FrancophonIA/ELRC3.0 huggingface dataset:
English: If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with TRISENOX 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 TRISENOX genoptages med 0,11 mg/kg dagligt i endnu en uge.
English: Forty-four per cent 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 TRISENOX.
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 TRISENOX.
English: Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, United Kingdom
Danish: Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, Storbritannien
English: Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called “differentiation syndrome”, which might be fatal: - difficulty in breathing - coughing - chest pain - fever
Danish: Du skal straks fortælle det til lægen eller sygeplejersken, hvis du oplever følgende bivirkninger, da disse kan være tegn på en alvorlig tilstand kaldet ”differentieringssyndrom”, som kan være dødelig: - 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 TRISENOX once every day as an infusion.
Danish: Patienter med akut promyelocyt-leukæmi, hvor sygdommen ikke har reageret på andre behandlinger Lægen vil give dig TRISENOX én gang om dagen som en infusion.
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 TRISENOX 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 TRISENOX-behandlingen til slutningen af induktionsbehandlingen hos APL-patienter.
English: Wernicke encephalopathy after arsenic trioxide treatment was reported in patients with vitamin B1 deficiency.
Danish: Der blev indberettet Wernickes encefalopati efter behandling med arsentrioxid hos patienter med B1-vitaminmangel.
English: Hepatotoxicity (grade 3 or greater)
Danish: Hepatotoksicitet (grad 3 eller derover)
English: • medicines for depression (e.g. amitriptyline)
Danish: • medicin til behandling af depression (f.eks. amitriptylin)
English: Aspartate amino transferase increased
Danish: Forhøjet aspartat-aminotransferase
English: As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with TRISENOX 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 TRISENOX genoptages med 50 % af den tidligere dosis i de første 7 dage.
English: Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you TRISENOX once every day as an infusion.
Danish: Patienter med nydiagnosticeret akut promyelocyt-leukæmi Lægen vil give dig TRISENOX én gang om dagen som en infusion.
English: Twenty relapsed/refractory APL patients (50 %) experienced leucocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leucopheresis 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: Metabolism and nutrition disorders Hyperglycaemia
Danish: Metabolisme og ernæring Hyperglykæmi
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Biotransformation The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Danish: Biotransformation Metaboliseringen af arsentrioxid omfatter oxidering af arsensyrling (AsIII), den aktive form af arsentrioxid, til arsensyre (AsV), såvel som oxidativ metylering til monometylarsonsyre (MMAV) og dimetylarsinsyre (DMAV) via metyltransferaser, primært i leveren.
English: In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with TRISENOX.
Danish: Efter markedsføringen af TRISENOX er der også blevet rapporteret et differentieringssyndrom, såsom retinoinsyresyndrom, i forbindelse med behandling af andre maligniteter end APL.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasetiketten og æsken.
English: For storage conditions after dilution of the medicinal products, see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlerne, se pkt.
English: Clinically unstable APL patients are especially at risk and will require more frequent monitoring of electrolyte and glycaemia levels as well as more frequent haematologic, hepatic, renal and coagulation parameter tests.
Danish: Klinisk ustabile patienter med akut promyelocyt-leukæmi (APL) er specielt udsatte og vil kræve hyppigere monitorering af elektrolyt- og glykæmiske niveauer samt hyppigere hæmatologiske, hepatiske, renale og koagulationsparameteranalyser.
English: The diluted solution must be clear and colourless.
Danish: Den fortyndede infusionsvæske skal være klar og farveløs.
English: The experience in patients with severe renal impairment is insufficient to determine if dose adjustment is required.
Danish: Erfaringerne fra patienter med alvorligt nedsat nyrefunktion er utilstrækkelige til at vurdere, om dosisjustering er nødvendig.
English: In case of reappearance of hepatotoxicity, TRISENOX must be permanently discontinued.
Danish: Hvis hepatotoksicitet genopstår, skal TRISENOX seponeres permanent.
English: The median age in the multicentre study was 40 years (age range 5 to 73).
Danish: Gennemsnitsalderen i multicenterstudiet var 40 år (aldersinterval 5 til 73).
English: The median age in the single centre study was 33 years (age range 9 to 75).
Danish: Gennemsnitsalderen i enkeltcenterstudiet var 33 år (aldersinterval 9 til 75).
English: Cases of encephalopathy were reported with treatment with arsenic trioxide.
Danish: Der blev indberettet tilfælde af encefalopati under behandling med arsentrioxid.
English: TRISENOX must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Danish: TRISENOX skal indgives under tilsyn af en læge, der har erfaring med behandlingen af akut leukæmi.
English: The plasma concentration of AsIII declines from peak plasma concentration in a biphasic manner with a mean terminal elimination half-life of 10 to 14 hours.
Danish: falder fra maksimal plasmakoncentration på en bifasisk måde med en gennemsnitlig terminal eliminationshalveringstid på 10-14 timer.
English: Medicinal products known to cause QT/QTc interval prolongation, hypokalaemia or hypomagnesaemia
Danish: Lægemidler, der vides at forårsage forlængelse af QT/QTc-intervallet, hypokaliæmi eller hypomagnesiæmi
English: Electrocardiogram (ECG) abnormalities
Danish: Elektrokardiogram (ekg)-anomalier
English: The majority of patients do not require permanent termination of TRISENOX therapy during treatment of the APL differentiation syndrome.
Danish: Hos de fleste patienter vil det ikke være nødvendigt at seponere TRISENOX permanent under behandling af APL-differentieringssyndrom.
English: TRISENOX has no or negligible influence on the ability to drive and use machines.
Danish: TRISENOX påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing TRISENOX.
Danish: Tre patienter fra enkeltinstitutionsstudiet og 15 patienter fra multicenterstudiet fik stamcelletransplantationer efter afslutning af TRISENOX.
English: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland
Danish: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Irland
English: 32 days
Danish: 32 dage
English: Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro.
Danish: Arsentrioxid fremkalder morfologiske ændringer og deoxyribonukleinsyre (dna)-fragmenteringsegenskaber, som er karakteristisk for apoptose ved NB4-humane promyelocyt-leukæmi-celler in vitro.
English: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all-trans-retinoic acid (ATRA)
Danish: • Nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL) (antal hvide blodlegemer ≤ 10 x 103/µl) i kombination med all-trans-retinoinsyre (ATRA)
English: Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
Danish: Arsentrioxid kan forårsage forlænget QT-interval og komplet atrieventrikulær blokering.
English: TRISENOX must be diluted with a solution containing glucose or a solution containing sodium chloride.
Danish: TRISENOX skal fortyndes med en injektionsvæske, der indeholder enten glucose eller natriumchlorid.
English: In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %.
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL blev der observeret QTcforlængelse hos 15,6 %.
English: Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX 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 TRISENOX i den anbefalede dosis på 0,15 mg/kg/dag opnåede komplet respons (se pkt.
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during TRISENOX clinical trials in 52 patients with refractory/relapsed APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 1/1,000 to < 1/100), not known (cannot be estimated from available data).
Danish: Bivirkningerne, der er listet i Tabel 2 nedenfor i henhold til anbefalede termer efter MedDRA-systemorganklasse oghyppighed, blev observeret i kliniske studier af TRISENOX hos 52 patienter med behandlingsresistent/recidiverende APL. Bivirkningsfrekvenserne defineres som følger: meget almindelig ( 1/10), almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the case of the reappearance of symptoms TRISENOX should be reduced to the previous dosage.
Danish: Hvis symptomerne genopstår, skal TRISENOX reduceres til den tidligere dosis.
English: TRISENOX must be diluted before administration.
Danish: TRISENOX skal fortyndes før indgift.
English: Leucocytosis 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: Because of the potential for serious adverse reactions in breast-feeding infants and children from TRISENOX, breast-feeding must be discontinued prior to and throughout administration.
Danish: På grund af muligheden for alvorlige bivirkninger af TRISENOX hos ammede spædbørn og børn, skal amningen ophøre forud for og under behandlingen.
English: TRISENOX is expected to have no or negligible influence on your ability to drive and use machines.
Danish: TRISENOX forventes ikke at påvirke eller påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: After dilution, if not used immediately, storage times and conditions before use are the responsibility of your doctor, pharmacist or nurse and would normally not be longer than 24 hours at 2 to 8 ºC, unless dilution has taken place in a sterile environment.
Danish: Efter fortynding: Hvis præparatet ikke bruges umiddelbart efter fortynding, er opbevaringstider og betingelser din læges, apotekspersonalets eller sygeplejerskens ansvar, og det vil normalt ikke være længere end 24 timer ved 2 til 8C, medmindre fortyndingen har fundet sted i et sterilt miljø.
English: Each pack contains 10 ampoules.
Danish: Hver pakning indeholder 10 ampuller.
English: You must not receive TRISENOX
Danish: Du må ikke få TRISENOX
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 TRISENOX 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 TRISENOX 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: Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made.
Danish: De foreliggende data for børn i alderen 5 til 16 år er beskrevet i pkt.
English: Skin and subcutaneous tissue disorders Pruritus
Danish: Hud og subkutane væv Pruritus
English: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Danish: Det aktive stof i TRISENOX, arsentrioxid, er karcinogent hos mennesker.
English: However, toxic effects resolved with temporary discontinuation of either TRISENOX, ATRA or both (see section 4.4).
Danish: De toksiske virkninger ophørte imidlertid med en midlertidig afbrydelse af enten TRISENOX, ATRA eller begge (se pkt.
English: If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, TRISENOX must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 g per day may be considered.
Danish: Hvis der opstår symptomer, der tyder på alvorlig akut arsen-toksicitet (f.eks. kramper, muskelsvækkelse og konfusion), skal TRISENOX øjeblikkeligt seponeres, og kelatterapi med penicillamin i en daglig dosis på ≤ 1 g kan overvejes.
English: TRISENOX 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: TRISENOX 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: Prior to initiating therapy with TRISENOX, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; pre-existing 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 TRISENOX 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: 2-Year event-free survival (EFS)
Danish: 2-års hændelsesfri overlevelse (EFS)
English: If complete remission has not occurred by day 50, dosing must be discontinued.
Danish: Hvis der ikke er opnået komplet remission inden 50 dage, skal behandlingen seponeres.
English: In general, treatment-emergent adverse events tended to decrease over time, in relapsed/refractory APL patients perhaps accounted for by amelioration of the underlying disease process.
Danish: Der var generelt en tendens til, at behandlingskrævende bivirkninger aftog med tiden hos patienter med recidiverende/refraktær APL, måske på grund af en forbedring af den tilgrundliggende sygdomsproces.
English: Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukaemia/retinoic acid receptor-alpha (PML/RAR alpha).
Danish: Arsentrioxid skader og nedbryder også fusionsproteinet Promyelocyt-leukæmi/retinoinsyrereceptor-alfa (PML/RAR-alfa).
English: Multicentre trial N with CR = 34
Danish: Multicenterstudie N med CR = 34
English: TRISENOX has been investigated in 77 newly diagnosed patients with low to intermediate risk APL, in a controlled, randomized, non-inferiority Phase 3 clinical study comparing the efficacy and safety of TRISENOX combined with all-trans-retinoic acid (ATRA) with those of ATRA + chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Danish: TRISENOX er blevet undersøgt hos 77 nydiagnosticerede patienter med lav til intermediær risiko APL i et kontrolleret, randomiseret klinisk fase 3-non-inferioritetsstudie, der sammenlignede virkningen og sikkerheden af TRISENOX i kombination med all-trans-retinoinsyre (ATRA) versus ATRA+kemoterapi (f.eks. idarubicin og mitoxantron) (studie APL0406).
English: TRISENOX 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: TRISENOX 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: If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Danish: Hvis der optræder symptomer i form af synkoper, hurtig eller uregelmæssig hjerteslag, skal patienten indlægges og observeres konstant, serumelektrolytter skal bestemmes, og TRISENOXterapi bør afbrydes midlertidigt, indtil QTc-intervallet vender tilbage til under 460 msek., elektrolytanomalierne er korrigeret, og synkoper og uregelmæssige hjerteslag ophører.
English: APL = acute promyelocytic leukaemia; ATRA = all-trans-retinoic acid
Danish: APL = akut promyelocyt-leukæmi, ATRA = all-trans-retinoinsyre
English: TRISENOX has been investigated in 52 APL patients, previously treated with an anthracycline and a retinoid regimen, in two open-label, single-arm, non-comparative studies.
Danish: TRISENOX er blevet undersøgt hos 52 APL-patienter, som tidligere er blevet behandlet med anthracyclin og retinoid i to åbne enkeltarmede ikke-komparative studier.
English: As soon as signs and symptoms have subsided, treatment with TRISENOX can be resumed at 50 % of the previous dose during the first 7 days.
Danish: Så snart symptomerne er aftaget, kan behandlingen med TRISENOX genoptages med 50 % af den tidligere dosis i de første 7 dage.
English: Arsenic compounds induce chromosomal aberrations and morphological transformations of mammalian cells in vitro and in vivo.
Danish: Arsensammensætninger påfører kromosomafvigelser og morfologiske ændringer af pattedyrsceller in vitro og in vivo.
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: Hyperleucocytosis
Danish: Hyperleukocytose
English: Caution is advised when TRISENOX is co-administered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalaemia or hypomagnesaemia.
Danish: Forsigtighed tilrådes, når TRISENOX indgives sammen med andre lægemidler, som vides at forårsage QT/QTc-intervalforlængelse såsom makrolid-antibiotika, det antipsykotiske stof thioridazin, eller lægemidler som er kendt for at forårsage hypokaliæmi eller hypomagnesiæmi.
English: • medicines to treat psychosis (loss of contact with reality, e.g. thioridazine)
Danish: • medicin til behandling af psykose (manglende realitetsopfattelse, f.eks. thioridazin)
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RARα by RT-PCR or micro speckled PML nuclear distribution in leukaemic cells were included.
Danish: Patienter med nydiagnosticeret APL, bekræftet ved tilstedeværelse af t(15; 17) eller PML-RARα ved RT-PCR, eller med hypergranulære leukæmiceller blev inkluderet.
English: In newly diagnosed patients with low to intermediate risk APL, differentiation syndrome was observed in 19 % including 5 severe cases.
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL blev der observeret differentieringssyndrom hos 19 %, herunder 5 svære tilfælde.
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 TRISENOX, ATRA eller begge.
English: Since no data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
Danish: Da der ikke foreligger data for alle grupper med nedsat nyrefunktion, tilrådes forsigtighed ved brug af TRISENOX hos patienter med nedsat nyrefunktion.
English: Differentiation syndrome
Danish: Differentieringssyndrom
English: Single centre pilot trial N with CR = 11
Danish: Enkeltcenter-pilotstudie N med CR = 11
English: Because TRISENOX can harm nursing infants, do not breast-feed while on TRISENOX.
Danish: Da TRISENOX kan være skadeligt for spædbørn, der ammes, må du ikke amme, så længe du får TRISENOX.
English: Other antileukaemic medicinal products The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
Danish: Andre lægemidler mod leukæmi TRISENOX' indvirkning på andre lægemidler mod leukæmi er ukendt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/02/204/002
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig for batchfrigivelse
English: 2-Year disease-free survival (DFS)
Danish: 2-års sygdomsfri overlevelse (DFS)
English: Ventricular tachycardia
Danish: Ventrikulær takykardi
English: TRISENOX is supplied in glass ampoules as a concentrated, clear, colourless, aqueous solution.
Danish: TRISENOX leveres i glasampuller som en koncentreret, klar, farveløs, vandig opløsning.