FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information What Arsenic trioxide Accord contains
Danish: Pakningsstørrelser og yderligere oplysninger Arsenic trioxide Accord indeholder:
English: Time to bone marrow remission (median)
Danish: Tid til knoglemarvsremission (median)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: - fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Danish: - vejrtrækningsbesvær - feber - pludselig vægtstigning - ophobning af væske (f.eks. hævede hænder og fødder) - besvimelse - kraftig hjertebanken.
English: If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Accord.
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention under behandlingen med Arsenic trioxide Accord.
English: Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Danish: Arsentrioxid skal indgives intravenøst 5 dage om ugen i en dosis på 0,15 mg/kg/dag.
English: Cytogenetics after arsenic trioxide therapy
Danish: Cytogenetik efter arsentrioxid-behandling
English: Patients in the first study received a median dose of 0.16 mg/kg/day of arsenic trioxide (range 0.06
Danish: Patienter i det første studie fik en gennemsnitlig dosis arsentrioxid 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: Fertility studies have not been conducted with arsenic trioxide.
Danish: Der er ikke gennemført fertilitetsstudier med arsentrioxid.
English: There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleukocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Danish: Behandling med arsentrioxid er blevet sammenkædet med udvikling af hyperleukocytose (≥10 x 103/µl) hos nogle patienter med recidiverende/refraktær APL. Der syntes ikke at være nogen forbindelse mellem baseline-antallet af hvide blodlegemer (WBC) og udviklingen af hyperleukocytose, ligesom der ikke syntes at være en korrelation imellem baseline WBC-tal og topWBC-tal.
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 arsenic trioxide 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 arsentrioxid i kombination med ATRA.
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with Arsenic trioxide, caution is advised in the use of Arsenic trioxide 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 arsentrioxid, tilrådes forsigtighed ved brug af arsentrioxid hos patienter med nedsat leverfunktion (se pkt.
English: The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord.
Danish: • cisaprid (medicin som bruges til at lindre visse maveproblemer) Disse lægemidlers virkning på din hjerterytme kan forværres af Arsenic trioxide Accord.
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Danish: Patienter med signifikant arytmi, ekg-anomali (medfødt langt QT-syndrom, tidligere eller aktuel signifikant ventrikulær eller atrial takyarytmi, klinisk signifikant bradykardi i hvile (<50 slag/minut), QTc > 450 msek.
English: No clinical or non-clinical fertility studies have been conducted with arsenic trioxide.
Danish: Fertilitet Der er ikke udført kliniske eller prækliniske fertilitetsstudier med arsentrioxid.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller for nylig har taget anden medicin.
English: • some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
Danish: • visse typer medicin til behandling af allergier, f.eks. høfeber (antihistaminer, f.eks.
English: Arsenic trioxide must be administered intravenously over 1-2 hours.
Danish: Arsentrioxid skal indgives intravenøst over 1-2 timer.
English: Package leaflet: Information for the user Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Danish: Indlægsseddel: Information til patienten Arsenic trioxide Accord 1 mg/ml, koncentrat til infusionsvæske, opløsning arsentrioxid
English: If your doctor gives you more Arsenic trioxide Accord than he/she should
Danish: Hvis din læge giver dig for meget Arsenic trioxide Accord
English: One vial of 10 ml contains 10 mg of arsenic trioxide.
Danish: 1 hætteglas med 10 ml indeholder 10 mg arsentrioxid.
English: One ml contains 1 mg of arsenic trioxide.
Danish: 1 ml indeholder 1 mg arsentrioxid
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
Danish: Ikke kendt* *I CALGB-studiet C9710 blev der rapporteret 2 tilfælde af CGT-forhøjelse, grad ≥3 blandt de 200 patienter, som fik arsentrioxid konsolideringscyklusser (cyklus 1 og cyklus 2), versus ingen i kontrolgruppen.
English: 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: • 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: Arsentrioxid er indiceret til induktion af remission og konsolidering hos voksne patienter med: - nydiagnosticeret lav til intermediær risiko akut promyelocyt-leukæmi (APL) (antal hvide blodlegemer ≤ 10 x 103/µl) i kombination med all-trans-retinoinsyre (ATRA) - 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).
English: In a phase 3, multicenter, noninferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
Danish: I et non-inferioritets fase 3-multicenterstudie, der sammenlignede all-trans-retinoinsyre (ATRA) plus kemoterapi med ATRA plus arsentrioxid hos nydiagnosticerede patienter med lav til intermediær risiko APL (studie APL0406; se også pkt.
English: • some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
Danish: f.eks. kinidin, amiodaron, sotalol, dofetilid)
English: One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
Danish: 1 ml koncentrat til infusionsvæske, opløsning indeholder 1 mg arsentrioxid.
English: Use of Arsenic trioxide Accord
Danish: Anvendelse af Arsenic trioxide Accord
English: In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion.
Danish: QTc-forlængelse blev observeret mellem 1 og 5 uger efter arsentrioxid-infusionen og vendte derefter tilbage til baseline efter 8 uger efter arsentrioxid-infusionen.
English: Treatment with arsenic trioxide must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Danish: Behandling med arsentrioxid skal altid afbrydes før behandlingens planlagte afslutning, hvis der observeres hepatotoksicitet af grad 3 eller derover iht.
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Danish: Arsenic trioxide Accord 1 mg/ml koncentrat til infusionsvæske, opløsning
English: Arsenic trioxide Accord may cause harm to the foetus when used by pregnant women.
Danish: Du må ikke få Arsenic trioxide Accord, hvis du er gravid, da det kan skade fosteret.
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Danish: Arsenic trioxide Accord 1 mg/ml koncentrat til infusionsvæske, opløsning arsentrioxid
English: What Arsenic trioxide Accord is and what it is used for What you need to know before you use Arsenic trioxide Accord How to use Arsenic trioxide Accord Possible side effects
Danish: Det skal du vide, før du begynder at bruge Arsenic trioxide Accord Sådan skal du bruge Arsenic trioxide Accord Bivirkninger
English: Arsenic trioxide Accord must then be diluted immediately 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.
Danish: Fortynding: Før forsigtigt kanylen på en injektionssprøjte ind i hætteglasset via gummiproppen og træk alt indholdet op. Arsenic trioxide Accord skal derefter straks fortyndes med 100 til 250 ml 50 mg/ml (5 %) glucose injektionsvæske, opløsning, eller 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning.
English: Dilution of Arsenic trioxide Accord
Danish: Fortynding af Arsenic trioxide Accord
English: Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR.
Danish: Patienter i ATRA+arsentrioxid-gruppen fik ATRA 45 mg/m2
English: Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide.
Danish: Stoffer, der er substrater for disse CYP-enzymer,
English: Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Danish: Derefter kan arsentrioxid genoptages ved den fulde dosering, hvis den tidligere toksicitet ikke forværres.
English: If your disease responds to Arsenic trioxide Accord, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
Danish: Hvis din sygdom reagerer positivt på Arsenic trioxide Accord, vil du få endnu et behandlingsforløb med 25 doser.
English: - If you have further questions, please ask your doctor or your pharmacist or nurse.
Danish: - Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Electrocardiogram QT prolonged
Danish: QT-forlængelse i elektrokardiogram Meget almindelig Almindelig Hyperbilirubinæmi
English: Psychiatric disorders
Danish: Psykiske forstyrrelse
English: How to use Arsenic trioxide Accord Duration and frequency of treatment
Danish: Sådan skal du bruge Arsenic trioxide Accord Behandlingens varighed, og hvor tit du skal have Arsenic trioxide Accord
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Danish: Der tilrådes forsigtighed, når arsentrioxid administreres sammen med andre lægemidler, der vides at forårsage hepatotoksiske virkninger (se pkt.
English: If your disease responds to Arsenic trioxide Accord, you will be given 4 additional treatment cycles 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 behandlingspause.
English: Other medicines and Arsenic trioxide Accord
Danish: Brug af anden medicin sammen med Arsenic trioxide Accord
English: Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to Arsenic trioxide treatment.
Danish: Behandlingen med arsentrioxid skal afbrydes midlertidigt før behandlingens planlagte afslutning, hvis der observeres en toksicitetsgrad på 3 eller derover iht.
English: In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with arsenic trioxide in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL opstod der gastrointestinal toksicitet, grad 3-4 neutropeni og grad 3 eller 4 trombocytopeni.
English: After first opening Once opened the product should be used immediately.
Danish: Efter anbrud Lægemidlet skal anvendes straks efter anbrud.
English: • cisapride (a medicine used to relieve certain stomach problems).
Danish: • visse typer antiarytmika (medicin, som bruges til at korrigere uregelmæssig hjerterytme,
English: Induction treatment schedule
Danish: LISTE OVER HJÆLPESTOFFER
English: APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
Danish: Bivirkningerne, der er listet i Tabel 2 nedenfor i henhold til anbefalede termer efter MedDRA-systemorganklasse oghyppighed, blev observeret i kliniske studier af arsentrioxid hos 52 patienter med behandlingsresistent/recidiverende APL. Bivirkningsfrekvenserne defineres som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Hyperbilirubinaemia
Danish: Hyperleukocytose
English: Myelosuppression is thus common.
Danish: Myelosuppression er derfor almindelig.
English: From a microbiological point of view the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart.
English: This event is called extravasation.
Danish: Denne hændelse kaldes ekstravasation.
English: System Organ Classes (SOC)
Danish: Systemorgan- klasser (SOC)
English: • Infection (after an operation or other infections)
Danish: • Infektion (efter en operation eller andre infektioner)
English: In both studies the dosage regimen was the same.
Danish: I begge studier var doseringsregimet det samme.
English: The infusion will last 1-2 hours.
Danish: Infusionen tager 1-2 timer.
English: Powder and solvent: 3 years.
Danish: Pulver og solvens: 3 år.
English: It is important that you read the entire content of this procedure prior to the preparation of Savene.
Danish: Det er vigtigt, at De læser hele indholdet i denne procedure inden tilberedning af Savene.
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Danish: FORBEREDELSE TIL INTRAVENØS ADMINISTRATION
English: Calcium Total (Hypo)
Danish: Total kalcium (Hypo)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/350/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/06/350/001
English: CTC grade 3-4
Danish: CTC grad 3-4
English: All adverse reactions have been rapidly reversible.
Danish: Alle bivirkninger er hurtigt reversible.
English: Both of these effects are expected for this class of compound.
Danish: Begge disse effekter kan forventes i denne stofklasse.
English: Inter- and intra-individual pharmacokinetic variabilities have not been studied systematically.
Danish: Inter- og intraindividuel farmakokinetisk variabilitet er ikke blevet undersøgt systematisk.
English: The toxicity in combination with doxorubicin was additive and not synergistic.
Danish: Toksiciteten i kombination med doxorubicin var additiv og ikke synergistisk.
English: Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours.
Danish: Behandlingen med Savene skulle påbegyndes inden for 6 timer efter hændelsen og blev gentaget efter 24 og 48 timer.
English: Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution.
Danish: Monitorering Lokale undersøgelser skal foretages regelmæssigt efter behandlingen indtil resolution.
English: The apparent effects were greater during chronic than acute administration.
Danish: Den tilsyneladende effekt var større ved kronisk end ved akut administration.
English: Adverse reactions observed in the two studies are listed below.
Danish: Bivirkninger, der blev observeret i de to studier, angives nedenfor.
English: It is a serious complication as it can cause severe tissue damage.
Danish: Dette er en alvorlig komplikation, da den kan forårsage svær vævsskade.
English: Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1.
Danish: Behandlingen på Dag 2 og Dag 3 skal startes på samme tid (+/- 3 timer) som for Dag 1.
English: Systemic clearance is independent of dose.
Danish: Systemisk clearance er uafhængig af dosis.
English: Eighteen were evaluable for efficacy and safety and a further five patients were evaluable for toxicity only.
Danish: Atten var evaluerbare for effekt og sikkerhed og yderligere fem patienter var kun evaluerbare for toksicitet.
English: There is insufficient data available to draw any definite conclusions regarding intrinsic pharmacokinetic factors such as age, gender, race and weight.
Danish: Der foreligger ikke tilstrækkelige data til at drage nogen afgørende konklusion med hensyn til interne farmakokinetiske faktorer som alder, køn, race og vægt.
English: The preparation should not be handled by pregnant staff.
Danish: Tilberedningen må ikke foretages af personale, der er gravide.
English: • Changes in liver function (these may be seen in test results)
Danish: • Ændret leverfunktion (kan ses i analyseresultater)
English: 36 patients were evaluable for efficacy.
Danish: 36 patienter var evaluerbare for effekt.
English: Children and adolescents Savene should not be administered to children below the age of 18 years.
Danish: Børn og unge Savene må ikke anvendes til børn under 18 år.
English: Concomitant use not recommended:
Danish: Samtidig anvendelse anbefales ikke:
English: None of the patients required surgical intervention.
Danish: Ingen af patienterne havde behov for kirurgisk indgreb.
English: White to off-white lyophilisate.
Danish: Hvidt til offwhite lyofilisat.
English: The recommended adult dose (with normal kidney function) is:
Danish: Den anbefalede dosis for voksne (med normal nyrefunktion) er:
English: In both studies all patients had received anthracycline.
Danish: I begge studier havde alle patienterne fået antracyklin.
English: The pharmacokinetics of the metabolites is derived from a single study with five patients.
Danish: Metabolitternes farmakokinetik stammer fra et enkelt studie med fem patienter.
English: • Other live attenuated vaccines: risk of systemic, possible fatal disease.
Danish: • Andre levende, svækkede vacciner: Risiko for systemisk, potentiel livstruende sygdom.
English: FORMULATION
Danish: FORMULERING
English: Solutions containing a precipitate should be discarded.
Danish: Opløsninger, som indeholder udfældning, skal kasseres.
English: • Inflammation of a blood vessel just under the skin, often with a small blood clot
Danish: • Inflammation i et blodkar lige under huden, ofte med en lille blodprop
English: Most anti-cancer medicines are administered intravenously (into a vein).
Danish: De fleste lægemidler mod cancer indgives intravenøst (i en vene).
English: The concentrate is slightly yellow.
Danish: Koncentratet er let gult.
English: Total urinary recovery of unchanged dexrazoxane is 34-60 %.
Danish: Den samlede genfindelse af uændret dexrazoxan i urin er 34-60 %.
English: Date of latest renewal: 18 July 2011
Danish: Dato for første markedsføringstilladelse: 28. juli 2006 Dato for seneste fornyelse: 18. juli 2011
English: Alopecia Pruritus
Danish: Alopeci Pruritus
English: Only one of the 36 patients required surgery.
Danish: Kun en af de 36 patienter havde behov for kirurgisk indgreb.
English: - Ciclosporin or tacrolimus (both treatments lower the body's immune system and are used to prevent organ rejection after an organ transplant).
Danish: - Ciclosporin eller tacrolimus (begge behandlinger nedsætter kroppens immunsystem, og anvendes til at undgå organafstødning efter en organtransplantation).
English: You must not breast-feed while you are treated with Savene.
Danish: De må ikke amme, mens De er i behandling med Savene.
English: For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg.
Danish: Hos patienter med en legemsoverflade på mere end 2 m2 bør enkeltdosis ikke overstige 2.000 mg.
English: Your doctor will calculate your body surface area in square meter (m2) to determine the dose you should receive.
Danish: Deres læge beregner Deres legemsoverfladeareal i kvadratmeter (m2) for at bestemme, hvilken dosis De skal have.
English: Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV %) was estimated to be approximately 30 % for the main pharmacokinetic parameters.
Danish: På basis af et begrænset antal patienter blev den interindividuelle variabilitet, beregnet som variationskoefficienten (CV %), vurderet til at være cirka 30 % for de vigtigste farmakokinetiske parametre.
English: The first infusion should be initiated as soon as possible, within the first six hours after the accident.
Danish: Den første infusion skal påbegyndes snarest muligt, inden for de første 6 timer efter skaden.
English: Haematological monitoring should therefore be undertaken regularly.
Danish: Hæmatologisk overvågning skal derfor foretages regelmæssigt.
English: ADR-925 is reported to increase three-fold within 15 min after infusion of 1500 mg/m2 and remain relatively constant on a plateau for 4 hours and then decreased to about half at 24 hours.
Danish: Det er rapporteret, at ADR-925 øges 3 gange inden for 15 minutter efter infusion af 1.500 mg/m2 og forbliver relativt konstant på et niveau i 4 timer, hvorefter det mindskes til cirka halvdelen efter 24 timer.
English: This risk is increased in subjects who are already immunosuppressed by their underlying disease or by concomitant chemotherapy.
Danish: Denne risiko øges hos personer, som allerede er immunsupprimerede af deres grundsygdom eller ved samtidig kemoterapi.
English: Savene is supplied as:
Danish: Savene leveres som:
English: • Blood clot in the vein, usually in an arm or leg
Danish: • Blodprop i venen, normalt i en arm eller et ben
English: Caution must be exercised during reconstitution and dilution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Danish: Der skal udvises forsigtighed under rekonstitution og fortynding, og de normale procedurer for korrekt håndtering af cytotoksiske lægemidler skal anvendes.