FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Trisenox, og de behøver ikke blive gentaget for Arsenic trioxide Accord.
English: As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Arsenic trioxide Accord løbende overvåget.
English: Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Arsenic trioxide Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
Danish: Det aktive stof i lægemidlet, arsentrioxid, har været anvendt i lægemidler i mange år, bl.a. til behandling for leukæmi.
English: During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Danish: I konsolideringsfasen gives Arsenic trioxide Accord fem dage om ugen, men varigheden af behandlingen og af pauserne ind imellem forløbene afhænger af, om patienten tidligere har modtaget behandling.
English: As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Arsenic trioxide Accord.
English: This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
Danish: Det betyder, at Arsenic trioxide Accord indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Trisenox.
English: This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Det skyldes, at Arsenic trioxide Accord gives som infusion i en vene, så det aktive stof leveres direkte i blodbanen.
English: During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Danish: I induktionsfasen gives Arsenic trioxide Accord dagligt, indtil der er tegn på, at behandlingen virker (når knoglemarven er fri for leukæmiceller).
English: Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Danish: Arsenic trioxide Accord indeholder det aktive stof arsentrioxid og er et "generisk lægemiddel".
English: For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Arsenic trioxide Accord, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
Danish: • patienter med nydiagnosticeret lav eller mellemhøj risiko for akut promyelocyt leukæmi, hvor det anvendes sammen med lægemidlet hel-trans-retinsyre
English: An overview of Arsenic trioxide Accord and why it is authorised in the EU
Danish: En oversigt over Arsenic trioxide Accord, og hvorfor det er godkendt i EU
English: Arsenic trioxide Accord is used in:
Danish: Arsenic trioxide Accord anvendes hos:
English: Other information about Arsenic trioxide Accord
Danish: Andre oplysninger om Arsenic trioxide Accord
English: What are the benefits and risks of Arsenic trioxide Accord?
Danish: Hvilke fordele og risici er der forbundet med Arsenic trioxide Accord?
English: Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Arsenic trioxide Accord opvejer de identificerede risici som for Trisenox, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Arsenic trioxide Accord?
English: What is Arsenic trioxide Accord and what is it used for?
Danish: Hvad er Arsenic trioxide Accord, og hvad anvendes det til?
English: Arsenic trioxide Accord (arsenic trioxide)
Danish: Arsenic trioxide Accord (arsentrioxid)
English: Why is Arsenic trioxide Accord authorised in the EU?
Danish: Hvorfor er Arsenic trioxide Accord godkendt i EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord 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 Arsenic trioxide Accord.
English: How has Arsenic trioxide Accord been studied?
Danish: Hvordan er Arsenic trioxide Accord blevet undersøgt?
English: How is Arsenic trioxide Accord used?
Danish: Hvordan anvendes Arsenic trioxide Accord?
English: How does Arsenic trioxide Accord work?
Danish: Hvordan virker Arsenic trioxide Accord?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Insulatard den 7. oktober 2002.
English: The full EPAR for Insulatard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Insulatard findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Insulatard
Danish: Andre oplysninger om Insulatard
English: This is a summary of the European public assessment report (EPAR) for Insulatard.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Insulatard.
English: A risk management plan has been developed to ensure that Insulatard is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Insulatard anvendes så sikkert som muligt.
English: It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor's recommendation.
Danish: Det kan gives en eller to gange dagligt med eller uden hurtigtvirkende insulin (i forbindelse med måltider) efter lægens anvisninger.
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 Insulatard.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Insulatard.
English: For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Insulatard, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Insulatard?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Insulatard?
English: Insulatard is used to treat diabetes.
Danish: Insulatard anvendes til behandling af diabetes (sukkersyge).
English: In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Danish: Hos størstedelen af patienterne blev Insulatard sammenlignet med andre typer human insulin eller insulinanaloger.
English: Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Danish: Insulatard blev undersøgt i fire kliniske hovedundersøgelser med i alt 557 patienter med type 1diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 81 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (to undersøgelser, som omfattede 476 patienter).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Insulatard, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Insulatard (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
English: Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Danish: Insulatard medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau svarende til det, der var observeret for andre typer human insulin.
English: Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Danish: Insulatard var effektivt ved såvel type 1- som type 2-diabetes og ved anvendelsen af en standardinjektion eller en af de fyldte penne.
English: The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Insulatard opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Insulatard.
English: The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Danish: Det aktive stof i Insulatard, human insulin, produceres via en metode, der er kendt som "rekombinant teknologi": Insulinet fremstilles af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere insulin.
English: Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Danish: Insulatard indeholder insulin blandet med et andet stof, protamin, i en form, der kaldes "isofan", som optages langsommere dagen igennem.
English: What is the risk associated with Insulatard?
Danish: Hvilken risiko er der forbundet med Insulatard?
English: Insulatard is a long-acting insulin.
Danish: Insulatard er et langtidsvirkende insulin.
English: Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
Danish: Der blev også gennemført yderligere undersøgelser af 225 patienter, hvor man sammenlignede injektion af Insulatard med kanyle eller med brug af en fyldt pen (InnoLet eller FlexPen).
English: Insulatard is a suspension for injection that contains the active substance human insulin.
Danish: Insulatard er en injektionsvæske, suspension, som indeholder det aktive stof human insulin.
English: Why has Insulatard been approved?
Danish: Hvorfor blev Insulatard godkendt?
English: The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Danish: I undersøgelserne målte man blodsukkeret i fastende tilstand eller mængden af glykosyleret hæmoglobin (HbA1c, et hæmoglobin, som binder glukose til sig).
English: Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Danish: Insulatard gives som injektion under huden i låret, bugvæggen (maveskindet), sædemuskelregionen (ballerne) eller deltamuskelregionen (skulderen).
English: Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas.
Danish: Insulatard er et erstatningsinsulin, der næsten er identisk med det insulin, som produceres af bugspytkirtlen.
English: It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Danish: Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (InnoLet eller FlexPen).
English: What is Insulatard?
Danish: Hvad er Insulatard?
English: This gives Insulatard a longer duration of action.
Danish: Det giver Insulatard en længerevarende virkning.
English: What benefit has Insulatard shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Insulatard?
English: How has Insulatard been studied?
Danish: Hvordan blev Insulatard undersøgt?
English: What is Insulatard used for?
Danish: Hvad anvendes Insulatard til?
English: How is Insulatard used?
Danish: Hvordan anvendes Insulatard?
English: How does Insulatard work?
Danish: Hvordan virker Insulatard?
English: In particular, you must not be given certain vaccines called live vaccines:
Danish: Du må især ikke få visse vacciner kaldet levende vacciner:
English: This can take 3 to 6 hours and may need to be repeated.
Danish: Det kan tage 3 til 6 timer og skal muligvis gentages.
English: These other medicines may include:
Danish: Disse lægemidler kan inkludere:
English: - Pain in the hands or feet.
Danish: Smerter i hænder eller fødder.
English: TLS, which may be severe, has occasionally been observed.
Danish: TLS, som kan være alvorlig, er lejlighedsvist blevet observeret.
English: - have had a stem cell transplant in the last 4 months.
Danish: - Har fået en stamcelletransplantation inden for de sidste 4 måneder.
English: • After treatment while the immune system is recovering.
Danish: • Efter behandlingen mens immunsystemet stadig er i færd med at komme sig.
English: Date of first authorisation: 23 August 2018
Danish: Dato for første markedsføringstilladelse: 23. august 2018
English: • Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Danish: • Kontrollere, om du blev vaccineret inden for de sidste 6 uger eller planlægger at blive vaccineret inden for de næste par måneder.
English: Thawing should take approximately 3 to 5 minutes.
Danish: Optøningen bør tage cirka 3 til 5 minutter.
English: Irradiation could lead to inactivation of the product.
Danish: Stråling kan føre til inaktivering af produktet.
English: • You will be given a pregnancy test before treatment starts.
Danish: • Du vil få en graviditetstest, inden behandlingen startes.
English: A summary of the patient demographics is provided in Table 4.
Danish: En sammenfatning af patientdemografi gives i Tabel 4.
English: These reactions are presented by system organ class and by frequency.
Danish: Reaktionerne er anført efter systemorganklasse og hyppighed.
English: Your doctor or nurse will check carefully that this medicine is yours.
Danish: Din læge eller sygeplejerske vil nøje kontrollere, at det er din medicin.
English: Do not try to treat your symptoms with other medicines on your own.
Danish: Forsøg ikke selv at behandle dine symptomer med anden medicin.
English: YESCARTA should only be given if the results show you are not pregnant.
Danish: YESCARTA må kun gives, hvis resultaterne viser, at du ikke er gravid.
English: A clear to opaque, white to red dispersion.
Danish: En klar til uigennemsigtig, hvid til rød dispersion.
English: One out of 111 patients did not receive the product due to manufacturing failure.
Danish: En ud af 111 patienter modtog ikke lægemidlet på grund af fejl under fremstillingen.
English: You may be given medicines to help prevent the condition.
Danish: Du vil muligvis få medicin for at hjælpe med at forebygge tilstanden.
English: If the bag is compromised, follow the local guidelines (or immediately contact Kite).
Danish: Hvis posen er beskadiget, skal lokale retningslinjer følges (eller kontakt straks Kite).
English: An impact of these antibodies on efficacy or safety was not discernible.
Danish: Disse antistoffers indvirkning på virkning eller sikkerhed var ikke mærkbar.
English: Nearly all patients experienced some degree of CRS.
Danish: Næsten alle patienter oplevede en vis grad af CRS.
English: Median duration of response and median overall survival have not been reached (Table 5).
Danish: Gennemsnitlig varighed af respons og gennemsnitlig samlet overlevelse er ikke nået (Tabel 5).
English: As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product.
Danish: Da dette lægemiddel administreres af kvalificeret sundhedspersonale, er de ansvarlige for korrekt bortskaffelse af produktet.
English: It is used to treat these conditions when other available medicines have stopped working for you.
Danish: Det anvendes til at behandle disse sygdomme, når andre tilgængelige lægemidler ikke længere virker på dig.
English: - notice the symptoms of your cancer are getting worse.
Danish: - Bemærker, at symptomerne på din kræft bliver værre.
English: • Look for signs of graft-versus-host disease that can happen after a transplant.
Danish: • Se efter tegn på graft-versus-host-sygdom, der kan forekomme efter en transplantation.
English: Response and survival after treatment with available standard-of-care therapy was evaluated.
Danish: Respons og overlevelse efter behandling med tilgængelig standard behandling blev evalueret.
English: Active graft-versus-host disease (GVHD).
Danish: • Aktiv graft-versus-host disease (GVHD).
English: Monitoring of vital signs and organ functions should be considered depending on the severity of the reaction.
Danish: Monitorering af vitale parametre og organfunktioner skal overvejes afhængig af reaktionens sværhedsgrad.
English: This is to help prevent infusion reactions and fever.
Danish: Det er for at hjælpe med forebygge infusionsreaktioner og feber.
English: This is so your doctor can check if your treatment is working and help you if you have any side effects.
Danish: Det er for at din læge kan kontrollere, om din behandling virker og hjælpe dig, hvis du har bivirkninger.
English: The most common site of infection was in the respiratory tract.
Danish: Det mest almindelige infektionssted var i luftvejene.
English: • Your doctor or nurse will give you a single infusion of YESCARTA into your vein for approximately 30 minutes.
Danish: • Din læge eller sygeplejerske vil give dig en enkelt infusion af YESCARTA i din vene i cirka 30 minutter.
English: In addition worsening of underlying organ pathologies can occur in the setting of CRS.
Danish: Endvidere kan forværring af tilgrundliggende organpatologier forekomme i forbindelse med CRS.
English: Thawed product should not be refrozen.
Danish: Det optøede produkt må ikke nedfryses igen.
English: Outcomes were consistent between patients with Eastern Cooperative Oncology Group (ECOG) of 0 and 1 and by sex.
Danish: Resultaterne var overensstemmende mellem patienter med Eastern Cooperative Oncology Group (ECOG) på 0 og 1 og efter køn.
English: Kite Pharma, Inc. 2355 Utah Avenue El Segundo California CA 90245
Danish: Kite Pharma, Inc. 2355 Utah Avenue El Segundo Californien CA 90245
English: Efficacy was consistent with the overall treated patient population.
Danish: Virkning var overensstemmende med den samlede behandlede patientpopulation.
English: If not improving, manage as Grade 4 (below).
Danish: Hvis der ikke ses forbedring, behandl som grad 4 (herunder).
English: Take your temperature twice a day for 3-4 weeks after treatment with YESCARTA.
Danish: Tag din temperatur to gange dagligt i 3-4 uger efter behandlingen med YESCARTA.
English: HBV reactivation
Danish: Reaktivering af HBV
English: Alanine aminotransferase increased Aspartate aminotransferase increased
Danish: Forhøjet alanin aminotransferase Forhøjet aspartat aminotransferase
English: • Fever, which may be a symptom of an infection.
Danish: • Feber, som kan være symptom på infektion.
English: • Check if your cancer is getting worse.
Danish: • Kontrollere om din kræft bliver værre.
English: In some cases, it might not be possible to go ahead with the planned treatment with YESCARTA.
Danish: I visse tilfælde vil det muligvis ikke være muligt at gennemføre den planlagte behandling med YESCARTA.
English: • Check your lungs, heart and blood pressure.
Danish: • Kontrollere dine lunger, dit hjerte og dit blodtryk.
English: Other outcomes were consistent with those of the mITT population.
Danish: Andre resultater var overensstemmende med resultaterne i mITT-populationen.
English: Peak elevation was observed within the first 14 days after infusion, and levels generally returned to baseline within 28 days.
Danish: Peakværdier blev observeret inden for de første 14 dage efter infusion, og niveauerne vendte generelt tilbage til baseline inden for 28 dage.
English: Your doctor will take some of your blood using a catheter placed in your vein (a procedure call leukapheresis).
Danish: Din læge vil tage noget af dit blod med et kateter i din vene (en procedure der kaldes leukaferese).
English: Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Danish: Din læge vil regelmæssigt tjekke dine blodcelletal, da antallet af blodceller og andre blodkomponenter kan falde.
English: • YESCARTA is a one-time treatment.
Danish: • YESCARTA er en engangsbehandling.
English: Active uncontrolled infection.
Danish: • Aktiv ukontrolleret infektion.
English: • Tocilizumab and emergency equipment should be available prior to infusion and during the monitoring period.
Danish: • Tocilizumab og nødudstyr skal være til rådighed inden infusion og under monitoreringsperioden.
English: Patients relapsed within 1 year of ASCT Patients with International Prognostic Index 3/4 Patients with disease stage III/IV
Danish: Patienter med recidiv inden for 1 år fra ASCT Patienter med international prognostisk indeks på 3/4 Patienter med sygdomsstadie III/IV
English: ITT was defined as all patients who underwent leukapheresis; mITT was defined as all patients who received YESCARTA.
Danish: ITT blev defineret som alle patienter, der gennemgik leukaferese; mITT blev defineret som alle patienter, der modtog YESCARTA.
English: CRS Grade (a)
Danish: Grad af CRS (a)
English: Life-threatening symptoms.
Danish: Livstruende symptomer.
English: Summary of efficacy results for ZUMA-1 phase 2
Danish: Sammenfatning af resultaterne for effekt for ZUMA-1, fase 2
English: Of these, 49 patients had GCB-type and 17 patients had ABC-type.
Danish: Af disse patienter havde 49 patienter GCB-type, og 17 patienter havde ABC-type.
English: < 1/1,000); very rare (< 1/10,000).
Danish: < 1/1.000), meget sjælden (< 1/10.000).
English: Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Danish: Nogle af din hvide blodlegemer adskilles fra dit blod, og resten af blodet returneres til din vene.