natgillin/translations-raw huggingface dataset:
The Package Leaflet should also be amended accordingly.
Ustrezno je treba spremeniti tudi navodilo za uporabo.
The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
Konjugirano protitelo ima očitno afinitetno konstanto za antigen CD20, ki znaša približno 17 nM.
Zevalin is indicated in adults.
Zdravilo Zevalin je indicirano pri odraslih.
Infections were very commonly observed.
Okužbe so opazili pogosto.
Must be administered by authorised personnel only.
Zdravilo sme aplicirati le pooblaščeno osebje.
WHAT ZEVALIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZEVALIN IN ZA KAJ GA UPORABLJAMO
The secondary endpoints, duration of response and time to progression, were not significantly different between the two treatment arms.
Sekundarna kriterija učinkovitosti, trajanje odgovora in čas do napredovanja se v obeh krakih študije nista značilno razlikovala.
Its receipt, preparation, use, transfer, storage, and disposal are subject to the regulations and/or appropriate authorisation/licences of the local competent official organisations.
Za prejem, pripravo, uporabo, prenos, shranjevanje in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja/licence lokalnih pristojnih uradnih organov.
Zevalin attaches to a protein (CD20) on the surface of certain white blood cells (B-cells) and kills them by irradiation.
Zdravilo Zevalin se veže na beljakovino (DC20) na površini nekaterih belih krvnih celic (celice B) in jih uniči s sevanjem.
Zevalin therapeutic regimen N = 54
Zevalin terapevtska shema n = 54
Zevalin therapeutic regimen N = 73
Zevalin terapevtska shema n = 73
Studies on the mutagenic and carcinogenic potential of Zevalin have not been performed.
Študije mutagenega in tumorogenega potenciala zdravila Zevalin niso bile izvedene.
The radiation dose to the ovaries has not been established.
Odmerka sevanja za jajčnike niso ugotavljali.
Count each vial in a beta counter or in an appropriate counter for one minute (CPM), record net counts, corrected for background.
Postavite vsako od vial za eno minuto v beta števec ali drug ustrezen števec (CPM), zabeležite dobljena števila s korekcijo za ozadje.
Please tell your doctor that you were given Zevalin if you are due for vaccination after using it.
Povejte svojemu zdravniku, da ste prejemali zdravilo Zevalin, če boste po njegovi uporabi cepljeni.
For instructions on extemporary preparation of the medicinal product before administration,see section 12.
Za navodila za pripravo zdravila tik pred uporabo glejte poglavje 12.
The infusion must not be administered as an intravenous bolus.
Infuzije se ne sme dati v obliki intravenskega bolusa.
Name and address of the manufacturer responsible for batch release CIS bio international
Ime in naslov izdelovalca, odgovornega za sproščanje serij CIS bio international
The maximum dose must not exceed 1200 MBq.
Največji odmerek ne sme preseči 1200 MBq.
This may include discontinuation of Zevalin therapy and treatment with growth factors or your own stem cells.
To lahko vključuje prekinitev zdravljenja z zdravilom Zevalin in zdravljenje z rastnimi faktorji ali lastnimi matičnimi celicami.
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).
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).
Therefore, complete blood cell and platelet counts must be monitored following Zevalin treatment weekly until levels recover or as clinically indicated.
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.
Adverse reactions listed below are classified according to frequency and System Organ Class (MedDRA).
Neželeni učinki so opredeljeni spodaj po pogostnosti in glede na organske sisteme (MedDRA).
After treatment your doctor will perform regular blood tests to check your platelet and white cell counts.
Po zdravljenju bo vaš zdravnik v rednih časovnih intervalih opravljal krvne preiskave za spremljanje števila trombocitov in belih krvnih celic.
You may, therefore, need to be tested for special antibodies.
Zato bodo morali pri vas opraviti preiskave za določena protitelesa.
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.
Vezni kelat tiuksetan tvori stabilen kompleks z radioizotopoma itrijem-90 in indijem-111, pričakovana degradacija zaradi radiolize pa je zanemarljiva.
Please see the package leaflet for further information.
Glejte navodilo za uporabo za več informacij.
Caution: Patient dose not to exceed 1200 MBq.
Opozorilo: Odmerek za bolnika ne sme presegati 1200 MBq.
Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Mediani čas do najnižje točke trombocitov in granulocitov je bil približno 60 dni po začetku zdravljenja.
The adverse drug reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known“.
Neželeni učinki iz obdobja trženja, za katere pogostnosti ni bilo možno oceniti, so navedeni pod „neznana“.
Treatment consists of discontinuation of Zevalin and supportive therapy, which may include growth factors.
Zdravljenje temelji na prekinitvi aplikacij zdravila Zevalin in podpornem zdravljenju, ki lahko vključuje tudi rastne faktorje.
The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Tveganje za pojav sekundarne mielodisplazije ali levkemije po zdravljenju z alkilirajočimi zdravili je dobro znano.
In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
In] označenim zdravilom Zevalin, iz vzorcev krvi in s programsko opremo MIRDOSE3.
• Secondary malignancies
• Sekundarne maligne bolezni
Do not use Zevalin after the expiry date which is stated on the pack.
Zdravila Zevalin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Izpostavljanje ionizirajočemu sevanju je povezano z nastankom raka in možnostjo razvoja genetskih okvar.
Control of these metals can be achieved either through process validation or release test.
Te kovine se kontrolirajo bodisi z validacijo postopka ali s testiranjem ob sproščanju.
In patients experiencing a severe mucocutaneous reaction treatment must be discontinued.
Pri bolnikih s hudimi mukokutanimi reakcijami se mora zdravljenje prekiniti.
Store the vials in the original container in order to protect from light.
Viale shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Potrebno je skrbno spremljanje pojava ekstravazacije v času injiciranja zdravila Zevalin, da se prepreči poškodovanje tkiva zaradi sevanja.
Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Y] označeno zdravilo Zevalin sme sprejeti, uporabljati in aplicirati le strokovno usposobljeno osebje, ki ga mora pripraviti v skladu z zahtevami za varstvo pred sevanjem in farmacevtsko kakovost (za več podrobnosti glejte tudi poglavja 4.4, 6.6 in 12).
The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Korist uporabe zdravila Zevalin po zdravljenju z rituksimabom v kombinaciji s kemoterapijo, ni bila potrjena.
The path length of beta emission (90) by yttrium-90 in tissue is 5 mm.
Domet delcev (sevanja) beta (90) itrija-90 v tkivu je 5 mm.
The product of radioactive decay is stable zirconium-90.
Produkt radioaktivnega razpada je stabilen cirkonij-90.
Y] ibritumomab tiuxetan in a total volume of 10 ml.
Y] ibritumomab tiuksetana v skupnem volumnu 10 ml.
If your doctor plans to treat you with some other antibody after treatment with Zevalin, you will need to be tested for special antibodies.
Če vas namerava vaš zdravnik zdraviti z drugimi protitelesi po zdravljenju z zdravilom Zevalin, boste morali opraviti tudi preiskave za določena protitelesa.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or approporiate licences of the competent official organisation.
Za njihov sprejem, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja/licence pristojne uradne organizacije.
Total organic carbon (e.g. organic chelators)
Skupni organski ogljik (npr. organski kelatorji)
PFS increased from 13.5 months (control) to 37 months (Zevalin; p<0.0001; HR 0.465).
PFS se je podaljšalo s 13,5 mesecev (kontrolne osebe) na 37 mesecev (Zevalin, p < 0,0001, razmerje ogroženosti 0,465).
Complete Response Rate (%)
Popolni odgovor (%)
The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Terapija z zdravilom Zevalin je potekala v dveh fazah (glejte poglavje 4.2).
• severe mucous membrane reactions, which may occur days or months after Zevalin and/or rituximab administration.
• hude reakcije sluznice, ki se lahko pojavijo dneve ali mesece po dajanju zdravila Zevalin in/ali riuksimaba.
Empty
prazna
10 ml of formulation buffer
10 ml pufra za pripravo formulacije
Infusions must be administered under the close supervision of an experienced physician with full resuscitation facilities immediately available (for radiopharmaceutical precautions see also sections ‘4.2 and 12').
Infuzijo se daje pod skrbnim nadzorom izkušenega zdravnika v prostoru, ki je ustrezno opremljen s celotno, takoj dosegljivo opremo za oživljanje (za previdnostne ukrepe v zvezi z radiofarmaki glejte tudi poglavji 4.2 in 12).
• Risk Management Plan (RMP) The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v farmakovigilančnem načrtu, dogovorjenem v različici 1.1 načrta za obvladovanje tveganja (RMP), predloženi v modulu 1.8.2 vloge za dovoljenje za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Appropriate aseptic precautions must be taken, complying with the requirements of Good Manufacturing Practice of pharmaceuticals.
Upoštevati je treba ustrezne previdnostne ukrepe za zagotavljanje aseptičnih pogojev, ki so v skladu z Dobro proizvodno prakso za zdravila.
Due to the exposure to ionising radiation derived from the radiolabel, a risk of mutagenic and carcinogenic effects has to be taken into account.
Zaradi izpostavljenosti ionizirajočemu sevanju, ki izvira iz radioaktivnega markerja, je treba upoštevati možnost mutagenih in tumorogenih učinkov.
Grade 3 and grade 4 infections were reported commonly.
Pogosto so poročali o okužbah 3. in 4. stopnje.
In clinical studies, the [
V kliničnih študijah je povzročilo z [
After radiolabelling, immediate use is recommended.
Po označevanju z radioizotopom se priporoča takojšnja uporaba.
In case of a potential severe infusion reaction treatment must be stopped immediately.
V primeru potencialno hude reakcije je treba zdravljenje z infuzijo takoj prekiniti.
These reports originated either from clinical trials or from postmarking experience.
Poročila izvirajo iz kliničnih preskušanj ali iz obdobja trženja.
In particular, your doctor will need to interrupt treatment with growth factors such as filgrastim for a period of three weeks before giving you Zevalin to two weeks after Zevalin treatment.
Vaš zdravnik bo moral prekiniti predvsem zdravljenje z rastnimi faktorji kot je filgrastim za obdobje treh tednov, v katerem prejemate zdravilo Zevalin, in dva tedna po zdravljenju z zdravilom Zevalin.
Zevalin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Uporaba zdravila Zevalin se ne priporoča pri otrocih in mladostnikih, mlajših od 18 let, ker ni na voljo dovolj podatkov o varnosti in učinkovitosti.
The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied.
Študij varnosti in učinkovitosti imunizacije s katerimkoli cepivom, zlasti z živimi virusnimi vakcinami, po zdravljenju z zdravilom Zevalin niso izvedli.
Since Zevalin is used after pretreatment with rituximab (for details see section 4.2), see also the prescribing information of rituximab.
Ker se zdravilo Zevalin uporablja po predhodnem zdravljenju z rituksimabom (za podrobnosti glejte poglavje 4.2), glejte tudi informacije o predpisovanju rituksimaba.
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.
Bolniki brez odgovora so bili tisti, pri katerih po zadnjem predhodnem zdravljenju z rituksimabom ni prišlo do popolne ali delne remisije, oziroma, če je bil čas do napredovanja bolezni (TPP - time to progress) < 6 mesecev.
Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C and protected from light.
Ugotovljeno je bilo, da je raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi od 2 °C - 8 °C in zaščitena pred svetlobo.
Overall Response Rate (%)
Celokupni odgovor (%)
In most patients, administration of Zevalin (after pretreatment with rituximab) results in severe and prolonged cytopenia which is generally reversible (see section 4.8).
Pri večini bolnikov povzroči dajanje zdravila Zevalin (po predhodnem zdravljenju z rituksimabom) hudo in dolgo trajajočo citopenijo, ki je večinoma reverzibilna (glejte poglavje 4.8).
No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
Na voljo ni podatkov o bolnikih z limfomom osrednjega živčevja, ker ti bolniki niso bili vključeni v klinične študije.
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.
Vsebina kompleta je namenjena samo uporabi pri pripravi ibritumomab tiuksetana, označenega z radioaktivnim itrijem-90, in je ne smete dati neposredno bolniku, ne da bi prej izvedli postopek priprave.
Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [
Analizo ocenjenega absorbirane doze sevanja radioaktivnosti so opravljali s kvantitativno analizo slike s sevalcem gama - z [
In addition, Zevalin is not recommended for the use in patients with non-Hodgkin's lymphoma involving the brain and/or spinal cord as those patients were not included in clinical studies.
Poleg tega se uporaba zdravila Zevalin ne priporoča pri bolnikih z ne-Hodgkinovim limfomom, ki zajema možgane in/ali hrbtenjačo, saj ti bolniki niso bili vključeni v klinične študije.
Place ITLC strip in the developing chamber and allow the solvent front to migrate past the 5.4 cm mark.
3) Vstavite ploščico za ITLC v razvijalno komoro in pustite, da fronta topila potuje prek oznake 5,4 cm.
Induction therapies included CVP n=106, CHOP (-like) n=188, fludarabine combinations n=22, chlorambucil n=39 and rituximab-chemotherapy combinations n=59.
Med indukcijskimi zdravljenji so bile CVP (n = 106), CHOP oz. podobne (n = 188), kombinacije s fludarabinom (n = 22), klorambucil (n = 39) in kombinacije kemoterapije in rituksimaba (n = 59).
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.
Treba je navesti, da je pogostnost "pogosti", ki je pripisana temu neželenemu učinku zdravila, pridobljena iz študije konsolidacijskega zdravljenja po nastopu remisije, pri predhodno nezdravljenih bolnikih s folikularnim limfomom.
• The usual dose is 11 or 15 MBq per kg body weight, depending on your blood platelet count.
• Običajni odmerek je 11 ali 15 MBq na kg telesne mase, odvisno od števila trombocitov.
The dose of Zevalin depends on your body weight, blood platelet counts and what Zevalin is being used for (indication).
Odmerek zdravila Zevalin je odvisen od vaše telesne mase, števila trombocitov in namena uporabe zdravila Zevalin (indikacija).
• extravasation (leakage of the infusion to the surrounding tissue): pain, burning sensation, stinging or another reaction at the infusion site during administration.
• ekstravazacija (iztekanje infuzije v okoliško tkivo): bolečina, pekoč občutek, zbadanje ali druge reakcije na mestu infundiranja med dajanjem infuzije.
The recommended radioactivity dose of [
Priporočen odmerek radioaktivnosti z [
The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied (see also section ‘Special warnings and precautions for use').
Študij varnosti in učinkovitosti imunizacije s katerimkoli cepivom, zlasti z živimi virusnimi cepivi, po zdravljenju z zdravilom Zevalin niso izvedli (glejte tudi poglavje Posebna opozorila in previdnostni ukrepi).
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.
CD20 pozitivnih celic B. Farmakodinamična analiza je pokazala, da je ta učinek le začasen; v 6 mesecih so se začele normalne celice B ponovno regenerirati, njihovo mediano število pa je 9 mesecev po zdravljenju bilo znotraj meja normalnih vrednosti.
The efficacy and safety of a variation of the Zevalin therapeutic regimen employing a reduced dose of ibritumomab tiuxetan [
Učinkovitost in varnost različice terapevtske sheme z zdravilom Zevalin, pri kateri so uporabljali nižje odmerke ibritumomab tiuksetana [
What Zevalin is and what it is used for What you need to know before you are given Zevalin How to use Zevalin
Kaj je zdravilo Zevalin in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Zevalin Kako uporabljati zdravilo Zevalin Možni neželeni učinki
A potentially limited ability to generate a primary or anamnestic humoral response to any vaccine following Zevalin treatment has to be taken into consideration.
Zevalin potencialno omejena sposobnost generiranja primarnega ali anamnestično humoralnega odziva na katerokoli cepivo.
A 0.2 or 0.22 micron low protein-binding filter must be on line between the patient and the infusion port.
Na liniji med bolnikom in infuzijskim vhodom mora biti nameščen 0,2- ali 0,22mikronski filter, ki veže beljakovine z nizko molekulsko maso.
Like all medicines, Zevalin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Zevalin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Pri sedmih bolnikih (3,4 %, 7/204) so po zdravljenju z zdravilom Zevalin postavili diagnozo MDS/AML, v kontrolnem kraku pa pri enem bolniku (0,5 %, 1/205), ob medianem spremljanju 7,3 leta.
Study 2 was a randomized, controlled, multicenter study comparing the Zevalin therapeutic regimen versus treatment with rituximab.
Druga študija je bila randomizirana, kontrolirana, multicentrična študija, v kateri so terapevtsko shemo zdravljenja z zdravilom Zevalin primerjali z zdravljenjem z rituksimabom.
After use of Zevalin, patients must generally be tested for HAMA before any further treatment with murine-derived proteins.
Po uporabi zdravila Zevalin je treba bolnike praviloma testirati za prisotnost HAMA pred nadaljevanjem zdravljenja z beljakovinami, pridobljenimi iz glodavcev.
In a secondary analysis comparing objective response to the Zevalin therapeutic regimen with that observed with the most recent treatment with rituximab, the median duration of response following the Zevalin therapeutic regimen was 6 vs. 4 months.
V sekundarni analizi, kjer so primerjali objektivne odgovore na terapevtsko shemo z zdravilom Zevalin s tistimi, ki so jih dosegli z najnovejšim zdravljenjem z retuksimabom, je bilo srednje trajanje odgovora po zdravljenju z zdravilom Zevalin 6 mesecev, z retuksimabom pa 4 mesece.
Patients who have developed HAMAs may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Pri bolnikih, ki so razvili HAMA, se lahko pri zdravljenju z zdravilom Zevalin ali z drugimi beljakovinami, pridobljenimi iz glodavcev pojavijo alergijske ali preobčutljivostne reakcije.
• Low counts of blood cells: unusual bruising, more bleeding then usual after injury, fever, or if you feel unusually tired or breathless
• nizko število krvnih celic:nenavadne podplutbe, več krvavitev, kot je navadno po poškodbi, zvišana telesna temperatura ali nenavadna utrujenost ali če ste brez sape
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Radiofarmake smejo sprejemati, uporabljati in dajati bolnikom samo pooblaščene osebe v za to določenem kliničnem okolju.
The risk of haematological toxicity may be increased after prior therapy with fludarabine containing regimens (for details see section 4.5).
Tveganje za hematološko toksičnost se lahko zveča po predhodnem zdravljenju s fludarabinom (za podrobnosti glejte poglavje 4.5).
• 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).
• alergijske (preobčutljivostne) reakcije/reakcije na infuzijo: simptomi alergijskih reakcij/reakcij na infuzijo so lahko kožne reakcije, težave z dihanjem, oteklost, srbenje, oblivanje, mrzlica, omotičnost (kot možen znak za nizek krvni pritisk).
In case of hypersensitivity reactions, Zevalin infusion must be stopped immediately.
V primeru preobčutljivostnih reakcij je treba infundiranje zdravila Zevalin takoj prenehati.
The use of Zevalin is associated with an increased risk of secondary malignancies, including acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS), (see also section 4.8).
Uporaba zdravila Zevalin je povezana z zvečanim tveganjem za sekundarne maligne bolezni, vključno z akutno mieloidno levkemijo (AML) in mielodisplastičnim sindromom (MDS) (glejte tudi poglavje
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.
Volumen dodane raztopine natrijevega acetata je enak 1,2-kratnemu volumnu itrijevega-90 klorida, ki se prenese v 2. fazi.
The single and repeated dose toxicity studies of the non-radioactive compound in cynomolgus monkeys did not indicate any other risk than the expected B-cell depletion arising from the use of ibritumomab tiuxetan alone or in combination with rituximab.
Študije toksičnosti ne-radioaktivnih sestavin po enkratnem in večkratnem odmerjanju pri opicah vrste Macacca fascicularis niso pokazale nobenega drugega tveganja razen pričakovanega zmanjšanja števila celic B zaradi uporabe ibritumomab tiuksetana samega ali v kombinaciji z rituksimabom.
- Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, or to any of the excipients listed in section 6.1.
- preobčutljivost na ibritumomab tiuksetan, itrijev klorid ali katero koli pomožno snov, navedeno v poglavju 6.1;