FrancophonIA/ELRC3.0 huggingface dataset:
English: In advanced renal cell carcinoma, Cabometyx was shown to prolong the time previously treated patients lived without their disease getting worse.
Danish: Ved fremskredent nyrecellekarcinom er det påvist, at Cabometyx forlænger den tid, som tidligere behandlede patienterne lever uden sygdomsforværring.
English: What benefits of Cabometyx have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cabometyx?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabometyx have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cabometyx.
English: How is Cabometyx used?
Danish: Hvordan anvendes Cabometyx?
English: • advanced renal cell carcinoma (a kidney cancer).
Danish: • fremskredent nyrecellekarcinom (en form for nyrekræft).
English: Hepatocellular carcinoma
Danish: Levercellekarcinom
English: Patients treated with Cabometyx lived for an average of 8.6 months without their disease getting worse compared with 5.3 months in those treated with sunitinib.
Danish: De patienter, som fik Cabometyx, levede gennemsnitligt i 8,6 måneder uden sygdomsforværring sammenlignet med 5,3 måneder hos dem, der fik sunitinib.
English: How does Cabometyx work?
Danish: Hvordan virker Cabometyx?
English: Patients treated with Cabometyx lived for an average of 7.4 months without their disease getting worse compared with 3.8 months in patients treated with everolimus.
Danish: De patienter, som fik Cabometyx, levede gennemsnitligt i 7,4 måneder uden sygdomsforværring sammenlignet med 3,8 måneder hos dem, der fik everolimus.
English: The majority of studies in adults have been conducted in breast cancer patients.
Danish: Størstedelen af undersøgelserne af voksne er foretaget på brystkræftpatienter.
English: The CHMP also recommends conditions to the marketing authorisations, as set out in Annex IV.
Danish: CHMP anbefaler også betingelser for markedsføringstilladelserne som fastsat i bilag IV.
English: The CHMP considered that a direct healthcare professional communication should be sent in order to inform adequately on the changes recommended.
Danish: CHMP mente, at der skulle udsendes en direkte meddelelse til sundhedsmedarbejdere for at informere ordentligt om de anbefalede ændringer.
English: AML was also identified as an uncommonly reported adverse reaction.
Danish: AML blev også identificeret som en sjældent rapporteret bivirkning.
English: Overall summary of the scientific evaluation of dexrazoxane-containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende dexrazoxan (se bilag I)
English: Based on the limited data on efficacy in this patient population, and the observed safety concerns, the Committee recommended that the use in children and adolescents up to 18 years of age should be contraindicated.
Danish: På grundlag af de begrænsede data om virkning i denne patientpopulation og de observerede sikkerhedsproblemer anbefalede udvalget, at brugen hos børn og unge under 18 år skulle kontraindiceres.
English: Although a significant effect on troponin T levels was observed in an early report there was no evidence for clinical benefit in an updated analysis after a medium follow-up time of 5 years.
Danish: Selv om der blev observeret en væsentlig virkning på troponin T-niveauerne i en tidlig rapport, var der intet bevis for den kliniske fordel i en ajourført analyse efter en gennemsnitlig opfølgningstid på 5 år.
English: In addition, a signal of increased risk of solid tumours was noted.
Danish: Desuden blev der set tegn på forøget risiko for faste tumorer.
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dexrazoxane-containing medicinal products;
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende dexrazoxan;
English: An increased risk of myelosuppression and infection was also observed in paediatric patients.
Danish: En forøget risiko for myelosuppression og infektion blev også observeret hos børn.
English: • The Committee took into account all available data, including the responses from the MAHs and the conclusion of the SAG Oncology;
Danish: • Udvalget tog højde for alle tilgængelige data, herunder svar fra indehaverne af markedsføringstilladelsen og konklusionen fra den rådgivende gruppe vedrørende onkologi;
English: • The Committee also recommended that the ratio of dexrazoxane to doxorubicin should be reduced to take due account of the safety risks observed, including myelosuppression;
Danish: • Udvalget anbefalede også, at forholdet mellem dexrazoxan og doxorubicin reduceres for at tage hensyn til den observerede sikkerhedsrisiko, herunder myelosuppression;
English: This was also the view of the SAG Oncology and the CHMP therefore recommended that the ratio of dexrazoxane to doxorubicin should be reduced from 20:1 to 10:1.
Danish: Dette var også holdningen i den videnskabelige rådgivende gruppe vedrørende onkologi, og CHMP anbefalede derfor, at forholdet mellem dexrazoxan og doxorubicin skulle reduceres fra 20:1 til 10:1.
English: The dose ratio of dexrazoxane to epirubicin remained unchanged at 10:1.
Danish: Dosisforholdet mellem dexrazoxan og epirubicin forblev uændret 10:1.
English: As additional risk minimisation measures, the PSUR submission cycle will be shortened to an annual submission and the monitoring of the effectiveness of the risk minimisation measures will be conducted through a drug utilisation study.
Danish: Som en yderligere foranstaltning til at nedbringe risikoen vil PSUR-fremsendelsescyklussen blive afkortet til en årlig fremsendelse, og overvågningen af effektiviteten af risikominimeringsforanstaltningerne vil blive gennemført via en undersøgelse af lægemiddelanvendelsen.
English: • The Committee considered that use of dexrazoxane in children and adolescents up to 18 years of age is associated with second primary malignancies and should therefore be contraindicated;
Danish: • Udvalget fandt, at brugen af dexrazoxan hos børn og unge under 18 år er forbundet med nye primære maligniteter og derfor bør kontraindiceres;
English: Dexrazoxane is authorised in Europe through mutual recognition (MR), decentralised and national procedures for the prevention of anthracycline (doxorubicin or epirubicin)-induced cardiotoxicity.
Danish: Dexrazoxan er godkendt i Europa via gensidige, decentrale og nationale anerkendelsesprocedurer for forebyggelse af antracyklininduceret (doxorubicin eller epirubicin) kardiotoksicitet.
English: Dexrazoxane is indicated in combination with anthracycline chemotherapy, and the risk of myelosuppressive effects may be additive to those of chemotherapy, which increases the risk of developing serious infections.
Danish: Dexrazoxan er indiceret i kombination med antracyklinbaseret kemoterapi, og risikoen for myelosuppressive virkninger kan være additiv til virkningerne af kemoterapi, som øger risikoen for at udvikle alvorlige infektioner.
English: The CHMP further advised that dexrazoxane should not be used in combination with adjuvant breast cancer therapy or chemotherapy intended as curative.
Danish: CHMP's anbefaling gik endvidere ud på, at dexrazoxan ikke burde bruges i kombination med adjuverende brystkræftbehandling eller kemoterapi tænkt som helbredende behandling.
English: In addition to serious infections, other important potential safety risks include a higher incidence of death observed in some studies in groups treated with dexrazoxane plus chemotherapy compared to those treated with chemotherapy alone, and evidence of possible interference with anthracycline efficacy.
Danish: Ud over alvorlige infektioner omfatter andre store potentielle sikkerhedsrisici en højere dødelighed i nogle undersøgelser af grupper behandlet med dexrazoxan plus kemoterapi sammenlignet med dem, der behandles med kemoterapi alene, og forekomsten af en mulig interferens med antracyklins virkning.
English: Following the consultation of the Scientific Advisory Group (SAG) on oncology, the CHMP agreed that the therapeutic indication should be restricted to adult breast cancer patients who had received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.
Danish: Efter høringen af den videnskabelige rådgivende gruppe (SAG) vedrørende onkologi besluttede CHMP, at den terapeutiske indikation skulle begrænses til voksne brystkræftpatienter, som har modtaget en forudgående kumulativ dosis på 300 mg/m2 doxorubicin eller en forudgående kumulativ dosis på 540 mg/m2 epirubicin, når yderligere behandling med antracyklin er påkrævet.
English: • The Committee considered that the benefit-risk balance of dexrazoxane for the prevention of anthracycline (doxorubicin and epirubicin)-induced cardiotoxicity remains favourable in adult patients with advanced and/or metastatic breast cancer who have received a minimum prior cumulative dose of anthracyclines; therefore the CHMP recommended a restriction of the indication accordingly.
Danish: • Udvalget fandt, at risk/benefit-forholdet for dexrazoxan til forebyggelse af antracyklininduceret (doxorubicin og epirubicin) kardiotoksicitet forbliver gunstigt hos voksne patienter med fremskreden og/eller metastaserende brystkræft, som har modtaget en forudgående kumulativ minimumsdosis antracycliner; derfor anbefalede CHMP en begrænsning af indikationen i overensstemmelse hermed;
English: Dexrazoxane efficacy in the prevention of anthracycline cardiotoxicity is supported by available clinical trial data.
Danish: Dexrazoxans virkning med hensyn til forebyggelse af antracyklininduceret kardiotoksicitet støttes af tilgængelige kliniske undersøgelsesdata.
English: The fact that clinical trials of razoxane (a racemic mixture of S(+)dexrazoxane and R(-) levrazoxane) were suspended due to safety concerns related to AML added to the concerns.
Danish: Den omstændighed, at de kliniske undersøgelser med razoxan (en racemisk blanding af S(+) dexrazoxan og R(-) levrazoxan) blev suspenderet på grund af betænkeligheder med hensyn til sikkerheden i forbindelse med AML, gav anledning til yderligere bekymring.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMA
Danish: BILAG II VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL FREMLAGT AF EMA
English: Sub-analysis of these studies also showed a significant reduction of congestive heart failure (CHF) events and a reduction in the severity of CHF events.
Danish: En delanalyse af disse undersøgelser har også vist en signifikant reduktion i antallet af tilfælde af kongestiv hjerteinsufficiens og en reduktion i sværhedsgraden af tilfælde af kongestiv hjerteinsufficiens.
English: In addition, considering the observed risks, including myelosuppression and excess early mortality reported in placebo-controlled US studies employing a dexrazoxane:doxorubicin dose ratio of 20:1, the CHMP considered that a reduction in the dexrazoxane dose is expected to have a favourable effect on dose-related safety issues.
Danish: På baggrund af de observerede risici, herunder myelosuppression og forhøjet tidlig dødelighed rapporteret i placebokontrollerede amerikanske undersøgelser, hvor der anvendes et dexrazoxandoxorubicindosisforhold på 20:1, fandt CHMP desuden, at en reduktion i dexrazoxandosen forventes at have en gunstig virkning på de dosisrelaterede sikkerhedsproblemer.
English: A significantly increased risk of other toxicities compared to controls were also reported in the study in paediatric patients with Hodgkin's disease and included grade 4 neutropenia, grade 3/4 thrombocytopenia, grade 3/4 sepsis and grade 3/4 pulmonary toxicity.
Danish: En betydelig øget risiko for anden toksicitet sammenlignet med kontroller blev også indberettet i undersøgelsen af børn med Hodgkins sygdom og omfattede neutropeni i grad 4, trombocytopeni i grad 3/4, sepsis i grad 3/4 og pulmonar toksicitet i grad 3/4.
English: In addition there were concerns regarding the potential carcinogenic/leukaemogenic risk of dexrazoxane, which is a known cytotoxic agent with topoisomerase II inhibition activity.
Danish: Derudover gav den potentielle carcinogene/leukæmiske risiko, der er forbundet med dexrazoxan, som er et kendt cytotoksisk stof med topoisomerase II-hæmmende aktivitet, anledning til bekymring.
English: During the evaluation of a periodic safety update report (PSUR), concerns were raised regarding an increase risk of second malignancies neoplasms (SMN), in particular acute myelogenous leukaemia (AML)/myelodyspastic syndrome (MDS) and solid tumours in paediatric patients observed in studies reported in the literature.
Danish: Under evalueringen af en periodisk sikkerhedsopdatering (PSUR) blev der givet udtryk for en øget risiko for nye maligne neoplasmer, navnlig akut myeloid leukæmi (AML)/myelodysplastisk syndrom (MDS) og solide tumorer hos børn observeret i undersøgelser, der er rapporteret i litteraturen.
English: Grounds for amendment of the summary of product characteristics and package leaflet
Danish: Begrundelser for ændring af produktresumé og indlægsseddel
English: Regarding use of dexrazoxane in paediatric patients, available data on the efficacy of dexrazoxane was considered very limited by the CHMP, as only one adequately sized randomised study which used troponin T as a surrogate endpoint is available.
Danish: Med hensyn til brugen af dexrazoxan til børn anså CHMP de tilgængelige data om dexrazoxans virkning for at være meget begrænsede, da der kun foreligger en randomiseret undersøgelse af passende omfang, der brugte troponin T som et surrogat-effektmål.
English: The role of dexrazoxane in preventing epirubicin cardiotoxicity was also investigated in clinical studies which reported a reduction in the incidence of cardiac events (primarily a fall in LVEF) in patients treated with dexrazoxane and epirubicin compared with epirubicin alone.
Danish: Dexrazoxans rolle i forebyggelsen af epirubicininduceret kardiotoksicitet blev også undersøgt i kliniske undersøgelser, der indberettede en reduktion i forekomsten af kardiale hændelser (primært et fald i venstre ventrikel ejektionsfraktion) hos patienter, der behandles med dexrazoxan og epirubicin, sammenlignet med epirubicin alene.
English: In particular, three open randomised studies conducted in the EU and the US and two placebo controlled studies conducted in the US showed that dexrazoxane significantly reduced the incidence of cardiac events (primarily a fall in left ventricular ejection fraction - LVEF) in breast cancer patients treated with doxorubicin.
Danish: Navnlig tre åbne, randomiserede undersøgelser gennemført i EU og USA og to placebokontrollerede undersøgelser gennemført i USA viste, at dexrazoxan reducerede forekomsten af kardiale hændelser væsentligt (primært et fald i venstre ventrikel ejektionsfraktion - LVEF) hos brystkræftpatienter, der behandles med doxorubicin.
English: Two large randomised open studies in childhood Hodgkin's disease and acute lymphoblastic leukaemia (ALL) reported a three-fold increase in the incidence of second primary malignancies (particularly AML and MDS) in dexrazoxane treated patients compared with controls.
Danish: I to store randomiserede, åbne undersøgelser af Hodgkins sygdom hos børn og akut lymfoblastisk leukæmi (ALL) rapporteredes der om en tredobling af forekomsten af nye primære maligniteter (særligt AML og MDS) hos patienter behandlet med dexrazoxan sammenlignet med kontrolgrupperne.
English: • The Committee recommended conditions to the marketing authorisation, including a direct healthcare professional communication, the shortening of the PSUR submission cycle to an annual submission and the monitoring of the effectiveness of the risk minimisation measures by means of a drug utilisation study.
Danish: • Udvalget anbefalede betingelser for markedsføringstilladelsen, herunder en fremsendelse af en direkte meddelelse til sundhedsmedarbejdere, afkortning af PSUR-fremsendelsescyklussen til en årlig fremsendelse og overvågning af effektiviteten af risikominimeringsforanstaltningerne ved hjælp af en undersøgelse af lægemiddelanvendelsen anbefaler CHMP en ændring af vilkårene for markedsføringstilladelsen for lægemidler indeholdende dexrazoxan (jf. bilag I), for hvilke de relevante afsnit i produktresuméerne og indlægssedlen er anført i bilag III.
English: You should specifically tell your doctor if you take:
Danish: Det er særlig vigtigt, at du fortæller det til din læge, hvis du tager:
English: Adopted at the 13-16 May 2019 PRAC
Danish: Vedtaget på PRAC's møde 13.-16. maj 2019
English: What you need to know before you take [X] Other medicines and [X]
Danish: Det skal du vide, før du begynder at tage [X] Brug af anden medicin sammen med [X]
English: - anti-retroviral medicines (medicines to treat HIV infections).
Danish: - antiretrovirale lægemidler (hiv-medicin).
English: There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.
Danish: Der har været indberetninger om langvarig seksuel dysfunktion, hvor symptomerne er blevet ved på trods af seponering af SSRI/SNRI.
English: Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Seksuel dysfunktion
English: Rare: spots in front of eyes, glaucoma, double vision, light hurts eye, blood in the eye, unequal sized pupils, vision abnormal, tear problem
Danish: Sjælden: pletter for øjnene, grøn stær, dobbeltsyn, lysfølsomme øjne, blod i øjnene, forskellig størrelse pupiller, unormalt syn, tåreproblemer
English: 2 Desvenlafaxine; duloxetine; milnacipran; venlafaxine
Danish: 2 Desvenlafaxin, duloxetin, milnacipran, venlafaxin
English: 3 Citalopram; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline 4 Clomipramine and vortioxetine were part of the signal assessment but are not concerned by the recommendation to update the product information.
Danish: 3 Citalopram, escitalopram, fluoxetin, fluvoxamin, paroxetin, sertralin 4 Clomipramin og vortioxetin indgik i signalvurderingen, men er ikke omfattet af anbefalingen om at opdatere produktinformationen.
English: Not known: maculopathy
Danish: Ikke kendt: makulopati
English: Sertraline - Maculopathy (EPITT no 19341)
Danish: Sertralin - makulopati (EPITT nr. 19341)
English: Pantoprazole - Colitis microscopic (EPITT no 19342)
Danish: Pantoprazol - mikroskopisk colitis (EPITT nr. 19342)
English: Not known: partial loss of vision
Danish: Ikke kendt: delvist synstab
English: Interaction with other medicinal products and other forms of interaction A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Danish: Interaktion med andre lægemidler og andre former for interaktion En signifikant lavere eksponering for clopidogrels aktive metabolit og reduceret trombocythæmning er påvist hos hiv-smittede patienter i behandling med ritonavir- eller cobicistat-boostet antiretroviral terapi (ART).
English: Medicines like [Invented name] (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4).
Danish: Lægemidler som [Særnavn] (såkaldte SSRI/SNRI'er) kan give symptomer på seksuel dysfunktion (se pkt.
English: Clopidogrel; clopidogrel, acetylsalicylic acid - Interaction with boosted antiviral human immunodeficiency virus (HIV) therapy leading to insufficient inhibition of platelet aggregation (EPITT no 19325)
Danish: Clopidogrel; clopidogrel, acetylsalicylsyre - interaktion med antiviral booster-terapi mod humant immundefektvirus (hiv), der medfører utilstrækkelig hæmning af trombocytaggregationen (EPITT nr. 19325)
English: Inflammation in the large bowel, that causes persistent watery diarrhoea
Danish: Tyktarmsbetændelse, der giver vedvarende, vandig diarré
English: Serotonin and noradrenaline reuptake inhibitors (SNRI)2; selective serotonin reuptake inhibitors (SSRI)3 4 - Persistent sexual dysfunction after drug withdrawal (EPITT no 19277)
Danish: Serotonin- og noradrenalingenoptagelseshæmmere (SNRI)2; selektive serotoningenoptagelseshæmmere (SSRI)3 4 - vedvarende seksuel dysfunktion efter seponering (EPITT nr. 19277)
English: Undesirable effects Tabulated list of adverse reactions Gastrointestinal disorders Frequency not known: Microscopic colitis
Danish: Hyppighed ikke kendt: Mikroskopisk colitis
English: BACKGROUND:
Danish: BAGGRUND:
English: PRESENT DECISION:
Danish: DENNE BESLUTNING:
English: The Standing Committee for Medicinal Products for Human Use discussed the matter on 20 January 2008.
Danish: Det Stående Udvalg for Humanmedicinske Lægemidler drøftede sagen den 20. januar 2008.
English: • This disagreement was also observed in the Standing Committee meeting of 20 January 2008.
Danish: • Denne uenighed gjorde sig fortsat gældende på Det Stående Udvalgs møde den 20. januar 2008.
English: It follows from the above:
Danish: På grundlag af ovenstående kan følgende konstateres:
English: ANNEX V DETAILED EXPLANATION OF THE REASONS FOR THE ADDITIONAL CONDITIONS AND RESTRICTIONS TO THE CHMP OPINION
Danish: BILAG V DETALJERET REDEGØRELSE FOR ÅRSAGERNE TIL DE SUPPLERENDE BETINGELSER OG BEGRÆNSNINGER TIL UDTALELSEN FRA CHMP
English: The European Commission considers it appropriate to maintain the marketing authorisation for medicinal products containing nimesulide.
Danish: Europa-Kommissionen finder det hensigtsmæssigt at opretholde markedsføringstilladelserne for lægemidler, der indeholder nimesulide.
English: The majority view within the CHMP sustained such maintenance when the committee adopted its opinion of 20 September 2007 and it appears adequate to follow this majority view.
Danish: Flertallet i CHMP gik ind for en sådan opretholdelse, da udvalget vedtog sin udtalelse af 20. september 2007, og det synes hensigtsmæssigt at følge dette flertal.
English: Moreover, the relevance of new information was discussed in the meeting.
Danish: Det blev ligeledes drøftet, hvorvidt det var nødvendigt med nye oplysninger.
English: The relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of nimesulide and of the Conditions of the Marketing Authorisation are amended as set out in Annexes III and IV of this Decision.
Danish: De relevante afsnit i produktresuméet og indlægssedlen om systemiske formuleringer af nimesulide og i betingelserne for markedsføringstilladelsen ændres i overensstemmelse med bilag III og IV til denne beslutning.
English: The CHMP could not reach a majority for the adoption of the opinion with the same recommendations.
Danish: Der var i CHMP ikke flertal for at vedtage udtalelsen med de samme anbefalinger.
English: In the course of the meeting, it became clear that there would be neither a qualified majority in support of a draft Commission decision following the opinion of the CHMP nor a qualified majority against it.
Danish: Det fremgik klart på dette møde, at der hverken var et kvalificeret flertal til støtte for et udkast til Kommissionens beslutning på grundlag af udtalelsen fra CHMP eller et kvalificeret flertal mod dette.
English: The use of nimesulide in second line treatment is already recommended in some Member States via prescription guidelines.
Danish: Anvendelsen af nimesulide som andenlinjebehandling anbefales allerede i visse medlemsstater i deres receptvejledninger.
English: These relate in particular to restrictions to the indications (with a limitation to second line treatment) and to conditions of use and prescription practices.
Danish: Det drejer sig for det meste om en begrænsning af indikationerne (med en begrænsning til andenlinjebehandling), om anvendelsesbetingelserne og om praksis for ordinering.