FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ibritumomab tiuxetan, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za ibritumomab tiuksetan je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Infusion reactions may occur during or following Zevalin administration after pretreatment with Rituximab.
Slovenian: Reakcije na infuzijo se lahko pojavijo med ali po zdravljenju z zdravilom Zevalin po predhodnem zdravljenju z zdravilom Rituksimab.
English: From the final analysis at around 7.5 years of a study investigating the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy (Study 4, Section 5.1) of the 204 patients receiving Y-90 Zevalin following first line chemotherapy, 26 (12.7%) patients in the Zevalin arm developed a second primary malignancy compared to 14 (6.8%) of patients in the control arm.
Slovenian: Y], po okrog 7,5 leta študije, v kateri so raziskovali učinkovitost in varnost konsolidacije z zdravilom Zevalin pri bolnikih z napredovalim stadijem folikularnega limfoma, ki se odzivajo na kemoterapijo prve izbire (študija 4, poglavje 5.1), se je v kraku z zdravilom Zevalin razvila druga primarna maligna bolezen pri 26 bolnikih (12,7 % bolnikov), v kontrolnem kraku pa pri 14 bolnikih (6,8 % bolnikov).
English: • Immune system disorders
Slovenian: • Bolezni imunskega sistema
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.
Slovenian: Z 1-mililitrsko sterilno injekcijsko brizgo aseptično prenesite 1500 MBq itrijevega-90 klorida v reakcijsko vialo, v kateri je raztopina natrijevega acetata, ki ste jo prenesli v 1. fazi.
English: Uncommon side effects: (may effect up to 1 in 100 people) - rapid heart beat (tachycardia),
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): - zvišan srčni utrip (tahikardija)
English: Y]-radiolabelled Zevalin solution must be prepared according to section 12.
Slovenian: Y] označeno raztopino zdravila Zevalin morate pripraviti v skladu z navodili v poglavju 12.
English: Y occurs in a radius of 5 mm around the isotope.
Slovenian: Obsevanje z beta delci, ki jih oddaja Y, sega v radiju 5 mm okrog izotopa.
English: 2 ml of sodium acetate solution
Slovenian: 2 ml raztopine natrijevega acetata
English: • infection: fever, chills
Slovenian: • okužba: zvišana telesna temperatura, mrzlica
English: Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling
Slovenian: Z zdravilom Zevalin povezano sevanje lahko poškoduje tkivo okoli limfoma in povzroči zaplete zaradi oteklega limfoma.
English: Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Slovenian: Ibritumomab tiuksetan je kappa monoklonsko protitelo na osnovi rekombinantnega mišjega IgG1, ki je specifično za B-celični antigen CD20.
English: The treatment regimen consists of two intravenous administrations of rituximab and one administration of [
Slovenian: Režim zdravljenja vključuje dve intravenski aplikaciji rituksimaba in eno aplikacijo raztopine z [
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).
Slovenian: Glede na naravo zdravilne učinkovine morajo ženske v rodni dobi, enako pa tudi moški, med zdravljenjem z zdravilom Zevalin in še do 12 mesecev po tem uporabljati učinkovito kontracepcijo (glejte poglavji 4.6 in 5.2).
English: In patients given intravenous infusions of 250 mg/m rituximab followed by intravenous injections of
Slovenian: Pri bolnikih, ki so prejeli intravensko infuzijo z 250 mg/m rituksimaba, temu pa je sledila intravenska injekcija 15 MBq/kg z [
English: Haemorrhage while thrombocytopenic Hypertension** Hypotension**
Slovenian: krvavitev pri trombocitopeniji* hipertenzija** hipotenzija**
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.
Slovenian: *IgG monoklonsko protitelo glodavcev, pridobljeno z rekombinantno DNA tehnologijo iz celic jajčnika kitajskega hrčka (CHO) in konjugirano s kelatorjem MX-DTPA.
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.
Slovenian: V kliničnih preskušanjih z indikacijo relapsne in neodzivne NHL so poročali o trombocitopeniji 3. stopnje z medianim časom 13 dni in 4. stopnje z medianim časom 21 dni ter nevtropeniji 3. stopnje z medianim časom do okrevanja 8 dni in 4. stopnje z medianim časom do okrevanja 14. dni.
English: Patients who had received murine-derived proteins before Zevalin treatment must be tested for human anti-murine antibodies (HAMA).
Slovenian: • Humana protitelesa proti antigenom glodavcev Bolnike, ki so pred zdravljenjem z zdravilom Zevalin prejemali mišje beljakovine, je treba testirati na prisotnost humanih protiteles proti antigenom glodavcev (HAMA-human anti-mouse antibodies).
English: Step 2: Transfer yttrium-90 chloride to the reaction vial
Slovenian: 2. faza: prenesite raztopino itrijevega-90 klorida v reakcijsko vialo.
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.
Slovenian: Po zdravljenju z zdravilom Zevalin kot konsolidacijsko zdravljenje po nastopu remisije z zdravljenjem prvega izbora je bil mediani čas do okrevanja 20 dni za trombocitopenijo 3. stopnje in 35 dni za trombocitopenijo 4. stopnje ter 20 dni za nevtropenijo 3. stopnje in 28 dni za nevtropenijo 4. stopnje.
English: Place cold kit reaction vial in a suitable dispensing shield (plastic enclosed in lead).
Slovenian: Namestite reakcijsko vialo kompleta v zaščitni vsebnik, primeren za rokovanje in odmerjanje (plastiko, zaprto v svincu).
English: • Severe and prolonged cytopenias (see also ‘Special warnings and precautions for use')
Slovenian: • hude in trdovratne citopenije (glejte tudi Posebna opozorila in previdnostni ukrepi)
English: The final formulation after radiolabelling contains 2.08 mg ibritumomab tiuxetan [
Slovenian: Končna formulacija po označevanju z radiofarmakom vsebuje 2,08 mg ibritumomab tiuksetana [
English: Zevalin is also used in previously untreated patients with follicular lymphoma.
Slovenian: Zdravilo Zevalin se uporablja tudi za zdravljenje predhodno nezdravljenih bolnikov s folikularnim limfomom.
English: Tumour pain, Myelodysplastic syndrome/Acute myeloid leukaemia*, **
Slovenian: bolečina zaradi tumorja, mielodisplastični sindrom/akutna mieloblastna levkemija*, **
English: Febrile neutropenia, Pancytopenia*, Lymphocytopenia
Slovenian: febrilna nevtropenija, pancitopenija*, limfocitopenija
English: Study 1 was a single-arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Slovenian: Prva študija je imela en krak, v katerem je bilo 54 bolnikov s ponovitvijo folikularnega limfoma, brez odgovora na zdravljenje z rituksimabom.
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').
Slovenian: stopnje) vključno z anafilaksijo so se pojavile pri manj kot 1 % bolnikov (glejte tudi poglavje Posebna opozorila in previdnostni ukrepi).
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
Slovenian: - Druge sestavine zdravila so: - viala z ibritumomab tiuksetanom: natrijev klorid, voda za injekcije - viala z natrijevim acetatom: natrijev acetat, voda za injekcije - viala s pufrom za pripravo formulacije: raztopina humanega albumina, dinatrijev fosfat dodekahidrat, natrijev hidroksid, kalijev dihidrogen fosfat, kalijev klorid, klorovodikova kislina, pentetična kislina (razredčena) za uravnavanje pH, voda za injekcije
English: Following administration of [
Slovenian: Po aplikaciji z [
English: Assay procedure:
Slovenian: Postopek testiranja:
English: Preparation of Zevalin
Slovenian: Priprava zdravila Zevalin
English: Y]-Zevalin activity per body weight (11 MBq/kg) was used.
Slovenian: Y] označenega zdravila Zevalin glede na telesno maso (11 MBq/kg).
English: Y forms a stable complex with ibritumomab tiuxetan, the biodistribution of the radiolabel follows the biodistribution of the antibody.
Slovenian: Y skupaj z ibritumomab tiuksetanom tvori stabilen kompleks, biološka porazdelitev radioaktivnega markerja sledi biološki porazdelitvi protitelesa.
English: Step 3: Transfer ibritumomab tiuxetan solution to the reaction vial
Slovenian: 3. faza: prenesite raztopino ibritumomab tiuksetana v reakcijsko vialo
English: This medicinal product can contain up to 28 mg sodium per dose, depending on the radioactivity concentration.
Slovenian: To zdravilo lahko vsebuje do 28 mg natrija na odmerek, odvisno od koncentracije radioaktivnosti.
English: For therapy of patients with relapsed or refractory Non-Hodgkin's lymphoma not responding to rituximab
Slovenian: Za zdravljenje bolnikov z relapsnim ali neodzivnim ne-Hodgkinovim limfomom, ki se ne odziva na rituksimab
English: Zevalin could affect the ability to drive and to use machines, as dizziness has been reported as a common side effect.
Slovenian: Zevalin lahko vpliva na sposobnost vožnje in upravljanja s stroji, saj se kot pogosto opisan neželeni učinek pojavlja vrtoglavica.
English: No incompatibilities have been observed between Zevalin and infusion sets.
Slovenian: Med zdravilom Zevalin in kompleti za infundiranje niso opazili inkompatibilnosti.
English: Therefore, women must discontinue breast-feeding, as the potential for absorption and immunosuppression in the infant is unknown.
Slovenian: Ker absorpcijski in imunosupresijski potencial pri dojenčkih nista znana mora ženska prenehati dojiti.
English: Limited data in elderly patients (aged ≥ 65 years) are available.
Slovenian: Na voljo je premalo podatkov o uporabi zdravila Zevalin pri starejših bolnikih (> 65 let).
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Read complete directions thoroughly before starting the preparation procedure.
Slovenian: Preden se lotite postopka priprave, skrbno preberite celotna navodila.
English: Sepsis*, Pneumonia*, Urinary tract infection, Oral candidiasis
Slovenian: sepsa*, pljučnica*, okužbe sečil, oralna kandidoza
English: - Data from 204 patients receiving Zevalin as consolidation therapy after first line remission induction:
Slovenian: - Podatki, zbrani od 204 bolnikov, ki so prejemali zdravilo Zevalin kot konsolidacijsko zdravljenje po nastopu remisije z zdravljenjem prvega izbora:
English: Meningioma
Slovenian: meningiom
English: • Myelodysplastic syndrome / acute myeloid leukaemia
Slovenian: • mielodisplastični sindrom / akutna mieloična levkemija
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
Slovenian: Študija 3 je imela en krak, v katerem je bilo 30 bolnikov z relapsnim ali neodzivnim nizkostopenjskim folikularnim NHL ali z NHL s transformacijo celic B, ki so imeli blago trombocitopenijo (število trombocitov: 100.000 - 149.000 celic/mm
English: The isotope yttrium-90 is a pure β-emitter and has a mean path length of about 5 mm.
Slovenian: Izotop itrij-90 je čisti sevalec žarkov β z dometom okoli 5 mm.
English: This medicine contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Slovenian: To zdravilo vsebuje do 28 mg natrija na odmerek, kar je odvisno od koncentracije radioaktivnosti.
English: Individual patient dosimetry results were not predictive for [
Slovenian: Rezultati dozimetrije pri posameznih bolnikih nimajo napovedane vrednosti za toksičnost z [
English: Please refer to the Summary of Product Characteristics of rituximab for detailed guidance on its use.
Slovenian: Za podrobna navodila glede uporabe glejte povzetek glavnih značilnosti zdravila za rituksimab.
English: HOW TO USE ZEVALIN
Slovenian: KAKO UPORABLJATI ZDRAVILO ZEVALIN
English: Sodium acetate vial: Sodium acetate Water for injections
Slovenian: Viala z natrijevim acetatom: natrijev acetat voda za injekcije
English: • General disorders and administration site conditions Reports of extravasation with subsequent infusion site reactions including e.g. infusion site dermatitis, infusion site desquamation, and infusion site ulcer have been received.
Slovenian: • Splošne težave in spremembe na mestu aplikacije Poročali so o ekstravazaciji s posledično reakcijo na mestu infundiranja, ki vključujejo npr. dermatitis na mestu infundiranja, luščenje kože na mestu infundiranja in razjede na mestu infundiranja.
English: The use of Zevalin does involve exposure to small amounts of radioactivity.
Slovenian: Pri uporabi zdravila Zevalin boste izpostavljeni majhnim odmerkom radioaktivnosti.
English: Y]-radiolabelled Zevalin solution is:
Slovenian: Y] označene raztopine zdravila Zevalin je:
English: Y]-radiolabelled Zevalin solution contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Slovenian: Y] označena raztopina zdravila Zevalin vsebuje do 28 mg natrija na odmerek, odvisno od koncentracije radioaktivnosti.
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
Slovenian: Veljalo je, da so imeli bolniki prizadeto rezervo kostnega mozga, če so imeli kaj od naslednjega: predhodno ablacijo kostnega mozga s podporo matičnih celic; predhodno obsevanje, ki je zajelo več kot 25 % delujočega kostnega mozga; število trombocitov < 100.000 celic/mm
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.
Slovenian: V primeru alergijske reakcije med dajanjem rituksimaba ali zdravila Zevalin morajo biti takoj na razpolago zdravila za zdravljenje preobčutljivostnih reakcij, npr. adrenalin, antihistaminiki in kortikosteroidi.
English: Radiochemical purity of the radiolabelled preparation applies as long as more than 95% of yttrium-90 is incorporated into the monoclonal antibody.
Slovenian: Radiokemijska čistoto radioaktivno označenega preparata je ustrezna, če je 95 % itrija-90 vezanega na monoklonsko protitelo.
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.
Slovenian: Navodila za določanje odstotka vezave radioaktivnega izotopa Radiokemijsko čistoto določamo s tenkoplastno kromatografijo hitre izvedbe (ITLC - Instant Thin Layer Chromatography) po naslednjem postopku:
English: - patients with 100,000-150,000 platelets/mm 3: 11 MBq/kg
Slovenian: - bolniki s 150.000 ali več trombociti/mm 3: 15 MBq/kg telesne mase - bolniki z 100.000 - 150.000 trombociti/mm 3: 11 MBq/kg
English: Rituximab pretreatment is necessary to clear circulating B-cells, enabling ibritumomab tiuxetan [
Slovenian: Predhodno zdravljenje z rituksimabom je potrebno za odstranitev celic B v obtoku, s čimer dosežemo, da je sevanje ibritumomab tiuksetana [
English: Patients with hepatic impairment The safety and efficacy have not been studied in patients with hepatic impairment.
Slovenian: Bolniki z motnjami v delovanju ledvic Študij varnosti in učinkovitosti pri bolnikih z motnjami v delovanju ledvic niso izvedli.
English: After Zevalin consolidation, 77% of patients in PR after induction therapy converted to CR.
Slovenian: Po konsolidacijski terapiji z zdravilom Zevalin je 77 % bolnikov z delnim odzivom prešlo v popoln odziv.
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
Slovenian: Povzetek podatkov o učinkovitosti pri bolnikih z relapsnim/neodzivnim nizkostopenjskim ali folikularnim ne-Hodgkinovim limfomom (NHL) ali NHL s transformacijo celic B
English: Estimated with observed range.
Slovenian: Opazovano področje je sakrum.
English: Do not foam, shake, or agitate the mixture.
Slovenian: Ne stresajte, da se mešanica ne speni ali pretrese.
English: The ORR was significantly higher (80% vs. 56%, p = 0.002) for patients treated with the Zevalin therapeutic regimen.
Slovenian: Pri bolnikih zdravljenih z zdravilom Zevalin je bil ORR značilno višji (80 %: 56 %; p = 0,002).
English: Y]-radiolabelled Zevalin, the median serum effective half-life of ibritumomab tiuxetan [
Slovenian: Y] označenega zdravila Zevalin, je bila srednja efektivna razpolovna doba z ibritumomab tiuksetana [
English: Vomiting, Abdominal pain, Diarrhoea, Dyspepsia, Throat irritation, Constipation
Slovenian: Bolezni prebavil siljenje na bruhanje bruhanje, bolečine v trebuhu, driska, dispepsija, draženje grla, zaprtost
English: • Infection
Slovenian: • okužba
English: See section 4.
Slovenian: Preglednica 2.
English: Hypersensitivity reactions following Zevalin administration are commonly observed.
Slovenian: Preobčutljivostne reakcije po dajanju zdravila Zevalin so opazili pogosto.
English: Women of childbearing potential as well as males must use effective contraceptive methods during and up to 12 months after treatment with Zevalin.
Slovenian: Ženske v rodni dobi, enako pa tudi moški, morajo med zdravljenjem z zdravilom Zevalin in še do 12 mesecev po tem uporabljati učinkovito kontracepcijo.
English: * fatal outcome has been observed ** has been observed in a study with 204 patients receiving Zevalin as consolidation after first-line remission induction
Slovenian: * smrtni izid ** v študiji z 204 bolniki, ki so prejemali zdravilo Zevalin kot konsolidacijsko zdravljenje po nastopu remisije z zdravljenjem prvega izbora
English: Zevalin can affect your ability to drive and use machines, as dizziness is a common side effect.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zevalin lahko vpliva na vašo sposobnost vožnje in upravljanja različnih strojev in orodij, saj je vrtoglavica eden pogostih neželenih učinkov.
English: 3; or neutrophil count <1,500
Slovenian: 3; število nevtrofilnih celic < 1.500 celic/mm
English: LIST OF EXCIPIENTS Ibritumomab tiuxetan vial: Sodium chloride Water for injections
Slovenian: Viala z ibritumomab tiuksetanom: natrijev klorid voda za injekcije
English: Using a 2-3 ml sterile syringe, transfer 1.3 ml ibritumomab tiuxetan solution to the reaction vial.
Slovenian: S sterilno 2-3-mililitrsko injekcijsko brizgo prenesite raztopino ibritumomab tiuksetana v reakcijsko vialo.
English: Y]-radiolabelled Zevalin after pretreatment with rituximab could cause toxic effects on the male and female gonads (see sections 4.4 and 4.6).
Slovenian: Y] označeno zdravilo po predhodnem zdravljenju z rituksimabom toksične učinke na moške in ženske spolne žleze (glejte poglavji 4.4 in 4.6).
English: Excluded from the study were patients with 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Slovenian: Bolniki z  25 % limfomsko infiltracijo kostnega mozga in/ali prizadeto rezervo kostnega mozga so bili izključeni iz te študije.
English: Vascular disorders Petechiae**
Slovenian: Žilne bolezni petehija**
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.
Slovenian: V primerjavi s 1. in 2. študijo so bili doseženi objektivni dolgotrajni klinični odgovori [67 % ORR (95 % CI: 48 - 85 %), 11,8 mesecev srednji DR
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.
Slovenian: Vsako žensko, ki ji je izostala menstruacija, je treba obravnavati kot da je noseča, dokler se ne dokaže nasprotno.
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:
Slovenian: • Infekcijske in parazitske bolezni - Podatki, zbrani pri 349 bolnikih z relapsnim ali refraktornim nizkostopenjskim, folikularnim limfomom ali NHL s transformacijo celic, preučevanih v petih preskušanjih:
English: Treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL):
Slovenian: Zdravljenje relapsnega ali neodzivnega CD20+ folikularnega B-celičnega ne-Hodgkinovega limfoma (NHL) po rituksimabu:
English: intravenous infusion of 250 mg/m rituximab shortly (within 4 hours) before administration of [
Slovenian: intravenska infuzija 250 mg/m rituksimaba tik (v 4 urah) pred aplikacijo raztopine z Y] označenega zdravila Zevalin.
English: (radiolabelling).
Slovenian: (označevanje).
English: Radiopharmaceuticals must be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Uporabnik mora pri pripravi radiofarmakov upoštevati zahteve varstva pred sevanji kot tudi zahteve glede farmacevtske kakovosti.
English: Using a 1 ml insulin syringe with a 25- to 26-G needle, place a hanging drop (7-10 µl) of [
Slovenian: 2) Z 1-mililitrsko insulinsko injekcijsko brizgo s 25-26 G iglo spustite visečo kapljico (7-10 µl) z Y] označenega zdravila Zevalin na ploščico za ITLC, na oznako za nanos vzorca.
English: • Immunization
Slovenian: • Imunizacija
English: What Zevalin contains
Slovenian: Kaj vsebuje zdravilo Zevalin
English: • The following minimum yttrium-90 characteristics are recommended: Radioactivity concentration at time of use
Slovenian: • Priporočljivo je upoštevati naslednje minimalne karakteristike za itrij-90:
English: Day 1: intravenous infusion of 250 mg/m rituximab.
Slovenian: označenega zdravila Zevalin v naslednjem vrstnem redu: 1. dan: intravenska infuzija 250 mg/m rituksimaba
English: The primary efficacy endpoint of the study was the overall response rate (ORR) using the
Slovenian: Primarni kriterij učinkovitosti v študiji je bil delež skupnega odgovora (ORR-overall response rate), ocenjen po kriterijih IWRC (International Workshop Response Criteria).
English: Using a 1-ml sterile syringe, transfer sodium acetate solution to reaction vial.
Slovenian: S sterilno 1-mililitrsko injekcijsko brizgo prenesite raztopino natrijevega acetata v reakcijsko vialo.
English: Zevalin contains sodium
Slovenian: Zdravilo Zevalin vsebuje natrij
English: Step 1: Transfer sodium acetate solution to the reaction vial
Slovenian: 1. faza: prenesite raztopino natrijevega acetata v reakcijsko vialo
English: Sterile, pyrogen-free yttrium-90 chloride of the above specified quality must be used for the preparation of [
Slovenian: Za pripravo z [90Y] označenega zdravila Zevalin se uporablja sterilen in apirogen itrijev-90 klorid, ki mora ustrezati zgoraj navedenim merilom kakovosti.