FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Edurant opvejer risiciene hos patienter med lavt indhold af hiv-1, og anbefalede udstedelse af markedsføringstilladelse for denne gruppe af patienter.
English: Why has Edurant been approved?
Danish: Hvorfor blev Edurant godkendt?
English: What is the risk associated with Edurant?
Danish: Hvilken risiko er der forbundet med Edurant?
English: Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
Danish: Edurant blev givet sammen med en fast kombination af antivirale lægemidler og blev ikke sammenlignet med andre behandlinger.
English: In all studies, the main measure of effectiveness was based on the reduction in viral load.
Danish: I alle undersøgelser blev behandlingens virkning hovedsagelig bedømt på mindskelsen af virusindholdet.
English: By blocking this enzyme, Edurant, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym mindsker Edurant, anvendt i kombination med andre antivirale lægemidler, hiv-mængden i blodet og holder den nede.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
Danish: • carbamazepin, oxcarbazepin, phenobarbital, fenytoin (lægemidler mod krampeanfald)
English: Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Danish: Edurant var genstand for to hovedundersøgelser med 1 368 tidligere ubehandlede patienter, der var inficeret med hiv-1.
English: Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Edurant anvendes i kombination med andre antivirale lægemidler til behandling af voksne og unge i alderen 12 år og opefter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er et virus, der forårsager erhvervet immundefektsyndrom (aids).
English: It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Danish: Lægemidlet anvendes kun til patienter, der ikke tidligere er behandlet mod hiv, og hvis indhold af hiv i blodet højst er 100 000 hiv-1 RNA-kopier/ml.
English: For the full list of all side effects reported with Edurant, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Edurant fremgår af indlægssedlen.
English: Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Danish: Edurant var også genstand for en anden undersøgelse omfattende 36 tidligere ubehandlede unge (mellem 12 og 18 år) smittet med hiv-1.
English: In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood.
Danish: Hos voksne var Edurant, i kombination med andre antiretrovirale lægemidler, lige så effektivt som sammenligningspræparatet til at mindske indholdet af hiv-1 i patienternes blod.
English: In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.
Danish: I den anden undersøgelse blev Edurant sammenlignet med efavirenz, når begge lægemidler blev givet sammen med en fast kombination af de antivirale lægemidler tenofovirdisoproxil og emtricitabin eller sammen med to andre nukleosid- eller nukleotidreverse transkriptasehæmmere.
English: How has Edurant been studied?
Danish: Hvordan blev Edurant undersøgt?
English: In the first study, Edurant was compared with another NNRTI called efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine.
Danish: I den første undersøgelse blev Edurant sammenlignet med et andet NNRTI, efavirenz, og de to lægemidler blev givet sammen med en fast kombination af de antivirale lægemidler tenofovirdisoproxil og emtricitabin.
English: What is Edurant?
Danish: Hvad er Edurant?
English: What benefit has Edurant shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Edurant?
English: What is Edurant used for?
Danish: Hvad anvendes Edurant til?
English: The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Danish: CHMP konkluderede, at Edurant i kombination med andre antiretrovirale lægemidler er lige så effektivt som de vigtigste NNRTI, der i dag anvendes som førstevalgsbehandling af patienter med hiv-1infektion.
English: How is Edurant used?
Danish: Hvordan anvendes Edurant?
English: • St John's wort (a herbal antidepressant medicine).
Danish: • prikbladet perikum (naturlægemiddel mod depression).
English: How does Edurant work?
Danish: Hvordan virker Edurant?
English: From a microbiological point of view, the product must be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes umiddelbart.
English: This syndrome can be fatal.
Danish: Dette syndrom kan være dødeligt.
English: The same dose is recommended for adults and elderly.
Danish: Samme dosis anbefales til voksne og ældre.
English: Caution is needed in these patients.
Danish: Forsigtighed er påkrævet hos disse patienter.
English: Monitoring and management for these patients should be as described above.
Danish: Monitorering og styring i forbindelse med disse patienter skal ske som beskrevet ovenfor.
English: These include:
Danish: Disse kan bl.a. være:
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: Vd is also weight dependent, increasing with increasing body weight.
Danish: Vd er også vægtafhængig og stiger med stigende kropsvægt.
English: You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Danish: Du skal fortælle om alle nye og usædvanlige symptomer og omstændigheder, når du ser lægen.
English: Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
Danish: Dato for første markedsføringstilladelse: 5. marts 2002 Dato for seneste fornyelse: 5. marts 2007
English: Observation is the recommended approach with intervention only in selected cases.
Danish: Observation er den anbefalede forholdsregel, kun med intervention i særlige tilfælde.
English: The response rate was similar for both genders.
Danish: Responshyppigheden var ens for de to køn.
English: No data are available for children under 5 years.
Danish: Der foreligger ingen data for børn under 5 år.
English: - In addition, you will receive electrocardiograms twice weekly.
Danish: - Derudover vil du få taget et elektrokardiogram to gange ugentlig.
English: NEW CONCENTRATION
Danish: NY KONCENTRATION
English: You must be sure to tell your doctor about all medicines you are taking.
Danish: Du skal sørge for at fortælle din læge om al den medicin, du tager.
English: This accumulation was slightly more than expected based on single-dose results.
Danish: Denne akkumulering var en smule højere end forventet ud fra enkeltdosisresultater.
English: TRISENOX is normally given by a doctor or a nurse.
Danish: TRISENOX gives normalt af en læge eller en sygeplejerske.
English: Procedure for proper disposal
Danish: Procedure for korrekt bortskaffelse
English: 18-Month survival
Danish: 18-måneders overlevelse
English: Monitor patients for the development of second primary malignancies.
Danish: Monitorér patienterne for udvikling af anden primær malignitet.
English: Do not save any unused portions for later administration.
Danish: Gem ikke de ikke-anvendte portioner til senere indgift.
English: The results are summarised in the table 4 below.
Danish: Resultaterne er opsummeret i Tabel 4 nedenfor.
English: Negative Positive Not evaluable
Danish: Negativ Positiv Kan ikke evalueres
English: She went onto consolidation without further evidence of QT prolongation.
Danish: Hun fortsatte med konsolidering uden yderligere tegn på QT-forlængelse.
English: Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Danish: Patienter udviste tendens til at tolerere konsolidering og vedligeholdelse med mindre toksicitet end i induktionen.
English: Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Danish: Patienterne skal indlægges i behandlingens begyndelse på grund af sygdomssymptomer og for at sikre tilstrækkelig monitorering.
English: Time to CR (median)
Danish: Tid til CR (median)
English: Table 1 Recommendation for initiation of hydroxyurea WBC
Danish: Tabel 1 Anbefaling for påbegyndelse af hydroxyurea WBC
English: Patients who experience a recurrence of toxicity must be removed from treatment.
Danish: Patienter, der oplever en gentagelse af toksiciteten, skal tages ud af behandlingen.
English: Very Common Very Common
Danish: Meget almindelig Meget almindelig
English: While on treatment with TRISENOX, you may experience some of the following reactions:
Danish: Mens du er i behandling med TRISENOX, kan du opleve nogle af følgende reaktioner:
English: - Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.
Danish: - Opfølgning af dine kognitive funktioner og din mobilitet, hvis du har risiko for B1vitaminmangel.
English: Development of second primary malignancies
Danish: Udvikling af anden primær malignitet
English: This means that the medicine is essentially ‘sodium-free'.
Danish: Det betyder, at medicinen i det væsentlige er natriumfri.
English: AsV is present in plasma only at relatively low levels.
Danish: AsV findes kun i relativt lave koncentrationer i plasma.
English: The extent of accumulation of these metabolites is dependent on the dosing regimen.
Danish: Akkumuleringsgraden af disse metabolitter afhænger af doseringsregimet.
English: The key efficacy results are summarised in table 3 below:
Danish: De vigtigste effektresultater er opsummeret i Tabel 3 nedenfor:
English: 95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX
Danish: 95 % CI for forskellen, 2-22 procentpoints p < 0,001 for noninferioritet p = 0,02 for superioritet af ATRA+TRISENOX
English: If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking this product, the patient must be informed of the potential harm to the foetus.
Danish: Hvis dette lægemiddel anvendes under graviditet, eller hvis patienten bliver gravid, mens hun tager lægemidlet, bør patienten informeres om den mulige skade på fostret.
English: Serious adverse reactions were common (1-10 %) and not unexpected in the relapsed/refractory population.
Danish: Alvorlige bivirkninger var almindeligt forekommende (1-10 %) og ikke uventede i den recidiverende/refraktære patientgruppe.
English: Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Danish: Personalet skal uddannes i håndtering og fortynding af arsentrioxid og skal bruge passende beskyttelsesbeklædning.
English: Some cases recovered with vitamin B1 supplementation.
Danish: Nogle tilfælde gik væk med B1-vitamintilskud.
English: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
Danish: Konsolideringsbehandling skal begyndes 3 til 4 uger efter afslutning af induktionsbehandlingen.
English: However all cases were successfully managed with hydroxyurea therapy.
Danish: Alle tilfældene blev imidlertid håndteret på vellykket vis med hydroxyurea.
English: Children and adolescents TRISENOX is not recommended in children and adolescents below 18 years of age.
Danish: Børn og unge TRISENOX anbefales ikke til børn og unge under 18 år.
English: The Kaplan-Meier median CR duration for the single institution study is 14 months and has not been reached for the multicentre study.
Danish: Kaplan-Meier medianvarigheden af CR for enkeltinstitutionsstudiet var 14 måneder og blev ikke nået for multicenterstudiet.
English: Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding.
Danish: Fordeling Fordelingsvolumen (Vd) for AsIII er stort (> 400 l), hvilket tyder på en betydelig fordeling ind i vævene med en ubetydelig proteinbinding.
English: There is limited clinical data on the use of TRISENOX in the elderly population.
Danish: Der foreligger begrænsede kliniske data vedrørende anvendelsen af TRISENOX i den ældre population.
English: It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.
Danish: Den gives som et drop (infusion) i en vene i løbet af 1-2 timer, men infusionen kan vare længere, hvis der optræder bivirkninger som blussen og svimmelhed.
English: TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
Danish: TRISENOX er indiceret til induktion af remission og konsolidering hos voksne patienter med:
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig: (kan forekomme hos mere end 1 ud af 10 personer)
English: Responses were seen across all age groups tested, ranging from 6 to 75 years.
Danish: Der sås respons hen over alle testede aldersgrupper, varierende fra 6 til 75 år.
English: If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Danish: Hvis du er gravid, eller du bliver gravid under behandlingen med TRISENOX, skal du spørge din læge til råds.
English: Post-marketing experience suggests that a similar syndrome may occur in patients with other types of malignancy.
Danish: Erfaringer efter frigørelse på markedet tyder på, at et tilsvarende syndrom kan forekomme hos patienter med andre former for maligniteter.
English: If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
Danish: Hvis dette sker, skal behandlingen med TRISENOX omgående stoppes, og din læge vil behandle arsen-overdoseringen.
English: - You should have an electrical recording of the heart (electrocardiogram ECG) performed before your first dose.
Danish: - Du skal have taget et elektrokardiogram (ekg) inden din første dosis.
English: CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)
Danish: FORSIGTIG, BEMÆRK NY KONCENTRATION (2 mg/ml)
English: Haematologic complete remission (HCR)
Danish: Komplet hæmatologisk remission (HCR)
English: Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Danish: Totalt arsen akkumuleres hovedsagligt i lever, nyre og hjerte og i mindre grad i lunge, hår og negle.
English: Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leucocytosis, and no standard approach has proven effective.
Danish: Lægemidler, der anvendes til at sænke antallet af hvide blodlegemer, forværrer ofte toksiciteten i forbindelse med leukocytose, og ingen standardbehandling har vist sig effektiv.
English: Approximately 15 % of the administered TRISENOX dose is excreted in the urine as unchanged AsIII.
Danish: Cirka 15 % af den indgivne TRISENOX-dosis udskilles i urinen som uændret AsIII.
English: - if you are taking or have recently taken any medicine which may affect your liver.
Danish: - hvis du tager eller for nyligt har taget medicin, der kan påvirke leveren.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Teva B.V.
English: The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
Danish: De metylerede metabolitter af AsIII (MMAV, DMAV) bliver primært udskilt i urinen.
English: In these studies, leucocytosis was not treated with chemotherapeutic medicinal products.
Danish: I disse studier blev leukocytose ikke behandlet med kemoterapeutiske lægemidler.
English: The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Danish: Den daglige dosis kan igen optrappes til 100 % af den oprindelige dosis, hvis der ikke opstår nogen forlængelse.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig: (kan forekomme hos op til 1 ud af 10 personer)
English: 2-Year overall survival (OS)
Danish: 2-års samlet overlevelse (OS)
English: Opening the ampoule: Hold the ampoule of TRISENOX with the coloured point upwards and in front of you.
Danish: Åbning af ampullen: Hold ampullen med TRISENOX med det farvede punkt opad og foran dig.
English: The decline from peak plasma concentration of AsIII occurs in a biphasic manner and is characterized by an initial rapid distribution phase followed by a slower terminal elimination phase.
Danish: Faldet fra maksimal plasmakoncentration af AsIII sker bifasisk og er karakteriseret ved en initial hurtig distributionsfase efterfulgt af en langsommere terminal eliminationsfase.
English: Grades ≥ 3
Danish: Grad≥3
English: - Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in TRISENOX, may cause other cancers.
Danish: - Din læge vil overvåge dit helbred under og efter behandlingen, da arsentrioxid, det aktive stof i TRISENOX, kan forårsage andre kræftformer.
English: Kaplan-Meier estimates of 18-month survival for each study are shown below.
Danish: Kaplan-Meier skøn for 18-måneders overlevelse for begge forsøg er vist nedenfor.
English: Peripheral neuropathy, characterised by paraesthesia/dysaesthisia, is a common and well known effect of environmental arsenic.
Danish: Perifer neuropati, karakteriseret ved paræstesi/dysæstesi, er en almindelig og velkendt miljøeffekt af arsen.
English: The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Danish: TRISENOX' sikkerhed og virkning hos børn i alderen op til 17 år er ikke klarlagt.
English: Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Danish: Der skal tages elektrokardiogram to gange ugentlig, og endnu hyppigere for klinisk ustabile patienter, under induktion og konsolidering.
English: Twenty-seven patients had leucocytosis (WBC  10 x 103/l) during induction, 4 of whom had values above 100,000/l.
Danish: 27 patienter havde leukocytose (WBC 10 x 103/l) under induktion, hvoraf 4 havde værdier over 100,000/l.
English: ECG and electrolyte monitoring recommendations
Danish: Anbefalinger for ekg og elektrolyt-monitorering
English: The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Danish: Infusionsvarigheden kan forlænges op til 4 timer, hvis der observeres vasomotoriske reaktioner.
English: TRISENOX is for single use only.
Danish: TRISENOX er kun til engangsbrug.
English: Thereafter, penicillamine at a daily dose ≤ 1 g per day may be given.
Danish: Derefter kan der gives penicillamin i en dosis ≤ 1 g pr. dag.
English: Previous treatment with anthracyclines may increase the risk of QT prolongation.
Danish: Tidligere behandling med antracykliner kan øge risikoen for QT-forlængelse.
English: Arsenic is excreted in human milk.
Danish: Arsen udskilles i human mælk.
English: TRISENOX must be administered intravenously over 1-2 hours.
Danish: TRISENOX skal indgives intravenøst over 1-2 timer.
English: The duration of treatment with penicillamine must be evaluated taking into account the urinary arsenic laboratory values.
Danish: Varigheden af behandlingen med penicillamin skal evalueres under hensyntagen til laboratorieværdien for arsen i urinen.
English: The mechanism of action of TRISENOX is not completely understood.
Danish: TRISENOX' virkningsmekanisme er ikke helt klarlagt.
English: The most commonly reported reactions were hyperglycaemia, hypokalaemia, neutropenia, and increased alanine amino transferase (ALT).
Danish: De hyppigst rapporterede reaktioner var hyperglykæmi, hypokaliæmi, neutropeni og forhøjet alanin-aminotransferase (ALAT).
English: Clearance is not dependent on the weight of the subject or the dose administered over the dose range studied.
Danish: Clearance er ikke afhængig af personens vægt eller den indgivne dosis i det undersøgte dosisinterval.
English: Now press your thumb on the coloured point and break the ampoule by holding firmly the body of the ampoule with the other hand.
Danish: Tryk nu med tommelfingeren på det farvede punkt og knæk ampullen ved at holde godt fast om ampullens hoveddel med den anden hånd.
English: Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles.
Danish: Behandlingen skal fortsættes i 4 uger med behandling og 4 uger uden, i alt 4 cyklusser.
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of TRISENOX.
Danish: Din læge vil tage følgende forsigtighedsregler: - Der vil blive taget prøver for at kontrollere mængden af kalium, magnesium, calcium og kreatinin i blodet, inden du får din første dosis TRISENOX.
English: Relapsed/refractory APL
Danish: Recidiverende/refraktær APL
English: TRISENOX dose, mg/kg/day (median, range) Complete remission Time to bone marrow remission (median)
Danish: TRISENOX dosis, mg/kg/dag (median, interval) Komplet remission Tid til knoglemarvsremission (median)
English: This is probably due to the confounding of adverse events by the uncontrolled disease process early on in the treatment course and the myriad concomitant medicinal products required to control symptoms and morbidity.
Danish: Dette skyldes sandsynligvis en sammenblanding af bivirkninger med den ukontrollerede sygdomsproces tidligt i behandlingsforløbet og de myriader af samtidige lægemidler, som er påkrævet for at kontrollere symptomer og morbiditet.
English: Hepatotoxicity (grade 3-4)
Danish: Hepatotoksicitet (grad 3-4)
English: In particular tell your doctor - if you are taking any of various types of medicines which could cause a change in the rhythm of your heartbeat.
Danish: Fortæl det især altid til lægen hvis du bruger forskellige typer medicin, som kan forårsage en ændring i din hjerterytme.
English: ATRA + Chemotherapy (n = 79)
Danish: ATRA + kemoterapi (n = 79)
English: If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
Danish: Hvis du mærker ubehag eller føler dig utilpas efter en TRISENOXinfusion, skal du vente, indtil symptomerne forsvinder, før du fører motorkøretøj eller betjener maskiner.
English: TRISENOX is for single use only and any unused portions of each ampoule or of each vial must be discarded properly.
Danish: TRISENOX er kun til engangsbrug, og alle ubrugte portioner fra hver ampul eller fra hvert hætteglas skal bortskaffes forsvarligt.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Danish: Farmakoterapeutisk klassifikation: Andre neoplastiske midler, ATC-kode: L01XX27
English: No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted.
Danish: Der er ikke gennemført nogen formel vurdering af farmakokinetiske interaktioner mellem TRISENOX og andre terapeutiske lægemidler.