FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a potential risk that [
Slovenian: Obstaja možno tveganje, da povzroča z [
English: 1097 JB Amsterdam The Netherlands
Slovenian: 1097 JB Amsterdam Nizozemska
English: There is a potential risk that ionizing radiation by [
Slovenian: Obstaja potencialno tveganje, da lahko ionizirajoče sevanje z [
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: S tem zdravilom bodo rokovali in vam ga dajali ljudje, ki so izobraženi in usposobljeni za njegovo varno uporabo.
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).
Slovenian: Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: (zelo pogosti ≥ 1/10, pogosti ≥ 1/100 do <1/10, občasni ≥ 1/1.000 do 1/100, redki  1/10.000 do < 1/1.000; zelo redki < 1/10.000).
English: Refractory or relapsed NHL:
Slovenian: Neodzivni ali relapsni NHL:
English: Below limit of quantitation*
Slovenian: pod mejo kvantifikacije*
English: N = 70
Slovenian: Rituksimab n = 70
English: Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Slovenian: Bolniki so si od teh toksičnih znakov opomogli, preveliki odmerki pa niso povzročili resnih ali usodnih posledic.
English: Zevalin contains 1 of each of the following:
Slovenian: Zdravilo Zevalin vsebuje po 1 od naslednjega:
English: In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
Slovenian: V celoti je bilo v CR(u) 87 % bolnikov; 76 % v CR in 11 % v Cru.
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.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
Slovenian: Vzorec vezave je zelo omejen, brez navzkrižne reaktivnosti nasproti drugim levkocitom ali drugim vrstam človeškega tkiva.
English: You will be given a total of 3 infusions in the course of two visits to a medical facility, 7 to 9 days apart.
Slovenian: Prejeli boste skupaj 3 infuzije v teku dveh obiskov bolnišnice, v razmaku 7 do 9 dni.
English: There are no known interactions with other medicinal products.
Slovenian: Interakcije z drugimi zdravili niso znane.
English: No overall differences in safety or efficacy were observed between these patients and younger patients.
Slovenian: Splošnih razlik v varnosti ali učinkovitosti med to skupino bolnikov in mlajšimi bolniki niso opazili.
English: This medicine will be stored by a healthcare professional.
Slovenian: To zdravilo bo shranil zdravstveni delavec.
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.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Infections may be bacterial, fungal, viral including reactivation of latent viruses.
Slovenian: Okužbe so lahko bakterijske, glivične in virusne, vključno z reaktivacijo latentnih virusov.
English: Process residuals (e.g. ammonia, nitrate)
Slovenian: Ostanki pri predelavi (npr. amoniak, nitrat)
English:  10 ppm each * Metals to be included need to be based on the specific manufacturing process.
Slovenian:  10 ppm vsaka * Pri kovinah, ki naj bi bile navedene, mora biti upoštevan specifičen proizvodni postopek.
English: Median progression free survival (PFS) was calculated at a median follow-up of 2.9 years.
Slovenian: Mediano preživetje brez napredovanja bolezni (PFS) so izračunali po medianem 2,9-letnem spremljanju.
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.
Slovenian: Uporablja se kot konsolidacijska terapija za izboljšanje zmanjšanja števila celic limfoma (remisija), ki se doseže z začetnim režimom kemoterapije.
English: • Mucocutaneous reactions, including Stevens-Johnson Syndrome
Slovenian: • mukokutane reakcije, vključno s Stevens-Johnsonovim sindromom
English: The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.
Slovenian: Ocenjene absorbirane doze sevanja, ki jih prejmejo normalni organi, so bile precej pod dovoljeno zgornjo varnostno mejo.
English: Pregnancy must be excluded before the start of treatment in women.
Slovenian: Pred začetkom zdravljenja pri ženskah je treba izključiti nosečnost.
English: Name and address of the manufacturer of the biological active substance Biogen IDEC, Inc.
Slovenian: Ime in naslov izdelovalca biološke učinkovine Biogen IDEC, Inc.
English: Median TTP (Months) [Range
Slovenian: Mediana TTP (meseci) [razpon
English: 1.67 to 3.34 GBq/ml
Slovenian: 1,67 do 3,34 GBq/ml
English: Studies on reproductive and developmental toxicity have not been performed.
Slovenian: Študij reproduktivne in razvojne toksičnosti niso izvedli.
English: Total other Beta impurities (non-strontium-90)
Slovenian: Skupne druge nečistote beta (ne-stroncij-90)
English: Mix completely by coating the entire inner surface of the reaction vial.
Slovenian: Temeljito premešajte, tako da bo prekrita celotna notranja površina reakcijske viale.
English: • infections of the lung (pneumonia): breathing difficulties
Slovenian: • okužbe pljuč (pljučnice): težave z dihanjem
English: Therefore, for one week after the Zevalin infusion you must wash your hands thoroughly each time after urinating.
Slovenian: Zato si morate en teden po infuziji zdravila Zevalin po vsakem uriniranju skrbno umivati roke.
English: If any signs or symptoms of extravasation have occurred, the infusion must be immediately terminated and restarted in another vein.
Slovenian: Če se pojavi kakršenkoli znak ali simptom ekstravazacije, je treba infundiranje takoj ustaviti in ga ponovno začeti v drugi veni.
English: Manufacturer CIS bio international RN 306- Saclay B.P.
Slovenian: CIS bio international RN 306- Saclay B.P.
English: net CPM bottom half x 100 net CPM top half + net CPM bottom half
Slovenian: neto CPM spodnja polovica x 100 neto CPM zgornja polovica + neto CPM spodnja polovica
English: Zevalin will only be used in special controlled areas.
Slovenian: Zdravilo Zevalin se sme uporabljati samo v posebnih nadzorovanih prostorih.
English: The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Slovenian: Varnost in učinkovitost zdravljenja z zdravilom Zevalin so ocenjevali v dveh multicentričnih študijah, v kateri je bilo vključenih skupno 197 oseb.
English: The final formulation after radiolabelling contains 2.08 mg [
Slovenian: Končna formulacija po označitvi z radioizotopom vsebuje 2,08 mg [
English: This medicine is a radiopharmaceutical product for therapy only.
Slovenian: To zdravilo je radiofarmacevtski izdelek, namenjen samo za zdravljenje.
English: The prepared solution must be given as a slow intravenous infusion over 10 minutes.
Slovenian: Pripravljeno raztopino je treba dati v obliki počasne intravenske infuzije, ki teče 10 minut.
English: Repeated use: Data on the re-treatment of patients with Zevalin are not available.
Slovenian: Ponovna uporaba: Podatki o ponovnem zdravljenju bolnikov z zdravilom Zevalin niso na voljo.
English: Patients should be advised that fertility may be affected and that male patients may wish to consider semen cryopreservation.
Slovenian: Bolnike je treba poučiti, da zdravilo lahko vpliva na plodnost in da bodo moški bolniki morda želeli svoja semenčeca shraniti z globokim zamrzovanjem.
English: The side effects marked with two asterisks (**) were observed additionally under consolidation therapy.
Slovenian: Neželene učinke, označene z dvema zvezdicama (**), so dodatno opazili v konsolidacijski terapiji.
English: For storage conditions of the radiolabelled product, see section 6.3.
Slovenian: Za pogoje shranjevanja radioaktivnega zdravila glejte poglavje 6.3.
English: • Sepsis
Slovenian: • sepsa
English: Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Slovenian: Itrij-90 razpada z oddajanjem visokoenergijskih delcev beta, njegov fizikalni razpolovni čas pa je 64,1 h (2,67 dneva).
English: If you have been treated with other proteins (especially mouse-derived) before Zevalin treatment, you may be more likely to have an allergic reaction.
Slovenian: Če ste bili zdravljeni z drugimi beljakovinami (zlasti pridobljenimi iz miši) pred zdravljenjem z zdravilom Zevalin, so pri vas alergijske reakcije bolj verjetne.
English: Women must not breast-feed during treatment and for 12 months following the treatment.
Slovenian: Ženske ne smejo dojiti med zdravljenjem in še 12 mesecev po zdravljenju.
English: Pharmacotherapeutic group: Various therapeutic radiopharmaceuticals, ATC code: V10XX02
Slovenian: Farmakoterapevtska skupina: Razni radioterapevtiki, oznaka ATC: V10XX02
English: In the following cases, Zevalin use is not recommended since its safety and efficacy have not been established:
Slovenian: V naslednjih primerih se uporaba zdravila Zevalin ne priporoča, saj varnosti in učinkovitosti niso ugotavljali:
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEVALIN
Slovenian: KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO ZEVALIN
English: Zevalin is not used directly, but must be prepared by your healthcare professional first.
Slovenian: Zdravilo Zevalin se ne uporablja neposredno, temveč ga najprej pripravi zdravstveni delavec.
English: The maximum dose must not exceed 1200 MBq (‘megabecquerel', a unit to measure radioactivity).
Slovenian: Največji odmerek ne sme preseči 1200 MBq ("megabekerelov", merske enote za radioaktivnost).
English: It is not shed from the cell surface and does not internalise on antibody binding.
Slovenian: Ne loči se s celične površine in se po vezavi protitelesa ne internalizira.
English: (monotherapy) and <150,000/mm
Slovenian: (monoterapija) in < 150.000/mm
English: Secondary efficacy endpoints included time to disease progression (TTP) and duration of response (DR).
Slovenian: Sekundarna kriterija učinkovitosti sta bila čas do napredovanja bolezni (TTP) in trajanje odgovora (DR-duration of response).
English: Reporting suspected adverse reactions afterauthorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
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).
Slovenian: - 1. dan boste prejeli eno infuzijo rituksimaba - 7., 8. ali 9 dan boste prejeli eno infuzijo rituksimaba, ki ji bo kmalu zatem sledila ena infuzija zdravila Zevalin (v roku 4 ur).
English: The amount of radiation that your body will be exposed to due to Zevalin is smaller than with radiotherapy.
Slovenian: Količina sevanja, ki mu bo izpostavljeno vaše telo zaradi zdravila Zevalin, je manjša kot bi bila tista pri radioterapiji.
English: If the average radiochemical purity is less than 95%, the preparation must not be administered.
Slovenian: Če je povprečna radiokemična čistost manj kot 95 %, se pripravka ne sme dati.
English: Although it is not known whether ibritumomab tiuxetan is excreted in human milk, maternal IgGs are known to be excreted in human milk.
Slovenian: Čeprav ni znano ali se ibritumomab tiuksetan pri ljudeh izloča v materino mleko, je znano, da se IgG matere izloča v materino mleko.
English: 91192 Gif-sur-Yvette Cedex France
Slovenian: 91192 Gif-sur-Yvette Cedex Francija
English: Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
Slovenian: Zdravilo Zevalin se lahko infundira neposredno z ustavitvijo toka iz infuzijske vrečke in aplikacijo neposredno v linijo.
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.
Slovenian: Po 5-minutni inkubaciji izvlecite iz reakcijske viale enako količino zraka kot je pufer za pripravo formulacije, ki ga boste dodali za normalizacijo pritiska in takoj nato previdno dodajte pufer za pripravo formulacije v reakcijsko vialo in s tem končajte inkubacijo.
English: Calculate the average Radiochemical Purity (RCP) as follows:
Slovenian: 5) Izračunajte povprečno radiokemijsko čistoto (RCP - radiochemical purity), kot sledi:
English: • Additional testing that might be required for suitability assessment: Process-specific impurities:
Slovenian: • Pri ocenjevanju primernosti bo morda treba opraviti naslednje dodatne teste: Za postopek značilne nečistote:
English: If you are given Zevalin less than 4 months after chemotherapy containing the active substance fludarabine, you may have a higher risk of having a reduced number of blood cells.
Slovenian: Če dobivate zdravilo Zevalin manj kot 4 mesece po kemoterapiji, ki je vključevala zdravilno učinkovino fludarabin, je morda pri vas tveganje zmanjšanega števila krvnih celic večje.
English: If available, autologous stem cell support must be administered to manage haematological toxicity.
Slovenian: Če so na razpolago avtologne matične celice, jih je treba uporabiti kot podporo pri obvladovanju hematološke toksičnosti.
English: The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 2).
Slovenian: Primarni kriterij učinkovitosti v študiji je bil določitev ORR po kriterijih IWRC (glejte preglednico 2).
English: During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
Slovenian: V prvih 13 tednih po zdravljenju z zdravilom Zevalin se je pri bolnikih pogosto pojavila okužba.
English: However, after Yttrium-90 is added, adequate shielding of the final preparation must be maintained.
Slovenian: Po dodatku itrija-90 pa je obvezna ustrezna zaščita končnega pripravka.
English: Metal impurities Total metals*
Slovenian: Kovinske nečistote Skupne kovine*
English: Based upon dosimetry studies with [
Slovenian: Na podlagi dozimetričnih študij z [
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..
Slovenian: Potrebno je izvesti ukrepe za zaščito pred sevanjem, saj pomeni dajanje radiofarmakov tveganje za druge ljudi zaradi zunanjega sevanja ali kontaminacijo zaradi razlitega urina, bruhanja, itd.
English: Blood samples, used to calculate residence times for red marrow, were drawn up to eight time-points.
Slovenian: Krvne vzorce za izračun rezidenčnih časov v rdečem kostnem mozgu so jemali v ustreznih časovnih presledkih do 8-krat.
English: If at any time in the preparation of this product the integrity of the containers is compromised it should not be used.
Slovenian: Če se kadarkoli med pripravljanjem tega zdravila poškoduje kak vsebnik, zdravila ne smete uporabiti.
English:  0.74 MBq strontium-90 / 37 GBq yttrium-90
Slovenian:  0,74 MBq stroncij-90/ 37 GBq itrij-90
English: Your doctor will immediately stop the infusion and restart it using another vein.
Slovenian: Vaš zdravnik bo takoj ustavil infuzijo in jo prestavil na drugo žilo
English: Special caution is required with respect to bone marrow depletion.
Slovenian: Posebna previdnost je potrebna glede na zmanjšan kostni mozeg.
English: Your doctor will perform tests to exclude pregnancy before you start the treatment.
Slovenian: Vaš zdravnik bo pred začetkom zdravljenja opravil teste za izključitev nosečnosti.
English: The Package Leaflet should also be amended accordingly.
Slovenian: Ustrezno je treba spremeniti tudi navodilo za uporabo.
English: The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
Slovenian: Konjugirano protitelo ima očitno afinitetno konstanto za antigen CD20, ki znaša približno 17 nM.
English: Zevalin is indicated in adults.
Slovenian: Zdravilo Zevalin je indicirano pri odraslih.
English: Infections were very commonly observed.
Slovenian: Okužbe so opazili pogosto.
English: Must be administered by authorised personnel only.
Slovenian: Zdravilo sme aplicirati le pooblaščeno osebje.
English: WHAT ZEVALIN IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO ZEVALIN IN ZA KAJ GA UPORABLJAMO
English: The secondary endpoints, duration of response and time to progression, were not significantly different between the two treatment arms.
Slovenian: Sekundarna kriterija učinkovitosti, trajanje odgovora in čas do napredovanja se v obeh krakih študije nista značilno razlikovala.
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.
Slovenian: Za prejem, pripravo, uporabo, prenos, shranjevanje in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja/licence lokalnih pristojnih uradnih organov.
English: Zevalin attaches to a protein (CD20) on the surface of certain white blood cells (B-cells) and kills them by irradiation.
Slovenian: Zdravilo Zevalin se veže na beljakovino (DC20) na površini nekaterih belih krvnih celic (celice B) in jih uniči s sevanjem.
English: Zevalin therapeutic regimen N = 54
Slovenian: Zevalin terapevtska shema n = 54
English: Zevalin therapeutic regimen N = 73
Slovenian: Zevalin terapevtska shema n = 73
English: • Haematological toxicity
Slovenian: • Hematološka toksičnost
English: Studies on the mutagenic and carcinogenic potential of Zevalin have not been performed.
Slovenian: Študije mutagenega in tumorogenega potenciala zdravila Zevalin niso bile izvedene.
English: The radiation dose to the ovaries has not been established.
Slovenian: Odmerka sevanja za jajčnike niso ugotavljali.
English: Count each vial in a beta counter or in an appropriate counter for one minute (CPM), record net counts, corrected for background.
Slovenian: Postavite vsako od vial za eno minuto v beta števec ali drug ustrezen števec (CPM), zabeležite dobljena števila s korekcijo za ozadje.
English: Please tell your doctor that you were given Zevalin if you are due for vaccination after using it.
Slovenian: Povejte svojemu zdravniku, da ste prejemali zdravilo Zevalin, če boste po njegovi uporabi cepljeni.
English: For instructions on extemporary preparation of the medicinal product before administration,see section 12.
Slovenian: Za navodila za pripravo zdravila tik pred uporabo glejte poglavje 12.
English: The infusion must not be administered as an intravenous bolus.
Slovenian: Infuzije se ne sme dati v obliki intravenskega bolusa.
English: Name and address of the manufacturer responsible for batch release CIS bio international
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij CIS bio international
English: The maximum dose must not exceed 1200 MBq.
Slovenian: Največji odmerek ne sme preseči 1200 MBq.
English: This may include discontinuation of Zevalin therapy and treatment with growth factors or your own stem cells.
Slovenian: To lahko vključuje prekinitev zdravljenja z zdravilom Zevalin in zdravljenje z rastnimi faktorji ali lastnimi matičnimi celicami.
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).
Slovenian: Zaradi možnega tveganja za razvoj virusne okužbe se ne priporoča uporaba živih virusnih cepiv pri bolnikih, ki so pred kratkim prejeli zdravilo Zevalin (glejte poglavje 4.5).
English: Therefore, complete blood cell and platelet counts must be monitored following Zevalin treatment weekly until levels recover or as clinically indicated.
Slovenian: Zato je treba po zdravljenju z zdravilom Zevalin tedensko nadzirati skupno število krvnih celic in trombocitov, dokler se ravni ne povrnejo ali kakor je klinično indicirano.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (MedDRA).
Slovenian: Neželeni učinki so opredeljeni spodaj po pogostnosti in glede na organske sisteme (MedDRA).
English: After treatment your doctor will perform regular blood tests to check your platelet and white cell counts.
Slovenian: Po zdravljenju bo vaš zdravnik v rednih časovnih intervalih opravljal krvne preiskave za spremljanje števila trombocitov in belih krvnih celic.
English: You may, therefore, need to be tested for special antibodies.
Slovenian: Zato bodo morali pri vas opraviti preiskave za določena protitelesa.
English: The linker chelate tiuxetan forms a stable complex with the radioisotopes yttrium-90 and indium-111 and only negligible degradation due to radiolysis is expected.
Slovenian: Vezni kelat tiuksetan tvori stabilen kompleks z radioizotopoma itrijem-90 in indijem-111, pričakovana degradacija zaradi radiolize pa je zanemarljiva.
English: Please see the package leaflet for further information.
Slovenian: Glejte navodilo za uporabo za več informacij.
English: Caution: Patient dose not to exceed 1200 MBq.
Slovenian: Opozorilo: Odmerek za bolnika ne sme presegati 1200 MBq.
English: Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Slovenian: Mediani čas do najnižje točke trombocitov in granulocitov je bil približno 60 dni po začetku zdravljenja.
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“.
Slovenian: Neželeni učinki iz obdobja trženja, za katere pogostnosti ni bilo možno oceniti, so navedeni pod „neznana“.
English: Treatment consists of discontinuation of Zevalin and supportive therapy, which may include growth factors.
Slovenian: Zdravljenje temelji na prekinitvi aplikacij zdravila Zevalin in podpornem zdravljenju, ki lahko vključuje tudi rastne faktorje.
English: The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Slovenian: Tveganje za pojav sekundarne mielodisplazije ali levkemije po zdravljenju z alkilirajočimi zdravili je dobro znano.
English: In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
Slovenian: In] označenim zdravilom Zevalin, iz vzorcev krvi in s programsko opremo MIRDOSE3.
English: • Secondary malignancies
Slovenian: • Sekundarne maligne bolezni
English: Do not use Zevalin after the expiry date which is stated on the pack.
Slovenian: Zdravila Zevalin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Chloride identification
Slovenian: Identifikacija klorida
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Slovenian: Izpostavljanje ionizirajočemu sevanju je povezano z nastankom raka in možnostjo razvoja genetskih okvar.
English: Control of these metals can be achieved either through process validation or release test.
Slovenian: Te kovine se kontrolirajo bodisi z validacijo postopka ali s testiranjem ob sproščanju.
English: In patients experiencing a severe mucocutaneous reaction treatment must be discontinued.
Slovenian: Pri bolnikih s hudimi mukokutanimi reakcijami se mora zdravljenje prekiniti.