FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Danish: - Spørg den nuklearmedicinske læge, hvis der er mere, De vil vide.
English: Brain
Danish: Binyrer
English: Breastfeeding It is not known whether ioflupane (
Danish: Amning Det vides ikke, om ioflupane (
English: How DaTSCAN is stored
Danish: Hvis De har fået for meget DaTSCAN
English: • The active substance is ioflupane (
Danish: Hvad DaTSCAN indeholder • Det aktive stof er ioflupan (
English: The studies included data from 970 patients.
Danish: Undersøgelserne omfattede data fra 970 patienter.
English: Ga) chloride.
Danish: Ga)-klorid.
English: The PET scan images are then taken 40 to 90 minutes later.
Danish: PET-billederne tages 40-90 minutter senere.
English: This makes it possible to see where the tumours are and whether they have spread.
Danish: Det gør det muligt at se, hvor tumorerne er, og om de har spredt sig.
English: edotreotide
Danish: edotreotid
English: The substance that is used for radiolabelling SomaKit TOC is called gallium (
Danish: Det stof, der anvendes til radioaktiv mærkning af SomaKit TOC, kaldes gallium (
English: The tumours can then spread elsewhere in the body (metastasis).
Danish: Tumorerne kan derefter sprede sig til andre steder i kroppen (metastaser).
English: A comparison using data from several of these studies (a meta-analysis) was also presented.
Danish: En sammenligning af data fra flere af disse undersøgelser (en metaanalyse) blev også fremlagt.
English: Not all cells have these receptors but most welldifferentiated GEP-NET cells have high amounts on their surface.
Danish: Ikke alle celler har disse receptorer, men de fleste veldifferentierede GEP-NETceller har store mængder af dem på overfladen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine had been demonstrated.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at lægemidlets tekniske og diagnostiske effektivitet var blevet påvist.
English: This is a summary of the European public assessment report (EPAR) for SomaKit TOC.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for SomaKit TOC.
English: The risks of side effects seemed to be low and the CHMP therefore decided that SomaKit TOC's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Risikoen for bivirkninger synes at være lav, og CHMP konkluderede derfor, at fordelene ved SomaKit TOC opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones.
Danish: GEP-NET-tumorer er kræftknuder, der starter i en type celler i tarmene eller bugspytkirtlen, som normalt frigiver hormoner.
English: Because the number of patients with GEP-NETs is low, the disease is considered ‘rare', and SomaKit TOC was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 March 2015.
Danish: Da antallet af patienter med GEP-NET-tumorer er lavt, betragtes sygdommen som "sjælden", og SomaKit TOC blev udpeget som "lægemiddel til sjældne sygdomme" den 19. marts 2015.
English: Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours).
Danish: Nogle undersøgelser så på PET-scanningernes følsomhed (hvor gode scanningerne var til at identificere patienter med GEP-NETtumorer eller metastaser), mens andre analyserede specificitet (hvor pålidelige scanningerne var til at identificere forsøgspersoner uden GEP-NET-tumorer), og atter andre så på raten for identifikation af læsioner (hvor gode scanningerne var til at identificere tumorerne).
English: Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied.
Danish: Samlet set var undersøgelserne tilstrækkelige til at påvise SomaKit TOC's virkning, om end de eksakte resultater varierede noget.
English: It is given as a single injection into a vein immediately after being radiolabelled.
Danish: Injektionsvæsken indgives som en enkelt injektion i en blodåre umiddelbart efter, at den er blevet radioaktivt mærket.
English: SomaKit TOC contains the active substance edotreotide.
Danish: SomaKit TOC indeholder det aktive stof edotreotid.
English: In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.
Danish: Det blev i fire sammenlignende undersøgelser observeret, at der ved anvendelse af det aktive stof i SomaKit TOC blev identificeret flere tumorer end med indium (111In)-pentetreotid hos de samme patienter.
English: The resulting build-up of radiation can be detected by the special camera of the PET scan.
Danish: Dermed akkumuleres der stråling, som kan spores af et særligt kamera i PET-scanneren.
English: The full EPAR for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for SomaKit TOC findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.
Danish: Virksomheden fremlagde derfor oplysninger fra mange, hovedsageligt mindre, undersøgelser fra faglitteraturen for at dokumentere SomaKit TOC's virkning.
English: What measures are being taken to ensure the safe and effective use of SomaKit TOC?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af SomaKit TOC?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om SomaKit TOC findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with SomaKit TOC, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med SomaKit TOC, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Danish: SomaKit TOC er et diagnostisk lægemiddel, der anvendes hos voksne patienter, hvor der er mistanke om såkaldte veldifferentierede gastroenteropancreatiske neuroendokrine tumorer (GEP-NET-tumorer).
English: After SomaKit TOC is radiolabelled it emits a small amount of radiation which poses a low risk of cancer or hereditary abnormalities.
Danish: Når SomaKit TOC er radioaktivt mærket, udsender det en lille mængde stråling, som giver en lille risiko for udvikling af kræft eller arvelige anomalier.
English: The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells.
Danish: Det aktive stof i SomaKit TOC, edotreotid, binder specifikt til de såkaldte somatostatin-receptorer på cellernes overflade.
English: The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells.
Danish: Det klargjorte lægemiddel, mærket med gallium (68Ga)-klorid, binder til disse receptorer på GEP-NET-cellerne.
English: SomaKit TOC can only be obtained with a prescription and the injection must only be prepared and given in a suitable facility by experts in handling radioactive medicines.
Danish: SomaKit TOC udleveres kun efter recept, og injektionen må kun klargøres og indgives af speciallæger med erfaring i at håndtere radioaktive lægemidler.
English: It is not intended to provide practical advice on how to use SomaKit TOC.
Danish: Det er ikke en praktisk vejledning i, hvordan SomaKit TOC bør anvendes.
English: Other information about SomaKit TOC
Danish: Andre oplysninger om SomaKit TOC
English: What is SomaKit TOC and what is it used for?
Danish: Hvad er SomaKit TOC, og hvad anvendes det til?
English: For practical information about using SomaKit TOC, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af SomaKit TOC, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is SomaKit TOC approved?
Danish: Hvorfor blev SomaKit TOC godkendt?
English: SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers.
Danish: SomaKit TOC anvendes sammen med en scanningsteknik, der kaldes positronemissionstomografi (PETscanning), hvor der tages billeder til lokalisering af kræftvævet.
English: What are the risks associated with SomaKit TOC?
Danish: Hvilke risici er der forbundet med SomaKit TOC?
English: The medicine is not used directly, but must be ‘radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation.
Danish: Lægemidlet bruges ikke direkte, men skal undergå "radioaktiv mærkning", før det injiceres.
English: For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity.
Danish: Hvad angår lokalisering af den primære GEP-NET-tumor, viste en af undersøgelserne, at SomaKit TOC havde en følsomhed på 45 %, mens følsomheden kun var 10 % hos patienter, der fik et andet godkendt diagnostisk lægemiddel (indium (111In)-pentetreotid).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SomaKit TOC have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af SomaKit TOC
English: For the full list of side effects or restrictions with SomaKit TOC, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved SomaKit TOC fremgår af indlægssedlen.
English: Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%.
Danish: Resultater af yderligere undersøgelser tyder på, at edotreotid mærket med gallium (68Ga)-klorid har en følsomhed og en specificitet på hhv. 100 % og 89 %, mens raten for identifikation af læsioner er 75 %.
English: SomaKit TOC is available as a kit for preparing a solution for injection.
Danish: SomaKit TOC fås som et sæt til klargøring af en injektionsvæske.
English: The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs.
Danish: Anvendelsen af det aktive stof i SomaKit TOC, edotreotid mærket med gallium (68Ga)-klorid, til identifikation af GEP-NET-tumorer er almindeligt anerkendt.
English: What benefits of SomaKit TOC have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved SomaKit TOC?
English: How is SomaKit TOC used?
Danish: Hvordan anvendes SomaKit TOC?
English: How does SomaKit TOC work?
Danish: Hvordan virker SomaKit TOC?
English: PRAC recommendations on signals for update of the product information
Danish: PRAC's anbefalinger om signaler til opdatering af produktinformationen
English: Adopted at the 9-12 March 2015 PRAC
Danish: Vedtaget på PRAC's møde den 9.-12. marts 2015.
English: Frequency ‘not known': aggression
Danish: Ukendt hyppighed: aggression
English: Having considered the available evidence in the literature and from individual case safety reports, the PRAC has agreed that the MAH(s) of aripiprazole-containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Danish: Efter at have behandlet de tilgængelige oplysninger i faglitteraturen og fra indberettede bivirkninger har PRAC vedtaget, at indehaveren/indehaverne af markedsføringstilladelse for lægemidler indeholdende aripiprazol inden for to måneder bør indsende en variationsansøgning med henblik på at ændre produktinformationen som beskrevet nedenfor (ny tekst er understreget).
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: Aggression
Danish: Siden markedsføringen af oral aripiprazol er der blevet indberettet følgende bivirkninger, men hyppigheden af dem kendes ikke: aggression
English: The PRAC has further agreed that the MAH for Abilify and Abilify Maintena should submit in the next PSUR (data lock point 16/07/2015), a cumulative review of aripiprazole overdose and the risk of aggression and related events.
Danish: PRAC er endvidere nået til enighed om, at indehaveren af markedsføringstilladelse for Abilify og Abilify Maintena i den kommende PSUR (dataslutpunkt den 16. juli 2015) bør indsende en kumulativ gennemgang af overdosering med aripiprazol og risikoen for aggression og lignende hændelser.
English: Aripiprazole - Aggression and related events (EPITT no
Danish: Aripiprazol - aggression og lignende hændelser (EPITT nr. 18127)
English: Section 4: Possible side effects
Danish: Tabel over bivirkninger
English: Bottle (HDPE) 100 capsules
Danish: Flaske (HDPE) 100 kapsler
English: 0.5 mg Capsule, hard
Danish: 0,5 mg Kapsel, hård
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Package size
Danish: Lægemiddelform Indgivelsesvej
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet kan ligeledes findes på agenturets websted.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ifirmacombi on 4 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ifirmacombi den 4. marts 2011.
English: This is a summary of the European public assessment report (EPAR) for Ifirmacombi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ifirmacombi.
English: The full EPAR for Ifirmacombi can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ifirmacombi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Irbesartan/hydrochlorothiazide
Danish: Irbesartan/hydrochlorothiazid
English: This means that Ifirmacombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
Danish: Det betyder, at Ifirmacombi er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder CoAprovel.
English: For more information about treatment with Ifirmacombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ifirmacombi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Ifirmacombi.
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, hvordan Ifirmacombi skal anvendes.
English: What are the benefits and risks of Ifirmacombi?
Danish: Hvilken fordel og risiko er der forbundet med Ifirmacombi?
English: It is available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide; 300 mg irbesartan and 12.5 mg hydrochlorothiazide).
Danish: Det fås som tabletter (150 mg irbesartan og 12,5 mg hydrochlorothiazid, 300 mg irbesartan og 25 mg hydrochlorothiazid, 300 mg irbesartan og 12,5 mg hydrochlorothiazid).
English: Ifirmacombi is a ‘generic medicine'.
Danish: Ifirmacombi er et "generisk lægemiddel".
English: The Committee recommended that Ifirmacombi be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ifirmacombi.
English: The CHMP concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Ifirmacombi er af sammenlignelig kvalitet og er bioækvivalent med CoAprovel.
English: Other information about Ifirmacombi
Danish: Andre oplysninger om Ifirmacombi
English: The dose of Ifirmacombi to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Danish: Dosen af Ifirmacombi afhænger af den dosis af irbesartan eller hydrochlorothiazid, som patienten tog tidligere.
English: Ifirmacombi is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Danish: Ifirmacombi anvendes til voksne med essentiel hypertension (forhøjet blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
English: Why has Ifirmacombi been approved?
Danish: Hvorfor blev Ifirmacombi godkendt?
English: Ifirmacombi may be added to other treatments for hypertension.
Danish: Ifirmacombi kan bruges som tillægsbehandling til andre behandlinger mod hypertension.
English: Because Ifirmacombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ifirmacombi er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Ifirmacombi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Danish: Da Ifirmacombi er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet CoAprovel.
English: What is Ifirmacombi?
Danish: Hvad er Ifirmacombi?
English: Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Ifirmacombi er et lægemiddel, der indeholder de to aktive stoffer irbesartan og hydrochlorothiazid.
English: Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.
Danish: Ifirmacombi indeholder to aktive stoffer, irbesartan og hydrochlorothiazid.
English: What is Ifirmacombi used for?
Danish: Hvad anvendes Ifirmacombi til?
English: How has Ifirmacombi been studied?
Danish: Hvordan blev Ifirmacombi undersøgt?
English: How does Ifirmacombi work?
Danish: Hvordan virker Ifirmacombi?
English: How is Ifirmacombi used?
Danish: Hvordan anvendes Ifirmacombi?
English: The company will also carry out studies to further characterise this risk.
Danish: Virksomheden vil desuden gennemføre undersøgelser for at beskrive denne risiko yderligere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rienso on 15 June 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rienso den 15. juni 2012.
English: Depending on the severity of the anaemia and the patient's body weight, a second infusion may be given two to eight days after the first dose.
Danish: Afhængigt af anæmiens sværhedsgrad og patientens kropsvægt kan der gives endnu en infusion to til otte dage efter den første dosis.
English: The full EPAR for Rienso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Rienso findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rienso.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rienso.
English: The doctor should ensure that the patient is observed for adverse reactions for at least 30 minutes following the infusion.
Danish: Lægen bør sikre, at patienten observeres for bivirkninger i mindst 30 minutter efter infusionen.
English: In studies with Rienso, side effects were seen in 7.9% of patients taking the medicine, of which 0.2% were considered serious.
Danish: I undersøgelserne med Rienso blev der observeret bivirkninger hos 7,9 % af de patienter, som fik lægemidlet, hvor 0,2 % var alvorlige bivirkninger.
English: In all three studies, patients taking Rienso had higher average increases in haemoglobin: 1.2 g/dl versus 0.5 g/dl; 0.8 g/dl versus 0.2 g/dl; and 1.0 g/dl versus 0.5 g/dl.
Danish: I alle tre undersøgelser sås en større gennemsnitlig stigning i hæmoglobinniveauet hos patienter, der fik Rienso: 1,2 g/dl i forhold til 0,5 g/dl; 0,8 g/dl i forhold til 0,2 g/dl; og 1,0 g/dl i forhold til 0,5 g/dl.
English: A risk management plan has been developed to ensure that Rienso is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Riensoi anvendes så sikkert som muligt.
English: Patients should have their blood and iron levels tested after at least one month following treatment.
Danish: Patientens blod og jernindhold bør kontrolleres mindst en måned efter behandlingen.
English: The main measure of effectiveness was how much haemoglobin levels (measured in grams per decilitre, g/dl) rose after five weeks.
Danish: Hovedmålet for virkningen var, hvor meget hæmoglobinniveauet (målt i gram pr. deciliter, g/dl) var steget efter fem uger.
English: Serious cases of hypersensitivity (allergic reaction) or hypotension were uncommon and were seen in 0.2% of patients.
Danish: Svær hypersensitivitet (allergisk reaktion) eller hypotension er ikke almindelige og blev indberettet for 0,2 % af patienterne.
English: Other information about Rienso
Danish: Andre oplysninger om Rienso
English: Rienso is given as an infusion into a vein lasting at least 15 minutes.
Danish: Rienso gives som en infusion, der varer mindst 15 minutter.
English: For more information about treatment with Rienso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rienso, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Rienso.
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, hvordan Rienso skal anvendes.
English: What measures are being taken to ensure the safe and effective use of Rienso?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rienso?