FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with severe, acute arsenic overdose, dialysis should be considered
Danish: For patienter med alvorlig, akut arsenoverdosis skal man overveje dialyse.
English: The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Danish: De pentavalente metabolitter, MMAV og DMAV optræder langsomt i plasma (cirka 10-24 timer efter første administration af arsentrioxid), men på grund af deres længere halveringstid, akkumuleres de mere ved gentagen dosering end AsIII.
English: No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Danish: Der blev ikke set nogen klar tendens til øget systemisk eksponering for AsIII, AsV, MMAV eller DMAV ved faldende leverfunktionsniveau vurderet ved dosisnormaliseret (pr mg dosis) AUC.
English: WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation.
Danish: WBC-tal under konsolidering var ikke så høje som under induktionsbehandling og var < 10 x 103/µl, med undtagelse af én patient, som havde et WBC-tal på 22 x 103/µl under konsolidering.
English: There is no experience on the effect of TRISENOX on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Danish: Der er ingen erfaring med effekten af TRISENOX på varianten APL indeholdende t(11;17) og t(5;17) kromosomtranslokationer.
English: Consolidation therapy began 6 weeks (range, 3-8) after induction in the single institution study and 4 weeks (range, 3-6) in the multicentre study.
Danish: Konsolideringsterapien påbegyndtes 6 uger (interval 3-8) efter induktion i enkeltinstitutionsstudiet og 4 uger (interval 3-6) i multicenterstudiet.
English: Pharmacokinetic data from patients with hepatocellular carcinoma having mild to moderate hepatic impairment indicate that AsIII or AsV do not accumulate following twice-weekly infusions.
Danish: Farmakokinetiske data fra patienter med hepatocellulært karcinom og let til moderat nedsat leverfunktion indikerer, at AsIII eller AsV ikke akummulerer efter infusion to gange ugentligt.
English: Patients at risk of B1 deficiency should be closely monitored for signs and symptoms of encephalopathy after arsenic trioxide initiation.
Danish: Patienter med risiko for B1-mangel bør overvåges nøje for tegn og symptomer på encefalopati efter arsentrioxid påbegyndes.
English: However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Danish: Dog er arsentrioxid og andre uorganiske arsensammensætninger kendt som karcinogene for mennesker.
English: In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
Danish: In vitro enzymatiske forsøg med humane levermikrosomer viste, at arsentrioxid ikke har nogen hæmmende virkning på substrater for de centrale cytochrom P450-enzymer såsom 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
English: TRISENOX with food and drink There are no restrictions on your food or drink while you are receiving TRISENOX.
Danish: Brug af TRISENOX sammen med mad og drikke Der er ingen begrænsninger med hensyn til mad og drikke, mens du får TRISENOX.
English: Patients with risk factors of QTc prolongation or risk factors of torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Danish: Patienter med risikofaktorer for QTc-forlængelse eller risikofaktorer for torsades de pointes bør observeres med kontinuerlig hjertemonitorering (ekg).
English: Each course of consolidation was initiated at haematological recovery from the previous course defined as absolute neutrophil count > 1.5 × 109/l and platelets > 100 × 109/l.
Danish: Hvert konsolideringsforløb blev påbegyndt ved hæmatologisk restitution efter det tidligere behandlingsforløb, defineret som absolut neutrofiltal > 1,5 × 109/l og trombocytter > 100 × 109/l.
English: If complete remission has not occurred by day 60, dosing must be discontinued.
Danish: Hvis der ikke er opnået komplet remission på dag 60, skal behandlingen seponeres.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV are 32 hours and
Danish: Den gennemsnitlige estimerede terminale eliminationshalveringstid for metabolitterne MMAV og DMAV er henholdsvis 32 timer og 70 timer.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om fortynding af lægemidlet før administration, se pkt.
English: 500 mg four times a day
Danish: 500 mg 4 gange dagligt
English: During therapy with TRISENOX, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Danish: Under behandling med TRISENOX skal kaliumkoncentrationerne holdes på over 4 mEq/l, og magnesium koncentrationerne skal holdes over 1,8 mg/dl.
English: At last follow-up, 6 of 12 patients in the single institution study were alive with a median follow-up time of 28 months (range 25 to 29).
Danish: Ved sidste opfølgning var 6 af 12 patienter i enkeltinstitutionsstudiet i live med en medianopfølgningstid på 28 måneder (område 25 til 29).
English: 2-Year cumulative incidence of relapse (CIR)
Danish: 2-års kumulativ forekomst af recidiv (CIR)
English: Patients with complete remission received consolidation therapy with TRISENOX for 25 additional doses over a 5 week period.
Danish: Patienter med komplet remission fik konsolideringsterapi med TRISENOX i yderligere 25 doser over en 5-ugers periode.
English: - If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously.
Danish: - Hvis der er risiko for, at du har en bestemt type unormal hjerterytme (f.eks. torsades de pointes eller QT-forlængelse), vil dit hjerte blive kontrolleret løbende.
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 TRISENOX.
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 TRISENOX.
English: Substances that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Danish: Stoffer, der er substrater for disse CYP-enzymer, forventes ikke at interagere med TRISENOX.
English: Only 2 relapsed/refractory APL patients discontinued treatment early due to this adverse event and one went on to receive additional TRISENOX on a subsequent protocol.
Danish: Kun 2 patienter med recidiverende/refraktær APL ophørte med behandling på et tidligt tidspunkt på grund af denne bivirkning, og én fortsatte med at få yderligere TRISENOX i henhold til en efterfølgende protokol.
English: - Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with TRISENOX.
Danish: - Blodprøver (for kalium, calcium, magnesium og til kontrol af leverfunktionen) bør gentages under behandlingen med TRISENOX.
English: 1000 mg four times a day
Danish: 1.000 mg 4 gange dagligt
English: At Risk
Danish: I risikozonen
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 TRISENOX.
Danish: I en opfølgende behandling efter konsolidering fik 7 patienter i enkeltinstitutionsstudiet og 18 patienter i multicenterstudiet yderligere vedligeholdelsesterapi med TRISENOX.
English: There are no data on the effect of arsenic trioxide on the QTc interval during the infusion.
Danish: Der foreligger ingen data om virkningerne af arsentrioxid på QTc under infusionen.
English: TRISENOX 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: TRISENOX blev indgivet intravenøst over 1 til 2 timer, indtil knoglemarven var fri for leukæmiceller, op til maksimalt 60 dage.
English: Confidence interval (CI)
Danish: Konfidensinterval (CI)
English: Hyperleucocytosis was never treated with additional chemotherapy and resolved on continuation of TRISENOX.
Danish: Hyperleukocytose blev aldrig behandlet med yderligere kemoterapi og bedredes ved fortsættelse af TRISENOX.
English: Infections and infestations Herpes zoster
Danish: Infektioner og parasitære sygdomme Herpes zoster
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 den første behandlingscyklus vil du blive behandlet hver dag i op til højst 60 dage, eller indtil lægen bestemmer, at din sygdom er i bedring.
English: The following undesirable effects have been reported in the APL0406 study in newly diagnosed patients and in clinical trials and/or post-marketing experience in relapsed/refractory APL patients.
Danish: Følgende bivirkninger er rapporteret i APL0406-studiet hos nydiagnosticerede patienter og i kliniske studier og/eller efter markedsføring hos recidiverende/refraktære APL-patienter.
English: Single Center Multicenter Study
Danish: Enkeltcenter Multicenter-forsøg
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 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: One was a single investigator clinical study (n=12) and the other was a multicentre, 9-institution study (n=40).
Danish: Det ene var et klinisk studie, som kun involverede én investigator (n=12), og det andet var et multicenterstudie med 9 institutioner
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 den første behandlingscyklus vil du blive behandlet hver dag i op til højst 50 dage, eller indtil lægen bestemmer, at din sygdom er i bedring.
English: Blood and lymphatic system disorders Febrile neutropenia
Danish: Blod og lymfesystem Febril neutropeni
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 200 patients who received TRISENOX consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.
Danish: *I CALGB-studiet C9710 blev der rapporteret 2 tilfælde af CGT-forhøjelse, grad ≥,3 blandt de 200 patienter, som fik TRISENOX konsolideringscyklusser (cyklus 1 og cyklus 2), versus ingen i kontrolgruppen.
English: Approximate accumulation ranged from 1.4- to 8-fold following multiple as compared to single dose administration.
Danish: Omtrentlig akkumulering var fra 1,4 til 8-dobbelt ved gentagen administration sammenlignet med enkeltdosis.
English: Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Danish: Komplet remission (CR) blev defineret som fravær af synlige leukæmiceller i knoglemarven og perifer restituering af blodplader og hvide blodlegemer.
English: If your disease responds to TRISENOX, you will be given 4 additional treatment cycles.
Danish: Hvis din sygdom reagerer positivt på TRISENOX, vil du få yderligere 4 behandlingscyklusser.
English: All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Danish: Alle parenterale opløsninger skal nøje efterses for partikler og misfarvning forud for indgivelsen.
English: No data are available on patient with variant translocations like t(11;17) (PLZF/RARα).
Danish: Der foreligger ingen data for patienter med andre translokationer, såsom t(11;17) (PLZF/RARα).
English: APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur.
Danish: APL er en speciel type myeloid leukæmi, en sygdom, hvor der forekommer unormale hvide blodlegemer og unormal blødning og blå mærker.
English: The patient's electrolyte and glycaemia levels, as well as haematologic, hepatic, renal and coagulation parameter tests must be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.
Danish: Patientens elektrolyt- og glykæmiske niveauer samt hæmatologiske, hepatiske, renale og koagulationsparameteranalyser skal kontrolleres mindst to gange om ugen og oftere for klinisk ustabile patienter under induktionsfasen og mindst ugentligt under konsolideringsfasen.
English: The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Danish: Den uorganiske, frysetørrede form af arsentrioxid danner efter opløsning straks hydrolyseproduktet arsensyrling (AsIII).
English: TRISENOX contains less than 1 mmol sodium (23 mg) per dose.
Danish: TRISENOX indeholder mindre end 1 mmol (23 mg) natrium pr. dosis.
English: The use of TRISENOX in patients on dialysis has not been studied.
Danish: Anvendelse af arsentrioxid hos patienter i dialyse er ikke undersøgt.
English: • some types of medicines to treat bacterial infections (e.g. erythromycin and sparfloxacin)
Danish: • visse typer medicin til behandling af bakterieinfektioner (f.eks. erythromycin og sparfloxacin)
English: TRISENOX is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies.
Danish: TRISENOX anvendes til voksne patienter med nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL), og til voksne patienter, hvis sygdom ikke har reageret på andre behandlinger.
English: In newly diagnosed and relapsed/refractory APL patients who develop sustained leucocytosis 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: For patients who cannot take oral medicinal product, dimercaprol administered at a dose of 3 mg/kg intramuscularly every 4 hours until any immediately life-threatening toxicity has subsided may be considered.
Danish: For patienter, der ikke kan tage oral medicin, kan dimercaprol indgivet i en dosis på 3 mg/kg intramuskulært hver 4. time overvejes, indtil den umiddelbare livstruende toksicitet er aftaget.
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: In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: If clinically justified/required, concomitant diuretic therapy is also recommended.
Danish: Hvis det er klinisk berettiget/påkrævet, anbefales også samtidig behandling med diuretika.
English: Newly diagnosed non high risk APL patients
Danish: Nydiagnosticerede APL-patienter, der ikke er i højrisikogruppe
English: There are no studies in pregnant women using TRISENOX.
Danish: Der er ikke udført studier hos gravide kvinder, der anvender TRISENOX.
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 TRISENOX 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 TRISENOX skal vurderes.
English: Your doctor will decide exactly how long you must continue on therapy with TRISENOX.
Danish: Din læge beslutter nøjagtigt, hvor længe du skal fortsætte behandlingen med TRISENOX.
English: One patient treated under a compassionate use program died from cerebral infarct due to leucocytosis, 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: Arsenic trioxide has been shown to be embryotoxic and teratogenic in animal studies (see section 5.3).
Danish: Arsentrioxid har vist sig embryotoksisk og teratogent i dyrestudier (se pkt.
English: AsIII is the pharmacologically active species of arsenic trioxide.
Danish: AsIII er den farmakologisk aktive form af arsentrioxid.
English: After administration at 0.15 mg/kg on a daily (n=6) or twice-weekly (n=3) regimen, an approximate 2-fold accumulation of AsIII was observed as compared to a single infusion.
Danish: Efter indgivelse af 0,15 mg/kg dagligt (n=6) eller to gange ugentligt (n=3) sås en cirka dobbelt så høj akkumulering af AsIII sammenlignet med en enkelt infusion.
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 torsades de pointes og komplet hjerteblok er rapporteret.
English: • any medicines that cause a decrease in magnesium or potassium in your blood (e.g. amphotericin B)
Danish: • medicin, som medfører nedsat indhold af magnesium eller kalium i dit blod (f.eks. amphotericin B)
English: Patients who experience such reactions that are considered TRISENOX 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 TRISENOX, må behandlingen først genoptages, når den toksiske hændelse er forsvundet, eller den anomali, der forårsagede afbrydelsen, er vendt tilbage til baseline-status.
English: • some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
Danish: • visse typer antiarytmika (medicin, som bruges til at korrigere uregelmæssig hjerterytme, f.eks. kinidin, amiodaron, sotalol, dofetilid)
English: Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the recommended clinical dose (mg/m2).
Danish: Begrænsede reproduktionstoksiske studier af arsentrioxid i dyr indikerer embryotoksicitet og teratogenicitet (neuralrørsdefekter, anoftalmia og mikroftalmia) ved indgivelse 1-10 gange den anbefalede kliniske dosis (mg/m2).
English: Psychiatric disorders Confusional state
Danish: Psykiske forstyrrelser Konfusionstilstand
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: If your doctor or nurse gives you more TRISENOX than he/she should You may experience convulsions, muscle weakness and confusion.
Danish: Hvis din læge eller sundhedspersonalet giver dig for meget TRISENOX Du kan opleve kramper, muskelsvaghed og forvirring.
English: If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for arsentrioxid eller et af de øvrige indholdsstoffer i TRISENOX (angivet i punkt 6).
English: Read the leaflet for the shelf-life of the diluted product
Danish: Læs indlægssedlen vedrørende det fortyndede produkts holdbarhed
English: Warnings and precautions You must talk to your doctor or nurse before you are given TRISENOX, if - you have impaired kidney function.
Danish: Advarsler og forsigtighedsregler Du skal kontakte lægen eller sundhedspersonalet, før du får TRISENOX, hvis - du har nedsat nyrefunktion, - du har leverproblemer.
English: Investigations Alanine amino transferase increased
Danish: Undersøgelser Forhøjet alanin-aminotransferase
English: After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15-30 °C and 72 hours at refrigerated (2-8 °C) temperatures.
Danish: Efter fortynding i intravenøse opløsninger er TRISENOX kemisk og fysisk stabilt i 24 timer ved 15-30 C og i 72 timer i køleskab ved 2-8 C.
English: A central venous catheter is not required.
Danish: Der er ikke behov for et centralt venekateter.
English: General disorders and administration site conditions Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Pyreksi
English: Patients in the first study received a median dose of 0.16 mg/kg/day of TRISENOX (range 0.06 to 0.20 mg/kg/day) and patients in the multicentre study received a fixed dose of 0.15 mg/kg/day.
Danish: Patienter i det første studie fik en gennemsnitlig dosis TRISENOX på 0,16 mg/kg/dag (interval 0,06 til 0,20 mg/kg/dag), og patienter i multicenterstudiet fik en fast dosis på 0,15 mg/kg/dag.
English: Ventricular extrasystoles
Danish: Ventrikulære ekstrasystoler
English: Baseline white blood cell (WBC) counts did not correlate with development of leucocytosis 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 konsolideringesterapien var ikke så høje som under induktionen.
English: In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25).
Danish: I multicenterstudiet var 27 af 40 patienter i live med en middelopfølgningstid på 16 måneder (område 9 til 25).
English: Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RAR 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/RAR konversion til normal er vist i Tabel 5 nedenfor.
English: Unused portions of each ampoule must be discarded properly.
Danish: Ubrugte portioner fra hver ampul skal bortskaffes forsvarligt.
English: Do not use this medicine after the expiry date which is stated on the ampoule label and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på ampuletiketten og æsken.