FrancophonIA/ELRC3.0 huggingface dataset:
English: On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Danish: Den 13. januar 2017 meddelte Amgen Europe BV officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Xgeva til behandling af hyperkalcæmi af malignitet (højt calciumniveau i blodet forårsaget af cancer).
English: It contains the active substance denosumab and is available as a solution to be injected under the skin.
Danish: Det indeholder det aktive stof denosumab og fås som en injektionsvæske til injektion under huden.
English: Xgeva was also expected to be used to reduce hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer) that did not respond to previous treatment with medicines called bisphosphonates.
Danish: Xgeva forventedes også anvendt til at reducere hyperkalcæmi af malignitet (højt calciumniveau i blodet forårsaget af cancer), som ikke reagerede på tidligere behandling med lægemidler kaldet bisfosfonater.
English: Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments.
Danish: Da patienterne endvidere var i andre former for behandling af hyperkalcæmi eller for nylig havde stoppet behandlingen med bisfosfonater, var det ikke muligt at fastslå virkningens omfang, eller om de fordele, der blev observeret i undersøgelsen, skyldtes Xgeva eller var virkningerne af disse andre behandlinger.
English: Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Danish: Xgeva er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med en solid tumor, der har spredt sig til knoglerne.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application because the CHMP considered the data provided insufficient to conclude that the benefits of Xgeva outweighed its risks in the treatment of hypercalcaemia caused by cancer.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi CHMP fandt, at de fremlagte data var utilstrækkelige til at konkludere, at fordelene ved Xgeva opvejede risiciene ved behandling af hyperkalcæmi forårsaget af cancer.
English: The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Danish: Virksomheden har til CHMP oplyst, at der for øjeblikket ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Xgeva.
English: The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Danish: CHMP fandt, at der var flere problemer med hovedundersøgelsen, som gjorde, at det ikke var muligt for udvalget at drage konklusioner om virkningen af Xgeva: Undersøgelsen sammenlignede ikke Xgeva med nogen anden behandlingsform og omfattede kun et lille antal patienter; det fremgik ikke klart, om patienternes sygdom havde reageret på bisfosfonater, da patienternes tidligere calciumniveauer ikke var tilgængelige.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Xgeva ikke kunne være blevet godkendt til behandling af hyperkalcæmi forårsaget af cancer, der ikke reagerede på behandling med bisfosfonater.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Danish: Xgeva anvendes desuden til behandling af kæmpecelletumor, der er en form for knoglekræft hos voksne og unge med fuldt udviklede knogler.
English: How does Xgeva work?
Danish: Hvordan virker Xgeva?
English: There were also concerns over the quality of the medicine.
Danish: Endvidere var der betænkelighed ved lægemidlets kvalitet.
English: London, 16 August 2007 Doc.
Danish: London, den 16. august 2007 Ref.dok.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for RETISERT
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for RETISERT
English: International non-proprietary name (INN): fluocinolone acetonide
Danish: Internationalt fællesnavn (INN): fluocinolonacetonid
English: The study was still ongoing at the time of assessment, but was designed to last a total of three years.
Danish: Undersøgelsen var stadig i gang på bedømmelsestidspunktet, men skulle i alt vare i tre år.
English: What is RETISERT?
Danish: Hvad er RETISERT?
English: What are the consequences of the withdrawal for patients undergoing clinical trials with RETISERT?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med RETISERT?
English: The effects of RETISERT were first tested in experimental models before being studied in humans.
Danish: Virkningerne af RETISERT blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The company informed the CHMP that there are no clinical trials with RETISERT ongoing in Europe.
Danish: Firmaet har oplyst til CHMP, at der er ikke er igangværende kliniske undersøgelser med RETISERT i Europa.
English: It contains the active substance fluocinolone acetonide, which is released slowly by the implant over a period of around three years.
Danish: Det indeholder det aktive stof fluocinolonacetonid, der langsomt frigives fra implantatet i løbet af en periode på ca. tre år.
English: On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.
Danish: Den 16. juli 2007 meddelte Bausch & Lomb Ireland officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for RETISERT til behandling af kronisk ikke-infektionsbetinget årehindebetændelse i øjets bageste del. RETISERT blev udpeget som lægemiddel til sjældne sygdomme den 7. marts 2005.
English: Ref. EMEA/342023/2007
Danish: EMEA/482585/2007
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to the questions.
Danish: CHMP havde opstillet en række spørgsmål, som firmaet skulle besvare, hvilket endnu ikke var sket.
English: In addition, the Committee did not consider the main measure of effectiveness to be appropriate for this type of study.
Danish: Desuden fandt udvalget, at den metode, der var anvendt som hovedgrundlag for vurderingen af medicinens virkning, ikke var hensigtsmæssig til en undersøgelse af denne art.
English: It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation.
Danish: Det virker ligesom binyrebarkhormoner (en gruppe naturligt forekommende hormoner) ved at dæmpe immunsystemets aktivitet og mindske betændelse.
English: What was RETISERT expected to be used for?
Danish: Hvad forventedes RETISERT anvendt til?
English: The active substance in RETISERT, fluocinolone acetonide, is a synthetic corticosteroid.
Danish: Det aktive stof i RETISERT, fluocinolonacetonid, er et syntetisk binyrebarkhormon.
English: The main measure of effectiveness was the time taken until the disease came back.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil sygdommen kom igen.
English: The use of RETISERT was also linked to side effects, including eye pain, increased pressure within the eyeball and cataracts, which led to vision problems in some patients.
Danish: Anvendelsen af RETISERT var desuden forbundet med bivirkninger i form af øjensmerter, øget væsketryk i øjet og grå stær, som hos nogle patienter gav problemer med synet.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of RETISERT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved RETISERT ikke var tilfredsstillende godtgjort, og at eventuelle fordele ikke opvejede de fundne risici.
English: How is RETISERT expected to work?
Danish: Hvordan forventedes RETISERT at virke?
English: RETISERT is an intravitreal implant (inserted into the vitreous humour, the jelly-like fluid in the central chamber of the eye).
Danish: RETISERT er et intravitrealt implantat (det indgives i glaslegemet, den geléagtige væske i øjets centrale del).
English: RETISERT was expected to be used to treat chronic (persistent) non-infectious uveitis affecting the posterior (rear) part of the eye.
Danish: RETISERT forventedes anvendt til behandling af kronisk (langvarig) ikke-infektionsbetinget årehindebetændelse i øjets bageste del.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that RETISERT could not have been approved for the treatment of chronic non-infectious uveitis.
Danish: Efter gennemgang af de oplysninger, der forelå på tilbagetrækningstidspunktet, var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at RETISERT ikke kunne godkendes til behandling af kronisk, ikke infektionsbetinget årehindebetændelse.
English: RETISERT was studied in one main study involving 146 patients who had had non-infectious uveitis affecting the posterior part of one or both eyes for at least a year, and had been treated with corticosteroids or immunosuppressant medicines for at least a month.
Danish: Patienterne havde i mindst ét år haft ikke-infektionsbetinget årehindebetændelse i bageste del af det ene eller begge øjne, og de var blevet behandlet med binyrebarkhormon eller immundæmpende medicin i mindst en måned.
English: This is inflammation within the eye, which is not caused by an infection, but which affects areas including the retina (the light-sensitive layer at the back of the eye), and the choroid (the layer below the retina that contains blood vessels).
Danish: Derved forstås en betændelse i øjet, som ikke skyldes en infektion, men som bl.a. angriber nethinden (det lysfølsomme lag på øjets bagvæg) og årehinden (det karførende lag under nethinden).
English: This anti-inflammatory activity was expected to reduce the symptoms of uveitis.
Danish: Det forventedes, at den betændelsesdæmpende virkning ville mindske symptomerne på årehindebetændelsen.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en
English: The effects of RETISERT, implanted into the more severely affected eye, were compared to those of standard care (the use of corticosteroids or immunosuppressant medicines affecting the whole body).
Danish: Virkningerne af RETISERT, implanteret i det hårdest angrebne øje, blev sammenlignet med virkningerne af standardbehandling.
English: The CHMP was concerned that a benefit of RETISERT had not been demonstrated based on the two year results presented in the application, since the patients receiving RETISERT in the main study did not have a longer time until their disease came back than those taking standard care.
Danish: Hos de patienter, der fik RETISERT i hovedundersøgelsen, gik der således ikke længere tid, før sygdommen kom igen, end hos dem, der fik standardbehandling.
English: It is used to treat type 2 diabetes in:
Danish: Det anvendes til behandling af type 2-diabetes hos:
English: It is given as 2 tablets of the appropriate strength once a day with food.
Danish: Det gives som 2 tabletter i den relevante styrke én gang dagligt, taget sammen med mad.
English: Having all three active ingredients in one tablet reduces the number of tablets the patient needs to take and may improve adherence to treatment, which can improve overall management of the disease.
Danish: At have alle tre aktive stoffer i én tablet reducerer antallet af tabletter, som patienten skal tage, og kan forbedre overholdelsen af behandlingen, hvilket kan forbedre den generelle håndtering af sygdommen.
English: Further information on Qtrilmet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/qtrilmet.
Danish: Yderligere information om Qtrilmet findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/qtrilmet.
English: Other information about Qtrilmet
Danish: Andre oplysninger om Qtrilmet
English: As for all medicines, data on the use of Qtrilmet are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Qtrilmet løbende overvåget.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin or when the body cannot use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer nok insulin, eller hvor kroppen ikke kan udnytte insulinet effektivt.
English: Insulin is important for controlling how the body converts glucose (a type of sugar) to energy and how the glucose is stored in the body.
Danish: Insulin er vigtigt for at kunne kontrollere, hvordan kroppen omdanner glukose (en type sukker) til energi, og hvordan glukosen lagres i kroppen.
English: Qtrilmet contains three active substances which all work in different ways.
Danish: Qtrilmet indeholder tre aktive stoffer, som alle virker forskelligt.
English: The HbA1c levels of patients in the studies were at least 8% and treatment was aimed at reducing HbA1c levels to 7% or less.
Danish: HbA1c-niveauet hos patienterne i studierne var mindst 8 %, og behandlingen tog sigte på at reducere mængden af HbA1c til 7 % eller mindre.
English: These studies measured the change in HbA1c levels after 24 weeks of treatment.
Danish: Disse studier målte ændringen i HbA1cindholdet efter 24 ugers behandling.
English: However, reducing doses or interrupting treatment with Qtrilmet is more complicated than using the active ingredients separately.
Danish: Det er dog mere kompliceret at reducere doser eller afbryde behandlingen med Qtrilmet end at anvende de aktive stoffer hver for sig.
English: The European Medicines Agency considered that the combined use of the active ingredients in Qtrilmet produces worthwhile reduction in HbA1c and that all the active ingredients contribute to this effect.
Danish: Det Europæiske Lægemiddelagentur vurderede, at den kombinerede anvendelse af de aktive stoffer i Qtrilmet bevirkede en betydelig reduktion af HbA1c, og at alle aktive stoffer bidrager til denne virkning.
English: What measures are being taken to ensure the safe and effective use of Qtrilmet?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Qtrilmet?
English: Saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, has been authorised in the EU as Onglyza since 2009.
Danish: Saxagliptin, en dipeptidylpeptidase-4 (DPP-4)-hæmmer, har været godkendt i EU under navnet Onglyza siden 2009.
English: What is Qtrilmet and what is it used for?
Danish: Hvad er Qtrilmet, og hvad anvendes det til?
English: HbA1c (glycosylated haemoglobin) is an indicator of glucose levels in the blood over the previous 2 to 3 months.
Danish: HbA1c (glycosyleret hæmoglobin) er en indikator for blodsukkerniveauet i de foregående 2-3 måneder.
English: Why is Qtrilmet authorised in the EU?
Danish: Hvorfor er Qtrilmet godkendt i EU?
English: An overview of Qtrilmet and why it is authorised in the EU
Danish: En oversigt over Qtrilmet, og hvorfor det er godkendt i EU
English: The Agency decided that Qtrilmet's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Qtrilmet opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Qtrilmet are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Qtrilmet vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Qtrilmet can only be obtained with a prescription.
Danish: Qtrilmet fås kun på recept.
English: Dapagliflozin has been authorised in the EU as Forxiga since 2012
Danish: Dapagliflozin har været godkendt i EU under navnet Forxiga siden
English: What are the risks associated with Qtrilmet?
Danish: Hvilke risici er der forbundet med Qtrilmet?
English: • Metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Danish: • Metformin virker hovedsageligt ved at mindske produktionen af glukose og mindske dets optagelse i tarmen.
English: The dose of Qtrilmet is calculated to match the dose of metformin the patient has been taking.
Danish: Qtrilmet-dosen beregnes, så den svarer til den dosis metformin, som patienten hidtil har taget.
English: Qtrilmet must also not be used in patients with certain kidney, liver or heart problems or metabolic acidosis (build-up of acid in the blood), or in patients with certain conditions that can lead to metabolic acidosis.
Danish: Qtrilmet må heller ikke anvendes hos patienter med bestemte nyre-, lever- eller hjerteproblemer eller metabolisk acidose (ophobning af syre i blodet) eller hos patienter med visse sygdomme, der kan føre til metabolisk acidose.
English: • adults whose blood sugar is not controlled well enough with metformin combined with either saxagliptin or dapagliflozin (including those also taking a sulphonylurea, another type of diabetes medicine);
Danish: • voksne, hvis blodsukker ikke kontrolleres tilstrækkeligt med metformin i kombination med enten saxagliptin eller dapagliflozin (herunder dem, der også tager et sulfonylurinstof, en anden type diabeteslægemiddel)
English: It is available in two strengths of tablets containing: metformin 850 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg; and metformin 1,000 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg.
Danish: Det fås i to tabletstyrker, der indeholder: metformin 850 mg, saxagliptin 2,5 mg og dapagliflozin 5 mg; og metformin 1.000 mg, saxagliptin 2,5 mg and dapagliflozin 5 mg.
English: • Saxagliptin blocks the breakdown of incretin hormones, which are released after a meal and cause the pancreas to produce insulin.
Danish: • Saxagliptin blokerer nedbrydningen af inkretinhormoner, som frigives efter et måltid og får bugspytkirtlen til at producere insulin.
English: The most common side effects with Qtrilmet (which may affect more than 1 in 10 people) are infections of the nose and throat, hypoglycaemia (low blood sugar) when used with a sulphonylurea and effects on the gut such as nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Danish: De hyppigste bivirkninger ved Qtrilmet (som kan forekomme hos mere end 1 ud af 10 personer) er infektioner i næse og hals, hypoglykæmi (lavt blodsukker), når det anvendes sammen med et sulfonylurinstof og påvirker tarmen, f.eks. kvalme, opkastning, diarré, mavesmerter og appetitløshed.
English: Diabetes leads to high levels of glucose in the blood.
Danish: Diabetes medfører for højt blodsukker.
English: For the full list of side effects and restrictions of Qtrilmet, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Qtrilmet fremgår af indlægssedlen.
English: Three main studies have shown that the combination of metformin, saxagliptin and dapagliflozin was effective at lowering blood glucose in adults with type 2 diabetes.
Danish: Tre hovedstudier har vist, at kombinationen af metformin, saxagliptin og dapagliflozin var effektiv til at sænke blodsukkeret hos voksne med type 2-diabetes.
English: • adults who are already taking metformin, saxagliptin and dapagliflozin.
Danish: • voksne, som allerede tager metformin, saxagliptin og dapagliflozin.
English: Qtrilmet must not be used in people who are hypersensitive (allergic) to metformin, saxagliptin or dapagliflozin or to any of the other ingredients or in people who have had serious allergic reactions to a DPP-4 inhibitor (medicines similar to saxagliptin) or to a SGLT2 inhibitor (medicines similar to dapagliflozin).
Danish: Qtrilmet må ikke anvendes hos personer, der er overfølsomme (allergiske) over for metformin, saxagliptin eller dapagliflozin eller nogen af de øvrige indholdsstoffer eller hos personer, der har haft alvorlige allergiske reaktioner mod en DPP-4-hæmmer (lægemidler, der ligner saxagliptin) eller mod en SGLT2-hæmmer (lægemidler, der ligner dapagliflozin).
English: Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin.
Danish: Qtrilmet er et diabeteslægemiddel, der indeholder de aktive stoffer metformin, saxagliptin og dapagliflozin.
English: How is Qtrilmet used?
Danish: Hvordan anvendes Qtrilmet?
English: • Dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: • Dapagliflozin blokerer virkningen af proteinet natrium-glukose-kotransporter 2 (SGLT2) i nyrerne.
English: The pattern of Qtrilmet's side effects is manageable and similar to that in patients treated with saxagliptin and dapagliflozin added to metformin.
Danish: Qtrilmets bivirkningsmønster er håndterbart og svarer til mønstret hos de patienter, der behandles med saxagliptin og dapagliflozin føjet til metformin.
English: By blocking their breakdown, saxagliptin causes the pancreas to produce more insulin when blood glucose levels are high.
Danish: Ved at blokere deres nedbrydning får saxagliptin bugspytkirtlen til at producere mere insulin, når blodsukkeret er højt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtrilmet have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Qtrilmet.
English: How does Qtrilmet work?
Danish: Hvordan virker Qtrilmet?
English: In the first main study in 534 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 1.47 percentage points compared with metformin combined with either saxagliptin (0.88 percentage point reduction) or dapagliflozin (1.20 percentage point reduction).
Danish: I det første hovedstudie med 534 patienter sænkede kombinationen af metformin, saxagliptin og dapagliflozin gennemsnitligt HbA1c med 1,47 procentpoint sammenlignet med metformin kombineret med enten saxagliptin (en reduktion på 0,88 procentpoint) eller dapagliflozin (en reduktion på 1,20 procentpoint).
English: What benefits of Qtrilmet have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Qtrilmet?