FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs that your liver may not be working properly include: nausea (urge to vomit) vomiting fever (high temperature) pain in your stomach (abdomen) jaundice (yellowing of your skin or the whites of your eyes) dark-coloured urine itching of your skin lethargy or fatigue (unusual tiredness or exhaustion) flu-like syndrome (joint and muscle pain with fever)
Danish: Letargi eller træthed (usædvanlig træthed eller udmattelse) Influenzalignende syndrom (led- og muskelsmerter med feber)
English: Moreover, if you are suffering from pulmonary arterial hypertension, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Danish: Opsumit kan skade fostrets udvikling.Derfor må du ikke tage Opsumit, hvis du er gravid, og du skal også undgå at blive gravid, så længe du tager Opsumit.Hvis du lider af pulmonal arteriel hypertension, kan graviditet desuden forværre symptomerne på din sygdom i alvorlig grad.
English: • pallor
Danish: • Mavesmerter
English: • Prescribing checklists;
Danish: • Ordinationstjekliste;
English: The film-coated tablets are not breakable and are to be swallowed whole, with water.
Danish: De skal synkes hele med vand.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets macitentan
Danish: LÆGEMIDLETS NAVN Opsumit 10 mg filmovertrukne tabletter macitentan
English: Swallow the whole tablet, with a glass of water, do not chew or break the tablet.
Danish: Tabletten må ikke tygges eller deles.
English: If you take more Opsumit than you should
Danish: Hvis du har taget for meget Opsumit
English: Patient Card Page 1 (front)
Danish: Side 1 (forside)
English: Ask your doctor for advice.
Danish: Er du i tvivl, så spørg lægen.
English: Thrombocytopenia7
Danish: Trombocytopeni
English: Excipients
Danish: Trombocytter
English: If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting.
Danish: Du kan opleve hovedpine, kvalme eller opkastning.
English: • feeling sick (nausea)
Danish: • Svælgkatar (halsbetændelse)
English: Talk to your doctor, who will decide whether this medicine is suitable for you.
Danish: Kontakt lægen, hvis noget af ovennævnte gør sig gældende for dig.
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (see section 4.4).
Danish: Eksponeringen for macitentans aktive metabolit faldt med 26 %: Der skal udvises forsigtighed ved samtidig administration af macitentan og stærke CYP3A4-hæmmere (se pkt.
English: In healthy subjects, the exposure to macitentan and its active metabolite is unchanged in the presence of food and, therefore, macitentan may be taken with or without food.
Danish: Hos raske forsøgsdeltagere påvirker føde ikke eksponeringen for macitentan og dets aktive metabolit.
English: Oedema, fluid retention3
Danish: Ødem, væskeretention
English: Therefore, from a pharmaceutical perspective, elixirs are a type of oral solutions and are expected to behave in vivo as such.
Danish: Fra et farmaceutisk perspektiv er eliksirer derfor en type af orale opløsninger og forventes at opføre sig sådan in vivo.
English: Overall summary of the scientific evaluation of Dexamethasone Alapis
Danish: Samlet resumé af den videnskabelige vurdering af Dexamethason Alapis
English: The application for Dexamethasone Alapis has therefore been made in accordance with Article 10a of Directive 2001/83/EC, as amended.
Danish: Ansøgningen vedrørende Dexamethason Alapis er derfor udarbejdet i overensstemmelse med artikel 10a i direktiv 2001/83/EF med senere ændringer.
English: • Prevention of nausea and vomiting and treatment of cancer with oncolytics that have a serious emetic effect.
Danish: • Forebyggelse af kvalme og opkastning og behandling af cancer med onkolytiske midler, der har stærk emetisk effekt.
English: • Treatment of non-endocrine corticosteroid responsive conditions
Danish: • Behandling af ikke-endokrine tilstande, som responderer på kortikosteroider
English: This corresponds to over 180 literature reports (Randomized Clinical Trials (RCTs); Reviews, Monographs (Martindale etc.).
Danish: Disse svarer til mere end 180 rapporter fra litteraturen (randomiserede kliniske undersøgelser (RCT), evalueringer, monografier (Martindale m.v.)).
English: It is used principally as an anti-inflammatory or immunosuppressant agent.
Danish: Det anvendes hovedsageligt som antiinflammatorisk og immunosuppresivt middel.
English: The Applicant specifically focussed its response on the concerns raised about bridging data.
Danish: I sit svar fokuserede ansøgeren specifikt på de fremførte betænkeligheder vedrørende brobygningsdata.
English: Elixirs are sweetened hydro-alcoholic oral solutions that are specially formulated for oral use in infants and children (Strickley, 2004).
Danish: Eliksirer er sødede orale opløsninger baseret på vand og alkohol, der er særligt formuleret til oral brug hos spædbørn og børn (Strickley, 2004).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR POSITIV UDTALELSE
English: It also showed that dexamethasone had a broad therapeutic index.
Danish: Desuden viste den, at dexamethason har et bredt terapeutisk indeks.
English: Dexamethasone has a biological half life of 36 - 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required.
Danish: Dexamethason har en biologisk halveringstid på 36-54 timer og er derfor egnet ved tilstande, hvor vedvarende glucokortikoid virkning er påkrævet.
English: The Summary of Product Characteristics achieved during the Coordination group procedure was considered to address adequately the safety concerns of this medicinal product.
Danish: Produktresuméet, som blev indhentet under behandlingen i koordinationsgruppen, blev anset for i tilstrækkelig grad at imødegå betænkelighederne ved dette lægemiddels sikkerhed.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Danish: CHMP vurderede dossieret og de tilgængelige data, herunder de spørgsmål, som den berørte medlemsstat, der havde gjort indsigelse, havde rejst.
English: The mechanism of action is mediated via activation of glucorticoid receptors that leads to increased or decreased transcription of a number of genes involved in the inflammatory process, particularly the repression of cytokine gene transcription and the direct interaction between the glucocorticoid receptor and other transcription factors activated in chronic inflammation.
Danish: Virkningsmekanismen opstår via aktivering af glucokortikoidreceptorer, der medfører øget eller nedsat transskription af en række gener, der er involveret i den inflammatoriske proces, især repression af cytokin gentransskription og direkte interaktion mellem glucokortikoidreceptoren og andre transskriptionsfaktorer, som aktiveres ved kronisk inflammation.
English: Because it has only minimal mineral corticoid properties, the drug is inadequate as a monotherapy for the management of adrenocortical insufficiency.
Danish: Da lægemidlet har minimale mineralkortikoide egenskaber, er det ikke egnet som monoterapi til behandling af adrenokortikal insufficiens.
English: At Day 60 of the CMD(h) procedure, since no agreement could be reached, the procedure was referred to the CHMP.
Danish: Da CMD(h) ikke var nået til enighed i proceduren efter 60 dage, blev proceduren indbragt for CHMP.
English: The strength and quality of evidence gathered from the above information was considered adequate for a medicinal product with a well established and broad therapeutic index as dexamethasone.
Danish: Styrken og kvaliteten af den evidens, der er indhentet fra ovennævnte information, blev anset for at være tilstrækkelig for et lægemiddel med et veldokumenteret og bredt terapeutisk indeks som dexamethason.
English: From the literature submitted during the decentralised procedure, it was shown that dexamethasone has been widely used in clinical practice for a number of indications for more than 40 years.
Danish: Den litteratur, der var indsendt under den decentraliserede procedure, viste, at dexamethason i mere end 40 år har været almindeligt anvendt i klinisk praksis til en række indikationer.
English: Most of the literature provided by the Applicant concerned the administration of an oral solid dosage form, i.e. tablet.
Danish: Det meste af den litteratur, der er fremlagt af ansøgeren, vedrørte indgift af en oral, fast doseringsform, dvs. tabletter.
English: Therefore, a huge volume of efficacy and safety data exists for the dexamethasone pharmaceutical substance.
Danish: Der foreligger således en meget stor mængde data for virkning og sikkerhed for lægemiddelstoffet dexamethason.
English: This active substance is considered to have a ‘well-established use' within the European Community for at least 10 years, with recognised efficacy and an acceptable level of safety in the use in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction.
Danish: Det aktive stof anses for at være "almindeligt anvendt" inden for Den Europæiske Union gennem i hvert fald de seneste 10 år, dets virkning er anerkendt, og det har et acceptabelt sikkerhedsniveau ved brug til visse endokrine og ikke-endokrine lidelser, til visse tilfælde af cerebrale ødemer og til diagnostisk test af adrenokortikal hyperfunktion.
English: In vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
Danish: In vivo-bioækvivalensundersøgelser kan være undtaget, hvis en antagelse af, at virkningen in vivo er ækvivalent, kan begrundes fuld ud med tilstrækkelige in vitro-data.
English: Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties.
Danish: Dexamethason er et meget stærkt og langtidsvirkende glucokortikoid med ubetydelig natriumretention.
English: In addition, the limited number of published studies that used a solution formulation used a similar posology to the tablet formulation.
Danish: Det begrænsede antal offentliggjorte undersøgelser, hvor en opløsningsformulering blev anvendt, brugte endvidere en dosering, der svarede til tabletformuleringen.
English: Literature data available on the various routes of administration for the same treatment show that dexamethasone is equally effective via any administration route.
Danish: De tilgængelige data i litteraturen vedrørende de forskellige indgivelsesveje for den samme behandling viser, at dexamethason har samme virkning via alle indgivelsesveje.
English: A referral was thus triggered at the CMD(h) and the Applicant was asked to provide detailed literature and critical assessment of the efficacy and safety of dexamethasone oral solution in the indications applied for.
Danish: Der blev derfor foretaget en indbringelse for CMD(h), og ansøgeren blev bedt om at fremsende detaljeret litteratur og en kritisk vurdering af virkning og sikkerhed af dexamethason oral opløsning til de ansøgte indikationer.
English: The bibliography provided was considered sufficient to support the well established use of dexamethasone substance in different tablet formulations.
Danish: Den indsendte bibliografi blev anset for at være tilstrækkelig til støtte for den anerkendte brug af stoffet dexamethason i forskellige tabletformuleringer.
English: The BCS-based biowaiver approach is meant to reduce in vivo bioequivalence studies.
Danish: Hensigten med den BCS-baserede tilgang med dispensation fra bioækvivalensundersøgelse er at reducere bioækvivalensundersøgelserne in vivo.
English: The objecting Concerned Member State raised a potential serious risk to public health as it considered that the literature data on dexamethasone tablets that had been submitted could not be extrapolated to dexamethasone oral solution without adequate bridging data and therefore the efficacy and safety of Dexamethasone Alapis could not be demonstrated in the application.
Danish: Den berørte medlemsstat, der gjorde indsigelse, påpegede, at der var en mulig alvorlig risiko for folkesundheden, da den mente, at de indsendte data fra litteraturen vedrørende dexamethason-tabletter ikke kunne ekstrapoleres til oral opløsning af dexamethason uden tilstrækkelige brobygningsdata, og at virkning og sikkerhed for Dexamethason Alapis derfor ikke kunne påvises i ansøgningen.
English: According to the Appendix II of the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)”, applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.
Danish: I henhold til "Guideline on the investigation of bioequivalence, Appendix II" (retningslinjer for undersøgelse af bioækvivalens, bilag II) (CPMP/PWP/EWP/1401/98 Rev 1/Corr) kan der kun ansøges om BCS-baseret dispensation fra bioækvivalensundersøgelse ved lægemiddelstoffer med høj opløselighed og kendt human absorption, som anses for ikke at have et snævert terapeutisk indeks.
English: The CHMP therefore agreed that the bibliographic data provided in support of the application demonstrates the well-established use of dexamethasone sodium phosphate used in the oral solution and that a bioequivalence study was not necessary to show the relevance of the literature used in support of the pharmaceutical form concerned.
Danish: CHMP var derfor enig i, at de bibliografiske data, som blev fremlagt som støtte for ansøgningen, viser, at det dexamethasonnatriumfosfat, som bruges i den orale opløsning, er almindeligt anvendt, og at en bioækvivalensundersøgelse ikke er nødvendig for at vise relevansen af den litteratur, der er anvendt som støtte for den pågældende lægemiddelform.
English: From the literature data provided by the Applicant, it was shown that there were no significant differences between the bioavailabilities of immediate release tablet formulations and elixir formulations of dexamethasone (irrespective of the elixir formulation used).
Danish: De data fra litteraturen, som ansøgeren fremlagde, viste, at der ikke var nogen signifikant forskel i biotilgængelighed ved tabletformuleringer med umiddelbar frigivelse og eliksirformuleringer med dexamethason (uanset hvilken eliksirformulering der blev anvendt).
English: It was therefore concluded by the CHMP that efficacy and safety of dexamethasone active substance in the therapeutic indications applied for had been sufficiently demonstrated by the provided literature.
Danish: CHMP konkluderede derfor, at virkning og sikkerhed ved dexamethason som aktivt stof i de ansøgte terapeutiske indikationer er tilstrækkeligt påvist i den fremlagte litteratur.
English: Data on the solubility and on the absorption and permeability of dexamethasone were provided by the Applicant during the decentralised and the CMD(h) referral procedure to show that Dexamethasone Alapis met all criteria for a BCS-based biowaiver.
Danish: Ansøgeren indsendte data om dexamethasons opløselighed, absorption og permeabilitet under den decentrale procedure og indbringelsesproceduren for CMD(h) for at vise, at Dexamethason Alapis opfylder alle kriterier for en BCS-baseret dispensation for bioækvivalensundersøgelse.
English: In addition, a few literature reports (CTs) on the efficacy and safety of dexamethasone in oral solution/syrup have been submitted in the following indications applied for:
Danish: Desuden er nogle få rapporter fra litteraturen (kliniske undersøgelser (CT)) vedrørende sikkerhed og virkning af dexamethason som oral opløsning/syrup indsendt til følgende ansøgte indikationer:
English: The majority of data submitted supporting efficacy and safety with dexamethasone in the indications being sought have been obtained with tablet formulations.
Danish: Størstedelen af de indsendte data til støtte for virkning og sikkerhed ved dexamethason til de ansøgte indikationer er hentet fra tabletformuleringer.
English: Although the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)” states: “In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required”, the application of a BCS-based biowaiver to bridge data from different pharmaceutical forms was considered to have been adequately justified from a scientific point of view, by provision of parallel artificial membrane permeability assay (PAMPA) data, literature and dissolution data, demonstrating that Dexamethasone drug substance has biopharmaceutical characteristics of BCS Class I/III, and that the excipients have no adverse affects on bioavailability.
Danish: Selvom det i "Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)" anføres, at "bioækvivalensundersøgelser er påkrævet i de tilfælde, hvor forsøgslægemidlet er en oral opløsning, som er beregnet til at være bioækvivalent med en anden oral doseringsform til umiddelbar frigivelse", blev ansøgningen om en BCS-baseret dispensation for bioækvivalensundersøgelse som brobygning mellem data fra forskellige lægemiddelformer anset for at være tilstrækkeligt begrundet ud fra et videnskabeligt synspunkt gennem fremlæggelse af data for test af parallel artificiel membranpermeabilitet (PAMPA), data fra litteraturen og data om opløsning, som påviser, at lægemiddelstoffet dexamethason har biofarmaceutiske karakteristika i BCS-klasse I/II, og at hjælpestofferne ikke har nogen utilsigtet virkning på biotilgængeligheden.
English: Whereas, - the Applicant has provided sufficient literature data to demonstrate well-established use of dexamethasone, - efficacy and safety of dexamethasone has been adequately shown in the indications applied for - adequate bridging data between the tablet formulation and the oral solution formulation have been provided by the Applicant, the CHMP has recommended the granting of the marketing authorisation(s) for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Danish: Ud fra følgende betragtninger: - ansøgeren har fremlagt tilstrækkelige data fra litteraturen til at påvise, at dexamethason er almindeligt anvendt, - dexamethasons virkning og sikkerhed er tilstrækkeligt påvist til de ansøgte indikationer, - ansøgeren har fremlagt tilstrækkelige data til brobygning mellem tabletformuleringen og formuleringen af den orale opløsninganbefaler CHMP, at der udstedes markedsføringstilladelse(r), for hvilke(n) produktresumé, etikettering og indlægsseddel bevares som i de endelige udgaver, der blev fastlagt under koordinationsgruppens procedure som nævnt i bilag III til denne udtalelse.
English: In order to extrapolate efficacy and safety data from these studies to the oral solution formulation applied for, the Applicant provided data that showed that irrespective of immediate release oral dosage formulation (tablet or solution), the bioavailability of dexamethasone in terms of extent and rate of absorption, was similar.
Danish: For at ekstrapolere data for virkning og sikkerhed fra disse undersøgelser til formuleringen af den orale opløsning, som der er ansøgt om, fremlagde ansøgeren data, som viste, at uanset formuleringen af den orale opløsning med umiddelbar frigivelse (tablet eller opløsning) svarede denne til dexamethasons biotilgængelighed for så vidt angår omfang og hastighed.
English: However, as information on the composition of the dexamethasone syrup, elixir or oral solution investigated in the provided studies was missing in all articles, some concerns were raised on whether those data could be considered as sufficient to allow bridging of the data between the tablets and the oral formulation applied for.
Danish: Da ingen af artiklerne om de fremlagte undersøgelser imidlertid indeholdt information om sammensætningen af de undersøgte syrupper, eliksirer og orale opløsninger med dexamethason, blev der udtrykt betænkeligheder med hensyn til, hvorvidt disse data kunne betragtes som tilstrækkelige til at udgøre en brobygning mellem tabletterne og den orale formulering, som der blev ansøgt om.
English: As a justification for not providing bioequivalence study to bridge the data submitted on the tablet formulation and the oral solution formulation applied for, the Applicant applied for a BCS (Biopharmaceutics Classification System)-based biowaiver.
Danish: Som begrundelse for, at ansøgeren ikke fremlagde en bioækvivalensundersøgelse som brobygning mellem de indsendte data for tabletformuleringen og formuleringen for den orale opløsning i ansøgningen, blev der ansøgt om dispensation for bioækvivalensundersøgelse baseret på BCS (Biopharmaceutics Classification System).
English: Additional bridging data (or its absence fully justified) between the bibliographic data and the proposed pharmaceutical product were therefore requested to the Applicant during the decentralised and the CMD(h) referral procedures.
Danish: Ansøgeren blev derfor under den decentrale procedure og under indbringelsesproceduren for CMD(h) anmodet om yderligere data (eller fyldestgørende begrundelse for manglende data) til brobygning mellem de bibliografiske data og det foreslåede lægemiddel.
English: The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Danish: Indehaveren af markedsføringstilladelsen forelægger fyldestgørende og tilfredsstillende data, der bekræfter lægemidlets bioækvivalens med referencelægemidlet, inden for et år efter EuropaKommissionens afgørelse.
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Danish: De nationale kompetente myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: This difference was considered to be too small to be relevant.
Danish: Denne forskel blev anset for at være for lille til at være relevant.
English: Ref. EMEA/CHMP/502946/2008
Danish: ref. EMEA/548999/2008
English: All of the studies but one were short-term, lasting five weeks or less.
Danish: Alle undersøgelserne undtagen en var kortfristede og varede fem uger eller derunder.
English: Most of the studies were carried out in sleep laboratories, but the three main studies were carried out in the ‘natural setting' (at home) in a total of 2,807 patients.
Danish: De fleste af undersøgelserne blev gennemført i søvnlaboratorier, men de tre hovedundersøgelser blev dog gennemført i ‘naturlige omgivelser' (i hjemmet) af i alt 2 807 patienter.
English: International non-proprietary name (INN): ramelteon
Danish: Internationalt fællesnavn (INN): ramelteon
English: The effects of Ramelteon were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Ramelteon blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The one long-term study lasted six months, during which patients spent some nights in a sleep laboratory.
Danish: Den eneste langfristede undersøgelse varede seks måneder, i løbet af hvilke patienterne tilbragte visse nætter i et søvnlaboratorium.
English: ‘Primary' means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
Danish: ‘Primær' betyder, at der ikke er påvist nogen årsag til søvnløsheden, herunder heller ingen medicinske, psykologiske eller miljømæssige årsager.
English: Questions and answers on the withdrawal of the marketing application for Ramelteon
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Ramelteon
English: What is Ramelteon?
Danish: Hvad er Ramelteon?
English: The main measure of effectiveness was the time taken for the patients to fall asleep.
Danish: Den vigtigste målestok for virkningen var den tid, det tog patienterne at falde i søvn.