FrancophonIA/ELRC3.0 huggingface dataset:
English: The relevance of the results was also questioned because the patients in the main studies were not representative of European HIV patients, who have a lower average body mass index (BMI) and smaller amounts of abdominal fats than the patients in the studies.
Danish: Relevansen af resultaterne blev desuden draget i tvivl, fordi patienterne i hovedundersøgelserne ikke var repræsentative for europæiske hiv-patienter, der har mindre legemsmasseindeks (BMI) og mindre fedtdannelse omkring maven end patienterne i undersøgelserne.
English: In terms of safety, the CHMP noted that there was an increase in the level of a protein called insulinlike growth factor 1 (IGF-1) in a considerable number of patients treated with Egrifta.
Danish: Hvad angår sikkerheden bemærkede CHMP, at der var en stigning i niveauet af proteinet insulinlignende vækstfaktor 1 (IGF-1) hos en betydelig del af de patienter, der blev behandlet med Egrifta.
English: The company presented the results from two main studies involving 816 HIV patients with excessive accumulation of abdominal fat.
Danish: Virksomheden har fremlagt resultater af to hovedundersøgelser, der omfatter 816 hiv-patienter med stærk fedtdannelse omkring maven.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
English: How is Egrifta expected to work?
Danish: Hvordan forventes Egrifta at virke?
English: The active substance in Egrifta, tesamorelin, is similar to ‘human growth hormone-releasing factor' (GRF), a hormone in the body that stimulates the release of growth hormone.
Danish: Det aktive stof i Egrifta, tesamorelin, ligner kroppens eget hormon “human growth hormone-releasing factor” (GRF), der stimulerer frigivelsen af væksthormon.
English: In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance.
Danish: I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi CHMP fandt, at de forelagte data ikke gjorde det muligt for udvalget at vurdere benefit/riskforholdet som positivt.
English: In addition, although the main studies showed a reduction in abdominal fat with Egrifta, the reduction has not been shown to be clinically meaningful in terms of actual health benefits to patients.
Danish: Skønt der i hovedundersøgelserne opnåedes en reduktion i fedtdannelse omkring maven med Egrifta, blev denne reduktion ikke påvist at have klinisk betydning i form af en egentlig helbredsmæssig fordel for patienterne.
English: Growth hormone has been shown to play a role in regulating the formation and breakdown of fat tissue.
Danish: Væksthormon vides at have betydning for reguleringen af fedtvævets dannelse og nedbrydning.
English: The company informed the CHMP that there are no consequences for patients currently included in compassionate use programmes using Egrifta.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i programmer for anvendelse med særlig udleveringstilladelse for Egrifta.
English: The CHMP considered a suggestion by the company to restrict the medicine to patients with abdominal fat above a certain amount (defined as greater than 130 cm2), but the evidence supporting the cut-off point was not considered to be sufficient.
Danish: CHMP overvejede et forslag fra virksomheden om at begrænse lægemidlets anvendelse til patienter med fedtdannelse omkring maven af et vist omfang (defineret som over 130 cm2), men fandt ikke, at der var tilstrækkelig dokumentation for valget af dette afskæringspunkt.
English: Lipodystrophy is known to occur in some HIV-infected patients, where it leads to the loss of fat in certain areas of the body and sometimes to excessive accumulation of fat in the abdomen.
Danish: Lipodystrofi optræder hos nogle hiv-smittede patienter, hos hvem sygdommen medfører tab af fedt på visse dele af kroppen og undertiden stærk fedtdannelse i maveregionen.
English: On 21 June 2012, Ferrer Internacional, S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egrifta, for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Danish: Den 21.06.12 meddelte Ferrer Internacional, S.A. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Egrifta til behandling af stærk fedtdannelse omkring maven hos hiv-patienter med lipodystrofi.
English: High levels of IGF-1 may be associated with an increased risk of cancer and a potential worsening of diabetic eye disease, and the Committee considered this to be a major safety concern.
Danish: Et højt IGF-1-niveau kan være forbundet med øget kræftrisiko og mulig forværring af sukkersygebetinget øjensygdom.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Egrifta eller i programmer for anvendelse af Egrifta med særlig udleveringstilladelse?
English: The CHMP was concerned about how Egrifta would be used in clinical practice as it would be difficult to differentiate excess abdominal fat due to lipodystrophy from excess fat due to obesity.
Danish: I CHMP var der betænkelighed ved, hvordan Egrifta ville blive anvendt i praksis, da det ville være vanskeligt at skelne stærk fedtdannelse som følge af lipodystrofi fra almindelig stærk fedtdannelse.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Egrifta did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Egrifta ikke var tilfredsstillende påvist og ikke er større end risiciene.
English: Egrifta was expected to be used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that leads to changes in the distribution of body fat.
Danish: Egrifta forventedes anvendt til behandling af stærk fedtdannelse omkring maven hos hiv-smittede patienter med lipodystrofi, en sygdom, der ændrer kroppens fedtfordeling.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Egrifta could not have been approved for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Danish: Efter gennemgang af de foreliggende oplysninger og virksomhedens besvarelse af CHMP's spørgsmål havde CHMP visse betænkeligheder, og udvalgets foreløbige standpunkt var, at Egrifta ikke kunne godkendes til behandling af stærk fedtdannelse omkring maven hos hiv-smittede patienter med lipodystrofi.
English: It was to be available as a powder to be made up into a solution for injection.
Danish: Det var hensigten, at det skulle leveres som et pulver til fremstilling af en injektionsvæske, opløsning.
English: The studies compared Egrifta with placebo (a dummy treatment), and the main measure of effectiveness was the change in abdominal fat after 26 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i mængden af fedt på maven efter 26 ugers behandling.
English: Tesamorelin is expected to act in a similar way to GRF, causing the release of growth hormone, which is then expected to increase the breakdown of fat in HIV patients with lipodystrophy, thereby reducing excess fat in the abdomen.
Danish: Tesamorelin forventes at virke ligesom GRF og medføre frigivelse af væksthormon.
English: This summary was last updated in 06-2013.
Danish: Dette sammendrag blev sidst ajourført i 06-2013.
English: This is a summary of the European public assessment report (EPAR) for MACI.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MACI.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
English: The full EPAR for MACI can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for MACI findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is MACI and what is it used for?
Danish: Hvad er MACI, og hvad anvendes det til?
English: matrix applied characterised autologous cultured chondrocytes
Danish: matrix-applicerede karakteriserede dyrkede autologe chondrocytter
English: The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
Danish: Undersøgelsen omfattede 144 voksne, der havde defekter med et areal mellem 3 og 20 cm2.
English: A risk management plan has been developed to ensure that MACI is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at MACI anvendes så risikofrit som muligt.
English: The CHMP's recommendation is based on an initial assessment by the CAT.
Danish: CHMP's anbefalinger er baseret på denne indledende vurdering i CAT.
English: What measures are being taken to ensure the safe and effective use of MACI?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af MACI?
English: What are the risks associated with MACI?
Danish: Hvilke risici er der forbundet med MACI?
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 anvendes til at reparere,
English: Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Danish: Overdreven bruskvækst og løsning af implantatet kan forekomme hos mellem 1 og 10 ud af hver 1 000 patienter behandlet med MACI.
English: It is not intended to provide practical advice on how to use MACI.
Danish: Det er ikke en praktisk vejledning i, hvordan MACI bør anvendes.
English: MACI must also not be used in patients whose growth plates in the thigh bone have not fully closed.
Danish: MACI må heller ikke anvendes hos patienter, hos hvem vækstpladerne i lårknoglen ikke er helt lukket.
English: MACI should only be used by a surgeon specifically trained and qualified to use it and the product can
Danish: MACI bør kun anvendes af en kirurg, der er særlig oplært og kvalificeret til at anvende det, og produktet fås kun på recept.
English: The other important risks are those related to the surgical procedure itself, including infection, inflammation, haemoarthrosis (blood in the joints), arthrofibrosis (scar tissue in the joints), and thromboembolic events (blood clots).
Danish: Andre vigtige risici er dem, der er forbundet med selve det kirurgiske indgreb, herunder infektion, inflammation, hæmartron (blødning i leddet), artrofibrose (ardannelse i leddet) og tromboemboliske hændelser (blodpropper).
English: MACI is an advanced therapy product called a ‘tissue engineered product'.
Danish: MACI er et lægemiddel til avanceret terapi, som kaldes et “produkt fremstillet ved vævsteknik”.
English: How does MACI work?
Danish: Hvordan virker MACI?
English: It consists of the patient's own cartilage cells on 14.5 cm2 collagen membranes, which are used by a surgeon to fill in the spaces where cartilage is damaged.
Danish: Det består af patientens egne bruskceller på 14,5 cm2 kollagenmembraner, som af kirurgen anvendes til at udfylde de mellemrum, hvor brusken er beskadiget.
English: The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in
Danish: Udvalget konstaterede, at lægemidler som MACI i forvejen er velkendte i klinisk praksis, og at resultaterne af hovedundersøgelsen var i overensstemmelse med resultaterne fra den videnskabelige litteratur.
English: The cells are then placed onto the collagen membrane.
Danish: Derefter anbringes cellerne på kollagenmembranen.
English: As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Danish: Da MACI er et lægemiddel til avanceret terapi, blev det først vurderet i Udvalget For Avancerede Terapier (CAT).
English: The study showed that MACI is more effective than microfracture surgery at relieving pain and improving knee function: two years after surgery, patients treated with MACI had an average score of 82 for pain and 61 for knee function, compared with 71 and 49 respectively for patients treated with microfracture surgery.
Danish: Undersøgelsen viste, at MACI er mere effektivt end mikrofrakturoperation til at lindre smerter og forbedre knæfunktionen: To år efter operationen havde patienter, der var behandlet med MACI, en gennemsnitsscore på 82 for smerter og 61 for knæfunktion, sammenlignet med henholdsvis 71 og 49 for patienter behandlet med mikrofrakturoperation.
English: In the first stage of treatment, a sample of cartilage cells is taken from the patient's joint and grown in a laboratory.
Danish: I første trin af behandlingen udtages en prøve af bruskceller fra patientens led og dyrkes i laboratoriet.
English: Growth plates close (or harden) when a child has become skeletally mature and their bones have stopped growing.
Danish: Vækstpladerne lukker sig (eller bliver hårde), når et barns knogler er færdigudvokset.
English: The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Danish: Det aktive stof i MACI består af patientens egne bruskceller, der implanteres i det defekte område af brusken i knæet.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at hovedundersøgelsen havde vist, at MACI var overlegent over mikrofrakturoperation til behandling af bruskdefekter i knæet.
English: MACI is used to repair full-thickness defects with a surface area of between 3 to 20 cm2 in adults who are experiencing symptoms (such as pain and problems moving the knee).
Danish: MACI anvendes til reparation af defekter, der går helt igennem brusken og har et overfladeareal på mellem 3 og 20 cm2 hos voksne med symptomer (såsom smerter og nedsat bevægelighed af knæet).
English: MACI must not be used in patients with severe osteoarthritis (swelling and pain) of the knee, inflammatory joint disease, or uncorrected inborn blood clotting disorders.
Danish: MACI må ikke anvendes hos patienter med svær osteoartritis (slidgigt med hævelse og smerter) i knæene, inflammatoriske ledsygdomme eller ubehandlede medfødte forstyrrelser i blodets koagulation.
English: For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
Danish: Både med hensyn til smerter og funktion var bedringen ca. 45 point hos patienter behandlet med MACI, sammenholdt med ca. 35 point hos patienter, der fik foretaget mikrofrakturoperation.
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, der anvendes til at reparere defekter i brusken på enderne af knoglerne i knæleddet.
English: For more information about treatment with MACI, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med MACI, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: A standard scale, known as the ‘knee injury and osteoarthritis outcome score' (KOOS), was used to measure pain and knee function, where 0 reflects extreme problems and 100 reflects an absence of problems.
Danish: Smerter og knæfunktion blev bedømt på en standardskala for udfaldet ved knæskader og osteoartritis (KOOS), hvor 0 betyder meget ekstreme problemer, og 100 betyder ingen problemer.
English: The cells are used to fill in the space where the cartilage has been damaged, thereby regenerating the damaged areas and helping to resolve the patient's symptoms such as pain and problems moving the knee.
Danish: Cellerne anvendes til at udfylde det mellemrum, hvor brusken er beskadiget, så de beskadigede områder repareres, og der opnås bedring i patientens symptomer i form af smerter og
English: Around 6 weeks later, the surgeon shapes the membrane to fit the damaged area in the knee cartilage and then implants it using a surgical procedure.
Danish: Ca. 6 uger senere tilpasser kirurgen membranen til formen af det beskadigede område af knæets brusk og opererer det derefter ind i knæet.
English: MACI was compared with microfracture surgery (a surgical procedure commonly used to treat cartilage defects) in a main study which looked at pain relief and improvements in knee function in patients with full thickness cartilage defects in the knee.
Danish: MACI blev sammenlignet med mikrofrakturkirurgi (en almindeligt anvendt behandling af bruskdefekter) i en hovedundersøgelse, der registrerede smertelindring og forbedring i knæfunktionen hos patienter med knæledsdefekter i hele bruskens tykkelse.
English: What benefits of MACI have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved MACI?
English: The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
Danish: CHMP afgjorde derfor, at fordelene ved MACI overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MACI, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Produktresuméet og indlægssedlen for MACI indeholder sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal overholdes af sundhedspersonale og patienter.
English: For the full list of all side effects reported with MACI,
Danish: Den fuldstændige liste over indberettede bivirkninger med MACI fremgår af indlægssedlen.
English: For practical information about using MACI, patients should read the package leaflet or contact their
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af MACI, kan du læse indlægssedlen eller kontakte
English: In addition, patients treated with MACI had fewer side effects compared with microfracture
Danish: Desuden var der færre bivirkninger hos patienter behandlet med MACI end hos patienter behandlet
English: MACI was evaluated to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the EMA in order to obtain an EU-wide marketing authorisation.
Danish: Ifølge disse regler skal alle sådanne lægemidler i EU's medlemsstater vurderes af EMA for at få udstedt markedsføringstilladelse i hele EU.
English: In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Danish: Materialet skal indeholde detaljeret vejledning i anvendelsen af MACI og information om risiciene og nødvendigheden af opfølgning af patienter, der er behandlet
English: A type of glue known as a fibrin sealant, which is made from blood clotting proteins, is used to hold the implant in place on the cartilage.
Danish: Implantatet fastgøres til brusken med fibrinklæber, som er en lim fremstillet af blodkoagulerende
English: A response is usually seen in two to four weeks.
Danish: Virkningen ses sædvanligvis efter to til fire uger.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Danish: • generaliseret angstsygdom (langvarig angst eller nervøsitet over hverdagsanliggender)
English: The full EPAR and risk management plan summary for Duloxetine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Duloxetine Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This prevents the active substance being destroyed by the acid in the stomach.
Danish: Derved undgås det, at det aktive stof ødelægges af mavesyren.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Mylan on 19 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duloxetine Mylan den 19. juni 2015.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duloxetine Mylan.
English: Patients who also have major depression should start with 60 mg once a day.
Danish: Patienter, der også har svær depression, bør begynde med 60 mg én gang dagligt.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Danish: "Enterokapsler" er kapsler, hvis indhold passerer gennem mavesækken uden at nedbrydes, før det når frem til tarmen.
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne serotonin (5-hydroxytryptamin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: Most patients will need to take 60 mg per day.
Danish: De fleste patienter har brug for 60 mg dagligt.
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Danish: Hos patienter, der har gavn af Duloxetine Mylan, bør behandlingen fortsætte i flere måneder for at undgå, at sygdommen vender tilbage, eller længere hos patienter, der tidligere har haft gentagne perioder med depression.
English: The Committee recommended that Duloxetine Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Duloxetine Mylan godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Duloxetine Mylan anvendes så sikkert som muligt.
English: This means that Duloxetine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Danish: Det betyder, at Duloxetine Mylan er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cymbalta.
English: Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg).
Danish: Duloxetine Mylan fås som enterokapsler (30 og 60 mg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Duloxetine Mylan, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.