FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee noted that there is a plausible mechanism for how these medicines may cause fibrosis, through activation of ‘5-HT2B receptors', leading to cell division and formation of fibrous tissue, although other mechanisms might be involved.
Danish: Udvalget bemærkede, at der er en sandsynlig mekanisme for, hvordan disse lægemidler kan forårsage fibrose gennem aktivering af "5-HT2B-receptorer", som medfører celledeling og dannelse af fibrøst væv, selv om andre mekanismer kan være medvirkende.
English: This group of dopamine agonists are called ‘ergotderived', because they were first produced from a type of fungus called ergot.
Danish: Denne gruppe af dopaminagonister kaldes "ergotderiverede", fordi de først blev fremstillet af en type svamp ved navn ergot.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for these medicines should be maintained.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at markedsføringstilladelserne for disse lægemidler bør opretholdes.
English: QUESTIONS AND ANSWERS ON THE REVIEW OF ERGOT-DERIVED DOPAMINE AGONISTS
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE VURDERING AF ERGOTDERIVEREDE DOPAMINAGONISTER
English: • To reduce the risk of cardiac fibrosis, patients should be prescribed a daily maximum of 3 mg pergolide or cabergoline, or 30 mg bromocriptine.
Danish: • For at nedsætte risikoen for hjerteklapfibrose skal patienterne ordineres en maksimal daglig dosis på 3 mg pergolid eller cabergolin eller 30 mg bromocriptin.
English: Fibrosis can affect a number of body structures such as the heart, the lungs or the abdomen.
Danish: Fibrose kan påvirke en række af strukturerne i kroppen, såsom hjertet, lungerne eller maven.
English: This suggested that cardiac fibrosis may be more common that previously thought.
Danish: Dette antydede, at hjerteklapfibrose muligvis er langt mere almindeligt end hidtil antaget.
English: • Doctors should prescribe ergot-derived dopamine agonists according to the updated prescribing information.
Danish: • Lægerne skal ordinere ergotderiverede dopaminagonister i henhold til de opdaterede ordinationsoplysninger.
English: The CHMP also concluded that the risk of fibrosis, including fibrosis of the heart valves, does not appear to be the same for all five medicines in the class.
Danish: CHMP konkluderede endvidere, at risikoen for fibrose, herunder hjerteklapfibrose, ikke synes at være lige stor for alle fem lægemidler i gruppen.
English: Therefore, the CHMP recommended that the prescribing information for these two medicines should be updated to include:
Danish: CHMP anbefalede derfor, at ordinationsoplysningerne for disse to lægemidler opdateres, så de indeholder:
English: • Ergot-derived dopamine agonists should not be taken by patients who have had fibrosis in the heart, lungs or abdomen.
Danish: • Ergotderiverede dopaminagonister må ikke tages af patienter, som har haft fibrose i hjertet, lungerne eller maven.
English: The CHMP reviewed all of the available information on the risk of fibrosis and valve problems from clinical trials, observational studies (studies looking at the effects of medicines as they are used by patients) and ‘spontaneous reports' of side effects made by patients or doctors to the companies that make the medicines or to health authorities.
Danish: CHMP gennemgik alle de tilgængelige oplysninger om risikoen for fibrose og hjerteklapproblemer fra kliniske undersøgelser, observationsundersøgelser (undersøgelser af lægemidlernes virkning, når de anvendes af patienter) og "spontane rapporteringer" om bivirkninger fra patienter eller læger til de virksomheder, der fremstiller lægemidlerne, eller til sundhedsmyndighederne.
English: The dose of bromocriptine should also be limited to 30 mg a day.
Danish: Dosis af bromocriptin må endvidere ikke overstige 30 mg/dag.
English: • Patients should be monitored for the signs of fibrosis in the heart and elsewhere in the body throughout treatment, using blood tests or chest X-rays as appropriate.
Danish: • Patienterne skal monitoreres for tegn på fibrose i hjertet og andre steder i kroppen gennem hele behandlingsforløbet ved hjælp af blodprøver eller thoraxrøntgen efter behov.
English: However, two studies published in scientific journals using echocardiography (ultrasound scans of the heart) have shown that fibrosis of the heart valves can begin to develop well before symptoms start to appear.
Danish: To undersøgelser, der blev gennemført med anvendelse af ekkokardiografi (ultralydskanning af hjertet), og som blev publiceret i videnskabelige tidsskrifter, har imidlertid vist, at udvikling af fibrose i hjerteklapperne kan begynde, længe før symptomerne begynder at vise sig.
English: The development of the symptoms of fibrosis has been known as a side effect of ergot-derived dopamine agonists for many years, particularly when the medicines are used for long periods.
Danish: Udvikling af symptomer på fibrose har i mange år været en kendt bivirkning af ergotderiverede dopaminagonister, særlig når lægemidlerne anvendes gennem længere tid.
English: For cabergoline and pergolide, the Committee noted that the risk of fibrosis of the heart valves is well established, that the prescribing information for both products already includes contraindications stating that patients with evidence of heart valve problems should not take them, and that the medicines should only be used for Parkinson's disease in patients who have already taken or cannot take other treatments.
Danish: Hvad angår cabergolin og pergolid, bemærkede udvalget, at risikoen for hjerteklapfibrose er veldokumenteret, at ordinationsoplysningerne for begge lægemidler allerede indeholder kontraindikationer, ifølge hvilke disse ikke må anvendes af patienter, der viser symptomer på hjerteklapproblemer, samt at lægemidlerne kun må anvendes til behandling af Parkinsons sygdom hos patienter, som tidligere har modtaget eller ikke kan modtage anden behandling.
English: The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af sikkerheden ved ergotderiverede dopaminagonister, som er en gruppe af lægemidler, der primært anvendes til behandling af Parkinsons sygdom.
English: The CHMP also recommended that companies that make these two medicines should conduct studies to look at how closely doctors follow the updated prescribing information and the impact that these changes have on the incidence of fibrosis of the heart valves.
Danish: CHMP anbefalede også, at virksomheder, der fremstiller de to lægemidler, gennemfører undersøgelser med henblik på at klarlægge, hvor nøje lægerne følger de opdaterede ordinationsoplysninger, og de virkninger, som disse ændringer har på forekomsten af hjerteklapfibrose.
English: • ‘cardiac fibrosis' as a ‘very common' side effect (seen in more than 1 patient in 10 taking either medicine).
Danish: • angivelse af "hjerteklapfibrose" som en "meget almindelig" bivirkning (ses hos mere end 1 ud af
English: They are also used to treat conditions including hyperprolactinaemia (high levels of the hormone prolactin in the blood) and prolactinoma (a non-cancerous tumour of the pituitary gland at the base of the brain), and to prevent lactation (production of breast milk) and migraine.
Danish: De anvendes endvidere til behandling af blandt andet hyperprolaktinæmi (høje koncentrationer af hormonet prolaktin i blodet) og prolaktinomer (godartet tumor på hypofysen på undersiden af hjernen) samt til forebyggelse af laktation (produktion af modermælk) og migræne.
English: However, since such a risk cannot completely be excluded, the Committee recommended that warnings on the possible risk of fibrosis in patients taking these medicines at high doses for long periods should be included in their prescribing information.
Danish: Eftersom en sådan risiko ikke fuldstændig kan udelukkes, anbefalede udvalget dog, at ordinationsoplysningerne for patienter, der tager disse lægemidler ved høje doser gennem længere tid, skal indeholde en advarsel om den potentielle risiko for fibrose.
English: In contrast, there is not enough evidence to determine whether there is an increased risk of fibrosis of the heart valves in patients taking bromocriptine, dihydroergocryptine or lisuride.
Danish: Der er derimod ikke tilstrækkelig dokumentation til at afgøre, hvorvidt der er en øget risiko for hjerteklapfibrose hos patienter, der behandles med bromocriptin, dihydroergocryptin eller lisurid.
English: Ergot-derived dopamine agonists are a group of medicines consisting of bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Danish: Ergotderiverede dopaminagonister er en gruppe af lægemidler bestående af bromocriptin, cabergolin, dihydroergocryptin, lisurid og pergolid.
English: The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves).
Danish: Der blev i vurderingen lagt fokus på risikoen for fibrose (dannelse af fibrøst væv i visse strukturer i kroppen) hos patienter, der behandles med disse lægemidler gennem længere tid, navnlig hjerteklapfibrose (unormal fortykkelse af hjerteklapperne).
English: Dopamine agonists work by stimulating brain and nerve cells in a similar way to dopamine, a messenger substance in the nervous system.
Danish: Dopaminagonister virker ved at stimulere hjerne- og nerveceller på samme måde som dopamin, som er et signalstof i nervesystemet.
English: Why have ergot-derived dopamine agonists been reviewed?
Danish: Hvorfor blev ergotderiverede dopaminagonister vurderet igen?
English: Based on the information available, the CHMP has concluded that the marketing authorisations for the ergot-derived dopamine agonists should be maintained, but changes to the prescribing information for the medicines should be introduced to reduce the risk of fibrosis.
Danish: CHMP har på baggrund af de tilgængelige oplysninger konkluderet, at markedsføringstilladelserne for ergotderiverede dopaminagonister bør opretholdes, men der bør med henblik på at nedsætte risikoen for fibrose indføres ændringer i ordinationsoplysningerne for lægemidlerne.
English: What are ergot-derived dopamine agonists?
Danish: Hvad er ergotderiverede dopaminagonister?
English: Among the ergot-derived dopamine agonists, cabergoline and pergolide activate these receptors most strongly, possibly explaining the greater risk of fibrosis seen with these medicines.
Danish: Ud af de ergotderiverede dopaminagonister er det cabergolin og pergolid, der forårsager den stærkeste aktivering af disse receptorer, hvilket kan være en forklaring på, hvorfor disse lægemidler medfører en større risiko for fibrose.
English: Consequently, the United Kingdom's medicines regulatory authority asked the CHMP to review the risk of fibrosis, including cardiac fibrosis, associated with the use of ergot-derived dopamine agonists.
Danish: Det Forenede Kongeriges lægemiddelmyndighed anmodede derfor CHMP om at vurdere risikoen for fibrose, herunder hjerteklapfibrose, i forbindelse med anvendelsen af ergotderiverede dopaminagonister.
English: The absence of fibrosis in the heart should be verified before treatment is started.
Danish: Inden behandlingsstart skal det kontrolleres, at der ikke forekommer fibrose i hjertet.
English: • a warning stating that patients must be monitored for signs of fibrosis with echocardiography before treatment is started and regularly during treatment;
Danish: • en advarsel om, at patienter skal monitoreres for tegn på fibrose ved hjælp af ekkokardiografi,
English: In addition, the CHMP recommended that a contraindication for patients with pre-existing valve problems should be included in the prescribing information for bromocriptine and dihydroergocryptine-containing medicines.
Danish: CHMP anbefalede også, at der i ordinationsoplysningerne for lægemidler indeholdende bromocriptin og dihydroergocryptin skal indgå en kontraindikation for patienter med allerede eksisterende hjerteklapproblemer.
English: --1 ≥ 394AU/ml (Antigenic units determined by ELISA) (1400 AU corresponding to ≥ 492 AU in the potency test)
Danish: --1 : ≥ 394 AE/ml (Antigen enheder målt ved ELISA-metoden) (1400 AE svarende til ≥ 492 AE i potency test)
English: Vial (type I glass) closed with a rubber stopper secured with aluminium cap
Danish: Hætteglas (type I glas) lukket med gummiprop forseglet med aluminiums-hætte
English: 10 vials Zero days
Danish: 10 hætteglas 0 dage
English: Strength Pharmaceutical form
Danish: EU-nummer Særnavn Styrke Lægemiddel¬ form
English: Target species
Danish: Dyrearter, som læge-midlet er beregnet til
English: It was to be available as 10 mg tablets.
Danish: Det var hensigten, at det skulle leveres som 10 mg tabletter.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: What is Jenzyl?
Danish: Hvad er Jenzyl?
English: Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Jenzyl (ridaforolimus)
English: 14 December 2012 EMA/807998/2012 EMEA/H/C/2259
Danish: Den 14. december 2012 EMA/20325/2013
English: This is expected to slow down the growth and proliferation of cancer cells.
Danish: Dette forventes at bremse kræftcellernes vækst og formering.
English: Jenzyl is a medicine that contains the active substance ridaforolimus.
Danish: Jenzyl er et lægemiddel, der indeholder det aktive stof ridaforolimus.
English: What was Jenzyl expected to be used for?
Danish: Hvad forventedes Jenzyl anvendt til?
English: The study compared Jenzyl with placebo (a dummy treatment).
Danish: I undersøgelsen blev Jenzyl sammenlignet med placebo (virkningsløs behandling).
English: The CHMP considered this benefit to be modest, when taking into account that patients usually survived for a long time after their disease had progressed.
Danish: CHMP fandt denne fordel beskeden, når det tages i betragtning, at patienterne sædvanligvis overlevede længe efter, at sygdommen var skredet frem.
English: The company had not yet responded to the last round of questions at the time of the withdrawal.
Danish: Virksomheden havde endnu ikke besvaret den sidste række spørgsmål, da ansøgningen blev trukket tilbage.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list 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 Jenzyl expected to work?
Danish: Hvordan forventes Jenzyl at virke?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Jenzyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma and primary malignant bone tumours).
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Jenzyl findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (bløddelssarkom og primære ondartede knoglesvulster).
English: In terms of safety, the CHMP was concerned by the high frequency of side effects interfering with the patient's wellbeing as well as some uncommon but potentially lifethreatening side effects.
Danish: Hvad sikkerheden angår, var CHMP betænkelig ved den store hyppighed af bivirkninger, der påvirkede patienternes velvære, foruden visse ualmindelige bivirkninger, der kunne være livstruende.
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, ridaforolimus prevents the division of tumour cells and reduces their blood supply.
Danish: Da mTOR medvirker ved styringen af cellernes deling og blodkarrenes vækst, forhindrer ridaforolimus kræftcellerne i at dele sig og nedsætter deres blodforsyning.
English: The CHMP also considered that the somewhat larger effect seen in patients who had received two or three previous regimens of chemotherapy compared with those who received one or more regimens might not reflect the medicine's true effect size, as the reason the medicine would work better at later stages of the disease was unclear.
Danish: CHMP fandt desuden, at den iagttagne noget større virkning hos patienter, som havde fået to eller tre forskellige forudgående behandlinger med kemoterapi, sammenlignet med dem, der havde fået én eller flere behandlinger, ikke nødvendigvis afspejler størrelsen af lægemidlets virkning, da det er uklart, hvorfor lægemidlet skulle virke bedre i senere stadier af sygdommen.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Jenzyl?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Jenzyl.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Jenzyl.
English: The main measure of effectiveness was the time patients lived until their disease got worse.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil sygdommen forværredes.
English: What were the reasons given by the company for withdrawing the application?
Danish: Hvilken begrundelse gav virksomheden for tilbagetrækningen af ansøgningen?
English: The CHMP was concerned that taking Jenzyl only led to a small increase in the time patients lived until their disease got worse compared with placebo (18 versus 15 weeks in patients who had one or more regimens of previous chemotherapy, and 16 versus 10 weeks in patients who had received two or three previous regimens of chemotherapy).
Danish: CHMP var betænkelig ved, at indtagelse af Jenzyl i forhold til placebo kun medførte en lille forlængelse af den tid, patienterne levede, indtil sygdommen blev værre (18 mod 15 uger hos patienter, der havde fået én eller flere forudgående behandlinger med kemoterapi, og 16 uger mod 10 uger hos patienter, der havde fået to eller tre forudgående behandlinger med kemoterapi).
English: On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy.
Danish: Den 27. november 2012 meddelte Merck Sharp & Dohme Limited officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at trække sin ansøgning om markedsføringstilladelse for Jenzyl tilbage til behandling af patienter med metastatisk bløddelssarkom eller knoglesarkom, der tidligere er behandlet med kemoterapi.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Jenzyl did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Jenzyl ikke var tilfredsstillende påvist og ikke større end risiciene.
English: The company presented the results of one main study involving 711 patients with metastatic soft tissue sarcoma or bone sarcoma who have received up to four cycles of one, two or three alternative chemotherapy regimens.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 711 patienter med metastatisk bløddelssarkom eller knoglesarkom, der havde fået op til fire kure med én, to eller tre alternative kemoterapibehandlinger.
English: It was expected to be used as maintenance therapy in patients who have already received two or three regimens of chemotherapy.
Danish: Jenzyl forventedes anvendt til vedligeholdelsesbehandling af patienter, der i forvejen har fået to eller tre forskellige typer kemoterapi.
English: Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma (a type of cancer that affects the soft, supporting tissues of the body) or bone sarcoma (bone cancer) that are metastatic (have spread to other parts of the body).
Danish: Jenzyl forventedes anvendt til behandling af voksne med bløddelssarkom (en kræfttype, der angriber kroppens bløde støttevæv) eller knoglesarkom (knoglekræft), som er metastatisk (dvs. har bredt sig til andre dele af kroppen).
English: The active substance in Jenzyl, ridaforolimus, blocks the action of an enzyme called ‘mammalian target of rapamycin' (mTOR), which regulates the growth and division of cells in the body and which has increased activity in patients with sarcoma.
Danish: Det aktive stof i Jenzyl, ridaforolimus, blokerer enzymet mTOR ("mammalian target of rapamycin"), der regulerer vækst og deling af kroppens celler.
English: In the body, ridaforolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Danish: I kroppen bindes ridaforolimus først til proteinet FKBP-12 og danner derved et kompleks med dette.
English: Jenzyl was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 August 2005 and 28 October 2005 for the treatment of soft tissue sarcoma and primary malignant bone tumours.
Danish: Den 26. august 2005 blev Jenzyl udpeget som "lægemiddel til sjældne sygdomme", og den 28. oktober 2005 blev det godkendt til behandling af bløddelssarkom og primære ondartede knoglesvulster.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it decided to withdraw the application since 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 på det forelagte grundlag ikke kunne konkludere, at benefit/risk-forholdet er positivt.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy.
Danish: Udvalgets foreløbige standpunkt var, at Jenzyl ikke kunne godkendes til vedligeholdelsesbehandling af patienter med metastatisk bløddelssarkom eller knoglesarkom.
English: 5 x 2 tablets
Danish: 5 χ 2 tabletter
English: Package sizes perforated unit dose blister (PVC/Alu)
Danish: Oral anvendelse perforeret enkeltdosisblister (PVC/aluminium)
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: MA (EU) number (Invented) name
Danish: MF (EU)nummer
English: This difference was not statistically significant.
Danish: Denne forskel var ikke statistisk signifikant.
English: These measures will help to protect the environment.
Danish: Disse forholdsregler vil hjælpe med at beskytte miljøet.
English: Frequencies are defined as:
Danish: Frekvenserne er defineret som:
English: Therefore, these findings are considered to be incidental.
Danish: Derfor anses disse resultater for at være tilfældige.
English: Summary of the safety profile:
Danish: Resumé af sikkerhedsprofilen:
English: The significance for man is unknown.
Danish: Betydningen for mennesker er ukendt.
English: 30 months
Danish: 30 måneder.
English: This includes studies with immunosuppressive medicinal products.
Danish: Dette inkluderer studier med immunosuppresive lægemidler.
English: Dry hands thoroughly and allow the area to dry.
Danish: Tør hænderne grundigt og lad området tørre.