FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical efficacy of radium-223 dichloride in the authorised indication was established during the initial marketing authorisation application based on the assessment of data from one pivotal phase III study (15245/BC1-06, ALSYMPCA), in which an improved overall survival and delayed symptomatic skeletal events were observed.
Danish: Den kliniske virkning af radium-223 dichlorid i den godkendte indikation blev fastlagt i forbindelse med den oprindelige ansøgning om markedsføringstilladelse på grundlag af en vurdering af data fra én central fase III-undersøgelse (15245/BC1-06, ALSYMPCA), hvori der blev observeret en forbedre samlet overlevelse og forsinkede symptomatiske knogle-hændelser.
English: In view of the above, the Committee considers that the benefit-risk balance of Xofigo (radium Ra223 dichloride) remains favourable subject to the agreed provisional amendments to the product information.
Danish: I lyset af ovenstående konkluderer udvalget, at benefit/risk-forholdet for Xofigo (radium Ra223 dichlorid) fortsat er positivt under forudsætning af, at de vedtagne ændringer indføres i produktinformationen.
English: • The PRAC noted that the use of radium Ra223 dichloride in Study ERA 223 was at earlier stages of the disease, albeit partially overlapping with that included in the authorised indication.
Danish: • PRAC bemærkede, at anvendelsen af radium Ra223 dichlorid i ERA-223-undersøgelsen skete på tidligere stadier af sygdommen, selvom den var delvist overlappende med beskrivelsen i den godkende indikation.
English: Xofigo (radium Ra223 dichloride, also radium-223 herein) is a centrally authorised product indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Danish: Xofigo (radium Ra223 dichlorid, også omtalt som radium-223 heri) er et centralt godkendt lægemiddel, der er indiceret til behandling af voksne med kastrationsresistent prostatakræft, symptomatiske knoglemetastaser og ingen kendte viscerale metastaser.
English: In view of the significance of the findings of the ERA 223 clinical trial, it was considered that they should be thoroughly reviewed in the context of all available data related to radium-223 dichloride (including evidence from non-authorised use that might impact the authorised use) in order to assess their potential impact on the benefit-risk balance of Xofigo in the authorised indication of the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Danish: I lyset af betydningen af fundene i den kliniske ERA 223-undersøgelse blev det vurderet, at de burde gennemgås grundigt i sammenhæng med alle tilgængelige data, der er relateret til radium-223 dichlorid (herunder evidens fra ikke-godkendt anvendelse, der kan påvirke den godkendte anvendelse), for at vurdere deres eventuelle indvirkning på benefit/risk-forholdet for Xofigo i den godkendte indikation for behandling af voksne med kastrationsresistent prostatakræft, symptomatiske knoglemetastaser og ingen kendte viscerale metastaser.
English: The PRAC also noted that data available show that radium Ra223 dichloride is used to some extent in clinical practice in combination with anti-androgens such as abiraterone and enzalutamide.
Danish: PRAC bemærkede også, at de tilgængelige data viser, at radium Ra223 dichlorid i nogen grad anvendes i kombination med antiandrogener som f.eks. abirateron og enzalutamid i klinisk praksis.
English: The PRAC also considered other available data, including further data from the ALSYMPCA clinical trial submitted in support of the initial marketing authorisation, in relation to the potential impact of results of Study ERA 223 on the benefit-risk balance of radium Ra223 dichloride in its authorised indication.
Danish: PRAC vurderede også andre tilgængelige data, herunder yderligere data fra den kliniske ALSYMPCA-undersøgelse, der var indsendt som støtte for den oprindelige ansøgning om markedsføringstilladelse, i forbindelse med den mulige indvirkning på resultaterne af ERA-223-undersøgelsen på benefit/riskforholdet for radium Ra223 dichlorid i den godkendte indikation.
English: In view of the seriousness of these results, the fact that they were observed in a patient population with earlier disease characteristics but partly overlapping with that described in the authorised indication, and considering that the mechanism behind the events observed remain largely unexplained at this stage, the PRAC considered that, as a provisional measure, the use of radium-223 in combination with abiraterone acetate and prednisone/prednisolone should be contraindicated.
Danish: I lyset af den alvorlige karakter af disse resultater og det faktum, at de blev observeret i en patientpopulation med tidligere sygdomskarakteristika, men delvist overlappende med beskrivelsen i den godkendte indikation, samt under hensyn til, at mekanismen bag de observerede hændelser fortsat er stort set ukendt på nuværende tidspunkt, er PRAC af den opfattelse, at anvendelsen af radium-223 i kombination med abirateronacetat og prednison/prednisolon bør kontraindiceres som en foreløbig sikkerhedsforanstaltning.
English: The PRAC considered preliminary data analyses from a randomized, placebo-controlled multicentre phase III study (15396/ERA-223) in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases (CRPC).
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: • In addition, in the absence of definite evidence that the results observed were specific to the combination with abiraterone acetate and prednisone/prednisolone, the PRAC considered that healthcare professionals and patients should be warned that the safety and efficacy of radium Ra223 dichloride in combination with second-generation androgen receptor antagonists including enzalutamide have not been established.
Danish: • I mangel af definitiv evidens for, at de observerede resultater var specifikke for kombinationen med abirateronacetat og prednison/prednisolon, finder PRAC, at sundhedspersoner og patienter bør advares om, at sikkerheden og virkningen ved radium Ra223 dichlorid i kombination med andengenerations androgen-receptorantagonister, herunder enzalutamid, ikke er fastlagt.
English: Therefore and in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to contraindicate the use of radium Ra223 dichloride in combination with abiraterone acetate and prednisone/prednisolone and inform on the results of Study ERA 223.
Danish: Derfor og i lyset af den alvorlige karakter af de observerede hændelser anbefaler PRAC som midlertidig ændring af produktinformationen, at anvendelsen af radium Ra223 dichlorid i kombination med abirateronacetat og prednison/prednisolon kontraindiceres, og at der tilføjes oplysninger om resultaterne af ERA-223-undersøgelsen.
English: Considering current therapeutic options available for patients with symptomatic castration resistant prostate cancer with bone metastases, the PRAC considered that as a provisional measure, a warning that the safety and efficacy of Xofigo in combination with second-generation androgen receptor antagonists such as enzalutamide have not been established, should be included in the product information.
Danish: I betragtning af de aktuelle behandlingsmuligheder, der er til rådighed for patienter med symptomatisk kastrationsresistent prostatakræft med knoglemetastaser, finder PRAC, at der i produktinformationen bør tilføjes en advarsel om, at sikkerheden og virkningen af Xofigo i kombination med andengenerations androgen-receptorantagonister som enzalutamid ikke er fastlagt.
English: Healthcare professionals should be informed of the increased incidence of fractures and deaths among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone in Study ERA-223, and of the reduced incidence of fractures observed in both treatment arms with concurrent use of bisphosphonates or denosumab bone health agents.
Danish: Sundhedspersoner bør informeres om den øgede incidens af frakturer og dødsfald blandt patienter, der fik Xofigo i kombination med abirateronacetat og prednison/prednisolon sammenholdt med patienter, der fik placebo i kombination med abirateronacetat og prednison/prednisolon i ERA-223-undersøgelsen, og om den reducerede forekomst af frakturer, der er observeret i begge behandlingsgrupper ved samtidig brug af bisphosphonater eller denosumab-holdige knoglestyrkende midler.
English: Analyses of uncleaned preliminary data of a clinical trial evaluating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in a patient population with asymptomatic or mildly symptomatic prostate cancer (ERA 223), found that the incidences of treatment emergent fractures and deaths were increased in the treatment arm (radium-223 dichloride plus abiraterone acetate and prednisone/prednisolone) compared to the control arm (placebo plus abiraterone acetate and prednisone/prednisolone).
Danish: Analyser af urensede foreløbige data fra en klinisk undersøgelse af Xofigo i kombination med abirateronacetat og prednison/prednisolon hos en patientpopulation med asymptomatisk eller mildt symptomatisk prostatakræft (ERA 223) viste, at incidensen af behandlingsrelaterede frakturer og dødsfald var højere i behandlingsgruppen (radium-223 dichlorid plus abirateronacetat og prednison/prednisolon) end i kontrolgruppen (placebo plus abirateronacetat og prednison/prednisolon).
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No
Danish: Disse midlertidige foranstaltninger gennemføres med forbehold for udfaldet af den igangværende gennemgangsprocedure i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: • Further to the review of the preliminary analyses available, the underlying mechanism for the increased risks of fracture and mortality observed in ERA 233, and therefore the potential impact of these findings in the authorised indication, remain uncertain.
Danish: • Ud over gennemgangen af de tilgængelige foreløbige analyser er den underliggende mekanisme for den øgede risiko for frakturer og dødsfald, der er observeret i ERA-223
English: • The PRAC reviewed the preliminary data analyses of Study ERA 223 that suggested an increased risk of fracture and mortality when radium Ra223 dichloride treatment, compared to placebo, is initiated concurrently with abiraterone acetate and prednisone/prednisolone treatment.
Danish: • PRAC gennemgik analyserne af de foreløbige data fra ERA-223-undersøgelsen, der antydede en øget risiko for frakturer og dødsfald (i forhold til placebo), når radium Ra223 dichlorid gives samtidig med abirateronacetat og prednison/prednisolon.
English: Based on the available data, Study 15396 shows that in chemotherapy-naïve asymptomatic or mildly symptomatic patients with CRPC, radium-223 in combination with concurrent abiraterone acetate and prednisolone/prednisone decreases overall survival and increases the risk of fractures compared to placebo in combination with abiraterone acetate and prednisone/prednisolone.
Danish: På grundlag af de tilgængelige data viser undersøgelse 15396, at radium-223 i kombination med samtidig abirateronacetat og prednison/prednisolon reducerer den samlede overlevelse og øger risikoen for frakturer sammenholdt med placebo i kombination med abirateronacetat og prednison/prednisolon hos kemoterapi-naive, asymptomatisk eller mildt symptomatiske patienter med CRPC.
English: Abasaglar is given once a day at the same time each day.
Danish: Abasaglar gives én gang dagligt på samme klokkeslæt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abasria den 09. september 2014.
English: Other information about Abasaglar
Danish: Andre oplysninger om Abasaglar
English: This is a summary of the European public assessment report (EPAR) for Abasaglar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Abasaglar.
English: The full EPAR and risk management plan summary for Abasaglar 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 Abasaglar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Abasaglar is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Abasaglar svarer til et biologisk lægemiddel (også kaldet »referencelægemidlet«), der allerede er godkendt i Den Europæiske Union (EU).
English: A risk management plan has been developed to ensure that Abasaglar is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Abasaglar anvendes så sikkert som muligt.
English: It is used in adults and children over the age of two for the treatment of diabetes.
Danish: Det anvendes hos voksne og børn over to år til behandling af sukkersyge.
English: The reference medicine for Abasaglar is Lantus.
Danish: Referencelægemidlet for Abasaglar er Lantus.
English: What is Abasaglar and what is it used for?
Danish: Hvad er Abasaglar, og hvad anvendes det til?
English: Abasaglar is a ‘biosimilar medicine'.
Danish: Abasaglar er et »biosimilært« lægemiddel.
English: Patients can inject themselves with Abasaglar if they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne med Abasaglar efter at have fået passende oplæring.
English: The Committee recommended that Abasaglar be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Abasaglar.
English: The name of the medicine was changed to Abasaglar on 3 December
Danish: Navnet blev ændret til Abasaglar den 3. december 2014.
English: Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.
Danish: Reaktioner på injektionsstedet (rødme, smerte, kløe og hævelse) og hudreaktioner (udslæt) er oftere set hos børn end hos voksne.
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Danish: Der skal skiftes injektionssted for hver injektion for at undgå hudforandringer (såsom fortykkelse), der kan få insulinet til at virke dårligere end forventet.
English: What measures are being taken to ensure the safe and effective use of Abasaglar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abasaglar?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and effectiveness to Lantus.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Abasaglars og Lantus' kvalitet, sikkerhed og virkning svarer til hinanden.
English: Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively.
Danish: Den gennemsnitlige startværdi af HbA1c var 8,3 %, som faldt til under 7 % hos 48,8 % af dem, der fik Abasaglar, og 52,5 % af dem, der fik Lantus, svarende til et gennemsnitligt fald på henholdsvis 1,29 og 1,34 procentpoint.
English: Insulin glargine is slightly different from human insulin.
Danish: Insulin glargin er en smule forskelligt fra humant insulin.
English: The dose is adjusted individually, and the patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Danish: Dosis tilpasses den enkelte patient, og blodsukkeret skal regelmæssigt kontrolleres for at fastlægge den laveste effektive dosis.
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Når blodsukkeret reguleres, mindskes symptomerne og komplikationerne ved sukkersygen.
English: The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Danish: Den hyppigste bivirkning ved Abasaglar (som kan forekomme hos over 1 ud af 10 patienter) er for lavt blodsukker (hypoglykæmi).
English: Why is Abasaglar approved?
Danish: Hvorfor er Abasaglar blevet godkendt?
English: It is not intended to provide practical advice on how to use Abasaglar.
Danish: Det er ikke en praktisk vejledning i, hvordan Abasaglar bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abasaglar, 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 Abasaglar, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What are the risks associated with Abasaglar?
Danish: Hvilke risici er der forbundet med Abasaglar?
English: Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Lantus.
English: For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Abasaglar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Abasaglar is a medicine that contains the active substance insulin glargine.
Danish: Abasaglar er et lægemiddel, der indeholder det aktive stof insulin glargin.
English: Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes.
Danish: Abasaglar kan også gives sammen med sukkersygemedicin, der tages gennem munden af patienter med type 2-sukkersyge.
English: For the full list of all side effects and restrictions with Abasaglar, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Abasaglar fremgår af indlægssedlen.
English: In addition, treatment with once-daily Abasaglar has been shown to be comparable to the reference medicine, Lantus, in two supportive studies involving a total of 1,295 adults with diabetes.
Danish: Desuden er Abasaglar, givet én gang dagligt, påvist at være sammenligneligt med referencelægemidlet Lantus i to støttende undersøgelser med i alt 1 295 voksne med sukkersyge.
English: The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Danish: Denne forskel gør, at Abasaglar optages langsommere og jævnere af kroppen efter en indsprøjtning og virker i lang tid.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Erstatningsinsulinet virker på samme måde som naturligt produceret insulin og bevirker, at sukkeret fra blodet føres ind i cellerne.
English: • In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes.
Danish: • I den ene undersøgelse blev Abasaglar sammenlignet med Lantus som tillægsbehandling til korttidsvirkende insulin hos 536 patienter med type 1-sukkersyge.
English: Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts on blood glucose were similar to Lantus.
Danish: Der er udført undersøgelser for at påvise, at Abasaglars optagelse i kroppen og virkning på blodsukkeret svarer til Lantus.
English: Abasaglar is a replacement insulin that is very similar to the insulin made by the body.
Danish: Abasaglar er en insulinerstatning, der stærkt ligner det insulin, der produceres af kroppen.
English: Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained with a prescription.
Danish: Abasaglar leveres som cylinderampuller og fyldte penne til engangsbrug (KwikPen) og udleveres kun efter recept.
English: For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Abasaglar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (upper arm).
Danish: Det indgives ved injektion under huden (subkutant) i maveskindet, låret eller deltaområdet (overarmen).
English: How is Abasaglar used?
Danish: Hvordan anvendes Abasaglar?
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Danish: Ved sukkersyge producerer kroppen ikke tilstrækkeligt med insulin til at regulere blodsukkeret.
English: insulin glargine
Danish: Abasaglar insulin glargin
English: In both studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: I begge undersøgelser blev lægemidlets virkning hovedsagelig bedømt ved at måle blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c).
English: Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target of 7%.
Danish: Patienternes gennemsnitlige HbA1c før behandlingen var 7,8 %, og efter seks måneder var det gennemsnitlige fald i hver gruppe omtrent det samme (0,35 % i Abasaglar-gruppen og 0,46 % i Lantus-gruppen).
English: What benefits of Abasaglar have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Abasaglar?
English: • In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, as an addition to diabetes medicines taken by mouth.
Danish: • I den anden undersøgelse deltog 759 patienter med type 2-sukkersyge.
English: The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce insulin glargine.
Danish: Det aktive stof i Abasaglar, insulin glargin, fremstilles ved »rekombinant DNA-teknologi«.
English: How does Abasaglar work?
Danish: Hvordan virker Abasaglar?
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I LISTE OVER NAVNE, LÆGEMIDDELFORMER, STYRKER PÅ LÆGEMIDLERNE, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
English: 08960 Sant Just Desvern (Barcelona) Spain
Danish: 08960 Sant Just Desvern (Barcelona)
English: 37 avenue Gabriel PériB.P.
Danish: AMIDO 37 avenue Gabriel PériB.P.
English: INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona, Spain
Danish: INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona,
English: HEXAPNEUMI NE
Danish: HEXAPNEUMIN E