FrancophonIA/ELRC3.0 huggingface dataset:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Livensa.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Livensa.
English: The two main studies involved 1,095 women with an average age of 49 years who received Livensa for up to a year.
Danish: De to hovedundersøgelser omfattede 1 095 kvinder med en gennemsnitsalder på 49 år, som havde fået Livensa i op til et år.
English: The active substance in Livensa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Danish: Det aktive stof i Livensa, testosteron, er et naturligt kønshormon, der produceres hos mænd og i mindre grad hos kvinder.
English: The CHMP decided that Livensa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Livensa opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The full EPAR for Livensa can be found here.
Danish: Den fuldstændige EPAR for Livensa findes her.
English: For more information about treatment with Livensa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Livensa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Livensa was compared with placebo (a patch containing no active substance).
Danish: Livensa blev sammenlignet med placebo (et plaster, som intet aktivt stof indeholder).
English: Women using Livensa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Livensa is not as effective as the combination of other types of oestrogen with Livensa.
Danish: Kvinder, der anvender Livensa, bør også tage østrogener, men ikke af den type, der er kendt som ‘konjugerede østrogener', da denne kombination ikke er lige så effektiv sammen med Livensa som kombinationen af andre typer østrogen og Livensa.
English: The company will review all of the ongoing studies with Livensa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Danish: Det skal gennemgå alle igangværende undersøgelser med Livensa for at se på de potentielle langsigtede risici, herunder brystkræft, endometriecancer (livmoderslimhindekræft) og bivirkninger, der påvirker hjertet og blodkarrene.
English: What measures are being taken to ensure the safe use of Livensa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Livensa?
English: It must not be used in women who have or have had breast cancer or another oestrogen-dependent cancer, or who have other conditions that mean that they cannot take oestrogen-containing medicines.
Danish: Det bør heller ikke anvendes af kvinder der har, eller har haft, brystkræft eller andre østrogenkrævende kræfttyper, eller af kvinder der har andre lidelser, der gør at de ikke kan tage østrogenholdige lægemidler.
English: Livensa is a transdermal patch (a patch that delivers a medicine across the skin).
Danish: Livensa er et transdermalt plaster (et plaster, der afgiver et lægemiddel gennem huden).
English: Livensa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Danish: Livensa bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for testosteron eller overfor nogen af indholdsstofferne.
English: Because testosterone is a male sex hormone, women who are taking Livensa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Danish: Da testosteron er et mandligt kønshormon, bør kvinder, der tager Livensa, overvåges med henblik på at se, om de udvikler 'androgene bivirkninger' (mandlige karaktertræk) såsom hårvækst i ansigtet, dybere stemme, hårtab.
English: Livensa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Danish: Livensa frigiver testosteron gennem huden ind i blodbanen for at opnå testosteronniveauer, der ligner niveauerne inden fjernelsen af livmoderen og æggestokkene.
English: The most common side effects with Livensa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Danish: De mest almindelige bivirkninger ved Livensa (som ses hos flere end 1 ud af 10 patienter) var hirsutisme (øget hårvækst, navnlig på hage og overlæben) og reaktioner på det sted, hvor plastret blev sat på (rødme, og kløe).
English: The company that makes Livensa will monitor some of the side effects of Livensa closely, such as its androgenic side effects.
Danish: Firmaet, som fremstiller Livensa, skal nøje overvåge nogle af bivirkningerne ved Livensa såsom de androgene bivirkninger.
English: What is the risk associated with Livensa?
Danish: Hvilken risiko er der forbundet med Livensa?
English: When the results of the two studies were looked at together, the women who used Livensa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Danish: Når resultaterne fra de to undersøgelser blev analyseret sammen, oplevede de kvinder, der anvendte Livensa en gennemsnitlig forbedring på 1,07 tilfredsstillende seksuelle episoder i sammenligning med de kvinder der fik placebo over en fireugers periode.
English: Livensa is used to treat lack of sexual thoughts and desire that is causing distress in women who have had their womb and both ovaries removed.
Danish: Livensa anvendes til behandling af manglende seksuallyst og fravær af seksuelle tanker hos kvinder, der har fået fjernet deres uterus (livmoder) og begge ovarier (æggestokke).
English: Why has Livensa been approved?
Danish: Hvorfor blev Livensa godkendt?
English: On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Livensa for six months.
Danish: Dette betyder i gennemsnit, at kvinder, der inden behandlingen gennemsnitligt havde tre tilfredsstillende seksuelle episoder i en fireugers periode, havde ca. fem sådanne episoder i en fireugers periode efter at havde taget Livensa i seks måneder.
English: What is Livensa used for?
Danish: Hvad anvendes Livensa til?
English: For the full list of all side effects reported with Livensa, see the
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Livensa fremgår af indlægssedlen.
English: How has Livensa been studied?
Danish: Hvordan blev Livensa undersøgt?
English: What benefit has Livensa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Livensa?
English: How is Livensa used?
Danish: Hvordan anvendes Livensa?
English: How does Livensa work?
Danish: Hvordan virker Livensa?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Possia to AstraZeneca on 03 December 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Possia til AstraZeneca den 03 december 2010.
English: The full EPAR for Possia can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Possia findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The effects of Possia were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Possia blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: This is a summary of the European public assessment report (EPAR) for Possia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Possia.
English: The doctor may, for health reasons, tell them not to take aspirin.
Danish: Lægen kan dog af sundhedsmæssige årsager give patienten besked om ikke at tage aspirin.
English: The starting dose of Possia is two tablets taken at once, followed by a regular dose of one tablet taken twice a day.
Danish: Startdosis for Possia er to tabletter samtidig, hvorefter den sædvanlige dosis er én tablet to gange dagligt.
English: They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.
Danish: Patienten skal fortsætte behandlingen i op til et år, medmindre lægen siger, at behandlingen skal afbrydes tidligere.
English: What is the risk associated with Possia?
Danish: Hvilken risiko er der forbundet med Possia?
English: Other information about Possia
Danish: Andre oplysninger om Possia:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Possia.
English: For more information about treatment with Possia, read the package leaflet (also part of the EPAR) or contact your doctor or
Danish: Hvis du ønsker yderligere oplysninger om behandling med Possial, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Possia is a medicine that contains the active substance ticagrelor.
Danish: Possia er et lægemiddel, der indeholder det aktive stof ticagrelor.
English: In the main study, 9.3% of the patients taking Possia had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Danish: I hovedundersøgelsen fik 9,3 % af de patienter, der blev behandlet med Possia, endnu et hjerteanfald, et slagtilfælde eller døde af en hjerte-kar-sygdom sammenlignet med 10,9 % af de patienter, der blev behandlet med clopidogrel.
English: The CHMP noted that the main study showed that, compared with clopidogrel, Possia reduces the risk of heart attacks and cardiovascular deaths.
Danish: CHMP bemærkede, at hovedundersøgelsen viste, at Possia, sammenlignet med clopidogrel, reducerede risikoen for hjerteanfald og for dødsfald forårsaget af hjerte-kar-sygdomme.
English: The CHMP decided that Possia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Possia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Danish: Ticagrelor forhindrer blodpladerne i at aggregere ved at forhindre funktionen af et stof, der kaldes ADP, når det binder sig til blodpladernes overflade.
English: Possia should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients.
Danish: Possia bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for ticagrelor eller andre af indholdsstofferne.
English: The most common side effects with Possia (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured).
Danish: De hyppigste bivirkninger ved Possia (som optræder hos mellem 1 og 10 patienter ud af 100) er dyspnø (vejrtrækningsproblemer), epistaxis (næseblod), gastrointestinale blødninger (blødninger i mave eller tarme), blødning i huden eller under huden, blå mærker og blødning fra indstikssted (hvor der er stukket hul på et blodkar).
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent a stroke or another heart attack.
Danish: Det får blodpladerne til at holde op med at "klæbe sammen", hvilket mindsker risikoen for, at der opstår en blodprop, og er med til at forebygge et slagtilfælde eller endnu et hjerteanfald.
English: These are medicines such as ketoconazole (used to treat fungal infections), clarithromycin (an antibiotic), atazanavir and ritonavir (medicines used in HIV-positive patients) and nefazodone (used to treat depression).
Danish: Sådanne lægemidler omfatter bl.a. ketoconazol (mod svampeinfektioner), clarithromycin (et antibiotikum), atazanavir og ritonavir (mod hiv-infektion) og nefazodon (mod depression).
English: The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.
Danish: Det primære effektmål var baseret på, hvor mange patienter der fik et nyt hjerteanfald, et slagtilfælde eller der døde af en hjertekar-sygdom.
English: Patients should also be taking aspirin as directed by their doctor.
Danish: Patienter, der tager Possia, skal også tage aspirin, som anvist af lægen.
English: Possia was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Danish: Possia blev sammenlignet med clopidogrel (et andet stof, der hæmmer blodpladernes aggregation) i en hovedundersøgelse med over 18.000 voksne, som havde haft et hjerteanfald eller havde ustabil angina pectoris.
English: The active substance in Possia, ticagrelor, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Possia, ticagrelor, hæmmer blodpladernes aggregation.
English: Possia was shown to be beneficial to patients who have had a heart attack or unstable angina.
Danish: Possia viste sig af have en gavnlig virkning for patienter, der har haft et hjerteanfald eller har ustabil angina pectoris.
English: Possia is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Danish: Possia anvendes sammen med aspirin til forebyggelse af aterotrombotiske hændelser (problemer, der skyldes blodpropper og åreforkalkning), såsom hjerteanfald og slagtilfælde.
English: It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain.
Danish: Det må ikke anvendes hos patienter, som lider af en moderat til svær leversygdom, som har en aktiv blødning, eller som har haft et slagtilfælde, der skyldtes en blødning i hjernen.
English: However Possia was not more effective than clopidogrel in
Danish: Possia var imidlertid ikke mere effektivt end clopidogrel til at reducere risikoen for slagtilfælde.
English: It is available as round, yellow
Danish: Det fås som runde, gule tabletter (90 mg).
English: It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to
Danish: Det anvendes hos voksne, som har haft et hjerteanfald eller har ustabil angina pectoris (en type smerter i brystet, der skyldes problemer med hjertets blodforsyning).
English: For the full list of all side effects reported with Possia, see the
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Possia fremgår af indlægssedlen.
English: What benefit has Possia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Possia?
English: How does Possia work?
Danish: Hvordan virker Possia?
English: It must not be used in the following groups:
Danish: Det må ikke anvendes til følgende grupper:
English: • patients whose bones are still growing such as children and adolescents.
Danish: • patienter, hvis knogler stadig vokser, såsom børn og unge.
English: The full EPAR for Opgenra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Opgenra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Opgenra on 19 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Opgenra den 19. februar 2009.
English: Other information about Opgenra
Danish: Andre oplysninger om Opgenra
English: The company will also submit plans for long-term studies to the CHMP.
Danish: Virksomheden indsender også sine planer for langtidsundersøgelser til CHMP.
English: This is a summary of the European public assessment report (EPAR) for Opgenra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Opgenra.
English: The effects of Opgenra were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Opgenra blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness was the number of patients whose treatment was successful after two years.
Danish: Det primære effektmål var antallet af patienter, for hvem behandlingen var vellykket efter to år.
English: Eptotermin alfa has been authorised in the European Union (EU) since May 2001 in Osigraft.
Danish: Eptotermin alfa har været godkendt i EU siden maj 2001 i Osigraft.
English: • patients with cancer or being treated for cancer;
Danish: • patienter med cancer eller i behandling for cancer;
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Opgenra.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Opgenra.
English: The company that makes Opgenra will provide educational packs and training DVDs for surgeons in each Member State.
Danish: Den virksomhed, der fremstiller Opgenra, leverer pakker med uddannelsesmateriale og undervisningsdvd'er til kirurger i hver medlemsstat.
English: These studies will look at the medicine's safety and effectiveness, and how it is used in real life.
Danish: Disse undersøgelser har til formål at undersøge lægemidlets sikkerhed og virkning og at undersøge, hvordan det anvendes i det virkelige liv.
English: For more information about treatment with Opgenra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Opgenra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This can cause pain, instability, and problems due to pressure on the nerves, including tingling, numbness, weakness and difficulty controlling certain muscles.
Danish: Dette kan forårsage smerter, ustabilitet og problemer på grund af tryk på nerverne, herunder snurren, følelsesløshed, kraftløshed og besvær med at styre bestemte muskler.
English: It is a copy of a protein called osteogenic protein 1, also known as bone morphogenic protein 7 (BMP-7), which is produced naturally by the body and helps the formation of new bone tissue.
Danish: Det er en kopi af et protein ved navn osteogent protein 1, også kaldet bone morphogenic protein 7 (BMP-7), som produceres naturligt i kroppen og er medvirkende ved dannelsen af nyt knoglevæv.
English: The Committee recommended that Opgenra be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Opgenra.
English: • patients who have an active infection at the operation site or have had repeated infections;
Danish: • patienter, som har haft en aktiv infektion ved operationsstedet eller har haft gentagne infektioner;
English: • patients with an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue);
Danish: • patienter med autoimmun sygdom (en sygdom, hvor kroppens eget immunsystem angriber normalt væv);
English: • patients who have received a medicine containing BMP in the past;
Danish: • patienter, som tidligere har fået behandling med et lægemiddel indeholdende BMP;
English: EPAR summary for the public eptotermin alfa
Danish: EPAR - sammendrag for offentligheden eptotermin alfa
English: Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce eptotermin alfa.
Danish: Eptotermin alfa fremstilles ved en metode, der kaldes "rekombinant DNA-teknologi": Det fremstilles af celler, der har modtaget et gen (DNA), som gør dem i stand til at producere eptotermin alfa.
English: After two years, treatment with Opgenra was successful in 39% of the patients, compared with 49% with autograft.
Danish: Efter to år var behandling med Opgenra vellykket hos 39 % af patienterne, sammenlignet med 49 % af de patienter, som havde fået behandling med autologt knogletransplantat.
English: The company also used some of the data used to support the authorisation of Osigraft.
Danish: Ansøgeren anvendte også nogle af de data, der blev anvendt ved ansøgningen om godkendelse af Osigraft.
English: In addition, Opgenra had advantages over autograft, including shorter operations, less blood loss and less pain.
Danish: Derudover havde Opgenra nogle fordele frem for behandling med autologt knogletransplantat, heriblandt kortere operationer, mindre blodtab og færre smerter.
English: The replacement eptotermin alfa acts in the same way as naturally produced BMP-7.
Danish: Det kunstigt tilførte eptotermin alfa virker på samme måde som naturligt produceret BMP-7.
English: The company also presented evidence from the published scientific literature on patients treated in the United States of America (USA), where the medicine has been approved as a medical device for spine fusion since 2004.
Danish: Ansøgeren fremlagde også data fra faglitteraturen om patienter, der havde fået behandling i USA, hvor lægemidlet har været godkendt som medicinsk udstyr til rygsøjlesammensmeltning siden 2004.
English: What is the risk associated with Opgenra?
Danish: Hvilken risiko er der forbundet med Opgenra?
English: • patients who do not have adequate skin covering or blood supply at the operation site;
Danish: • patienter, som ikke har tilstrækkeligt med hud til at dække operationsstedet eller tilstrækkelig blodcirkulation ved operationsstedet;
English: Opgenra has been studied in one main study involving 336 patients who needed spinal fusion surgery for spondylolisthesis.
Danish: Opgenra er blevet undersøgt i én hovedundersøgelse med 336 patienter, som havde behov for sammensmeltende kirurgi i rygsøjlen ved behandling af spondylolistese.
English: Opgenra is a medicine that contains the active substance eptotermin alfa.
Danish: Opgenra er et lægemiddel, der indeholder det aktive stof eptotermin alfa.
English: It is supplied as two vials, one containing eptotermin alfa and another containing a substance called carmellose.
Danish: Det leveres i to hætteglas, hvoraf det ene indeholder eptotermin alfa, og det andet indeholder et stof kaldet carmellose.