natgillin/translations-raw huggingface dataset:
Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
If you get any side effects, talk to your doctor or pharmacist or nurse.
Kun til engangsbrug, og alle ubrugte portioner fra hvert hætteglas skal bortskaffes forsvarligt.
It is for single use only, and any unused portions of each vial must be discarded properly.
Hvis QTc-forlængelsen ikke vender tilbage inden for 7 dage efter, behandlingen er genstartet med den reducerede dosis, kan behandlingen med arsentrioxid genoptages med 0,11 mg/kg dagligt i endnu en uge.
If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Lægemidler, der vides at forårsage forlængelse af QT/QTc-intervallet, hypokaliæmi eller hypomagnesiæmi
Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia
Patienter med nydiagnosticeret akut promyelocyt-leukæmi Lægen vil give dig Arsenic trioxide Accord én gang om dagen som en infusion.
Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Under konsolidering blev ATRA givet i den samme dosis i perioder på 2 uger med behandling og 2 uger uden, til i alt 7 behandlingsforløb, og arsentrioxid blev givet i den samme dosis 5 dage om ugen, 4 uger med behandling og 4 uger uden, til i alt 4 behandlingsforløb.
During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and arsenic trioxide was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Responsraten af andre undertyper af akut myelogen leukæmi på arsentrioxid er ikke undersøgt.
The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.
Så snart bilirubin og/eller ASAT og/eller basisk fosfatase er faldet til under 4 gange den øvre normalgrænse, skal behandlingen med arsentrioxid genoptages med 50 % af den tidligere dosis i de første 7 dage.
As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with arsenic trioxide should be resumed at 50 % of the previous dose during the first 7 days.
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.
Twenty relapsed/refractory APL patients (50 %) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
APL = akut promyelocyt-leukæmi, ATRA = all-trans-retinoinsyre
APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
5 ud af 7 patienter under 18 år (i alderen 5 til 16 år) behandlet med arsentrioxid i den anbefalede dosis på 0,15 mg/kg/dag opnåede komplet respons (se pkt.
Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
- Øvrige indholdsstoffer: natriumhydroxid, saltsyre; koncentreret (til pH-justering) og vand til injektionsvæsker.
- The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections.
Steril, klar, farveløs, vandig opløsning, fri for partikler og med pH-værdi på 7,7-8,3.
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3.
De toksiske virkninger bedredes imidlertid med en midlertidig afbrydelse af enten arsentrioxid, ATRA eller begge.
However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both.
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) - lungebetændelse, blodforgiftning - inflammation (betændelsesagtig tilstand) i lungerne som medfører smerter i brystet og åndenød,
Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion
Arsenic trioxide Accord skal indgives under tilsyn af en læge, der har erfaring med behandlingen af akut leukæmi.
Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Se punkt 2 ” Arsenic trioxide Accord indeholder natrium”.
See section 2, “Arsenic trioxide Accord contains sodium”.
Hvis hepatotoksicitet genopstår, skal arsentrioxid seponeres permanent.
In case of reappearance of hepatotoxicity, arsenic trioxide must be permanently discontinued.
Leukocytose optrådte hos 50 % af patienter med recidiverende/refraktær APL vurderet ud fra en hæmatologisk bedømmelse.
Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.
Der er ikke udført studier hos gravide kvinder, der anvender arsentrioxid.
There are no studies in pregnant women using arsenic trioxide.
Tre patienter fra enkeltinstitutionsstudiet og 15 patienter fra multicenterstudiet fik stamcelletransplantationer efter afslutning af arsentrioxid.
Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
På grund af muligheden for alvorlige bivirkninger af arsentrioxid hos ammede spædbørn, skal amningen ophøre forud for og under behandlingen.
Because of the potential for serious adverse reactions in breastfeeding infants from arsenic trioxide, breast-feeding must be discontinued prior to and throughout administration.
Efter godkendelse af arsentrioxid er der også blevet rapporteret et differentieringssyndrom, såsom retinoinsyresyndrom, i forbindelse med behandling af andre maligniteter end APL.
In post authorisation experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with arsenic trioxide.
I tilfælde af koagulopati anbefales oral indgivelse af det kelerende middel dimercaptosuccinsyresuccimer (DCI) 10 mg/kg eller 350 m2 hver 8. time i 5 dage og derefter hver 12. time i to uger.
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.
Hos de fleste patienter vil det ikke være nødvendigt at seponere arsentrioxid permanent under behandling af APL-differentieringssyndrom.
The majority of patients do not require permanent termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome.
Accord Healthcare Polska Sp.z o.o.
Accord Healthcare Polska Sp.z o.o., ul.
Under behandling med arsentrioxid skal kaliumkoncentrationerne holdes på over 4 mEq/l, og magnesium koncentrationerne skal holdes over
During therapy with arsenic trioxide, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Arsentrioxid skal indgives intravenøst dagligt i en fast dosis på 0,15 mg/kg/dag, indtil komplet remission er opnået (mindre end 5 % blastceller i cellulær knoglemarv og ingen evidens på leukæmiceller).
Arsenic trioxide must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
Patienter med nydiagnosticeret APL, bekræftet ved tilstedeværelse af t(15; 17) eller PML-RAR alfa ved RT-PCR, eller med hypergranulære leukæmiceller blev inkluderet.
Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Ved de første tegn, der kan tyde på syndromet (uforklarlig feber, dyspnø og/eller øget vægt, abnorme stetoskopifund på brystet eller røntgenabnormiteter), skal behandlingen med arsentrioxid afbrydes midlertidigt og behandling med højdosis-steroid (dexamethason 10 mg intravenøst to gange om dagen) straks påbegyndes, uden hensyntagen til leukocyttælling, og fortsættes i mindst 3 dage eller længere, indtil symptomerne er ophørt.
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with arsenic trioxide must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Hvis symptomerne genopstår, skal arsentrioxid reduceres til den tidligere dosis.
In the case of the reappearance of symptoms arsenic trioxide should be reduced to the previous dosage.
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.
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.
Da Arsenic trioxide Accord kan være skadeligt for spædbørn, der ammes, må du ikke amme, så længe du får Arsenic trioxide Accord.
Because Arsenic trioxide Accord can harm nursing infants, do not breast-feed while on Arsenic trioxide Accord.
Arsenic trioxide Accord forventes ikke at påvirke eller påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Arsenic trioxide Accord is expected to have no or negligible influence on your ability to drive and use machines.
Arsenic trioxide Accord indeholder arsentrioxid, der er et lægemiddel mod kræft.
Arsenic trioxide Accord contains arsenic trioxide which is an anticancer medicine.
Inden behandling med arsentrioxid indledes, skal der tages et ekg med 12 afledninger, og serumelektrolytter (kalium, kalcium og magnesium) samt kreatinin skal bedømmes; tidligere elektrolyt-anomalier skal korrigeres, og om muligt skal behandling med lægemidler, der vides at forlænge QT-intervallet, seponeres.
Prior to initiating therapy with arsenic trioxide, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Arsentrioxid skal indgives under vejledning af en læge, som har erfaring i behandling af akut leukæmi, og de særlige monitoreringsprocedurer, der er beskrevet i pkt.
Arsenic trioxide must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed.
QTforlængelse kan føre til en ventrikelarytmi af typen Torsade de pointes, hvilket kan få dødelig udgang.
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Arsentrioxid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
Arsenic trioxide has no or negligible influence on the ability to drive and use machines.
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.
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.
- hvis du er allergisk over for arsentrioxid eller et af de øvrige indholdsstoffer i Arsenic trioxide Accord (angivet i punkt 6).
If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section
Kontakt lægen eller sygeplejersken, før du bruger Arsenic trioxide Accord - hvis du har nedsat nyrefunktion, - hvis du har leverproblemer.
You must talk to your doctor or nurse before using Arsenic trioxide Accord, if - you have impaired kidney function.
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.
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.
Det aktive stof i Arsenic trioxide Accord, arsentrioxid, er karcinogent hos mennesker.
The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen.
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,
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.
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.
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.
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.
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.
Arsentrioxid er blevet undersøgt hos 52 APL-patienter, som tidligere er blevet behandlet med anthracyclin og retinoid i to åbne enkeltarmede ikke-komparative studier.
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.
Så snart symptomerne er aftaget, kan behandlingen med arsentrioxid genoptages med 50 % af den tidligere dosis i de første 7 dage.
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.
Arsentrioxids virkningsmekanisme er ikke helt klarlagt.
The mechanism of action of arsenic trioxide is not completely understood.
Det skal du vide, før du begynder at bruge Arsenic trioxide Accord
What you need to know before you use Arsenic trioxide Accord
Yderligere information om QT-forlængende lægemidler kan ses i pkt.
Additional information about QT prolonging medicinal agents is provided in Section 4.4.
De toksiske virkninger ophørte imidlertid med en midlertidig afbrydelse af enten arsentrioxid, ATRA eller begge (se pkt.
However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4).
Saltsyre, koncentreret (til pH-justering) Vand til injektionsvæsker
Hydrochloric acid, concentrated (for pH adjustment) Water for injections
Arsenic trioxide Accord skal fortyndes før indgift.
Arsenic trioxide Accord must be diluted before administration.
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.
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.
Patienter i multicenterstudiet havde recidiv efter 1-4 forudgående behandlingsregimer, og 5 patienter havde recidiv efter stamcelletransplantation.
Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
ASEPTISK TEKNIK SKAL NØJE OVERHOLDES UNDER HELE HÅNDTERINGEN AF ARSENIC TRIOXIDE ACCORD, DA DET IKKE INDEHOLDER KONSERVERINGSMIDDEL.
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF ARSENIC TRIOXIDE ACCORD SINCE NO PRESERVATIVE IS PRESENT.
Arsenic trioxide Accord skal fortyndes med en injektionsvæske, der indeholder enten glucose eller natriumchlorid.
Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Arsenic trioxide Accord skal administreres intravenøst over 1-2 timer.
Arsenic trioxide Accord must be administered intravenously over 1-2 hours.
Patienter i enkeltcenterstudiet havde recidiv efter 1-6 forudgående behandlingsregimer, og 2 patienter havde recidiv efter stamcelletransplantation.
Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
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.
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.
Hos nydiagnosticerede APL-patienter i behandling med arsentrioxid og ATRA blev RA-APL-syndromet observeret hos 19 %, herunder 5 alvorlige tilfælde.
In newly diagnosed APL patients treated with arsenic trioxide and ATRA, APL differentiation syndrome was observed in 19 % including 5 severe cases.
15,6 % af nydiagnosticerede APLpatienter udviste QTc-forlængelse med arsentrioxid i kombination med ATRA (se pkt.
In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Ikke anvendt lægemiddel, eventuelle genstande, der kommer i kontakt hermed, samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Opbevaringsforhold efter fortynding eller anbrud af lægemidlet, se pkt.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
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.
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).
Den totale clearance for As
The volume of distribution (Vd) for As
Kemisk og fysisk stabilitet efter anbrud er dokumenteret i 24 timer ved 25°C og i 48 timer ved 2-8°C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
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.
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.
Nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL) Induktionsbehandling
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
I kliniske studier forekom der lægemiddelrelaterede bivirkninger af CTC grad 3 og 4 hos 37 % af patienterne med recidiverende/refraktær APL.
Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical trials.
• medicin, som medfører nedsat indhold af magnesium eller kalium i dit blod (f.eks.
• any medicines that cause a decrease in magnesium or potassium in your blood (e.g. amphotericin B)
Andre lægemidler mod leukæmi Arsentrioxids indvirkning på andre lægemidler mod leukæmi er ukendt.
The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
(kreatininclearance mindre end 30 ml/min) var 40 % lavere sammenlignet med patienter med normal nyrefunktion (se pkt.
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).
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).
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).
Arsenic trioxide Accord må ikke blandes med eller indgives i samme intravenøse slange samtidigt med andre lægemidler.
Arsenic trioxide Accord must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
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.
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.