FrancophonIA/ELRC3.0 huggingface dataset:
English: - Data from 204 patients receiving Zevalin as consolidation therapy after first line remission induction:
Danish: - Data fra 204 patienter, der fik Zevalin som konsolideringsbehandling efter 1. linjeremissionsinduktion:
English: This medicinal product can contain up to 28 mg sodium per dose, depending on the radioactivity concentration.
Danish: Dette lægemiddel kan indeholde op til 28 mg natrium pr. dosis afhængig af koncentrationen af radioaktivitet.
English: In addition, the adverse drug reactions marked with ** were observed in the study with 204 patients receiving Zevalin as consolidation therapy after first-line remission induction where indicated.
Danish: Desuden blev de bivirkninger, der er markeret med ** set i studiet med 204 patienter, der modtog Zevalin som konsolideringsbehandling efter 1. linjeremissionsinduktion, hvor det var indiceret.
English: Waterproof gloves must be utilised in the preparation and during the determination of radiochemical purity of [
Danish: Vandtætte handsker bør anvendes ved præparation og under bestemmelsen af radiokemisk renhed af Y]-mærket Zevalin.
English: Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Danish: Ibritumomab tiuxetan er et rekombinant murint IgG1 kappa-monoklonalt antistof specifikt for B-celle antigenet CD20.
English: Therefore, for one week after the Zevalin infusion you must wash your hands thoroughly each time after urinating.
Danish: Du skal derfor vaske dine hænder meget grundigt, hver gang du har ladet vandet, i én uge efter Zevalin-infusionen.
English: This medicine contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Danish: Denne medicin indeholder op til 28 mg natrium pr. dosis afhængig af koncentrationen af radioaktiviteten.
English: Since the Zevalin regimen includes rituximab, see also the Summary of Product Characteristics of rituximab.
Danish: Da behandlingen med Zevalin omfatter rituximab, skal man også læse produktresuméet for rituximab.
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEVALIN
Danish: DET SKAL DU VIDE, FØR DU FÅR ZEVALIN
English: Reporting suspected adverse reactions afterauthorisation of the medicinal product is important.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: Treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL):
Danish: Behandling af rituximab- recidiverende eller refraktær CD20+ follikulær B-celle non-Hodgkin's lymfom (NHL):
English: Zevalin must be used following pretreatment with rituximab.
Danish: Zevalin skal anvendes efter en forbehandling med rituximab.
English: Lower Large Intestinal Wall Upper Large Intestinal Wall Heart Wall
Danish: Nedre tyktarmsvæg Øvre tyktarmsvæg Hjertevæg Lunger
English: After you are given Zevalin
Danish: Efter du har modtaget Zevalin
English: Patients with renal impairment The safety and efficacy have not been studied in patients with renal impairment.
Danish: Sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling
Danish: Zevalin-relateret stråling kan skade vævet omkring lymfomet og forårsage komplikationer på grund af forstørrelse af lymfomet.
English: Complete Response Rate (%)
Danish: Total responsgrad (%) CRu grad2 (%)
English: - One sodium acetate glass vial, with 2 ml clear, colourless solution.
Danish: - Et hætteglas med natriumacetat med 2 ml klar, farveløs opløsning.
English: fungal infections in the mouth such as oral thrush (oral candidiasis) - other blood related cancers (myelodysplastic syndrome (MDS) / acute myeloid leukaemia
Danish: svampeinfektioner i munden som fx trøske (oral candidiasis) - Anden blodrelateret kræft (myelodysplastisk syndrom (MDS) / akut myeloid leukæmi (AML)*, **;
English: Assay procedure:
Danish: Bestemmelsesprocedure:
English: Animal reproduction studies were not conducted with ibritumomab tiuxetan.
Danish: Der er ikke udført dyreforsøg med ibritumomab tiuxetan vedrørende forplantningsevne.
English: Meningioma
Danish: Meningiom
English: Deaths due to MDS/AML included five (2.5%) patients in the Zevalin arm compared to no patients in the control arm.
Danish: 5 (2,5 %) patienter i Zevalin-armen døde som følge af MDS/AML sammenlignet med ingen patienter i kontrolarmen.
English: Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Danish: Y] radioaktivt mærket Zevalin er indiceret til behandling af voksne patienter med rituximab recidiverende eller refraktær CD20+ follikulær B-celle non-Hodgkin's lymfom (NHL).
English: The human radiation dose estimates derived from biodistribution studies in mice with [
Danish: Vurderinger af humane strålingsdoser afledt fra biodistributionsstudier med mus ved brug af [
English: Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Danish: Prins Bernhardplein 200
English: Y forms a stable complex with ibritumomab tiuxetan, the biodistribution of the radiolabel follows the biodistribution of the antibody.
Danish: Da 90Y danner et stabilt kompleks med ibritumomab tiuxetan, følger biodistributionen af radiomarkøren antistoffets biodistribution.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Read complete directions thoroughly before starting the preparation procedure.
Danish: Læs hele brugsanvisningen grundigt, inden præparationsproceduren påbegyndes.
English: Tumour pain, Myelodysplastic syndrome/Acute myeloid leukaemia*, **
Danish: Tumorsmerter, Myelodysplastisk syndrom/akut myeloid leukæmi*, **
English: Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Danish: Y] radioaktivt mærket Zevalin må kun modtages, håndteres og indgives af kvalificeret personale, og skal præpareres i overensstemmelse med gældende regler både i forhold til strålingssikkerhed og farmaceutisk kvalitet (se også pkt.
English: The kit allows the coupling of antibody ibritumomab tiuxetan with the radioactive isotope yttrium
Danish: Med præparationssættet kan der foretages en kobling mellem antistoffet ibritumomab tiuxetan og den radioaktive isotop yttrium
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REACTION VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER REAKTIONSHÆTTEGLAS
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion Ibritumomab tiuxetan [
Danish: Zevalin 1,6 mg/ml radiofarmaceutisk præparationssæt til infusion Ibritumomab tiuxetan [
English: Y]-radiolabelled Zevalin solution contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Danish: Y] radioaktivt mærkede Zavalin-opløsning indeholder op til 28 mg natrium pr. dosis afhængig af koncentrationen af radioaktivitet.
English: Hypersensitivity reactions following Zevalin administration are commonly observed.
Danish: Overfølsomhedsreaktioner efter Zevalin-behandling er almindeligt forekommende.
English: Zevalin is also used in previously untreated patients with follicular lymphoma.
Danish: Zevalin anvendes også hos patienter med follikulært lymfom, som ikke tidligere er blevet behandlet.
English: Peripheral oedema, Sweating increased
Danish: Perifert ødem, Øget svedafsondring
English: Due to the nature of the compound, women of child-bearing potential, as well as males, must use effective contraceptive methods during and up to 12 months after treatment with Zevalin (see also section 4.6 and 5.2).
Danish: På grund af stoffets beskaffenhed bør kvinder i den fødedygtige alder samt mænd anvende effektive præventionsmidler under og indtil 12 måneder efter behandlingen med Zevalin (se også pkt.
English: Using a 10-ml syringe with a large bore needle (18-20 G), draw formulation buffer that will result in a combined total volume of 10 ml.
Danish: Trin 4: Tilfør bufferopløsning til reaktionshætteglasset Træk ved brug af en 10-ml sprøjte med en nål med stor lumen (18-20 G) så meget bufferopløsning op, at det vil resultere i et kombineret totalvolumen på 10 ml.
English: Depending on the kind/severity of reaction your doctor will decide if treatment must be stopped immediately.
Danish: Din læge vil beslutte, om behandlingen skal stoppes straks, afhængig af hvilken slags reaktion det er, og hvor alvorlig den er.
English: Y]-radiolabelled Zevalin could cause toxic effects on female and male gonads.
Danish: Y] radioaktivt mærket Zevalin kan have en toksisk effekt på de kvindelige og mandlige gonader.
English: Y]-radiolabelled
Danish: Y]-radioaktivt mærket
English: Aseptically transfer 1500 MBq of yttrium-90 chloride with a 1 ml sterile syringe to the reaction vial containing the sodium acetate solution transferred in step 1.
Danish: Trin 2: Overfør yttrium-90-chlorid til reaktionshætteglasset Overfør med en 1-ml steril sprøjte 1500 MBq yttrium-90-chlorid aseptisk til reaktionshætteglasset, som indeholder natriumacetatopløsningen, der er overført i trin 1.
English: Doses up to 19.2 MBq/kg of Zevalin have been administered in clinical trials.
Danish: Der er i kliniske studier givet doseringer på op til 19,2 MBq/kg Zevalin.
English: The PRAC considered that the information on myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) in section 4.8 of the SmPC should be further clarified.
Danish: PRAC vurderede, at oplysningerne om myelodysplasi (MDS)/ akut myeloid leukæmi (AML) i pkt.
English: • Infection
Danish: • Infektion
English: The use of Zevalin does involve exposure to small amounts of radioactivity.
Danish: Når du får Zevalin, bliver du udsat for en lille mængde radioaktivitet.
English: Y]-radiolabelled Zevalin solution is:
Danish: Y]-radioaktivt mærket Zevalin-opløsning er:
English: Pharmacotherapeutic group: Various therapeutic radiopharmaceuticals, ATC code: V10XX02
Danish: ATC-kode: V10XX02
English: *murine IgG1 monoclonal antibody produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line and conjugated to the chelating agent MX-DTPA.
Danish: *murint IgG1 monoklonalt antistof, der er fremstillet ved rekombinant DNA-teknologi i en kinesisk hamsterovarie (CHO)-cellelinie, og konjugeret til det chelaterende stof MX-DTPA.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Danish: Radioaktive lægemidler skal opbevares i overensstemmelse med nationale krav til radioaktive materialer.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Det er udelukkende personer med erfaring og kvalifikationer i at anvende præparatet sikkert, der vil håndtere det og give det til dig.
English: What Zevalin looks like and contents of the pack Zevalin is a kit for radiopharmaceutical preparation for infusion, containing: - One ibritumomab tiuxetan glass vial, with 2 ml clear, colourless solution.
Danish: Zevalin er et sæt til radiofarmaceutisk præparation til infusion og indeholder: - Et hætteglas med ibritumomab tiuxetan med 2 ml klar, farveløs opløsning.
English: No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
Danish: ● NHL med påvirkning af centralnervesystemet((CNS) Der foreligger ikke data om patienter med CNS-lymfomer, da disse patienter ikke indgik i de kliniske studier.
English: For storage conditions of the radiolabelled product, see section 6.3.
Danish: Opbevaringsforhold for det radioaktivt mærkede lægemiddel, se pkt.
English: *recombinant murine IgG1 monoclonal antibody produced by DNA technology in a Chinese hamster ovary (CHO) cell line and conjugated to the chelating agent MX-DTPA.
Danish: *rekombinant murint IgG1 monoklonalt antistof, der er fremstillet ved DNA-teknologi i en kinesisk hamsterovarie (CHO)-cellelinie, og konjugeret til det chelaterende stof MX-DTPA.
English: Signs and symptoms of infusion reactions may include dizziness, cough, nausea, vomiting, rash, pruritus, tachycardia, asthenia, pyrexia and rigors (see section 4.8).
Danish: Tegn og symptomer på infusionsreaktioner kan omfatte svimmelhed, hoste, kvalme, opkastning, udslæt, pruritus, takykardi, asteni, pyreksi, og kulderystelser (se pkt.
English: The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
Danish: Det konjugerede antistof har en tilsyneladende affinitetskonstant til CD20-antigenet på cirka 17 nM. Bindingsmønsteret er meget begrænset og har ingen krydsreaktivitet til andre leukocytter eller til andre typer humant væv.
English: Potassium dihydrogen phosphate Sodium chloride
Danish: Kaliumdihydrogenphosphat Natriumchlorid
English: - pain; flu-like symptoms; generally feeling unwell (malaise), swelling caused by build-up of fluid in the arms and legs and other tissues (peripheral oedema); increased sweating - high blood pressure (hypertension)** - low blood pressure (hypotension)** - absence of menstruation (amenorrhea)**
Danish: - Smerter; influenzalignende symptomer; generel følelse af ubehag; hævelse på grund af væskeansamling i arme og ben og andet væv (perifert ødem); øget svedafsondring - Højt blodtryk (hypertension)**
English: The treatment regimen consists of two intravenous administrations of rituximab and one administration of [
Danish: Behandlingen består af to intravenøse indgifter af rituximab og én indgift af [
English: Table 2.Summary of Efficacy Data in patients with relapsed/refractory low-grade or follicular non-Hodgkin's lymphoma (NHL), or transformed B-cell NHL
Danish: Resume af effektivitetsdata hos patienter med recidiverende/refraktær lavgrads eller follikulær non-Hodgkin's lymfom (NHL) eller transformeret B-celle NHL
English: Zevalin is not recommended for use in children below age 18 since safety and efficacy have not been established.
Danish: Zevalin bør ikke anvendes til børn under 18 år, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe.
English: - Developing chamber for chromatography - Mobile phase: sodium chloride 9 mg/ml (0.9%) solution, bacteriostatic-free - ITLC strips (e.g. ITLC TEC-Control Chromatography Strips, Biodex, Shirley, New York, USA, Art. Nr. 150-772 or equivalent, dimensions: approximately 0.5-1 cm x 6 cm) - Scintillation vials - Liquid scintillation cocktail (e.g. Ultima Gold, catalog No. 6013329, Packard Instruments, USA or equivalent)
Danish: - Fremkalderkammer til kromatografi - Mobil fase: 9 mg/ml (0,9 %) natriumchloridopløsning, fri for bakteriostatiske stoffer - ITLC-strips (f.eks. ITLC Tec-Control Chromatography Strips, Biodex, Shirley, New York,
English: - On day 1 you will be given one rituximab infusion - On day 7, 8, or 9 you will be given one rituximab infusion, followed by one Zevalin infusion shortly afterwards (within 4 hours).
Danish: På dag 7, 8 eller 9 vil du få én infusion med rituximab.
English: - patients with 100,000-150,000 platelets/mm 3: 11 MBq/kg
Danish: - patienter med ≥ 150.000 blodplader/mm 3: 15 MBq/kg legemsvægt - patienter med 100.000-150.000 blodplader/mm 3: 11 MBq/kg.
English: Side effects for which frequency is not known: - reaction of the skin and mucous membranes (including Stevens-Johnson Syndrome)* - leakage of the infusion to the surrounding tissue (extravasation), causing skin inflammation (infusion site dermatitis) and shedding (infusion site desquamation) or injection site ulcers - tissue damage around tumours of the lymph system and complications due to swelling of such tumours
Danish: Bivirkninger, hvor hyppigheden ikke er kendt - Reaktioner i hud og slimhinder (herunder Stevens-Johnsons symdrom)* - Udsivning fra infusionen til det omgivende væv (ekstravasation), som fører til betændelse i huden
English: Zevalin must be used following pretreatment with rituximab for which breast-feeding is not recommended during treatment and up to 12 months following treatment (please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use).
Danish: hvor amning frarådes under behandlingen og i op til 12 måneder efter behandlingen (se produktresuméet for rituximab for detaljeret vejledning i brugen).
English: - One formulation buffer glass vial, with 10 ml clear, yellow to amber coloured solution.
Danish: - Et hætteglas med formuleringsbuffer med 10 ml klar, gul til ravgul opløsning.
English: The trial was conducted in 143 rituximab-naïve patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL), or transformed B-cell NHL.
Danish: Studiet blev udført med deltagelse af 143 rituximab-naive-patienter med recidiverende eller refraktær non-Hodgkin's lymfom (NHL) eller transformeret B-celle NHL.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Ibritumomab tiuxetan solution Intravenous infusion, after preparation.
Danish: Zevalin 1,6 mg/ml radiofarmaceutisk præparationssæt Ibritumomab tiuxetan-opløsning Intravenøs infusion, efter præparation
English: Other medicines and Zevalin
Danish: Brug af anden medicin sammen med Zevalin
English: The kit contains one ibritumomab tiuxetan vial, one sodium acetate vial, one formulation buffer vial, and one empty reaction vial.
Danish: Sættet indeholder ét hætteglas med ibritumomab tiuxetan, ét hætteglas med natriumacetat, ét hætteglas med bufferopløsning og ét tomt reaktionshætteglas.
English: - Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for ibritumomab tiuxetan, yttriumchlorid eller over for et eller flere af hjælpestofferne anført i pkt.
English: • The other ingredients are: - ibritumomab tiuxetan vial: sodium chloride, water for injections - sodium acetate vial: sodium acetate, water for injections - formulation buffer vial: human albumin solution, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide, potassium dihydrogen phosphate, potassium chloride, pentetic acid, hydrochloric acid (diluted) for pH adjustment, water for injections
Danish: - hætteglas med formuleringsbuffer: albumininfusionsvæske, natriumklorid, dinatriumphosphatdodecahydrat, natriumhydroxid, kaliumdihydrogenphosphat, kaliumchlorid, pentensyre, saltsyre (fortyndet) til justering af pH, vand til injektionsvæsker
English: Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Danish: Y] radioaktivt mærket Zevalin er indiceret til konsolideringsbehandling af tidligere ubehandlede patienter med follikulært lymfom efter remissionsinduktion.
English: Following administration of [
Danish: Efter indgivelse af [
English: Place each half into separate scintillation vials to which 5 ml LSC cocktail must be added (e.g. Ultima Gold, catalog No. 6013329, Packard Instruments, USA or equivalent).
Danish: Placér hver halvdel i separate scintillationsglas, og tilfør 5 ml LSC cocktail (f.eks. Ultima Gold, katalognr.
English: Y]-radiolabelled Zevalin solution must be prepared according to section 12.
Danish: Y]-radioaktivt mærket Zevalin-opløsning skal præpareres i henhold til pkt.
English: Reaction vial: type I glass vial with a rubber stopper (teflon-lined bromobutyl)
Danish: Reaktionshætteglas: Glastype I-hætteglas med en gummiprop (teflon-foret bromobutyl)
English: Pancreas Skin
Danish: Bugspytkirtel Hud
English: Syndrome) *
Danish: Petekkier**
English: Hydrochloric acid, diluted Water for injections
Danish: Saltsyre, fortyndet Vand til injektionsvæsker
English: Vomiting, Abdominal pain, Diarrhoea, Dyspepsia, Throat irritation, Constipation
Danish: Diarré, Dyspepsi, Halsirritation, Forstoppelse
English: The frequencies of the adverse drug reactions which were considered to be at least possibly related to Zevalin after pretreatment with rituximab are represented in the table below.
Danish: I tabellen nedenfor ses hyppigheden af de bivirkninger, der anses for i det mindste at have en mulig relation til Zevalin efter forbehandling med rituximab.
English: The onset of the reactions varied from days to months.
Danish: Reaktionerne begyndte fra dage til måneder efter behandlingen.
English: Small Intestine Red Marrow
Danish: Tyndtarm Rød knoglemarv Urinblærevæg Knogleoverflader Ovarier
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: - Spørg lægen eller på apotekspersonalet, hvis der er mere, du vil vide.
English: One vial contains 3.2 mg ibritumomab tiuxetan* to be diluted in 2 ml solution (1.6 mg per ml).
Danish: Ét hætteglas indeholder 3,2 mg ibritumomab tiuxetan*, der skal fortyndes i 2 ml opløsning (1,6 mg per ml).
English: • Immune system disorders
Danish: • Immunsystemet
English: • Excipients The final [
Danish: ● Hjælpestoffer Den endelige [
English: • Immunization
Danish: ● Immunisering
English: Disodium phosphate dodecahydrate Human albumin solution Hydrochloric acid, diluted (for pH adjustment) Pentetic acid
Danish: Hætteglas med bufferopløsning: Dinatriumphosphatdodecahydrat Albumininfusionsvæske Saltsyre, fortyndet (til justering af pH) Pentetatsyre
English: Incubate the yttrium-90 chloride/acetate/ibritumomab tiuxetan solution at room temperature for five minutes.
Danish: Inkubér yttrium-90-chlorid/acetat/ibritumomab tiuxetan opløsningen ved stuetemperatur i fem minutter.
English: * fatal outcome has been observed ** has been observed in a study with 204 patients receiving Zevalin as consolidation after first-line remission induction
Danish: ** Er set i et studie med 204 patienter, der fik Zevalin som konsolidering efter 1. linjeremissionsinduktion.
English: LIST OF EXCIPIENTS Ibritumomab tiuxetan vial: Sodium chloride Water for injections
Danish: • Øvrige indholdsstoffer: - hætteglas med ibritumomab tiuxetan: natriumchlorid, vand til injektionsvæsker.
English: • Infections and infestations - Data from 349 patients with relapsed or refractory low-grade, follicular lymphoma, or transformed non-Hodgkin's lymphoma studied in five trials:
Danish: • Infektioner og parasitære sygdomme - Data fra fem kliniske studier med 349 patienter med recidiverende eller refraktær lavgrads follikulær eller transformeret B-celle non-Hodgkin's lymfom:
English: Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Danish: For at undgå strålerelaterede vævsskader kræves nøje overvågning for at opdage eventuel ekstravasation under Zevalin-administrationen.
English: Marketing Authorisation Holder Spectrum Pharmaceuticals B.V. Prins Bernhardplein 200
Danish: Indehaver af markedsføringstilladelsen Spectrum Pharmaceuticals B.V.
English: Each vial contains 3.2 mg ibritumomab tiuxetan in 2 ml solution (1.6 mg per ml).
Danish: Hvert hætteglas indeholder 3,2 mg ibritumomab tiuxetan i 2 ml opløsning (1,6 mg pr. ml).
English: Process residuals (e.g. ammonia, nitrate)
Danish: Totalt organisk kulstof (f.eks. organiske chelatdannere) Under kvantiseringsgrænsen* Restprodukter (f.eks. ammoniak, nitrat)
English: - neutrophil counts < 1,500/mm - prior bone marrow transplant or stem cell support
Danish: - patienter med et neutrofiltal på <1.500/mm - patienter, som tidligere har fået foretaget knoglemarvstransplantation eller stamcellesupport.
English: The imaging dose of [
Danish: Scanningsdosen af [
English: Intracranial haemorrhage while thrombocytopenic*
Danish: Intrakraniel blødning under trombocytopeni*
English: If you have received more Zevalin than you should Your doctor will treat you, as appropriate, if you have any particular ill effects.
Danish: Din læge vil behandle dig på passende måde, hvis du får særlige uønskede reaktioner.
English: Women of childbearing potential as well as males must use effective contraceptive methods during and up to 12 months after treatment with Zevalin.
Danish: Fertile kvinder samt mænd skal anvende sikre kontraceptionsmetoder under behandlingen med Zevalin og i op til 12 måneder efter behandlingen.
English: Y]-radiolabelled Zevalin solution in the following order:
Danish: Zevalin-opløsning i følgende rækkefølge: