FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalemia or hypomagnesaemia.
Danish: Forsigtighed tilrådes, når arsentrioxid 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: If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for arsentrioxid eller et af de øvrige indholdsstoffer i Arsenic trioxide Accord (angivet i punkt 6).
English: You must talk to your doctor or nurse before using Arsenic trioxide Accord, if - you have impaired kidney function.
Danish: Kontakt lægen eller sygeplejersken, før du bruger Arsenic trioxide Accord - hvis du har nedsat nyrefunktion, - hvis du har leverproblemer.
English: If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, arsenic trioxide must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 gm per day may be considered.
Danish: Hvis der opstår symptomer, der tyder på alvorlig akut arsen-toksicitet (f.eks. kramper, muskelsvækkelse og konfusion), skal arsentrioxid øjeblikkeligt seponeres, og kelatterapi med penicillamin i en daglig dosis på ≤1 g kan overvejes.
English: The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen.
Danish: Det aktive stof i Arsenic trioxide Accord, arsentrioxid, er karcinogent hos 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,
English: If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, arsenic trioxide 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 arsentrioxidbehandling bør afbrydes midlertidigt, indtil QTc-intervallet vender tilbage til under 460 msek., elektrolytanomalierne er korrigeret, og synkoper og uregelmæssige hjerteslag ophører.
English: > 50 x 10
Danish: >50 x 103/µl
English: Type I transparent colorless glass vial sealed with a silicon-oil free, elastomer type, grey rubber stopper made of bromobutyl and aluminium seal with a plastic flip off cap containing 10 ml of concentrate.
Danish: Transparent, farveløst hætteglas (type-I-glas) forseglet med en grå bromobutylgummiprop af elastomertypen, fri for silikoneolie, og aluminiumsforsegling med en flip-off-hætte af plastik.
English: Arsenic trioxide 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: Arsentrioxid 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 arsenic trioxide can be resumed at 50 % of the previous dose during the first 7 days.
Danish: Så snart symptomerne er aftaget, kan behandlingen med arsentrioxid genoptages med 50 % af den tidligere dosis i de første 7 dage.
English: The mechanism of action of arsenic trioxide is not completely understood.
Danish: Arsentrioxids virkningsmekanisme er ikke helt klarlagt.
English: What you need to know before you use Arsenic trioxide Accord
Danish: Det skal du vide, før du begynder at bruge Arsenic trioxide Accord
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: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4).
Danish: De toksiske virkninger ophørte imidlertid med en midlertidig afbrydelse af enten arsentrioxid, ATRA eller begge (se pkt.
English: Hydrochloric acid, concentrated (for pH adjustment) Water for injections
Danish: Saltsyre, koncentreret (til pH-justering) Vand til injektionsvæsker
English: Arsenic trioxide Accord must be diluted before administration.
Danish: Arsenic trioxide Accord skal fortyndes før indgift.
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 3 months.
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: 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 behandlingsregimer, og 5 patienter havde recidiv efter stamcelletransplantation.
English: ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF ARSENIC TRIOXIDE ACCORD SINCE NO PRESERVATIVE IS PRESENT.
Danish: ASEPTISK TEKNIK SKAL NØJE OVERHOLDES UNDER HELE HÅNDTERINGEN AF ARSENIC TRIOXIDE ACCORD, DA DET IKKE INDEHOLDER KONSERVERINGSMIDDEL.
English: Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Danish: Arsenic trioxide Accord skal fortyndes med en injektionsvæske, der indeholder enten glucose eller natriumchlorid.
English: Arsenic trioxide Accord must be administered intravenously over 1-2 hours.
Danish: Arsenic trioxide Accord skal administreres intravenøst over 1-2 timer.
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 behandlingsregimer, og 2 patienter havde recidiv efter stamcelletransplantation.
English: Arsenic trioxide Accord 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 vial.
Danish: Arsenic trioxide Accord skal fortyndes med 100 til 250 ml 50 mg/ml (5 %) glucose injektionsvæske, opløsning eller 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning umiddelbart efter udtrækning fra hætteglasset.
English: In newly diagnosed APL patients treated with arsenic trioxide and ATRA, APL differentiation syndrome was observed in 19 % including 5 severe cases.
Danish: Hos nydiagnosticerede APL-patienter i behandling med arsentrioxid og ATRA blev RA-APL-syndromet observeret hos 19 %, herunder 5 alvorlige tilfælde.
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 APLpatienter udviste QTc-forlængelse med arsentrioxid i kombination med ATRA (se pkt.
English: Any unused product, any items that come into contact with the product, and 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: For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter fortynding eller anbrud af lægemidlet, se pkt.
English: During arsenic trioxide 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 leukocytosis (see section 4.4).
Danish: Under arsentrioxid-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: The volume of distribution (Vd) for As
Danish: Den totale clearance for As
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Danish: Kemisk og fysisk stabilitet efter anbrud er dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C.
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 arsenic trioxide.
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 arsentrioxid overvejes.
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
Danish: Nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL) Induktionsbehandling
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: • 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.
English: The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
Danish: Andre lægemidler mod leukæmi Arsentrioxids indvirkning på andre lægemidler mod leukæmi er ukendt.
English: The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/min) was 40% lower when compared with patients with normal renal function (see section 4.4).
Danish: (kreatininclearance mindre end 30 ml/min) var 40 % lavere sammenlignet med patienter med normal nyrefunktion (se pkt.
English: Arsenic trioxide 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 arsenic trioxide combined with all-trans-retinoic acid (ATRA) with those of ATRA+chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Danish: Nydiagnosticerede APL-patienter, der ikke er i højrisikogruppe Arsentrioxid 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 arsentrioxid i kombination med all-trans-retinoinsyre (ATRA) versus ATRA+kemoterapi (f.eks. idarubicin og mitoxantron) (studie APL0406).
English: Arsenic trioxide Accord must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Danish: Arsenic trioxide Accord må ikke blandes med eller indgives i samme intravenøse slange samtidigt med andre lægemidler.
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 med det samme er opbevaringstider og -betingelser før anvendelse brugerens ansvar og vil normalt ikke overstige 24 timer ved 2 til 8°C, med mindre fortyndingen er udført under kontrollerede og validerede aseptiske betingelser.
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 hypokalemia or hypomagnesaemia.
Danish: Risikoen for Torsade 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), Torsade 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: Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leukocytosis (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 Torsade de pointes), atrieflimmer/atrieflagren (1), hyperglykæmi (2) og en række forskellige alvorlige bivirkninger i relation til blødninger, infektioner, smerte, diarré, kvalme.
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: 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 asymptomatisk Torsade de pointes under induktionsterapi med arsentrioxid.
English: Arsenic trioxide Accord must not be mixed with, or infused through the same tube with other medicines.
Danish: Arsenic trioxide Accord må ikke blandes med andre lægemidler eller gives som infusion gennem samme slange som anden medicin.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV
Danish: Den gennemsnitlige estimerede terminale eliminationshalveringstid for metabolitterne MMAV og DMAV er henholdsvis 32 timer og 70 timer.
English: Thereafter, in absence of worsening of the previous toxicity, arsenic trioxide should be resumed at full dosage.
Danish: Hvis den tidligere toksicitet ikke forværres, skal arsentrioxid-behandlingen herefter genoptages med den fulde dosis.
English: Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Danish: Arsentrioxid skal indgives intravenøst dagligt i en dosis på 0,15 mg/kg/dag, indtil der opnås komplet remission.
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 leukocytosis.
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: Arsenic trioxide 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: Arsentrioxid 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: 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, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Danish: Risikoen for Torsade de pointes er relateret til sværhedsgraden af QT-forlængelsen, samtidig indgift af QT-forlængende lægemidler, Torsade de pointes i anamnesen, allerede eksisterende QT-intervalforlængelse, kongestiv hjertestop, indgift af kaliumsænkende diuretika, eller andre konditioner, som resulterer i hypokaliæmi eller hypomagnesiæmi.
English: In newly diagnosed patients with low to intermediate risk APL leukocytosis 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: Common (may affect up to 1 in 10 people): - 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: Almindelig: (kan forekomme hos op til 1 ud af 10 personer) - 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: Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Danish: Mænd skal bruge sikker prævention under behandlingen med Arsenic trioxide Accord.
English: Do not use Arsenic trioxide Accord
Danish: Brug ikke Arsenic trioxide Accord
English: After dilution in intravenous solutions, Arsenic trioxide Accord is chemically and physically stable for 24 hours at 25°C and 48 hours at refrigerated (2-8°C) temperatures.
Danish: Efter fortynding i intravenøse opløsninger er Arsenic trioxide Accords kemiske og fysiske stabilitet efter anbrud dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C.
English: Since no data are available across all renal impairment groups, caution is advised in the use of Arsenic trioxide in patients with renal impairment.
Danish: Da der ikke foreligger data for alle grupper med nedsat nyrefunktion, tilrådes forsigtighed ved brug af arsentrioxid hos patienter med nedsat nyrefunktion.
English: Women of childbearing potential and men must use effective contraception during treatment with arsenic trioxide.
Danish: Kvinder i den fertile alder og mænd skal anvende sikker prævention under behandling med arsentrioxid.
English: Patients in the ATRA+chemotherapy treatment group received iv idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then iv mitoxantrone at 10 mg/m2 on days 1 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 2, 4, 6 og 8 og ATRA 45 mg/m2 oralt dagligt indtil CR. Under konsolidering fik patienterne idarubicin 5 mg/m2 på dag 1 til 4 og ATRA 45 mg/m2 dagligt i 15 dage, og dernæst mitoxantron 0 mg/m2 i.v.
English: Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Danish: Meget almindelig: (kan forekomme hos mere end 1 ud af 10 personer) - træthed (mathed), smerter, feber, hovedpine - kvalme, opkastning, diarré, - svimmelhed, muskelsmerter, følelsesløshed eller snurrende fornemmelser i huden, - udslæt eller kløe, - øget blodsukker, ødemer (hævelse som følge af væskeophobning), - kortåndethed, hurtig hjerterytme (puls), unormalt hjertediagram (ekg), - nedsat indhold af kalium eller magnesium i blodet, unormale prøver for leverfunktion inklusive forhøjet indhold af bilirubin eller gammaglutamyltransferase i blodet.
English: Arsenic trioxide Accord is a concentrate for solution for infusion.
Danish: Arsenic trioxide Accord er et koncentrat til infusionsvæske, opløsning.
English: Relapsed/refractory acute promyelocytic leukaemia (APL)
Danish: Recidiverende/refraktær akut promyelocyt-leukæmi (APL) Induktionsbehandling
English: Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Danish: Holdbarhed efter fortynding: Kemisk og fysisk stabilitet efter anbrud er dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C.
English: Preparation of Arsenic trioxide Accord Aseptic technique must be strictly observed throughout handling of Arsenic trioxide Accord since no preservative is present.
Danish: Aseptisk teknik skal nøje overholdes under hele håndteringen af Arsenic trioxide Accord, da det ikke indeholder konserveringsmiddel.
English: The arsenic in Arsenic trioxide Accord passes into breast milk.
Danish: Arsentrioxid i Arsenic trioxide Accord udskilles i mælken.
English: Arsenic trioxide Accord contains sodium
Danish: Arsenic trioxide Accord indeholder natrium
English: Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/min) or moderate renal impairment (creatinine clearance of 30-49 mL/min).
Danish: (kreatininclearance 50-80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/min).