FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Glybera, alipogene tiparvovec, is derived from a virus that has been modified so it can carry the lipoprotein lipase gene into the body's cells.
Danish: Det aktive stof i Glybera, alipogentiparvovec, er afledt af et virus, der er ændret, så det kan føre lipoproteinlipase-genet ind i kroppens celler.
English: What information is still awaited for Glybera?
Danish: Hvilke oplysninger afventes der stadig for Glybera?
English: The company will also provide data from a registry to monitor the outcome of patients treated with Glybera, and will add a step to the manufacturing of the product to improve the safety profile.
Danish: Virksomheden vil desuden forelægge data fra et register til overvågning af resultaterne af behandling med Glybera og vil tilføje et led i fremstillingsprocessen for at forbedre produktets sikkerhedsprofil.
English: Glybera must not be used in patients with immunodeficiency (weakened immunity), increased risk of bleeding and muscle disease.
Danish: Glybera må ikke anvendes hos patienter med nedsat immunforsvar, forhøjet blødningsrisiko og muskelsygdom.
English: What is the risk associated with Glybera?
Danish: Hvilken risiko er der forbundet med Glybera?
English: Although there were data for only a small number of patients, the results indicate that Glybera would be of benefit to those patients with severe or multiple pancreatitis attacks.
Danish: Skønt der kun fandtes resultater for et lille antal patienter, viser de, at Glybera vil være til fordel for patienter med svære eller gentagne anfald af pankreatitis.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Glybera, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Glybera, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The enzyme produced by these cells can then help to break down fats in the blood, reducing the number of pancreatitis attacks and the severity of the disease.
Danish: Det enzym, der produceres af disse celler, kan nedbryde fedtstoffer i blodet, så patienten får færre anfald af pankreatitis, og sygdommens sværhed mindskes.
English: Why has Glybera been approved?
Danish: Hvorfor blev Glybera godkendt?
English: Glybera should only be prescribed and given under the supervision of a doctor with expertise in treating lipoprotein lipase deficiency and in gene therapy.
Danish: Behandling med Glybera skal ordineres og administreres under opsyn af en læge med ekspertise i behandling af lipoproteinlipase-mangel og i genterapi.
English: For more information on the dose of Glybera to be given, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om, hvilken dosis af Glybera, der skal gives, fremgår af produktresuméet (også en del af denne EPAR).
English: Glybera is given as a single treatment involving multiple injections into the muscles of the upper and lower legs.
Danish: Glybera gives som en enkelt behandling bestående af en række injektioner i musklerne i lår og underben.
English: Glybera is only for patients whose disease has been confirmed by appropriate genetic testing and who have detectable levels of the lipoprotein lipase enzyme in their blood.
Danish: Glybera er kun til anvendelse i tilfælde, hvor sygdommen er bekræftet ved egnede genetiske test, og hvor der er målelige mængder af enzymet lipoproteinlipase i blodet.
English: Glybera is used to treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet.
Danish: Glybera anvendes til behandling af voksne, der har fået diagnosen lipoproteinlipase-mangel og får svære eller gentagne anfald af akut pankreatitis (betændelse i bugspytkirtlen), selvom de følger en fedtfattig diæt.
English: Glybera has been studied in 27 patients with lipoprotein lipase deficiency on a low-fat diet.
Danish: Glybera er undersøgt hos 27 patienter, som havde lipoproteinlipase-mangel og var på fedtfattig diæt.
English: The company will also provide patients and healthcare professionals with educational materials, including information on how to administer Glybera and how to manage risks with the medicine.
Danish: Virksomheden vil desuden udlevere oplysningsmateriale til patienter og sundhedspersoner om, hvordan Glybera skal gives, og hvordan man håndterer risiciene ved lægemidlet.
English: The data showed a reduction in blood fat levels after meals in some patients.
Danish: Blodets fedtstofindhold efter måltiderne faldt hos nogle af patienterne.
English: For the full list of all side effects reported with Glybera, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Glybera fremgår af indlægssedlen.
English: What is Glybera?
Danish: Hvad er Glybera?
English: The main measures of effectiveness were the reduction in blood fat levels after meals and the reduction in the number of pancreatitis attacks.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i blodets fedtstofindhold efter måltiderne og faldet i antallet af anfald af pankreatitis.
English: Lipoprotein lipase deficiency is a rare disease in which patients have a defect in the gene for lipoprotein lipase, an enzyme responsible for breaking down fats.
Danish: Lipoproteinlipase-mangel er en sjælden sygdom, som skyldes en fejl i genet for det fedtnedbrydende enzym lipoproteinlipase.
English: How has Glybera been studied?
Danish: Hvordan blev Glybera undersøgt?
English: What is Glybera used for?
Danish: Hvad anvendes Glybera til?
English: How is Glybera used?
Danish: Hvordan anvendes Glybera?
English: What benefit has Glybera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Glybera?
English: How does Glybera work?
Danish: Hvordan virker Glybera?
English: Due to the multiple injections required, it is advisable to give it with a spinal or regional anaesthetic (medicines which numb certain parts of the body to block pain).
Danish: På grund af det store antal nødvendige injektioner tilrådes det at bruge rygmarvsbedøvelse eller lokalbedøvelse.
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration
English: Blister (unit-dose)
Danish: Blister (enkeltdosis) 120x1 tabletter
English: Immediate Packaging
Danish: Indre emballage Pakningsstørr else
English: Unit-dose blister
Danish: 60x1 tabletter
English: This should be repeated at suitable intervals.
Danish: Dette bør gentages med passende intervaller.
English: Continuous (real time) ECG monitoring is recommended.
Danish: Kontinuerlig (real time) ekg-monitorering anbefales.
English: • Information about the Fingolimod Pregnancy Exposure Registry
Danish: • Information om Fingolimod Pregnancy Exposure Registry
English: • QTc interval 500 msec.
Danish: • QTc-interval ≥500 msek.
English: o GILENYA may increase the risk of infections.
Danish: o Gilenya kan øge risikoen for infektioner.
English: Concomitant treatment with immunosuppressant or immune-modulating medicines should be avoided.
Danish: Samtidig behandling med immunsuppressiva eller immunmodulerende lægemidler bør undgås.
English: Patients may be monitored with a continuous ECG during the first 6 hours.
Danish: Patienter kan monitoreres ved et kontinuerligt ekg i de første 6 timer.
English: The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch in their territory.
Danish: Medlemslandene skal godkende det endelige uddannelsesmateriale fra indehaveren af markedsføringstilladelsen (MAH) inden lancering i deres land.
English: Treatment initiation in patients with severe active infection should be delayed until the infection is resolved.
Danish: Behandlingsstart hos patienter med svær aktiv infektion skal udsættes, indtil infektionen er ophørt.
English: o Where at the 6-hour time point:
Danish: o Hvor der ved 6-timers-målingen ses:
English: o With third degree AV block occurring at any time.
Danish: o Med 3. grads AV-blok opstået på et hvilket som helst tidspunkt.
English: o Perform an ECG at the end of the 6-hour monitoring period.
Danish: o Optag ekg ved afslutningen af 6-timers-monitoreringsperioden.
English: They will need an ECG at 6 hours and in some circumstances monitoring may involve an overnight stay.
Danish: At der skal optages et ekg efter 6 timer, og at monitorering under visse omstændigheder kan betyde en overnatning.
English: • Physician's checklist prior to prescribing GILENYA
Danish: • Lægers tjekliste inden ordination af Gilenya
English: • New onset second degree or higher AV block.
Danish: • Nyopstået AV-blok af 2. grad eller derover.
English: Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients: o Requiring pharmacological intervention during monitoring at treatment initiation.
Danish: Forlæng monitorering af hjertefrekvens mindst natten over på sygehus, og indtil tilstanden er ophørt, hos patienter: o Som har krævet farmakologisk intervention under monitoreringen ved behandlingsstart.
English: The physician's checklist shall contain the following key messages:
Danish: Lægernes tjekliste skal indeholde følgende vigtige oplysninger:
English: o The need to provide patients with the patient reminder card.
Danish: o Nødvendigheden af at udlevere et informationskort til patienterne.
English: o GILENYA reduces peripheral blood lymphocyte counts.
Danish: o Gilenya reducerer lymfocyttallet i det perifere blod.
English: o Specific recommendations regarding vaccination for patients initiating or currently on GILENYA treatment.
Danish: o Specifikke anbefalinger vedrørende vaccination af patienter, der skal starte eller er i behandling med Gilenya.
English: o The teratogenic risk of GILENYA: the importance of avoiding pregnancy when undergoing treatment with GILENYA and the need for a negative pregnancy test result prior to treatment initiation.
Danish: o Den teratogene risiko ved Gilenya: vigtigheden af at undgå graviditet under behandling med Gilenya og nødvendigheden af, at der foreligger en negativ graviditetstest, inden behandlingen påbegyndes.
English: o The need to report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA.
Danish: o Nødvendigheden af straks at indberette symptomer, som indikerer lav hjertefrekvens (som fx svimmelhed, følelse af at snurre rundt (vertigo), kvalme eller hjertebanken) efter den første Gilenya-dosis.
English: • Patient reminder card
Danish: • Patient-informationskort
English: The Member States shall ensure that, at launch and after launch, the MAH provides all physicians who intend to prescribe GILENYA with an updated physician information pack containing the following elements:
Danish: Medlemslandene skal sikre, at MAH udleverer en opdateret lægeminformationspakke til alle læger, som forventes at ordinere Gilenya ved lancering og efter lancering, som indeholder følgende elementer:
English: o The need for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Danish: o Nødvendigheden af at monitorere leverfunktionen ved måned 1, 3, 6, 9 og 12 under behandling med Gilenya og periodisk derefter.
English: The patient reminder card shall contain the following key messages:
Danish: Patientinformationskortet skal indholde følgende vigtige oplysninger:
English: o Perform a liver function test prior to treatment initiation.
Danish: o Foretag leverfunktionstest inden behandlingsstart.
English: o GILENYA is not recommended in patients concomitantly taking medicines which are known to decrease the heart rate.
Danish: o Gilenya anbefales ikke til patienter, som samtidig tager lægemidler, der er kendt for at sænke hjertefrekvensen.
English: There is a need to check the patient's peripheral lymphocyte count (CBC) prior to initiation and to monitor during treatment with GILENYA.
Danish: Det er nødvendigt at måle patientens perifere lymfocyttal (komplet blodtælling, CBC) inden behandlingsstart og at monitorere det under Gilenya-behandlingen.
English: o GILENYA is not recommended in patients concomitantly taking Class Ia or Class III antiarrhythmic medicines.
Danish: o Gilenya anbefales ikke til patienter, som samtidig tager klasse Ia- eller klasse III-antiarytmika.
English: o GILENYA is not recommended in patients with cardiac disease or those taking medicines concomitantly known to decrease heart rate and they should tell any doctor they see that they are being treated with GILENYA.
Danish: o Gilenya anbefales ikke til patienter med hjertesygdomme, eller som samtidig tager medicin kendt for at nedsætte hjertefrekvensen, og at patienterne skal fortælle alle læger, som tilser dem, at de er i behandling med Gilenya.
English: Suspension of treatment during serious infections should be considered.
Danish: Under alvorlige infektioner skal seponering af behandlingen overvejes.
English: o The need for a liver function test prior to treatment initiation and for liver function monitoring at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter.
Danish: o Nødvendigheden af, at der udføres en leverfunktionstest, inden behandlingen påbegyndes, og for at monitorere leverfunktionen ved måned 1, 3, 6, 9 og 12 under behandlingen med Gilenya og periodisk derefter.
English: o The need for a full ophthalmological assessment 3-4 months after starting GILENYA therapy for the early detection of visual impairment due to drug-induced macular oedema.
Danish: o Nødvendigheden af en komplet oftalmologisk undersøgelse 3-4 måneder efter behandlingsstart med Gilenya for tidligt at opdage nedsat syn pga. lægemiddelinduceret maculaødem.
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to switch to non heart-rate-lowering therapy or, if not possible, to determine appropriate monitoring.
Danish: Hvis behandling med Gilenya overvejes til disse patienter, skal de forventede fordele opveje de mulige risici, og der skal søges rådgivning hos en kardiolog om skift til en behandling, som ikke sænker hjertefrekvensen, eller hvis dette ikke er muligt for at fastlægge passende monitorering.
English: Until 6 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o Monitor the patient for 6 hours after the first dose of GILENYA has been administered for signs and symptoms of bradycardia, including hourly pulse and blood pressure checks.
Danish: Indtil 6 timer efter første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden) o Monitorer patienten i 6 timer efter den første dosis af Gilenya er blevet administreret for tegn og symptomer på bradykardi, inklusive måling af puls og blodtryk hver time.
English: • Heart rate <45 bpm.
Danish: • Hjertefrekvens <45 slag pr. minut.
English: o The need to advise women of child-bearing potential on the serious risk to the foetus and the need to practice effective contraception during treatment and for at least two months following discontinuation of treatment with GILENYA.
Danish: o Nødvendigheden af at informere kvinder i den fertile alder om de alvorlige risici for fosteret og om, at der skal anvendes effektiv antikonception under behandlingen og i mindst to måneder efter ophør med Gilenya-behandling.
English: o That GILENYA is not recommended in patients with: o Second degree Mobitz Type II or higher AV block o Sick-sinus syndrome o Sino-atrial heart block o QTc prolongation >470 msec (females) or >450 msec (males) o Ischaemic cardiac disease including angina pectoris o Cerebrovascular disease o History of myocardial infarction o Congestive heart failure o History of cardiac arrest o Severe sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension
Danish: o At Gilenya frarådes til patienter med: o Mobitz Type II AV-blok af 2.grad eller derover o Syg sinus-syndrom o Sinuatrialt blok o QTc-forlængelse >470 msek.
English: If GILENYA treatment is considered in these patients anticipated benefits must outweigh potential risks and a cardiologist must be consulted to determine appropriate monitoring, at least overnight extended monitoring is recommended.
Danish: Hvis behandling med Gilenya overvejes til disse patienter, skal de forventede fordele opveje de mulige risici, og der skal søges rådgivning hos en kardiolog for at fastlægge den mest hensigtsmæssige monitorering.
English: o Arrange ophthalmological assessment prior to initiation with GILENYA in patients with diabetes mellitus or with a history of uveitis.
Danish: o Inden behandlingsstart med Gilenya planlægges en oftalmologisk undersøgelse hos patienter med diabetes mellitus eller med uveitis i anamnesen.
English: o That their heart rate will need to be monitored for 6 or more hours after the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago), including hourly pulse and blood pressure checks.
Danish: o At det er nødvendigt at monitorere hjertefrekvensen i 6 timer eller mere efter den første Gilenya-dosis (eller hvis sidste dosis blev administreret for mere end 2 uger siden), inklusive måling af puls og blodtryk hver time.
English: >6 to 8 hours after first dose (or if the last dose of GILENYA was more than two weeks previously) o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose,
Danish: >6 til 8 timer efter den første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden) o Hvis hjertefrekvensen ved 6-timers-målingen er den laveste værdi efter den første dosering, skal monitorering af hjertefrekvensen forlænges med mindst 2 timer, og indtil hjertefrekvensen igen stiger.
English: o The signs and symptoms of infection and the need to report these immediately to the prescriber during and up to two months after treatment with GILENYA.
Danish: o Tegn og symptomer på infektion og nødvendigheden af straks at indberette disse til den ordinerende læge under behandlingen og i op til to måneder efter, behandling med Gilenya er stoppet.
English: o Report any (intended or unintended) pregnancy during and two months following discontinuation of treatment with GILENYA immediately to the prescriber.
Danish: o Straks indberette enhver (tilsigtet eller utilsigtet) graviditet under behandlingen og i to måneder efter behandlingsophør til den ordinerende læge.
English: • The Summary of Product Characteristics
Danish: • Produktresumé
English: o The need to instruct patients to report signs and symptoms of infections immediately to their prescriber during and for up to two months after treatment with GILENYA.
Danish: o Nødvendigheden af at informere patienten om straks at indberette tegn og symptomer på infektioner til den ordinerende læge under behandlingen og i op til to måneder efter behandling med Gilenya.
English: o Recommendation for overnight monitoring after the first dose (or if the last dose of GILENYA was more than two weeks previously).
Danish: o Anbefalinger for monitorering natten over efter første dosis (eller hvis den seneste dosis af Gilenya blev administreret for mere end to uger siden).
English: o The need for ophthalmological assessment during treatment with GILENYA in patients with diabetes mellitus or with a history of uveitis.
Danish: o Nødvendigheden af oftalmologisk vurdering af patienter med diabetes mellitus eller med uveitis i anamnesen under Gilenya-behandling.
English: o That they will have a baseline ECG and blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA has been administered more than two weeks ago).
Danish: o At der skal optages baseline-ekg og måles blodtryk før den første dosis af Gilenya (eller hvis sidste dosis blev administreret for mere end 2 uger siden).
English: o Monitoring requirements at treatment initiation Before first dose o Perform baseline ECG prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
Danish: o Påkrævet monitorering ved behandlingsstart Inden første dosis o Optag baseline-ekg før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden).
English: o The need to report any symptoms of visual impairment immediately to the prescriber during and for up to two months after the end of treatment with GILENYA.
Danish: o Nødvendigheden af straks at indberette ethvert tegn på nedsat syn til den ordinerende læge under behandlingen og i op til to måneder efter, behandling med Gilenya er stoppet.
English: o Perform blood pressure measurement prior to the first dose of GILENYA (or when the last dose of GILENYA was more than two weeks previously).
Danish: o Foretag blodtryksmåling før den første dosis af Gilenya (eller hvis den seneste dosis blev administreret for mere end to uger siden).
English: o That GILENYA is teratogenic so women with childbearing potential must: o Have a negative pregnancy test. o Be using effective contraception during and for at least two months following discontinuation of treatment with GILENYA.
Danish: o At Gilenya er teratogent, og derfor skal kvinder i den frugtbare alder: o Være testet negative for graviditet.
English: This increases the ability of the immune system to kill cancer cells.
Danish: Dette øger immunsystemets evne til at dræbe kræftceller.
English: The full EPAR and risk management plan summary for Nivolumab BMS can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Nivolumab BMS findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine contains the active substance nivolumab.
Danish: Lægemidlet indeholder det aktive stof nivolumab.
English: This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nivolumab BMS.
English: A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Nivolumab BMS anvendes så sikkert som muligt.
English: When it attaches to PD-1, nivolumab blocks the receptor and prevents it from switching off these immune cells.
Danish: Når nivolumab bindes til PD-1, blokerer det receptoren og hindrer den i at slukke for disse immunceller.
English: The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Danish: De hyppigste bivirkninger ved Nivolumab BMS (som optræder hos mere end 1 ud af 10 personer) er træthed, nedsat appetit og kvalme (utilpashed), der i de fleste tilfælde er milde eller moderate.
English: Patients whose cancer clearly expressed PD-1 seem to show most benefit, but as other patients also responded, further study to clarify patient groups most likely to benefit from the medicine is needed.
Danish: Patienter, hvis cancer klart udtrykte PD-1, synes at drage størst nytte, men da andre patienter også responderede, er yderligere studier nødvendige for at afklare, hvilke patientgrupper der mest sandsynligt drager nytte af lægemidlet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Nivolumab BMS opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.