FrancophonIA/ELRC3.0 huggingface dataset:
English: In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with arsenic trioxide.
Danish: I en opfølgende behandling efter konsolidering fik 7 patienter i enkeltinstitutionsstudiet og 18 patienter i multicenterstudiet yderligere vedligeholdelsesbehandling med arsentrioxid.
English: Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.
Danish: I de pivotale studier med recidiverende APL var mortaliteten i forbindelse med dissemineret intravaskulær koagulation (DIC) associeret blødning meget almindelig (>10 %), hvilket stemmer overens med den tidlige mortalitet, der er rapporteret i litteraturen.
English: In your first treatment cycle, you may be treated every day up to 60 days at most or until your doctor determines that your disease is better.
Danish: I det første behandlingsforløb vil du blive behandlet hver dag i op til højst 60 dage, eller indtil lægen afgør, at din sygdom er i bedring.
English: In your first treatment cycle, you may be treated every day up to 50 days at most or until your doctor determines that your disease is better.
Danish: I det første behandlingsforløb vil du blive behandlet hver dag i op til højst 50 dage, eller indtil lægen afgør, at din sygdom er i bedring.
English: There is no experience on the effect of arsenic trioxide on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Danish: Der er ingen erfaring med effekten af arsentrioxid på varianten APL indeholdende t(11;17) og t(5;17) kromosomtranslokationer.
English: In such cases, treatment must resume at 50% of the preceding daily dose.
Danish: I sådanne tilfælde skal behandlingen genoptages med 50 % af den forudgående daglige dosis.
English: It is recommended that chemotherapy not be added to treatment with steroids since there is no experience with administration of both steroids and chemotherapy during treatment of the leukocyte activation syndrome due to arsenic trioxide.
Danish: Det anbefales, at der ikke føjes kemoterapi til behandling med steroider, da der ikke er nogen erfaring med indgivelser af både steroider og kemoterapi under behandling af leukocytaktiveringssyndromet som følge af arsentrioxid.
English: - Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with Arsenic trioxide Accord.
Danish: - Blodprøver (for kalium, calcium, magnesium og til kontrol af leverfunktionen) bør gentages under behandlingen med Arsenic trioxide Accord.
English: 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: The use of arsenic trioxide in patients on dialysis has not been studied.
Danish: Anvendelse af arsentrioxid hos patienter i dialyse er ikke undersøgt.
English: Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes.
Danish: Patienter, som får eller som har fået lægemidler, som vides at bevirke hypokaliæmi eller hypomagnesiæmi, såsom diuretika eller amphotericin B, kan være udsat for en højere risiko for Torsade de pointes.
English: QT/QTc prolongation is expected during treatment with arsenic trioxide, and Torsade de pointes and complete heart block have been reported.
Danish: QT/QTc-forlængelse må forventes under behandling med arsentrioxid, og Torsade de pointes og komplet hjerteblok er rapporteret.
English: Patients with complete remission received consolidation therapy with arsenic trioxide for 25 additional doses over a 5 weeks period.
Danish: Patienter med komplet remission fik konsolideringsterapi med arsentrioxid i yderligere 25 doser over en 5-ugers periode.
English: The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Danish: Arsentrioxids sikkerhed og virkning hos børn i alderen op til 17 år er ikke klarlagt.
English: Hydroxyurea should be continued at a given dose to keep the white blood cell count ≤ 10 x 103/μl and subsequently tapered.
Danish: Behandlingen med hydroxyurea skal fortsættes i et givet dosisniveau for at holde antallet af hvide blodlegemer ≤10 x 103/μl, og derefter skal dosis nedtrappes.
English: Arsenic trioxide was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
Danish: Arsentrioxid blev indgivet intravenøst over 1 til 2 timer, indtil knoglemarven var fri for leukæmiceller, op til maksimalt 60 dage.
English: 44% of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with arsenic trioxide.
Danish: 44 % af recidiverende/refraktære APL-patienterne oplevede symptomer, der kunne forbindes med neuropati; de fleste var lette til moderate og reversible efter seponering af arsentrioxid.
English: Arsenic trioxide Accord is supplied in glass vials as a concentrated, sterile, clear, colourless, aqueous solution .
Danish: Arsenic trioxide Accord leveres i hætteglas (glas) som en koncentreret, steril, klar, farveløs, vandig opløsning.
English: In newly diagnosed and relapsed/refractory APL patients who develop sustained leukocytosis after initiation of therapy, hydroxyurea should be administered.
Danish: Nydiagnosticerede og recidiverende/refraktære APL-patienter, som udvikler vedvarende leukocytose efter påbegyndt behandling, skal indgives hydroxyurea.
English: One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Danish: En patient behandlet under et “compassionate use program” døde af cerebral infarkt på grund af leukocytose efter behandling med kemoterapeutiske lægemidler for at sænke WBC-tallet.
English: Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction:
Danish: Du skal straks fortælle det til lægen eller sygeplejersken, hvis du oplever følgende bivirkninger, da disse kan være tegn på en allergisk reaktion:
English: If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose.
Danish: Hvis den toksiske hændelse ikke genopstår inden for 7 dage efter genoptagelse af behandlingen med den reducerede dosis, kan den daglige dosis øges til 100 % af den oprindelige dosis.
English: ATRA + Arsenic trioxide (n = 77)
Danish: ATRA + arsentrioxid (n = 77)
English: No data are available on patient with variant translocations like t(11;17) (PLZF/RAR alpha).
Danish: Der foreligger ingen data for patienter med andre translokationer, såsom t(11;17) (PLZF/RAR alfa).
English: Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.
Danish: Arsentrioxid skader og nedbryder også fusionsproteinet PML/RAR-alfa.
English: Patients who reach an absolute QT interval value > 500 msec must be reassessed and immediate action must be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending arsenic trioxide therapy must be considered.
Danish: Patienter, der når et absolut QT-interval >500 msek., skal revurderes, og der skal træffes omgående forholdsregler for at korrigere eventuelle samtidigt forekommende risikofaktorer, og forholdet mellem risiko og fordele ved at fortsætte kontra seponere behandlingen med arsentrioxid skal vurderes.
English: Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord.
Danish: Lægen vil beslutte nøjagtigt, hvor længe du skal fortsætte behandlingen med Arsenic trioxide Accord.
English: Patients who experience such reactions that are considered arsenic trioxide related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption.
Danish: Hos patienter, der oplever sådanne reaktioner, vurderet som relateret til arsentrioxid, må behandlingen først genoptages, når den toksiske hændelse er forsvundet, eller den anomali, der forårsagede afbrydelsen, er vendt tilbage til baseline-status.
English: Hyperleukocytosis was never treated with additional chemotherapy and resolved on continuation of arsenic trioxide.
Danish: Hyperleukocytose blev aldrig behandlet med yderligere kemoterapi og bedredes ved fortsættelse af arsentrioxid.
English: Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RARα conversion to normal are shown in table 5 below.
Danish: Cytogenetisk bekræftelse af konversion til en normal genotype og påvisning ved revers transkriptasepolymerasekædereaktion (RT-PCR) af PML/RARα konversion til normal er vist i Tabel 5 nedenfor.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: After first opening: Once opened the product should be used immediately.
Danish: Efter første åbning: Lægemidlet skal anvendes straks efter første åbning.
English: Baseline white blood cell (WBC) counts did not correlate with development of leukocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Danish: Baseline-antal af hvide blodlegemer (WBC) korrelerede ikke med udvikling af leukocytose under studiet, og WBC-tal under konsolideringesbehandlingen var ikke så høje som under induktionen.
English: In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of arsenic trioxide application to the end of induction therapy in APL patients.
Danish: For at forhindre udvikling af APLdifferentieringssyndrom under induktionsbehandlingen kan prednison (0,5 mg/kg kropsvægt dagligt i hele induktionsperioden) indgives fra dag 1 af arsentrioxid-behandlingen til slutningen af induktionsbehandlingen hos APL-patienter.
English: Alanine amino transferase increased
Danish: Forhøjet alanin-aminotransferase
English: - difficulty in breathing - coughing - chest pain - fever
Danish: - vejrtrækningsbesvær - hoste - smerter i brystet - feber
English: Patients with acute promyelocytic leukaemia, whose disease has not responded to other therapies Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Danish: Patienter med akut promyelocyt-leukæmi, hvor sygdommen ikke har reageret på andre behandlinger Lægen vil give dig Arsenic trioxide Accord én gang om dagen som en infusion.
English: Arsenic trioxide Accord with food and drink
Danish: Brug af Arsenic trioxide Accord sammen med mad og drikke
English: Concentrate for solution for infusion 1 vial of 10 ml (10 mg/10 ml) 5 vials of 10 ml (10 mg/10 ml) 10 vials of 10 ml (10 mg/10 ml)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas med 10 ml (10 mg/10 ml) 5 hætteglas med 10 ml (10 mg/10 ml) 10 hætteglas med 10 ml (10 mg/10 ml)
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: 10-50 x 10
Danish: 10-50 x 103/µl
English: It is for single use only, and any unused portions of each vial must be discarded properly.
Danish: Kun til engangsbrug, og alle ubrugte portioner fra hvert hætteglas skal bortskaffes forsvarligt.
English: If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Danish: Hvis QTc-forlængelsen ikke vender tilbage inden for 7 dage efter, behandlingen er genstartet med den reducerede dosis, kan behandlingen med arsentrioxid genoptages med 0,11 mg/kg dagligt i endnu en uge.
English: Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia
Danish: Lægemidler, der vides at forårsage forlængelse af QT/QTc-intervallet, hypokaliæmi eller hypomagnesiæmi
English: Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Danish: Patienter med nydiagnosticeret akut promyelocyt-leukæmi Lægen vil give dig Arsenic trioxide Accord én gang om dagen som en infusion.
English: During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and arsenic trioxide was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Danish: Under konsolidering blev ATRA givet i den samme dosis i perioder på 2 uger med behandling og 2 uger uden, til i alt 7 behandlingsforløb, og arsentrioxid blev givet i den samme dosis 5 dage om ugen, 4 uger med behandling og 4 uger uden, til i alt 4 behandlingsforløb.
English: The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Danish: Responsraten af andre undertyper af akut myelogen leukæmi på arsentrioxid er ikke undersøgt.
English: As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with arsenic trioxide should be resumed at 50 % of the previous dose during the first 7 days.
Danish: Så snart bilirubin og/eller ASAT og/eller basisk fosfatase er faldet til under 4 gange den øvre normalgrænse, skal behandlingen med arsentrioxid genoptages med 50 % af den tidligere dosis i de første 7 dage.
English: Twenty relapsed/refractory APL patients (50 %) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
Danish: 20 patienter med recidiverende/refraktære APL (50 %) oplevede leukocytose, men hos alle disse patienter var WBC-tallet faldende eller havde normaliseret sig på tidspunktet for knoglemarvsremission, og cytotoksisk kemoterapi eller leukoferese var ikke påkrævet.
English: APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
Danish: APL = akut promyelocyt-leukæmi, ATRA = all-trans-retinoinsyre
English: Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
Danish: 5 ud af 7 patienter under 18 år (i alderen 5 til 16 år) behandlet med arsentrioxid i den anbefalede dosis på 0,15 mg/kg/dag opnåede komplet respons (se pkt.
English: - The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: natriumhydroxid, saltsyre; koncentreret (til pH-justering) og vand til injektionsvæsker.
English: Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3.
Danish: Steril, klar, farveløs, vandig opløsning, fri for partikler og med pH-værdi på 7,7-8,3.
English: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both.
Danish: De toksiske virkninger bedredes imidlertid med en midlertidig afbrydelse af enten arsentrioxid, ATRA eller begge.
English: Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) - lungebetændelse, blodforgiftning - inflammation (betændelsesagtig tilstand) i lungerne som medfører smerter i brystet og åndenød,
English: Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Danish: Arsenic trioxide Accord skal indgives under tilsyn af en læge, der har erfaring med behandlingen af akut leukæmi.
English: See section 2, “Arsenic trioxide Accord contains sodium”.
Danish: Se punkt 2 ” Arsenic trioxide Accord indeholder natrium”.
English: In case of reappearance of hepatotoxicity, arsenic trioxide must be permanently discontinued.
Danish: Hvis hepatotoksicitet genopstår, skal arsentrioxid seponeres permanent.
English: Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.
Danish: Leukocytose optrådte hos 50 % af patienter med recidiverende/refraktær APL vurderet ud fra en hæmatologisk bedømmelse.
English: There are no studies in pregnant women using arsenic trioxide.
Danish: Der er ikke udført studier hos gravide kvinder, der anvender arsentrioxid.
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
Danish: Tre patienter fra enkeltinstitutionsstudiet og 15 patienter fra multicenterstudiet fik stamcelletransplantationer efter afslutning af arsentrioxid.
English: Because of the potential for serious adverse reactions in breastfeeding infants from arsenic trioxide, breast-feeding must be discontinued prior to and throughout administration.
Danish: På grund af muligheden for alvorlige bivirkninger af arsentrioxid hos ammede spædbørn, skal amningen ophøre forud for og under behandlingen.
English: In post authorisation experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with arsenic trioxide.
Danish: Efter godkendelse af arsentrioxid er der også blevet rapporteret et differentieringssyndrom, såsom retinoinsyresyndrom, i forbindelse med behandling af andre maligniteter end APL.
English: In the presence of coagulopathy, the oral administration of the chelating agent dimercaptosuccinic acid succimer (DCI) 10 mg/kg or 350 mg/m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Danish: I tilfælde af koagulopati anbefales oral indgivelse af det kelerende middel dimercaptosuccinsyresuccimer (DCI) 10 mg/kg eller 350 m2 hver 8. time i 5 dage og derefter hver 12. time i to uger.
English: The majority of patients do not require permanent termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome.
Danish: Hos de fleste patienter vil det ikke være nødvendigt at seponere arsentrioxid permanent under behandling af APL-differentieringssyndrom.
English: Accord Healthcare Polska Sp.z o.o., ul.
Danish: Accord Healthcare Polska Sp.z o.o.
English: During therapy with arsenic trioxide, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Danish: Under behandling med arsentrioxid skal kaliumkoncentrationerne holdes på over 4 mEq/l, og magnesium koncentrationerne skal holdes over
English: Arsenic trioxide must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
Danish: Arsentrioxid skal indgives intravenøst dagligt i en fast dosis på 0,15 mg/kg/dag, indtil komplet remission er opnået (mindre end 5 % blastceller i cellulær knoglemarv og ingen evidens på leukæmiceller).
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Danish: Patienter med nydiagnosticeret APL, bekræftet ved tilstedeværelse af t(15; 17) eller PML-RAR alfa ved RT-PCR, eller med hypergranulære leukæmiceller blev inkluderet.
English: At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with arsenic trioxide must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Danish: Ved de første tegn, der kan tyde på syndromet (uforklarlig feber, dyspnø og/eller øget vægt, abnorme stetoskopifund på brystet eller røntgenabnormiteter), skal behandlingen med arsentrioxid afbrydes midlertidigt og behandling med højdosis-steroid (dexamethason 10 mg intravenøst to gange om dagen) straks påbegyndes, uden hensyntagen til leukocyttælling, og fortsættes i mindst 3 dage eller længere, indtil symptomerne er ophørt.
English: In the case of the reappearance of symptoms arsenic trioxide should be reduced to the previous dosage.
Danish: Hvis symptomerne genopstår, skal arsentrioxid reduceres til den tidligere dosis.
English: The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated.
Danish: Enkeltinstitutionsstudiet inkluderede 2 pædiatriske patienter (<18 år gamle), som begge opnåede CR. Multicenterstudietinkluderede 5 pædiatriske patienter (<18 år gamle), hvoraf 3 opnåede CR. Ingen børn under 5 år blev behandlet.
English: Because Arsenic trioxide Accord can harm nursing infants, do not breast-feed while on Arsenic trioxide Accord.
Danish: Da Arsenic trioxide Accord kan være skadeligt for spædbørn, der ammes, må du ikke amme, så længe du får Arsenic trioxide Accord.
English: Arsenic trioxide Accord is expected to have no or negligible influence on your ability to drive and use machines.
Danish: Arsenic trioxide Accord forventes ikke at påvirke eller påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Arsenic trioxide Accord contains arsenic trioxide which is an anticancer medicine.
Danish: Arsenic trioxide Accord indeholder arsentrioxid, der er et lægemiddel mod kræft.
English: Prior to initiating therapy with arsenic trioxide, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Danish: Inden behandling med arsentrioxid indledes, skal der tages et ekg med 12 afledninger, og serumelektrolytter (kalium, kalcium og magnesium) samt kreatinin skal bedømmes; tidligere elektrolyt-anomalier skal korrigeres, og om muligt skal behandling med lægemidler, der vides at forlænge QT-intervallet, seponeres.
English: Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed.
Danish: Arsentrioxid skal indgives under vejledning af en læge, som har erfaring i behandling af akut leukæmi, og de særlige monitoreringsprocedurer, der er beskrevet i pkt.
English: QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Danish: QTforlængelse kan føre til en ventrikelarytmi af typen Torsade de pointes, hvilket kan få dødelig udgang.
English: Arsenic trioxide has no or negligible influence on the ability to drive and use machines.
Danish: Arsentrioxid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.