?
Danish: Hvorfor blev Zevalin godkendt?
English: Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Danish: Radiomærkning er en teknik, hvor man mærker et stof med et radioaktivt stof.
English: Ibritumomab has been designed to target an antigen, CD20, which is present on the surface of all B lymphocytes.
Danish: Ibritumomab er opbygget, så det binder sig til et antigen, CD20, der findes på overfladen af alle B-lymfocytter.
English: Zevalin is a kit for the preparation of a ‘radiolabelled' infusion (drip into a vein) of the active substance ibritumomab tiuxetan.
Danish: Zevalin er et sæt til fremstilling af en ”radioaktivt mærket” infusion (dråbetilførsel i en vene) af det aktive stof ibritumomab tiuxetan.
English: Once the antibody has bound to the antigen, the radiation can act locally and destroy the lymphoma B cells.
Danish: Efter at antistoffet har bundet sig til antigenet, kan radioaktiviteten virke lokalt og ødelægge lymfom-B-cellerne.
English: This enables Zevalin to deliver radiation more specifically to the cancerous B-cells.
Danish: Zevalin kan herefter afgive stråling, der specifikt retter sig mod de kræftramte B-celler.
English: Before treatment with radiolabelled Zevalin, the patients must first receive an infusion of rituximab (at a dose lower than would be used for treatment) to clear B cells from their circulation, leaving the cancerous B cells in the lymph tissue.
Danish: Før behandlingen med radiomærket Zevalin skal patienten have en infusion med rituximab (i en lavere dosis end den, der ville blive anvendt til behandlingsformål) for at fjerne B-cellerne fra kredsløbet, så kun de kræftramte B-celler er tilbage i lymfevævet.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target CD20 antigen on the B cells.
Danish: Når det radioaktive lægemiddel injiceres i patienten, bærer det monoklonale antistof radioaktiviteten hen til målantigenet CD20 på B-cellerne.
English: • The radiolabelled medicine is used to treat adult patients with follicular B cell non Hodgkin's lymphoma.
Danish: Det radiomærkede lægemiddel anvendes til behandling af voksne patienter med follikulær B-celle non-Hodgkins lymfom.
English: The CHMP decided that Zevalin's benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory CD20-positive follicular B cell non Hodgkin's lymphoma.
Danish: CHMP konkluderede, at fordelene ved Zevalin opvejer risiciene ved anvendelse som konsoliderende behandling efter remissionsinduktion hos ubehandlede patienter med follikulær lymfom og ved behandling af voksne patienter med CD20-positiv follikulær B-celle non-Hodgkins lymfom, som fik tilbagefald eller ikke responderede på behandlingen med rituximab.
English: When Zevalin is radiolabelled, the radioactive element yttrium 90 (90Y) is attached to ibritumomab.
Danish: Når Zevalin bliver radiomærket, binder det radioaktive grundstof yttrium-90 (90Y) sig til ibritumomab.
English: The study compared patients who received Zevalin and patients who received no additional treatment.
Danish: I undersøgelsen blev patienter, som fik Zevalin, sammenlignet med patienter, som ingen supplerende behandling fik.
English: Zevalin has also been studied in a total of 306 patients with non Hodgkin's lymphoma who were not responding to other treatments or whose disease had come back after previous treatment.
Danish: Zevalin blev desuden undersøgt hos i alt 306 patienter med non-Hodgkins lymfom, som ikke responderede på andre behandlinger, eller hos hvem sygdommen var vendt tilbage efter tidligere behandling.
English: What is Zevalin?
Danish: Hvad er Zevalin?
English: Zevalin is radiolabelled by mixing it with a solution of radioactive yttrium (90Y) chloride.
Danish: Zevalin radiomærkes ved opblanding med en opløsning af radioaktivt yttrium (90Y)-chlorid.
English: The active substance in Zevalin, ibritumomab, is a monoclonal antibody.
Danish: Ibritumomab, det aktive stof i Zevalin, er et monoklonalt antistof.
English: In the additional study, radiolabelled Zevalin brought about a response in about half of the patients.
Danish: I den yderligere undersøgelse responderede ca. halvdelen af patienterne på radiomærket Zevalin.
English: For consolidation therapy, Zevalin has been studied in one main study involving 414 patients who had achieved a partial or complete remission during induction treatment for non Hodgkin's lymphoma.
Danish: Zevalin blev anvendt som konsoliderende behandling i en hovedundersøgelse med 414 patienter med non-Hodgkins lymfom, som havde opnået delvis eller fuld remission i løbet af en induktionsbehandling.
English: In an additional study, 57 patients with follicular lymphoma who had been previously treated and were not responding to rituximab received Zevalin.
Danish: I en yderligere undersøgelse blev der givet Zevalin til 57 patienter med follikulær lymfom, som tidligere var blevet behandlet med rituximab og ikke havde responderet på behandlingen.
English: ‘consolidation therapy' to improve the remission; patients in whom rituximab (another treatment for non Hodgkin's lymphoma) is no longer effective or whose disease has come back after rituximab treatment.
Danish: • patienter, hos hvem rituximab (et andet middel mod non-Hodgkins lymfom) ikke længere virker eller hos hvem sygdommen er vendt tilbage efter behandling med rituximab.
English: What is Zevalin used for?
Danish: Hvad anvendes Zevalin til?
English: How has Zevalin been studied?
Danish: Hvordan blev Zevalin undersøgt?
English: When Zevalin was used as consolidation therapy, patients survived for longer without their disease getting worse than when they received no further treatment.
Danish: De patienter, som fik Zevalin som konsoliderende behandling, overlevede længere uden at sygdommen forværredes end de patienter, som ingen supplerende behandling fik.
English: What benefit has Zevalin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zevalin?
English: How does Zevalin work?
Danish: Hvordan virker Zevalin?
English: How is Zevalin used?
Danish: Hvordan anvendes Zevalin?
English: This summary was last updated in 04-2014.
Danish: Dette sammendrag blev senest ajourført i 04-2014.
English: The capsules should be swallowed whole with water.
Danish: Kapslerne skal synkes hele med vand.
English: It is used to treat adults with the following conditions:
Danish: Det anvendes til behandling af voksne med følgende lidelser:
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information findes i sammendraget af risikohåndteringsplanen.
English: This medicine is the same as Lyrica, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Lyrica, som i forvejen er godkendt i EU.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Pfizer on 10 April 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Pfizer den 10. april 2014.
English: Patients who have kidney problems need to take lower doses.
Danish: Patienter med nyresygdomme skal have lavere dosis.
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg).
Danish: Pregabalin Pfizer udleveres kun på recept og leveres som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg).
English: Doses can be increased up to twice more until the most effective dose is reached.
Danish: indtil den mest effektive dosis er nået.
English: The full EPAR and risk management plan summary for Pregabalin Pfizer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og et sammendrag af risikohåndteringsplanen for Pregabalin Pfizer findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Stopping treatment with Pregabalin Pfizer should also be done gradually, over at least a week.
Danish: Eventuelt ophør af behandlingen med Pregabalin Pfizer bør ligeledes ske gradvis i løbet af mindst en uge.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Danish: Derved nedsætter det aktiviteten i visse nerveceller i hjernen og rygmarven og mindsker på denne måde frigivelsen af andre neurotransmittere, som er en medvirkende årsag til smerter, epilepsi og angst.
English: This compared with about 10% of the patients taking placebo.
Danish: Det samme var tilfældet hos ca. 10 % af dem, der fik placebo.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Pfizer.
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Danish: Det vides endnu ikke nøjagtigt, hvordan pregabalin virker, men det menes at påvirke den måde, hvorpå calcium strømmer ind i nerveceller.
English: The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent').
Danish: Den virksomhed, som fremstiller Lyrica, har indvilget i, at dens videnskabelige oplysninger må anvendes for Pregabalin Pfizer (informeret samtykke).
English: A risk management plan has been developed to ensure that Pregabalin Pfizer is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pregabalin Pfizer anvendes så sikkert som muligt.
English: Pregabalin Pfizer has been compared with placebo (a dummy treatment) in 22 studies.
Danish: Pregabalin Pfizer er blevet sammenlignet med placebo (virkningsløs behandling) i 22 undersøgelser.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: • som tillægsbehandling ved epilepsi med partielle anfald (epileptiske anfald, der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med den nuværende behandling,
English: The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Pfizer, pregabalin, minder i struktur om kroppens eget signalstof GABA (neurotransmitteren gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes.
English: Pregabalin Pfizer is a medicine that contains the active substance pregabalin.
Danish: Pregabalin Pfizer er et lægemiddel, der indeholder det aktive stof pregabalin.