natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
• 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.
• 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.
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.
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.
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.
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.
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.
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.
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).
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).
Disse midlertidige foranstaltninger gennemføres med forbehold for udfaldet af den igangværende gennemgangsprocedure i henhold til artikel 20 i forordning (EF) nr. 726/2004.
These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No
• 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
• 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.
• 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.
• 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.
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.
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.
Abasaglar gives én gang dagligt på samme klokkeslæt hver dag.
Abasaglar is given once a day at the same time each day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abasria den 09. september 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014.
Andre oplysninger om Abasaglar
Other information about Abasaglar
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Abasaglar.
This is a summary of the European public assessment report (EPAR) for Abasaglar.
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.
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.
Det betyder, at Abasaglar svarer til et biologisk lægemiddel (også kaldet »referencelægemidlet«), der allerede er godkendt i Den Europæiske Union (EU).
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).
Der er udarbejdet en risikostyringsplan for at sikre, at Abasaglar anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Abasaglar is used as safely as possible.
Det anvendes hos voksne og børn over to år til behandling af sukkersyge.
It is used in adults and children over the age of two for the treatment of diabetes.
Referencelægemidlet for Abasaglar er Lantus.
The reference medicine for Abasaglar is Lantus.
Hvad er Abasaglar, og hvad anvendes det til?
What is Abasaglar and what is it used for?
Abasaglar er et »biosimilært« lægemiddel.
Abasaglar is a ‘biosimilar medicine'.
Patienterne kan give sig selv indsprøjtningerne med Abasaglar efter at have fået passende oplæring.
Patients can inject themselves with Abasaglar if they have been trained appropriately.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Abasaglar.
The Committee recommended that Abasaglar be given marketing authorisation.
Navnet blev ændret til Abasaglar den 3. december 2014.
The name of the medicine was changed to Abasaglar on 3 December
Reaktioner på injektionsstedet (rødme, smerte, kløe og hævelse) og hudreaktioner (udslæt) er oftere set hos børn end hos voksne.
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.
Der skal skiftes injektionssted for hver injektion for at undgå hudforandringer (såsom fortykkelse), der kan få insulinet til at virke dårligere end forventet.
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abasaglar?
What measures are being taken to ensure the safe and effective use of Abasaglar?
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.
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.
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.
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.
Insulin glargin er en smule forskelligt fra humant insulin.
Insulin glargine is slightly different from human insulin.
Dosis tilpasses den enkelte patient, og blodsukkeret skal regelmæssigt kontrolleres for at fastlægge den laveste effektive dosis.
The dose is adjusted individually, and the patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Når blodsukkeret reguleres, mindskes symptomerne og komplikationerne ved sukkersygen.
By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Den hyppigste bivirkning ved Abasaglar (som kan forekomme hos over 1 ud af 10 patienter) er for lavt blodsukker (hypoglykæmi).
The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Hvorfor er Abasaglar blevet godkendt?
Why is Abasaglar approved?
Det er ikke en praktisk vejledning i, hvordan Abasaglar bør anvendes.
It is not intended to provide practical advice on how to use Abasaglar.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abasaglar, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
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.
Hvilke risici er der forbundet med Abasaglar?
What are the risks associated with Abasaglar?
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Lantus.
Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk.
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.
For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Abasaglar er et lægemiddel, der indeholder det aktive stof insulin glargin.
Abasaglar is a medicine that contains the active substance insulin glargine.
Abasaglar kan også gives sammen med sukkersygemedicin, der tages gennem munden af patienter med type 2-sukkersyge.
Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes.
Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Abasaglar fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Abasaglar, see the package leaflet.
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.
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.
Denne forskel gør, at Abasaglar optages langsommere og jævnere af kroppen efter en indsprøjtning og virker i lang tid.
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.
Erstatningsinsulinet virker på samme måde som naturligt produceret insulin og bevirker, at sukkeret fra blodet føres ind i cellerne.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
• I den ene undersøgelse blev Abasaglar sammenlignet med Lantus som tillægsbehandling til korttidsvirkende insulin hos 536 patienter med type 1-sukkersyge.
• In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes.
Der er udført undersøgelser for at påvise, at Abasaglars optagelse i kroppen og virkning på blodsukkeret svarer til Lantus.
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.
Abasaglar er en insulinerstatning, der stærkt ligner det insulin, der produceres af kroppen.
Abasaglar is a replacement insulin that is very similar to the insulin made by the body.
Abasaglar leveres som cylinderampuller og fyldte penne til engangsbrug (KwikPen) og udleveres kun efter recept.
Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained with a prescription.
Hvis du ønsker praktisk vejledning om anvendelsen af Abasaglar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist.
Det indgives ved injektion under huden (subkutant) i maveskindet, låret eller deltaområdet (overarmen).
It is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (upper arm).
Hvordan anvendes Abasaglar?
How is Abasaglar used?
Ved sukkersyge producerer kroppen ikke tilstrækkeligt med insulin til at regulere blodsukkeret.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Abasaglar insulin glargin
insulin glargine
I begge undersøgelser blev lægemidlets virkning hovedsagelig bedømt ved at måle blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c).
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.
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).
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%.
Hvilke fordele viser undersøgelserne, at der er ved Abasaglar?
What benefits of Abasaglar have been shown in studies?
• I den anden undersøgelse deltog 759 patienter med type 2-sukkersyge.
• 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.
Det aktive stof i Abasaglar, insulin glargin, fremstilles ved »rekombinant DNA-teknologi«.
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.
Hvordan virker Abasaglar?
How does Abasaglar work?
BILAG I LISTE OVER NAVNE, LÆGEMIDDELFORMER, STYRKER PÅ LÆGEMIDLERNE, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
30, 500 28802 Alcalá de Henares (Madrid)
30,500 28802 Alcalá de Henares (Madrid) Spain
RECTAGMIGDO L INFANTIL
RECTAGMIGD OL INFANTIL
Bismuth camphocarbonate
Bismuth camphocarbonat e
Cineol + kamfer + Gomenol (Niaouli oil)
Cineole + Camphor + Gomenol (Niaouli oil)
kamfer + Eucalyptol + Menthol
Camphor + Eucalyptol + Menthol
BI-QUI-NOL ENFANTS, suppositoire kamfer racémique, cineol
BI-QUI-NOL ENFANTS, suppositoire camphre racémique, cinéole
COQUELUSEDA L ENFANTS, suppositoire niaouli
COQUELUSED AL ENFANTS, suppositoire niaouli
Eucalyptol/ guaiacol
Lipobalsamo Eucalyptol/ guaiacol
EucalyptinePholcodine Enfants kamfer eucalyptol gaiacol phenol pholcodin
EucalyptinePholcodine Enfants camphre eucalyptol gaiacol phenol pholcodine
Eucalyptine Pholcodine Child kamfer inn:eucalyptol inn:guaiacol inn: pholcodin inn:phenol
Eucalyptine Pholcodine Child camphora inn:eucalyptol inn:guaiacol inn:pholcodine inn:phenol
Trophires Compose Nourrissons paracetamol Eucalypti aetheroleum tenoate de sodium
Trophires Compose Nourrissons paracetamol essence d'eucalyptus tenoate de sodium
Eucalyptine kamfer inn:eucalyptol inn:guaiacol
Eucalyptine camphora inn:eucalyptol inn:guaiacol
OZOTHINE ENFANTS 30 mg, suppositoire terpentinolie 0,03g
OZOTHINE ENFANTS 30 mg, suppositoire terebenthine (huile essentielle de)
Trophires Bebes Eucalypti aetheroleum tenuate de sodium
Trophires Bebes eucalyptus huile essentielle tenuate de sodium
Ozopulmin oxidationsprodukt af terpentin / Pini silvestris aetheroleum
Ozopulmin Oxidation product of turpentine/pine essential oil
Eucalypti aetheroleum thiophene carboxylate paracetamol
eucalyptus huile essentielle thiophene carboxylate paracetamo
Trophires Enfants Eucalypti aetheroleum thiophene carboxylate paracetamol
Trophires Enfants eucalyptus huile essentielle thiophene carboxylate paracetamo
BRONCHORECTI NE AU CITRAL ENFANTS, suppositoire terpinol, fyr, vild timian
BRONCHOREC TINE AU CITRAL ENFANTS, suppositoire terpinol, pin, serpolet
FEBRECTOL NOURRISSONS, suppositoire fyr
FEBRECTOL NOURRISSON S, suppositoire pin
Meda Pharma - Produtos farmacêuticos, S.A.
LABORATORIOS VIÑAS, S.A.
LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona, Spain
Provenza, 386
BRONCHORECTI NE AU CITRAL NOURRISSONS, suppositoire terpinol, fyr, vild timian
BRONCHOREC TINE AU CITRAL NOURRISSON S, suppositoire terpinol, pin, serpolet
Luxemborg Sanofi-Aventis Belgium 1C, Culliganlaan
Luxembourg Sanofi-Aventis Belgium
FEBRECTOL ENFANTS, suppositoire fyr
FEBRECTOL ENFANTS, suppositoire pin
100 mg 80 mg 30 mg 5 mg 6 mg
80 mg 30 mg 5 mg 6 mg
TERPONE ENFANTS, suppositoire niaouli, Eucalypti aetheroleum, terpin, Pini silvestris aetheroleum
TERPONE ENFANTS, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie
TERPONE NOURRISSONS, suppositoire niaouli, Eucalypti aetheroleum, terpin, Pini silvestris aetheroleum
TERPONE NOURRISSON S, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie