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.
Croatian: Na temelju znanstvenih zaključaka za ibritumomab tiuksetan, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) ibritumomab tiuksetan nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Sepsis*, Pneumonia*, Urinary tract infection, Oral candidiasis
Croatian: sepsa*, upala pluća*, infekcija mokraćnog sustava, oralna kandidijaza
English: Patients who have developed HAMAs may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Croatian: U bolesnika u kojih su se razvila humana antimišja protutijela mogu se prilikom liječenja Zevalinom ili drugim proteinima dobivenim iz mišjih tkiva razviti alergijske reakcije ili preosjetljivost.
English: Non-clinical data reveal no special hazard for humans based on studies of single and repeated dose toxicity.
Croatian: Neklinički podaci dobiveni iz ispitivanja toksičnosti jedne i ponovljenih doza ne ukazuju na poseban rizik za ljude.
English: The kit allows the coupling of antibody ibritumomab tiuxetan with the radioactive isotope yttrium
Croatian: Set omogućuje vezanje protutijela ibritumomab tiuksetana s radioaktivnim izotopom itrij
English: Directions for radio-labelling of Zevalin with yttrium-90:
Croatian: Upute za radioaktivno označavanje Zevalina izotopom itrij-90:
English: Seven patients (3.4%, 7/204) were diagnosed with MDS/AML after receiving Zevalin, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years.
Croatian: Nakon liječenja Zevalinom u 7 bolesnika (3,4%, 7/204) dijagnosticiran je mijelodisplastični sindrom/akutna mijeloična leukemija u usporedbi s 1 bolesnikom (0,5%, 1/205) u kontrolnoj skupini, s medijanom praćenja od 7,3 godine.
English: The primary efficacy endpoint of the study was the overall response rate (ORR) using the
Croatian: Primarni ishod ispitivanja vezan uz djelotvornost bila je ukupna stopa odgovora (ORR) na temelju IWRC kriterija (eng.
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.
Croatian: Ukupni sigurnosni profil Zevalina nakon prethodnog liječenja rituksimabom temelji se na podacima prikupljenim na 349 bolesnika s recidivirajućim ili refraktornim, folikularnim ili transformiranim B-staničnim ne-Hodgkinovim limfomom niskog stupnja ispitanih u pet kliničkih ispitivanja, na podacima iz ispitivanja provedenog na 204 bolesnika koji su Zevalin primali kao konsolidacijsku terapiju nakon indukcije remisije prvom linijom terapije te iz praćenja nakon stavljanja lijeka na tržište.
English: - Hypersensitivity to rituximab or to other murine-derived proteins.
Croatian: - Preosjetljivost na rituksimab ili na druge proteine dobivene iz miševa.
English: Total Gamma impurities
Croatian: Ukupne gama-nečistoće
English: The efficacy and safety of a variation of the Zevalin therapeutic regimen employing a reduced dose of ibritumomab tiuxetan [
Croatian: Djelotvornost i sigurnost varijante protokola u kojem se upotrebljava smanjena doza ibritumomab tiuksetana [
English: No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
Croatian: Za bolesnike s limfomom središnjeg živčanog sustava ne postoje nikakvi podaci jer takvi bolesnici nisu sudjelovali u kliničkim ispitivanjima.
English: Zevalin is a kit for the preparation of the active substance ibritumomab tiuxetan [
Croatian: Zevalin je set za pripravu djelatne tvari ibritumomab tiuksetana [
English: Febrile neutropenia, Pancytopenia*, Lymphocytopenia
Croatian: febrilna neutropenija, pancitopenija*, limfocitopenija
English: Step 2: Transfer yttrium-90 chloride to the reaction vial
Croatian: 2. korak: prenesite itrij-90 klorid u bočicu za reakciju
English: Zevalin can affect your ability to drive and use machines, as dizziness is a common side effect.
Croatian: Zevalin može utjecati na sposobnost upravljanja vozilima i strojevima jer je omaglica česta nuspojava.
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.
Croatian: CD20+ folikularni limfom 1. ili 2. stupnja, stadij III ili IV u trenutku dijagnoze, uredna krvna slika, zahvaćeno < 25 % koštane srži, dob ≥ 18 godina te potpuni odgovor (CR/CRu) ili djelomični odgovor (PR) nakon prve linije kemoterapije utvrđen fizikalnim pregledom, CT-om i biopsijom koštane srži.
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.
Croatian: Učestalost nuspojava koje su bile barem moguće povezane sa Zevalinom nakon prethodnog liječenja rituksimabom navedene su u sljedećoj tablici.
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.
Croatian: • Opći poremećaji i reakcije na mjestu primjene Primljena su izvješća o ekstravazacijama s posljedičnim reakcijama na mjestu infuzije, uključujući, primjerice, dermatitis na mjestu infuzije, deskvamaciju na mjestu infuzije i vrijed na mjestu infuzije.
English: 1.67 to 3.34 GBq/ml
Croatian: Koncentracija radioaktivnosti u trenutku primjene 1,67 do 3,34 GBq/ml
English: In patients experiencing a severe mucocutaneous reaction treatment must be discontinued.
Croatian: Liječenje bolesnika kod kojih se pojavi teška reakcija na koži ili sluznici mora se prekinuti.
English: The line must be flushed with at least 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection after the infusion of Zevalin.
Croatian: Nakon infuzije Zevalina infuzijsku cjevčicu je potrebno isprati s najmanje 10 ml otopine za injekciju natrijevog klorida od 9 mg/ml (0,9 %) .
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
Croatian: • Pomoćne tvari su: - bočica ibritumomab tiuksetana: natrijev klorid, voda za injekcije - bočica natrijevog acetata: natrijev acetat, voda za injekcije - bočica pufera za pripremu formulacije: otopina humanog albumina, natrijev klorid, natrijev hidrogenfosfat dodekahidrat, natrijev hidroksid, kalijev dihidrogenfosfat, kalijev klorid, pentetična kiselina, kloridna kiselina (razrijeđena) za podešavanje pH, voda za injekcije
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).
Croatian: Tri tjedna prije te 2 tjedna poslije liječenja Zevalinom bolesnici ne smiju primati terapiju čimbenikom rasta, primjerice G-CSF, kako bi se točno procijenila adekvatna rezerva koštane srži i zbog potencijalne osjetljivosti brzoproliferativnih mijeloidnih stanica na zračenje (vidjeti također dio 4.5).
English: Therefore, complete blood cell and platelet counts must be monitored following Zevalin treatment weekly until levels recover or as clinically indicated.
Croatian: Stoga se nakon liječenja Zevalinom mora tjedno pratiti kompletna krvna slika i broj trombocita do oporavka hematopoeze ili dok postoje kliničke indikacije.
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.
Croatian: Kako Zevalin izgleda i sadržaj pakiranja Zevalin je set za pripravu radiofarmaceutika za infuziju koji sadrži: - jednu staklenu bočicu ibritumomab tiuksetana s 2 ml bistre, bezbojne otopine - jednu staklenu bočicu natrijevog acetata s 2 ml bistre, bezbojne otopine
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).
Croatian: Y] nakon prethodnog liječenja rituksimabom mogao djelovati toksično na muške i ženske spolne žlijezde (vidjeti dijelove 4.4 i 4.6).
English: Tumour pain, Myelodysplastic syndrome/Acute myeloid leukaemia*, **
Croatian: tumorska bol, mijelodisplastični sindrom/akutna mijeloična leukemija*, **
English: Vomiting, Abdominal pain, Diarrhoea, Dyspepsia, Throat irritation, Constipation
Croatian: Poremećaji probavnog sustava mučnina povraćanje, bol u trbuhu, proljev, dispepsija, iritacija grla, konstipacija
English: Since the Zevalin regimen includes rituximab, see also the Summary of Product Characteristics of rituximab.
Croatian: Budući da režim liječenja Zevalinom obuhvaća rituksimab, vidjeti i Sažetak opisa svojstava lijeka za rituksimab.
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.
Croatian: Y] smije zaprimati, koristiti i primjenjivati samo kvalificirano osoblje koje su nadležna tijela ovlastila za rukovanje radionuklidima u za to namijenjenom kliničkom okruženju.
English: For therapy of patients with relapsed or refractory Non-Hodgkin's lymphoma not responding to rituximab
Croatian: Za terapiju u bolesnika s recidivirajućim ili refraktornim ne-Hodgkinovim limfomom koji ne odgovara na rituksimab
English: Very common side effects (may effect more than 1 in 10 people) - decreased number of blood platelets, white and red blood cells (thrombocytopenia,
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - smanjenje broja trombocita, leukocita i eritrocita (trombocitopenija, leukocitopenija,
English: Table 1 summarizes efficacy data from this study.
Croatian: Podaci o djelotvornosti dobiveni tim ispitivanjem sažeti su u tablici 1.
English: Day 1: intravenous infusion of 250 mg/m rituximab.
Croatian: Y] sljedećim redoslijedom: 1. dan: intravenska infuzija rituksimaba u dozi od 250 mg/m
English: Radiochemical purity of the yttrium-90 chloride solution
Croatian: Radiokemijska čistoća otopine itrij-90 klorida
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.
Croatian: Pomoću sterilne štrcaljke volumena 1 ml aseptičkom tehnikom prenesite 1500 MBq itrij-90 klorida u bočicu za reakciju koja sadrži otopinu natrijevog acetata prenesenu u 1. koraku.
English: Haemorrhage while thrombocytopenic Hypertension** Hypotension**
Croatian: krvarenje tijekom trombocitopenije*, hipertenzija**, hipotenzija**
English: Doses up to 19.2 MBq/kg of Zevalin have been administered in clinical trials.
Croatian: U kliničkim ispitivanjima primijenjene su doze do 19,2 MBq/kg Zevalina.
English: Metal impurities Total metals*
Croatian: Ukupno metala*
English: 2 ml of sodium acetate solution
Croatian: 2 ml otopine natrijevog acetata
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
Croatian: Ispitivanje 3 bilo je ispitivanje na jednoj skupini od 30 bolesnika s recidivirajućim/refraktornim, folikularnim ili transformiranim B-NHL-om niskog stupnja s blagom trombocitopenijom (broj trombocita u rasponu od 100 000 do 149 000 stanica/mm
English: The most serious adverse drug reactions in patients receiving Zevalin after pretreatment with rituximab are:
Croatian: Najozbiljnije nuspojave lijeka u bolesnika koji su primali Zevalin nakon prethodnog liječenja rituksimabom jesu:
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.
Croatian: *Mišje IgG1 monoklonsko protutijelo proizvedeno tehnologijom rekombinantne DNK u staničnoj liniji jajnika kineskog hrčka (CHO) i konjugirano kelirajućim agensom MX-DTPA.
English: A 0.2 or 0.22 micron low protein-binding filter must be on line between the patient and the infusion port.
Croatian: Između bolesnika i infuzijskog priključka mora se postaviti filtar malog kapaciteta za vezivanje proteina propusnosti od 0,2 ili 0,22 mikrona.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations Ibritumomab tiuxetan solution Intravenous infusion, after preparation.
Croatian: Zevalin 1,6 mg/ml set za pripravu radiofarmaceutika Otopina ibritumomab tiuksetana Za infuziju u venu, nakon pripreme.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REACTION VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA ZA REAKCIJU
English: The risk of haematological toxicity may be increased after prior therapy with fludarabine containing regimens (for details see section 4.5).
Croatian: Rizik od hematološke toksičnosti može biti u slučaju prethodne primjene protokola koji sadrže fludarabin (pojedinosti potražite u dijelu 4.5).
English: • Infection
Croatian: • infekcija
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.
Croatian: *Mišje IgG1 monoklonsko protutijelo proizvedeno tehnologijom DNK u staničnoj liniji jajnika kineskog hrčka (CHO) i konjugirano kelirajućim agensom MX-DTPA.
English: Zevalin contains sodium
Croatian: Zevalin sadrži natrij
English: Zevalin is supplied as a kit for the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan.
Croatian: Zevalin se isporučuje kao set za pripravu ibritumomab tiuksetana označenog radioaktivnim izotopom itrij-90.
English: If available, autologous stem cell support must be administered to manage haematological toxicity.
Croatian: Ako su dostupne, radi liječenja hematološke toksičnosti mora se primijeniti potporna terapija autolognim matičnim stanicama.
English: Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Croatian: Y] indiciran je kao konsolidacijska terapija nakon indukcije remisije u prethodno neliječenih bolesnika s folikularnim limfomom.
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..
Croatian: Budući da primjena radiofarmaceutika u drugih osoba stvara rizik od vanjskog zračenja ili kontaminacije od prolijevanja mokraće, povraćanja itd., potrebno je poduzeti mjere opreza za zaštitu od zračenja sukladno lokalnim propisima.
English: (lymphocytopenia) - allergic (hypersensitivity) reactions - severe loss of appetite (anorexia) - feeling anxious (anxiety); trouble sleeping (insomnia) - dizziness; headache, - bleeding due to decreased blood platelet counts*, - cough; runny nose - vomiting, stomach (abdominal) pain; diarrhoea; indigestion; throat irritation; constipation - rash; itching (pruritus) - joint pain (arthralgia) aching muscles (myalgia); back pain; neck pain
Croatian: (limfocitopenija) - alergijske reakcije (preosjetljivost) - izrazito smanjenje teka (anoreksija) - osjećaj tjeskobe (anksioznost), poremećaji sna (nesanica) - omaglica, glavobolja - krvarenje zbog smanjenja broja trombocita*, - kašalj, curenje nosa - povraćanje, bolovi u trbuhu (abdomenu), proljev, loša probava, nadraženost grla, zatvor - osip, svrbež (pruritus) - bolovi u zglobovima (artralgija), tupi bolovi u mišićima (mialgija), bolovi u leđima, bolovi u vratu - bol, simptomi slični gripi, opće loše stanje (malaksalost), oticanje izazvano nakupljanjem tekućine u rukama, nogama i drugim tkivima (periferni edem), pojačano znojenje - povišeni krvni tlak (hipertenzija)** - sniženi krvni tlak (hipotenzija)** - izostanak mjesečnice (amenoreja)**
English: * fatal outcome has been observed ** has been observed in a study with 204 patients receiving Zevalin as consolidation after first-line remission induction
Croatian: * primijećen smrtni ishod ** primijećeno u ispitivanju na 204 bolesnika koji su primali Zevalin kao konsolidaciju nakon indukcije remisije prvom linijom terapije
English: The Package Leaflet should also be amended accordingly.
Croatian: Sukladno tome treba izmijeniti i uputu o lijeku.
English: Reporting suspected adverse reactions afterauthorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
English: • Severe and prolonged cytopenias (see also ‘Special warnings and precautions for use')
Croatian: • teške i dugotrajne citopenije (vidjeti dio "Posebna upozorenja i mjere opreza pri uporabi")
English: 10-minute intravenous infusion of [90Y]-radiolabelled Zevalin solution.
Croatian: - 10-minutna intravenska infuzija otopine Zevalina radioaktivno označenog izotopom Y].
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.
Croatian: K tome, nuspojave lijeka označene s dvije zvjezdice (**), uočene su i u ispitivanju provedenom na 204 bolesnika koji su Zevalin primali kao konsolidacijsku terapiju nakon indukcije remisije prvom linijom terapije, gdje je to bilo indicirano.
English: - One formulation buffer glass vial, with 10 ml clear, yellow to amber coloured solution.
Croatian: - jednu staklenu bočicu pufera za pripremu formulacije s 10 ml bistre otopine žute do žutosmeđe boje - jednu staklenu bočicu za reakciju (praznu)
English: Calculate the average Radiochemical Purity (RCP) as follows:
Croatian: 5.) Prosječnu radiokemijsku čistoću (RCP) izračunajte na sljedeći način: 6.) Prosječni % RCP =
English: • Immunization
Croatian: • Imunizacija
English: Sodium acetate vial: Clear colourless solution.
Croatian: Bočica natrijevog acetata: bistra, bezbojna otopina.
English: Y]-radiolabelled Zevalin after pretreatment with rituximab results in a significant radiation dose to the testes.
Croatian: Y] nakon početnog liječenja rituksimabom stvara značajne doze zračenja na testisima.
English: Formulation buffer vial: Clear yellow to amber coloured solution.
Croatian: Bočica pufera za pripremu formulacije: bistra otopina žute do žutosmeđe boje.
English: Zevalin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Croatian: Zbog nedostatka podataka o sigurnosti i djelotvornosti lijeka ne preporučuje se primjena Zevalina u djece i adolescenata mlađih od 18 godina.
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
Croatian: Tablica 2. Sažetak podataka o djelotvornosti dobivenih u ispitivanjima na bolesnicima s recidivirajućim/refraktornim niskostupanjskim ili folikularnim ne-Hodgkinovim limfomom (NHL-om) ili transformiranim B-staničnim NHL-om Ispitivanje 1
English: • Infections
Croatian: • infekcije
English: Intracranial haemorrhage while thrombocytopenic*
Croatian: intrakranijalno krvarenje tijekom trombocitopenije*
English: The human radiation dose estimates derived from biodistribution studies in mice with [
Croatian: Prema procjenama doza zračenja za ljude izvedenim iz ispitivanja biološke raspodjele Y]-radioaktivno označenog ili [
English: Sodium acetate vial: Sodium acetate Water for injections
Croatian: Bočica natrijevog acetata: natrijev acetat voda za injekcije
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.
Croatian: Ispitivanje je provedeno na 143 bolesnika koji prethodno nisu primali rituksimab s recidivirajućim ili refraktornim niskostupanjskim ili folikularnim ne-Hodgkinovim limfomom (NHL-om) ili transformiranim B-staničnim NHL-om.
English: The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Croatian: Za opis određene reakcije i njezinih sinonima i povezanih stanja služi najprikladniji pojam prema MedDRA-i.
English: SODIUM ACETATE VIAL
Croatian: BOČICA NATRIJEVOG ACETATA
English: In this study, a modification of the Zevalin therapeutic regimen with a lower [
Croatian: U ovom ispitivanju koristio se modificirani terapijski protokol Zevalina s manjom aktivnošću [
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.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: • Severe mucocutaneous reactions (see also ‘Special warnings and precautions for use')
Croatian: • jake reakcije na koži ili sluznici (vidjeti dio "Posebna upozorenja i mjere opreza pri uporabi")
English: Each vial contains 3.2 mg ibritumomab tiuxetan in 2 ml solution (1.6 mg per ml).
Croatian: Svaka bočica sadrži 3,2 mg ibritumomab tiuksetana u 2 ml otopine (1,6 mg po ml).
English: Y]-radiolabelled ibritumomab tiuxetan binds specifically to CD20-expressing B-cells, including malignant cells.
Croatian: Y] veže se specifično za B-stanice koje izražavaju CD20, uključujući zloćudne stanice.
English: LIST OF EXCIPIENTS Ibritumomab tiuxetan vial: Sodium chloride Water for injections
Croatian: POPIS POMOĆNIH TVARI Bočica ibritumomab tiuksetana: natrijev klorid voda za injekcije
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).
Croatian: Y] indiciran je za liječenje odraslih bolesnika s recidivirajućim ili refraktornim CD20+ folikularnim B-staničnim ne-Hodgkinovim limfomom (NHLom) liječenih rituksimabom.
English: Thrombocytopenia, Leukocytopenia, Neutropenia, Anaemia*
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija, leukocitopenija, neutropenija, anemija*
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Croatian: Postupke primjene treba provoditi tako da se rizik od kontaminacije lijeka te ozračivanja osoba koje postupak provode svede na najmanju moguću mjeru.
English: Ibritumomab tiuxetan vial: Sodium chloride Water for injections
Croatian: Bočica ibritumomab tiuksetana: natrijev klorid voda za injekcije
English: Using a 1 ml insulin syringe with a 25- to 26-G needle, place a hanging drop (7-10 µl) of [
Croatian: 2.) Pomoću inzulinske štrcaljke volumena 1 ml s iglom od 25-26 G ispustite kap (7-10 µl) Y]-radioaktivno označenog Zevalina na trakicu za ITLC na njezinu početku.