FrancophonIA/ELRC3.0 huggingface dataset:
English: It should be specified that the frequency ‘common' attributed to this adverse drug reaction has been derived from a study on consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Croatian: Potrebno je navesti da je učestalost „često“, koja se odnosi na tu nuspojavu lijeka, dobivena u ispitivanju konsolidacijske terapije nakon indukcije remisije u prethodno neliječenih bolesnika s folikularnim limfomom.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike smiju preuzimati, upotrebljavati i primjenjivati samo ovlaštene osobe u za to određenom kliničkom okruženju.
English: Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling
Croatian: Zračenje povezano sa Zevalinom može izazvati oštećenje tkiva oko limfoma i komplikacije zbog oticanja limfoma.
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').
Croatian: Teške reakcije preosjetljivosti (3. ili 4. stupnja), uključujući anafilaksiju, pojavljuju se u manje od 1 % bolesnika (vidjeti također dio "Posebna upozorenja i mjere opreza pri uporabi").
English: Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen versus treatment with rituximab.
Croatian: Ispitivanje 2 bilo je randomizirano, kontrolirano, multicentrično ispitivanje radi usporedbe terapijskog protokola Zevalina i liječenja rituksimabom.
English: Zevalin is also used in previously untreated patients with follicular lymphoma.
Croatian: Zevalin se koristi i u prethodno neliječnih bolesnika s folikularnim limfomom.
English: • blood poisoning (sepsis): fever and chills, changes in mental status, rapid breathing, increased heart rate, decreased urine output, low blood pressure, shock, problems with bleeding or clotting
Croatian: • trovanje krvi (sepsa): vrućica i zimica, promjene mentalnog stanja, ubrzano disanje, ubrzani otkucaji srca, smanjena količina mokraće, sniženi krvni tlak, šok, problemi s krvarenjem ili zgrušavanjem
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).
Croatian: Zbog prirode sastojaka lijeka žene i muškarci u reproduktivnoj dobi moraju koristiti učinkovite kontracepcijske metode tijekom i u razdoblju od 12 mjeseci nakon dovršetka liječenja Zevalinom (vidjeti također dio 4.6 i 5.2).
English: • Immune system disorders
Croatian: • Poremećaji imunološkog sustava
English: The description of the ADR in the same section of the SmPC should be amended accordingly to clarify which statements relate to each of the two indications (consolidation therapy in follicular lymphoma vs relapsed or refractory Non-Hodgkin's lymphoma (NHL)).
Croatian: U skladu s tim treba izmijeniti i opis nuspojave lijeka u istom dijelu sažetka opisa svojstava lijeka, kako bi bilo jasno što se od navedenog odnosi na svaku od tih dviju indikacija (konsolidacijska terapija u folikularnom limfomu naspram recidivirajućeg ili refraktornog ne-Hodgkinovog limfoma (NHL)).
English: Zevalin is used to treat patients suffering from specific subgroups of B-cell non-Hodgkin's lymphoma (CD20+ indolent or transformed B-cell NHL) if an earlier rituximab, another monoclonal antibody, treatment has not worked, or has stopped working (refractory or relapsed disease).
Croatian: Zevalin se koristi za liječenje bolesnika koji boluju od specifičnih podgrupa B-staničnog ne-Hodgkinovog limfoma (CD20+ indolentnog ili transformiranog B-staničnog NHL-a) ako prethodno liječenje rituksimabom, još jednim monoklonskim protutijelom, nije djelovalo ili je prestalo djelovati (refraktorna ili recidivirajuća bolest).
English: Excluded from the study were patients with 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Croatian: Iz ispitivanja su bili isključeni bolesnici kojima je limfom zahvatio  25 % koštane srži i/ili s narušenom rezervom koštanom srži.
English: • Pancytopenia
Croatian: • pancitopenija
English: Uncommon side effects: (may effect up to 1 in 100 people) - rapid heart beat (tachycardia),
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - ubrzani otkucaji srca (tahikardija)
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.
Croatian: PRAC smatra da je potrebno dodatno razjasniti informacije o mijelodisplastičnom sindromu (MDS)/ akutnoj mijeloičnoj leukemiji (AML) u dijelu 4.8 sažetka opisa svojstava lijeka.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Croatian: Čuvanje radiofarmaceutika mora biti sukladno nacionalnim propisima o radioaktivnim materijalima.
English: Contents of the kit are intended only for use in the preparation of yttrium-90 radiolabelled ibritumomab tiuxetan and are not to be administered directly to the patient without first undergoing the preparative procedure.
Croatian: Sadržaj seta namijenjen je samo za pripravu ibritumomab tiuksetana označenog radioaktivnim izotopom itrij-90 i ne smije se primjenjivati izravno bolesniku bez prethodnog postupka pripreme.
English: Place cold kit reaction vial in a suitable dispensing shield (plastic enclosed in lead).
Croatian: Bočicu za reakciju iz hladnog seta stavite u odgovarajući štitnik za raspodjelu (od plastike obložene olovom).
English: Zevalin must be used following pretreatment with rituximab.
Croatian: Zevalin se mora koristiti nakon početnog liječenja rituksimabom.
English: This may include discontinuation of Zevalin therapy and treatment with growth factors or your own stem cells.
Croatian: To može obuhvaćati prekid terapije Zevalinom i liječenje čimbenicima rasta ili vlastitim matičnim stanicama.
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).
Croatian: - Na dan 7, 8 ili 9 primit ćete jednu infuziju rituksimaba pa nedugo potom (unutar 4 sata) jednu infuziju Zevalina.
English: • allergic (hypersensitivity) reactions/infusion reactions: symptoms for allergic reactions/ infusion reactions may be skin reactions, breathing difficulties, swelling, itching, flushing, chills, dizziness (as potential sign for low blood pressure).
Croatian: • alergijske reakcije (preosjetljivost) / infuzijske reakcije: simptomi alergijskih/infuzijskih reakcija mogu biti reakcije na koži, otežano disanje, oticanje, svrbež, crvenilo uz osjećaj vrućine, zimica, omaglica (kao potencijalni znak sniženog krvnog tlaka).
English: Table 1: Adverse drug reactions reported in clinical trials or during post-marketing surveillance in patients treated with Zevalin after pretreatment with rituximab
Croatian: Tablica 1: Nuspojave lijeka prijavljene u kliničkim ispitivanjima ili tijekom praćenja nakon stavljanja lijeka na tržište u bolesnika liječenih Zevalinom nakon prethodnog liječenja rituksimabom
English: Appropriate aseptic precautions should be taken.
Croatian: Potrebno je provesti aseptičke mjere opreza.
English: Hence the risk of haematological toxicity may be increased when Zevalin is administered shortly (< 4 months) after fludarabine-containing regimens (see also section 4.4).
Croatian: Stoga bi rizik od hematološke toksičnosti mogao biti veći kad se Zevalin primjenjuje neposredno (< 4 mjeseca) nakon terapijskog režima koji sadrži fludarabin (vidjeti također dio 4.4).
English: The path length of beta emission (90) by yttrium-90 in tissue is 5 mm.
Croatian: Duljina puta beta-čestica (90) koje emitira itrij-90 iznosi 5 mm.
English: Zevalin 1.6 mg/ml kit for radiopharmaceutical preparations for infusion Ibritumomab tiuxetan [
Croatian: Zevalin 1,6 mg/ml set za pripravu radiofarmaceutika za infuziju ibritumomab tiuksetan [
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.
Croatian: U kliničkim ispitivanjima s indikacijom recidivirajućeg i refraktornog NHL-a prijavljena je trombocitopenija 3. ili 4. stupnja s medijanima vremena do oporavka od 13 dana i 21 dan te neutropenija 3. i 4. stupnja s medijanima vremena do oporavka od 8 i 14 dana.
English: Of these, grade 3 was common, grade 4 uncommon.
Croatian: Tijekom razdoblja praćenja infekcije 3. stupnja su bile česte, a one 4. stupnja manje česte.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS Read complete directions thoroughly before starting the preparation procedure.
Croatian: Prije početka postupka priprave temeljito pročitajte sve upute.
English: The kit contains one ibritumomab tiuxetan vial, one sodium acetate vial, one formulation buffer vial, and one empty reaction vial.
Croatian: Set sadrži jednu bočicu ibritumomab tiuksetana, jednu bočicu natrijevog acetata, jednu bočicu pufera za pripremu formulacije i jednu praznu bočicu za reakciju.
English: A total of 73 patients received the Zevalin therapeutic regimen, and 70 patients received rituximab given as an intravenous infusion at 375 mg/m weekly times 4 doses.
Croatian: Zevalina ukupno je primalo 73 bolesnika, a 70 bolesnika primalo je rituksimab u obliku intravenske infuzije u dozi od 375 mg/m jedanput tjedno tijekom 4 tjedna.
English: Take special care with Zevalin
Croatian: Budite posebno oprezni sa Zevalinom
English: Y]-radiolabelled Zevalin solution must not be administered to patients who are likely to develop life-threatening haematological toxicity signs.
Croatian: Y] ne smije se davati bolesnicima za koje postoji vjerojatnost razvoja životno opasnih znakova hematološke toksičnosti.
English: Rare side effects: (may effect up to 1 in 1,000 people) - benign brain tumour (meningioma), - bleeding in the head due to decreased blood platelet counts*,
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - dobroćudni tumor mozga (meningeom) - krvarenje u glavi zbog smanjenja broja trombocita*
English: Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
Croatian: Infuzija Zevalina može se davati izravno zaustavljanjem protoka iz infuzijske vrećice i izravnom primjenom u infuzijsku cjevčicu.
English: Y forms a stable complex with ibritumomab tiuxetan, the biodistribution of the radiolabel follows the biodistribution of the antibody.
Croatian: Y stvara stabilan kompleks s ibritumomab tiuksetanom, biološka distribucija radioaktivnog biljega prati biološku distribuciju protutijela.
English: Zevalin is used with another medicine containing the active substance rituximab.
Croatian: Zevalin se primjenjuje s još jednim lijekom koji sadrži djelatnu tvar rituksimab.
English: The most frequently observed adverse drug reactions in patients receiving Zevalin after pretreatment with rituximab are thrombocytopenia, leukocytopenia, neutropenia, anaemia, infections, pyrexia, nausea, asthenia, rigors, petechiae, and fatigue.
Croatian: Najčešće primijećene nuspojave lijeka u bolesnika koji su primali Zevalin nakon prethodnog liječenja rituksimabom jesu trombocitopenija, leukocitopenija, neutropenija, anemija, infekcije, pireksija, mučnina, astenija, tresavica, petehije i umor.
English: • Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Secondary malignancies
Croatian: • Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) - Sekundarne zloćudne bolesti
English: Study 1 was a single-arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Croatian: Ispitivanje 1 bilo je ispitivanje na jednoj skupini od 54 bolesnika s recidivirajućim folikularnim limfomom refraktornim na liječenje rituksimabom.
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.
Croatian: Nuspojave označene zvjezdicom (*) u nekim su slučajevima, bilo u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet, dovele do smrtnih ishoda.
English: Before administration to the patient, the percent radioincorporation of the prepared Y]-radiolabelled Zevalin must be checked according to the procedure outlined below.
Croatian: Prije primjene bolesniku, mora se provjeriti postotak radioinkorporacije pripremljenog Y]-radioaktivno označenog Zevalina u skladu s postupkom opisanim u nastavku.
English: Study 4 investigated the efficacy and safety of Zevalin consolidation in patients with advanced-stage follicular lymphoma responding to first-line chemotherapy.
Croatian: Ispitivanjem 4 ispitivale su se djelotvornost i sigurnost konsolidacijske terapije Zevalinom u bolesnika s uznapredovalim folikularnim limfomom koji su odgovorili na prvu liniju kemoterapije.
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
Croatian: Nuspojave za koje učestalost nije poznata: - reakcija na koži i sluznicama (uključujući Stevens-Johnsonov sindrom)* - izlijevanje infuzije u okolna tkiva (ekstravazacija) koja izaziva upalu kože (dermatitis na mjestu infuzije), ljuštenje kože (deskvamacija na mjestu infuzije) ili vrijed na mjestu infuzije - oštećenja tkiva oko tumora limfnog sustava i komplikacije zbog oticanja takvih tumora
English: • Low counts of blood cells: unusual bruising, more bleeding then usual after injury, fever, or if you feel unusually tired or breathless
Croatian: • smanjenje broja krvnih stanica: neuobičajene modrice, krvarenja nakon ozljede obilnija no obično, vrućica, pojačan umor ili gubitak daha
English: In]-radiolabelled Zevalin, whole body scans were performed at up to eight time-points, acquiring both anterior and posterior images.
Croatian: In] napravljene su snimke cijelog tijela u najviše osam vremenskih točaka, sprijeda i straga.
English: Severe mucocutaneous reactions, including Stevens-Johnson Syndrome, some with fatal outcome, have been reported in association with Zevalin after pretreatment with rituximab.
Croatian: Prijavljene su teške reakcije na koži i sluznici, uključujući Stevens-Johnsonov sindrom, a neke i sa smrtnim ishodom, povezane sa Zevalinom nakon prethodnog liječenja rituksimabom.
English: In a clinical trial in which Zevalin was administered as consolidation after prior first line chemotherapy, a higher frequency of severe and prolonged neutropenia and thrombocytopenia was observed in patients who had received Zevalin within 4 months after a combination chemotherapy of fludarabine with mitoxantrone and/or cyclophosphamide compared to those patients who had received any other chemotherapy.
Croatian: U kliničkom ispitivanju u kojem se Zevalin davao kao konsolidacija nakon prethodne kemoterapije prvog izbora, primijećena je veća učestalost teške i dugotrajne neutropenije i trombocitopenije u bolesnika koji su primili Zevalin u razdoblju unutar 4 mjeseca od primjene kombinirane kemoterapije fludarabina s mitoksantronom i/ili ciklofosfamidom u usporedbi s bolesnicima koji su primali neku drugu kemoterapiju.
English: In]-radiolabelled Zevalin was always given immediately following an infusion with rituximab at 250 mg/m² to deplete peripheral CD20+ cells and to optimise biodistribution.
Croatian: In] za snimanje uvijek se davala neposredno nakon infuzije rituksimabom u dozi od 250 mg/m² radi smanjenja broja perifernih CD20+ stanica i optimizacije biološke raspodjele.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or approporiate licences of the competent official organisation.
Croatian: Preuzimanje, čuvanje, upotreba, prijevoz i zbrinjavanje radiofarmaceutika podliježe propisima i/ili odgovarajućim dozvolama nadležne službene organizacije.
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
Croatian: Smatralo se da bolesnici imaju narušenu rezervu koštane srži ako su imali nešto od sljedećeg: prethodnu mijeloablativnu terapiju s potpornim liječenjem matičnim stanicama, prethodno vanjsko zračenje na > 25 % aktivne koštane srži, broj trombocita < 100 000 stanica/mm ili broj neutrofila
English: to deliver radiation more specifically to the lymphoma B-cells.
Croatian: Y] omogućuje specifičnije zračenje B-stanica limfoma.
English: Please see the package leaflet for further information.
Croatian: Vidjeti Uputu o lijeku za dodatne informacije.
English: This medicine contains up to 28 mg sodium per dose, depending on the radioactivity concentration.
Croatian: Ovaj lijek sadrži do 28 mg natrija po dozi, ovisno o koncentraciji radioaktivnosti.
English: - Data from 204 patients receiving Zevalin as consolidation therapy after first line remission induction:
Croatian: - Podaci dobiveni ispitivanjem 204 bolesnika koji su primali Zevalin kao konsolidacijsku terapiju nakon indukcije remisije prvom linijom terapije:
English: Y]-radiolabelled Zevalin solution must be prepared according to section 12.
Croatian: Y] potrebno je pripremiti u skladu s dijelom 12.
English:  0.74 MBq strontium-90 / 37 GBq yttrium-90
Croatian: Sadržaj radionuklidne čistoće izotopa stroncij-90  0,74 MBq izotopa stroncij-90 / 37 GBq izotopa itrij-90
English: Total extractable activity to deliver at time of use  1.48 GBq corresponding to 0.44 ml to 0.89 ml of yttrium-90 solution
Croatian:  1,48 GBq, što odgovara otopini od 0,44 ml do 0,89 ml izotopa itrij-90
English: Women of child-bearing potential and male patients must use reliable contraception during treatment with Zevalin and for up to one year after stopping treatment.
Croatian: Žene i muškarci u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja Zevalinom i godinu dana nakon prestanka liječenja.
English: leukocytopenia, neutropenia, anaemia )* - feeling sick (nausea) - weakness, fever, chills (rigor) - infection* - tiredness** - red pinpoint spots under the skin (petechia)**
Croatian: neutropenija, anemija)* - mučnina (nauzeja) - slabost, vrućica, zimica (tresavica) - infekcija* - umor** - crvene točkice pod kožom (petehije)**
English: Infections and infestations
Croatian: Infekcije i infestacije infekcija*
English: • Blood and lymphatic system disorders
Croatian: • Poremećaji krvi i limfnog sustava
English: Radiochemical purity of the radiolabelled preparation applies as long as more than 95% of yttrium-90 is incorporated into the monoclonal antibody.
Croatian: Radioaktivno označeni preparat radiokemijski je čist dok god je u monoklonsko protutijelo inkorporirano više od 95 % izotopa itrij-90.
English: Deaths due to second primary malignancy included 8 (3.9%) patients in the Zevalin arm compared to 3 (1.5%) patients in the control arm.
Croatian: U skupini koja je primala Zevalin, zbog druge primarne zloćudne bolesti umrlo je 8 bolesnika (3,9%) u usporedbi s 3 bolesnika (1,5%) iz kontrolne skupine.
English: Assay procedure:
Croatian: Postupak testiranja:
English: Y] was further defined in a third study enrolling a total of 30 patients who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/mm
Croatian: Y] dodatno su utvrđene trećim ispitivanjem u kojem je sudjelovalo ukupno 30 bolesnika s blagom trombocitopenijom (broj trombocita u rasponu od 100 000 do 149 000 stanica/mm
English: • Myelodysplastic syndrome / acute myeloid leukaemia
Croatian: • mijelodisplastični sindrom / akutna mijeloična leukemija
English: After completing induction therapy, patients were randomized to receive either Zevalin (250 mg/m rituximab on day -7 and on day 0 followed on day 0 by Zevalin 15 MBq/kg body weight; maximal dose 1200 MBq; [n=208]) or no further treatment (control; n=206).
Croatian: Nakon dovršetka indukcijske terapije bolesnici su randomizirani ili u skupinu koja je primala Zevalin (250 mg/m rituksimaba na dan -7 i na dan 0 pa Zevalin od 15 MBq/kg tjelesne težine na dan 0 uz maksimalnu dozu od 1200 MBq [n = 208]) ili skupinu koja nije primala dodatnu terapiju (kontrolnu skupinu, n = 206).
English: Mix by inversion, rolling the container, avoid foaming or agitating the solution.
Croatian: Miješajte izvrtanjem preokrećući spremnik, pri čemu valja izbjegavati pjenjenje ili potresanje otopine.
English: This medicinal product can contain up to 28 mg sodium per dose, depending on the radioactivity concentration.
Croatian: Ovaj lijek može sadržavati do 28 mg natrija po dozi, ovisno o koncentraciji radioaktivnosti.
English: Storage must be in accordance with national regulations for radioactive materials.
Croatian: Čuvanje mora biti sukladno državnim propisima o radioaktivnim materijalima.
English: Zevalin must not be administered in patients mentioned below, as safety and efficacy have not been established: - > 25% of the bone marrow infiltrated by lymphoma cells - prior external beam radiation affecting more than 25% of active bone marrow
Croatian: Budući da sigurnost i djelotvornost nije utvrđena, Zevalin se ne smije davati: - bolesnicima kojima je > 25 % koštane srži infiltrirano limfomskim stanicama - bolesnicima kojima je prethodnom vanjskom zračenju izloženo više od 25 % djelatne koštane srži
English: Anxiety, Insomnia
Croatian: Psihijatrijski poremećaji anksioznost, nesanica
English: Gallbladder Wall Muscle
Croatian: Stijenka žučnog mjehura Mišić
English: After use of Zevalin, patients must generally be tested for HAMA before any further treatment with murine-derived proteins.
Croatian: Nakon primjene Zevalina bolesnike se u pravilu mora testirati na humana antimišja protutijela prije svakog daljnjeg liječenja proteinima dobivenim iz mišjih tkiva.
English: Name and address of the manufacturer responsible for batch release CIS bio international
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet CIS bio international
English: Pack size of 1 kit.
Croatian: Pakiranje sadrži 1 set.
English: Rituximab pretreatment is necessary to clear circulating B-cells, enabling ibritumomab tiuxetan [
Croatian: Prethodno liječenje rituksimabom nužno je radi uklanjanja cirkulirajućih B-stanica, što ibritumomab tiuksetanu [
English: Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Croatian: Ibritumomab tiuksetan rekombinantno je mišje IgG1 kapa-monoklonsko protutijelo specifično za B-stanični antigen CD20.
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.
Croatian: Nakon Zevalina kao konsolidacijske terapije nakon indukcije remisije prvom linijom liječenja medijani vremena do oporavka bili su 20 i 35 dana za trombocitopeniju 3., odnosno 4. stupnja te 20 i 28 dana za neutropeniju 3., odnosno 4. stupnja.
English: The volume of sodium acetate solution added is equivalent to 1.2 times the volume of yttrium-90 chloride to be transferred in step 2.
Croatian: Volumen otopine natrijevog acetata koji se dodaje ekvivalentan je volumenu itrij-90 klorida koji se prenosi u 2. koraku pomnoženom s 1,2.