natgillin/translations-raw huggingface dataset:
Når billedet er optaget, vurderes det af læger, der er særlig oplært i at vurdere PET-scanninger med Neuraceq.
After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Neuraceq fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Når stoffet bindes til plak, kan dets stråling iagttages på PET-scanningen, så lægerne kan se, om der er nævneværdige mængder plak til stede.
After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Det aktive stof i Neuraceq, florbetaben (18F), er et radioaktivt lægemiddel, der udsender små mængder stråling og virker ved at bindes til β-amyloid plak i hjernen.
The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
I produktresuméet og indlægssedlen for Neuraceq er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients.
Neuraceq blev undersøgt i én hovedundersøgelse med 216 forsøgspersoner fordelt på to grupper: en gruppe unge raske forsøgspersoner og en gruppe patienter, der var højt oppe i årene og som havde samtykket i at få foretaget obduktion, når de døde.
Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Ved den planlagte afslutning af undersøgelsen var 31 patienter døde og fik foretaget obduktion for at afgøre, om de havde nævneværdige mængder β-amyloidplak i hjernen.
At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
CHMP bemærkede dog, at der ikke er sikkert bevis for et bedre udfald for patienterne gennem tidlig diagnose efter PET-scanning med Neuraceq og tidlig behandling.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Neuraceq anvendes ved scanning af hjernen hos patienter med hukommelsesproblemer, for at lægerne kan se, om de har nævneværdige mængder β-amyloidplak i hjernen.
Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Neuraceq er en injektionsvæske, der indeholder det aktive stof florbetaben (18F).
Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Hvis du ønsker praktisk vejledning om anvendelsen af Neuraceq, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Resultaterne fra hovedundersøgelsen viste, at PET-scanningerne med Neuraceq havde høj følsomhed og specificitet til påvisning af βamyloidplak i hjernen, og at scanningsresultaterne nøje afspejlede obduktionsresultaterne.
Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Undersøgelsen vedrørte PETscanningernes følsomhed og deres specificitet (dvs. hvor sikkert de var i stand til at skelne forsøgspersoner med betydelig plakdannelse i hjernen fra personer uden plak).
The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
Hvilke fordele viser undersøgelserne, at der er ved Neuraceq?
What benefits of Neuraceq have been shown in studies?
Hvordan anvendes Neuraceq?
How is Neuraceq used?
Det blev påvist, at PET-scanning med Neuraceq har høj specificitet og følsomhed til udpegelse af patienter med nævneværdige mængder β-amyloidplak i hjernen.
PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Hvordan virker Neuraceq ?
How does Neuraceq work?
Xgeva har været godkendt siden juli 2011.
Xgeva has been authorised since July 2011.
Den fuldstændige europæiske offentlige vurderingsrapport for Xgeva findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Hvad sker der med Xgeva til forebyggelse og behandling af andre sygdomme?
What is happening with Xgeva for the prevention and treatment of other diseases?
Højt calciumniveau er en alvorlig komplikation, der kan ramme cancerpatienter i de sidste faser af deres sygdom.
High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Virksomheden fremlagde resultaterne af en undersøgelse omfattende 33 patienter med hyperkalcæmi.
The company presented the results of a study involving 33 patients with hypercalcaemia.
Hvad er Xgeva?
What is Xgeva?
Xgeva blev ikke sammenlignet med nogen anden behandlingsform i denne undersøgelse.
Xgeva was not compared with any other treatment in this study.
Det anvendes hos patienter, der ikke kan behandles med operation, eller hos hvem operation vil medføre alvorlige problemer.
It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Dette reducerer knogletabet og gør knoglebrud og andre alvorlige knoglekomplikationer mindre sandsynlige og reducerer også calciumniveauet i blodet.
This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
Hvad forventedes Xgeva anvendt til?
What was Xgeva expected to be used for?
Virkningen blev hovedsageligt bedømt på antallet af patienter, som behandlingen virkede på, defineret som en reduktion af calciumniveauet i blodet til 2,9 mmol/l eller lavere inden for 10 dage efter den første dosis.
The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Afgørelsen vil ikke få konsekvenser for brugen af Xgeva til de godkendte indikationer.
There are no consequences for the use of Xgeva in its authorised indications.
Ved at binde sig til og blokere RANKL reducerer denosumab dannelsen og funktionen af osteoklaster.
By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Det aktive stof i Xgeva, denosumab, er et monoklonalt antistof, et protein, der er udformet, så det genkender og bindes til et andet protein kaldet RANKL.
The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Disse komplikationer omfatter knoglebrud, sammenfald i ryggen (når rygmarven trykkes sammen af knoglen) eller komplikationer, der kræver strålebehandling eller operation.
These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at undersøgelsens resultater ikke var tilstrækkelige, og konkluderede, at lægemidlet ikke kunne være blevet godkendt på baggrund af de oplysninger, som virksomheden havde fremlagt.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
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).
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).
Det indeholder det aktive stof denosumab og fås som en injektionsvæske til injektion under huden.
It contains the active substance denosumab and is available as a solution to be injected under the skin.
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.
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.
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.
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.
Xgeva er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med en solid tumor, der har spredt sig til knoglerne.
Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
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.
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.
Virksomheden har til CHMP oplyst, at der for øjeblikket ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Xgeva.
The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
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.
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.
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.
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.
Xgeva anvendes desuden til behandling af kæmpecelletumor, der er en form for knoglekræft hos voksne og unge med fuldt udviklede knogler.
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.
Hvordan virker Xgeva?
How does Xgeva work?
Endvidere var der betænkelighed ved lægemidlets kvalitet.
There were also concerns over the quality of the medicine.
London, den 16. august 2007 Ref.dok.
London, 16 August 2007 Doc.
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for RETISERT
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for RETISERT
Internationalt fællesnavn (INN): fluocinolonacetonid
International non-proprietary name (INN): fluocinolone acetonide
Undersøgelsen var stadig i gang på bedømmelsestidspunktet, men skulle i alt vare i tre år.
The study was still ongoing at the time of assessment, but was designed to last a total of three years.
Hvad er RETISERT?
What is RETISERT?
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med RETISERT?
What are the consequences of the withdrawal for patients undergoing clinical trials with RETISERT?
Virkningerne af RETISERT blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of RETISERT were first tested in experimental models before being studied in humans.
Firmaet har oplyst til CHMP, at der er ikke er igangværende kliniske undersøgelser med RETISERT i Europa.
The company informed the CHMP that there are no clinical trials with RETISERT ongoing in Europe.
Det indeholder det aktive stof fluocinolonacetonid, der langsomt frigives fra implantatet i løbet af en periode på ca. tre år.
It contains the active substance fluocinolone acetonide, which is released slowly by the implant over a period of around three years.
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.
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.
EMEA/482585/2007
Ref. EMEA/342023/2007
CHMP havde opstillet en række spørgsmål, som firmaet skulle besvare, hvilket endnu ikke var sket.
The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to the questions.
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.
In addition, the Committee did not consider the main measure of effectiveness to be appropriate for this type of study.
Det virker ligesom binyrebarkhormoner (en gruppe naturligt forekommende hormoner) ved at dæmpe immunsystemets aktivitet og mindske betændelse.
It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation.
Hvad forventedes RETISERT anvendt til?
What was RETISERT expected to be used for?
Det aktive stof i RETISERT, fluocinolonacetonid, er et syntetisk binyrebarkhormon.
The active substance in RETISERT, fluocinolone acetonide, is a synthetic corticosteroid.
Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil sygdommen kom igen.
The main measure of effectiveness was the time taken until the disease came back.
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.
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.
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.
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.
Hvordan forventedes RETISERT at virke?
How is RETISERT expected to work?
RETISERT er et intravitrealt implantat (det indgives i glaslegemet, den geléagtige væske i øjets centrale del).
RETISERT is an intravitreal implant (inserted into the vitreous humour, the jelly-like fluid in the central chamber of the eye).
RETISERT forventedes anvendt til behandling af kronisk (langvarig) ikke-infektionsbetinget årehindebetændelse i øjets bageste del.
RETISERT was expected to be used to treat chronic (persistent) non-infectious uveitis affecting the posterior (rear) part of the eye.
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.
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.
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.
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.
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).
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).
Det forventedes, at den betændelsesdæmpende virkning ville mindske symptomerne på årehindebetændelsen.
This anti-inflammatory activity was expected to reduce the symptoms of uveitis.
Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en
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.
Virkningerne af RETISERT, implanteret i det hårdest angrebne øje, blev sammenlignet med virkningerne af standardbehandling.
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).
Hos de patienter, der fik RETISERT i hovedundersøgelsen, gik der således ikke længere tid, før sygdommen kom igen, end hos dem, der fik standardbehandling.
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.
Det anvendes til behandling af type 2-diabetes hos:
It is used to treat type 2 diabetes in:
Det gives som 2 tabletter i den relevante styrke én gang dagligt, taget sammen med mad.
It is given as 2 tablets of the appropriate strength once a day with food.
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.
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.
Yderligere information om Qtrilmet findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/qtrilmet.
Further information on Qtrilmet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/qtrilmet.
Andre oplysninger om Qtrilmet
Other information about Qtrilmet
Som for alle lægemidler bliver data vedrørende brugen af Qtrilmet løbende overvåget.
As for all medicines, data on the use of Qtrilmet are continuously monitored.
Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer nok insulin, eller hvor kroppen ikke kan udnytte insulinet effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin or when the body cannot use insulin effectively.
Insulin er vigtigt for at kunne kontrollere, hvordan kroppen omdanner glukose (en type sukker) til energi, og hvordan glukosen lagres i kroppen.
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.
Qtrilmet indeholder tre aktive stoffer, som alle virker forskelligt.
Qtrilmet contains three active substances which all work in different ways.
HbA1c-niveauet hos patienterne i studierne var mindst 8 %, og behandlingen tog sigte på at reducere mængden af HbA1c til 7 % eller mindre.
The HbA1c levels of patients in the studies were at least 8% and treatment was aimed at reducing HbA1c levels to 7% or less.
Disse studier målte ændringen i HbA1cindholdet efter 24 ugers behandling.
These studies measured the change in HbA1c levels after 24 weeks of treatment.
Det er dog mere kompliceret at reducere doser eller afbryde behandlingen med Qtrilmet end at anvende de aktive stoffer hver for sig.
However, reducing doses or interrupting treatment with Qtrilmet is more complicated than using the active ingredients separately.
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.
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Qtrilmet?
What measures are being taken to ensure the safe and effective use of Qtrilmet?
Saxagliptin, en dipeptidylpeptidase-4 (DPP-4)-hæmmer, har været godkendt i EU under navnet Onglyza siden 2009.
Saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, has been authorised in the EU as Onglyza since 2009.
Hvad er Qtrilmet, og hvad anvendes det til?
What is Qtrilmet and what is it used for?