FrancophonIA/ELRC3.0 huggingface dataset:
English: The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.
Danish: Suspensionen og begrænsningen af brugen af de lineære stoffer kan ophæves, hvis de berørte virksomheder fremlægger dokumentation for nye fordele i en identificeret patientgruppe, der opvejer risikoen for hjerneaflejring, eller hvis virksomhederne kan ændre deres lægemidler, så de ikke i væsentlig grad frigiver gadolinium eller ophobes i væv.
English: These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
Danish: Disse lægemidler kan fortsat anvendes i deres aktuelle indikationer, men i de lavest mulige doser, der giver tilstrækkelig kontrastforstærkning, og kun når ikkekontrastforstærket kropsscanning ikke er egnet.
English: • Healthcare professionals in the EU will be sent a letter with information about EMA's review of gadolinium contrast agents.
Danish: • Sundhedspersoner i EU modtager et brev med oplysninger om EMA's gennemgang af gadoliniumholdige kontrastmidler.
English: • Gadolinium deposition in the brain has been confirmed by mass spectrometry and increases in signal intensity in brain tissue.
Danish: • Gadoliniumaflejring i hjernen er blevet bekræftet ved massespektrometri og øget signalintensitet i hjernevæv.
English: On 20 July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium contrast agents, confirming recommendations to restrict the use of some linear gadolinium agents used in MRI body scans and to suspend the authorisations of others.
Danish: Det Europæiske Lægemiddelagentur (EMA) afsluttede den 20. juli 2017 sin gennemgang af gadoliniumholdige kontrastmidler og bekræftede anbefalingerne om at begrænse brugen af visse lineære gadoliniumholdige midler, der anvendes ved MR-kropsscanninger, og suspendere tilladelserne for andre.
English: • Gadolinium contrast agents are essential for diagnosing a wide range of life-threatening and debilitating diseases.
Danish: • Gadoliniumholdige kontrastmidler er afgørende for diagnosticeringen af en lang række livstruende og invaliderende sygdomme.
English: • Data on stability, as well as in vitro and non-clinical studies, show that linear gadolinium agents release gadolinium from the ligand molecules to a greater extent than macrocyclic agents.
Danish: • Data om stabilitet, såvel som in vitro- og ikkekliniske undersøgelser, viser, at lineære gadoliniumstoffer frigiver gadolinium fra ligandmolekyler i højere grad end makrocykliske midler.
English: • Healthcare professionals should use gadolinium contrast agents only when essential diagnostic information cannot be obtained with unenhanced scans.
Danish: • Sundhedspersoner bør kun anvende gadoliniumholdige kontrastmidler, når vigtige diagnostiske oplysninger ikke kan opnås med ikkeforstærkede scanninger.
English: This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Danish: Denne gennemgang omfatter midler, der indeholder følgende aktive stoffer: gadobensyre, gadobutrol, gadodiamid, gadopentetinsyre, gadoterinsyre, gadoteridol, gadoversetamid og gadoxetinsyre.
English: • The product information for gadolinium contrast agents remaining on the EU market is being updated accordingly.
Danish: • Produktinformationen for de gadoliniumholdige kontrastmidler, der forbliver godkendte i EU, bliver opdateret i overensstemmelse hermed.
English: There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.
Danish: Der er for øjeblikket ikke dokumentation for, at gadoliniumaflejring i hjernen har forårsaget skade på patienter; EMA anbefaler dog begrænsning af brugen og suspension af en række intravenøse lineære midler for at forhindre en eventuel risiko, der kunne være forbundet med gadoliniumaflejring.
English: The recommendations - confirmed by EMA's Committee for Medicinal Products for Human Use (CHMP) - followed a review that found that gadolinium deposition occurs in brain tissues following use of gadolinium contrast agents.
Danish: Anbefalingerne, der blev bekræftet af EMA's Udvalg for Lægemidler til Mennesker (CHMP), blev fremsat efter en gennemgang, der konstaterede, at der sker en gadoliniumaflejring i hjernevæv efter brug af gadoliniumholdige kontrastmidler.
English: Most gadolinium-containing contrast agents have been authorised nationally in the EU.
Danish: De fleste gadoliniumholdige kontrastmidler er godkendt nationalt i EU.
English: • If you need a scan with a gadolinium contrast agent to help in your treatment, your doctor will use the lowest dose required for a clear image.
Danish: • Hvis du har behov for et gadoliniumholdigt kontrastmiddel som led i din behandling, vil lægen anvende den lavest mulige dosis, der giver et klart billede.
English: Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents.
Danish: En anden klasse gadoliniumstoffer, de såkaldte makrocykliske stoffer (gadobutrol, gadoterinsyre og gadoteridol), er mere stabil og har en lavere tilbøjelighed til at frigive gadolinium end de lineære stoffer.
English: EMA's scientific review of gadolinium deposition in brain and other tissues is now concluded.
Danish: EMA's videnskabelige gennemgang af gadoliniumaflejring i hjernen og andre væv er nu afsluttet.
English: (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: PRAC's anbefalinger blev fremsendt til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • The marketing authorisations for the intravenous linear agents gadodiamide and gadoversetamide, as well as the intravenous formulation of the linear agent gadopentetic acid, are now suspended in the EU.
Danish: • Markedsføringstilladelserne for de intravenøse lineære stoffer gadodiamid og gadoversetamid samt den intravenøse formulering af det lineære stof gadopentetinsyre, er nu suspenderet i EU.
English: All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Danish: Alle andre intravenøse lineære lægemidler (gadodiamid, gadopentinsyre og gadoversetamid) bør suspenderes i EU.
English: • As a precaution, doctors will stop using some contrast agents given into the vein while some others will only be used when other agents are not suitable (e.g. for liver scans).
Danish: • Som en forholdsregel skal brugen af visse kontrastmidler, der indgives intravenøst, ophøre, mens visse andre stoffer kun må bruges, når andre stoffer ikke er egnede (f.eks. til leverscanninger).
English: As a result of this interaction, the water molecules give a stronger signal, helping to obtain a brighter image.
Danish: Som følge heraf bliver signalet fra vandmolekylerne kraftigere og billedet klarere.
English: • Gadolinium contrast agents are given to patients during body scans to help obtain a clear image of the inside of the body.
Danish: • Gadoliniumholdige kontrastmidler gives til patienter, der skal scannes, for at opnå et tydeligere billede af kroppens indre.
English: Gadolinium contrast agents are used as contrast enhancers to improve image quality with magnetic resonance scans.
Danish: Gadoliniumholdige kontrastmidler anvendes som kontrastforstærkning til forbedring af billedkvaliteten ved MR-scanninger.
English: • Intra-articular formulations of the linear agent gadopentetic acid will continue to be available because the dose of gadolinium that is required for these scans is very low.
Danish: • Intraartikulære formuleringer af det lineære stof gadopentetinsyre vil fortsat kunne fås, da den gadoliniumdosis, der er nødvendig til disse scanninger, er meget lav.
English: The intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need.
Danish: De intravenøse lineære stoffer gadoxetinsyre og gadobensyre kan fortsat anvendes til leverscanninger, da de optages i leveren og opfylder et vigtigt diagnostisk formål.
English: • All macrocyclic agents reviewed - gadobutrol, gadoteric acid and gadoteridol - also remain available.
Danish: • Alle makrocykliske stoffer, der er gennemgået (gadobutrol, gadoterinsyre og gadoteridol), forbliver tilgængelige.
English: • No adverse neurological effects, such as cognitive or movement disorders, have been attributed to gadolinium deposition in the brain with any gadolinium agents.
Danish: • Der er ikke konstateret nogen neurologiske bivirkninger, som f.eks. kognitive forstyrrelser eller bevægeforstyrrelser, efter brug af et gadoliniumholdigt stof, der har medført gadoliniumaflejring i hjernen.
English: Product
Danish: Lægemiddel
English: • Two intravenous linear agents - gadoxetic acid and gadobenic acid - remain available as these agents undergo hepatic uptake, and can be used for imaging poorly vascularised hepatic lesions, especially in delayed phase imaging, that cannot be adequately studied with other agents.
Danish: • To intravenøse lineære stoffer (gadoxetinsyre og gadobensyre) kan fortsat anvendes, da disse stoffer optages i leveren og kan bruges til kontrastforstærkning af dårligt vaskulariserede leverlæsioner (især ved billeddannelse i den forsinkede fase), som ikke kan undersøges tilstrækkeligt med andre stoffer.
English: In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.
Danish: Derudover kan gadopentetinsyre, der gives intraartikulært (i leddene), fortsat anvendes ved ledscanninger, da gadoliniumdosen ved ledinjektioner er meget lav.
English: Optimark (gadoversetamide)
Danish: Optimark (gadoversetamid)
English: Multihance (gadobenic acid)
Danish: Multihance (gadobensyre)
English: Primovist (gadoxetic acid)
Danish: Primovist (gadoxetinsyre)
English: Omniscan (gadodiamide)
Danish: Omniscan (gadodiamid)
English: Patients with moderate or severe liver problems should be treated with lower doses.
Danish: Patienter med moderate eller alvorlige leverproblemer bør behandles med lavere doser.
English: If a patient develops severe side effects, treatment must be discontinued, delayed or the dose adjusted.
Danish: Hvis patienten udvikler alvorlige bivirkninger, skal behandlingen afbrydes eller udskydes, eller dosen justeres.
English: The full EPAR for Bortezomib Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bortezomib Hospira findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Bortezomib Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Danish: Det betyder, at Bortezomib Hospira er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Velcade.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Hospira.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bortezomib Hospira.
English: At least 72 hours must pass between two doses of Bortezomib Hospira.
Danish: Der skal gå mindst 72 timer mellem hver dosis af Bortezomib Hospira.
English: The Committee recommended that Bortezomib Hospira be approved for use in the EU.
Danish: Udvalget anbefalede, at Bortezomib Hospira godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Bortezomib Hospira has been shown to be comparable to Velcade.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Bortezomib Hospira er sammenligneligt med Velcade.
English: No additional studies were needed as Bortezomib Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Bortezomib Hospira er et generisk lægemiddel, der indgives ved injektion og indeholder det samme aktive stof som referencelægemidlet Velcade.
English: The company that markets Bortezomib Hospira will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Danish: Den virksomhed, der markedsfører Bortezomib Hospira, vil udarbejde informationsmateriale til sundhedspersoner vedrørende klargøring og indgivelse af injektionen, beregning af dosen samt ordinering og håndtering af den korrekte behandling til patienter, der gennemgår transplantation af blodstamceller.
English: Bortezomib Hospira must not be given by other routes.
Danish: Bortezomib Hospira må ikke gives på andre måder.
English: Bortezomib Hospira is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Danish: Bortezomib Hospira er et kræftlægemiddel, der anvendes til behandling af myelomatose, som er blodkræft, hos følgende patientgrupper:
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Danish: Bortezomib Hospira udleveres kun efter recept, og behandlingen bør kun indledes og gives under tilsyn af en læge med erfaring i anvendelse af kemoterapi til behandling af kræft.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Hospira?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bortezomib Hospira?
English: What are the benefits and risks of Bortezomib Hospira?
Danish: Hvilke fordele og risici er der forbundet med Bortezomib Hospira?
English: Because Bortezomib Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Bortezomib Hospira er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Bortezomib Hospira is a ‘generic medicine'.
Danish: Bortezomib Hospira er et "generisk lægemiddel".
English: Bortezomib Hospira is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Danish: Bortezomib Hospira anvendes desuden til behandling af en anden form for blodkræft, mantelcellelymfom, hos ubehandlede voksne, som ikke kan få transplantation af blodstamceller.
English: Other information about Bortezomib Hospira
Danish: Andre oplysninger om Bortezomib Hospira
English: Doses of Bortezomib Hospira are given with rest periods between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Hospira is given alone or in combination with other medicines.
Danish: Bortezomib Hospira-doser gives i behandlingsforløb på tre til seks uger, afhængigt af om det gives alene eller i kombination med andre lægemidler, med hvileperioder mellem doserne.
English: The active substance in Bortezomib Hospira, bortezomib, is a proteasome inhibitor.
Danish: Det aktive stof i Bortezomib Hospira, bortezomib, er en proteasomhæmmer.
English: Bortezomib Hospira contains the active substance bortezomib.
Danish: Bortezomib Hospira indeholder det aktive stof bortezomib.
English: For more information about treatment with Bortezomib Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bortezomib Hospira, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For more information on the use of Bortezomib Hospira see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Bortezomib Hospira fremgår af produktresuméet (også en del af denne EPAR).
English: It is not intended to provide practical advice on how to use Bortezomib Hospira.
Danish: Det er ikke en praktisk vejledning i, hvordan Bortezomib Hospira bør anvendes.
English: Bortezomib Hospira is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Danish: Bortezomib Hospira fås i hætteglas med 3,5 mg pulver, der blandes til en opløsning til injektion i en vene eller under huden.
English: What is Bortezomib Hospira and what is it used for?
Danish: Hvad er Bortezomib Hospira, og hvad anvendes det til?
English: For practical information about using Bortezomib Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Bortezomib Hospira, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For mantle cell lymphoma, Bortezomib Hospira is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Ved mantelcellelymfom anvendes Bortezomib Hospira i kombination med rituximab, cyclophosphamid, doxorubicin og prednison.
English: In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone;
Danish: Hos disse patienter anvendes Bortezomib Hospira i kombination med melphalan og prednison
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Hospira have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Bortezomib Hospira.
English: In this group of patients, Bortezomib Hospira is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Danish: Inden for denne gruppe patienter anvendes Bortezomib Hospira i kombination med dexamethason eller med dexamethason og thalidomid.
English: Why is Bortezomib Hospira approved?
Danish: Hvorfor blev Bortezomib Hospira godkendt?
English: Bortezomib Hospira is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
Danish: Hos disse patienter anvendes Bortezomib Hospira enten alene eller i kombination med pegyleret liposomal doxorubicin eller dexamethason
English: How has Bortezomib Hospira been studied?
Danish: Hvordan blev Bortezomib Hospira undersøgt?
English: How is Bortezomib Hospira used?
Danish: Hvordan anvendes Bortezomib Hospira?
English: When injected under the skin, it is given in the thigh or abdomen (tummy).
Danish: Når Bortezomib Hospira gives som injektion under huden, sker det i låret eller maven.
English: How does Bortezomib Hospira work?
Danish: Hvordan virker Bortezomib Hospira?
English:  Before you start.
Danish:  Inden du begynder.
English: The median follow-up duration was 33 months.
Danish: Den mediane opfølgningstid var 33 måneder.
English: • You may see an air bubble.
Danish: • Du kan måske se en luftboble.
English:  Look at the window.
Danish:  Kig på vinduet.
English: Nominal significance
Danish: Nominel signifikans
English: A total of 99.5% of patients were followed for survival until the end of the trial.
Danish: I alt 99,5 % af patienterne blev fulgt med hensyn til overlevelse indtil studieafslutning.
English: All of the studies met their primary endpoint.
Danish: Alle studierne nåede deres primære effektmål.
English: o outer side of your upper arm
Danish: o ydersiden af din overarm
English: Consequently, the frequency of these adverse events is qualified as "not known".
Danish: Følgelig er hyppigheden af disse bivirkninger kvalificeret som "ikke kendt".
English: (See section 6.6)
Danish: (angivet i afsnit 6).
English: With long-term treatment, efficacy was sustained over the duration of the studies (up to 2 years).
Danish: Ved langtidsbehandling var effekten vedvarende i studiernes fulde forløb (op til 2 år).
English: • You will hear a click.
Danish: • Der lyder et klik.
English: The observed cases of pruritus were typically mild and transient.
Danish: De observerede tilfælde af pruritus var typisk milde og forbigående.
English: The primary cause of death in the majority of these patients was CV events.
Danish: Den primære dødsårsag hos størstedelen af disse patienter var kardiovaskulære hændelser.
English: There were no significant differences observed in safety and efficacy with increasing age.
Danish: Der blev ikke observeret signifikante forskelle i sikkerhed og virkning ved stigende alder.
English: If you stop using Praluent, your cholesterol levels can increase.
Danish: Hvis du stopper med at bruge Praluent, kan dit kolesterolniveau stige.
English: Protect from light.
Danish: Beskyt mod lys.
English: • Wash your hands with soap and water and dry with a towel.
Danish: • Vask hænder med vand og sæbe og tør dem i et håndklæde.
English: This will keep you on the original schedule.
Danish: På den måde vil du holde dig til den oprindelige plan.
English: • itching (pruritus).
Danish: • kløe (pruritus).
English: • If the window does not turn completely yellow, call sanofi-aventis for help.
Danish: • Hvis hele vinduet ikke bliver gult, skal du ringe til sanofi-aventis og få hjælp.
English: Not all presentations and pack sizes may be marketed.
Danish: Ikke alle styrker og pakningsstørrelser er nødvendigvis markedsført.
English: Your injection has now started.
Danish: Injektionen er begyndt.
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the ADA assay.
Danish: Immunogenicitetsdata er meget afhængige af følsomheden og specificiteten af ADA-analysen.
English: On-treatment analysis - analysis restricted to the time period that patients actually received treatment.
Danish: I behandling” analyse - analyse, der begrænser sig til den periode, hvor patienterne faktisk var i behandling.
English: • You can inject into your:
Danish: • Du kan foretage injektionen i:
English: Your doctor will check your cholesterol levels and may adjust the dose (up or down) during treatment.
Danish: Lægen vil undersøge dit kolesterolniveau og kan justere dosis (op eller ned) under behandlingen.
English: The following side effects have been reported since the marketing of Praluent, but how often they occur is not known:
Danish: Følgende bivirkninger er blevet rapporteret efter markedsføring af Praluent, men hvor ofte de forekommer vides ikke:
English: For the remaining duration of breast-feeding, exposure is expected to be low.
Danish: I den resterende del af ammeperioden forventes eksponeringen at være lav.
English: This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab.
Danish: Dette medfører øget target-medieret clearance og nedsat systemisk eksponering af alirocumab.
English: • Check that the syringe is not open or damaged.
Danish: • Kontroller at sprøjten ikke er åbnet eller beskadiget.
English:  Keep holding the pen against your skin after releasing the button • The injection may take up to 20 seconds.
Danish:  Bliv ved med at holde pennen nede mod huden efter du har sluppet knappen • Injektionen kan tage op til 20 sekunder.
English: Other side effects are:
Danish: Øvrige bivirkninger:
English: • Use a different spot each time you inject.
Danish: • Brug et nyt sted hver gang du injicerer.