FrancophonIA/ELRC3.0 huggingface dataset:
English: This may include discontinuation of Zevalin therapy and treatment with growth factors or your own stem cells.
Danish: Det kan indebære, at Zevalin-behandlingen afbrydes, og at du skal behandles med vækstfaktorer eller med dine egne stamceller.
English: Preparation of Zevalin
Danish: Forberedelse af Zevalin
English: The radionuclide is not part of the kit.
Danish: Radionukleidet er ikke en del af dette sæt.
English: A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/m weekly times 4 doses.
Danish: I alt 73 patienter modtog det terapeutiske Zevalin regimen, og 70 patienter modtog rituximab, indgivet som en intravenøs infusion på 375 mg/m ugentlig gange 4 doser.
English: Your doctor will immediately stop the infusion and restart it using another vein.
Danish: Din læge vil straks stoppe infusionen og foretage den på ny i en anden blodåre.
English: There is a potential risk that [
Danish: Der er en potentiel risiko for, at behandling med [
English: Manufacturer CIS bio international RN 306- Saclay B.P.
Danish: CIS bio international RN 306- Saclay B.P. 32
English: Zevalin is used with another medicine containing the active substance rituximab.
Danish: Zevalin anvendes sammen med en anden medicin, der indeholder den aktive substans rituximab.
English: Due to the exposure to ionising radiation derived from the radiolabel, a risk of mutagenic and carcinogenic effects has to be taken into account.
Danish: På grund af udsættelse for ioniserende stråling fra den radioaktive mærkning skal risikoen for mutagene og karcinogene virkninger tages i betragtning.
English: Bacterial endotoxins
Danish: Bakterielle endotoksiner
English: The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Danish: Fordelen ved at anvende Zevalin efter behandling med rituximab i kombination med kemoterapi er ikke fastslået.
English: Time to Disease Progression: interval from the first infusion to disease progression.
Danish: Time to Disease Progression (tiden til sygdommens progression): interval fra første infusion til progression af sygdom.
English: Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
Danish: Zevalin kan indgives direkte ved at stoppe flowet fra en infusionspose og indgive det direkte i slangen.
English: The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 2).
Danish: Studiets primære effektivitetsendepunkt var at bestemme ORR ved hjælp afIWRC (se Tabel 2).
English: intravenous infusion of 250 mg/m rituximab shortly (within 4 hours) before administration of [
Danish: - Intravenøs infusion af 250 mg/m rituximab kort tid (inden for 4 timer) før indgiften af [
English: In case of hypersensitivity reactions, Zevalin infusion must be stopped immediately.
Danish: Ved overfølsomhedsreaktioner skal Zevalin-infusionen stoppes øjeblikkeligt.
English: Febrile neutropenia, Pancytopenia*, Lymphocytopenia
Danish: Febril neutropeni, Pancytopeni*, Lymfocytopeni
English: If available, autologous stem cell support must be administered to manage haematological toxicity.
Danish: Hvis tilgængelig, bør der administreres autolog stamcellestøtte til behandling af hæmatologisk toksicitet.
English: PFS increased from 13.5 months (control) to 37 months (Zevalin; p<0.0001; HR 0.465).
Danish: PFS steg fra 13,5 måned (kontrolgruppen) til 37 måneder (Zevalingruppen, p < 0,0001, HR 0,465).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet i rækkefølge efter aftagende alvorlighed.
English: It should be specified that the frequency ‘common' attributed to this adverse drug reaction has been derived from a study on consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Danish: Det skal specificeres, at hyppigheden “almindelig”, der er tilskrevet denne lægemiddelbivirkning, stammer fra et studie af konsolideringsbehandling efter remissionsinduktion hos tidligere ubehandlede patienter med follikulært lymfom.
English: Patients whose response status changed after Zevalin from PR to CR showed a significantly longer median progression free survival time (986 days) compared to those patients who remained in PR (median progression free survival time of 460 days, p=0.0004).
Danish: De patienter, som skiftede respons efter behandling med Zevalin fra PR til CR, havde en signifikant længere median progressionsfri overlevelse (986 dage) sammenlignet med de patienter, som forblev i PR (median progressionsfri overlevelse: 460 dage, p = 0,0004).
English: The side effects marked with two asterisks (**) were observed additionally under consolidation therapy.
Danish: Bivirkninger mærket med to stjerner (**) blev desuden set under konsolideringsbehandling.
English: Patients who have developed HAMAs may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Danish: Hos patienter, der har udviklet HAMA, kan der forekomme allergiske reaktioner eller overfølsomhedsreaktioner, når de bliver behandlet med Zevalin eller andre murin-deriverede proteiner.
English: Limited data in elderly patients (aged ≥ 65 years) are available.
Danish: Der er begrænsede data vedrørende brugen hos ældre patienter (≥ 65 år).
English: Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra toksicitet efter enkeltdoser og gentagne doser.
English: Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen versus treatment with rituximab.
Danish: Studie 2 var et randomiseret, kontrolleret multicenterstudie, hvor det terapeutiske Zevalin-regimen blev sammenlignet med behandling med rituximab.
English: Since IgGs are known to cross the placenta, and because of the significant risk associated with radiation, Zevalin is contraindicated during pregnancy (see section 4.3).
Danish: Da IgG vides at passere placenta, og på grund af den signifikante risiko der er forbundet med stråling, er Zevalin kontraindiceret under graviditet (se pkt.
English: Grade 3 and grade 4 infections were reported commonly.
Danish: Grad 3- og grad 4-infektioner var almindeligt forekommende.
English: Studies on reproductive and developmental toxicity have not been performed.
Danish: Der er ikke udført studier af reproduktions- og udviklingstoksicitet.
English: How Zevalin is given Zevalin is given by intravenous infusion (drip into a vein) usually lasting about 10 minutes.
Danish: Sådan gives Zevalin Zevalin gives via en intravenøs infusion (et drop i en blodåre), der normalt varer omkring 10 minutter.
English: Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [
Danish: Analyser af den estimerede absorberede strålingsdosis blev udført ved brug af kvantitativ scanning med gamma-emitter [
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Place cold kit reaction vial in a suitable dispensing shield (plastic enclosed in lead).
Danish: Placér det kolde reaktionshætteglas inde i en egnet afskærmning (plastik indkapslet i bly).
English: • Pneumonia
Danish: • Pneumoni
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ibritumomab tiuxetan, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for ibritumomab tiuxetan er CHMP nået frem til følgende videnskabelige konklusioner:
English: In a secondary analysis comparing objective response to the Zevalin therapeutic regimen with that observed with the most recent treatment with rituximab, the median duration of response following the Zevalin therapeutic regimen was 6 vs. 4 months.
Danish: I en sekundær analyse, hvor den objektive respons over for terapeutisk Zevalin-regimen blev sammenlignet med reaktionen, der observeredes med den seneste behandling med rituximab, var den gennemsnitlige varighed af respons efter det terapeutiske Zevalin-regimen 6 måneder versus 4 måneder.
English: Yttrium identification
Danish: Yttriumidentifikation
English: net CPM bottom half x 100 net CPM top half + net CPM bottom half
Danish: 6) Gennemsnit % RCP = netto CPM nederste halvdel x 100 netto CPM øverste halvdel + netto CPM nederste halvdel
English: During B-cell maturation, CD20 is first expressed in the midstage of B-lymphoblast (pre-B-cell), and is lost during the final stage of B-cell maturation to plasma cells.
Danish: Under B-celle modning viser CD20 sig først i mellemstadiet af B-lymfoblast (præ-B-celle) og forsvinder under slutstadiet af B-cellernes modning til plasmaceller.
English: Objective, durable clinical responses were observed [67% ORR (95% CI: 48-85%), 11.8 months median DR (range: 4-17 months)] and resulted in a greater incidence of haematologic toxicity (see 4.8) than in Studies 1 and 2.
Danish: Objektiv, varig klinisk respons blev observeret [67% ORR (95% CI: 48-85%), 11,8 måneder gennemsnits DR (område: 4-17 måneder)], hvilket resulterede i flere tilfælde af hæmatologisk toksicitet (se afsnit 4.8) end i studie 1 og 2.
English: Chloride identification
Danish: Chlorididentifikation
English: • Infusion reactions
Danish: ● Infusionsreaktioner
English: Zevalin is supplied as a kit for the preparation of yttrium-90 (
Danish: Zevalin leveres som et sæt til præparation af yttrium-90 [
English: If the average radiochemical purity is less than 95%, the preparation must not be administered.
Danish: Hvis den gennemsnitlige radiokemiske renhed er mindre end 95 %, må præparatet ikke indgives.
English: For patient subgroups in PR or CR after induction, median PFS was 6.3 vs 29.7 months (p<0.0001; HR 0.304) and 29.9 vs 54.6 months (p=0.015; HR 0.613), respectively.
Danish: Hos patienter, som opnåede PR eller CR efter induktion, var den mediane PFS hhv. 6,3 og 29,7 måneder (p < 0,0001, HR 0,304) og 29,9 og 54,6 måneder (p = 0,015, HR 0,613).
English: The volume of sodium acetate solution added is equivalent to 1.2 times the volume of yttrium-90 chloride to be transferred in step 2.
Danish: Voluminet af den tilførte natriumacetatopløsning er 1,2 gange større end voluminet af yttrium-90-chlorid, som overføres i trin 2.
English: Myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) has been reported in eleven out of 211 patients with relapsed or refractory NHL assigned to treatment with Zevalin in four studies.
Danish: Myelodysplasi (MDS) / akut myeloid leukæmi (AML) er set hos 11 ud af 211 patienter med recidiverende eller refraktær NHL, som fik Zevalin-behandling, i fire studier.
English: The recommended radioactivity dose of [
Danish: Den anbefalede radioaktive dosis af [
English: Y]-radiolabelled Zevalin at activities of 15 MBq/kg and 11 MBq/kg was calculated according to Medical Internal Radiation Dosimetry (MIRD) (Table 3).
Danish: Y] radioaktivt mærket Zevalin ved aktiviteter på 15 MBq og 11 MBq udregnet ifølge Medical Internal Radiation Dosimetry (MIRD) (Tabel 3).
English: No animal studies have been performed to determine the effects of Zevalin on fertility in males or females.
Danish: Der er ikke udført dyreforsøg for at bestemme virkningen af Zevalin på fertiliteten hos hankøn eller hunkøn.
English: The efficacy and safety of a variation of the Zevalin therapeutic regimen employing a reduced dose of ibritumomab tiuxetan [
Danish: Virkningen og sikkerheden af en variation af det terapeutiske Zevalin-regimen, hvori der anvendtes en reduceret dosis ibritumomab tiuxetan [
English: Its receipt, preparation, use, transfer, storage, and disposal are subject to the regulations and/or appropriate authorisation/licences of the local competent official organisations.
Danish: Modtagelse, præparering, anvendelse, overførsel, opbevaring og bortskaffelse skal ske i henhold til regler og/eller relevante autorisationer/tilladelser fra de lokale myndigheder.
English: This medicine is a radiopharmaceutical product for therapy only.
Danish: Dette lægemiddel er et radioaktivt lægemiddel.
English: Contents of the kit are intended only for use in the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan and are not to be administered directly to the patient without first undergoing the preparative procedure.
Danish: Indholdet af sættet er kun beregnet til præparation af Yttrium-90 radioaktivt mærket ibritumomab tiuxetan, og det må ikke administreres til patienten, før præparationsproceduren er udført.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Danish: Radioaktive lægemidler må kun modtages, anvendes og administreres af bemyndigede personer i specielt afmærkede kliniske områder.
English: Sterility
Danish: Sterilitet
English: Infection*
Danish: Infektion*
English: Duration of response: interval from the onset of response to disease progression.
Danish: Duration of response (responsvarighed):interval fra start af respons til progression af sygdom.
English: • extravasation (leakage of the infusion to the surrounding tissue): pain, burning sensation, stinging or another reaction at the infusion site during administration.
Danish: • Ekstravasation (udsivning fra infusionen til det omgivende væv): smerte, brændende fornemmelse eller anden reaktion på infusionsstedet under infusionen.
English: Zevalin contains sodium
Danish: Zevalin indeholder natrium
English: Clean the rubber stopper of all cold kit vials and the yttrium-90 chloride vial with a suitable alcohol swab and allow to air dry.
Danish: Rengør gummipropperne på alle kolde hætteglas samt hætteglasset med yttrium-90-chlorid med en egnet spritserviet, og lad dem lufttørre.
English: Kit for radiopharmaceutical preparations for infusion.
Danish: Sæt til klargøring af radiofarmaceutisk præparat til infusion
English: IWRC: International Workshop response criteria CRu: Unconfirmed complete response
Danish: Gennemsnits DR (Måneder) [Område Gennemsnits TTP (Måneder) [Område IWRC:International Workshop response criteria CRu:Unconfirmed complete response (ubekræftet total respons) Estimeret med observeret område.
English: For consolidation therapy in patients with follicular lymphoma • The usual dose is 15 MBq/kg body weight.
Danish: Til konsolideringsbehandling hos patienter med follikulært lymfom - Den sædvanlige dosis er 15 MBq/kg kropsvægt
English: In most patients, administration of Zevalin (after pretreatment with rituximab) results in severe and prolonged cytopenia which is generally reversible (see section 4.8).
Danish: Hos de fleste patienter resulterer indgift af Zevalin (efter forbehandling med rituximab) i alvorlig og længerevarende cytopeni, der almindeligvis er reversibel (se pkt.
English: The content of the kit before extemporary preparation is not radioactive.
Danish: Indholdet i sættet er ikke radioaktivt før ekstemporær præparation.
English: • Haematological toxicity
Danish: • Hæmatologisk toksicitet
English: The line must be flushed with at least 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection after the infusion of Zevalin.
Danish: Slangen skal skylles med mindst 10 ml natriumchlorid 9 mg/ml (0,9%) injektonsvæske, opløsning, efter indgiften af Zevalin.
English: Y] was further defined in a third study enrolling a total of 30 patients who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/mm
Danish: Y], blev yderligere defineret i et tredje studie, hvori der i alt deltog 30 patienter, som havde mild trombocytopeni (blodpladetal 100.000 til 149.000 celler/mm
English: Total Gamma impurities
Danish: Totale Gamma-urenheder
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or approporiate licences of the competent official organisation.
Danish: Modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse skal ske i henhold til regler og/eller relevante autorisationer/tilladelser fra kompetente officielle organisationer.
English: • Contraception
Danish: ● Kontraception
English: Excluded from the study were patients with 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Danish: Ekskluderet fra studiet var patienter med 25% lymfomer i marven og/eller nedsat knoglemarvreserve.
English: Infusions must be administered under the close supervision of an experienced physician with full resuscitation facilities immediately available (for radiopharmaceutical precautions see also sections ‘4.2 and 12').
Danish: Indgiften skal gives under tæt overvågning af en erfaren læge med komplet genoplivningsudstyr umiddelbart tilgængeligt (for radiofarmaceutiske forsigtighedsregler se også pkt.
English: Induction therapies included CVP n=106, CHOP (-like) n=188, fludarabine combinations n=22, chlorambucil n=39 and rituximab-chemotherapy combinations n=59.
Danish: Induktionsbehandlinerne bestod af CVP, n = 106, CHOP (lignende), n = 188, kombinationer med fludarabin, n = 22, chlorambucil, n = 39 og kombinationer af rituximab og kemoterapi, n = 59.
English: Severe (Grade 3/4) hypersensitivity reactions including anaphylaxis occur in less than 1% of patients (see also section ‘Special warnings and precautions for use').
Danish: Alvorlige (grad 3/4) overfølsomhedsreaktioner, herunder anafylaktiske reaktioner forekommer hos mindre end 1% af patienterne (se også ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: Characteristics of yttrium-90
Danish: Specifikation for yttrium-90
English: Radiochemical purity of the yttrium-90 chloride solution
Danish: Radiokemisk renhed af yttrium-90chloridopløsningen
English: In]-radiolabelled ibritumomab tiuxetan predicted acceptable radiation to normal human tissue with limited levels of skeleton and bone marrow radiation.
Danish: In]-radioaktivt mærket ibritumomab tiuxetan forudsagde acceptabel stråling af normalt humant væv med begrænset stråling af skelet og knoglemarv.
English: Using a 1 ml insulin syringe with a 25- to 26-G needle, place a hanging drop (7-10 µl) of [
Danish: 2) Placér med en 1 ml insulinsprøjte med en 25- til 26-G nål en hængende dråbe (7-10 µl) af [
English: • severe mucous membrane reactions, which may occur days or months after Zevalin and/or rituximab administration.
Danish: • Alvorlige reaktioner i slimhinderne, hvilket kan ske dage eller måneder efter Zevalinog/eller riuximab-behandlingen.
English: The use of Zevalin is associated with an increased risk of secondary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), (see also section 4.8).
Danish: Brugen af Zevalin er forbundet med en øget risiko for sekundære maligniteter, herunder akut myeloid leukæmi (AML) og myelodysplasi (MDS) (se også pkt.
English: Haemorrhage while thrombocytopenic Hypertension** Hypotension**
Danish: Blødning under thrombocytopeni* Hypertension** Hypotension**
English: In]-radiolabelled Zevalin, whole body scans were performed at up to eight time-points, acquiring both anterior and posterior images.
Danish: In] radioaktivt mærket Zevalin blev der udført helkrops-scanninger på op til otte forskellige tidspunkter med både anteriore og posteriore scanninger.
English: You will be given a total of 3 infusions in the course of two visits to a medical facility, 7 to 9 days apart.
Danish: Du vil få i alt 3 infusioner i løbet af to besøg på klinikken.
English: After completing induction therapy, patients were randomized to receive either Zevalin (250 mg/m rituximab on day -7 and on day 0 followed on day 0 by Zevalin 15 MBq/kg body weight; maximal dose 1200 MBq; [n=208]) or no further treatment (control; n=206).
Danish: Efter afslutning af induktionsbehandlingen blev patienterne randomiseret til behandling med enten Zevalin (250 mg/m rituximab på dag -7 og 0), efterfulgt på dag 0 af Zevalin 15 MBq/kg legemsvægt, maksimaldosis 1200 MBq [n = 208]) eller ingen yderligere behandling (kontrolgruppe; n = 206).
English: Study 1 was a single-arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Danish: Studiet 1 var et enkelt-arm studie med 54 patienter med recidiverende follikulære lymfomer, der er refraktære over for rituximab-behandling.
English: Seven patients (3.4%, 7/204) were diagnosed with MDS/AML after receiving Zevalin, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years.
Danish: Syv patienter i Zevalin-armen (3,4 %, 7/204) blev diagnosticeret med MDS/AML sammenlignet med en patient (0,5 %, 1/205) i kontrolarmen, med en median followup på 7,3 år.
English: Storage must be in accordance with national regulations for radioactive materials.
Danish: Skal opbevares i overensstemmelse med nationale krav til radioaktive materialer.
English: In]-radiolabelled Zevalin was always given immediately following an infusion with rituximab at 250 mg/m² to deplete peripheral CD20+ cells and to optimise biodistribution.
Danish: In] radioaktivt mærket Zevalin blev altid indgivet umiddelbart efter en infusion med rituximab på 250 mg/m² for at nedsætte antallet af perifere CD20+ celler og til at optimere biodistributionen.
English: The most serious adverse drug reactions in patients receiving Zevalin after pretreatment with rituximab are:
Danish: De mest alvorlige bivirkninger hos patienter, der får Zevalin efter forbehandling med rituximab, er:
English: • Severe mucocutaneous reactions (see also ‘Special warnings and precautions for use')
Danish: • Alvorlige mukokutane reaktioner (se også ”Særlige advarsler og forsigtighedsregler vedrørende brugen”)
English: After the 5-minute incubation period, withdraw from the reaction vial the same volume of air as the formulation buffer to be added in order to normalise pressure and immediately thereafter gently add the formulation buffer down the side of the reaction vial to terminate incubation.
Danish: Efter de fem minutters inkubationstid udtrækkes fra reaktionshætteglasset et lige så stort volumen luft som den bufferopløsning, der skal tilsættes, for at normalisere trykket.
English: The single and repeated dose toxicity studies of the non-radioactive compound in cynomolgus monkeys did not indicate any other risk than the expected B-cell depletion arising from the use of ibritumomab tiuxetan alone or in combination with rituximab.
Danish: Toksicitetsstudier med cynomolgus-aber efter enkeltdoser og gentagne doser med det ikke-radioaktive stof indikerede ikke andre risici end den forventede depletering i antallet af B-celler efter brug af ibritumomab tiuxetan alene eller kombineret med rituximab.
English: In patients experiencing a severe mucocutaneous reaction treatment must be discontinued.
Danish: Behandlingen skal seponeres hos patienter, der oplever en alvorlig mukokutan reaktion.
English: Rituximab pretreatment is necessary to clear circulating B-cells, enabling ibritumomab tiuxetan [
Danish: Rituximab forbehandling er nødvendig for at fjerne cirkulerende B-celler, således at ibritumomab tiuxetan [
English: Zevalin could affect the ability to drive and to use machines, as dizziness has been reported as a common side effect.
Danish: Zevalin kunne have indvirkning på evnen til at føre motorkøretøj og til at betjene maskiner, da svimmelhed er blevet rapporteret som en almindelig bivirkning.
English: After radiolabelling, immediate use is recommended.
Danish: Efter præparation anbefales umiddelbar brug.