FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for ibritumomab tiuxetan the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ibritumomab tiuxetan is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Danish: På baggrund af de videnskabelige konklusioner for ibritumomab tiuxetan er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder ibritumomab tiuxetan, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Total extractable activity to deliver at time of use  1.48 GBq corresponding to 0.44 ml to 0.89 ml of yttrium-90 solution
Danish:  1,48 GBq svarende til 0,44 ml til 0,89 ml yttrium-90 opløsning
English: The path length of beta emission (90) by yttrium-90 in tissue is 5 mm.
Danish: Rækkevidden af betaemission af yttrium-90 i væv er 5 mm.
English: In particular, your doctor will need to interrupt treatment with growth factors such as filgrastim for a period of three weeks before giving you Zevalin to two weeks after Zevalin treatment.
Danish: Det er især nødvendigt, at din læge afbryder behandling med vækstfaktorer, som fx filgrastim, i en periode på 3 uger før du får Zevalin og i indtil 2 uger efter Zevalin-behandlingen.
English: Patients were considered to have impaired bone marrow reserve if they had any of the following: prior myeloablative therapy with stem cell support; prior external beam radiation to >25% of active marrow; a platelet count <100,000 cells/mm
Danish: Patienter blev betragtet som havende nedsat knoglemarvreserve, hvis de havde et eller flere af følgende: Tidligere myeloablativ terapi med stamcellestøtte; tidligere ekstern stråling til > 25% af den aktive marv; et blodpladetal <100.000 celler/mm
English: 10 ml of formulation buffer
Danish: 10 ml bufferopløsning
English: Y]radiolabelled Zevalin onto the ITLC strip at its origin.
Danish: Y] radioaktivt mærket Zevalin på ITLC-strippen ved dens begyndelsespunkt.
English: In clinical studies, the [
Danish: I kliniske studier medfører behandling med [
English: • blood poisoning (sepsis): fever and chills, changes in mental status, rapid breathing, increased heart rate, decreased urine output, low blood pressure, shock, problems with bleeding or clotting
Danish: • Blodforgiftning (sepsis): feber og kulderystelser, ændringer i mental tilstand, hurtig vejrtrækning, øget hjertefrekvens, nedsat vandladning, lavt blodtryk, shock, problemer med blødning eller koagulation
English: The radioincorporation assay for radiochemical purity, is performed by Instant Thin Layer Chromatography (ITLC) and must be carried out according to the following procedure.
Danish: Anvisninger for bestemmelse af den procentvise radioaktive inkorporation Bestemmelse af den radiokemiske renhed udføres ved brug af tyndtlagskromatografi (Instant Thin Layer Chromatography (ITLC)) og bør udføres ifølge nedenstående procedure.
English: Hence the risk of haematological toxicity may be increased when Zevalin is administered shortly (< 4 months) after fludarabine-containing regimens (see also section 4.4).
Danish: Derfor kan risikoen for hæmatologisk toksicitet være øget, når Zevalin indgives kort efter (< 4 måneder) en behandling, der omfatter fludarabin (se også pkt.
English: cells/mm 3.
Danish: celler/mm
English: Long-term animal studies on the effect on fertility and reproductive function have not been performed.
Danish: Der er ikke udført langvarige dyreforsøg af virkningen på fertilitet og forplantningsevne.
English: In addition, Zevalin is not recommended for the use in patients with non-Hodgkin's lymphoma involving the brain and/or spinal cord as those patients were not included in clinical studies.
Danish: Desuden bør Zevalin ikke anvendes til patienter med non-Hodgkin's lymfom, der involverer hjernen og/eller rygmarven, da disse patienter ikke var omfattet af undersøgelserne på mennesker (kliniske studier).
English: Infusion reactions may occur during or following Zevalin administration after pretreatment with Rituximab.
Danish: Der kan opstå infusionsreaktioner under eller efter indgift af Zevalin efter forbehandling med Rituximab.
English: Paediatric population
Danish: Specielle populationer Pædiatrisk population
English: • allergic (hypersensitivity) reactions/infusion reactions: symptoms for allergic reactions/ infusion reactions may be skin reactions, breathing difficulties, swelling, itching, flushing, chills, dizziness (as potential sign for low blood pressure).
Danish: • Allergisk reaktion (overfølsomhed)/reaktioner på infusionen: symptomer på allergiske reaktioner/infusionsreaktioner kan være reaktioner i huden, åndedrætsbesvær, opsvulmen, kløe, rødmen, kulderystelser, svimmelhed (som et potentielt tegn på lav blodtryk).
English: Y) radiolabelled ibritumomab tiuxetan.
Danish: Y] radioaktivt mærket ibritumomab tiuxetan.
English: These reports originated either from clinical trials or from postmarking experience.
Danish: Indberetningerne er enten sket i forbindelse med kliniske studier eller efter markedsføringen.
English: Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes.
Danish: Ibritumomab tiuxetan er specifik for antigenet CD20, som befinder sig på overfladen af maligne og normale B-lymfocytter.
English: The use of Zevalin is therefore not recommended in NHL patients with CNS involvement.
Danish: Zevalin bør derfor ikke anvendes til NHL-patienter, hvor der er påvirkning af CNS.
English: Women of child-bearing potential and male patients must use reliable contraception during treatment with Zevalin and for up to one year after stopping treatment.
Danish: Kvinder i den fødedygtige alder og mandlige patienter skal anvende sikker prævention under behandlingen med Zevalin og i op til ét år efter, at behandlingen er ophørt.
English: In patients given intravenous infusions of 250 mg/m rituximab followed by intravenous injections of
Danish: Hos patienter, der har fået intravenøse infusioner med 250 mg/m rituximab efterfulgt af intravenøse injektioner med 15 MBq/kg af [
English: Total Alpha impurities
Danish: Totale Alpha-urenheder
English: Thrombocytopenia, Leukocytopenia, Neutropenia, Anaemia*
Danish: Trombocytopeni, Leukocytopeni, Neutropeni, Anæmi*
English: Zevalin must not be administered in patients mentioned below, as safety and efficacy have not been established: - > 25% of the bone marrow infiltrated by lymphoma cells - prior external beam radiation affecting more than 25% of active bone marrow
Danish: Zevalin må ikke indgives til de nedenfor nævnte patienter, da sikkerheden og virkningen ikke er blevet fastslået: - patienter, hos hvem mere end 25 % af knoglemarven er infiltreret af lymfomceller, - patienter, som tidligere er behandlet med ekstern strålebehandling, der involverede mere end 25 %
English: Zevalin is used to treat patients suffering from specific subgroups of B-cell non-Hodgkin's lymphoma (CD20+ indolent or transformed B-cell NHL) if an earlier rituximab, another monoclonal antibody, treatment has not worked, or has stopped working (refractory or relapsed disease).
Danish: Zevalin anvendes til at behandle patienter der lider af særlige undergrupper af sygdommen B-celle non-Hodgkin's lymfom (CD20+ smertefri eller transformeret B-celle NHL), hvis en tidligere behandling med rituximab, som er et andet monoklonalt antistof, ikke har virket eller er holdt op med at virke (refraktær eller recidiverende sygdom).
English: Y]-radiolabelled Zevalin solution must not be administered to patients who are likely to develop life-threatening haematological toxicity signs.
Danish: [90Y] radioaktivt mærket Zevalin-opløsning må ikke indgives til patienter, der sandsynligvis vil udvikle tegn på livstruende hæmatologisk toksicitet.
English: Table 1: Adverse drug reactions reported in clinical trials or during post-marketing surveillance in patients treated with Zevalin after pretreatment with rituximab
Danish: Tabel 1: Bivirkninger rapporteret i kliniske studier eller efter markedsføringen hos patienter, der er blevet behandlet med Zevalin efter forbehandling med rituzimab.
English: Please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use.
Danish: Se produktresuméet for rituximab for detaljeret vejledning i brugen af rituximab.
English: The final formulation after radiolabelling contains 2.08 mg ibritumomab tiuxetan [
Danish: Den endelige formulering efter radioaktiv mærkning indeholder 2,08 mg ibritumomab tiuxetan [
English: Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting (see also section ‘Special warnings and precautions for use').
Danish: Hæmatologisk toksicitet er meget almindeligt forekommende i kliniske studier, og er dosisbegrænsende (se også ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: Radionuclidic purity strontium-90 content
Danish: Radionukleid renhed strontium-90 indhold
English: Patients must not receive growth factor treatment such as G-CSF for 3 weeks prior to Zevalin administration as well as for 2 weeks following completion of the treatment in order to assess the adequate bone marrow reserve correctly and because of the potential sensitivity of rapidly dividing myeloid cells to radiation (see also section 4.5).
Danish: Patienten må ikke blive behandlet med vækstfaktorer, fx G-CSF i 3 uger før behandlingen med Zevalin og i 2 uger efter afslutningen af behandlingen, for at der kan foretages en korrekt vurdering af, om der er en tilstrækkelig knoglemarvsreserve, og da hurtigt delende myeloide celler er potentielt sensive over for stråling (se også pkt.
English: Mucocutaneous reaction (including Stevens Johnson
Danish: Mukokutane reaktioner (herunder Stevens-Johnsons syndrom)*
English: • Risk Management Plan (RMP) The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, som er beskrevet i modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Zevalin can affect your ability to drive and use machines, as dizziness is a common side effect.
Danish: Zevalin kan påvirke din evne til at føre motorkøretøj og betjene maskiner, da svimmelhed er en almindeligt forekommende bivirkning.
English: • Severe and prolonged cytopenias (see also ‘Special warnings and precautions for use')
Danish: • Alvorlige og langvarige cytopenier (se også ”Særlige advarsler og forsigtighedsregler vedrørende brugen”)
English: - Pregnancy and lactation (see section 4.6).
Danish: Graviditet og amning (se pkt.
English: The most frequently observed adverse drug reactions in patients receiving Zevalin after pretreatment with rituximab are thrombocytopenia, leukocytopenia, neutropenia, anaemia, infections, pyrexia, nausea, asthenia, rigors, petechiae, and fatigue.
Danish: De hyppigste bivirkninger hos patienter, der fik Zevalin efter forbehandling med rituximab, er trombocytopeni, leukocytopeni, neutropeni, anæmi, infektioner, pyrexi, kvalme, asteni, kulderystelser (rigors), petekkier og træthed.
English: The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied (see also section ‘Special warnings and precautions for use').
Danish: Der er ikke foretaget studier af sikkerheden og virkningen ved immunisering med vacciner, især levende virusvacciner, efter behandling med Zevalin (se også ”Særlige advarsler og forsigtighedsregler vedrørende brugen”).
English: Common side effects (may effect up to 1 in 10 people) - blood poisoning (sepsis)*; infection of the lungs (pneumonia)*; urinary tract infection,
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - Blodforgiftning (sepsis)*; infektion i lungerne (lungebetændelse)*; urinvejsinfektion,
English: Y]-radiolabelled Zevalin also leads to depletion of normal CD20+ B-cells.
Danish: Y] radioaktivt mærket Zevalin fører desuden til depletering af normale CD20+ Bceller.
English: In a clinical trial in which Zevalin was administered as consolidation after prior first line chemotherapy, a higher frequency of severe and prolonged neutropenia and thrombocytopenia was observed in patients who had received Zevalin within 4 months after a combination chemotherapy of fludarabine with mitoxantrone and/or cyclophosphamide compared to those patients who had received any other chemotherapy.
Danish: I et klinisk studie, hvor Zevalin blev indgivet som konsolidering efter forudgående 1. linjekemoterapi, sås en højere hyppighed af alvorlig og vedvarende neutropeni og trombocytopeni hos de patienter, der havde fået Zevalin inden for 4 måneder efter en kombinationskemoterapi med fludarabin og mitoxantron og/eller cyclofosfamid sammenlignet med de patienter, der havde fået anden kemoterapi.
English: Add approximately 0.8 ml sodium chloride 9 mg/ml (0.9%) solution to developing chamber assuring the liquid will not touch the 1.4 cm origin mark on the ITCL strip.
Danish: 1) Tilfør cirka 0,8 ml 9 mg/ml (0,9%) natriumchloridopløsning til fremkalderkammeret, men sørg for, at væsken ikke når 1,4 cm begyndelsespunktet på ITCL-strippen.
English: What Zevalin is and what it is used for What you need to know before you are given Zevalin How to use Zevalin
Danish: Virkning og anvendelse Det skal du vide, før du får Zevalin Sådan får du Zevalin
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: to deliver radiation more specifically to the lymphoma B-cells.
Danish: Y] kan videregive den radioaktive stråling mere specifikt til B-celllerne i lymfomet.
English: Y]-radiolabelled Zevalin after pretreatment with rituximab results in a significant radiation dose to the testes.
Danish: Y] radioaktivt mærket Zevalin efter forbehandling med rituximab en signifikant strålingsdosis af testes.
English: Studies on the mutagenic and carcinogenic potential of Zevalin have not been performed.
Danish: Der er ikke udført studier med Zevalin vedrørende potentiel mutagenicitet og karcinogenicitet.
English: Store the vials in the original container in order to protect from light.
Danish: Opbevar hætteglassene i den originale beholder for at beskytte mod lys.
English: • infection: fever, chills
Danish: • Infektion: feber eller kulderystelser
English: Radiopharmaceuticals must be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radiofarmaceutiske midler skal præpareres af brugeren på en sådan måde, at både kravene til strålingssikkerhed og farmaceutisk kvalitet er opfyldt.
English: The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied.
Danish: Der er ikke foretaget studier af sikkerheden og virkningen ved immunisering med vacciner, især levende virusvacciner, efter behandling med Zevalin.
English: The description of the ADR in the same section of the SmPC should be amended accordingly to clarify which statements relate to each of the two indications (consolidation therapy in follicular lymphoma vs relapsed or refractory Non-Hodgkin's lymphoma (NHL)).
Danish: i produktresuméet skal ændres i overensstemmelse hermed til præcisering af, hvilke udsagn der vedrører hver af de to indikationer (konsolideringsbehandling ved follikulært lymfom vs. recidiverende eller refraktær non-Hodgkin's lymfom (NHL)).
English: Special caution is required with respect to bone marrow depletion.
Danish: Der skal særligt udvises forsigtighed ved knoglemarvssupression.
English: • Extravasation
Danish: ● Ekstravasation
English: In clinical trials with the indication of relapsed and refractory NHL, grade 3 or 4 thrombocytopenia was reported with median times to recovery of 13 and 21 days and grade 3 or 4 neutropenia with median times to recovery of 8 and 14 days.
Danish: I de kliniske studier med indikationen recidiverende eller refraktær NHL, blev trombocytopeni grad 3 eller 4 indberettet med en gennemsnitstid til regenerering på 13 og 21 dage, og neutropeni grad 3 eller 4 med en gennemsnitstid til regenerering på 8 og 14 dage.
English: Store the vials in the original package in order to protect from light.
Danish: Opbevar hætteglassene i den originale yderpakning for at beskytte mod lys.
English: Sepsis*, Pneumonia*, Urinary tract infection, Oral candidiasis
Danish: Pneumoni*, Urinvejsinfektion Oral candidiasis,
English: Place ITLC strip in the developing chamber and allow the solvent front to migrate past the 5.4 cm mark.
Danish: 3) Placér ITLC-strippen i fremkalderkammeret, og lad væskefronten vandre forbi 5,4 cm mærket.
English: Severe hypersensitivity reactions including anaphylaxis occur in < 1 % of patients (see also section 4.8).
Danish: Alvorlige overfølsomhedsreaktioner, herunder anafylaksi forekommer hos  1% af patienterne (se også pkt.
English: Y]-radiolabelled Zevalin solution must only be received, handled and administered by qualified personnel with the appropriate government authorization for the use and manipulation of radionuclides within a designated clinical setting.
Danish: Y] radioaktivt mærket Zevalin-opløsning må kun modtages, håndteres og administreres af kvalificeret personale med behørig statsautorisation til brug og håndtering af radionuklider i specielt afmærkede kliniske områder.
English: Growth factor treatment such as G-CSF must not be given to patients for 3 weeks prior to Zevalin administration as well as for 2 weeks following completion of the treatment (see also section 4.4).
Danish: Vækstfaktor-behandling som fx G-CSF må ikke gives til patienten i 3 uger før Zevalin-behandlingen, samt i 2 uger efter behandlingen er afsluttet (se også pkt.
English: In the following cases, Zevalin use is not recommended since its safety and efficacy have not been established:
Danish: Vær ekstra forsigtig med at anvende Zevalin: Zevalin bør ikke anvendes i følgende tilfælde, da sikkerheden og virkningen ikke er klarlagt:
English: Zevalin is a kit for the preparation of the active substance ibritumomab tiuxetan [
Danish: Zevalin er et sæt til præparation af det aktive stof ibritumomab tiuxetan [
English: The overall safety profile of Zevalin after pretreatment with rituximab is based on data from 349 patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma studied in five clinical trials, on data from a study with 204 patients receiving Zevalin as consolidation therapy after first-line remission induction, and from post-marketing surveillance.
Danish: Den samlede sikkerhedsprofil for Zevalin efter forbehandling med rituzimab er baseret på data fra fem kliniske studier med 349 patienter med recidiverende eller refraktær i mindre grad, follikulær eller transformeret B-celle non-Hodgkin's lymfom, og desuden på data fra et studie med 204 patienter, der fik Zevalin som konsolideringsbehandling efter remissionsinduktion med 1. linjebehandling og fra overvågning efter markedsføringen.
English: Y]-radiolabelled ibritumomab tiuxetan binds specifically to CD20-expressing B-cells, including malignant cells.
Danish: Y] radioaktivt mærket ibritumomab tiuxetan bindes specifikt til B-celler, inklusive maligne celler, der udtrykker CD20.
English: Y]-radiolabelled Zevalin, the median serum effective half-life of ibritumomab tiuxetan [
Danish: Y] radioaktivt mærket Zevalin, var den gennemsnitlige effektive halveringstid i serum af ibritumomab tiuxetan [
English: • Myelodysplastic syndrome / acute myeloid leukaemia
Danish: • Myelodysplastisk syndrom / akut myeloid leukæmi
English: • Blood and lymphatic system disorders
Danish: • Blod og lymfesystem
English: Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Danish: Zevalin leveres som et sæt til præparation af yttrium-90 radioaktivt mærket ibritumomab tiuxetan.
English: Study 4 investigated the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy.
Danish: Studie 4 undersøgte effekt og sikkerhed af konsolidering med Zevalin hos patienter med fremskredent follikulært lymfom, som responderede på 1. linjebehandling med kemoterapi.
English: Extravasation with subsequent infusion site reactions, Damage to lymphomasurrounding tissue and complications due to lymphoma swelling
Danish: Ekstravasation med efterfølgende reaktioner på infusionsstedet Skade på vævet omkring lymfomet og komplikationer på grund af hævelse af lymfomet
English: - One reaction glass vial (empty)
Danish: - Et reaktionshætteglas (tomt).
English: Before radiolabelling, bring refrigerated Zevalin cold kit to room temperature 25°C.
Danish: Før den radioaktive mærkning skal det nedkølede Zevalin-sæt bringes op til stuetemperatur (25°C).
English: Following Zevalin as consolidation after first line remission induction the median times to recovery was 20 days and 35 days for grade 3 or 4 thrombocytopenia and 20 days and 28 days for grade 3 or 4 neutropenia.
Danish: Når Zevalin blev givet som konsolidering efter remissionsinduktion med 1. linjebehandling, var gennemsnitstiden til regenerering hhv. 20 og 35 dage for trombocytopeni grad 3 eller 4, og 20 og 28 dage for neutropeni grad 3 eller 4.
English: Study 3 was a single arm study of 30 patients with relapsed or refractory low-grade, follicular, or transformed B-cell NHL who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/mm
Danish: Studie 3 var et enkelt-arm studie med 30 patienter med recidiverende eller refraktær lavgrads, follikulær eller transformeret B-celle NHL, som havde mild trombocytopeni (blodpladetal 100.000 til 149.000 eller/mm
English: The primary efficacy endpoint of the study was the overall response rate (ORR) using the
Danish: Studiets primære effektivitetsendepunkt var den overordnede responsgrad (ORR = overall response rate) ved anvendelse af "International Workshop Response Criteria" (IWRC).
English: • The active substance is ibritumomab tiuxetan.
Danish: • Aktivt stof: ibritumomab tiuxetan.
English: Uncommon side effects: (may effect up to 1 in 100 people) - rapid heart beat (tachycardia),
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - Hurtig hjertefrekvens (takykardi)
English: Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Danish: Radioaktive lægemidler skal præpareres på en sådan måde, at både kravene til strålingssikkerhed og farmaceutisk kvalitet opfyldes.
English: The risk of haematological toxicity may be increased after prior therapy with fludarabine containing regimens (for details see section 4.5).
Danish: Risikoen for hæmatologisk toksicitet kan øges efter forudgående behandling, der inkluderer fludarabin (for detaljer se pkt.
English: Deaths due to second primary malignancy included 8 (3.9%) patients in the Zevalin arm compared to 3 (1.5%) patients in the control arm.
Danish: 8 (3,9 %) patienter i Zevalin-armen døde som følge af anden primær malignitet sammenlignet med 3 (1,5 %) patienter i kontrolarmen.
English: • Hypersensitivity
Danish: ● Overfølsomhed
English: Major inclusion criteria were: CD20+ grade 1 or 2 follicular lymphoma; stage III or IV at diagnosis; normal peripheral blood cell counts; < 25% bone marrow involvement; age ≥ 18 yrs; and complete response (CR/Cru) or partial response (PR) after first-line chemotherapy determined by physical examination, CT scans and bone marrow biopsy.
Danish: CD20+ follikulær lymfom grad 1 eller 2, stadium III eller IV på diagnosetidspunktet, normale perifere blodcelletal, < 25 % involvering af knoglemarven, alder ≥ 18 år, komplet respons (CR/Cru) eller partiel respons (PR) efter 1. linjebehandling med kemoterapi bedømt ved en objektiv undersøgelse, CT-scanning og knoglemarvsbiopsi.