FrancophonIA/ELRC3.0 huggingface dataset:
English: As assessed in the initial marketing authorisation of Esmya, the clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Danish: Ligesom ved vurderingen i den oprindelige markedsføringstilladelse for Esmya var den kliniske virkning af ulipristalacetat ved præoperativ behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder baseret på kortvarige undersøgelser, der viste det aktive stofs evne til at reducere fibromrelateret blødning, anæmi og fibromstørrelse gennem administration af 5 mg dagligt i op til tre måneder.
English: While uncertainties around causality remain, PRAC recognised the very serious outcome of the reported cases of liver injury.
Danish: Skønt der tilbagestår usikkerheder omkring årsagssammenhængen, hæftede PRAC sig ved det meget alvorlige udfald af de indberettede tilfælde af leverskade.
English: In addition, other cases of hepatic injury were also reported post marketing for Esmya.
Danish: Derudover er der indberettet andre tilfælde af leverskader med Esmya efter markedsføring.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Danish: Esmya (ulipristalacetat, 5 mg) er et centralt godkendt lægemiddel, der er indiceret til præoperativ behandling og intermitterende behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder.
English: The marketing authorisation of Esmya was extended to include the therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Danish: Markedsføringstilladelsen for Esmya blev udvidet til at omfatte den terapeutiske indikation intermitterende behandling af moderate til svære symptomer på uterusfibromer hos voksne kvinder i den reproduktive alder.
English: • The PRAC recommended that intermittent treatment of moderate to severe symptoms of uterine fibroids with Esmya should be restricted to adult women of reproductive age who are not eligible for surgery.
Danish: • PRAC henstillede, at intermitterende behandling med Esmya af moderate til svære symptomer på uterusfibromer begrænses til voksne kvinder i den reproduktive alder, som ikke er egnede til operation.
English: The PRAC considers that in vitro studies should be performed by the MAH, in order to better characterize the mechanistic profile of DILI as associated with Esmya.
Danish: PRAC finder, at indehaveren af markedsføringstilladelsen bør udføre in vitro-undersøgelser til bedre karakterisering af virkningsprofilen for lægemiddelinduceret leverskade forbundet med Esmya.
English: In line with the exclusion criteria in the clinical studies of Esmya, patients with ALT or AST> 2 x ULN (isolated or in combination with bilirubin >2 x ULN) should not initiate treatment.
Danish: AST> 2 x ULN (alene eller i kombination med bilirubin > 2 x ULN) bør behandlingen ikke initieres, hvilket er i overensstemmelse med eksklusionskriterierne i de kliniske undersøgelser med Esmya.
English: In addition, in order to analyse data on risk of liver injury related with Esmya and on effectiveness of risk minimisation measures, observational studies should be performed.
Danish: Derudover bør der udføres observationsundersøgelser med henblik på at analysere data om risikoen for leverskader med sammenhæng med Esmya og om effektiviteten af risikominimeringsforanstaltningerne.
English: In order to exclude patients that would be potentially more susceptible to hepatic insult from the treatment with Esmya, the product should be contraindicated in patients with underlying hepatic disorder.
Danish: Produktet bør være kontraindiceret hos patienter med underliggende leversygdom for at udelukke patienter med potentielt større følsomhed for leverpåvirkning af behandling med Esmya.
English: In order to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures, a patient card should be issued.
Danish: Der bør udleveres et patientkort for at sikre, at patienterne er tilstrækkeligt informeret om de mulige risici for leverskade og de implementerede risikominimeringsforanstaltninger.
English: This summary was last updated in 11-2016.
Danish: Dette sammendrag blev sidst ajourført 11-2016.
English: The results from three main studies are as follows:
Danish: Resultaterne af tre hovedundersøgelser er følgende:
English: Emtriva emtricitabine
Danish: Emtriva emtricitabin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emtriva on 24 October 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emtriva den 24. oktober 2003.
English: This difference was maintained after 48 weeks of treatment (73% and 56%).
Danish: Denne forskel holdt sig efter 48 ugers behandling (73 % og 56 %).
English: The full EPAR for Emtriva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Emtriva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Emtriva:
Danish: Andre oplysninger om Emtriva:
English: This is a summary of the European public assessment report (EPAR) for Emtriva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Emtriva.
English: The Committee recommended that it be given marketing authorisation.
Danish: Udvalget anbefalede og anbefalede udstedelse af en markedsføringstilladelse.
English: Skin discoloration was very common in children.
Danish: Misfarvning af huden forekom meget ofte hos børn.
English: The oral solution is for patients who weigh less than 33 kg, and those who cannot swallow the capsules.
Danish: Den orale opløsning er til patienter, som vejer mindre end 33 kg, og dem, der ikke kan sluge kapslerne.
English: It blocks the activity of reverse transcriptase, an enzyme made by the virus that allows it to reproduce itself in the cells it has infected.
Danish: Det blokerer aktiviteten af reverse transcriptase, et enzym, som virussen producerer, så det kan formere sig i de celler, det har inficeret.
English: The usual dose of Emtriva is one capsule once a day for patients who weigh 33 kg or more.
Danish: Den normale dosis af Emtriva er en kapsel en gang om dagen til patienter, der vejer 33 kg eller mere.
English: The usual dose of oral solution is 6 mg per kilogram body weight once a day, up to a maximum of 240 mg (24 ml).
Danish: Den normale dosis er 6 mg pr. kilogram kropsvægt en gang om dagen til en maksimal dosis på 240 mg (24 ml).
English: What measures are being taken to ensure the safe and effective use of Emtriva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emtriva?
English: What is Emtriva and what is it used for?
Danish: Hvad er Emtriva, og hvad anvendes det til?
English: The dose may need to be adjusted in patients who have problems with their kidneys.
Danish: Det kan være nødvendigt at tilpasse dosen hos patienter med nyreproblemer.
English: Why is Emtriva approved?
Danish: Hvorfor blev Emtriva godkendt?
English: Emtriva is available as capsules (200 mg) and as a solution (10 mg/ml) to be taken by mouth.
Danish: Emtriva fås som kapsler (200 mg) og som en opløsning (10 mg/ml) til indtagelse gennem munden.
English: It is not intended to provide practical advice on how to use Emtriva.
Danish: Det er ikke en praktisk vejledning i, hvordan Emtriva bør anvendes.
English: Emtriva does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Emtriva kurerer ikke hivinfektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og hindre udvikling af infektioner og sygdomme, der er forbundet med aids.
English: What is the risk associated with Emtriva?
Danish: Hvilken risiko er der forbundet med Emtriva?
English: The most common side effects with Emtriva (seen in more than 1 patient in 10) are headache, diarrhoea, nausea (feeling sick), and elevated creatine kinase levels in the blood (an enzyme found in muscles).
Danish: De hyppigste bivirkninger ved Emtriva (som ses hos flere end 1 ud af 10 patienter) er hovedpine, diarré, kvalme og forhøjet indhold i blodet af kreatinkinase (et enzym, der findes i musklerne).
English: • In another study in 468 previously untreated patients, Emtriva was as effective as lamivudine (both taken in combination with stavudine and either efavirenz or nevirapine).
Danish: • I en anden undersøgelse af 468 tidligere ubehandlede patienter var Emtriva ligeså effektiv som lamivudin (begge taget i kombination med stavudin og eller efavirenz eller nevirapin).
English: Similar results on effectiveness were seen in two studies involving 120 children and adolescents taking Emtriva in combination with other antiviral medicines.
Danish: Tilsvarende resultater blev opnået i de to undersøgelser, der omfattede 120 børn og unge, der fik Emtriva i kombination med andre antivirale midler.
English: The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Danish: Det aktive stof i Emtriva, emtricitabin, er en nukleosid revers transkriptasehæmmer (NRTI).
English: Emtriva should only be started by a doctor experienced in managing HIV infections.
Danish: Behandlingen med Emtriva bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: For more information about treatment with Emtriva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Emtriva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Emtriva is used in combination with other antiviral medicines and contains the active substance emtricitabine.
Danish: Emtriva anvendes i kombination med andre antivirale lægemidler og indeholder det aktive stof emtricitabin.
English: In this study after 48 weeks, around two thirds of the patients had viral loads below 400 copies/ml, and slightly fewer had viral loads below 50 copies/ml.
Danish: Efter 48 uger havde ca. to tredjedele af patienterne et virusindhold under 400 kopier/ml, og en lidt mindre del havde et virusindhold under 50 kopier/ml.
English: For patients who have taken medicines to treat their HIV infection before and did not respond to that treatment, doctors should only prescribe Emtriva once they have looked at the antiviral medicines the patient has taken before and assessed the likelihood of the virus's response to any new antiviral medicines that might be prescribed.
Danish: Til patienter, der tidligere har fået forskellige lægemidler mod hivinfektion, men ikke reagerede på denne behandling, skal lægen, inden der ordineres Emtriva, gennemgå de antivirale lægemidler, patienten tidligere har fået, og vurdere sandsynligheden for, at virussen reagerer på nye antivirale lægemidler, der måtte ordineres.
English: Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Emtriva tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: Studies have shown that Emtriva, in combination with other antiviral medicines, reduces viral loads in HIV-infected patients and compares well with other medicines used in combination.
Danish: Undersøgelser har vist, at Emtriva i kombination med andre antivirale lægemidler, mindsker virusindholdet hos hiv-smittede patienter og udmærket kan sammenlignes med andre lægemidler, der anvendes i kombinationer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva's benefits are greater than its risks for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Emtriva opvejer risiciene til behandling af voksne og børn, der er smittet med hiv-1, i kombination med andre antivirale lægemidler.
English: For practical information about using Emtriva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Emtriva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Emtriva have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Emtriva?
English: • In a third study in 459 patients who had been taking three antiviral medicines (including lamivudine), the number of patients switching from lamivudine to Emtriva who had viral loads below 400 copies/ml after 48 weeks was similar to the number of those who continued taking lamivudine (73% and 82%, respectively).
Danish: • I en tredje undersøgelse af 459 patienter, som havde taget tre antivirale lægemdiler (herunder lamivudin), opnåede en ligeså stor andel af de patienter, der skiftede fra lamivudin til Emtriva, et virusindhold under 400 kopier/ml, som af dem, der fortsatte med at tage lamivudin (henholdsvis 73 og 82 %) efter 48 uger.
English: The Committee noted that this indication is based on studies in patients who have not received HIV treatment before, or whose HIV is already well controlled with antiviral medicines, and that there was no experience of Emtriva in patients whose previous treatment for HIV was not working.
Danish: Udvalget konstaterede, at denne indikation hovedsagelig bygger på undersøgelser hos patienter, der ikke tidligere har fået medicin mod hiv, eller hos hvem hiv-infektion i forvejen er velkontrolleret med antiviral medicin.
English: How is Emtriva used?
Danish: Hvordan anvendes Emtriva?
English: Emtriva is an antiviral medicine for treating adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Emtriva er et lægemiddel mod virus og anvendes til behandling af voksne, som er smittet med HIV-1 (humant immundefektvirus type 1).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtriva 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 Emtriva.
English: • In a study of 571 previously untreated adults, more patients taking Emtriva (in combination with didanosine and efavirenz) had viral loads below 50 copies/ml after 24 weeks of treatment than those taking stavudine (81% and 70%, respectively).
Danish: • I en undersøgelse af 571 tidligere ubehandlede var der flere patienter af dem, der fik Emtriva, som havde et virusindhold på under 50 kopier/ml efter 24 ugers behandling, end af dem, der fik stavudin (henholdsvis 81 % og 70 % %).
English: How does Emtriva work?
Danish: Hvordan virker Emtriva?
English: Because no agreement was reached at the Day 60, the procedure was referred to the CHMP.
Danish: Da der ikke var opnået enighed på dag 60, blev sagen henvist til CHMP.
English: Human plasma protein binding is under 5%.
Danish: Den humane plasmaproteinbinding er under 5 %.
English: The analysis results show that the finished products meet the specifications proposed.
Danish: Analyseresultaterne viser, at de færdige produkter opfylder de foreslåede specifikationer.
English: Betavert N was approved in EU, on 18 April 2007, during a Mutual Recognition Procedure (MRP) with Germany as Reference Member State (RMS) plus 7 Concerned Member States (CMS): AT, BG, CZ, HU, PL, RO and SK.
Danish: Betavert N blev godkendt i EU den 18. april 2007 ved en procedure for gensidig anerkendelse med Tyskland som referencemedlemsstat og med syv berørte medlemsstater: AT, BG, CZ, HU, PL, RO og SK.
English: The conditions used in the stability studies are according to the ICH stability guideline.
Danish: Forholdene i stabilitetsundersøgelserne er i overensstemmelse med ICH's stabilitetsretningslinjer.
English: Clinical efficacy/ safety
Danish: Klinisk virkning/sikkerhed
English: The Benefit-Risk-Assessment is positive.
Danish: Benefit/risk-vurderingen er positiv.
English: No new safety data are provided or needed.
Danish: Der foreligger ingen nye sikkerhedsdata, og nogle sådanne er ikke nødvendige.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR POSITIV UDTALELSE
English: Considering the dissolution test, both strengths of the test product can be classified as “very rapid dissolving tablets”.
Danish: Hvad angår opløsningstesten, kan begge testproduktets styrker klassificeres som "meget hurtigt opløselige tabletter".
English: Analytical data were submitted and the choice of excipients was justified and their functions explained.
Danish: Der blev indsendt analytiske data, og valget af hjælpestoffer blev begrundet, og deres funktioner beskrevet.
English: The drug substance is completely and fast dissolved independent of the applied medium.
Danish: Lægemiddelstoffet opløses hurtigt og fuldstændigt uafhængig af det anvendte medium.
English: The Czech Republic came to the conclusion that the bioequivalence has not been properly demonstrated in vivo because of the choice of the analytical method.
Danish: Den Tjekkiske Republik nåede frem til den konklusion, at bioækvivalens ikke var blevet tilstrækkeligt påvist in vivo på grund af den valgte analytiske metode.
English: The conditions for the suitability of this biowaiver have been discussed taking into account: solubility, dissolution, and absorption/permeability.
Danish: Betingelserne for egnethed til denne dispensation er blevet drøftet under hensyntagen til opløselighed, opløsning og absorption/permeabilitet.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BETAVERT N AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BETAVERT N OG TILKNYTTEDE NAVNE (SE BILAG I)
English: The CHMP assessed the dossier and the available data, including the issue raised by the objecting CMS.
Danish: CHMP vurderede dossieret og de tilgængelige data, herunder det spørgsmål, som var rejst af den berørte medlemsstat, der havde gjort indsigelse.
English: The preparation of Betahistine is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Danish: Betahistinpræparatet bør ikke anvendes til børn og unge på grund af manglende dokumentation for sikkerhed og virkning.
English: Its exact biochemical mode of action as well as its receptor specificity and affinity has not been clarified until now.
Danish: Dets præcise biokemiske virkemåde og dets receptorspecificitet og -affinitet er først nu blevet klarlagt.
English: The CHMP agreed that there were no objections to approval of Betavert N 8 mg and Betavert N 16 mg from a nonclinical point of view.
Danish: CHMP fastslog, at der ikke kunne gøres indsigelser mod godkendelsen af Betavert N 8 mg og Betavert N 16 mg fra et ikke-klinisk synspunkt.
English: The product specifications cover appropriate parameters for this dosage form.
Danish: Produktspecifikationerne omfatter passende parametre for denne formulering.
English: Biliary elimination is not a significant route of elimination for the active agent or any of its metabolites.
Danish: Udskillelse via galdevejene er ikke en signifikant eliminationsvej for det aktive stof eller nogen af dets metabolitter.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresume, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
English: Based on these, the CHMP proposed a re-test period of 5 years for betahistine hydrochloride.
Danish: På baggrund heraf foreslog CHMP en ny testperiode på fem år for betahistinhydrochlorid.
English: The mechanism of action of betahistine dihydrochloride is not compleately clear but the product has been on the EU market for a long time, therefore could be concluded that its use is well established and its efficacy is proven.
Danish: Virkningsmekanismen for betahistindihydrochlorid er ikke helt entydig, men lægemidlet har været markedsført i EU længe, og det kunne derfor konkluderes, at det har en almindelig kendt anvendelse, og at dets virkning er dokumenteret.
English: The CHMP has recommended the granting of the Marketing Authorisation(s) for Betavert N and associated names (see Annex I).
Danish: CHMP anbefaler, at der udstedes markedsføringstilladelse(r) for Betavert N og tilknyttede navne (se bilag I).
English: Absorption: following oral administration, betahistine dihydrochloride is rapidly and completely absorbed.
Danish: Absorption: Efter oral administration absorberes betahistindihydrochlorid hurtigt og fuldstændigt.
English: Validations of the analytical methods have been presented.
Danish: De analytiske metoder er blevet valideret.
English: The pure betahistine dihydrochloride could not reliably quantify in the human body.
Danish: Det rene betahistindihydrochlorid kunne ikke kvantificere i den menneskelige krop på en pålidelig måde.
English: Betahistine is a structural analogue of the endogenous histamine.
Danish: Betahistin er en strukturel analog af det endogene histamin.
English: The binding of Betahistine to human plasma proteins has been measured by equilibrium dialysis.
Danish: Betahistins binding til humane plasmaproteiner er blevet målt ved ligevægtsdialyse.
English: GmbH & Co. KG Liebigstraße 1 - 2 65439 Flörsheim/Main Germany
Danish: KG Liebigstraße 1 - 2 65439 Flörsheim/Main Tyskland
English: The issue was referred to the CMD(h) and an assessment was carried out by the RMS.
Danish: Sagen blev henvist til den humanmedicinske koordineringsgruppe CMD(h), og en vurdering blev gennemført af referencemedlemsstaten.
English: Metabolism: Betahistine dihydrochloride is rapidly metabolised in the liver to the inactive major metabolite, 2-pyridylacetic acid and to demethyl-betahistine [2-(2 aminoethylpyridine)].
Danish: Stofskifte: Betahistindihydrochlorid metaboliseres hurtigt i leveren til den inaktive primære metabolit, 2pyridyleddikesyre og demethylbetahistin [2-(2 aminoethylpyridin)].
English: Benefit Risk Assessment
Danish: Benefit/risk-vurdering
English: PK study, also, revealed no safety issues.
Danish: Endvidere viste den farmakokinetiske undersøgelse ingen problemer med sikkerheden.
English: Peak plasma concentrations of C14-labelled betahistine dihydrochloride are reached approximately 1 hour after oral administration in fasting volunteers.
Danish: Den maksimale plasmakoncentration af C14-mærket betahistindihydrochlorid opnås ca. 1 time efter oral administration hos fastende forsøgspersoner.
English: Non clinical aspects
Danish: Ikke-kliniske aspekter
English: No significant changes were observed in 6 months accelerated stability study (40°C/ 75% RH) and up to 5 years controlled room temperature stability study.
Danish: Kontrolprøverne og specifikationerne for lægemiddelstoffet var affattet på hensigtsmæssig vis. Der blev ikke observeret nogen signifikante ændringer i den fremskyndede seks måneders stabilitetsundersøgelse (40°C/ 75 % RH) og op til fem år lange kontrollerede stabilitetsundersøgelse ved stuetemperatur.
English: This procedure concerns Betavert N, a generic version of betahistine dihydrochloride tablets.
Danish: Denne procedure vedrører Betavert N, som er en generisk udgave af betahistindihydrochlorid-tabletter.