FrancophonIA/ELRC3.0 huggingface dataset:
English: That information was already present in the majority member states, and was in general acceptable.
Danish: Oplysningerne fandtes allerede i størstedelen af medlemsstaterne og kunne i det store hele godkendes.
English: The use of Flolan in children and elderly is not harmonised.
Danish: Anvendelse af Flolan til børn og ældre er ikke harmoniseret.
English: Flolan is authorised in the following member states: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, The Netherlands, Spain and United Kingdom and in Norway.
Danish: Flolan er godkendt i følgende medlemsstater: Østrig, Belgien, Tjekkiet, Danmark, Estland, Frankrig, Irland, Italien, Luxembourg, Malta, Nederlandene, Spanien og Det Forenede Kongerige samt Norge.
English: The effect of the overdose on the blood pressure was added in this section.
Danish: Virkningen af overdosering på blodtrykket blev tilføjet i dette afsnit.
English: The labelling has been updated according to the latest QRD v8 template.
Danish: Mærkningen er blevet opdateret i henhold til den seneste QRD v8-template.
English: Quality - Module 3
Danish: Kvalitet - Modul 3
English: In addition minor typographic errors were corrected.
Danish: Desuden blev der rettet mindre trykfejl.
English: A harmonised Module 3 was also adopted.
Danish: Der vedtoges ligeledes et harmoniseret Modul 3.
English: In some cases these differences are due to the differences in indications.
Danish: I nogle tilfælde består divergenserne i forskelle i indikationer.
English: The primary efficacy endpoint for the study was improvement in the 6MWT.
Danish: Det primære effektrelaterede endepunkt i forsøget var forbedring i 6MWT.
English: The proposal for changes in section 4.8 was mainly based on the Core Safety Profile (CSP) which has been agreed in 2009 during the PSUR Worksharing Procedure (IE/H/PSUR/0018/001).
Danish: Forslaget om ændringer i afsnit 4.8 var hovedsagelig baseret på de centrale sikkerhedsoplysninger (CSP), der blev godkendt i 2009 under arbejdsdelingsproceduren vedrørende PSUR (IE/H/PSUR/0018/001).
English: Section 4.4 - Special warnings and precaution for use There are differences in the special warnings and precautions for use included in Section 4.4, and in the detail given with respect to these warnings/precautions.
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Der er forskelle i de særlige advarsler og forsigtighedsregler i afsnit 4.4 og i, hvor detaljeret disse advarsler/forsigtighedsregler er angivet.
English: This section is one of the identified for harmonisation.
Danish: Dette afsnit er blandt dem, der bør harmoniseres.
English: Renal Dialysis
Danish: Renal dialyse
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned products (and its associated names), the European Commission notified on 15 June 2011 the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised SmPCs and thus to harmonise its divergent SmPCs labelling and package leaflet across the European Union.
Danish: På grund af medlemsstaternes divergerende nationale afgørelser ved godkendelsen af ovenstående produkt (og relaterede navne) indgav Europa-Kommissionen den 15. juni 2011 en officiel henvisning til CHMP/EMA's sekretariat i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktresuméer og derved harmonisere produktresuméer, etikettering og indlægssedler i EU.
English: It also agreed on the recommended schedule of infusion in adults.
Danish: Udvalget fastlagde desuden anbefalinger for en infusionsplan for voksne.
English: Also the CHMP agreed that given the absence of alternative medicines, epoprostenol can be used in those women who choose to continue their pregnancy, despite the known risk of pulmonary arterial hypertension during pregnancy.
Danish: CHMP fandt ligeledes, at epoprostenol på baggrund af manglende medikamentelle behandlingsalternativer kan anvendes hos kvinder, der vælger at fortsætte graviditeten trods den kendte risiko for pulmonal arteriel hypertension under graviditeten.
English: These haemodynamic improvements appeared to persist when epoprostenol was administered for at least 36 months in an open, nonrandomized study.
Danish: Disse hæmodynamiske forbedringer syntes at vedvare, mens epoprostenol blev administreret i mindst 36 måneder i en åben, ikke randomiseret undersøgelse.
English: Information on development, manufacture and control of powder and solvent for solution for infusion has been presented in a satisfactory manner.
Danish: Oplysninger om udvikling, fremstilling og kontrol af pulveret og solvenset til infusionsvæske, opløsning, er fremlagt tilfredsstillende.
English: Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Danish: De fleste af de dialyser med epoprostenol (67 %), hvor udskiftning af den kunstige nyre var nødvendig, blev efterfølgende suppleret med epoprostenol uden koagulation.
English: However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Danish: 9 ud af 27 dialyser med epoprostenol mislykkedes imidlertid trods gentagne forsøg.
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Danish: Resultaterne af de udførte test viser tilfredsstillende ensartethed af de vigtigste kvalitetsegenskaber ved produktet, og det konkluderes, at produkterne må forventes at have tilfredsstillende og ensartede egenskaber i klinikken.
English: Mean systemic arterial pressure was not significantly different between the two groups (-4.33 vs. -3.05 mm Hg).
Danish: Det systemiske arterielle middeltryk var ikke signifikant forskelligt i de to grupper (4,33 versus -3,05 mmHg).
English: Based on the above, the CHMP considers the benefit/risk ratio of Flolan and associated names to be favourable and the harmonised Product Information documents to be approvable.
Danish: På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Flolan og relaterede navne er positivt, og at den harmoniserede produktinformation kan godkendes.
English: Grounds for the variation to the terms of the marketing authorisations
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen
English: The CHMP agreed on the rearrangement of this section and the addition of the warning on patients with coronary artery disease.
Danish: CHMP vedtog omordning af dette afsnit og tilføjelse af advarslen om patienter med koronararteriesygdom.
English: Finally as there are no data on the effects of epoprostenol on fertility in humans this information was introduced in the SmPC together with the information on reproductive studies in animals which have shown no effects on fertility.
Danish: Da der endelig ikke foreligger data om virkningerne af epoprostenol på fertiliteten hos mennesker, blev dette angivet i produktresuméet sammen med oplysningen om, at reproduktionsundersøgelser i dyr ikke har vist indvirkning på fertiliteten.
English: Flolan has been included in the list of products for Summary of Product Characteristics (SmPC) harmonisation in accordance with Article 30(2) of Directive 2001/83/EC.
Danish: Flolan er optaget på listen over produkter, der kræver harmonisering af produktresuméet i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF.
English: • The committee considered the identified divergences for Flolan and associated names regarding the therapeutic indications, posology, the contraindications and warnings.
Danish: • udvalget behandlede de konstaterede divergenser vedrørende Flolan og relaterede navne hvad angår terapeutiske indikationer, dosering, kontraindikationer og advarsler,
English: The final Package Leaflet wording was adopted by the CHMP.
Danish: Ordlyden af den endelige indlægsseddel blev vedtaget af CHMP.
English: Increases in exercise capacity were accompanied by statistically significant improvements in dyspnoea, as measured by the Borg Dyspnoea Index.
Danish: Stigningen i fysisk kapacitet var ledsaget af statistisk signifikant forbedring af dyspnø, målt ved Borgdyspnøindeks.
English: There are differences in wording of the contraindications across Member States and detail given with respect to these contraindications.
Danish: Der er divergenser mellem medlemsstaterne i ordlyden af kontraindikationerne og i, hvor detaljeret kontraindikationerne er angivet.
English: In particular, the indications and their associated posology recommendations, the warnings and the information of fertility, pregnancy and lactation were harmonised.
Danish: Herunder blev indikationerne og de tilhørende doseringsanvisninger, advarsler og oplysninger om fertilitet, graviditet og amning harmoniseret.
English: Functional Class III-IV symptoms to improve exercise capacity (see section 5.1).
Danish: funktionsklasse III-IV (se afsnit 5.1).
English: Flolan must not be used chronically in patients who develop pulmonary oedema during dose-ranging.
Danish: Flolan må ikke anvendes kronisk til patienter, som får lungeødem under dosisfastsættelsen.
English: Except for five NYHA functional Class II patients, all patients were either functional Class III or Class IV.
Danish: Bortset fra 5 patienter med NYHA funktionsklasse II var alle patienter enten i funktionsklasse III eller IV.
English: In major controlled studies and emergency studies, major clotting occurred in approximately 9% (n=56) of all epoprostenol dialyses and in <1% (n=1) of heparin dialyses.
Danish: I de kontrollerede hovedundersøgelser og undersøgelserne ved akut anvendelse forekommer større koagulationsepisoder ved ca. 9 % (n=56) af alle dialyser med epoprostenol og ved <1 % (n=1) af dialyser med heparin.
English: The main divergences were the following SmPC sections:
Danish: Hoveddivergenserne vedrørte følgende afsnit i produktresuméet:
English: It is a potent inhibitor of platelet aggregation and also a potent vasodilator.
Danish: Det er en potent hæmmer af trombocytaggregation og er desuden en potent vasodilator.
English: Epoprostenol or heparin were used during each dialysis for one month in study 30 and for two months in study 31.
Danish: Ved hver dialyse blev der anvendt epoprostenol eller heparin i en måned i undersøgelse 30 og 2 måneder i undersøgelse 31.
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics and package leaflet are set out in Annex III for Flolan and associated names (see Annex I).
Danish: anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Flolan og relaterede navne (se bilag I).
English: Differences identified include, events occurring during infusion, ischemia in patients with severe angina.
Danish: Divergenserne vedrører hændelser under infusionen og iskæmi hos patienter med svær angina.
English: Epoprostenol sodium is also indicated for the treatment of pulmonary arterial hypertension (PAH).
Danish: Epoprostenolnatrium er desuden indiceret til behandling af pulmonal arteriel hypertension (PAH).
English: There was no clear consistent evidence that patients receiving either treatment improved more often or worsened less often.
Danish: Der var ikke samstemmende dokumentation for, at patienternes tilstand oftere bedredes eller mindre ofte forværredes med nogen af de to behandlinger.
English: Flolan contains epoprostenol sodium which is the monosodium salt of epoprostenol, a naturally occurring prostaglandin produced by the blood vessels.
Danish: Flolan indeholder epoprostenolnatrium, som er mononatriumsaltet af det naturlige prostaglandin epoprostenol, der produceres af blodkarrene.
English: Overall, these results indicate that renal dialysis with epoprostenol was consistently beneficial in patients at very high risk of hemorrhage.
Danish: Samlet viser resultaterne, at renal dialyse med epoprostenol konsekvent var til fordel for patienter med meget høj blødningsrisiko.
English: Patients at Very High Risk of Haemorrhage were assessed in major controlled studies; 12 patients at very high risk of haemorrhage received 35 epoprostenol dialyses and 11 patients received 28 heparin dialyses.
Danish: Patienter med meget høj blødningsrisiko blev vurderet i kontrollerede hovedundersøgelser; 12 patienter med meget høj blødningsrisiko fik 35 dialyser med epoprostenol, og 11 patienter fik 28 dialyser med heparin.
English: For renal dialysis the MAH presented an overview of 14 clinical studies investigating the use of epoprostenol in renal dialysis: three cross over studies, six major controlled studies and five emergency also known and as expanded access studies.
Danish: Vedrørende renal dialyse fremlagde indehaveren af markedsføringstilladelsen en gennemgang af 14 kliniske undersøgelser, hvor epoprostenol blev anvendt ved renal dialyse: tre overkrydsningsundersøgelser, seks kontrollerede hovedundersøgelser og fem undersøgelser ved akut anvendelse, der også blev betegnet som undersøgelser med udvidet adgang.
English: The MAH was asked to evaluate all other sections of the nationally approved SmPC and suggest appropriate changes in the text where divergences exist.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at vurdere alle øvrige afsnit i de nationalt godkendte produktresuméer og foreslå passende ændringer i teksten, hvor der er divergenser.
English: Following the discussion on the efficacy and safety data the CHMP agreed in the final indications for Flolan for pulmonary arterial hypertension and renal dialysis as per the wording below:
Danish: Efter drøftelsen af data vedrørende virkning og sikkerhed vedtog CHMP de endelige indikationer for Flolan til pulmonal arteriel hypertension og renal dialyse i henhold til følgende ordlyd:
English: There was no indication that efficiency was reduced with repeated use of epoprostenol or heparin as shown by the intradialytic removal of BUN, creatinine, potassium and changes in body weight.
Danish: Intet tydede på forringet effektivitet ved gentagen brug af epoprostenol eller heparin, vurderet ud fra den intradialytiske fjernelse af blodets indhold af urinkvælstof, kreatinin og kalium samt vægtændringer.
English: Two major prospectively controlled studies (19 and 27), and 5 emergency studies were conducted to investigate bleeding during dialysis.
Danish: Der blev udført to prospektive, kontrollerede hovedundersøgelser (19 og 27) og fem undersøgelser ved akut anvendelse til at belyse blødning under dialyse.
English: However, more patients in both treatment groups (28/51 [55%] with epoprostenol and 35/48 [73%] with conventional therapy alone) showed no change in functional class, and 2/51 (4%) with epoprostenol and 13/48 (27%) with conventional therapy alone worsened.
Danish: Hos størstedelen af patienterne i begge behandlingsgrupper (28/51 [55 %] på epoprostenol og 35/48 [73 %] på konventionel terapi alene) var der imidlertid ingen bedring i funktionsklasse, og hos 2/51 (4 %) på epoprostenol og 13/48 (27 %) på konventionel terapi var der en forværring.
English: Each patient was randomly assigned to a sequence of heparin or epoprostenol dialyses and received up to 6 dialyses per entry in study 19 and up to 3 dialyses per entry in study 27.
Danish: Hver patient blevet tilfældigt tilordnet til en sekvens af dialyser med enten heparin eller epoprostenol og fik op til seks dialyser pr. inklusion i undersøgelse 19 og op til 3 dialyser pr. inklusion i undersøgelse 27.
English: Patients were assigned to 1 of 4 bleeding risk groups prior to receiving their first study dialysis.
Danish: Patienterne blev tilordnet en af fire blødningsrisikogrupper, inden de fik den første dialyse i undersøgelsen.
English: The enhanced hypotensive effects of epoprostenol due to the acetate buffer used during renal dialysis was also emphasised in this section.
Danish: I dette afsnit fremhævedes ligeledes den forstærkede hypotensive virkning af epoprostenol som følge af den acetatbuffer, der anvendes ved renal dialyse.
English: When all dialyses were combined for each treatment (heparin or epoprostenol), more heparin patients bled during the day prior to dialysis (-24-0 hours), dialysis day (0-24 hours) and the day following dialysis (24-48 hours) than epoprostenol patients during the same time periods.
Danish: Når alle dialyser blev kombineret for hver behandling (heparin eller epoprostenol), var der blandt patienterne på heparin flere, der blødte i døgnet før dialysen (-24-0 timer), i dialysedøgnet (0-24 timer) og i døgnet efter dialysen (24-48 timer) end blandt de patienter, der blev behandlet med epoprostenol i samme perioder.
English: Epoprostenol sodium is indicated for use in renal dialysis when use of heparin carries a high risk of causing or exacerbating bleeding.
Danish: Epoprostenolnatrium er indiceret til anvendelse ved renal dialyse, hvor brug af heparin medfører høj risiko for blødning eller forværring af blødning.
English: The CHMP assessed the submitted data and recommended the re-arrangement of this section by separating the posology in the administration of epoprostenol for PAH during short-term (acute) dose ranging versus long-term continuous infusion.
Danish: CHMP vurderede de forelagte data og anbefalede, at dette afsnit blevet omordnet gennem udskillelse af kortvarig (akut) dosisfastlæggelse for epoprostenol ved PAH fra kontinuerlig kronisk infusion.
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holders.
Danish: • udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlen, der er foreslået af indehaveren af markedsføringstilladelsen,
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the Product Information.
Danish: • udvalget gennemgik de data, der er forelagt indehaverne af markedsføringstilladelsen fra eksisterende kliniske undersøgelser og data vedrørende lægemiddelovervågning og den publicerede litteratur, som begrunder den foreslåede harmonisering af produktinformationen,
English: For renal dialysis the CHMP recommended the addition to the PI that Flolan is suitable for continuous infusion only, either intravascularly or into the blood supplying the dialyser.
Danish: Hvad angår renal dialyse anbefalede CHMP, at det i produktinformationen angives, at Flolan udelukkende er egnet til kontinuerlig infusion, enten intravaskulært eller i blodtilførslen til dialyseapparatet.
English: Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Danish: 19 patienter fik 51 dialyser med heparin, og 19 fik 44 dialyser med epoprostenol i kontrollerede hovedundersøgelser.
English: At week 12, NYHA functional class improved in 21 of 51 (41%) patients treated with epoprostenol compared to none of the 48 patients treated with conventional therapy alone.
Danish: I uge 12 var NYHA funktionsklassen blevet bedre hos 21 af 51 (41 %) patienter, der blev behandlet med epoprostenol, hvorimod der ikke var bedring hos de 48 patienter, der blev behandlet med konventionel terapi alene.
English: Section 4.6 - Fertility, Pregnancy and lactation The CHMP agreed that there is limited amount of data from the use of epoprostenol in pregnant women (Schaefer 2007, Reprotox 2010).
Danish: CHMP fandt, at der er begrænsede data om anvendelse af epoprostenol til gravide kvinder (Schaefer 2007, Reprotox 2010).
English: Flolan is indicated for Pulmonary Arterial Hypertension (PAH) and Renal Dialysis.
Danish: Flolan er indiceret til pulmonal arteriel hypertension (PAH) og renal dialyse.
English: Patients at high risk of haemorrhage just prior to their first study dialysis, but who bled within 3 days prior were classified at high risk of haemorrhage.
Danish: Patienter, der havde høj blødningsrisiko lige inden deres første dialyse i undersøgelsen, og som havde blødt inden for de foregående 3 døgn, blev klassificeret som patienter med høj blødningsrisiko.
English: Two studies (30 and 31) addressed the possibility that patients' platelets may become refractory to repeated use of epoprostenol and thereby compromise dialysis efficiency with prolonged use.
Danish: I to undersøgelser (30 og 31) undersøgtes, om gentagen anvendelse af epoprostenol kan medføre, at trombocytterne bliver refraktære, hvilket på længere sigt vil forringe effektiviteten af dialysen.
English: Improvements were apparent in some patients at the end of the first week of therapy.
Danish: Forbedringerne kunne hos nogle patienter ses så tidligt som i første behandlingsuge.
English: Eight patients received 21 epoprostenol dialyses in emergency studies.
Danish: 8 patienter fik 21 dialyser med epoprostenol i undersøgelser ved akut anvendelse.
English: The CHMP was requested to assess the available data on the indications and confirm the wording proposed by the MAH.
Danish: CHMP blev anmodet om at vurdere de foreliggende data vedrørende indikationerne og bekræfte den ordlyd, der er foreslået af indehaveren af markedsføringstilladelsen.
English: The indications authorised in various Member States are: Pulmonary Arterial Hypertension and Renal dialysis.
Danish: I medlemsstaterne er følgende indikationer godkendt: Pulmonal arteriel hypertension og renal dialyse.
English: In emergency studies, 16 patients received 24 epoprostenol dialyses.
Danish: I undersøgelserne ved akut anvendelse fik 16 patienter 24 dialyser med epoprostenol.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients, supplemental oxygen and diuretics in two thirds of the patients, oral vasodilators in 40% of the patients, and digoxin in a third of the patients.
Danish: Den konventionelle terapi afveg mellem patienterne og omfattede alle eller nogle af følgende: antikoagulantia hos stort set alle patienter, iltsupplement og diuretika til to tredjedele af patienterne, orale vasodilatorer til 40 % af patienterne, samt digoxin til en tredjedel af patienterne.
English: Improvements were apparent as early as the first week of therapy.
Danish: Forbedringen kunne iagttages så tidligt som i første behandlingsuge.
English: The CHMP has agreed that taking into account the latest SmPC guidelines the long known information from the clinical studies justifying the indications needed to be added in this section.
Danish: På baggrund af de seneste retningslinjer for produktresuméer har CHMP vedtaget, at det er nødvendigt at tilføje de velkendte oplysninger fra de kliniske undersøgelser, der begrunder indikationerne.
English: The CHMP assessed the data from the available clinical studies, post-marketing data and published literature and agreed with the following contraindications:
Danish: CHMPet gennemgik data fra de foreliggende kliniske undersøgelser, data efter markedsføring og den publicerede litteratur, og vedtog følgende kontraindikationer:
English: Editorial changes and clarifications were requested by the CHMP in the table of ADRs.
Danish: CHMP anmodede om redaktionelle ændringer og præciseringer i tabellen over bivirkninger.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients; oral vasodilators, diuretics, and digoxin in one half to two thirds of patients; and supplemental oxygen in about half the patients.
Danish: Den konventionelle terapi afveg mellem patienterne og omfattede alle eller nogle af følgende: antikoagulantia hos stort set alle patienter; orale vasodilatorer, diuretika og digoxin hos halvdelen til to tredjedele af patienterne; iltsupplement til omkring halvdelen af patienterne.