FrancophonIA/ELRC3.0 huggingface dataset:
English: <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Slovenian: (≥ 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).
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
Slovenian: izkušnjah iz obdobja trženja z več kot 5.000 zdravljenimi bolniki je bila ta incidenca približno 19 % (glejte poglavje 4.2).
English: Infections due to contaminated product also occurred in some patients.
Slovenian: Pri nekaterih bolnikih se je pojavila tudi okužba zaradi kontaminacije zdravila.
English: 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.
Slovenian: Zdravilo Provenge se mora dajati pod nadzorom zdravnika z izkušnjami v zdravljenju raka prostate in v okolju, kjer je na razpolago oprema za oživljanje.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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%).
Slovenian: 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 %).
English: Secondary endpoints included time to objective disease progression, time to clinical progression, and PSA doubling time (PSADT).
Slovenian: Sekundarni opazovani dogodek je vključeval čas do objektivnega napredovanja bolezni, čas do kliničnega napredovanja in časa podvojitve PSA (PSADT, PSA doubling time).
English: Appropriate medical therapy, which could include paracetamol, intravenous H1 and/or H2 blockers, and low dose intravenous pethidine, should be administered as needed.
Slovenian: Nuditi je treba ustrezno terapijo z zdravili, ki po potrebi vključujejo paracetamol, intravenska zaviralca H1 in/ali H2 in nizkoodmerni intravenski pethidin.
English: Like all medicines, Provenge can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila, ima lahko tudi zdravilo Provenge neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Hypertension Hypotension
Slovenian: Žilne bolezni hipertenzija hipotenzija
English: - reduced sense of touch or sensation (hypoaesthesia) - collapse of one of the bones in the spine (spinal cord compression)
Slovenian: - zmanjšan občutek za dotik ali občutenje (hipoestezija) - kolaps ene od kosti v hrbtenici (kompresija hrbtenjače) - nereden ali hiter srčni utrip
English: Provenge is for use in adult men only.
Slovenian: Zdravilo Provenge se uporablja samo pri odraslih moških.
English: • You have not received the Final Product Disposition Notification form.
Slovenian: • niste prejeli obrazca z obvestilom o končnem razpolaganju z zdravilom,
English: 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.
Slovenian: 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.
English: • 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)
Slovenian: • 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)
English: Physicians must provide the educational materials to the patient as well as the package leaflet and the Patient Alert Card.
Slovenian: Zdravniki morajo vsem bolnikom izročiti izobraževalna gradiva, navodilo za uporabo in kartico z opozorili za bolnika.
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: The insulated container and the gel packs within are designed to maintain the appropriate transportation and storage temperature of Provenge until infusion.
Slovenian: Izolirani vsebnik in gelni vložki so zasnovani tako, da ohranjajo ustrezno temperaturo zdravila Provenge med transportom in shranjevanjem do infundiranja.
English: Your Provenge treatment will be given by a drip (infusion) into one of your veins (intravenous use).
Slovenian: Zdravilo Provenge boste prejeli v obliki kapalne infuzije v eno od ven (intravenska uporaba).
English: The other ingredients are: sodium chloride, sodium lactate, potassium chloride, and calcium chloride.
Slovenian: Druge sestavine zdravila so natrijev klorid, natrijev laktat, kalijev klorid in kalcijev klorid.
English: 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:
Slovenian: 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)
English: You will receive a total of 3 infusions of Provenge at approximately 2 week intervals.
Slovenian: Skupaj boste prejeli 3 infuzije zdravila Provenge v približno 2-tedenskih intervalih.
English: 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.
Slovenian: 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.
English: Antibody (IgM and
Slovenian: Odzive protiteles (IgM in IgG) proti antigenoma
English: • Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
Slovenian: • Zdravilo Provenge se pripravlja iz človeške krvi specifičnega bolnika in se ne testira za povzročitelje nalezljivih bolezni.
English: • high temperature, chills, breathing difficulties
Slovenian: • zvišana telesna temperatura, mrzlica, težave z dihanjem
English: 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.
Slovenian: 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.
English: When Provenge cannot be given
Slovenian: Kdaj zdravila Provenge ne smete prejeti
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja z zdravilom Provenge niso izvedli.
English: Method of administration Provenge is solely intended for autologous use via intravenous infusion.
Slovenian: Zdravilo Provenge se uporablja samo za avtologno uporabo prek intravenske infuzije.
English: If you need a vaccination whilst receiving Provenge, you should first discuss this with your doctor.
Slovenian: Če se morate med uporabo zdravila Provenge cepiti, se o tem najprej pogovorite z zdravnikom.
English: In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
Slovenian: kliničnih študijah so bili pri približno eni četrtini bolnikov potrebni več kot 3 postopki levkafereze za prejem 3 infuzij zdravila Provenge.
English: • Any unused product or waste material should be disposed of in accordance with local
Slovenian: • Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: 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.
Slovenian: Stopnja višanja CD54 korelira s celokupnim preživetjem v randomiziranih kontroliranih kliničnih preskušanjih z zdravilom Provenge pri metastatskem, na kastracijo odpornim rakom prostate.
English: 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%).
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: Date {DD month YYYY}, Exp. Time {hh:mm}, Time Zone
Slovenian: Datum izteka roka uporabnosti {DD mesec LLLL}, čas izteka roka uporabnosti {hh.mm}, časovni pas
English: Interim data submitted in each PSUR Final study report by 31 December 2018
Slovenian: Začasne podatke predložiti v vsakem PSUR Končno poročilo študije do 31. decembra 2018
English: • The disposition form verifying the product has been APPROVED has been provided
Slovenian: • obrazec za razpolaganje z ODOBRITVIJO zdravila je bil predložen
English: Your doctor will work with you to schedule new appointments for cell collection and infusion.
Slovenian: Vaš zdravnik bo skupaj z vami načrtoval nov obisk za odvzem celic in infundiranje.
English: 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.
Slovenian: modrikasto obarvano kožo, ustnic in/ali podnohtja zaradi nizkih ravni kisika v krvi, sopenje, visok ali nizek krvni tlak in težave z dihanjem.
English: • The essential unique patient information on the infusion bag does not match that of the
Slovenian: • se bistvena edinstvena informacija o bolniku na infuzijski vrečki ne ujema z bolnikovimi podatki,
English: Provenge undergoes several tests before use to show that it is sterile.
Slovenian: Z zdravilom Provenge se opravi več testov, s katerimi se zagotovi, da je sterilno.
English: For intravenous infusion
Slovenian: za intravensko infundiranje
English: 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)].
Slovenian: 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)].
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • If the Provenge bag leaks, is damaged, or if particles or clumps remain in the bag after gentle manual mixing, the product must not be used.
Slovenian: • Če vrečka z zdravilom Provenge pušča, je poškodovana ali v njej po nežnem ročnem mešanju ostanejo delci ali grudice, zdravila ne smete uporabiti.
English: Provenge should be delayed in patients with active systemic infection until resolution.
Slovenian: Uporabo zdravila Provenge je treba pri bolnikih z aktivno sistemsko okužbo prestaviti, dokler okužba ne izzveni.
English: You will be monitored before and during the infusion.
Slovenian: Med infundiranjem in po njem vas bodo nadzirali.
English: No Grade 4 or 5 acute infusion reactions were reported in patients in the Provenge group.
Slovenian: O reakcijah na infundiranje 4. ali 5. stopnje pri bolnikih v skupini z zdravilom Provenge niso poročali.
English: • Provenge is shipped directly to the medical facility where the infusion will be administered.
Slovenian: • Zdravilo Provenge se pošlje neposredno zdravstveni ustanovi, kjer bo bolnik prejel infuzijo.
English: Intermediate results were observed in patients with baseline PSA > 22.1 to 50.1 ng/mL [HR=0.685 (95% CI: 0.431, 1.088)] and patients with baseline PSA > 50.1 to 134.1 ng/mL [HR=0.819 (95% CI: 0.532, 1.262)].
Slovenian: Vmesne rezultate so upoštevali pri bolnikih z izhodiščnim PSA > 22,1 do 50,1 ng/ml [RT = 0,685 (95-% IZ: 0,431; 1,088)] in pri bolnikih z izhodiščnim PSA > 50,1 do 134,1 ng/ml [RT = 0,819 (95-% IZ: 0,532; 1,262)].
English: Neither endpoint met statistical significance.
Slovenian: Noben opazovani dogodek ni bil statistično značilen.
English: In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction.
Slovenian: V primeru akutne reakcije na infundiranje se lahko hitrost infundiranja zmanjša ali infundiranje ustavi, odvisno od resnosti reakcije.
English: Provenge can only be administered by a doctor or nurse who has been trained in using this medicine.
Slovenian: Zdravilo Provenge vam lahko da samo zdravnik ali medicinska sestra, ki sta se usposobila za dajanje tega zdravila.
English: Control (N=45)
Slovenian: Kontrola (N = 45)
English: Serious adverse reactions include acute infusion reactions, catheter sepsis, staphylococcal bacteraemia, myocardial infarction, and cerebrovascular events.
Slovenian: Resni neželeni učinki vključujejo akutne reakcije na infundiranje, sepso zaradi katetra, stafilokokno bakteriemijo, miokardni infarkt, in cerebrovaskularne dogodke.
English: Common side effects (may affect up to 1 in 10 patients):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INSULATED POLYURETHANE CONTAINER
Slovenian: PODATKI NA ZUNANJI OVOJNINI IZOLIRANI POLIURETANSKI VSEBNIK
English: Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD United Kingdom
Slovenian: Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD Velika Britanija
English: Patient leukapheresis material is tested for transmissible infectious agents in line with applicable local requirements.
Slovenian: Bolnikov levkaferezni material je testiran za povzročitelje nalezljivih bolezni v skladu z veljavnimi lokalnimi zahtevami.
English: Dendreon UK Limited 41 Chalton Street London, NW1 1JD United Kingdom
Slovenian: Dendreon UK Limited 41 Chalton Street London, NW1 1JD Velika Britanija
English: A smaller treatment effect was observed in those with baseline PSA > 134.1 ng/mL [HR=0.853 (95% CI: 0.554, 1.315)].
Slovenian: Manjši učinek zdravljenja so opazili pri tistih z izhodiščnim PSA > 134,1 ng/ml [RT = 0,853 (95-% IZ: 0,554; 1,315)].
English: Control (N=171)
Slovenian: Kontrola (N = 171)
English: PSA doubling time, the number of patients who develop metastatic disease, subsequent therapies received after diagnosis of metastatic disease, and efficacy parameters following subsequent therapies, including PSA progression, PSA progression-free survival, time to next line therapy, and overall survival.
Slovenian: izhodišču, vključno s PSA in časom podvojitve PSA, številom bolnikov, ki razvijejo metastatsko bolezen, nadaljnjimi terapijami, ki so jih bolniki dobili po diagnozi metastatske bolezni, ter parametri učinkovitosti po nadaljnjih terapijah, med drugim nadaljnji razvoj PSA, preživetje brez napredovanja
English: There is no relevant use of Provenge in the paediatric population in children and adolescents less than 18 years of age in the indication of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Slovenian: Pediatrična populacija Zdravilo Provenge ni primerno za uporabo pri pediatrični populaciji pri otrocih in mladostnikih, starih manj kot 18 let, za indikacijo asimptomatskega ali minimalno simptomatskega metastatskega (nevisceralnega), na kastracijo odpornega raka prostate pri odraslih moških, pri katerih kemoterapija še ni klinično indicirana.
English: Acute infusion reactions
Slovenian: Akutne reakcije na infundiranje
English: In controlled clinical trials, 25.4% of patients treated with Provenge required more than 3 leukapheresis procedures in order to receive 3 infusions.
Slovenian: V kontroliranih kliničnih preskušanjih so bili pri 25,4 % bolnikov, zdravljenih z zdravilom Provenge, potrebni več kot 3 postopki levkafereze za prejem 3 infuzije.
English: Control (N=33)
Slovenian: Kontrola (N = 33)
English: Adverse reactions associated with leukapheresis
Slovenian: Neželeni učinki, povezani z levkaferezo
English: • Once the patient is prepared for infusion and the APPROVED Final Product Disposition Notification form has been received, the Provenge bag should be removed from the insulated container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Slovenian: • Ko je bolnik pripravljen na infundiranje in po prejemu ODOBRENEGA obvestilom o končnem razpolaganju z zdravilom, se vrečko z zdravilom Provenge odstrani iz izoliranega vsebnika in pregleda, ali pušča, ima vidne poškodbe, tujke, grudice ali strdke.
English: Before, or on the day, your blood cells are collected, a blood sample will be taken from you for a complete blood count (CBC) test.
Slovenian: Testi Pred dnevom odvzema krvnih celic ali na dan odvzema vam bodo odvzeli vzorec krvi, da opravijo preiskavo celotne krvne slike.
English: Product characterization shows that PAP and PAP-GM-CSF fusion protein-specific T cells are generated during treatment and are detected in the peripheral blood of patients after treatment with Provenge.
Slovenian: Karakterizacija zdravila kaže, da med zdravljenjem nastajajo T-celice PAP in PAP-GM-CSF, specifične za fuzijski protein, ki so po zdravljenju z zdravilom Provenge zaznavne v periferni krvi bolnikov.
English: Prior to infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form (see sections 4.2 and 6.6).
Slovenian: Pred infundiranjem je treba potrditi, da se identiteta bolnika ujema z bistveno edinstveno informacijo o bolniku na infuzijski vrečki z zdravilom Provenge in na obvestilu o končnem razpolaganju z zdravilom (glejte poglavji 4.2 in 6.6).
English: To minimize potential acute infusion reactions such as chills and/or fever, it is recommended that patients be pre-medicated orally with paracetamol and an antihistamine approximately 30 minutes prior to administration of Provenge.
Slovenian: Za zmanjšanje možne akutne reakcije na infundiranje, kot sta mrzlica in/ali zvišana telesna temperatura, se priporoča, da se bolnike približno 30 minut pred uporabo zdravila Provenge peroralno premedicira s paracetamolom in antihistaminikom.
English: If you have any further questions, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
English: Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Slovenian: Zdravilo Provenge je indicirano za zdravljenje asimptomatskega ali minimalno simptomatskega metastatskega (nevisceralnega), na kastracijo odpornega raka prostate pri odraslih moških, pri katerih kemoterapija še ni klinično indicirana.
English: To reduce these reactions your doctor may suggest that you take paracetamol and an antihistamine medicine about 30 minutes before your treatment with Provenge.
Slovenian: Za zmanjšanje teh reakcij lahko zdravnik predlaga, da približno 30 minut pred zdravljenjem z zdravilom Provenge vzamete paracetamol in antihistaminik.
English: Rash
Slovenian: Roki
English: In controlled clinical trials, cerebrovascular events (hemorrhagic and ischaemic strokes) were observed in 3.5% of patients in the Provenge group compared with 2.6% of patients in the control group.
Slovenian: V kontroliranih kliničnih preskušanjih so opazili cerebrovaskularne dogodke (hemoragična in ishemična kap) pri 3,5 % bolnikov v skupini z zdravilom Provenge v primerjavi z 2,6 % bolnikov v kontrolni skupini.
English: Other side effects with Provenge include:
Slovenian: Drugi neželeni učinki zdravila Provenge vključujejo: