natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
In the post-marketing setting, serious acute infusion reactions involving hypotension and syncope have been reported.
V obdobju trženja zdravila so poročali o hudih akutnih reakcijah na infundiranje, ki so vključevale hipotenzijo in sinkopo.
• At the request of the European Medicines Agency;
• Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila;
Practical information for handling and administration of Provenge for the doctor or nurse can be found at the end of this leaflet.
Praktične informacije o ravnanju z zdravilom Provenge in dajanju zdravila Provenge za zdravnike ali medicinske sestre so na koncu tega navodila.
Do not refrigerate or freeze the container.
vsebnika ne shranjujte v hladilniku in ne zamrzujte.
Conventional toxicology, carcinogenicity, mutagenicity, and reproductive toxicity studies have not been performed.
Običajnih študij toksičnosti, kancerogenosti, mutagenosti ali študij vpliva na sposobnost razmnoževanja niso opravili.
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja Imetnik dovoljenja za promet mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
• feeling or being sick (nausea and vomiting)
• občutek slabosti ali slabost (navzea in bruhanje)
• 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.
• poškodovanje zdravila po dospetju na kliniko; na primer, vrečka z zdravilom pušča ali pa so v njej nastale grudice, ki se ne razpustijo
Do not administer if the bag leaks during handling or if particles or clumps remain in the bag.
Zdravila ne dajajte, če vrečka med rokovanjem pušča ali v njej ostanejo delci ali grudice.
Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group.
Resne okužbe so se pojavile pri 4,7 % oseb v skupini z zdravilom Provenge in pri 4,0 % oseb v kontrolni skupini.
The primary endpoint was time to disease progression and the secondary endpoint was overall survival.
Primarni opazovani dogodek je bil čas do napredovanja bolezni, sekundarni opazovani dogodek pa celokupno preživetje.
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%).
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 %).
Do not remove this insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for
Izoliranega vsebnika ne jemljite iz transportne škatle in ne odpirajte pokrova izoliranega vsebnika, dokler ni bolnik pripravljen na
Table 1 Adverse reactions from clinical studies and post-marketing reports System organ class
Preglednica 1 Neželeni učinki iz kliničnih študij in poročil v obdobju trženja
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.
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.
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.
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.
Cerebrovascular disease
Cerebrovaskularna bolezen
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.
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.
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.
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.
• The outer shipping box should be opened to verify the product and patient-specific labels located on the top of the insulated container.
• Zunanjo transportno škatlo je treba odpreti, da se preveri zdravilo in nalepke, specifične za bolnika, ki se nahajajo na vrhu izoliranega vsebnika.
Provenge is used to control your prostate cancer.
Zdravilo Provenge se uporablja za nadzor raka prostate.
Heart attack
Srčni napad
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.
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.
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.
Če bolnik zaradi katerega koli razloga ne more prejeti načrtovane infuzije zdravila Provenge, mora opraviti dodatni postopek levkafereze, preden se lahko potek zdravljenja nadaljuje.
The recommended course of treatment is 3 doses at approximately 2-week intervals.
Priporočeni potek zdravljenja je 3 odmerke v približno 2-tedenskih intervalih.
• 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).
• 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).
However, as it is an autologous product, a positive test does not preclude the manufacture of the product.
Vendar pa je to avtologno zdravilo, zato pozitivni test ne prepreči izdelave zdravila.
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.
V drugem koraku se odvzete celice pošljejo v posebni proizvodni obrat, kjer se jih premeša z antigenom in pripravi za infundiranje.
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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).
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).
Prior to the first leukapheresis procedure, a complete blood count (CBC) test should be performed and be within ranges acceptable for the local facility.
Pred prvim postopkom levkafereze je treba opraviti preiskavo celotne krvne slike; rezultati morajo biti v razponu, sprejemljivem za lokalno ustanovo.
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.
(2,1 % v primerjavi z 0,8 % po prvem infundiranju), in se je po tretjem infundiranju zmanjšala na 1,3 %.
<1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
(≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1000); zelo redki (< 1/10.000), neznana (iz razpoložljivih podatkov ni mogoče oceniti).
In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
izkušnjah iz obdobja trženja z več kot 5.000 zdravljenimi bolniki je bila ta incidenca približno 19 % (glejte poglavje 4.2).
Infections due to contaminated product also occurred in some patients.
Pri nekaterih bolnikih se je pojavila tudi okužba zaradi kontaminacije zdravila.
Provenge must be administered under the supervision of a physician experienced in the medical treatment of prostate cancer and in an environment where availability of resuscitation equipment must be ensured.
Zdravilo Provenge se mora dajati pod nadzorom zdravnika z izkušnjami v zdravljenju raka prostate in v okolju, kjer je na razpolago oprema za oživljanje.
Provenge should be used with caution in immunocompromised patients in general including patients taking systemic immunosuppressive therapy, after careful consideration of the potential risk-benefit on an individiual basis.
Imunokompromitirani bolniki Na splošno je treba zdravilo Provenge pri imunokompromitiranih bolnikih, vključno z bolniki, ki uporabljajo sistemsko imunosupresivno terapijo, uporabljati previdno in po skrbni presoji razmerja med možnimi tveganji in koristmi za vsakega posameznika.
Contact a doctor immediately if you experience sudden vision loss in one eye, difficulty speaking, numbness and/or weakness affecting one side of the body as any of these may be signs of a stroke.
Takoj pojdite k zdravniku, če se pojavijo nenadna izguba vida na enem očesu, težave z govorom ter otrplost in/ali šibkost po eni strani telesa, saj so lahko to znaki možganske kapi.
Adverse reactions that were reported most commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included citrate toxicity (14.6%), oral paraesthesia (12.0%), and paraesthesia (11.1%).
Neželeni učinki, o katerih so najpogosteje poročali ≤ 1 dan po postopku levkofereze v kontroliranih kliničnih preskušanjih, so vključevali citratno toksičnost (14,6 %), oralno parestezijo (12,0 %) in parestezijo (11,1 %).
Secondary endpoints included time to objective disease progression, time to clinical progression, and PSA doubling time (PSADT).
Sekundarni opazovani dogodek je vključeval čas do objektivnega napredovanja bolezni, čas do kliničnega napredovanja in časa podvojitve PSA (PSADT, PSA doubling time).
Appropriate medical therapy, which could include paracetamol, intravenous H1 and/or H2 blockers, and low dose intravenous pethidine, should be administered as needed.
Nuditi je treba ustrezno terapijo z zdravili, ki po potrebi vključujejo paracetamol, intravenska zaviralca H1 in/ali H2 in nizkoodmerni intravenski pethidin.
Like all medicines, Provenge can cause side effects, although not everybody gets them.
Kot vsa zdravila, ima lahko tudi zdravilo Provenge neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Hypertension Hypotension
Žilne bolezni hipertenzija hipotenzija
- reduced sense of touch or sensation (hypoaesthesia) - collapse of one of the bones in the spine (spinal cord compression)
- zmanjšan občutek za dotik ali občutenje (hipoestezija) - kolaps ene od kosti v hrbtenici (kompresija hrbtenjače) - nereden ali hiter srčni utrip
Provenge is for use in adult men only.
Zdravilo Provenge se uporablja samo pri odraslih moških.
• You have not received the Final Product Disposition Notification form.
• niste prejeli obrazca z obvestilom o končnem razpolaganju z zdravilom,
Of the control arm patients, 64% crossed over to receive an investigational autologous cellular immunotherapy manufactured from cells cryopreserved at the time the control was manufactured; patients were not randomised to subsequent autologous cellular immunotherapy.
Med bolniki v kontrolnem kraku jih je 64 % zamenjalo obstoječe zdravilo za raziskovano avtologno celično imunoterapijo, izdelano iz celic, krioprezerviranih v času izdelave kontrole; bolniki niso bili randomizirani v nadaljevalno avtologno celično imunoterapijo.
• You are immunocompromised (your immune system's ability to fight infections is reduced) or taking any 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)
• oslabljen imunski sistem (sposobnost vašega imunskega sistema za premagovanje okužb je zmanjšana) ali če jemljete imunosupresive (na primer za zdravljenje ali preprečevanje zavrnitve organa in nekatera zdravila, ki se uporabljajo za zdravljenje revmatoidnega artritisa, multiple skleroze, Crohnove bolezni in ulceroznega kolitisa)
Physicians must provide the educational materials to the patient as well as the package leaflet and the Patient Alert Card.
Zdravniki morajo vsem bolnikom izročiti izobraževalna gradiva, navodilo za uporabo in kartico z opozorili za bolnika.
Exclusion criteria included visceral (liver, lung, or brain) metastases, malignant pleural effusions or malignant ascites, pathologic long bone fractures, imminent pathologic long-bone fractures (cortical erosion on radiography >50%), spinal cord compression, moderate to severe prostate cancer-related pain and use of narcotics for cancerrelated pain, and treatment with chemotherapy at least 3 months prior to randomisation.
Izključitveni kriteriji so vključevali visceralne (jetra, pljuča ali možgani) metastaze, maligni plevralni izliv ali maligni ascites, patološke zlome dolgih kosti, grozeče patološke zlome dolgih kosti (erozija korteksa na radiografiji > 50 %), kompresija hrbtenjače, zmerna do huda z rakom povezana bolečina in uporaba narkotikov zaradi bolečin, povezanih z rakom in zdravljenje s kemoterapijo v roku prejšnjih
Contact a doctor immediately if you experience chest pain, pain in the left arm and/or shortness of breath as any of these may be signs of a heart attack.
Takoj pojdite k zdravniku, če se pojavijo bolečine v prsnem košu, bolečine v levi roki in/ali zasoplost, saj so lahko to znaki srčnega napada.
The insulated container and the gel packs within are designed to maintain the appropriate transportation and storage temperature of Provenge until infusion.
Izolirani vsebnik in gelni vložki so zasnovani tako, da ohranjajo ustrezno temperaturo zdravila Provenge med transportom in shranjevanjem do infundiranja.
Your Provenge treatment will be given by a drip (infusion) into one of your veins (intravenous use).
Zdravilo Provenge boste prejeli v obliki kapalne infuzije v eno od ven (intravenska uporaba).
The other ingredients are: sodium chloride, sodium lactate, potassium chloride, and calcium chloride.
Druge sestavine zdravila so natrijev klorid, natrijev laktat, kalijev klorid in kalcijev klorid.
You may need one or more additional visits in order to have your blood tested before your leukapheresis procedure (depending on the usual pratice in the clinic where you are having your treatment), or your blood may be tested during your leukapheresis visits:
Morda bo potreben en ali več dodatnih obiskov za preiskavo krvi pred postopkom levkafereze (odvisno od običajne prakse klinike, kjer se zdravite), preiskave krvi pa lahko opravijo tudi med obiski zaradi levkafereze: 1. obisk - odvzem krvnih celic (levkafereza)
You will receive a total of 3 infusions of Provenge at approximately 2 week intervals.
Skupaj boste prejeli 3 infuzije zdravila Provenge v približno 2-tedenskih intervalih.
Provenge is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
Zdravilo Provenge je avtologna celična imunoterapija, razvita za induciranje imunskega odgovora, ki cilja na prostatično kislo fosfatazo (PAP, prostatic acid phosphatase), to je antigen, izražen v večini rakov prostate.
Antibody (IgM and
Odzive protiteles (IgM in IgG) proti antigenoma
• Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
• Zdravilo Provenge se pripravlja iz človeške krvi specifičnega bolnika in se ne testira za povzročitelje nalezljivih bolezni.
• high temperature, chills, breathing difficulties
• zvišana telesna temperatura, mrzlica, težave z dihanjem
The patients enrolled in these trials had failed surgical or medical castration (e.g. luteinising hormone-releasing hormone [LHRH] agonist or gonadotropin-releasing hormone [GnRh] antagonist) therapies and had metastatic disease in the soft tissue and/or bone.
Bolniki, vključeni v ta preskušanja, so imeli neuspešno terapijo s kirurško kastracijo ali kastracijo z zdravili (npr. agonistov hormona za sproščanje luteinizirajočega hormona [LHRH, luteinizing hormone releasing hormone] ali agonistov hormona za sproščanje gonadotropina [GnRh, gonadotropin-releasing hormone]) in metastatsko bolezen v mehkem tkivu in/ali kosteh.
When Provenge cannot be given
Kdaj zdravila Provenge ne smete prejeti
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z zdravilom Provenge niso izvedli.
Method of administration Provenge is solely intended for autologous use via intravenous infusion.
Zdravilo Provenge se uporablja samo za avtologno uporabo prek intravenske infuzije.
If you need a vaccination whilst receiving Provenge, you should first discuss this with your doctor.
Če se morate med uporabo zdravila Provenge cepiti, se o tem najprej pogovorite z zdravnikom.
In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
kliničnih študijah so bili pri približno eni četrtini bolnikov potrebni več kot 3 postopki levkafereze za prejem 3 infuzij zdravila Provenge.
• Any unused product or waste material should be disposed of in accordance with local
• Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
The degree of CD54 upregulation correlates with overall survival in the randomised controlled clinical trials carried out with Provenge in metastatic castrate resistant prostate cancer.
Stopnja višanja CD54 korelira s celokupnim preživetjem v randomiziranih kontroliranih kliničnih preskušanjih z zdravilom Provenge pri metastatskem, na kastracijo odpornim rakom prostate.
Additional adverse reactions that were seen commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included fatigue (5.5%), muscle spasm (4.0%), chills (3.0%), dizziness (2.8%), and anaemia (2.8%).
Dodatni neželeni učinki, pogosto opaženi ≤ 1 dan po postopku levkafereze v kontroliranih kliničnih preskušanjih, so vključevali utrujenost (5,5 %), mišični spazem (4,0 %), mrzlico (3,0 %), omotico (2,8 %) in anemijo (2,8 %).
How Provenge is given and duration of treatment Your doctor may suggest you take paracetamol and an antihistamine medicine about 30 minutes before your infusion to reduce the possible reactions to Provenge.
Kako boste prejeli zdravilo Provenge in trajanje zdravljenja Zdravnik lahko predlaga, da približno 30 minut pred infundiranjem vzamete paracetamol in antihistaminik, da se zmanjšajo možne reakcije na zdravilo Provenge.
Date {DD month YYYY}, Exp. Time {hh:mm}, Time Zone
Datum izteka roka uporabnosti {DD mesec LLLL}, čas izteka roka uporabnosti {hh.mm}, časovni pas
Interim data submitted in each PSUR Final study report by 31 December 2018
Začasne podatke predložiti v vsakem PSUR Končno poročilo študije do 31. decembra 2018
• The disposition form verifying the product has been APPROVED has been provided
• obrazec za razpolaganje z ODOBRITVIJO zdravila je bil predložen
Your doctor will work with you to schedule new appointments for cell collection and infusion.
Vaš zdravnik bo skupaj z vami načrtoval nov obisk za odvzem celic in infundiranje.
Common symptoms include a fainting episode, bluish discoloration of the skin, lips and/or nail beds due to low levels of oxygen in the blood, wheezing, high or low blood pressure and difficulty breathing.
modrikasto obarvano kožo, ustnic in/ali podnohtja zaradi nizkih ravni kisika v krvi, sopenje, visok ali nizek krvni tlak in težave z dihanjem.
• The essential unique patient information on the infusion bag does not match that of the
• se bistvena edinstvena informacija o bolniku na infuzijski vrečki ne ujema z bolnikovimi podatki,
Provenge undergoes several tests before use to show that it is sterile.
Z zdravilom Provenge se opravi več testov, s katerimi se zagotovi, da je sterilno.
For intravenous infusion
za intravensko infundiranje
A retrospective subgroup analysis has suggested a greater Provenge treatment effect in patients with a baseline PSA < 22.1 ng/mL [HR= 0.521 (95% CI: 0.309, 0.879)].
Retrospektivna analiza podskupine je pokazala večji učinek zdravljenja z zdravilom Provenge pri bolnikih z izhodiščnim PSA < 22,1 ng/ml [RT = 0,521 (95-% IZ: 0,309; 0,879)].
Tell your doctor after your Provenge treament if you get any symptoms of an infection, for example, a fever or high temperature above 38°C, chills, a fast heartbeat, fast breathing, dizziness on standing up, confusion or feeling/being sick.
Po zdravljenju z zdravilom Provenge takoj povejte svojemu zdravniku, če se pojavijo kateri od simptomov okužbe, na primer zvišana telesna temperatura nad 38°C, mrzlica, hiter srčni utrip, hitro dihanje, omotica pri vstajanju, zmedenost ali slabost/bruhanje.
In controlled clinical trials, myocardial infarctions were observed in 0.8% of patients in the Provenge group compared with 0.3% of patients in the control group.
V kontroliranih kliničnih preskušanjih so miokardni infarkt opazili pri 0,8 % bolnikov v skupini z zdravilom Provenge v primerjavi z 0,3 % bolnikov v kontrolni skupini.