FrancophonIA/ELRC3.0 huggingface dataset:
English: • Before starting and during treatment with Xofigo, an assessment of patients' bone status (e.g. by scintigraphy, bone mineral density measurement) and risk of fractures (e.g. osteoporosis, fewer than 6 bone metastases, medication increasing fracture risk, low body mass index) should be performed.
Danish: På baggrund af ovennævnte observationer vurderer PRAC, at der inden start af radium-223-behandling bør ske vurdering af patientens knoglestatus, f.eks. ved scintigrafi og måling af knogleminiraltæthed, og patientens baseline-risiko for frakturer baseret på kendte risikofaktorer og risikofaktorer, der er identificeret i denne procedure (f.eks. osteoporose, mindre end 6 knoglemetastaser, lægemidler, der øger risikoen for frakturer, og lavt BMI).
English: • In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Danish: PRAC vurderer, at behandlingsfordelene hos voksne med kastrationsresistent prostatakræft og mildt symptomatiske knoglemetastaser bør vurderes omhyggeligt, så man er sikker på, at de opvejer risiciene, idet høj osteoblastaktivitet sandsynligvis er en forudsætning for at have gavn af behandlingen.
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Danish: PRAC vurderer endvidere, at radium-223 bør være kontraindiceret i kombination med abirateronacetat og prednison/prednisolon.
English: The above recommendations are based on the assessment of data from a randomised, double blind, placebo controlled phase III trial (ERA-223), which showed that there was an increased incidence of fractures (28.6% vs 11.4%), a possible reduction in median overall survival (30.7 months vs 33.3 months, HR 1.195, 95% confidence interval (CI) 0.950 - 1.505, p=0.13) and an increased risk of radiological non-bone progression (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) among patients receiving Xofigo in combination with abiraterone acetate plus prednisone/prednisolone (n=401) compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone (n=405).
Danish: I løbet af denne procedure er datasættet blevet større, og det bemærkes, at den statistisk signifikante ubalance med hensyn til mortalitet i ERA-223-interimanalysen på tidspunktet for de foreløbige foranstaltninger (HR 1,347; 95 %-KI [1,047-1,732] p = 0,02) ikke længere var statistisk signifikant i analysen efter låsning af databasen den 8. juni 2018 (HR 1,195; 95 %-KI [0,950-1,505] p = 0,128).
English: More about the procedure
Danish: PRAC
English: The PRAC's recommendations were endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Danish: PRAC har også taget hensyn til udtalelserne fra den videnskabelige rådgivende gruppe for onkologi.
English: An increased fracture risk was found particularly in patients with a medical history of osteoporosis and in patients with fewer than 6 bone metastases.
Danish: I multivariat-analyser var risikoen for frakturer som regel øget hos patienter med mindre end 6 knoglemetastaser sammenholdt med patienter med 6 knoglemetastaser eller derover i radium-223-gruppen.
English: In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo.
Danish: I ALSYMPCA var forekomsten af frakturer hos patienter med mindre end 6 knoglemetastaser ca. to gange større sammenholdt med placebo-gruppen.
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Danish: Den 30. november 2017 anmodede Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004 agenturet om at udtale sig om, hvorvidt markedsføringstilladelsen for Xofigo (radium Ra223 dichlorid) burde opretholdes, ændres, suspenderes eller inddrages.
English: The medicine should also not be used in patients who have no symptoms, in line with the current indication; in addition, the use of Xofigo is not recommended in patients with a low number of bone metastases called osteoblastic bone metastases.
Danish: Det blev derfor bemærket, at den begrænsede indikation ikke tydeligt udelukker behandling af patienter med et lavt antal osteoblastiske knoglemetastaser.
English: The review of Xofigo was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone.
Danish: • PRAC gennemgik analyserne af de foreløbige data fra ERA-223-undersøgelsen, der viste en øget risiko for frakturer og en tendens til øget risiko for dødsfald (sammenholdt med placebo), når radium-223 blev kombineret med abirateronacetat og prednison/prednisolon.
English: • The use of Xofigo is associated with an increased risk of fractures.
Danish: Andre faktorer som f.eks. samtidig brug af steroider kan øge risikoen for frakturer yderligere.
English: EMA restricts use of prostate cancer medicine Xofigo
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for Xofigo (radium Ra223 dichlorid).
English: On 26 July 2018, the European Medicines Agency concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
Danish: Xofigo (radium-223 dichlorid) er et centralt godkendt lægemiddel, der er indiceret til behandling af voksne med kastrationsresistent prostatakræft med symptomatiske knoglemetastaser og ingen kendte viscerale metastaser.
English: • If you experience any new or unusual bone pain or swelling before, during or after your treatment with Xofigo, you should consult your doctor.
Danish: Behandlingsfri pauser før og efter behandling med radium-223 anbefales.
English: A possible increased risk of death was also observed in a clinical trial investigating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer.
Danish: PRAC har vurderet analyser af foreløbige data fra en randomiseret, placebokontrolleret fase IIIundersøgelse på flere forsøgscentre (15396/ERA-223) hos kemoterapi-naive patienter med asymptomatisk eller mildt symptomatisk kastrationsresistent prostatakræft med knoglemetastaser (CRPC).
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Danish: I overensstemmelse med konklusionen fra mødet i den videnskabelige rådgivende gruppe for onkologi vurderer PRAC derfor, at disse fund er relevante for den godkendte indikation.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Danish: På grund af manglende kliniske data vurderer PRAC, at lægerne bør rådes til at indføre en behandlingsfri pause (baseret på eliminationshalveringstid) på mindst 5 dage efter abirateron inden behandlingsstart af radium-223 og i mindst 30 dage efter den sidste dosis radium-223, før et efterfølgende systemisk kræftlægemiddel administreres.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Danish: Desuden er resultaterne af de to randomiserede, kontrollerede studier ikke konsistente med hensyn til samlet overlevelse.
English: In addition, Xofigo should not be started in the first 5 days following the last dose of abiraterone and prednisone/prednisolone.
Danish: Ud fra de tilgængelige data kan det ikke påvises, at de uønskede hændelser i ERA-223 skyldes en mekanisme, der er specifik for den samtidige anvendelse af abirateronacetat og prednison/prednisolon.
English: The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms.
Danish: En anden patientpopulation med en gruppe docetaxel-erfarne patienter afspejler derfor ikke automatisk den type patienter, der er omfattet af ALSYMPCA, hvad angår sygdommens udbredelse.
English: In March 2018, the PRAC recommended contraindicating the use of Xofigo with Zytiga and prednisone/prednisolone, as an interim measure, while the review was ongoing.
Danish: Samlet set vurderer PRAC, at den kontraindikation, der blev indført på tidspunktet for de foreløbige foranstaltninger, hvad angår anvendelse af radium-223 i kombination med abirateron og prednison/prednisolon, bør fastholdes.
English: Package size l t o r
Danish: Paknings-størrelse t r
English: These may include:
Danish: Disse kan omfatte:
English: Only results from Part 1 are described henceforth.
Danish: Det er kun resultaterne fra del 1, der er beskrevet i det følgende.
English: • then once every 4 weeks after that as long as your condition does not worsen.
Danish: • herefter hver 4. uge, så længe din tilstand ikke bliver værre.
English: * No Grade 4
Danish: * Ingen grad 4
English: Based on threshold of 10
Danish: Baseret på en tærskel på 10
English: Consider supportive care with transfusions or growth factors.
Danish: Overvej understøttende behandling med transfusioner eller vækstfaktorer.
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 24 April 2017
Danish: Dato for første markedsføringstilladelse: 20. maj 2016 Dato for seneste fornyelse: 24. april 2017
English: This is because it is not known how the medicine will affect them.
Danish: Det skyldes, at det ikke vides, hvordan medicinen påvirker dem.
English: Initial rate (first hour)
Danish: Initial hastighed (første time)
English: Indicates grouping of terms
Danish: Angiver gruppering af termer
English: Ringaskiddy, Co. Cork Ireland
Danish: Ringaskiddy, Co. Cork Irland
English: The procedure above should be repeated in the event of recurrence of Grade 3 symptoms.
Danish: Ovenstående procedure skal gentages, hvis der opstår grad 3-symptomer igen.
English: Therefore, the incidence of antibody development might not have been reliably determined.
Danish: Derfor er forekomsten af antistofudvikling muligvis ikke fastlagt pålideligt.
English: If you need a blood transfusion, you will have a blood test first to match your blood type.
Danish: Hvis du skal have en blodtransfusion, vil du få taget en blodprøve først for at matche din blodtype.
English: If you miss an appointment, make another one as soon as possible.
Danish: Hvis du udebliver fra en aftale, skal du aftale en ny tid hurtigst muligt.
English: Continuous monitoring for this safety signal will be performed in clinical studies and post-marketing safety data.
Danish: Der vil blive udført kontinuerlig monitorering for dette sikkerhedssignal i de kliniske studier og sikkerhedsdata efter markedsføringen.
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.
English: Otherwise, use a dilution volume of 1,000 mL.
Danish: Ellers skal der anvendes et fortyndingsvolumen på 1.000 ml.
English: • once a week for the first 8 weeks
Danish: • en gang om ugen i de første 8 uger
English: Regardless of response per IMWG
Danish: Uanset respons ifølge IMWG.
English: NL-2333 CB Leiden The Netherlands
Danish: NL-2333 CB Leiden Nederlandene
English: Efficacy results of the pre-planned interim analysis based on Independent Review Committee (IRC) assessment are presented in Table 10 below.
Danish: Effektresultater fra den på forhånd planlagte interimanalyse på grundlag af en vurdering fra en uafhængig review-komité (IRC) præsenteres i tabel 10 nedenfor.
English: These reactions can happen during the infusion or in the 3 days after the infusion.
Danish: Disse reaktioner kan opstå under infusionen eller i løbet af 3 dage efter infusionen.
English: Manage patients according to current clinical guidelines.
Danish: Sådanne patienter skal behandles i henhold til de gældende kliniske retningslinjer.
English: Four percent of all patients had an IRR at more than one infusion.
Danish: 4 % af alle patienter fik en IRR ved mere end én infusion.
English: If you have had an infusion-related reaction once it is less likely to happen again.
Danish: Hvis du har haft en infusionsrelateret reaktion én gang, er det mindre sandsynligt, at den opstår igen.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Danish: Hyppighed defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: Dilute under appropriate aseptic conditions.
Danish: Fortynding skal foretages under passende aseptiske forhold.
English: Increases in AUC were more than dose-proportional and clearance (CL) decreased with increasing dose.
Danish: Stigningerne i AUC var mere end proportionale med dosis, og clearance (CL) faldt i takt med stigende dosis.
English: • swollen hands, ankles or feet
Danish: • hævede hænder, ankler eller fødder
English: • unusual feeling in the skin (such as a tingling or crawling feeling).
Danish: • unormal fornemmelse i huden (for eksempel en prikkende eller kriblende fornemmelse).
English: There is a theoretical risk of haemolysis.
Danish: Der er en teoretisk risiko for hæmolyse.
English: Adverse reaction Frequency Incidence (%) Any Grade Grade 3-4
Danish: Hyppighed Forekomst (%) Alle grader Grad 3-4
English: The consolidation phase of treatment began a minimum of 30 days post-ASCT, when the patient had recovered sufficiently, and engraftment was complete.
Danish: Behandlingens konsolideringsfase indledtes mindst 30 dage efter ASCT, når patienten var tilstrækkeligt restitueret og engraftment var opnået.
English: Do not use DARZALEX if the above applies to you.
Danish: Du må ikke få DARZALEX, hvis ovenstående gælder for dig.
English: It belongs to a group of medicines called “monoclonal antibodies”.
Danish: Det tilhører en gruppe lægemidler, som kaldes monoklonale antistoffer.
English: This is because DARZALEX could cause hepatitis B virus to become active again.
Danish: Dette skyldes, at DARZALEX kan medføre, at hepatitis B-virussen bliver aktiv igen.
English: Tell your doctor if you have ever had or might now have a hepatitis B infection.
Danish: Fortæl det til lægen, hvis du nogensinde har haft en hepatitis B-infektion eller måske har det nu.
English: Fatal infections were primarily due to pneumonia and sepsis.
Danish: Infektioner med dødelig udgang var primært som følge af pneumoni og sepsis.
English: Unopened vials 24 months
Danish: Uåbnede hætteglas 24 måneder
English: There has been no experience of overdosage in clinical studies.
Danish: Der har ikke været tilfælde af overdosering i kliniske studier.
English: In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.
Danish: I tilfælde af overdosering skal patienten overvåges for tegn og symptomer på bivirkninger, og passende symptomatisk behandling skal iværksættes øjeblikkeligt.
English: • then once every 2 weeks for 16 weeks
Danish: • derefter hver 2. uge i 16 uger
English: Infusion-related reaction includes terms determined by investigators to be related to infusion, see below
Danish: Infusionsrelateret reaktion omfatter termer fastlagt af investigatorerne som værende relateret til infusion, se nedenfor
English: • medicines for an allergic reaction (anti-histamines)
Danish: • lægemidler mod en allergisk reaktion (antihistaminer)
English: These reactions are most likely to happen with the first infusion.
Danish: Der er størst risiko for disse reaktioner ved den første infusion.
English: The safety results of this subgroup were consistent with the overall population.
Danish: Sikkerhedsresultaterne for denne undergruppe svarede til den samlede population.
English: Clearance also decreased with multiple doses, which may be related to tumour burden decreases.
Danish: Clearance blev også lavere efter flere doser, hvilket kan være relateret til fald i tumorbyrde.
English: Eighty percent of patients had received prior autologous stem cell transplantation (ASCT).
Danish: 80 % af patienterne havde tidligere fået autolog stamcelletransplantation (ASCT).
English: • high level of sugar in the blood
Danish: • højt indhold af sukker i blodet
English: Your doctor will check you for signs of this infection before, during and for some time after treatment with DARZALEX.
Danish: Lægen vil kontrollere dig for tegn på denne infektion før, under og i nogen tid efter behandlingen med DARZALEX.
English: • medicines for fever (such as paracetamol).
Danish: • lægemidler mod feber (f.eks. paracetamol).
English: 9/L, leukocytes > 1.0 x 10
Danish: 9/l, leukocytter > 1,0 x 10
English: • Antipyretics (oral paracetamol 650 to 1,000 mg)
Danish: • Antipyretikum (paracetamol 650 til 1000 mg oralt)
English: Efficacy was evaluated by PFS based on IMWG criteria.
Danish: Virkning blev evalueret ud fra PFS baseret på kriterier fra IMWG.
English: Doses up to 24 mg/kg have been administered intravenously in a clinical study.
Danish: Der er blevet administreret doser på op til 24 mg/kg intravenøst i et klinisk studie.
English: Pneumonia was the most commonly reported severe (Grade 3 or 4) infection across studies.
Danish: Pneumoni var den hyppigst rapporterede alvorlige (grad 3 eller 4) infektion på tværs af studierne.
English: The solution is colourless to yellow.
Danish: Opløsningen er farveløs til gul.
English: p-value from Fisher's exact test.
Danish: p-værdi fra Fishers eksakte test.
English: This is because the medicine may pass into the mother's milk and it is not known how it will affect the baby.
Danish: Det skyldes, at medicinen kan udskilles i mælken, og at det ikke vides, hvordan det kan påvirke barnet.
English: Post-marketing adverse reactions are also included.
Danish: Bivirkninger indberettet efter markedsføring er også medtaget.
English: Combination treatment with bortezomib:
Danish: Kombinationsbehandling med bortezomib:
English: If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus.
Danish: Hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun orienteres om den potentielle risiko for fostret.
English: The incidence of infusion interruptions due to reactions was 30%.
Danish: Forekomsten af afbrydelser af infusionen som følge af reaktioner var 30 %.
English: Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate.
Danish: Ellers fortsættes der med instruktionerne i tabellen for infusionshastigheden for uge 2.
English: Terminal half-life increases with increasing dose and with repeated dosing.
Danish: Den terminale halveringstid øges ved stigende doser og med gentagne doser.
English: CARTON FOR INITIATION PACK COMPRISING 11 PACKS (WITH BLUE BOX)
Danish: ÆSKE TIL STARTPAKKE BESTÅENDE AF 11 PAKNINGER (MED BLÅ BOKS)
English: Overall response rate (ORR) in MMY2002 was similar regardless of type of prior anti-myeloma therapy.
Danish: Den samlede responsrate (ORR) i MMY2002 var den samme uanset typen af tidligere anti-myelombehandling.
English: • Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration.
Danish: • Parenterale lægemidler skal inspiceres visuelt for partikler og misfarvning før administration.
English: Monoclonal antibodies are proteins that have been designed to recognise and attach to specific targets in the body.
Danish: Monoklonale antistoffer er proteiner, som er designet til at genkende og koble sig fast bestemte steder i kroppen.
English: The efficacy results in this subgroup were consistent with the overall population.
Danish: Effektresultaterne i denne undergruppe svarede til den samlede population.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Danish: Sundhedspersonalet vil bortskaffe eventuelle medicinrester, der ikke længere skal bruges.
English: When these reactions go away, or get better, the infusion can be started again.
Danish: Når disse reaktioner er forsvundet eller blevet bedret, kan infusionen startes igen.
English: The estimated terminal half-life of daratumumab following the last 16 mg/kg dose increased, but there are insufficient data for a reliable estimation.
Danish: Den estimerede terminale halveringstid for daratumumab efter den sidste dosis på 16 mg/kg blev længere, men der er ikke tilstrækkelige data til at kunne give et pålideligt estimat.
English: 9/L, and platelets > 50 x 10 9/L without transfusion).
Danish: 9/l og trombocytter > 50 x 10 9/l uden transfusion).
English: Store in a refrigerator (2 °C-8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: In the first week your doctor may give you the DARZALEX dose split over two consecutive days.
Danish: I den første uge kan lægen beslutte at give dig dosen af DARZALEX fordelt over to dage i træk.
English: Treatment was continued in both arms until disease progression or unacceptable toxicity.
Danish: Behandlingen fortsatte i begge arme indtil sygdomsprogression eller uacceptabel toksicitet.
English: However, fatigue has been reported in patients taking daratumumab and this should be taken into account when driving or using machines.
Danish: Der er dog indberettet træthed hos patienter, der får daratumumab, og der skal tages højde for dette, når der føres motorkøretøj eller betjenes maskiner.
English: • low level of calcium in the blood
Danish: • lavt indhold af calcium i blodet
English: The dose of DARZALEX will depend on your body weight.
Danish: Dosen af DARZALEX afhænger af din vægt.
English: The Patient Alert Card, shall contain the following key elements:
Danish: Patientkortet der skal indeholde følgende nøgleelementer:
English: In the unlikely event that you are given too much (an overdose) your doctor will check you for side effects.
Danish: Hvis du mod al forventning skulle få for meget (en overdosis), vil din læge undersøge dig for bivirkninger.
English: Therefore daratumumab should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus.
Danish: Derfor skal daratumumab ikke anvendes under graviditet, medmindre de terapeutiske fordele for kvinden anses for at opveje de potentielle risici for fosteret.
English: Based on Intent-to-treat population and threshold of 10
Danish: Baseret på Intent-to-treat-populationen og tærskel på 10 Et chi
English: Do not give DARZALEX to children or young people below 18 years of age.
Danish: DARZALEX må ikke gives til børn og unge under 18 år.
English: This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Danish: Denne interferens kan påvirke bestemmelsen af komplet respons og af sygdomsprogression hos visse patienter med IgG kappa-myelomprotein.
English: • The active substance is daratumumab.
Danish: • Aktivt stof: daratumumab.
English: Efficacy was evaluated by the stringent Complete Response (sCR) rate at Day 100 post-transplant and Progression free survival (PFS).
Danish: Effekten blev evalueret vha. stringent komplet respons (sCR) på dag 100 efter transplantationen og progresionsfri overlevelse (PFS).
English: Median OS was not reached for either treatment group.
Danish: Median OS blev ikke nået for nogen af behandlingsgrupperne.
English: The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established.
Danish: DARZALEX' sikkerhed og virkning hos børn i alderen under 18 år er ikke klarlagt.