natgillin/translations-raw huggingface dataset:
Following randomization, patients from both treatment groups underwent a series of 3 leukapheresis procedures (at approximately 2 week intervals, range 1 to 15 weeks).
Po randomizaciji so imeli bolniki iz obeh skupin zdravljenja serijo 3 postopkov lefkafereze (v približno 2tedenskih intervalih, v razponu 1 do 15 tednov).
• Only one of the 2 spike ports should be used and should not be opened prior to administration in order to avoid contamination.
• Uporabi se lahko samo en od 2 vhodov za igle, ki se ga lahko odpre šele pred dajanjem, da se prepreči kontaminacija.
Summary of Product Characteristics (SmPC) 2.
Povzetek glavnih značilnosti zdravila (SmPC)
Provenge should be infused intravenously over a period of approximately 60 minutes.
Zdravilo Provenge je treba infundirati intravensko v približno 60-minutnem obdobju.
It is important that you read the entire content of this procedure prior to administering Provenge.
Pomembno je, da preberete celotno vsebino tega postopka, preden bolniku aplicirate zdravilo Provenge.
Tell your doctor or nurse if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Svojemu zdravniku ali medicinski sestri povejte, če se pojavi kateri od teh simptomov, saj bo morda treba infundiranje upočasniti ali ustaviti.
A total of 512 patients were randomised in a 2:1 ratio to receive Provenge (n=341) or control (n=171).
Skupaj je bilo randomiziranih 512 bolnikov v razmerju 2:1 v prejemanje zdravila Provenge (n = 341) ali kontrole (n = 171).
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.
Naprava vam jemlje kri iz ene roke, odvzame iz nje bele krvne celice, preostalo kri pa vam vrne, običajno v drugo roko.
The entire volume of the bag should be infused.
Infundirati je treba celotno količino vrečke.
Patients should be advised not to drive or use machines if they experience these symptoms following their infusion.
Bolnike je treba opozoriti, da naj ne vozijo ali upravljajo strojev, če po infundiranju opazijo te simptome.
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.
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.
The primary endpoint was overall survival.
Primarni opazovani dogodek je bilo celokupno preživetje.
Patients with cardiac or pulmonary conditions should be closely monitored (see section 4.8).
Bolnike s srčnimi ali pljučnimi stanji je treba skrbno nadzirati (glejte poglavje 4.8).
Very common side effects (may affect more than 1 in 10 patients):
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
What to check prior to infusion
Kaj je treba pred infundiranjem preveriti
Citrate is generally the preferred anticoagulant used during leukapheresis and can result in hypocalcaemia.
Citrat je na splošno prednostni antikoagulant, ki se uporablja med levkaferezo in lahko povzroči hipokalciemijo.
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).
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).
Each Provenge bag contains one individual infusion treatment and the container will only be opened when you are ready to receive your treatment.
Vsaka vrečka zdravila Provenge vsebuje odmerek za eno individualno zdravljenje z infundiranjem, vsebnik pa se bo odprlo samo, ko boste pripravljeni na sprejem zdravila.
These immune cells are then mixed with an antigen (a protein, which is able to stimulate your immune system) at a specific manufacturing facility.
Te imunske celice se nato premešajo z antigenom (beljakovino, ki lahko spodbuja vaš imunski sistem) v posebnem proizvodnem obratu.
Immunocompromised patients and patients taking systemic immunosuppressive therapy were excluded from controlled clinical trials.
Imunokompromitirani bolniki in bolniki, ki uporabljajo sistemsko imunosupresivno terapijo, so bili izključeni iz kontroliranih kliničnih preskušanj.
The final (7-day incubation) sterility test results will not be available at the time of infusion.
V času infundiranja končni (7-dnevna inkubacija) rezultati testov sterilnosti ne bodo na voljo.
• The need to provide patients with the educational material and explain the use of the patient
• Potrebo, da se bolnikom zagotovi izobraževalno gradivo in jim pojasniti, kako naj uporabljajo
There are no known instances of overdose from either a single infusion or a full course of therapy with Provenge.
Ni znanih primerov prevelikega odmerjanja zaradi enkratnega infundiranja ali celotnega cikla terapije z zdravilom Provenge.
If you are allergic (hypersensitive) to the active substances or any of the ingredients of this medicine (listed in section 6).
Če ste alergični na zdravilne učinkovine ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
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.
What Provenge is and what it is used for What you need to know before you are given Provenge
Kaj je zdravilo Provenge in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Provenge
Following disease progression, patients were treated at the physician's discretion with other anti-cancer interventions.
Po napredovanju bolezni so bolnike zdravili po presoji zdravnika z drugimi oblikami zdravljenja raka.
The control was nonactivated autologous peripheral blood mononuclear cells.
Kontrola je bila sestavljena iz neaktiviranih avtolognih mononuklearnih celic iz periferne krvi.
Some patients developed infection, including sepsis.
Pri nekaterih bolnikih je prišlo do okužbe, vključno s sepso.
CD54 is an adhesion and costimulatory molecule essential in the formation of the immunological synapse between an APC and a T cell.
CD54 je adhezijska in kostimulacijska molekula, bistvena za nastajanje imunološke sinapse med APC in T-celico.
After removal from the insulated container, the medicinal product should be used immediately.
Po odstranitvi iz izoliranega vsebnika je treba zdravilo Provenge uporabiti takoj.
To reduce the risk of catheter-related infections, CVCs should be considered only for patients with poor peripheral venous access.
Za zmanjšanje z okužbami povezanega tveganja je treba CVC uporabiti le pri bolnikih, ki imajo slab periferni venski dostop.
All physicians who intend to prescribe Provenge must review the educational materials and sign the training verification form.
Vsi zdravniki, ki nameravajo predpisovati zdravilo Provenge, morajo pregledati izobraževalna gradiva in podpisati obrazec s potrdilom o usposabljanju.
• increased heart rate, high blood pressure, low blood pressure, fainting.
• hitrejši srčni utrip, visok krvni tlak, nizek krvni tlak, omedlevica
Patients treated with Provenge had a statistically significant survival advantage compared with control.
Bolniki, zdravljeni z zdravilom Provenge, so imeli statistično značilno prednost preživetja v primerjavi s kontrolo.
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).
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).
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.
Ti testi so zakonska zahteva in zagotavljajo, da lahko zdravstveno osebje, ki sodeluje pri vašem zdravljenju, varno ravna z vašimi krvnimi celicami.
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.
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.
Hence it is important that the procedures for handling and administering the product are precisely followed (see section 6.6).
Zato je pomembno natančno upoštevanje postopkov za rokovanje z zdravilom in njegovo dajanje (glejte poglavje 6.6).
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.
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.
Do not use this medicine after the expiration date and time, which is stated on the insulated container and the infusion bag.
Tega zdravila ne smete uporabljati po datumu in času izteka roka uporabnosti, ki je naveden na izoliranem vsebniku in infundirni vrečki.
• The expiration date and time have passed.
• sta potekla datum in čas uporabnosti zdravila,
Do not use a cell filter for infusion.
Za infundiranje ne uporabljajte celičnega filtra.
Do not remove the top insulated lid and do not open the insulated box until both of the following have occurred:
Vrhnjega izoliranega pokrova ne odstranite in ne odpirajte izolirane škatle, dokler ne izvedete obe spodnji dejanji:
Provenge contains sodium and potassium This medicine contains:
Zdravilo Provenge vsebuje natrij in kalij To zdravilo vsebuje:
Neutralising antibody responses to GM-CSF were transient.
Nevtralizirajoč odgovor protiteles na GM-CSF je bil prehoden.
You will have to have this procedure on at least 3 occasions approximately 3 days before each of your 3 Provenge infusion treatments.
Ta postopek bodo pri vas opravili vsaj 3-krat, približno 3 dni pred vsakim od 3 zdravljenj z infuzijo zdravila Provenge.
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)
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)
The primary endpoint was time to disease progression, which did not reach statistical significance.
Primarni opazovani dogodek je bil čas do napredovanja bolezni, ki ni bil statistično značilen.
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.
Vzrok so lahko neizpolnjeni kriteriji za sprostitev med izdelavo, prekoračitev datuma uporabnosti zdravila ali nezmožnost bolnika, da se udeleži načrtovanega infundiranja.
a b b p-value
vrednost p
Patient Alert card to record the scheduled leukapheresis and infusion dates
Opozorilno kartico za bolnika za evidentiranje redne levkafereze in datumov infuzij
• Selection of patients for treatment with Provenge
• Izbor bolnikov za zdravljenje z zdravilom Provenge
As Provenge is made from your own blood cells, your cells will be collected approximately 3 days before each scheduled infusion.
Ker je zdravilo Provenge narejeno iz vaših lastnih krvnih celic, vam bodo približno 3 dni pred načrtovanim infundiranjem odvzeli vaše celice.
Gently mix and re-suspend the contents of the bag.
Nežno premešajte in ponovno suspendirajte vsebino vrečke.
Forty-eight percent of patients were receiving bisphosphonates and 18% had received prior chemotherapy, including docetaxel.
Oseminštirideset odstotkov bolnikov je prejemalo bisfosfonate in 18 % jih je pred tem prejelo kemoterapijo, vključno z docetakselom.
In such cases, the patient may need to undergo an additional leukapheresis procedure if the treatment is to be continued.
V takih primerih bo morda moral bolnik ponovno na postopek levkafereze, če naj se zdravljenje nadaljuje.
The infusion bag is placed inside an insulated polyurethane container and packed in a shipping box.
Infuzijska vrečka je v izoliranem poliuretanskem vsebniku, pakirana v transportno škatlo.
On the first day of the infusion, Provenge may cause infusion-related reactions such as:
Prvi dan infuzije lahko zdravilo Provenge povzroči z infundiranjem povezane reakcije, kot so:
Provenge is intended solely for autologous use and should under no circumstances be administered to other patients.
Zdravilo Provenge je namenjeno izključno za avtologno uporabo in ga v nobenih okoliščinah ni dovoljeno dajati drugim bolnikom.
IMPORTANT - Do not infuse Provenge if
POMEMBNO - ne infundirajte zdravila Provenge, če
Therefore, concurrent use of immunosuppressive agents (such as systemic corticosteroids) should be avoided during Provenge treatment.
Zato se je treba sočasni uporabo imunosupresivov (kot so sistemski kortikosteroidi) med zdravljenjem z zdravilom Provenge izogniti.
Provenge is designed to stimulate the immune system.
Zdravilo Provenge je zasnovano za spodbujanje imunskega sistema.
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.
Zdravilo Provenge morate prejeti kmalu po njegovi izdelavi, končni rezultati sterilnosti morda ne bodo vedno na voljo, preden boste prejeli infuzijo z zdravilom Provenge.
• Provenge is infused over a period of approximately 60 minutes through a large bore needle appropriate for transfusion of red blood cells.
• Zdravilo Provenge se infundira približno 60 minut skozi iglo z veliko luknjo za transfuzijo eritrocitov.
In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C).
Poleg tega bodo opravili krvne preiskave za ugotavljanje prisotnosti določenih virusov (na primer HIV-1, HIV-2, hepatitis B in hepatitis C).
• The existence of the EU Registry of patients treated for metastatic castrate resistant prostate cancer and how to enter patients in it.
• Obstoj seznama EU za bolnike, zdravljene zaradi metastatskega, na skopitev odpornega raka prostate, z navodili, kako vanj vnašati bolnike.
The number of cells in Provenge does not exceed the number of cells from the leukapheresis.
Število celic v zdravilu Provenge ne presega števila celic iz levkafereze.
Provenge is manufactured specifically for you using your own blood and must not be used in anyone else.
Zdravilo Provenge je izdelano posebej za vas iz vaše krvi, zato se ne sme uporabiti pri nikomer drugem.
The most common reactions (≥ 20%) were chills, fever, and fatigue.
Najpogostejše reakcije (≥ 20 %) so bile mrzlica, zvišana telesna temperatura in utrujenost.
In the pivotal randomised controlled study (D9902B, IMPACT, see section 5.1) Provenge was discontinued in 1.5% of patients due to adverse reactions.
V osrednji randomizirani kontrolirani študiji (D9902B, IMPACT, glejte poglavje 5.1) so uporabo zdravila Provenge prekinili pri 1,5 % bolnikov zaradi neželenih učinkov.
250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
250 ml disperzije v vrečki (predušna poliolefinska trislojna vrečka s 3 izhodi za vzorčenje (2 igelna vhoda in 1 vhod z zatesnjenim cevjem)).
Other medicines and Provenge
Druga zdravila in zdravilo Provenge
The nature of Provenge is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Narava zdravila Provenge je taka, da običajne študije farmakokinetike, absorpcije, porazdelitve, presnove in izločanja niso smiselne.
This involves a procedure called leukapheresis, which consists of extracting white blood cells from your blood, usually from the veins in your arms.
To zajema postopek, ki se imenuje levkafereza, in predstavlja postopek odvzema belih krvnih celic iz krvi, običajno iz ven na roki.
In some cases, you may be unable to receive a scheduled infusion of Provenge.
V nekaterih primerih morda ne boste mogli prejeti načrtovane infuzije zdravila Provenge.
The cellular composition and the cell number per dose of Provenge will vary according to the patient's leukapheresis.
Celična sestava in število celic na odmerek zdravila Provenge se razlikujeta glede na levkaferezo bolnika.
The effects of Provenge on male fertility are not known at this time.
Vpliv zdravila Provenge na plodnost pri moških trenutno ni znan.
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.
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.
Provenge is an autologous cellular therapy.
Zdravilo Provenge je avtologna celična terapija.
Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure.
Vsako infuzijo zdravila Provenge sestavlja največje število celic, ki se lahko izdela v enem postopku levkafereze.
Each leukapheresis was followed approximately 3 days later by infusion of Provenge or control.
Vsaki levkaferezi je približno 3 dni kasneje sledila infuzija zdravila Provenge ali kontrole.
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.
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.
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).
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).
The first step in your Provenge treatment is to collect your blood cells in order to manufacture your personal infusion of Provenge.
Prvi korak vašega zdravljenja z zdravilom Provenge je postopek odvzema vaših krvnih celic, ki jih bodo uporabili za izdelavo vaše osebne infuzije zdravila Provenge.
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.
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.
Missed treatment
Izpuščena zdravljenja
Summary of study results Table 2 presents overall survival results observed in IMPACT, study D9901, and study D9902A.
V preglednici 2 so predstavljeni rezultati celokupnega preživetja, ki so jih opazili v študiji IMPACT, študiji D9901 in študiji D9902A.
PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, in a sealed, patient-specific polyolefin bag.
PAP-GM-CSF, suspendiranih v 250 ml raztopine Ringerjevega laktata, v zatesnjeni, za bolnika specifični poliolefinski vrečki.
▼ This medicine is subject to additional monitoring.
▼ Za to zdravilo se izvaja dodatno spremljanje varnosti.
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.
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.
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).
Bolnike je treba skrbno oceniti, da se ugotovi, ali je medicinsko ustrezno prekiniti uporabo imunosupresiva pred zdravljenjem z zdravilom Provenge (glejte poglavje 4.4).
• You are on a controlled sodium/potassium diet or you have reduced kidney function.
• ste na dieti z nadziranim vnosom natrija/kalija ali imate zmanjšano delovanje ledvic
There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Obstajala je korelacija med celičnimi ali protitelesnimi odgovori na PAP ali PAP-GM-CSF v skupini z zdravilom Provenge in izboljšanim preživetjem.
Analyses of time to objective disease progression, time to clinical progression, or PSA doubling time (PSADT) did not meet statistical significance.
Analize časa do objektivnega napredovanja bolezni, časa do kliničnega napredovanja ali časa podvojitev PSA (PSADT) niso bile statistično značilne.
Some (1.2%) patients in the Provenge group were hospitalized within 1 day of infusion for management of acute infusion reactions.
Nekateri bolniki (1,2 %) v skupini z zdravilom Provenge so bili v 1 dnevu po infundiranju hospitalizirani zaradi obravnave akutnih reakcij na infundiranje.
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.
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.
Fevers and chills generally resolved within 2 days (71.9% and 89.0%, respectively).
Zvišana telesna temperatura in mrzlica sta polagoma izzveneli v 2 dneh (71,9 % oz. 89,0 %).
Practical information for medical or healthcare professionals on handling and administration of Provenge dispersion for infusion
Praktične informacije za medicinsko ali zdravstveno osebje o ravnanju z zdravilom Provenge disperzija za infundiranje in dajanju zdravila
Older people No dose adjustment is required in the elderly population.
Prilagajanje odmerka za starejše bolnike ni potrebno.
Interim data submitted in each PSUR Final study report by 30 September 2016
Začasne podatke predložiti v vsakem PSUR Končno poročilo študije do 30. septembra 2016