FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean fraction of an oral dose of netupitant excreted unchanged in urine is less than 1%; a total of 3.95% and 70.7% of the radioactive dose was recovered in the urine and faeces, respectively.
Danish: I alt hhv. 3,95 % og 70,7 % af den radioaktive dosis blev genfundet i urin og fæces.
English: Netupitant is mainly metabolized by CYP3A4; therefore, co-administration with medicinal products that inhibit or induce CYP3A4 activity may influence plasma concentrations of netupitant.
Danish: Derfor kan administration sammen med lægemidler, der hæmmer eller inducerer CYP3A4-aktiviteten, påvirke plasmakoncentrationen af netupitant.
English: • high levels of creatinine - which measures kidney function (shown in blood tests)
Danish: • højt niveau af kreatinin - som måler nyrefunktionen (kan ses i blodprøver).
English: Eructation
Danish: Opkastnng
English: Capsule shell Gelatin
Danish: Kapselskal Gelatine Glycerol Sorbitol
English: • constipation
Danish: • døsighed
English: Electrocardiogram ST-T segment abnormal Myoglobin blood increased Neutrophil count increased Troponin increased
Danish: Forhøjet neutrofilantal Forhøjet niveau af troponin
English: What Akynzeo is and what it is used for What you need to know before you take Akynzeo How to take Akynzeo
Danish: Det skal du vide, før du begynder at tage Akynzeo Sådan skal du tage Akynzeo Bivirkninger
English: Constipation
Danish: Varmefølelse
English: • high levels of blood urea - which indicates kidney dysfunction (shown in blood tests)
Danish: • højt niveau af urinstof i blodet - hvilket indikerer nedsat nyrefunktion (kan ses i blodprøver)
English: Contains sucrose and sorbitol.See package leaflet for further information.
Danish: Indeholder saccharose og sorbitol.
English: Musculoskeletal and connective tissue disorders
Danish: Abdominalsmerter Dysfagi Diarré
English: Treatment regimen
Danish: LISTE OVER HJÆLPESTOFFER
English: General disorders and administration site conditions
Danish: Systemorganklasse Almindelig Ikke almindelig Sjælden Almene symptomer og reaktioner på administrationsstedet
English: Conjunctivitis Vision blurred
Danish: Konjunktivitis Sløret syn
English: Blood creatinine
Danish: Forhøjet niveau af kreatinin i blodet
English: If you take more Akynzeo than you should
Danish: Hvis du har taget for meget Akynzeo
English: Haemorrhoids
Danish: Hæmorider
English: • heart valve disorder (mitral valve incompetence)
Danish: • hjerteklapsygdom (utæt mitralklap)
English: • severe allergic reaction signs include hives, skin rash, itching, difficulty breathing or swallowing,
Danish: • alvorlig allergisk reaktion - tegnene omfatter nældefeber, hududslæt, kløe, vejrtræknings- eller synkebesvær, hævelse i mund, ansigt, læber, tunge eller hals og til tider et blodtryksfald.
English: Blood urea increased
Danish: Forhøjet niveau af urinstof i blodet
English: Printing ink
Danish: Belægning på tungen
English: Monitoring should continue for at least 24 months.
Danish: Overvågningen bør fortsætte i mindst 24 måneder.
English: In addition, the combination used in this study is now contraindicated.
Danish: Desuden er den kombination, der blev anvendt i studiet, nu kontraindiceret.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Danish: Årsagerne til en mulig tidligere død, som sås i studiet, er endnu ikke helt klarlagt.
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: Gennemgangen af Xofigo blev indledt den 1. december 2017 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: The company that markets Xofigo will have to conduct studies to further characterise these events and clarify the mechanisms behind them.
Danish: Den virksomhed, der markedsfører Xofigo, skal gennemføre studier for at beskrive disse hændelser nærmere og klarlægge mekanismerne bag dem.
English: Therefore such preventive measures should be considered before starting or resuming treatment with Xofigo.
Danish: Derfor bør sådanne forebyggende foranstaltninger træffes før påbegyndelse eller genoptagelse af behandling med Xofigo.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Danish: Efterfølgende systemisk kræftbehandling bør ikke påbegyndes inden for mindst 30 dage efter sidste indgift af Xofigo.
English: The final PRAC recommendations were adopted on 12 July 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: De endelige anbefalinger fra PRAC blev vedtaget den 12. juli 2018 og derefter fremsendt til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
English: Depending on the results of these tests, Xofigo may be interrupted or stopped, and you may be given an alternative treatment.
Danish: Alt efter resultaterne af disse test kan behandlingen med Xofigo blive afbrudt eller bragt til ophør, og det kan være, at du skal have en anden behandling.
English: • The use of Xofigo is associated with an increased risk of fractures.
Danish: • Anvendelse af Xofigo er forbundet med øget risiko for frakturer.
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: • Hvis du oplever nye eller usædvanlige knoglesmerter eller hævelser før, under eller efter behandlingen med Xofigo, skal du kontakte lægen.
English: More information on Xofigo is available on the EMA website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
Danish: ema.europa.eu/Find medicine/Human medicines/European public assessment reports
English: The study included patients with no or only mild symptoms, whereas Xofigo is only authorised in patients with symptoms.
Danish: Studiet omfattede patienter med ingen eller kun lette symptomer, mens Xofigo kun er godkendt til patienter med symptomer.
English: It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Danish: Det er godkendt til brug, når medicinsk eller kirurgisk kastration (standsning af produktionen af mandlige kønshormoner i kroppen enten med lægemidler eller ved operation) ikke virker, og når kræften har spredt sig til knoglerne og giver symptomer såsom smerter, men ikke har spredt sig til andre indre organer.
English: In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination.
Danish: Derudover sås frakturer hos 29 % af de patienter, der fik kombinationen med Xofigo, sammenholdt med 11 % af de patienter, der fik kombinationen med placebo.
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: Det sås i studiet, at patienter, der fik kombinationen med Xofigo, i gennemsnit døde 2,6 måneder tidligere end dem, der fik kombinationen med placebo.
English: It is thought that Xofigo, which is taken up by the bone, accumulates at sites where the bone is already damaged, for example by osteoporosis or micro-fractures, increasing the risk of fracture.
Danish: Det menes, at Xofigo, der optages af knoglerne, ophobes på steder, hvor knoglerne allerede er beskadiget, f.eks. på grund af knogleskørhed eller mikrofrakturer, hvorved risikoen for frakturer øges.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018 EMA/500948/2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28.
English: Medicine to be used only after two previous treatments or when other treatments cannot be taken
Danish: Lægemidlet må kun anvendes, hvis patienten allerede har fået to tidligere behandlinger, eller hvis patienten ikke kan behandles med andre lægemidler
English: EMA restricts use of prostate cancer medicine Xofigo
Danish: EMA begrænser brugen af lægemidlet Xofigo mod prostatakræft
English: • In patients with a high baseline risk of fracture, carefully consider the benefit of treatment against the risks.
Danish: • Hos patienter med høj risiko for frakturer ved baseline skal fordelen ved behandling i forhold til risikoen nøje overvejes.
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: • Hos patienter, der kun har lette symptomer, bør fordelen ved behandlingen vurderes nøje i forhold til risikoen, idet der skal tages hensyn til, at høj osteoblastisk aktivitet sandsynligvis er en forudsætning for, at patienten har gavn af behandlingen (se nedenfor for mere information).
English: • If you have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis du har spørgsmål eller betænkeligheder vedrørende behandlingen.
English: • Concurrent use of bisphosphonates or denosumab has been found to reduce the incidence of fractures in patients treated with Xofigo.
Danish: • Det er påvist, at samtidig anvendelse af bisfosfonater eller denosumab reducerer forekomsten af frakturer hos patienter, der behandles med Xofigo.
English: The Agency's 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: Ovenstående anbefalinger er baseret på en vurdering af data fra et randomiseret, dobbeltblindet, placebo-kontrolleret fase III-studie (ERA-223), hvor der sås øget forekomst af frakturer (28,6 % vs. 11,4 %), en mulig reduktion i median samlet overlevelse (30,7 måneder vs. 33,3 måneder, HR 1,195, 95 %-konfidensinterval (KI) 0,950-1,505, p = 0,13) og en øget risiko for radiologisk progression andre steder end i knoglerne (HR 1,376 [95 %-KI 0,972-1,948], p = 0,07) hos patienter, der fik Xofigo i kombination med abirateronacetat plus prednison/prednisolon (n = 401), sammenholdt med patienter, der fik placebo i kombination med abirateronacetat plus prednison/prednisolon (n = 405).
English: In addition, Xofigo should not be started in the first 5 days following the last dose of abiraterone and prednisone/prednisolone.
Danish: Derudover bør behandling med Xofigo ikke påbegyndes inden for de første 5 dage efter sidste dosis abirateron og prednison/prednisolon.
English: • Before starting and during treatment with Xofigo, your doctor may also give you a medicine to protect your bones from fractures.
Danish: • Før og under behandlingen med Xofigo kan lægen også give dig et lægemiddel, der beskytter dine knogler mod brud.
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: En øget risiko for frakturer sås navnlig hos patienter med osteoporose i anamnesen og patienter med mindre end 6 knoglemetastaser.
English: • Xofigo is not recommended in patients with a low level of osteoblastic bone metastases and in patients with only asymptomatic bone metastases.
Danish: • Xofigo anbefales ikke hos patienter, der kun har få osteoblastiske knoglemetastaser, og hos patienter, der kun har asymptomatiske knoglemetastaser.
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Danish: Xofigo anbefales heller ikke i kombination med systemiske kræftlægemidler, bortset fra GnRH-analoger.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Danish: CHMP's udtalelse blev fremsendt til EuropaKommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EUmedlemsstater den 28. september 2018.
English: Also, having Xofigo together with the cancer medicine Zytiga and a corticosteroid medicine (prednisone or prednisolone) for prostate cancer could possibly increase the risk of death.
Danish: Desuden kan anvendelse af Xofigo sammen med kræftlægemidlet Zytiga og et kortikosteroid (prednison eller prednisolon) til behandling af prostatakræft muligvis øge risikoen for dødsfald.
English: Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy).
Danish: Xofigo bør ikke anvendes sammen med andre systemiske kræftlægemidler (må dog gerne anvendes sammen med lægemidler til vedligeholdelse af et reduceret niveau af mandlige kønshormoner (hormonterapi)).
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: En mulig øget risiko for dødsfald sås også i et klinisk studie, der undersøgte Xofigo i kombination med abirateronacetat og prednison/prednisolon hos patienter med asymptomatisk eller let symptomatisk kastrationsresistent prostatakræft.
English: The European Medicines Agency has concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and has 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: Den 26. juli 2018 afsluttede Det Europæiske Lægemiddelagentur sin gennemgang af kræftlægemidlet Xofigo (radium-223 dichlorid) og anbefalede, at anvendelsen heraf begrænses til patienter, der allerede har fået to tidligere behandlinger for metastatisk prostatakræft (prostatakræft, der har spredt sig til knoglerne), eller som ikke kan behandles med andre lægemidler.
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: Gennemgangen af Xofigo er udført af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), efter at data fra et klinisk studie viste, at patienter, der fik Xofigo i kombination med Zytiga og prednison/prednisolon, kunne risikere at dø før tid og fik flere frakturer end patienter, der fik placebo (ikke-aktivt stof) sammen med Zytiga og prednison/prednisolon.
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Danish: • Xofigo er kontraindiceret i kombination med abirateronacetat og prednison/prednisolon.
English: • Before, during, and after treatment with Xofigo your doctor will carry out tests to check the health status of your bones.
Danish: • Før, under og efter behandling med Xofigo vil lægen ved hjælp af nogle test undersøge dine knoglers helbredstilstand.
English: • Your doctor will not use the combination of Xofigo and the other two medicines for prostate cancer.
Danish: • Lægen vil ikke anvende Xofigo i kombination med disse to lægemidler ved behandling af prostatakræft.
English: Xofigo must also not be used with the medicines Zytiga (abiraterone acetate) and the corticosteroid prednisone or prednisolone.
Danish: Xofigo må heller ikke anvendes sammen med lægemidlet Zytiga (abirateronacetat) eller kortikosteroiderne prednison og prednisolon.
English: PRAC recommended contraindicating the use of Xofigo with Zytiga and prednisone/prednisolone, as an interim measure, while the review was ongoing.
Danish: I marts 2018 anbefalede PRAC, at anvendelse af Xofigo sammen med Zytiga og prednison/prednisolon, som en midlertidig foranstaltning, skulle kontraindiceres, mens gennemgangen blev foretaget.
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: • Før og under behandling med Xofigo skal der foretages en vurdering af patienternes knoglestatus (f.eks. ved scintigrafi, måling af knogleminiraltæthed) og risiko for frakturer (f.eks. osteoporose, mindre end 6 knoglemetastaser, medicin, der øger risikoen for frakturer, lavt BMI).
English: • Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
Danish: • Xofigo bør kun anvendes som monoterapi eller i kombination med en GnRH-analog til behandling af voksne patienter, der har metastatisk kastrationsresistent prostatakræft (mCRPC) med symptomatiske knoglemetastaser og ingen kendte viscerale metastaser, hvor der ses sygdomsprogression efter mindst to tidligere linjer systemisk behandling af mCRPC (gælder ikke GnRH-analoger), eller som ikke er egnede til andre tilgængelige systemiske mCRPC-behandlinger.
English: • The prostate cancer medicine Xofigo can increase the risk of having fractures.
Danish: • Lægemidlet Xofigo mod prostatakræft kan øge risikoen for at få knoglebrud.
English: In March 2018, the
Danish: september 2018 EMA/680161/2018
English: In addition Xofigo, used on its own or with medicines called ‘luteinising hormone releasing hormone (LHRH) analogues', will be reserved for patients who have had at least two previous treatments for prostate cancer that has spread to the bone, or who cannot receive other treatments.
Danish: Derudover vil Xofigo anvendt alene eller sammen med såkaldte GnRH-analoger (gonadotropinfrigørende hormon-analoger) være forbeholdt patienter, som har fået mindst to tidligere behandlinger mod prostatakræft, der har spredt sig til knoglerne, eller som ikke kan få andre behandlinger.
English: Xofigo is currently used to treat adult men with cancer of the prostate (a gland of the male reproductive system).
Danish: Xofigo anvendes aktuelt til behandling af voksne mænd med prostatakræft (kræft i blærehalskirtlen).
English: In another randomised, double blind, placebo controlled phase III trial (ALSYMPCA), a statistically significant overall survival benefit of treatment with Xofigo could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.5531.466], p=0.674) or a baseline total alkaline phosphatase (ALP) <220 U/L (HR 0.823 95% CI 0.6331.068, p=0.142), indicating that efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Danish: placebo 0,901; 95 %-KI [0,553-1,466], p = 0,674) eller total alkalisk fosfatase (ALP) ved baseline < 220 E/l (HR 0,823 [95 %-KI 0,633-1,068], p = 0,142), hvilket peger på, at effekten kan være nedsat hos patienter med lav osteoblastisk aktivitet fra deres knoglemetastaser.
English: The PRAC's recommendations have now been endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision.
Danish: PRAC's anbefalinger blev støttet af EMA's udvalg for lægemidler til mennesker (CHMP).
English: • Xofigo is authorised for use only when the spreading cancer is causing symptoms; depending on how the cancer has spread to the bone, your doctor will decide whether Xofigo is the right treatment for you.
Danish: Alt efter, hvordan kræften har spredt sig til knoglerne, vil lægen vurdere, om Xofigo vil være den rigtige behandling for dig.
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: Xofigo bør heller ikke anvendes hos patienter, der ikke har nogen symptomer, i overensstemmelse med den nuværende indikation.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Danish: EuropaKommissionen vedtog en endelig juridisk bindende beslutning med gyldighed i hele EU den 28. september 2018.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in children aged 0 to less than 6 months for the treatment of chronic heart failure.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Procoralan til børn i alderen 0 til under 6 måneder til behandling af kronisk hjerteinsufficiens.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in all subsets of the paediatric population for the treatment of angina pectoris.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Procoralan i alle undergrupper af den pædiatriske population med angina pectoris.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25/10/2005
Danish: Dato for første markedsføringstilladelse: 25. oktober 2005 Dato for seneste fornyelse: 31. august 2010
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Procoralan.
Danish: Tal med lægen, hvis De ammer eller ønsker at amme, da amning skal ophøre, hvis De tager Procoralan.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om Procoralan findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Procoralan 5 mg film-coated tablets EU/1/05/316/001-007
Danish: Procoralan 5 mg filmovertrukne tabletter EU/1/05/316/001-007
English: Procoralan 7.5 mg film-coated tablets EU/1/05/316/008-014
Danish: Procoralan 7,5 mg filmovertrukne tabletter EU/1/05/316/008-014
English: Servier Austria GmbH Tel: +43 (1) 524 39 99
Danish: Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99