FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was time to disease progression, which did not reach statistical significance.
Slovenian: Primarni opazovani dogodek je bil čas do napredovanja bolezni, ki ni bil statistično značilen.
English: This may be due to release criteria not being met during manufacturing, the expiration time being exceeded, or the patient being unable to meet the scheduled infusion time.
Slovenian: Vzrok so lahko neizpolnjeni kriteriji za sprostitev med izdelavo, prekoračitev datuma uporabnosti zdravila ali nezmožnost bolnika, da se udeleži načrtovanega infundiranja.
English: a b b p-value
Slovenian: vrednost p
English: Patient Alert card to record the scheduled leukapheresis and infusion dates
Slovenian: Opozorilno kartico za bolnika za evidentiranje redne levkafereze in datumov infuzij
English: • Selection of patients for treatment with Provenge
Slovenian: • Izbor bolnikov za zdravljenje z zdravilom Provenge
English: As Provenge is made from your own blood cells, your cells will be collected approximately 3 days before each scheduled infusion.
Slovenian: Ker je zdravilo Provenge narejeno iz vaših lastnih krvnih celic, vam bodo približno 3 dni pred načrtovanim infundiranjem odvzeli vaše celice.
English: Gently mix and re-suspend the contents of the bag.
Slovenian: Nežno premešajte in ponovno suspendirajte vsebino vrečke.
English: Forty-eight percent of patients were receiving bisphosphonates and 18% had received prior chemotherapy, including docetaxel.
Slovenian: Oseminštirideset odstotkov bolnikov je prejemalo bisfosfonate in 18 % jih je pred tem prejelo kemoterapijo, vključno z docetakselom.
English: In such cases, the patient may need to undergo an additional leukapheresis procedure if the treatment is to be continued.
Slovenian: V takih primerih bo morda moral bolnik ponovno na postopek levkafereze, če naj se zdravljenje nadaljuje.
English: The infusion bag is placed inside an insulated polyurethane container and packed in a shipping box.
Slovenian: Infuzijska vrečka je v izoliranem poliuretanskem vsebniku, pakirana v transportno škatlo.
English: On the first day of the infusion, Provenge may cause infusion-related reactions such as:
Slovenian: Prvi dan infuzije lahko zdravilo Provenge povzroči z infundiranjem povezane reakcije, kot so:
English: Provenge is intended solely for autologous use and should under no circumstances be administered to other patients.
Slovenian: Zdravilo Provenge je namenjeno izključno za avtologno uporabo in ga v nobenih okoliščinah ni dovoljeno dajati drugim bolnikom.
English: IMPORTANT - Do not infuse Provenge if
Slovenian: POMEMBNO - ne infundirajte zdravila Provenge, če
English: Therefore, concurrent use of immunosuppressive agents (such as systemic corticosteroids) should be avoided during Provenge treatment.
Slovenian: Zato se je treba sočasni uporabo imunosupresivov (kot so sistemski kortikosteroidi) med zdravljenjem z zdravilom Provenge izogniti.
English: Provenge is designed to stimulate the immune system.
Slovenian: Zdravilo Provenge je zasnovano za spodbujanje imunskega sistema.
English: As it has to be given to you shortly after it has been manufactured, the final sterility results may not always be available before you are given your infusion of Provenge.
Slovenian: Zdravilo Provenge morate prejeti kmalu po njegovi izdelavi, končni rezultati sterilnosti morda ne bodo vedno na voljo, preden boste prejeli infuzijo z zdravilom Provenge.
English: • Provenge is infused over a period of approximately 60 minutes through a large bore needle appropriate for transfusion of red blood cells.
Slovenian: • Zdravilo Provenge se infundira približno 60 minut skozi iglo z veliko luknjo za transfuzijo eritrocitov.
English: In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C).
Slovenian: Poleg tega bodo opravili krvne preiskave za ugotavljanje prisotnosti določenih virusov (na primer HIV-1, HIV-2, hepatitis B in hepatitis C).
English: • The existence of the EU Registry of patients treated for metastatic castrate resistant prostate cancer and how to enter patients in it.
Slovenian: • Obstoj seznama EU za bolnike, zdravljene zaradi metastatskega, na skopitev odpornega raka prostate, z navodili, kako vanj vnašati bolnike.
English: The number of cells in Provenge does not exceed the number of cells from the leukapheresis.
Slovenian: Število celic v zdravilu Provenge ne presega števila celic iz levkafereze.
English: Provenge is manufactured specifically for you using your own blood and must not be used in anyone else.
Slovenian: Zdravilo Provenge je izdelano posebej za vas iz vaše krvi, zato se ne sme uporabiti pri nikomer drugem.
English: The most common reactions (≥ 20%) were chills, fever, and fatigue.
Slovenian: Najpogostejše reakcije (≥ 20 %) so bile mrzlica, zvišana telesna temperatura in utrujenost.
English: In the pivotal randomised controlled study (D9902B, IMPACT, see section 5.1) Provenge was discontinued in 1.5% of patients due to adverse reactions.
Slovenian: V osrednji randomizirani kontrolirani študiji (D9902B, IMPACT, glejte poglavje 5.1) so uporabo zdravila Provenge prekinili pri 1,5 % bolnikov zaradi neželenih učinkov.
English: 250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
Slovenian: 250 ml disperzije v vrečki (predušna poliolefinska trislojna vrečka s 3 izhodi za vzorčenje (2 igelna vhoda in 1 vhod z zatesnjenim cevjem)).
English: Other medicines and Provenge
Slovenian: Druga zdravila in zdravilo Provenge
English: The nature of Provenge is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Slovenian: Narava zdravila Provenge je taka, da običajne študije farmakokinetike, absorpcije, porazdelitve, presnove in izločanja niso smiselne.
English: This involves a procedure called leukapheresis, which consists of extracting white blood cells from your blood, usually from the veins in your arms.
Slovenian: To zajema postopek, ki se imenuje levkafereza, in predstavlja postopek odvzema belih krvnih celic iz krvi, običajno iz ven na roki.
English: In some cases, you may be unable to receive a scheduled infusion of Provenge.
Slovenian: V nekaterih primerih morda ne boste mogli prejeti načrtovane infuzije zdravila Provenge.
English: The cellular composition and the cell number per dose of Provenge will vary according to the patient's leukapheresis.
Slovenian: Celična sestava in število celic na odmerek zdravila Provenge se razlikujeta glede na levkaferezo bolnika.
English: The effects of Provenge on male fertility are not known at this time.
Slovenian: Vpliv zdravila Provenge na plodnost pri moških trenutno ni znan.
English: A third study, D9902A, similar in design to study D9901, was terminated prior to completion of planned accrual based on the time to disease progression results in study D9901.
Slovenian: Tretja študija, D9902A, po zasnovi podobna študiji D9901, je bila prekinjena pred zaključkom načrtovane osnove za zbiranje podatkov na podlagi rezultatov napredovanja bolezni v študiji D9901.
English: Provenge is an autologous cellular therapy.
Slovenian: Zdravilo Provenge je avtologna celična terapija.
English: Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure.
Slovenian: Vsako infuzijo zdravila Provenge sestavlja največje število celic, ki se lahko izdela v enem postopku levkafereze.
English: Each leukapheresis was followed approximately 3 days later by infusion of Provenge or control.
Slovenian: Vsaki levkaferezi je približno 3 dni kasneje sledila infuzija zdravila Provenge ali kontrole.
English: 36-month survival (%) a Hazard ratio and p-value based on the Cox Model adjusted for PSA (ln) and LDH (ln) and stratified by bisphosphonate use, number of bone metastases, and primary Gleason grade.
Slovenian: 36-mesečno preživetje (%) a Razmerje tveganja in vrednost p na podlagi Coxovega modela, prilagojenega za PSA (ln) in LDH (ln) in stratificiranega glede na uporabo bisfosfonata, število metastaz v kosteh in primarni rezultat po Gleasonu.
English: A statistically significant improvement in overall survival was seen in patients treated with Provenge, with a 22.5% reduction in the risk of death compared with control (see Table 2 and Figure 1).
Slovenian: Statistično značilno izboljšanje celokupnega preživetja so videli pri bolnikih, zdravljenih z zdravilom Provenge, z 22,5-% zmanjšanjem za tveganje smrti v primerjavi s kontrolo (glejte preglednico 2 in sliko 1).
English: The first step in your Provenge treatment is to collect your blood cells in order to manufacture your personal infusion of Provenge.
Slovenian: Prvi korak vašega zdravljenja z zdravilom Provenge je postopek odvzema vaših krvnih celic, ki jih bodo uporabili za izdelavo vaše osebne infuzije zdravila Provenge.
English: Patients in the control group could enrol in an open-label protocol and receive an investigational autologous cellular therapy manufactured from cells cryopreserved at the time the control product was prepared.
Slovenian: Bolniki v kontrolni skupini so se lahko vključili v odprti protokol in prejemali raziskovalno avtologno celično terapijo iz celic, krioprezerviranih v času, ko je bilo pripravljeno kontrolno zdravilo.
English: Missed treatment
Slovenian: Izpuščena zdravljenja
English: Summary of study results Table 2 presents overall survival results observed in IMPACT, study D9901, and study D9902A.
Slovenian: V preglednici 2 so predstavljeni rezultati celokupnega preživetja, ki so jih opazili v študiji IMPACT, študiji D9901 in študiji D9902A.
English: PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, in a sealed, patient-specific polyolefin bag.
Slovenian: PAP-GM-CSF, suspendiranih v 250 ml raztopine Ringerjevega laktata, v zatesnjeni, za bolnika specifični poliolefinski vrečki.
English: ▼ This medicine is subject to additional monitoring.
Slovenian: ▼ Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Provenge is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth.
Slovenian: Zdravilo Provenge se za infundiranje sprošča na podlagi rezultatov več testov prisotnosti mikrobov in sterilnosti: določanje mikrobne kontaminacije z barvanjem po Gramu, vsebnost endotoksinov in sterilnost med postopkom z 2-dnevno inkubacijo za ugotavljanje odsotnosti mikrobne rasti.
English: Patients should be carefully evaluated to determine whether it is medically appropriate to discontinue immunosuppressive agents prior to treatment with Provenge (see section 4.4).
Slovenian: Bolnike je treba skrbno oceniti, da se ugotovi, ali je medicinsko ustrezno prekiniti uporabo imunosupresiva pred zdravljenjem z zdravilom Provenge (glejte poglavje 4.4).
English: • You are on a controlled sodium/potassium diet or you have reduced kidney function.
Slovenian: • ste na dieti z nadziranim vnosom natrija/kalija ali imate zmanjšano delovanje ledvic
English: There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Slovenian: Obstajala je korelacija med celičnimi ali protitelesnimi odgovori na PAP ali PAP-GM-CSF v skupini z zdravilom Provenge in izboljšanim preživetjem.
English: Analyses of time to objective disease progression, time to clinical progression, or PSA doubling time (PSADT) did not meet statistical significance.
Slovenian: Analize časa do objektivnega napredovanja bolezni, časa do kliničnega napredovanja ali časa podvojitev PSA (PSADT) niso bile statistično značilne.
English: Some (1.2%) patients in the Provenge group were hospitalized within 1 day of infusion for management of acute infusion reactions.
Slovenian: Nekateri bolniki (1,2 %) v skupini z zdravilom Provenge so bili v 1 dnevu po infundiranju hospitalizirani zaradi obravnave akutnih reakcij na infundiranje.
English: Patients should be informed of the possibility of late onset reactions and instructed to contact their physician if symptoms of dyspnoea, bronchospasm, dizziness, rash, or pyrexia occur.
Slovenian: Bolnike je treba obvestiti o možnosti zapoznelega pojava reakcij in jim naročiti, naj se posvetujejo s svojim zdravnikom, če se pojavijo simptomi dispneje, bronhospazma, omotice, izpuščaj ali pireksija.
English: Fevers and chills generally resolved within 2 days (71.9% and 89.0%, respectively).
Slovenian: Zvišana telesna temperatura in mrzlica sta polagoma izzveneli v 2 dneh (71,9 % oz. 89,0 %).
English: Practical information for medical or healthcare professionals on handling and administration of Provenge dispersion for infusion
Slovenian: Praktične informacije za medicinsko ali zdravstveno osebje o ravnanju z zdravilom Provenge disperzija za infundiranje in dajanju zdravila
English: Older people No dose adjustment is required in the elderly population.
Slovenian: Prilagajanje odmerka za starejše bolnike ni potrebno.
English: Interim data submitted in each PSUR Final study report by 30 September 2016
Slovenian: Začasne podatke predložiti v vsakem PSUR Končno poročilo študije do 30. septembra 2016
English: The safety evaluation of Provenge is based on data from 601 prostate cancer patients in four randomized, controlled clinical trials (3 studies in metastatic castrate resistant prostate cancer and 1 study in androgen dependent prostate cancer) and post-marketing surveillance.
Slovenian: Povzetek varnostnega profila Ocena varnosti zdravila Provenge temelji na podatkih 601 bolnika z rakom prostate iz štirih randomiziranih, kontroliranih kliničnih preskušanj (3 študije metastatskega, na kastracijo odpornega raka prostate in 1 študija od androgenov odvisnega raka prostate) in iz spremljanja zdravila v obdobju trženja.
English: During ex vivo culture with PAP-GM-CSF, activated APCs (antigen presenting cells) take up and process the recombinant target antigen into peptides that are then presented to T cells.
Slovenian: V poskusih ex vivo kulture s PAP-GM-CSF, aktivirane APC celice (antigen predstavljajoče celice) privzamejo in predelajo rekombinantni ciljni antigen v peptide, ki se nato predstavijo T-celicam.
English: In the post-marketing setting, serious acute infusion reactions involving hypotension and syncope have been reported.
Slovenian: V obdobju trženja zdravila so poročali o hudih akutnih reakcijah na infundiranje, ki so vključevale hipotenzijo in sinkopo.
English: • At the request of the European Medicines Agency;
Slovenian: • Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila;
English: Practical information for handling and administration of Provenge for the doctor or nurse can be found at the end of this leaflet.
Slovenian: Praktične informacije o ravnanju z zdravilom Provenge in dajanju zdravila Provenge za zdravnike ali medicinske sestre so na koncu tega navodila.
English: Do not refrigerate or freeze the container.
Slovenian: vsebnika ne shranjujte v hladilniku in ne zamrzujte.
English: Conventional toxicology, carcinogenicity, mutagenicity, and reproductive toxicity studies have not been performed.
Slovenian: Običajnih študij toksičnosti, kancerogenosti, mutagenosti ali študij vpliva na sposobnost razmnoževanja niso opravili.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja Imetnik dovoljenja za promet mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: • feeling or being sick (nausea and vomiting)
Slovenian: • občutek slabosti ali slabost (navzea in bruhanje)
English: • damage to the product when it arrives at the clinic; for example, the bag containing the product has leaked, or the cells have formed clumps that cannot be dispersed.
Slovenian: • poškodovanje zdravila po dospetju na kliniko; na primer, vrečka z zdravilom pušča ali pa so v njej nastale grudice, ki se ne razpustijo
English: Do not administer if the bag leaks during handling or if particles or clumps remain in the bag.
Slovenian: Zdravila ne dajajte, če vrečka med rokovanjem pušča ali v njej ostanejo delci ali grudice.
English: Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group.
Slovenian: Resne okužbe so se pojavile pri 4,7 % oseb v skupini z zdravilom Provenge in pri 4,0 % oseb v kontrolni skupini.
English: The primary endpoint was time to disease progression and the secondary endpoint was overall survival.
Slovenian: Primarni opazovani dogodek je bil čas do napredovanja bolezni, sekundarni opazovani dogodek pa celokupno preživetje.
English: The most frequently occurring serious infections in the Provenge group were catheter sepsis (0.7%), staphylococcal bacteraemia (0.7%), sepsis (0.7%), staphylococcal sepsis (0.5%), and pneumonia (0.5%).
Slovenian: Resne okužbe, ki so se v skupini z zdravilom Provenge najpogosteje pojavile, so bile sepsa zaradi katetra (0,7 %), stafilokokna bakteriemija (0,7 %), sepsa (0,7 %), stafilokokna sepsa (0,5 %) in pljučnica (0,5 %).
English: Do not remove this insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for
Slovenian: Izoliranega vsebnika ne jemljite iz transportne škatle in ne odpirajte pokrova izoliranega vsebnika, dokler ni bolnik pripravljen na
English: Table 1 Adverse reactions from clinical studies and post-marketing reports System organ class
Slovenian: Preglednica 1 Neželeni učinki iz kliničnih študij in poročil v obdobju trženja
English: Eligible patients had metastatic disease in the soft tissue and/or bone with current or historical evidence of disease progression concomitant with surgical or medical castration, as evidenced by progression of serum prostate specific antigen (PSA) and/or bone or soft tissue disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Slovenian: Primerni bolniki so imeli metastatsko bolezen v mehkem tkivu in/ali kosteh z obstoječimi ali zgodovinskimi dokazi napredovanja bolezni, sočasno s kirurško kastracijo ali kastracijo z zdravili, kar je bilo dokazano z napredovanjem serumskega za prostato specifičnega antigena (PSA) in/ali bolezni kosti ali mehkega tkiva in stanjem zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 0 ali 1.
English: Provenge is designed to stimulate your immune system, and therefore it may not be appropriate to be treated with Provenge if you are currently taking other treatments that could affect the ability of your immune system to respond to Provenge e.g., immunosuppressant medicines such as those used to treat or prevent organ rejection and certain medicines used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease, and ulcerative colitis.
Slovenian: Zdravilo Provenge je zasnovano za spodbujanje vašega imunskega sistema, zato morda ni primerno, da se zdravite z zdravilom Provenge, če uporabljate druga zdravila, ki bi lahko vplivala na sposobnost vašega imunskega sistema, da se na zdravilo Provenge odzove, kot so npr. imunosupresivi, ki se uporabljajo za preprečevanje zavrnitve organa, ali nekatera zdravila za zdravljenje revmatoidnega artritisa, multiple skleroze, Crohnove bolezni in ulceroznega kolitisa.
English: Cerebrovascular disease
Slovenian: Cerebrovaskularna bolezen
English: As part of lot release, each product is assessed for activation of antigen presenting cells (APCs) by virtue of increased surface CD54 expression after culture with PAP-GM-CSF.
Slovenian: Kot del sproščanja serije se za vsako zdravilo oceni aktivacija antigen predstavljajočih celic (APC) s pomočjo večje izraženosti CD54 na površini po kulturi s PAP-GM-CSF.
English: The MAH shall also agree with the National Competent Authority any requirements for prior audit of apheresis centres and training courses for healthcare professionals in the use of Provenge.
Slovenian: Imetnik dovoljenja za promet mora prav tako dobiti soglasje pristojnega državnega organa glede zahtev za predhodno revizijo centrov za aferezo in za usposabljanje zdravstvenih delavcev v uporabi zdravila Provenge.
English: • The outer shipping box should be opened to verify the product and patient-specific labels located on the top of the insulated container.
Slovenian: • Zunanjo transportno škatlo je treba odpreti, da se preveri zdravilo in nalepke, specifične za bolnika, ki se nahajajo na vrhu izoliranega vsebnika.
English: Provenge is used to control your prostate cancer.
Slovenian: Zdravilo Provenge se uporablja za nadzor raka prostate.
English: Heart attack
Slovenian: Srčni napad
English: It is strongly recommended that upon completion of each Provenge infusion, the patient specific label on the infusion bag, which contains the patient name, product name, and chain of identity (COI) product lot number, is removed and adhered to the patient file in order to maintain a link between the patient and the lot of the product.
Slovenian: Močno se priporoča, da se po končanju vsakega infundiranja zdravila Provenge nalepka na infuzijski vrečki, s podatki, specifičnimi za bolnika, kot so bolnikovo ime, ime zdravila in številka serije zdravila z neprekinjeno verigo identitete (COI, chain of identity), odstrani in nalepi v bolnikovo kartoteko, da se ohrani vez med bolnikom in serijo zdravila.
English: If, for any reason, the patient is unable to receive a scheduled infusion of Provenge, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued.
Slovenian: Če bolnik zaradi katerega koli razloga ne more prejeti načrtovane infuzije zdravila Provenge, mora opraviti dodatni postopek levkafereze, preden se lahko potek zdravljenja nadaljuje.
English: The recommended course of treatment is 3 doses at approximately 2-week intervals.
Slovenian: Priporočeni potek zdravljenja je 3 odmerke v približno 2-tedenskih intervalih.
English: • The product integrity has been breached in any way (the infusion bag is damaged, leaks, or particles/clumps remain in the bag after gentle manual mixing).
Slovenian: • je celovitost zdravila bila na kakršen koli način okrnjena (infuzijska vrečka je poškodovana, pušča ali ima delce/grudice, ki se po nežnem ročnem mešanju ne razidejo).
English: However, as it is an autologous product, a positive test does not preclude the manufacture of the product.
Slovenian: Vendar pa je to avtologno zdravilo, zato pozitivni test ne prepreči izdelave zdravila.
English: The second step is to send your collected cells to a special manufacturing centre where they are mixed with an antigen to make them ready for your infusion.
Slovenian: V drugem koraku se odvzete celice pošljejo v posebni proizvodni obrat, kjer se jih premeša z antigenom in pripravi za infundiranje.
English: Dendreon UK Limited 41 Chalton Street London, NW1 1JD United Kingdom Tel: (0)20 7554 2222
Slovenian: Dendreon UK Limited 41 Chalton Street London, NW1 1JD Velika Britanija Tel.: (0)20 7554 2222
English: It must be ensured that the APPROVED Final Product Disposition Notification form has been received from the marketing authorisation holder and the product has not expired (see section 6.6).
Slovenian: Zagotoviti je treba, da ste od imetnika dovoljenja za promet z zdravilom prejeli ODOBREN obrazec z obvestilom o končnem razpolaganju z zdravilom in da zdravilu ni potekel rok uporabe (glejte poglavje 6.6).
English: Prior to the first leukapheresis procedure, a complete blood count (CBC) test should be performed and be within ranges acceptable for the local facility.
Slovenian: Pred prvim postopkom levkafereze je treba opraviti preiskavo celotne krvne slike; rezultati morajo biti v razponu, sprejemljivem za lokalno ustanovo.
English: The incidence of severe reactions was greater following the second infusion (2.1% vs. 0.8% following the first infusion), and decreased to 1.3% following the third infusion.
Slovenian: (2,1 % v primerjavi z 0,8 % po prvem infundiranju), in se je po tretjem infundiranju zmanjšala na 1,3 %.