FrancophonIA/ELRC3.0 huggingface dataset:
English: Zevalin is not used directly, but must be prepared by your healthcare professional first.
Croatian: Zevalin se ne primjenjuje izravno, već ga zdravstveni djelatnik najprije mora pripremiti.
English: Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Croatian: Vrijeme označavanja dulje od šest ili kraće od četiri minute dovest će do neadekvatne inkorporacije radioaktivnog izotopa.
English: Intravenous infusion, after preparation.
Croatian: Za infuziju u venu, nakon pripreme.
English: Infections may be bacterial, fungal, viral including reactivation of latent viruses.
Croatian: Infekcije mogu biti bakterijske, gljivične i virusne, uključujući reaktivaciju latentnih virusa.
English: Like all medicines, Zevalin can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Zevalin može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Name and address of the manufacturer of the biological active substance Biogen IDEC, Inc.
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Biogen IDEC, Inc.
English: Y]-Zevalin
Croatian: Y]-Zevalina
English: There are no known interactions with other medicinal products.
Croatian: Interakcije s drugim lijekovima nisu poznate.
English: Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Croatian: Itrij-90 raspada se emisijom visokoenergetskih beta-čestica uz fizikalni poluživot od 64,1 sat (2,67 dana).
English: The maximum dose must not exceed 1200 MBq (‘megabecquerel', a unit to measure radioactivity).
Croatian: Maksimalna doza ne smije premašivati 1200 MBq ("megabekerela", jedinica za mjerenje radioaktivnosti).
English: Depending on the kind/severity of reaction your doctor will decide if treatment must be stopped immediately.
Croatian: Ovisno o vrsti/težini reakcije, liječnik će odlučiti je li liječenje potrebno odmah prekinuti.
English: This results in the ability to kill both targeted and neighbouring cells.
Croatian: Zbog toga ima sposobnost uništavanja i ciljanih i susjednih stanica.
English: Pharmacotherapeutic group: Various therapeutic radiopharmaceuticals, ATC code: V10XX02
Croatian: Farmakoterapijska skupina: različiti terapijski radiofarmaceutici, ATK oznaka: V10XX02
English: Manufacturer CIS bio international RN 306- Saclay B.P.
Croatian: CIS bio international RN 306- Saclay B.P.
English: The onset of the reactions varied from days to months.
Croatian: Vrijeme pojave reakcija kretalo se u rasponu od nekoliko dana do nekoliko mjeseci.
English: The content of the kit before extemporary preparation is not radioactive.
Croatian: Sadržaj seta prije priprave nije radioaktivan.
English: The secondary endpoints, duration of response and time to progression, were not significantly different between the two treatment arms.
Croatian: Sekundarni ishodi, trajanje odgovora i vrijeme do napredovanja bolesti, nisu se značajno razlikovali između dviju terapijskih skupina.
English: Studies on the mutagenic and carcinogenic potential of Zevalin have not been performed.
Croatian: Ispitivanja mutagenog i kancerogenog potencijala Zevalina nisu provedena.
English: Other medicines and Zevalin
Croatian: Drugi lijekovi i Zevalin
English: Frequency groupings are defined according to the following convention: (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to 1/100, rare:  1/10,000 to <1/1,000; very rare: <1/10,000).
Croatian: Skupine učestalosti definirane su u skladu sa sljedećim smjernicama: (vrlo često ≥ 1/10, često ≥ 1/100 i < 1/10, manje često ≥ 1/1000 i  1/100, rijetko  1/10 000 i < 1/1000, vrlo rijetko < 1/10 000).
English: Please be cautious until you are sure you are not affected.
Croatian: Dok se ne uvjerite da je nemate, budite oprezni.
English: Women must not breast-feed during treatment and for 12 months following the treatment.
Croatian: Žene ne smiju dojiti tijekom liječenja i 12 mjeseci nakon liječenja.
English: 91192 Gif-sur-Yvette Cedex France
Croatian: 91192 Gif-sur-Yvette Cedex Francuska
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.
Croatian: Za sve žene kojima je izostala mjesečnica mora se pretpostaviti da su trudne dok se ne dokaže suprotno, a do tada je potrebno razmotriti alternativne terapije koje ne uključuju ionizirajuće zračenje.
English: Secondary efficacy endpoints included time to disease progression (TTP) and duration of response (DR).
Croatian: Sekundarni ishodi vezani uz djelotvornost obuhvaćali su vrijeme do napredovanja bolesti (TTP) i i trajanje odgovora (DR).
English: The infusion must not be administered as an intravenous bolus.
Croatian: Infuzija se ne smije primijeniti kao intravenski bolus.
English: net CPM bottom half x 100 net CPM top half + net CPM bottom half
Croatian: neto CPM donje polovice x 100 neto CPM gornje polovice + neto CPM donje polovice
English: Organ region of interest Sacrum region of interest Whole body region of interest
Croatian: Područje organa od interesa Područje sakralne kralježnice od interesa Područje cijelog tijela od interesa
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significang change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Complete Response Rate (%)
Croatian: Stopa potpunog odgovora (%)
English: If any signs or symptoms of extravasation have occurred, the infusion must be immediately terminated and restarted in another vein.
Croatian: Ako se pojave bilo kakvi znakovi ili simptomi ekstravazacije, infuzija se mora smjesta prekinuti i nastaviti davati u neku drugu venu.
English: Studies on reproductive and developmental toxicity have not been performed.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti nisu provedena.
English: The final formulation after radiolabelling contains 2.08 mg [
Croatian: Konačna formulacija nakon radioaktivnog označavanja sadrži 2,08 mg [
English: The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Croatian: Rizik od razvoja sekundarne mijelodisplazije ili leukemije nakon terapije alkilirajućim agensima dobro je poznat.
English: Empty reaction vial (10 ml)
Croatian: Prazna bočica za reakciju (10 ml)
English: Required materials not supplied in the Zevalin kit:
Croatian: Potrebni materijali koji se ne isporučuju u setu Zevalina:
English: No growth
Croatian: Nema rasta
English: Zevalin must not be used during pregnancy.
Croatian: Zevalin se ne smije primjenjivati tijekom trudnoće.
English: How Zevalin is given Zevalin is given by intravenous infusion (drip into a vein) usually lasting about 10 minutes.
Croatian: Kako se Zevalin daje Zevalin se daje intravenskom infuzijom (infuzija u venu) koja obično traje oko 10 minuta.
English: Total other Beta impurities (non-strontium-90)
Croatian: Ukupne beta-nečistoće (koje nisu stroncij-90)
English: The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Croatian: Sigurnost i djelotvornost terapijskog režima Zevalina procijenjene su dvama multicentričnim ispitivanjima u kojima je sudjelovalo ukupno 197 ispitanika.
English: In all cases it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Croatian: Za svakog je bolesnika nužno utvrditi jesu li rizici od zračenja manji od rizika same bolesti.
English: Control of these metals can be achieved either through process validation or release test.
Croatian: Kontrolu tih metala potrebno je postići validacijom procesa ili testom otpuštanja.
English: PFS increased from 13.5 months (control) to 37 months (Zevalin; p<0.0001; HR 0.465).
Croatian: PFS se povećao s 13,5 mjeseci (u kontrolnoj skupini) na 37 mjeseci (Zevalin, p < 0,0001; HR 0,465).
English: The ORR was significantly higher (80% vs. 56%, p = 0.002) for patients treated with the Zevalin therapeutic regimen.
Croatian: ORR je bio značajno viši (80 % nasuprot 56 %, uz p = 0,002) u bolesnika liječenim terapijskim režimom Zevalina.
English: • Sepsis
Croatian: • sepsa
English: This medicine will be stored by a healthcare professional.
Croatian: Ovaj će lijek čuvati zdravstveni djelatnik.
English: Bacterial endotoxins
Croatian: Bakterijski endotoksini
English: Time to Disease Progression: interval from the first infusion to disease progression.
Croatian: Vrijeme do napredovanja bolesti: razdoblje od prve infuzije do napredovanja bolesti.
English: Count each vial in a beta counter or in an appropriate counter for one minute (CPM), record net counts, corrected for background.
Croatian: Brojite svaku bočicu u beta-brojaču ili odgovarajućem brojaču jednu minutu (CPM) pa zabilježite neto vrijednosti, korigirane za pozadinu.
English: Patients were considered refractory if their last prior treatment with rituximab did not result in a complete or partial response, or if time to disease progression (TTP) was  6 months.
Croatian: Bolesnici su smatrani refraktornima ako im zadnje prethodno liječenje rituksimabom nije dovelo do potpunog ili djelomičnog odgovora ili ako je vrijeme do napredovanja bolesti (TTP) bilo manje od 6 mjeseci.
English: The prepared solution must be given as a slow intravenous infusion over 10 minutes.
Croatian: Pripremljena otopina mora se davati kao spora intravenska infuzija tijekom 10 minuta.
English: Median progression free survival (PFS) was calculated at a median follow-up of 2.9 years.
Croatian: Medijan preživljenja bez napredovanja bolesti (PFS, engl. progression free survival) izračunat je za medijan praćenja od 2,9 godina.
English: Blood samples, used to calculate residence times for red marrow, were drawn up to eight time-points.
Croatian: Uzorci krvi, pomoću kojih su se izračunavala vremena eliminacije za crvenu koštanu srž, uzimani su u najviše osam vremenskih točaka.
English: • infections of the lung (pneumonia): breathing difficulties
Croatian: • infekcije pluća (upala pluća): otežano disanje
English: Do not foam, shake, or agitate the mixture.
Croatian: Nemojte pjeniti, tresti ili potresati smjesu.
English: Proper aseptic technique and precautions for handling radioactive materials must be employed.
Croatian: Mora se primijeniti odgovarajuća aseptička tehnika i mjere opreza za rukovanje radioaktivnim materijalima.
English: Patients should be advised that fertility may be affected and that male patients may wish to consider semen cryopreservation.
Croatian: Bolesnike je potrebno obavijestiti da bi im plodnost mogla biti ugrožena, a muškim bolesnicima savjetovati da razmotre krioprezervaciju sjemena.
English: A potentially limited ability to generate a primary or anamnestic humoral response to any vaccine following Zevalin treatment has to be taken into consideration.
Croatian: Mora se uzeti u obzir potencijalno ograničenu sposobnost stvaranja primarnog ili memorijskog humoralnog odgovora na bilo koje cjepivo nakon liječenja Zevalinom.
English: Therefore, for one week after the Zevalin infusion you must wash your hands thoroughly each time after urinating.
Croatian: Stoga tjedan dana nakon infuzije Zevalina nakon svakog mokrenja morate temeljito oprati ruke.
English: Your doctor will immediately stop the infusion and restart it using another vein.
Croatian: Liječnik će odmah prekinuti infuziju i nastaviti je putem neke druge vene.
English: (monotherapy) and <150,000/mm
Croatian: (monoterapija) i < 150 000/mm
English: If at any time in the preparation of this product the integrity of the containers is compromised it should not be used.
Croatian: U slučaju da se u bilo kojem trenutku tijekom priprave ovog lijeka posumnja u neoštećenost spremnika, lijek se ne smije upotrijebiti.
English: Overall Response Rate (%)
Croatian: Ukupna stopa odgovora (%)
English: Pharmacodynamic analysis demonstrated that this was a temporary effect; recovery of normal B-cells began within 6 months and median counts of B-cells were within normal range within 9 months after treatment.
Croatian: Farmakodinamičkom analizom utvrđeno je da je to privremeni učinak jer je oporavak normalnih B-stanica počeo u roku od 6 mjeseci, a medijani broja B-stanica bili su u normalnom rasponu u roku od 9 mjeseci nakon liječenja.
English: Irradiation by the emitted beta particles from
Croatian: Zračenje emitiranim beta-česticama iz
English: The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.
Croatian: Procijenjene doze apsorbiranog zračenja u normalnim organima bile su znatno niže od utvrđenih gornjih granica neškodljivosti.
English: Kit for radiopharmaceutical preparations for infusion.
Croatian: Set za pripravu radiofarmaceutika za infuziju.
English: If the average radiochemical purity is less than 95%, the preparation must not be administered.
Croatian: Ako je prosječna radiokemijska čistoća manja od 95 %, preparat se ne smije primijeniti.
English: Before radiolabelling, bring refrigerated Zevalin cold kit to room temperature 25°C.
Croatian: Prije radioaktivnog označavanja u hladnjaku ohlađeni set Zevalina zagrijte na sobnu temperaturu od 25 °C.
English: Total organic carbon (e.g. organic chelators)
Croatian: Ukupni organski ugljik (npr. organski kelatori)
English: Y] ibritumomab tiuxetan in a total volume of 10 ml.
Croatian: Y] ibritumomab tiuksetana u ukupnom volumenu od 10 ml.
English: Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Croatian: Bolesnici su se od navedenog oporavili, a predoziranja nisu bila povezana s ozbiljnim ili smrtnih ishodima.
English: Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Croatian: Medijan vremena do najnižih razina trombocita i granulocita u krvi bio je oko 60 dana nakon početka liječenja.
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEVALIN
Croatian: ŠTO MORATE ZNATI PRIJE NEGO POČNETE PRIMATI ZEVALIN
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Croatian: Između tih i mlađih bolesnika nisu uočene nikakve ukupne razlike u pogledu sigurnosti ili djelotvornosti.
English: It is not shed from the cell surface and does not internalise on antibody binding.
Croatian: Ne odbacuje se s površine stanice i ne internalizira nakon vezivanja protutijela.
English: Stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Croatian: Stabilnost je dokazana tijekom 8 sati pri temperaturi od 2 °C do 8 °C uz zaštitu od svjetlosti.
English: Chloride identification
Croatian: Identifikacija klorida
English: (radiolabelling).
Croatian: (radioaktivno označavanje).
English: Must be administered by authorised personnel only.
Croatian: Lijek smije primijeniti samo ovlašteno osoblje.
English: After radiolabelling, an immediate use is recommended.
Croatian: Nakon radioaktivnog označavanja preporučuje se trenutna primjena.
English:  95% of free ionic yttrium-90
Croatian:  95 % slobodnog ionskog izotopa itrij-90
English: Rituximab is administered in a reduced dose when compared with the approved monotherapy.
Croatian: Rituksimab se primjenjuje u smanjenoj dozi u usporedbi s odobrenom monoterapijom.
English: What Zevalin is and what it is used for What you need to know before you are given Zevalin How to use Zevalin
Croatian: Što je Zevalin i za što se koristi Što morate znati prije nego počnete primati Zevalin Kako primjenjivati Zevalin Moguće nuspojave
English: Its receipt, preparation, use, transfer, storage, and disposal are subject to the regulations and/or appropriate authorisation/licences of the local competent official organisations.
Croatian: Njezino zaprimanje, priprava, uporaba, prijenos, pohrana i odlaganje podložni su propisima i/ili odgovarajućim ovlastima/dozvolama lokalnih službenih nadležnih ustanova.
English: For storage conditions of the radiolabelled product, see section 6.3.
Croatian: Za uvjete čuvanja radioaktivno označenog lijeka, vidjeti dio 6.3.
English: Appropriate aseptic precautions must be taken, complying with the requirements of Good Manufacturing Practice of pharmaceuticals.
Croatian: Potrebno je poduzeti odgovarajuće aseptičke mjere opreza sukladne dobroj proizvođačkoj praksi farmaceutskih proizvoda.
English: Special caution is required with respect to bone marrow depletion.
Croatian: Potreban je poseban oprez zbog deplecije koštane srži.
English: Store in a refrigerator (2C - 8C).
Croatian: Čuvati u hladnjaku (2 C-8 C).
English: Zevalin therapeutic regimen N = 54
Croatian: Terapijski protokol Zevalina N = 54
English: • Haematological toxicity
Croatian: • Hematološka toksičnost
English: Zevalin attaches to a protein (CD20) on the surface of certain white blood cells (B-cells) and kills them by irradiation.
Croatian: Zevalin se veže za protein (CD20) na površini određenih leukocita (B-stanica) i uništava ih zračenjem.
English: Due to the exposure to ionising radiation derived from the radiolabel, a risk of mutagenic and carcinogenic effects has to be taken into account.
Croatian: Zbog izloženosti ionizirajućem zračenju od radioizotopa za označavanje potrebno je uzeti u obzir rizik od mutagenih i kancerogenih učinaka.
English: The use of Zevalin does involve exposure to small amounts of radioactivity.
Croatian: Primjena Zevalina uključuje izlaganje malim količinama radioaktivnosti.
English: Zevalin therapeutic regimen N = 73
Croatian: Terapijski protokol Zevalina N = 73
English: It is used as a consolidation therapy to improve the reduction in the number of lymphoma cells (remission) achieved with the initial chemotherapy regimen.
Croatian: Koristi se kao konsolidacijska terapija radi pospješivanja smanjenja broja stanica limfoma (remisije) postignutog početnim kemoterapijskim režimom.
English: Mix completely by coating the entire inner surface of the reaction vial.
Croatian: Potpuno pomiješajte tako da ovlažite cijelu unutarnju površinu bočice za reakciju.
English: Caution: Patient dose not to exceed 1200 MBq.
Croatian: Oprez: doza za bolesnika ne smije premašivati 1200 MBq.
English: Empty
Croatian: Prazno
English: The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Croatian: Korist od Zevalina nakon liječenja rituksimabom u kombinaciji s kemoterapijom nije utvrđena.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Croatian: Izlaganje ionizirajućem zračenju povezano je s indukcijom raka i mogućim razvojem nasljednih oštećenja.
English: No animal studies have been performed to determine the effects of Zevalin on fertility in males or females.
Croatian: Nisu provedena ispitivanja na životinjama s ciljem utvrđivanja učinaka Zevalina na plodnost u muškaraca i žena.
English: Due to the potential risk of developing viral infections it is not recommended to administer live viral vaccines to patients who have recently received Zevalin (see section 4.5).
Croatian: Zbog potencijalnog rizika od razvoja virusnih infekcija ne preporučuje se primjena cjepiva sa živim virusima bolesnicima koji su nedavno primali Zevalin (vidjeti dio 4.5).
English: Remove ITLC strip and cut in half at the 3.5 cm cut line.
Croatian: 4.) Izvadite trakicu za ITLC pa je prerežite na pola po reznoj crti od 3,5 cm.
English: After Zevalin consolidation, 77% of patients in PR after induction therapy converted to CR.
Croatian: Nakon Zevalina kao konsolidacijske terapije 77 % bolesnika s PR-om nakon indukcijske terapije postiglo je CR.
English:  10 ppm each * Metals to be included need to be based on the specific manufacturing process.
Croatian: * Metale koje valja uključiti potrebno je temeljiti na konkretnom proizvodnom procesu.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Croatian: Ovim lijekom rukovat će, i Vama primjenjivati, samo osobe koje su uvježbane i stručno osposobljene za njegovu sigurnu primjenu.
English: Long-term animal studies on the effect on fertility and reproductive function have not been performed.
Croatian: Ispitivanja dugoročnih učinaka na plodnost i reproduktivnu funkciju nisu provedena.
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Croatian: Posebnu pozornost obratit će sigurnoj primjeni ovog lijeka i opisivat će Vam postupke koje provode.
English: • Infusion reactions
Croatian: • Infuzijske reakcije
English: The maximum dose must not exceed 1200 MBq.
Croatian: Maksimalna doza ne smije premašiti 1200 MBq.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 8 sati na temperaturi od 2 °C do 8 °C uz zaštitu od svjetlosti.
English: The side effects marked with two asterisks (**) were observed additionally under consolidation therapy.
Croatian: Nuspojave označene dvjema zvjezdicama (**) primijećene su dodatno tijekom konsolidacijske terapije.
English: After the 5-minute incubation period, withdraw from the reaction vial the same volume of air as the formulation buffer to be added in order to normalise pressure and immediately thereafter gently add the formulation buffer down the side of the reaction vial to terminate incubation.
Croatian: Nakon 5 minuta inkubacije iz bočice za reakciju izvucite volumen zraka jednak volumenu pufera za pripremu formulacije koji ćete dodati kako bi se normalizirao tlak pa odmah zatim oprezno dodajte pufer za pripremu formulacije niz stijenku bočice za reakciju da biste prekinuli inkubaciju.
English: The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 2).
Croatian: Primarni ishod ispitivanja vezan uz djelotvornost bilo je utvrditi ORR na temelju IWRC kriterija (vidjeti tablicu 2).
English: Repeated use: Data on the re-treatment of patients with Zevalin are not available.
Croatian: Ponovljena primjena: podaci o ponovljenom liječenju bolesnika Zevalinom nisu dostupni.
English: This medicine is a radiopharmaceutical product for therapy only.
Croatian: Ovaj lijek je radiofarmaceutik namijenjen samo za primjenu u terapiji.
English: However, after Yttrium-90 is added, adequate shielding of the final preparation must be maintained.
Croatian: Međutim, kad se doda itrij-90, potrebno je provoditi odgovarajuću zaštitu s obzirom na gotovi pripravak.
English: The adverse drug reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known“.
Croatian: Nuspojave lijeka otkrivene samo tijekom praćenja nakon stavljanja lijeka na tržište i za koje nije moguće procijeniti učestalost, navedene su u stupcu "nepoznato".
English: The radiation dose to the ovaries has not been established.
Croatian: Doza zračenja jajnika nije utvrđena.
English: What Zevalin contains
Croatian: Što Zevalin sadrži
English: You must not be given Zevalin: - if you are allergic (hypersensitive) to any of the following: ibritumomab tiuxetan, yttrium chloride or to any of the other ingredients of Zevalin (listed in section 6 ‘What Zevalin contains') rituximab or other murine-derived proteins - if you are pregnant or breast-feeding (see also section “pregnancy and breast feeding”).
Croatian: Ne smijete primati Zevalin: - ako ste alergični (preosjetljivi) na nešto od sljedećega: ibritumomab tiuksetan, itrijev klorid ili bilo koji drugi sastojak Zevalina (naveden u dijelu 6 "Što sadrži Zevalin") rituksimab ili druge proteine dobivene iz miševa - ako ste trudni ili dojite (pogledajte i dio "Trudnoća i dojenje").