FrancophonIA/ELRC3.0 huggingface dataset:
English: Encephalopathy, Wernicke encephalopathy
Danish: Encefalopati, Wernickes encefalopati
English: What TRISENOX looks like and contents of the pack - TRISENOX is a concentrate for solution for infusion (sterile concentrate).
Danish: Udseende og pakningsstørrelser - TRISENOX er et koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Hjælpestof, som behandleren skal være opmærksom på Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Aseptic technique must be strictly observed throughout handling of TRISENOX since no preservative is present.
Danish: Aseptisk teknik skal nøje overholdes under hele håndteringen af TRISENOX, da det ikke indeholder konserveringsmiddel.
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT.
Danish: ASEPTISK TEKNIK SKAL NØJE OVERHOLDES UNDER HELE HÅNDTERINGEN AF TRISENOX, DA DET IKKE INDEHOLDER KONSERVERINGSMIDDEL.
English: What TRISENOX contains - The active substance is arsenic trioxide.
Danish: TRISENOX indeholder: - Aktivt stof: arsentrioxid.
English: Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule.
Danish: Ryst eller bank let på ampullen for at få eventuel væske i skaftet ned i ampullens hoveddel.
English: Any unused medicinal product, any items that come into contact with the product or waste material must be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel, eventuelle genstande, der kommer i kontakt hermed samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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: - difficulty in breathing - fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Danish: Du skal straks fortælle det til lægen eller sygeplejersken, hvis du oplever følgende bivirkninger, da disse kan være tegn på en allergisk reaktion: - vejrtrækningsbesvær - feber - pludselig vægtstigning - ophobning af væske (f.eks. hævede hænder og fødder) - besvimelse - kraftig hjertebanken.
English: Dose delay, modification and reinitiation
Danish: Dosisudsættelse, -justering og -genoptagelse
English: Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Danish: Patienter i multicenterstudiet havde recidiv efter 1-4 forudgående terapiregimer, og 5 patienter havde recidiv efter stamcelletransplantation.
English: In newly diagnosed APL patients treated with arsenic trioxide and all-trans-retinoic acid (ATRA), APL differentiation syndrome was observed in 19 % including 5 severe cases.
Danish: Hos nydiagnosticerede APL-patienter i behandling med arsentrioxid og all-trans-retinoinsyre (ATRA) blev RA-APL-syndromet observeret hos 19 %, herunder 5 alvorlige tilfælde.
English: TRISENOX 2 mg/ml concentrate for solution for infusion 6 ml concentrate in a clear, Type I borosilicate glass vial with a chlorobutyl rubber stopper (FluroTec coated plug) and an aluminium crimp cap with a plastic flip-top button.
Danish: TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning 6 ml koncentrat i et klart hætteglas af type I borsilikat-glas med en prop af chlorbutylgummi (FluroTec-belagt prop) og en krympehætte af aluminium med en flip-top plasticknap.
English: 59 days
Danish: 59 dage
English: to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
Danish: på dag 1 til 5 og igen ATRA 45 mg/m2 dagligt i 15 dage, og endelig en enkeltdosis idarubicin på 12 mg/m2 og ATRA 45 mg/m2 dagligt i 15 dage.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstider og betingelser før anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2-8C, medmindre fortynding har fundet sted under kontrollerede og aseptiske forhold.
English: • Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Danish: • Recidiverende/refraktær akut promyelocyt-leukæmi (APL) (den tidligere behandling skal have omfattet et retinoid samt kemoterapi) kendetegnet ved tilstedeværelse af t(15;17) translokationen og/eller tilstedeværelse af genet promyelocyt-leukæmi/retinoinsyrereceptor-alfa (PML/RAR-alfa) Responsraten af andre undertyper af akut myelogen leukæmi på arsentrioxid er ikke undersøgt.
English: Fertility No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Danish: Fertilitet Der er ikke udført kliniske eller prækliniske fertilitetsstudier med TRISENOX.
English: Fertility studies have not been conducted with TRISENOX.
Danish: Der er ikke gennemført fertilitetsstudier med TRISENOX.
English: Women of childbearing potential and men must use effective contraception during treatment with TRISENOX.
Danish: Kvinder i den fertile alder og mænd skal anvende sikker kontraception under behandling med TRISENOX.
English: Consolidation schedule
Danish: Konsolidering
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 torsades de pointes, hvilket kan få dødelig udgang.
English: Additional information about QT prolonging medicinal agents, is provided in section 4.4.
Danish: Yderligere information om QT-forlængende lægemidler kan ses i pkt.
English: Gamma-glutamyltransferase increased*
Danish: Vægtstigning Forhøjet gammaglutamyltransferase*
English: Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Danish: Patienter i enkeltcenterstudiet havde recidiv efter 1-6 forudgående terapiregimer, og 2 patienter havde recidiv efter stamcelletransplantation.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 12 mg/6 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 12 mg/6 ml
English: Respiratory, thoracic and mediastinal disorders Differentiation syndrome
Danish: Luftveje, thorax og mediastinum Differentieringssyndrom
English: Patients in the ATRA + chemotherapy treatment group also received maintenance treatment for up to 2 years, consisting of oral 6-mercaptopurine at 50 mg/m2 daily, intramuscular methotrexate at 15 mg/m2 weekly, and ATRA at 45 mg/m2 daily for 15 days every
Danish: Patienterne i ATRA+kemoterapi-gruppen fik også vedligeholdelsesbehandling i op til 2 år, bestående af 6-mercaptopurin 50 mg/m2 oralt dagligt, methotrexat 5 mg/m2 intramuskulært ugentligt og ATRA 45 mg/m2 dagligt i 15 dage hver 3. måned.
English: • some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole)
Danish: • visse typer medicin til behandling af allergier, f.eks. høfeber (antihistaminer, f.eks. terfenadin og astemizol)
English: 54 days
Danish: 54 dage
English: For QTc greater than 500 msec, corrective measures must be completed and the QTc reassessed with serial ECGs and, if available, a specialist advice could be sought prior to considering using TRISENOX.
Danish: skal der gennemføres korrigerende foranstaltninger, og QTc skal revurderes med serielle ekg'er, og der skal søges specialistrådgivning, hvis det er tilgængeligt, inden behandling med TRISENOX overvejes.
English: TRISENOX contains sodium
Danish: TRISENOX indeholder natrium
English: In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Danish: 15,6 % af nydiagnosticerede APL-patienter udviste QTc-forlængelse med arsentrioxid i kombination med ATRA (se pkt.
English: - The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
Danish: - Øvrige indholdsstoffer: natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: During TRISENOX treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis (see section 4.4).
Danish: Under TRISENOX-behandling i APL-studierne havde 14 af de 52 patienter med recidiverende APL et eller flere symptomer på APL-differentieringssyndrom karakteriseret ved feber, dyspnø, vægtstigning, lungeinfiltrater og pleurale eller perikardiale effusioner med eller uden leukocytose (se pkt.
English: Patients in the ATRA + TRISENOX treatment group received oral ATRA at 45 mg/m2 daily and IV
Danish: Patienter i ATRA+TRISENOX-gruppen fik ATRA 45 mg/m2 oralt dagligt og TRISENOX
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL 2 MG/ML
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS 2 MG/ML
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
English: The arsenic in TRISENOX passes into breast milk.
Danish: Arsentrioxid i TRISENOX udskilles i mælken.
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37 % of relapsed/refractory APL patients in clinical trials.
Danish: I kliniske studier forekom der lægemiddelrelaterede bivirkninger af CTC grad 3 og 4 hos 37 % af patienterne med recidiverende/refraktær APL.
English: Haematological and gastrointestinal toxicity
Danish: Hæmatologisk gastrointestinal toksicitet
English: The total clearance of AsIII over the single-dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 l/h and the renal clearance is 9 l/h.
Danish: 7-32 mg (administreret som 0,15 mg/kg) er 49 l/time, og den renale clearance er 9 l/time.
English: Patients who are receiving, or who have received, medicinal products known to cause hypokalaemia or hypomagnesaemia, such as diuretics or amphotericin B,
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 torsades de pointes.
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia.
Danish: Risikoen for torsades de pointes er relateret til omfanget af QT-forlængelsen, samtidig indgivelse af QT-forlængende lægemidler (såsom klasse Ia og III antiarytmika (f.eks. kinidin, amiodaron, sotalol, dofetilid), antipsykotika (f.eks. thioridazin), antidepressiva (f.eks. amitriptylin), visse makrolider (f.eks. erythromycin), visse antihistaminer (f.eks. terfinadin og astemizol), visse quinolon-antibiotika (f.eks. sparfloxacin), og andre lægemidler, der er kendt for at forlænge QT-intervallet (f.eks. cisaprid), torsades de pointes i anamnesen, tidligere forlængelse af QT-intervallet, hjertestop, indgivelse af kaliumsænkende diuretika, amphotericin B, eller andre tilstande, som medfører hypokaliæmi eller hypomagnesiæmi.
English: Relapsed/refractory acute promyelocytic leukaemia (APL) Induction treatment schedule
Danish: Recidiverende/refraktær akut promyelocyt-leukæmi (APL) Induktionsbehandling
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 10 vials
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 10 hætteglas
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Danish: TRISENOX skal indgives intravenøst dagligt i en dosis på 0,15 mg/kg/dag, indtil der opnås komplet remission.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR THE 2 MG/ML VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL HÆTTEGLASSET MED 2 MG/ML
English: One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Danish: En patient med recidiverende APL (som fik flere lægemidler samtidig, inklusive amphotericin B) fik en asymptomatisk episode af torsades de pointes under induktionsterapi med arsentrioxid.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 10 mg/10 ml
English: Leukocyte activation syndrome (APL differentiation syndrome) 27 % of patients with APL, in the relapsed/refractory setting, treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis.
Danish: Leukocyt-aktiveringssyndrom (APL-differentieringssyndrom) 27 % af patienter med recidiverende/refraktær APL, behandlet med arsentrioxid, har oplevet symptomer svarende til et syndrom, der kaldes retinoinsyre-APL (RA-APL) eller APLdifferentieringssyndrom, kendetegnet ved feber, dyspnø, øget vægt, lungeinfiltrater og pleura- eller perikardie-effusioner, med eller uden leukocytose.
English: Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.
Danish: De alvorlige bivirkninger, der kunne henføres til arsentrioxid, inkluderede APL-differentieringssyndrom (3), leukocytose (3), forlænget QT-interval (4, 1 med torsades de pointes), atrieflimmer/atrieflagren (1), hyperglykæmi (2) og en række forskellige alvorlige bivirkninger i relation til blødninger, infektioner, smerte, diarré, kvalme.
English: TRISENOX 2 mg/ml concentrate for solution for infusion EU/1/02/204/002
Danish: TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning EU/1/02/204/002
English: TRISENOX 1 mg/ml concentrate for solution for infusion EU/1/02/204/001
Danish: TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning EU/1/02/204/001
English: Cytogenetics after TRISENOX therapy Table 5
Danish: Cytogenetik efter TRISENOX terapi
English: What you need to know before you are given TRISENOX
Danish: Det skal du vide, før du begynder at få TRISENOX
English: After recovery, treatment should be resumed at 50 % of the preceding daily dose.
Danish: Efter symptomerne er bedret, skal behandlingen genoptages med 50 % af den tidligere daglige dosis.
English: Thereafter, in absence of worsening of the previous toxicity, TRISENOX should be resumed at full dosage.
Danish: Hvis den tidligere toksicitet ikke forværres, skal TRISENOX-behandlingen herefter genoptages med den fulde dosis.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER AMPULETIKET
English: Each cycle consists of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption.
Danish: Du vil få en dosis 5 dage om ugen (efterfulgt af en pause på 2 dage) i 4 uger efterfulgt af 4 ugers pause.
English: 35 days
Danish: 35 dage
English: Teva Pharmaceuticals Europe B.V. Swensweg 5,
Danish: Teva Pharmaceuticals Europe B.V.
English: In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL udviklede 35 ud af 74 patienter (47 %) leukocytose under induktionsbehandlingen (se pkt.
English: TRISENOX must not be mixed with, or infused through the same tube with other medicines.
Danish: TRISENOX må ikke blandes med andre lægemidler eller gives som infusion gennem samme slange som anden medicin.
English: TRISENOX is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Danish: TRISENOX skal indgives intravenøst 5 dage om ugen i en dosis på 0,15 mg/kg/dag, efterfulgt af 2 dages pause, gentaget for 5 uger, i alt 25 doser.
English: TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the ampoule or vial.
Danish: TRISENOX skal fortyndes med 100 til 250 ml 50 mg/ml (5 %) glucose injektionsvæske, opløsning eller 9 mg/ml (0,9 %) natriumchloridinjektionsvæske, opløsning umiddelbart efter udtrækning fra ampullen eller hætteglasset..
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Danish: Risikoen for torsades de pointes er relateret til sværhedsgraden af QT-forlængelsen, samtidig indgift af QT-forlængende lægemidler, torsades de pointes i anamnesen, allerede eksisterende QT-intervalforlængelse, kongestiv hjertestop, indgift af kaliumsænkende diuretika, eller andre konditioner, som resulterer i hypokaliæmi eller hypomagnesiæmi.
English: Deaths
Danish: Dødsfald
English: Use of TRISENOX
Danish: Anvendelse af TRISENOX
English: It must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Danish: Det må ikke blandes med eller indgives i samme intravenøse slange samtidigt med andre lægemidler.
English: If you are not sure, show the bottle or pack to your doctor.
Danish: Vis beholderen eller pakningen til lægen, hvis du er i tvivl.
English: The effect of these medicines on your heartbeat can be made worse by TRISENOX.
Danish: • cisaprid (medicin som bruges til at lindre visse maveproblemer) Disse lægemidlers virkning på din hjerterytme kan forværres af TRISENOX.
English: For ECG, electrolytes abnormalities and hepatotoxicity see section 4.4.
Danish: 4.4 for ekg, elektrolytafvigelser samt hepatotoksicitet.
English: Dose delay and modification
Danish: Dosisudsættelse og -justering
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Danish: TRISENOX skal indgives intravenøst 5 dage om ugen i en dosis på 0,15 mg/kg/dag.
English: Marketing Authorisation Holder Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Danish: Indehaver af markedsføringstilladelsen Teva B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: Men should also use effective contraception during treatment with TRISENOX.
Danish: Mænd skal bruge sikker prævention under behandlingen med TRISENOX.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TRISENOX 1 mg/ml concentrate for solution for infusion Each ml of concentrate contains 1 mg of arsenic trioxide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning Hver ml koncentrat indeholder 1 mg arsentrioxid.
English: No formal carcinogenicity studies of arsenic trioxide have been performed.
Danish: Der er ikke gennemført nogen formelle karcinogenitetsstudier af arsentrioxid ved intravenøs indgift.
English: Unused portions of each vial must be discarded properly.
Danish: Ubrugte portioner fra hvert hætteglas skal bortskaffes forsvarligt.
English: 2031 GA Haarlem, The Netherlands
Danish: 2031 GA Haarlem, Holland
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) Induction treatment schedule
Danish: Nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL)
English: - reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
Danish: - nedsat antal blodceller (blodplader, røde og/eller hvide blodlegemer), øget antal hvide blodlegemer, - kulderystelser, vægtstigning, - feber på grund af infektion og lavt antal hvide blodlegemer, herpes zoster-infektion, - smerter i brystet, blødning i lungerne, hypoksi (lavt iltniveau), væskeansamling omkring hjertet eller lungerne, lavt blodtryk, unormal hjerterytme (hjerteslag), - krampeanfald, led- eller knoglesmerter, årebetændelse, - forhøjet natrium eller magnesium, ketoner i blod og urin (ketoacidose), unormale prøver for nyrefunktion, nyresvigt, - mavesmerter, - hudrødme, opsvulmet ansigt, sløret syn
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with TRISENOX, caution is advised in the use of TRISENOX in patients with hepatic impairment (see section 4.4 and 4.8).
Danish: Da der ikke foreligger data for alle grupper med nedsat leverfunktion, og da hepatotoksiske virkninger kan forekomme under behandlingen med TRISENOX, tilrådes forsigtighed ved brug af TRISENOX hos patienter med nedsat leverfunktion (se pkt.
English: TRISENOX at 0.15 mg/kg daily until CR. 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 TRISENOX 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 TRISENOX blev givet i den samme dosis 5 dage om ugen, 4 uger med behandling og 4 uger uden, til i alt 4 behandlingsforløb.
English: TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Danish: TRISENOX må ikke blandes med eller indgives i samme intravenøse slange samtidigt med andre lægemidler.
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with TRISENOX in combination with ATRA.
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL udviklede 63,2 % grad 3 eller 4 levertoksicitet under induktions- eller konsolideringsbehandlingen med TRISENOX i kombination med ATRA.