FrancophonIA/ELRC3.0 huggingface dataset:
English: - The organisation Gynuity Health Projects performed a GCP-compliant study in Mexico in 1000 women (open-label, non-comparative, prospective multi-site study of mifepristone 200 mg followed 24-48 hours later by buccal misoprostol 800 mcg for termination of pregnancy through 63 days).
Danish: - Organisationen Gynuity Health Projects udførte en undersøgelse om gennemførelse af god klinisk praksis i Mexico, der omfattede 1 000 kvinder (åben, ikke-komparativ, prospektiv multi-siteundersøgelse af administrationen af en dosis på 200 mg mifepriston efterfulgt 24 til 48 timer senere af 800 mcg oralt misoprostol til afbrydelse af graviditet, op til 63 dage).
English: The reason for this alternative was the fact that the combination of 200 mg mifepristone with oral misoprostol was associated with a potentially higher risk of continuing pregnancy, whereas 1mg gemeprost vaginally had been demonstrated in many studies to provide a strong prostaglandin action also in combination with a lower dose of mifepristone.
Danish: Baggrunden for dette alternativ var, at 200 mg mifepriston i kombination med oralt misoprostol indebar en højere risiko for fortsættelse af graviditet, hvorimod en lang række undersøgelser havde vist, at 1 mg gemeprost per vaginum havde en stærk prostaglandinindvirkning, også i kombination med en lavere dosis mifepriston.
English: • Therefore the Committee concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indications is favourable, the CHMP has recommended the granting of the marketing authorisation subject to a recommended condition with regard to the safe and effective use of the medicinal product as set out in Annex IV and for which the amended sections of the summary of product characteristics and package leaflet are set out in Annex III for Mifepristone Linepharma and associated names (see Annex I).
Danish: CHMP har derfor anbefalet, at der udstedes en markedsføringstilladelse, såfremt den anbefalede betingelse for sikker og virkningsfuld brug af lægemidlet i bilag IV opfyldes, for hvilke ændringerne i de relevante punkter i produktresuméet og indlægssedlen fremgår af bilag III for Mifepristone Linepharma og relaterede navne (se bilag I).
English: Based on the above, in view of the slightly increased Cmax, the CHMP is of the opinion that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information and a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed.
Danish: I lyset af ovenstående og den lidt højere Cmax er CHMP af den opfattelse, at den maksimale dosis skal være 200 mg Mifepristone Linepharma, og at dette skal angives klart i produktoplysningerne, og at der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet.
English: The MAH provided the synopsis and abstract of this study.
Danish: Indehaveren af markedsføringstilladelsen fremsendte synopsen og et sammendrag af denne undersøgelse.
English: Compared to Mifegyne, which can be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg was approved for Mifepristone Linepharma through the first wave of the Mutual Recognition Procedure and was also being proposed in the current MRP repeated procedure.
Danish: I forhold til Mifegyne, der kan administreres ved en høj dosis på 600 mg eller en lavere dosis på 200 mg, er det kun den lavere dosis på 200 mg, der blev godkendt for Mifepristone Linepharma i forbindelse med den første bølge af godkendelser under den gensidige anerkendelsesprocedure, hvilket også er indstillingen under den nuværende gensidige anerkendelsesprocedure for gentagen anvendelse.
English: Taking into consideration that Mifepristone Linepharma is only given once and as a single dose of 200mg, the CHMP is of the opinion that the provided clinical data supports that the slightly higher Cmax would not affect efficacy and safety of Mifepristone Linepharma.
Danish: Da Mifepristone Linepharma kun administreres en gang og som en enkelt dosis på 200 mg, er det CHMP's opfattelse, at de foreliggende kliniske data understøtter, at den lidt højere Cmax ikke vil indvirke på sikkerheden og virkningen af Mifepristone Linepharma.
English: A prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed as a condition to the marketing authorisation.
Danish: Der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet som en betingelse for markedsføringstilladelsen.
English: The CHMP considers however that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information.
Danish: CHMP er imidlertid af den opfattelse, at den maksimale dosis skal være 200 mg Mifepristone Linepharma, og at dette skal angives klart i produktoplysningerne.
English: The posology is different to the reference product Mifegyne.
Danish: Doseringen er ikke den samme som for referencelægemidlet Mifegyne.
English: In addition, a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed;
Danish: Der skal desuden udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet.
English: The current SmPC for the reference product mifepristone recommends mifepristone at the dose of 600 mg followed 36 to 48 hours later by 400 µg misoprostol orally or gemeprost 1 mg per vaginam for pregnancy termination up to 49 days of amenorrhea.
Danish: I det nuværende produktresumé for mifepriston-referencelægemidlet anbefales en dosis på 600 mg mifepriston efterfulgt 36 til 48 timer senere af misoprostol 400 µg oralt eller gemeprost 1 mg vaginalt til afbrydelse af graviditet, op til 49 dage med amenorré.
English: As proposed by the MAH at the time of the CMDh referral procedure, the protocol for the prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination was reviewed by the CHMP during the referral procedure.
Danish: På tidspunktet for indbringelsesproceduren for CMDh gennemgik CHMP som foreslået af indehaveren af markedsføringstilladelsen under indbringelsesproceduren protokollen for det prospektive observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet.
English: An alternative of 200 mg of mifepristone was also approved to be used as a single dose, provided that this dose is followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Danish: Alternativt kan 200 mg mifepriston også bruges som en enkelt oral dosis, hvis denne dosis efterfølges 36 til 48 timer senere af administration af prostaglandinanalogen gemeprost 1 mg vaginalt.
English: A preliminary publication in 1343 women has been provided by the MAH.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt en indledende undersøgelse vedrørende 1 343 kvinder.
English: The approved posology is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Danish: Den godkendte dosering er 200 mg mifepriston som en enkelt oral dosis efterfulgt 36 til 48 timer senere af administration af prostaglandinanalogen gemeprost 1 mg vaginalt.
English: Whereas,
Danish: Følgende noteres:
English: The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone ratiopharm GmbH, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: This means that Pioglitazone ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone ratiopharm GmbH er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav var blevet påvist, at Pioglitazone ratiopharm GmbH er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm GmbH for the treatment of type 2 diabetes.
Danish: På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone ratiopharm GmbH til behandling af type 2-diabetes.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes.
Danish: Den 3. februar 2012 meddelte ratiopharm GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone ratiopharm GmbH til behandling af type 2-diabetes tilbage.
English: Pioglitazone ratiopharm GmbH was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Danish: Pioglitazone ratiopharm GmbH skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige.
English: Pioglitazone ratiopharm GmbH was developed as a ‘generic medicine'.
Danish: Pioglitazone ratiopharm GmbH blev udviklet som et ‘generisk lægemiddel'.
English: Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone ratiopharm GmbH er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone ratiopharm GmbH er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: Pioglitazone ratiopharm GmbH was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone ratiopharm GmbH skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: What is Pioglitazone ratiopharm GmbH?
Danish: Hvad er Pioglitazone ratiopharm GmbH?
English: Pioglitazone ratiopharm GmbH was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Pioglitazone ratiopharm GmbH skulle have været anvendt alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: Pioglitazone ratiopharm GmbH was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Danish: Pioglitazone ratiopharm GmbH skulle også have været anvendt i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene (‘tostofsbehandling').
English: What was Pioglitazone ratiopharm GmbH expected to be used for?
Danish: Hvad forventedes Pioglitazone ratiopharm GmbH anvendt til?
English: How is Pioglitazone ratiopharm GmbH expected to work?
Danish: Hvordan forventedes Pioglitazone ratiopharm GmbH at virke?
English: The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014.
Danish: Den endelige udtalelse blev overdraget til Europa-Kommissionen, som vedtog en retligt bindende afgørelse den 19. november 2014.
English: More about the closure of the manufacturing site
Danish: Mere om lukningen af fremstillingsstedet
English: Since 2013 MACI has been marketed in Denmark, Greece and the UK.
Danish: MACI har siden 2013 været markedsført i Danmark, Grækenland og Det Forenede Kongerige.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
Danish: Denne type lægemiddel indeholder celler eller væv, der er manipuleret, så de kan bruges til at reparere, gendanne
English: MACI was on the market since 1998 in individual EU countries according to national procedures.
Danish: MACI har været markedsført siden 1998 i de enkelte EU-lande gennem nationale procedurer.
English: Closure of EU manufacturing site for MACI
Danish: Lukning af EU-fremstillingsstedet for MACI
English: Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met.
Danish: Artikel 118 i direktiv 2001/83/EF, der fastslår, at en markedsføringstilladelse skal suspenderes, hvis et eller flere af kravene i artikel 41 (såsom kravet om et fremstillingssted) ikke længere er opfyldt.
English: • New patients should be treated with a suitable alternative and surgeons should not order new
Danish: • Nye patienter bør behandles med et passende alternativ, og lægerne bør ikke bestille nye
English: • Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI.
Danish: • Læger og hospitaler, som har anvendt MACI, blev i juni 2014 underrettet om den planlagte lukning af EU-fremstillingsstedet for MACI.
English: • The closure was due to commercial reasons and is not related to any change in the safety and
Danish: • Lukningen skyldes forretningsmæssige årsager og hænger ikke sammen med nogen ændring i
English: MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Danish: MACI er et implantat til reparation af defekter i brusken på enderne af knoglerne i knæleddet.
English: Because MACI is an advanced therapy medicine, the review was carried out by the Committee on Advanced Therapies (CAT), and was subsequently endorsed by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use.
Danish: Fordi MACI er et lægemiddel til avanceret terapi, blev gennemgangen foretaget af Udvalget for Avancerede Terapier (CAT), og gennemgangen blev derefter godkendt af Udvalget for Lægemidler til Mennesker (CHMP), som er ansvarligt for spørgsmål vedrørende humanmedicinske lægemidler.
English: In addition, surgeons were asked not to start new patients on MACI.
Danish: Desuden blev lægerne anmodet om ikke at sætte nye patienter i behandling med MACI.
English: MACI is an advanced therapy medicinal product called a ‘tissue engineered product'.
Danish: MACI er et lægemiddel til avanceret terapi, som kaldes et »produkt fremstillet ved vævsteknik«.
English: Following the closure of the manufacturing site and because EU legislation1 requires authorised medicines to have a registered manufacturing site, a review was initiated at the request of the European Commission on 10 September 2014 (under Article 20 of Regulation (EC) No 726/2004) to determine whether the marketing authorisation for MACI should be suspended or revoked.
Danish: Efter lukningen af fremstillingsstedet for MACI bad Europa-Kommissionen den 10. september 2014 om en gennemgang (i henhold til artikel 20 i forordning (EF) nr. 726/2004) for at afgøre, om markedsføringstilladelsen skulle suspenderes eller inddrages.
English: • Patients who have already started treatment (i.e. those who have had their biopsies taken) should have been informed about the closure and should have discussed arrangements for completion of treatment with their treating surgeon.
Danish: • Patienter, der allerede er påbegyndt behandlingen (dvs. de, der har fået taget biopsi), skulle være blevet underrettet om lukningen, og de skulle med lægen have drøftet, hvordan behandlingen
English: Consequently, the licence of the manufacturing site was withdrawn.
Danish: Som følge af lukningen blev fremstillingstilladelsen for dette fremstillingssted inddraget.
English: Arrangements in place for existing patients to complete their treatment
Danish: Der er sørget for, at patienter i behandling kan fuldføre behandlingen
English: The closure was due to commercial reasons and the safety and effectiveness of
Danish: Lukningen skyldtes forretningsmæssige grunde, og sikkerheden og virkningen af MACI forbliver uændret.
English: Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete
Danish: Efter lukningen af fremstillingsstedet er indehaveren af markedsføringstilladelsen blevet anmodet om at opbevare tilbageværende biopsier, der endnu ikke er blevet anvendt, for at give mulighed for eventuel senere behandling med MACI, medmindre patienten og dennes behandlende læge udtrykkelig har angivet, at de ikke ønsker at fuldføre behandlingen med MACI.
English: The safety and effectiveness of the product has not changed.
Danish: Sikkerheden og virkningen
English: MACI is unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Danish: MACI stilles ikke til rådighed for nye patienter i EU, før der er registreret et nyt fremstillingssted i EU.
English: It was subsequently evaluated through the European Medicines Agency to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the Agency in order to obtain an EU-wide marketing authorisation; this was obtained in 2013.
Danish: Ifølge disse regler skal alle sådanne lægemidler i EU's medlemsstater vurderes af agenturet for at få markedsføringstilladelse i hele EU; denne tilladelse blev udstedt i 2013.
English: • The EU manufacturing site for MACI has been closed for commercial reasons and the product will remain unavailable for new patients in the EU until a new manufacturing site has been registered.
Danish: • EU-fremstillingsstedet for MACI er lukket af forretningsmæssige årsager, og nye patienter i EU vil ikke kunne få lægemidlet, før der er registreret et nyt fremstillingssted.
English: • For patients who have already started treatment (i.e. those who have had their biopsies taken) company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons have explicitly indicated that they no longer wish to complete treatment with MACI.
Danish: • For patienter, der allerede er sat i behandling (dvs. dem, der har fået taget biopsi), har virksomheden truffet foranstaltninger til opbevaring af alle eksisterende biopsier, så behandlingen kan fuldføres, medmindre patienterne og deres behandlende læge udtrykkelig har meddelt, at de ikke længere ønsker at fuldføre behandlingen med MACI.
English: The site has now been closed and MACI remains unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Danish: Fremstillingsstedet er nu lukket, og MACI vil ikke være tilgængeligt for nye patienter i EU, før der er registreret et nyt fremstillingssted i EU.
English: • The company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons explicitly indicated that they no longer wish
Danish: • Virksomheden har sørget for, at alle eksisterende biopsier opbevares, så behandlingen kan færdiggøres, medmindre patienterne og den læge, der behandler dem, udtrykkelig har meddelt, at de ikke ønsker at fuldføre behandlingen med MACI.
English: The European Medicines Agency has been working with the marketing authorisation holder since June 2014 to ensure that patients who had already started the treatment procedure were able to complete their treatment.
Danish: Det Europæiske Lægemiddelagentur har siden juni 2014 samarbejdet med indehaveren af markedsføringstilladelsen om at sikre, at de patienter, der allerede havde påbegyndt behandlingen, fik mulighed for at fuldføre den. Der blev udsendt et brev til sundhedspersoner med underretning om lukningen af fremstillingsstedet og anmodning om, at de underretter indehaveren af markedsføringstilladelsen om de patienter, der ønsker at fuldføre om behandlingen.
English: Based on the draft opinion adopted by the CAT, the CHMP adopted a final opinion on 25 September 2014, recommending the suspension of the marketing authorisation for MACI until a new manufacturing site is registered in the EU.
Danish: På grundlag af CAT's udkast til udtalelse vedtog CHMP den 25. september 2014 en endelig udtalelse.
English: On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark.
Danish: Den 5. september 2014 blev EU-fremstillingsstedet for MACI i Danmark lukket af markedsføringstilladelsesindehaveren.
English: (frequency cannot be estimated from the available data)
Danish: (frekvensen kan ikke estimeres ud fra forhåndenværende data)
English: Date of first authorisation: 9 March 2000 Date of latest renewal: 9 March 2010
Danish: Dato for første markedsføringstilladelse : 9. marts 2000 Dato for seneste fornyelse : 9. marts 2010
English: Your doctor may recommend that you take paracetamol if you develop these symptoms.
Danish: Din læge kan anbefale, at du tager paracetamol, hvis du udvikler disse symptomer.
English: Another 4 % had a transient decrease below the lower limit of normal.
Danish: Yderligere 4 % havde et forbigående fald til under den nedre normalgrænse.
English: Not all dose forms and strengths are appropriate for some indications.
Danish: Ikke alle formuleringer og styrker er hensigtsmæssige for visse indikationer.
English: - if you have severe heart disease.
Danish: - hvis du har alvorlig hjertesygdom.
English: Interactions between IntronA and other medicinal products have not been fully evaluated.
Danish: Interaktioner mellem IntronA og andre lægemidler er ikke fuldt vurderet.
English: Any or all of these activities may contribute to interferon's therapeutic effects.
Danish: Nogle eller alle af disse aktiviteter kan være medvirkende til interferons terapeutiske virkning.
English: You may need urgent medical attention or hospitalisation.
Danish: Du kan have behov for hurtig lægehjælp eller hospitalsindlæggelse.
English: There are no data on long term effects on sexual maturation.
Danish: Der er ingen langtidsdata af virkningen på kønsmodning.
English: You are now ready to inject the dose.
Danish: Du er nu klar til at injicere dosis.
English: Change your injection site each time.
Danish: Varier dit injektionssted hver gang.
English: Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.
Danish: Forsøg ikke selv at injicere med mindre du er sikker på, at du forstår proceduren og forudsætningen for selv-injektion.
English: Overall Response a (n=118)
Danish: Samlet respons a (n=118)
English: Do not use this medicine if you notice changes in the appearance of IntronA.
Danish: Brug ikke lægemidlet, hvis du bemærker ændringer i udseendet af IntronA.
English: All patients were to be followed for 24 weeks post-treatment.
Danish: Alle patienter skulle følges i 24 uger efter behandlingen.