FrancophonIA/ELRC3.0 huggingface dataset:
English: This peripheral delivery system is commonly used in clinical practice for the transfusion of blood components.
Slovenian: Ta periferni dostavni sistem se pogosto uporablja v klinični praksi za transfuzijo krvnih komponent.
English: Fax: (0)20 7554 2201 dendreonuk@dendreon.com
Slovenian: Faks: (0)20 7554 2201 dendreonuk@dendreon.com
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/867/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/867/001
English: Your treatment will involve at least 6 visits to the cell collection site and/or clinic.
Slovenian: Vaše zdravljenje bo obsegalo vsaj 6 obiskov na mestu za odvzem celic in/ali v kliniki.
English: The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Slovenian: Mediana starost je bila 71, 90 % bolnikov je bilo belcev, vsi pa so imeli pričakovano življenjsko dobo vsaj 6 mesecev.
English: The medicinal product should be used immediately.
Slovenian: Zdravilo je treba porabiti takoj.
English: The clinical significance is uncertain.
Slovenian: Klinični pomen ni znan.
English: The most severe side effects are described below:
Slovenian: Najpogostejši resni neželeni učinki so opisani spodaj:
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To vključuje tudi zdravila, ki ste jih kupili brez recepta in rastlinska zdravila.
English: In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate.
Slovenian: Pri 95,1 % bolnikov, ki so poročali akutne reakcije na infundiranje, so bili dogodki blagi ali zmerni.
English: All patients had baseline testosterone levels < 50 ng/mL.
Slovenian: Vsi bolniki so imeli ravni testosterona ob izhodišču < 50 ng/ml.
English: This procedure will take 3 to 4 hours (see section “Steps before Provenge treatment” below).
Slovenian: Ta postopek traja 3 do 4 ure (glejte poglavje "Koraki pred zdravljenjem z zdravilom Provenge" spodaj).
English: b Hazard ratio based on the unadjusted Cox Model.
Slovenian: b Razmerje tveganja na podlagi neprilagojenega Coxovega modela.
English: Since this medicine will be given by a qualified doctor or nurse, they are responsible for the correct disposal of the product.
Slovenian: Ker bo zdravilo predano usposobljenemu zdravniku ali medicinski sestri, sta odgovorna za pravilno odstranitev zdravila.
English: No data are available for these patients.
Slovenian: Podatki za te bolnike niso na voljo.
English: The first infusion of Provenge will be given approximately 3 days after the cell collection and will last approximately 1 hour (see also section 2 “Warnings and precautions”).
Slovenian: Prvo infuzijo zdravila Provenge boste prejeli približno 3 dni po odvzeli celic in bo trajala približno 1 uro (glejte tudi poglavje 2 "Opozorila in previdnostni ukrepi").
English: This test will determine whether you have enough blood cells to allow the leukapheresis procedure to be safely carried out.
Slovenian: S tem testom se določi, ali imate dovolj krvnih celic za varno izvedbo postopka levkafereze.
English: In case of using premedication, the status of the patient and possible contraindications/interactions should be taken into account.
Slovenian: V primeru uporabe premedikacije je treba upoštevati stanje bolnika in možne kontraindikacije/medsebojno delovanje.
English: Additionally, there is the small possibility/risk of transmitting infectious viruses to a patient if he is not the intended recipient of the product.
Slovenian: Dodatno obstaja tudi majhna možnost/tveganje za prenos kužnih virusov na bolnika, če ni prejemnik, ki mu je to zdravilo namenjeno.
English: Concurrent use of immunosuppressive agents (such as systemic corticosteroids) may alter its efficacy and/or safety.
Slovenian: Sočasna uporaba imunosupresivov (kot so sistemski kortikosteroidi) lahko spremeni njegovo učinkovitost in/ali varnost.
English: • A heart condition including blocked blood vessels which could lead to a heart attack
Slovenian: • bolezen srca, vključno z zamašenimi krvnimi žilami, kar lahko povzroči srčni napad
English: Overall survival Median, months (95% CI) Hazard ratio (95% CI)
Slovenian: Celokupno preživetje Mediana, meseci (95-% IZ) Razmerje tveganj (95-% IZ)
English: The doses of paracetamol and antihistamine given should be in accordance with local practice.
Slovenian: Odmerka paracetamola in antihistaminika je treba dati v skladu z lokalno prakso.
English: It is recommended that the minimum interval between leukapheresis procedures should not be less than 2 weeks.
Slovenian: Priporoča se, da čas med postopki levkafereze znaša najmanj 2 tedna.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Slovenian: Farmakoterapevtska skupina: Imunostimulanti, drugi imunostimulanti, oznaka ATC: L03AX17.
English: The entire volume of the infusion bag should be used.
Slovenian: Uporabiti je treba celotno količino infuzijske vrečke.
English: If you experience any of the following side effects several days after the infusion, contact a doctor immediately:
Slovenian: Če se pojavi kateri koli od naslednjih neželenih učinkov več dni po infundiranju, se takoj posvetujte z zdravnikom:
English: Final study report by 31 December 2020
Slovenian: Končno poročilo študije do 31. decembra 2020
English: Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: IMPACT study
Slovenian: Študija IMPACT
English: Educational material for patients and/or carers to explain:
Slovenian: Izobraževalno gradivo za bolnike in / ali oskrbovalno osebje, ki pojasnjuje:
English: You can also report any 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: After removal from the insulated container
Slovenian: Po odstranitvi iz izoliranega vsebnika
English: It consists of immune cells (part of your body's natural defense system) taken from your own blood (also called autologous immune cells).
Slovenian: Sestavljajo ga imunske celice (del naravnega obrambnega sistema telesa), pridobljene iz vaše krvi (imenovane tudi avtologne imunske celice).
English: No specific dose recommendation can be provided in these patients.
Slovenian: Specifičnega priporočila za odmerjanje pri teh bolnikih ni mogoče dati.
English: What Provenge is and what it is used for
Slovenian: Kaj je zdravilo Provenge in za kaj ga uporabljamo
English: In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Slovenian: Poleg antigen predstavljajočih celic (APC, antigen presenting cells) tako vsebuje končno zdravilo tudi celice T, celice B, naravne ubijalke (NK, natural killer) in druge celice.
English: This will be added to your Patient Alert Card that you should bring to each appointment.
Slovenian: Priložil ga bo vaši kartici z opozorili za bolnika, ki jo morate prinesti na vsak obisk.
English: Small clumps of cellular material should disperse with gentle manual mixing.
Slovenian: Majhne grudice celičnega materiala se morajo z nežnim ročnim mešanjem raziti.
English: Appropriate medical therapy should be administered as needed.
Slovenian: Uvesti je treba ustrezno terapijo z zdravili, kot je potrebno.
English: Therefore, vaccinations with live attenuated or inactivated vaccines whilst receiving Provenge should be carefully considered.
Slovenian: Zato je treba cepljenje z živimi oslabljenimi ali inaktiviranimi cepivi med prejemanjem zdravila Provenge skrbno pretehtati.
English: Patients should be observed for at least 30 minutes following each infusion.
Slovenian: Bolnike je treba opazovati vsaj 30 minut po vsakem infundiranju.
English: Your blood will be tested before it is collected (see section “Tests” below).
Slovenian: Pred odvzemom bodo vaši kri testirali (glejte poglavje "Testi" spodaj).
English: If the final results show that your medicine was not sterile, your doctor will be notified and you will be monitored closely for any signs of infection and will be treated accordingly.
Slovenian: Če končni rezultati pokažejo, da vaše zdravilo ni bilo sterilno, bo o tem obveščen vaš zdravnik, ki bo pri vas skrbno spremljal znake okužbe in jih bo ustrezno zdravil.
English: Thirty-five percent of patients had undergone radical prostatectomy, 54% had received local radiotherapy, and 82% had received combined androgen blockade.
Slovenian: Petintrideset odstotkov bolnikov je imelo radikalno prostatektomijo, 54 % jih je prejelo lokalno radioterapijo in 82 % jih je prejelo kombinirano androgensko blokado.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c (7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Conventional reproductive and development toxicity studies are not considered relevant given the nature and the intended clinical use of this autologous cell therapy product.
Slovenian: Običajne študije vpliva na sposobnost razmnoževanja in razvojne toksičnosti niso pomembne glede na naravo in nameravano klinično uporabo tega zdravila iz avtolognih celic.
English: • a delay in Provenge reaching the clinic where you will be given your treatment.
Slovenian: • zamuda dostave zdravila Provenge na kliniko, kjer boste deležni zdravljenja
English: Your doctor may decide that Provenge is not suitable for you due to one or more of these conditions.
Slovenian: Vaš zdravnik se lahko odloči, da zdravilo Provenge zaradi enega ali več od obstoječih stanj za vas ni primerno.
English: Patients did not require opioid analgesics for pain management and the majority had not received prior chemotherapy.
Slovenian: Bolniki za obravnavo bolečin niso potrebovali opioidnih analgetikov, večina pa predhodno ni prejela kemoterapije.
English: Dose and course of treatment
Slovenian: Odmerek in potek zdravljenja
English: Figure 1 Kaplan-Meier overall survival curve, IMPACT study
Slovenian: Slika 1 Splošna krivulja preživetja po Kaplan-Meierju, študija IMPACT
English: Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
Slovenian: Nekatere resne okužbe in sepsa so bili povezani z uporabo centralnih venskih katetrov (CVC, central venous catheter).
English: The risks and benefits of vaccinating patients during the course of treatment with Provenge have not been studied.
Slovenian: Tveganj in koristi cepljenja bolnikov med zdravljenjem z zdravilom Provenge niso preučili.
English: Following randomization, patients from both treatment groups underwent a series of 3 leukapheresis procedures (at approximately 2 week intervals, range 1 to 15 weeks).
Slovenian: Po randomizaciji so imeli bolniki iz obeh skupin zdravljenja serijo 3 postopkov lefkafereze (v približno 2tedenskih intervalih, v razponu 1 do 15 tednov).
English: • Only one of the 2 spike ports should be used and should not be opened prior to administration in order to avoid contamination.
Slovenian: • Uporabi se lahko samo en od 2 vhodov za igle, ki se ga lahko odpre šele pred dajanjem, da se prepreči kontaminacija.
English: Summary of Product Characteristics (SmPC) 2.
Slovenian: Povzetek glavnih značilnosti zdravila (SmPC)
English: Provenge should be infused intravenously over a period of approximately 60 minutes.
Slovenian: Zdravilo Provenge je treba infundirati intravensko v približno 60-minutnem obdobju.
English: It is important that you read the entire content of this procedure prior to administering Provenge.
Slovenian: Pomembno je, da preberete celotno vsebino tega postopka, preden bolniku aplicirate zdravilo Provenge.
English: Tell your doctor or nurse if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Slovenian: Svojemu zdravniku ali medicinski sestri povejte, če se pojavi kateri od teh simptomov, saj bo morda treba infundiranje upočasniti ali ustaviti.
English: A total of 512 patients were randomised in a 2:1 ratio to receive Provenge (n=341) or control (n=171).
Slovenian: Skupaj je bilo randomiziranih 512 bolnikov v razmerju 2:1 v prejemanje zdravila Provenge (n = 341) ali kontrole (n = 171).
English: A machine is used to take blood from one arm, extract the white blood cells and return the rest of the blood to you, usually in the other arm.
Slovenian: Naprava vam jemlje kri iz ene roke, odvzame iz nje bele krvne celice, preostalo kri pa vam vrne, običajno v drugo roko.
English: The entire volume of the bag should be infused.
Slovenian: Infundirati je treba celotno količino vrečke.
English: Patients should be advised not to drive or use machines if they experience these symptoms following their infusion.
Slovenian: Bolnike je treba opozoriti, da naj ne vozijo ali upravljajo strojev, če po infundiranju opazijo te simptome.
English: The efficacy and safety of Provenge in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were studied in three similar Phase III, randomised, double-blind, controlled, multicentre trials: D9902B (IMPACT), D9901, and D9902A.
Slovenian: Učinkovitost in varnost zdravila Provenge pri bolnikih z asimptomatskim ali minimalno simptomatskim metastatskim, na kastracijo odpornim rakom prostate, so preučili v treh podobnih randomiziranih, dvojno slepih, kontroliranih, multicentričnih preskušanjih 3. faze: D9902B (IMPACT), D9901 in D9902A.
English: The primary endpoint was overall survival.
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje.
English: Patients with cardiac or pulmonary conditions should be closely monitored (see section 4.8).
Slovenian: Bolnike s srčnimi ali pljučnimi stanji je treba skrbno nadzirati (glejte poglavje 4.8).
English: Very common side effects (may affect more than 1 in 10 patients):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: What to check prior to infusion
Slovenian: Kaj je treba pred infundiranjem preveriti
English: Citrate is generally the preferred anticoagulant used during leukapheresis and can result in hypocalcaemia.
Slovenian: Citrat je na splošno prednostni antikoagulant, ki se uporablja med levkaferezo in lahko povzroči hipokalciemijo.
English: In such cases, if your doctor decides that the course of treatment should be continued, he or she will arrange for another collection of your blood cells (leukapheresis) and the manufacturing process will be repeated (see information on leukapheresis in section 3).
Slovenian: V teh primerih bo zdravnik, če se odloči za nadaljevanje zdravljenja, uredil ponovni odvzem vaših krvnih celic (levkafereza), postopek izdelave pa bo ponovljen (za informacije o levkaferezi glejte poglavje 3).
English: Each Provenge bag contains one individual infusion treatment and the container will only be opened when you are ready to receive your treatment.
Slovenian: Vsaka vrečka zdravila Provenge vsebuje odmerek za eno individualno zdravljenje z infundiranjem, vsebnik pa se bo odprlo samo, ko boste pripravljeni na sprejem zdravila.
English: These immune cells are then mixed with an antigen (a protein, which is able to stimulate your immune system) at a specific manufacturing facility.
Slovenian: Te imunske celice se nato premešajo z antigenom (beljakovino, ki lahko spodbuja vaš imunski sistem) v posebnem proizvodnem obratu.
English: Immunocompromised patients and patients taking systemic immunosuppressive therapy were excluded from controlled clinical trials.
Slovenian: Imunokompromitirani bolniki in bolniki, ki uporabljajo sistemsko imunosupresivno terapijo, so bili izključeni iz kontroliranih kliničnih preskušanj.
English: The final (7-day incubation) sterility test results will not be available at the time of infusion.
Slovenian: V času infundiranja končni (7-dnevna inkubacija) rezultati testov sterilnosti ne bodo na voljo.
English: • The need to provide patients with the educational material and explain the use of the patient
Slovenian: • Potrebo, da se bolnikom zagotovi izobraževalno gradivo in jim pojasniti, kako naj uporabljajo
English: There are no known instances of overdose from either a single infusion or a full course of therapy with Provenge.
Slovenian: Ni znanih primerov prevelikega odmerjanja zaradi enkratnega infundiranja ali celotnega cikla terapije z zdravilom Provenge.
English: If you are allergic (hypersensitive) to the active substances or any of the ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na zdravilne učinkovine ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Eighty-two percent of patients had an ECOG performance status of 0; 75% had a Gleason sum ≤ 7; 44% had bone and soft tissue disease; 48% had bone-only disease; 7% had soft tissue-only disease; and 43% had greater than ten bony metastases.
Slovenian: Dvainosemdeset odstotkov bolnikov je imelo status zmogljivosti po ECOG 0; 75 % je imelo seštevek po Gleasonu ≤ 7; 44 % je imelo bolezni kosti in mehkih tkiv; 48 % je imelo le bolezen kosti; 7 % je imelo le bolezen mehkih tkiv in 43 % je imelo več kot deset metastaz v kosteh.
English: What Provenge is and what it is used for What you need to know before you are given Provenge
Slovenian: Kaj je zdravilo Provenge in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Provenge
English: Following disease progression, patients were treated at the physician's discretion with other anti-cancer interventions.
Slovenian: Po napredovanju bolezni so bolnike zdravili po presoji zdravnika z drugimi oblikami zdravljenja raka.
English: The control was nonactivated autologous peripheral blood mononuclear cells.
Slovenian: Kontrola je bila sestavljena iz neaktiviranih avtolognih mononuklearnih celic iz periferne krvi.
English: Some patients developed infection, including sepsis.
Slovenian: Pri nekaterih bolnikih je prišlo do okužbe, vključno s sepso.
English: CD54 is an adhesion and costimulatory molecule essential in the formation of the immunological synapse between an APC and a T cell.
Slovenian: CD54 je adhezijska in kostimulacijska molekula, bistvena za nastajanje imunološke sinapse med APC in T-celico.
English: After removal from the insulated container, the medicinal product should be used immediately.
Slovenian: Po odstranitvi iz izoliranega vsebnika je treba zdravilo Provenge uporabiti takoj.
English: To reduce the risk of catheter-related infections, CVCs should be considered only for patients with poor peripheral venous access.
Slovenian: Za zmanjšanje z okužbami povezanega tveganja je treba CVC uporabiti le pri bolnikih, ki imajo slab periferni venski dostop.
English: All physicians who intend to prescribe Provenge must review the educational materials and sign the training verification form.
Slovenian: Vsi zdravniki, ki nameravajo predpisovati zdravilo Provenge, morajo pregledati izobraževalna gradiva in podpisati obrazec s potrdilom o usposabljanju.
English: • increased heart rate, high blood pressure, low blood pressure, fainting.
Slovenian: • hitrejši srčni utrip, visok krvni tlak, nizek krvni tlak, omedlevica
English: Patients treated with Provenge had a statistically significant survival advantage compared with control.
Slovenian: Bolniki, zdravljeni z zdravilom Provenge, so imeli statistično značilno prednost preživetja v primerjavi s kontrolo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Provenge in all subsets of the paediatric population in the treatment of prostate cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Provenge za vse podskupine pediatrične populacije za zdravljenje raka prostate (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: This testing is a legal requirement and is to ensure that your blood cells can be safely handled by the healthcare professionals involved in your treatment.
Slovenian: Ti testi so zakonska zahteva in zagotavljajo, da lahko zdravstveno osebje, ki sodeluje pri vašem zdravljenju, varno ravna z vašimi krvnimi celicami.
English: If the sterility results become positive for microbial contamination after Provenge has been approved for infusion, the marketing authorisation holder will notify the treating physician and may request additional information from the physician in order to determine the source of contamination.
Slovenian: Če so rezultati sterilnosti, potem ko je bilo zdravilo Provenge odobreno za infundiranje, za mikrobno kontaminacijo pozitivni, bo imetnik dovoljenja za promet z zdravilom o tem obvestil lečečega zdravnika in zdravnika morda zaprosil za dodatne informacije, da ugotovi vir kontaminacije.
English: Hence it is important that the procedures for handling and administering the product are precisely followed (see section 6.6).
Slovenian: Zato je pomembno natančno upoštevanje postopkov za rokovanje z zdravilom in njegovo dajanje (glejte poglavje 6.6).
English: For patients with cardiovascular disease or those at risk for cardiac ischaemia, physicians should consider observing patients for at least 60 minutes following each infusion with vital signs taken at 30 minutes and 60 minutes following the infusion.
Slovenian: Za bolnike s kardiovaskularno boleznijo ali tiste, pri katerih obstaja tveganje za srčno ishemijo, mora zdravnik razmisliti o vsaj 60-minutnem opazovanju bolnika po vsakem infundiranju, s preverjanjem vitalnih znakov 30 minut in 60 minut po infundiranju.
English: Do not use this medicine after the expiration date and time, which is stated on the insulated container and the infusion bag.
Slovenian: Tega zdravila ne smete uporabljati po datumu in času izteka roka uporabnosti, ki je naveden na izoliranem vsebniku in infundirni vrečki.
English: • The expiration date and time have passed.
Slovenian: • sta potekla datum in čas uporabnosti zdravila,
English: Do not use a cell filter for infusion.
Slovenian: Za infundiranje ne uporabljajte celičnega filtra.
English: Do not remove the top insulated lid and do not open the insulated box until both of the following have occurred:
Slovenian: Vrhnjega izoliranega pokrova ne odstranite in ne odpirajte izolirane škatle, dokler ne izvedete obe spodnji dejanji:
English: Provenge contains sodium and potassium This medicine contains:
Slovenian: Zdravilo Provenge vsebuje natrij in kalij To zdravilo vsebuje:
English: Neutralising antibody responses to GM-CSF were transient.
Slovenian: Nevtralizirajoč odgovor protiteles na GM-CSF je bil prehoden.
English: You will have to have this procedure on at least 3 occasions approximately 3 days before each of your 3 Provenge infusion treatments.
Slovenian: Ta postopek bodo pri vas opravili vsaj 3-krat, približno 3 dni pred vsakim od 3 zdravljenj z infuzijo zdravila Provenge.
English: To establish and keep an observational EU-based registry of men with mCRPC to evaluate overall survival, the risk of ischemic stroke or myocardial infarction following treatment with Provenge and other identified and potential risks (observational study P13-1)
Slovenian: Da vzpostavi in vodi seznam EU opazovanj za moške z mCRPC, da se oceni celotno preživetje, tveganje ishemične možganske kapi ali infarkta miokarda po zdravljenju z zdravilom Provenge ter drugih identificiranih in možnih tveganj (opazovalna študija P13-1)