FrancophonIA/ELRC3.0 huggingface dataset:
English: The ORR was significantly higher (80% vs. 56%, p = 0.002) for patients treated with the Zevalin therapeutic regimen.
Danish: ORR var signifikant højere (80% vs. 56%, p = 0,002) for patienter behandlet med det terapeutiske Zevalin-regimen.
English: The infusion must not be administered as an intravenous bolus.
Danish: Infusionen må ikke indgives som en intravenøs bolus.
English: Radiation protection precaution in accordance with local regulations must be taken, since administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc..
Danish: Der skal tages forholdsregler for strålingsbeskyttelse i overensstemmelse med lokale regler, da administration af radioaktive lægemidler indebærer risici for andre personer fra ekstern stråling eller kontamination fra urinspild, opkastning etc.
English: After treatment your doctor will perform regular blood tests to check your platelet and white cell counts.
Danish: Efter behandlingen vil din læge regelmæssigt tage blodprøver for at kontrollere dit blodpladetal og antallet af hvide blodlegemer.
English: more than a quarter of your bone marrow contains malignant abnormal cells.
Danish: • Hvis mere end en fjerdedel af din knoglemarv indeholder ondartede abnorme celler
English: Sterile, pyrogen-free yttrium-90 chloride of the above specified quality must be used for the preparation of [
Danish: Steril, pyrogen-fri yttrium-90-chlorid af den oven for specificerede kvalitet skal anvendes til præparation af den [
English: Must be administered by authorised personnel only.
Danish: Må kun administreres af uddannet personale
English: It is not shed from the cell surface and does not internalise on antibody binding.
Danish: Den løsnes ikke fra celleoverfladen og internaliseres ikke ved binding af antistoffer.
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Danish: Der blev ikke set nogen samlede forskelle i sikkerhed og virkning mellem disse patienter og yngre patienter.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Danish: Patienterne kom sig efter disse tegn på toksicitet, og overdoserne fik ikke alvorlige eller letale følger.
English: Y]-Zevalin mGy/MBq Median
Danish: Y]-Zevalin mGy/MBq Gennemsnit
English:  10 ppm each * Metals to be included need to be based on the specific manufacturing process.
Danish:  10 ppm hver * Den specifikke fremstillingsproces bestemmer hvilke metaller, der skal inkluderes.
English: Secondary efficacy endpoints included time to disease progression (TTP) and duration of response (DR).
Danish: Sekundære effektivitetsendepunker inkluderede tiden til sygdommens progression (TTP) og responsens varighed (DR = duration of response).
English: Pharmacodynamic analysis demonstrated that this was a temporary effect; recovery of normal B-cells began within 6 months and median counts of B-cells were within normal range within 9 months after treatment.
Danish: Farmakodynamiske analyser påviste, at dette var en midlertidig virkning; restitution af normale B-celler begyndte inden for 6 måneder, og gennemsnitsantallet af B-celler var inden for normalområdet inden for 9 måneder efter behandlingen.
English: Patients were considered refractory if their last prior treatment with rituximab did not result in a complete or partial response, or if time to disease progression (TTP) was  6 months.
Danish: Patienter blev betragtet som refraktære, hvis deres sidste tidligere behandling med rituximab ikke resulterede i en komplet eller delvis respons, eller hvis tiden til sygdommens progression (TTP = time to disease progression) var  6 måneder.
English: During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
Danish: I løbet af de første 13 uger efter behandling med Zevalin var infektioner meget almindeligt forekommende hos patienterne.
English: Anxiety, Insomnia
Danish: Ængstelse, Søvnløshed
English: A 0.2 or 0.22 micron low protein-binding filter must be on line between the patient and the infusion port.
Danish: Der skal indsættes et 0,2 eller 0,22 mikron filter med lav proteinbinding til slangen mellem patienten og infusionsporten.
English: The side effects marked with an asterisk (*) have led to death in some cases, either in clinical trials or during the marketing of the product.
Danish: De bivirkninger, der er markeret med en stjerne (*), har i nogle tilfælde medført dødsfald, enten under undersøgelser på mennesker eller under markedsføringen af medicinen.
English: Amenorrhea**
Danish: Amenorrhoea**
English: Refractory or relapsed NHL:
Danish: Refraktær eller recidiverende NHL:
English: The maximum dose must not exceed 1200 MBq (‘megabecquerel', a unit to measure radioactivity).
Danish: Den maksimale dosis må ikke overstige 1200 MBq (megabecquerel, en enhed til måling af radioaktivitet).
English: Spot one strip at a time and run three ITLC strips.
Danish: Sæt en dråbe på én strip ad gangen, og kør tre ITLC-strips.
English: 1.67 to 3.34 GBq/ml
Danish: 1,67 til 3,34 GBq/ml
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Danish: Din læge og speciallægen i nuklearmedicin har fundet, at de kliniske fordele, du vil få af behandlingen med det radioaktive lægemiddel, opvejer strålingsrisikoen.
English: • Human anti-murine antibodies
Danish: ● Humane anti-murine antistoffer
English: Women must not breast-feed during treatment and for 12 months following the treatment.
Danish: Kvinder må ikke amme under behandlingen og i 12 måneder efter behandlingen.
English: Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Danish: Yttrium-90 henfalder ved emission af beta-partikler af højenergi med en fysisk halveringstid på 64,1 timer (2,67 dage).
English: • Severe mucocutaneous reactions
Danish: ● Alvorlig mukokutane reaktioner
English: In this study, a modification of the Zevalin therapeutic regimen with a lower [
Danish: I dette studie blev der anvendt en modifikation af det terapeutiske Zevalin regimen med en lavere [
English: The dose of Zevalin depends on your body weight, blood platelet counts and what Zevalin is being used for (indication).
Danish: Zevalin-dosis afhænger af din kropsvægt, dit blodpladetal og hvad Zevalin skal anvendes mod (indikation).
English: Pack size of 1 kit.
Danish: Pakningsstørrelse: 1 sæt.
English: The amount of radiation that your body will be exposed to due to Zevalin is smaller than with radiotherapy.
Danish: Mængden af stråling, som din krop vil blive udsat for på grund af Zevalin, er mindre end ved strålebehandling.
English: Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Danish: Den mediane tid til opnået blodplade- og granulocytnadir var cirka 60 dage efter behandlingsstart.
English: Zevalin attaches to a protein (CD20) on the surface of certain white blood cells (B-cells) and kills them by irradiation.
Danish: Zevalin binder sig til et protein (CD20) på overfladen af visse hvide blodlegemer (B-celler) og dræber dem ved stråling.
English: Mix completely by coating the entire inner surface of the reaction vial.
Danish: Bland det fuldstændigt ved at dække hele reaktionshætteglassets indvendige overflade.
English: Repeated use: Data on the re-treatment of patients with Zevalin are not available.
Danish: Gentagen brug: Data vedrørende genbehandling af patienter med Zevalin er ikke tilgængelige.
English: Any woman who has missed a period must be assumed to be pregnant until proven otherwise and alternative therapies which do not involve ionising radiation must be then considered.
Danish: Ved udebleven menstruation skal kvinden betragtes som værende gravid, indtil andet er påvist, og alternative behandlinger, der ikke involverer ioniserende stråling, bør derefter overvejes.
English: Zevalin therapeutic regimen N = 54
Danish: Terapeutisk Zevalin regimen N = 54
English: Please see the package leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English:  95% of free ionic yttrium-90
Danish:  95 % af fri ionisk yttrium-90
English: The adverse drug reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known“.
Danish: De bivirkninger, der kun er set efter markedsføringen, og hvor hyppigheden ikke kunne fastslås, er opført under ”ikke kendt”.
English: Control of these metals can be achieved either through process validation or release test.
Danish: Metallerne kan kontrolleres gennem procesvalidering eller frigivelsestest.
English: If you have had external beam radiation (a type of radiotherapy) to more than a quarter of your bone marrow.
Danish: • Hvis du har fået ekstern strålebehandling (en bestemt slags radioterapi) på mere end en fjerdedel af din knoglemarv
English: Name and address of the manufacturer responsible for batch release CIS bio international
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse CIS bio international
English: Rituximab is administered in a reduced dose when compared with the approved monotherapy.
Danish: Rituximab indgives i en reduceret dosis sammenlignet med den godkendte monoterapi.
English: Based upon dosimetry studies with [
Danish: Baseret på dosimetriundersøgelser med [
English: Zevalin therapeutic regimen N = 73
Danish: Terapeutisk Zevalin regimen N = 73
English: If at any time in the preparation of this product the integrity of the containers is compromised it should not be used.
Danish: Hvis beholderne med dette præparat på noget tidspunkt beskadiges, må det ikke anvendes.
English: Of these, grade 3 was common, grade 4 uncommon.
Danish: Af disse var grad 3 almindeligt forekommende og grad 4 ikke almindeligt forekommende.
English: After Zevalin consolidation, 77% of patients in PR after induction therapy converted to CR.
Danish: Efter konsolidering med Zevalin blev 77 % af de patienter, der fik PR efter induktionsbehandling, konverteret til CR.
English: You can report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • Pancytopenia
Danish: • Pancytopeni
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Danish: Kemisk og fysisk stabilitet under brug er blevet påvist i 8 timer ved 2°C - 8°C, beskyttet mod lys.
English: • Secondary malignancies
Danish: • Sekundære maligniteter
English: During follow-up, infections occurred commonly.
Danish: Under opfølgningen var infektioner almindeligt forekommende.
English: Metal impurities Total metals*
Danish: Metalurenheder Totale metaller*
English: Empty reaction vial (10 ml)
Danish: Tomt reaktionshætteglas (10 ml)
English: Fatal outcomes have been reported for each of the following serious adverse drug reactions.
Danish: Dødelig udgang er set ved hver af følgende alvorlige bivirkninger.
English: * Needs to be included as release test or controlled through process validation if above limit of quantitation
Danish: Under kvantiseringsgrænsen* * Skal inkluderes som frigivelsestests eller kontrolleres gennem procesvalidering, hvis kvantiseringsgrænsen overskrides.
English: The product of radioactive decay is stable zirconium-90.
Danish: Produktet af det radioaktive henfald er stabilt zirconium-90.
English: No incompatibilities have been observed between Zevalin and infusion sets.
Danish: Der er ikke observeret uforligeligheder mellem Zevalin og infusionssæt.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages med i betragtning for patienter, der er på kontrolleret natriumdiæt.
English: The radiation dose to the ovaries has not been established.
Danish: Strålingsdosis af ovarierne er ikke klarlagt.
English: A potentially limited ability to generate a primary or anamnestic humoral response to any vaccine following Zevalin treatment has to be taken into consideration.
Danish: Den potentielt begrænsede mulighed for at generere primær eller anamnestisk humoral respons over for vacciner efter Zevalin-behandling skal tages med i betragtning.
English: Cough, Rhinitis
Danish: Hoste, Rhinitis
English: Calculate the average Radiochemical Purity (RCP) as follows:
Danish: 5) Beregn den gennemsnitlige radiokemiske renhed (RCP) på følgende måde:
English: Proper aseptic technique and precautions for handling radioactive materials must be employed.
Danish: Korrekt aseptisk teknik og forsigtighedsregler for håndtering af radioaktive materialer bør anvendes.
English: If any signs or symptoms of extravasation have occurred, the infusion must be immediately terminated and restarted in another vein.
Danish: Hvis der opstår tegn eller symptomer på ekstravasation, skal infusionen stoppes øjeblikkeligt, og genoptages i en ny vene.
English: Zevalin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Danish: Zevalin bør ikke anvendes til børn og unge under 18 år på grund af manglende oplysninger om sikkerhed og virkning.
English: 1097 JB Amsterdam The Netherlands
Danish: 1097 JB Amsterdam
English: The linker chelate tiuxetan forms a stable complex with the radioisotopes yttrium-90 and indium-111 and only negligible degradation due to radiolysis is expected.
Danish: Linker-chelatet tiuxetan danner et stabilt kompleks med radioisotoperne yttrium-90 og indium-111, og der forventes kun en ubetydelig degradering på grund af radiolyse.
English: For instructions on extemporary preparation of the medicinal product before administration,see section 12.
Danish: Instruktioner om ekstemporær præparation af lægemidlet før administration, se pkt.
English: The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Danish: Det terapeutiske Zevalin-regimen blev indgivet i to trin (se pkt.
English: After use of Zevalin, patients must generally be tested for HAMA before any further treatment with murine-derived proteins.
Danish: Efter anvendelse af Zevalin bør patienten generelt testes for HAMA, inden yderligere behandling med murinafledte proteiner.
English: There is a potential risk that ionizing radiation by [
Danish: Der er en potentiel risiko for, at ioniserende stråling med [
English: - Hypersensitivity to rituximab or to other murine-derived proteins.
Danish: - Overfølsomhed over for rituximab eller over for andre murine proteiner.
English: Limited data in elderly patients (aged 65 years or over) are available.
Danish: Der foreligger kun begrænsede data om ældre patienter (65 år og ældre).
English: Medicinal products for the treatment of hypersensitivity reactions, e.g. adrenaline, antihistamines and corticosteroids, must be available for immediate use in the event of an allergic reaction during administration of rituximab or Zevalin.
Danish: Lægemidler til behandling af overfølsomhedsreaktioner, f.eks. adrenalin, antihistaminer og kortikosteroider, bør være umiddelbart tilgængelig i tilfælde af allergiske reaktioner under indgivelse af rituximab eller Zevalin.
English: • Mucocutaneous reactions, including Stevens-Johnson Syndrome
Danish: • Mukokutane reaktioner, herunder Stevens-Johnsons syndrom
English: Required materials not supplied in the Zevalin kit:
Danish: Påkrævet udstyr, som ikke er indeholdt i Zevalin-sættet:
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Ekseponering for ioniserende stråling er forbundet med cancerinduktion og risiko for udvikling af arvelige defekter.
English: It is used as a consolidation therapy to improve the reduction in the number of lymphoma cells (remission) achieved with the initial chemotherapy regimen.
Danish: Det anvendes som en (konsolideringsbehandling) for at øge den nedsættelse i antallet af kræftceller (bedring), som er opnået ved den initiale kemoterapeutiske regime.
English: Caution: Patient dose not to exceed 1200 MBq.
Danish: Forsigtighed: Patientdosis må ikke overskride 1200 MBq.
English: If you have been treated with other proteins (especially mouse-derived) before Zevalin treatment, you may be more likely to have an allergic reaction.
Danish: Hvis du er blevet behandlet med andre proteiner (især museafledte) inden behandlingen med Zevalin, er det mere sandsynligt, du får en overfølsomhedsreaktion (allergisk reaktion).
English: The isotope yttrium-90 is a pure β-emitter and has a mean path length of about 5 mm.
Danish: Isotopen yttrium-90 er en ren -emitter og har en gennemsnitlig vejlængde på cirka 5 mm.
English: In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
Danish: In] radioaktivt mærket Zevalin, blodprøveudtagning og MIRDOSE3 softwareprogrammet.
English: Day 1: intravenous infusion of 250 mg/m rituximab.
Danish: Dag 1: Intravenøs indgift af 250 mg/m rituximab.
English: Stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Danish: Stabilitet er påvist i 8 timer ved 2 °C-8 °C og beskyttet mod lys.
English: Asthenia, Pyrexia, Rigors Fatigue**
Danish: Asteni, Pyrexi, Rigors Træthed**
English: The maximum dose must not exceed 1200 MBq.
Danish: Den maksimale dosis må ikke overskride 1200 MBq.
English: Treatment consists of discontinuation of Zevalin and supportive therapy, which may include growth factors.
Danish: Behandlingen består af ophør med anvendelse af Zevalin samt støttende behandling, hvilket kan omfatte vækstfaktorer.
English: • infections of the lung (pneumonia): breathing difficulties
Danish: • Infektioner i lungerne (lungebetænelse): vejrtrækningsproblemer
English: The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Danish: Sikkerheden og virkningen af terapeutisk Zevalin-regimen er blevet evalueret i to multicenterstudier, hvori der i alt deltog 197 patienter.
English: Y], a monoclonal antibody labelled with the radioactive substance yttrium-90 (
Danish: Y], som er et monoklonalt antistof, der er mærket med det radioaktive stof yttrium-90 [
English: (consolidation treatment)
Danish: (konsolidering)
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Danish: Administrationsprocedurerne skal udføres på en måde, så risikoen for kontaminering af lægemidlet og strålingsrisikoen for personalet minimeres.
English: Radiochemical purity of the radiolabelled preparation applies as long as more than 95% of yttrium-90 is incorporated into the monoclonal antibody.
Danish: Den radiokemiske renhed af det radioaktivt mærkede præparat gælder, så længe mere end 95 % af det tilførte yttrium-90 er inkorporeret i det monoklonale antistof.
English: Please tell your doctor that you were given Zevalin if you are due for vaccination after using it.
Danish: Fortæl det til lægen, at du har fået Zevalin, hvis du skal have en vaccination efter behandlingen.
English: If you are given Zevalin less than 4 months after chemotherapy containing the active substance fludarabine, you may have a higher risk of having a reduced number of blood cells.
Danish: Hvis du får Zevalin før 4 måneder efter, at du har fået kemoterapi, der indeholder det aktive stof fludarabin, kan du have en større risiko for, at dit blodcelletal falder.
English: Patients who had received murine-derived proteins before Zevalin treatment must be tested for human anti-murine antibodies (HAMA).
Danish: Patienter, som blev behandlet med murin-deriverede proteiner inden Zevalin-behandlingen, bør testes for humane anti-murine antistoffer (HAMA).
English: • Low counts of blood cells: unusual bruising, more bleeding then usual after injury, fever, or if you feel unusually tired or breathless
Danish: • Lavt antal blodlegemer: usædvanlige blå mærker, mere blødning end sædvanligt efter tilskadekomst, feber, eller hvis du føler dig usædvanligt træt eller stakåndet
English: Flu-like symptoms, Malaise,
Danish: Influenza-lignende symptomer, Ubehag,
English: Infections were very commonly observed.
Danish: Infektioner var meget almindeligt forekommende.
English: If you receive Zevalin alone and the number of your blood platelets is fewer than 100,000/mm
Danish: • Hvis du kun får Zevalin, og antallet af blodplader i dit blod er under 100.000/mm
English: Remove ITLC strip and cut in half at the 3.5 cm cut line.
Danish: 4) Tag ITLC-strippen ud, og skær den midt over ved 3,5 cm skæringslinjen.
English: 91192 Gif-sur-Yvette Cedex France
Danish: 91192 Gif-sur-Yvette Cedex Frankrig
English: Estimated Radiation Absorbed Doses From [
Danish: Estimerede absorberede strålingsdoser fra [
English: Therefore, complete blood cell and platelet counts must be monitored following Zevalin treatment weekly until levels recover or as clinically indicated.
Danish: Derfor skal det samlede blodcelle- og blodpladetal overvåges ugentligt efter Zevalin-behandlingen, indtil niveauerne bliver normale igen eller i henhold til klinisk indikation.
English: Directions for radio-labelling of Zevalin with yttrium-90:
Danish: Anvisninger for radioaktiv mærkning af Zevalin med yttrium-90:
English: Although it is not known whether ibritumomab tiuxetan is excreted in human milk, maternal IgGs are known to be excreted in human milk.
Danish: Selv om det ikke vides, om ibritumomab tiuxetan udskilles i human mælk, er det kendt, at IgG udskilles i human mælk.
English: Due to the potential risk of developing viral infections it is not recommended to administer live viral vaccines to patients who have recently received Zevalin (see section 4.5).
Danish: På grund af den potentielle risiko for at udvikle virale infektioner bør levende virale vacciner ikke gives til patienter, der for nylig har fået Zevalin (se pkt.
English: In case of a potential severe infusion reaction treatment must be stopped immediately.
Danish: Ved potentielt alvorlige infusionsreaktioner skal behandlingen stoppes øjeblikkeligt.
English: If your doctor plans to treat you with some other antibody after treatment with Zevalin, you will need to be tested for special antibodies.
Danish: Hvis din læge planlægger at behandle dig med nogle andre antistoffer efter Zevalin-behandlingen, skal du have foretaget prøver for specielle antistoffer.
English: There is a potential risk that ionizing radiation by Zevalin could harm your ovaries and testicles.
Danish: Der er en potentiel risiko for, at ioniserende stråling fra Zevalin kan skade æggestokke og testikler.
English: Y]-Zevalin activity per body weight (11 MBq/kg) was used.
Danish: Y]-Zevalin aktivitet i forhold til legemsvægt (11 MBq/kg).
English: If the number of your blood platelets is fewer than 150,000/mm after chemotherapy
Danish: • Hvis antallet af dine blodplader er under 150.000/mm efter kemoterapi
English: Appropriate aseptic precautions must be taken, complying with the requirements of Good Manufacturing Practice of pharmaceuticals.
Danish: Der skal tages passende aseptiske forholdsregler, som overholder kravene til God Klinisk Praksis for lægemidler.
English: The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Danish: Risikoen for at udvikle sekundær myelodysplasi eller leukæmi efter behandling med alkylerende stoffer er velkendt.
English: Individual patient dosimetry results were not predictive for [
Danish: Dosimetriresultater for individuelle patienter var ikke prædiktive for toksiciteten af [