FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Thalidomide Celgene are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Thalidomide Celgene løbende overvåget.
English: The study compared the effect of melphalan and prednisone, with or without Thalidomide Celgene.
Danish: I studiet sammenlignedes virkningen af melphalan og prednison, med eller uden Thalidomide Celgene.
English: Most patients taking thalidomide get side effects.
Danish: De fleste patienter, der behandles med thalidomid, får bivirkninger.
English: The European Medicines Agency concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at under forudsætning af at der træffes meget strenge forholdsregler for at undgå ufødte børns eksponering for thalidomid, opvejer fordelene ved Thalidomide Celgene risiciene, og at det kan godkendes til anvendelse i EU.
English: Previously known as Thalidomide Pharmion.
Danish: Tidligere kaldet Thalidomide Pharmion.
English: It contains the active substance thalidomide.
Danish: Det indeholder det aktive stof thalidomid.
English: It will also supply cards for patients to ensure that all appropriate safety measures are taken by each patient.
Danish: Virksomheden vil også sørge for patientkort for at sikre, at alle relevante sikkerhedsforanstaltninger følges af den enkelte patient.
English: Thalidomide Celgene must never be used by the following groups:
Danish: Thalidomide Celgene må aldrig anvendes til behandling af:
English: The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy.
Danish: Studiet omfattede patienter over 65 år samt yngre patienter, der ikke kunne behandles med højdosiskemoterapi.
English: Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.
Danish: Hver enkelt medlemsstat vil desuden sørge for, at undervisningsmateriale og patientkort sendes til de ordinerende læger og patienter som nødvendigt.
English: Side effects reported with Thalidomide Celgene are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Thalidomide Celgene vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.
Danish: Det anvendes til patienter fra 65 år og opefter og til yngre patienter, hvis de ikke kan behandles med højdosiskemoterapi.
English: What measures are being taken to ensure the safe and effective use of Thalidomide Celgene?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Thalidomide Celgene?
English: Thalidomide Celgene increased the time patients lived in one main study involving 447 patients with multiple myeloma.
Danish: Thalidomide Celgene øgede patienternes levetid i ét hovedstudie, der omfattede 447 patienter med multipelt myelom.
English: For more information about using Thalidomide Celgene, see the package leaflet or contact tour doctor or pharmacist.
Danish: For mere information om brug af Thalidomide Celgene, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Other information about Thalidomide Celgene
Danish: Andre oplysninger om Thalidomide Celgene
English: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion.
Danish: Yderligere information om Thalidomide Celgene findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomidepharmion.
English: The boxes containing Thalidomide Celgene capsules will include a warning that thalidomide is harmful to the unborn child.
Danish: Æskerne med Thalidomide Celgene-kapslerne vil være påført en advarsel om, at thalidomid er skadeligt for det ufødte barn.
English: It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely.
Danish: Den vil udlevere undervisningsmateriale til sundhedspersonale og brochurer til patienter med udførlig forklaring af, hvilke forholdsregler der skal træffes, for at lægemidlet kan anvendes sikkert.
English: Why is Thalidomide Celgene authorised in the EU?
Danish: Hvorfor blev Thalidomide Celgene godkendt i EU?
English: The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
Danish: De strenge forholdsregler, der er fastlagt for at forebygge graviditet og ufødte børns eksponering for thalidomid, skal overholdes af alle mænd og kvinder, der behandles med lægemidlet.
English: Thalidomide Celgene must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.
Danish: Thalidomide Celgene skal ordineres og udleveres i henhold til et særligt behandlingsprogram, der er fastlagt for at forebygge ufødte børns eksponering for lægemidlet.
English: What is Thalidomide Celgene and what is it used for?
Danish: Hvad er Thalidomide Celgene, og hvad anvendes det til?
English: Thalidomide Celgene thalidomide
Danish: Thalidomide Celgene1
English: The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘induction' treatment for multiple myeloma for use before high-dose chemotherapy.
Danish: Virksomheden fremlagde også resultaterne af et studie vedrørende kombinationen af Thalidomide Celgene og dexamethason som "induktionsbehandling" for multipelt myelom før påbegyndelse af højdosiskemoterapi.
English: Thalidomide Celgene can only be obtained with a prescription and treatment must be started and monitored under the supervision of a doctor skilled in using medicines that modulate the immune system or medicines to treat cancer.
Danish: Thalidomide Celgene udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges under tilsyn af en læge med erfaring i anvendelsen af immunmodulerende lægemidler eller kræftlægemidler.
English: The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system
Danish: Det aktive stof i Thalidomide Celgene, thalidomid, menes at virke ved at blokere udviklingen af kræftceller og ved at stimulere nogle af de specialiserede celler i immunsystemet (kroppens naturlige forsvar) til at angribe kræftcellerne.
English: Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before.
Danish: Thalidomide Celgene anvendes til at behandle multipelt myelom (knoglemarvskræft) i kombination med kræftmidlerne melphalan og prednison hos patienter, der ikke tidligere er blevet behandlet for multipelt myelom.
English: What are the risks associated with Thalidomide Celgene?
Danish: Hvilke risici er der forbundet med Thalidomide Celgene?
English: Thalidomide Celgene, in combination with melphalan and prednisone, has been shown to prolong the life of patients with multiple myeloma.
Danish: Det er påvist, at Thalidomide Celgene i kombination med melphalan og prednison forlænger livet for patienter med multipelt myelom.
English: For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Thalidomide Celgene fremgår af indlægssedlen.
English: How is Thalidomide Celgene used?
Danish: Hvordan anvendes Thalidomide Celgene?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thalidomide Celgene have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Thalidomide Celgene.
English: What benefits of Thalidomide Celgene have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Thalidomide Celgene?
English: How does Thalidomide Celgene work?
Danish: Hvordan virker Thalidomide Celgene?
English: It can only be obtained with a prescription.
Danish: udleveres kun efter recept.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eperzan on 28 March 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eperzan den 21. marts 2014.
English: This is a summary of the European public assessment report (EPAR) for Eperzan.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eperzan.
English: This was considered to be clinically meaningful and there were three-year data showing that this effect was maintained during long-term treatment.
Danish: Dette blev anset for klinisk meningsfuldt, og der var 3-ugers data, der viste, at denne virkning holdt sig under langtidsbehandling.
English: The full EPAR and risk management plan summary for Eperzan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Eperzan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Overall, the effect of Eperzan in reducing HbA1c varied between 0.6 and 0.9%.
Danish: Overordnet bevirkede Eperzan en reduktion af HbA1c på mellem 0,6 og 0,9 %.
English: Eperzan albiglutide
Danish: Eperzan albiglutid
English: The recommended dose is 30 mg injected once a week, though this may be increased by their doctor to 50 mg depending on the effects on their blood sugar levels.
Danish: Den anbefalede dosis er 30 mg, der injiceres én gang om ugen, men lægen kan øge dosis til 50 mg, afhængigt af virkningen på blodsukkeret.
English: Other information about Eperzan
Danish: Andre oplysninger om Eperzan
English: What is Eperzan and what is it used for?
Danish: Hvad er Eperzan, og hvad anvendes det til?
English: A risk management plan has been developed to ensure that Eperzan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Eperzan anvendes så risikofrit som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan'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 Eperzan er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Eperzan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Eperzan?
English: Why is Eperzan approved?
Danish: Hvorfor er Eperzan blevet godkendt?
English: The risks seen with the medicine were similar to those of other medicines in its class and Eperzan has the advantage of being given only once a week.
Danish: De iagttagne risici med lægemidlet svarede til risiciene med andre lægemidler i samme klasse, og Eperzan har den fordel, at det kun skal gives én gang om ugen.
English: It is not intended to provide practical advice on how to use Eperzan.
Danish: Det er ikke en praktisk vejledning i, hvordan Eperzan bør anvendes.
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen, thigh or the upper arm.
Danish: Patienterne indgiver selv lægemidlet (efter passende instruktion) på sig selv under huden på maven, låret eller overarmen.
English: Two other medicines, pioglitazone and liraglutide, were found to be more effective as an add-on than Eperzan.
Danish: To andre lægemidler pioglitazon og liraglutid, blev fundet at være mere effektive som tillægsbehandling end Eperzan.
English: The active substance in Eperzan, albiglutide, is a ‘GLP-1 receptor agonist'.
Danish: Det aktive stof i Eperzan, albiglutid, er en “GLP-1-receptoragonist”.
English: What are the risks associated with Eperzan?
Danish: Hvilke risici er der forbundet med Eperzan?
English: Eperzan is a diabetes medicine that contains the active substance albiglutide.
Danish: Eperzan er et lægemiddel mod sukkersyge, der indeholder det aktive stof albiglutid.
English: Eperzan is available as prefilled pens that contain a powder (30 and 50 mg) and solvent for making a solution to be injected under the skin.
Danish: Eperzan leveres som fyldte penne, der indeholder et pulver (30 og 50 mg), og en opløsningsvæske (et solvens), der bruges til at fremstille en opløsning til injektion under huden.
English: The most common side effects with Eperzan, affecting more than 1 in 20 people, are diarrhoea, nausea (feeling sick) and reactions at the injection site including rash, redness, or itching.
Danish: De hyppigste bivirkninger med Eperzan (som kan forekomme hos mere end 1 ud af hver 20 behandlede) er diarré, kvalme og reaktioner på injektionsstedet i form af udslæt, rødme og kløe.
English: The CHMP noted that the effects of Eperzan in controlling blood glucose were shown to be clinically meaningful when the medicine was used alone and when compared with other medicines in combination treatments.
Danish: CHMP bemærkede, at virkningerne af Eperzan til kontrol af blodsukkeret var påvist at være klinisk meningsfulde, når lægemidlet blev anvendt alene, og når det blev sammenlignet med andre lægemidler i kombinationsbehandlinger.
English: When Eperzan is injected, albiglutide reaches the receptors in the pancreas and activates them.
Danish: Når Eperzan indsprøjtes, føres albiglutid frem til receptorerne i bugspytkirtlen og aktiverer dem.
English: For more information about treatment with Eperzan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Eperzan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Eperzan er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Eperzan was more effective than placebo at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines sitagliptin and glimepiride and comparable to insulin glargine and insulin lispro when used as add-on to other treatments.
Danish: Eperzan var mere effektivt end placebo til at nedsætte indholdet af HbA1c, når det blev anvendt alene, og var mere effektivt end sukkersygelægemidlerne sitagliptin og glimepirid og sammenligneligt med insulin glargin og insulin lispro, når det blev anvendt som tillægsbehandling til andre behandlinger.
English: The benefits of Eperzan were studied in over 5,000 patients with type 2 diabetes in which Eperzan was compared with placebo (a dummy treatment) or with other diabetes medicines when used as an addon to various combination treatments or when used alone.
Danish: Fordelene ved Eperzan blev undersøgt hos over 5 000 patienter med type 2 sukkersyge, hos hvem Eperzan blev sammenlignet med placebo (virkningsløs behandling) eller med andre lægemidler mod sukkersyge, hvor det blev anvendt som tillægsbehandling til forskellige kombinationsbehandlinger eller blev anvendt alene.
English: When used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Eperzan anvendes i kombination med et sulfonylurinstof eller insulin, kan det være nødvendigt at sænke dosis af det pågældende sulfonylurinstof eller insulin for at undgå for lavt blodsukker (hypoglykæmi).
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Eperzan fremgår af indlægssedlen.
English: Eperzan can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Danish: Eperzan kan desuden anvendes som tillægsbehandling til andre lægemidler mod sukkersyge, også insulin, når disse lægemidler sammen med motion og diæt ikke giver tilfredsstillende regulering af blodsukkeret.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Danish: Dette medfører udskillelse af insulin og er medvirkende til at nedsætte blodsukkeret og regulere type 2-sukkersygen.
English: Eperzan can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Danish: Eperzan kan anvendes som selvstændig behandling til patienter, hos hvem blodsukkeret ikke er tilfredsstillende reguleret med diæt og motion alene, og som ikke må få metformin (et andet lægemiddel mod sukkersyge).
English: For practical information about using Eperzan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Eperzan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Eperzan have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Eperzan?
English: How is Eperzan used?
Danish: Hvordan anvendes Eperzan?
English: It is used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Danish: Det anvendes til regulering af blodsukkeret hos voksne med type 2-sukkersyge.
English: How does Eperzan work?
Danish: Hvordan virker Eperzan?
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Danish: Disse receptorer findes på overfladen af cellerne i bugspytkirtlen og stimulerer dem til at frigive insulin.
English: The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Danish: Det endelige indhold, format og distributionsmetode af begge dokumenter, skal aftales med de pågældende myndigheder i hvert medlemsland.
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Danish: Indehaveren af markedsføringstilladelsen skal implementere denne uddannelsesplan nationalt før markedsføring.
English: • contraindication of hypersensitivity
Danish: • kontraindikation ved hypersensitivitet
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandet skal sikre at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet er implementeret:
English: • how to recognise the potential side effects (thrombosis and embolism)
Danish: • hvordan potentielle bivirkninger opdages (trombose og embolisme)
English: • the importance of collecting safety data and how to enrol patients in the PASS and other registries
Danish: • vigtigheden af at indsamle sikkerhedsdata og hvordan patienter bliver registreret i PASS samt andre registre
English: Physician brochure Patient brochure
Danish: Brochure til læger Brochure til patienter
English: • how to safely store, handle, reconstitute and administer the product
Danish: • hvordan produktet opbevares sikkert, håndteres, rekonstitueres og administreres
English: Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Danish: Begge dokumenter skal bruges som led i et uddannelsesforløb, der skal sikre, at risikoen for fejlmedicinering, risiko for tromboemboliske hændelser på grund af det øgede niveau af nonproteolytisk aktiveret rFXIII i forbindelse med ukorrekt opbevaring og risiko for behandling af gennebrudsblødning uden for indikation minimeres.
English: • distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
Danish: • distribuering og brug af patientbrochurer og behovet for at sikre at patienten har læst og forstået denne
English: The MAH should ensure harmonisation between terminology used in the brochures and the product information.
Danish: Indehaveren af markedsføringstilladelsen skal sikre harmonisering i terminologien brugt i brochurerne og produktinformationen.
English: • appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
Danish: • hensigtsmæssige dianogstiske procedurer for at bekræfte mangel på FXIII A-subunit
English: • embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Danish: • emboliske og trombotiske hændelser inklusive den øgede risiko for karokklusioner hos patienter med risiko for trombose.
English: The physician brochure should contain the following key elements and item:
Danish: Brochuren til læger skal indeholde følgende nøgleelementer og ting:
English: The patient brochure, to be distributed to patients by the prescribers, should contain the following key elements and item:
Danish: Patientbrochure, der skal distribueres til patienter af den ordinerende læge, skal indeholde følgende nøgleelementer og ting:
English: • the risks associated with incorrect storage and mishandling
Danish: • risikoen forbundet med ukorrekt opbevaring og ukorrekt håndtering
English: • correct handling and the risks associated with mishandling
Danish: • korrekt håndtering og risikoen forbundet med ukorrekt håndtering
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, a letter is sent to all expected and actual prescribers of NovoThirteen with an Educational Pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering sikre, at læger, som forventes at skulle udskrive NovoThirteen, er blevet forsynet med en undervisningspakke, der indeholder følgende:
English: The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg).)
Danish: Dosismængden i milliliter = 0,042 x personens legemsvægt i kg.)
English: FXIII containing products (The recommended dose of NovoThirteen is 35 IU/kg body weight
Danish: • advarsel omkring forskellen i både dosering og koncentration mellem NovoThirteen og andre produkter indeholdende FXIII (Den anbefalede dosis er 35 IE/kg legemsvægt en gang månedligt, givet som en intravenøs bolusinjektion.
English: • warning and precautions regarding anaphylaxis
Danish: • advarsler og forholdsregler vedrørende anafylakse
English: • Package Leaflet
Danish: • Indlægsseddel
English: • you regularly drink alcohol
Danish: • Du regelmæssigt drikker alkohol.
English: The effects include:
Danish: Disse virkninger omfatter:
English: Date of first authorisation: 28th April 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 28. april 2014 Dato for seneste fornyelse:
English: There was no sign of development of tolerance over time.
Danish: Der var ingen tegn på udvikling af tolerance med tiden.