FrancophonIA/ELRC3.0 huggingface dataset:
English: Provenge undergoes several tests before use to show that it is sterile.
Croatian: Provenge se prije primjene ispituje s nekoliko testova kako bi se potvrdilo da je sterilan.
English: When Provenge cannot be given
Croatian: Kada se Provenge ne može primijeniti
English: Dendreon UK Limited 41 Chalton Street London, NW1 1JD United Kingdom Tel: (0)20 7554 2222
Croatian: Dendreon UK Limited 41 Chalton Street London, NW1 1JD Ujedinjeno Kraljevstvo Tel: (0)20 7554 2222
English: In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction.
Croatian: U slučaju akutne reakcije na infuziju, infuziju je moguće zaustaviti ili usporiti, ovisno o težini reakcije.
English: After removal from the insulated container, the medicinal product should be used immediately.
Croatian: Nakon vađenja iz izoliranog spremnika, lijek je potrebno primijeniti odmah.
English: Provenge is designed to stimulate your immune system, and therefore it may not be appropriate to be treated with Provenge if you are currently taking other treatments that could affect the ability of your immune system to respond to Provenge e.g., immunosuppressant medicines such as those used to treat or prevent organ rejection and certain medicines used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease, and ulcerative colitis.
Croatian: Provenge je napravljen kako bi poticao Vaš imunološki sustav, stoga liječenje može biti neadekvatno ako trenutno uzimate druge lijekove koji bi mogli utjecati na sposobnost imunološkog sustava da odgovori na Provenge, npr. imunosupresivne lijekove poput onih koje se koriste za liječenje ili spriječavanje odbacivanja organa nakon presađivanja i određene lijekove koji se koriste za liječenje reumatoidnog artritisa, multiple skleroze, Crohnove bolesti i ulceroznog kolitisa.
English: Method of administration Provenge is solely intended for autologous use via intravenous infusion.
Croatian: Način primjene Provenge je namijenjen isključivo za autolognu primjenu putem intravenske infuzije.
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.
Croatian: Kriteriji isključivanja bili su: visceralne (jetra, pluća ili mozak) presadnice, maligni pleuralni izljevi ili maligni ascites, patološki prijelomi dugih kostiju, teški patološki prijelomi dugih kostiju (radiografski prikazana kortikalna erozija > 50%), kompresija leđne moždine, umjerena do teška bol povezana s rakom prostate i uporabom narkotika za liječenje te boli te liječenje kemoterapijom najmanje 3 mjeseca prije randomizacije.
English: In such cases, the patient may need to undergo an additional leukapheresis procedure if the treatment is to be continued.
Croatian: U takvim slučajevima, bolesnik će možda morati ponovno proći postupak leukafereze ukoliko se liječenje želi nastaviti.
English: Summary of study results Table 2 presents overall survival results observed in IMPACT, study D9901, and study D9902A.
Croatian: Tablica 2 prikazuje ukupno preživljenje zabilježene u IMPACT ispitivanju, studiji D9901 i studiji D9902A.
English: There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Croatian: Primijećena je korelacija između staničnog odgovora i stvaranja protutijela na PAP ili PAP-GM-CSF u skupini Provenge i poboljšanog preživljenja.
English: Provenge has a shelf life of 18 hours in the insulated container that is shipped to the medical facility where the infusion will be administered.
Croatian: Provenge ima rok trajanja od 18 sati u izoliranom spremniku koji se isporučuje u zdravstvenu ustanovu u kojoj će infuzija biti primijenjena.
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.
Croatian: Ovo je testiranje zakonska obveza koja osigurava da zdravstveni djelatnici uključeni u Vaše liječenje mogu sigurno rukovati Vašim krvnim stanicama.
English: The control was nonactivated autologous peripheral blood mononuclear cells.
Croatian: Kontrolni lijek sadržavao je neaktivirane autologne mononuklearne stanice periferne krvi.
English: The primary endpoint was time to disease progression, which did not reach statistical significance.
Croatian: Primarni ishod bilo je vrijeme do progresije bolesti, u kojem nije uočena statistički značajna razlika.
English: To reduce the risk of catheter-related infections, CVCs should be considered only for patients with poor peripheral venous access.
Croatian: U svrhu smanjenja rizika od infekcija povezanih s kateterom, centralni venski kateter se preporučuje primjenjivati samo u bolesnika s perifernim venama loše kvalitete.
English: Provenge is intended solely for autologous use and should under no circumstances be administered to other patients.
Croatian: Provenge je namijenjen isključivo za autolognu primjenu i ni pod kojim okolnostima ne smije biti primijenjen dugim bolesnicima.
English: Patients treated with Provenge had a statistically significant survival advantage compared with control.
Croatian: Bolesnici liječeni lijekom Provenge pokazali su statistički značajnu dulje preživljenje u usporedbi s kontrolnom skupinom.
English: • The existence of the EU Registry of patients treated for metastatic castrate resistant prostate cancer and how to enter patients in it.
Croatian: • Objašnjenje nužnosti postojanja registra bolesnika EU liječenih zbog metastatskog raka prostate rezistentnog na kastraciju te načina unošenja bolesnika u registar.
English: Hence it is important that the procedures for handling and administering the product are precisely followed (see section 6.6).
Croatian: Stoga je važno pomno slijediti naputak za rukovanje i primjenu lijeka (vidjeti dio 6.6).
English: In some cases, you may be unable to receive a scheduled infusion of Provenge.
Croatian: U nekim slučajevima, možda nećete biti u mogućnosti primiti planiranu infuziju lijeka Provenge.
English: All physicians who intend to prescribe Provenge must review the educational materials and sign the training verification form.
Croatian: Svi liječnici koji namjeravaju propisivati Provenge dužni su proučiti edukacijske materijale i potpisati potvrdu o završenoj obuci.
English: However, as Provenge is an autologous product, a positive test does not preclude the manufacture of the product.
Croatian: Međutim, budući da je Provenge autologni lijek, pozitivan test ne isključuje njegovu proizvodnju.
English: In controlled clinical trials, the dosing interval range was 115 weeks (see section 5.1).
Croatian: U kontroliranim kliničkim ispitivanjima, interval doziranja iznosio je 1 - 15 tjedana (vidjeti dio 5.1).
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.
Croatian: Provenge je autologna stanična imunoterapija razvijena s ciljem poticanja imunološkog odgovora na prostatičnu kiselu fosfatazu (PAP), antigen izražen na većini stanica raka prostate.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot/COI {lot number/chain of identity} First Name, Middle Initial, Last Name {patient name} DOB {patient date of birth}
Croatian: 13. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Serija/COI {broj serije/identifikacijskog lanca} Ime, inicijal srednjeg imena, prezime {ime bolesnika}
English: Analyses of time to objective disease progression, time to clinical progression, or PSA doubling time (PSADT) did not meet statistical significance.
Croatian: Analize vremena do objektivne progresije bolesti, vremena do kliničke progresije i vremena udvostručenja PSA nisu pokazale statističku značajnost.
English: You will receive a total of 3 infusions of Provenge at approximately 2 week intervals.
Croatian: Primit ćete ukupno 3 infuzije lijeka Provenge u razmacima od približno 2 tjedna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INSULATED POLYURETHANE CONTAINER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU IZOLIRANI POLIURETANSKI SPREMNIK
English: When given as a drip (infusion) into your vein, Provenge works by teaching your immune cells to recognise and attack prostate cancer cells.
Croatian: Kada se primjenjuje venskim putem (u obliku infuzije), Provenge djeluje na način da potiče stanice Vašeg imunološkog sustava da prepoznaju i napadaju stanice raka prostate.
English: The entire volume of the bag should be infused.
Croatian: Potrebno je infundirati cijeli sadržaj vrećice.
English: The infusion bag is placed inside an insulated polyurethane container and packed in a shipping box.
Croatian: Infuzijska vrećica se stavlja u izolirani poliuretanski spremnik i pakira se u transportnu kutiju.
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.
Croatian: Karakterizacija proizvoda pokazuje da PAP i PAP-GM-CSF specifične T-stanice nastaju tijekom liječenja te se nalaze u perifernoj krvi bolesnika nakon liječenja lijekom Provenge.
English: Like all medicines, Provenge can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: The other ingredients are: sodium chloride, sodium lactate, potassium chloride, and calcium chloride.
Croatian: Drugi sastojci su natrijev klorid, natrijev laktat, kalijev klorid i kalcijev klorid.
English: Patients in the control group could enrol in an open-label protocol and receive an investigational autologous cellular therapy manufactured from cells cryopreserved at the time the control product was prepared.
Croatian: Bolesnici u kontrolnoj skupini mogli su se priključiti otvorenom protokolu i primiti eksperimentalnu autolognu staničnu terapiju proizvedenu od stanica krioprezerviranih u trenutku kada je kontrolni lijek pripremljen.
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.
Croatian: Česti simptomi uključuju epizode nesvjestice, plavičastu boju kože, usana i/ili noktiju zbog niske razine kisika u krvi, piskanje, visoki ili niski krvni tlak i otežano disanje.
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)
Croatian: • imunokompromitiranost (smanjena sposobnost Vašeg imunološkog sustava da se bori protiv infekcija) ili uzimanje bilo kakvih imunosupresivnih lijekova (poput lijekova koji se primjenjuju za liječenje ili sprječavanje odbacivanja organa nakon presađivanja i određenih lijekova koji se primjenjuju za liječenje reumatoidnog artritisa, multiple skleroze, Crohnove bolesti i ulceroznog kolitisa).
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.
Croatian: Za umanjivanje potencijalnih akutnih infuzijskih reakcija kao što su zimica i /ili vrućica, preporučuje se oralna premedikacija bolesnika paracetamolom i antihistaminikom oko 30 minuta prije primjene lijeka Provenge.
English: Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in clinical studies.
Croatian: Akutne infuzijske reakcije, kao što su zimica, umor, vrućica, mučnina i bol u zglobovima često su zabilježene u kliničkim ispitivanjima.
English: In some cases, the patient may be unable to receive a scheduled infusion of Provenge.
Croatian: U nekim slučajevima, bolesnik može biti u nemogućnosti primiti planiranu infuziju lijeka Provenge.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar šest mjeseci nakon dobivanja odobrenja.
English: Following disease progression, patients were treated at the physician's discretion with other anti-cancer interventions.
Croatian: Nakon progresije bolesti, bolesnici su liječeni uz liječničku diskreciju drugim oblicima onkološkog liječenja.
English: If, for any reason, the patient is unable to receive a scheduled infusion of Provenge, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued.
Croatian: Ako bolesnik iz bilo kojeg razloga ne može primiti predviđenu infuziju lijeka Provenge, bit će potrebno ponoviti postupak leukafereze ukoliko se liječenje želi nastaviti.
English: The MAH shall also agree with the National Competent Authority any requirements for prior audit of apheresis centres and training courses for healthcare professionals in the use of Provenge.
Croatian: Nositelj odobrenja treba s nadležnim državnim tijelom dogovoriti bilo kakve zahtjeve za prethodne preglede centara za aferezu i tečaje obuke zdravstvenih djelatnika o uporabi lijeka Provenge.
English: Prior to the first leukapheresis procedure, a complete blood count (CBC) test should be performed and be within ranges acceptable for the local facility.
Croatian: Prije prvog postupka leukafereze, potrebno je učiniti kompletnu krvnu sliku (KKS) čije vrijednosti moraju biti u okvirima prihvatljivim za ustanovu.
English: The insulated container and the gel packs within are designed to maintain the appropriate transportation and storage temperature of Provenge until infusion.
Croatian: Izolirani spremnik i pakiranja gela namijenjeni su održavanju odgovarajućih uvjeta transporta i temperature čuvanja lijeka Provenge do primjene.
English: Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnoea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia.
Croatian: Akutne infuzijske reakcije (prijavljene unutar jednog dana od infuzije) uključuju, ali ne isključivo,vrućicu, zimicu, respiratorne događaje (dispneja, hipoksija i bronhospazam), mučninu, povraćanje, umor, hipertenziju i tahikardiju.
English: a b b p-value
Croatian: p-vrijednost a c c
English: No specific dose recommendation can be provided in these patients.
Croatian: U tih bolesnika nema posebnih preporuka za prilagodbu doze lijeka.
English: Serious infections including sepsis have been observed in patients treated with Provenge.
Croatian: Ozbiljne infekcije, uključujući sepsu, zabilježene su u bolesnika liječenih lijekom Provenge.
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.
Croatian: Provenge se mora primjenjivati pod nadzorom liječnika s iskustvom u liječenju raka prostate, a u okruženju u kojem je dostupna reanimacijska oprema.
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.4).
Croatian: Prema postmarketinškom iskustvu u više od 5000 liječenih bolesnika, ta incidencija iznosi približno 19% (vidjeti dio 4.4).
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.
Croatian: Obavijestite svog liječnika ukoliko ste nakon liječenja lijekom Provenge primijetili bilo kakve simptome infekcije, primjerice vrućicu ili povišenu temperaturu iznad 38 °C, zimicu, ubrzani rad srca, ubrzano disanje, omaglicu pri ustajanju, smetenost ili mučninu/povraćanje.
English: Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure.
Croatian: Svaka infuzija lijeka Provenge sadrži najveći broj stanica koje mogu biti dobivene jednim postupkom leukafereze.
English: In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
Croatian: U kontroliranim kliničkim ispitivanjima, 71,2% bolesnika u skupini Provenge razvilo je akutnu infuzijsku reakciju.
English: Cerebrovascular disease
Croatian: Cerebrovaskularne bolesti
English: Fertility Effect on male fertility is not known.
Croatian: Plodnost Utjecaj na plodnost u muškaraca nije poznat.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Croatian: Zdravstveni djelatnici dužni su prijaviti svaku sumnju na nuspojavu.
English: Prior to the first leukapheresis proceedure, a complete blood count (CBC) test should be performed.
Croatian: Prije prvog postupka leukafereze, potrebno je učiniti kompletnu krvnu sliku (KKS).
English: No interaction studies have been performed with Provenge.
Croatian: Nisu provedena ispitivanja interakcija s lijekom Provenge.
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
Croatian: Prema postmarketinškom iskustvu u više od 5000 liječenih bolesnika, ta incidencija iznosi približno 19% (vidjeti dio 4.2).
English: Provenge is for use in adult men only.
Croatian: Provenge je namijenjen isključivo za primjenu u odraslih muškaraca.
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.
Croatian: Provenge je indiciran za liječenje asimptomatskog ili minimalno simptomatskog metastatskog (nevisceralnog) raka prostate rezistentnog na kastraciju u odraslih muškaraca u kojih kemoterapija još nije klinički indicirana.
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)].
Croatian: Retrospektivna analiza podgrupe upućuje na veći učinak liječenja lijekom Provenge u bolesnika s početnom vrijednošću PSA <22,1 ng/mL [HR = 0,521 (95% CI: 0,309, 0,879)].
English: This may be due to release criteria not being met during manufacturing, the expiration time being exceeded, or the patient being unable to meet the scheduled infusion time.
Croatian: Uzrok tome može biti nepoštivanje kriterija priprave tijekom proizvodnje, istekao rok valjanosti lijeka ili nemogućnost bolesnika da u određenom trenutku primi infuziju.
English: Provenge is intended solely for autologous use.
Croatian: Provenge je namijenjen isključivo za autolognu primjenu.
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.
Croatian: Bolesnici uključeni u ova ispitivanja bili su rezistentni na kiruršku ili medikamentoznu kastraciju (npr. agonistom hormona koji potiče otpuštanje luteinizirajućeg hormona [LHRH] ili antagonistom gonadotropin - otpuštajućeg hormona [GnRH]) te su imali presadnice u mekom tkivu i/ili kostima.
English: If your infusion of Provenge has to be interrupted for any reason, your doctor will not be able to restart the infusion if the medicine has been at room temperature for more than 3 hours.
Croatian: Ukoliko će Vaša infuzija morati biti prekinuta iz bilo kojeg razloga, Vaš liječnik neće moći nastaviti infuziju ako je lijek stajao na sobnoj temperaturi više od 3 sata.
English: • Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
Croatian: • Provenge se priprema od ljudske krvi pojedinog bolesnika i nije testiran na prenosive uzročnike zaraznih bolesti.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Croatian: Ako imate bilo kakvih dodatnih pitanja o uporabi ovog lijeka, upitajte svog liječnika ili medicinsku sestru.
English: Control (N=33)
Croatian: Kontrolna skupina (N=33)
English: In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
Croatian: U kliničkim ispitivanjima, kod približno jedne četvrtine bolesnika bila su potrebna više od 3 postupka leukafereze kako bi se primijenile 3 infuzije lijeka Provenge.
English: Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
Croatian: 30 minuta prije i 30 minuta poslije svake infuzije.
English: Atrial fibrillation Myocardial infarction Myocardial ischaemia
Croatian: Srčani poremećaji fibrilacija atrija infarkt miokarda ishemija miokarda
English: Neutralising antibody responses to GM-CSF were transient.
Croatian: Stvaranje protutijela koja neutraliziraju GM-CSF bilo je prolaznog karaktera.
English: Control (N=45)
Croatian: Kontrolna skupina (N=45)
English: In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
Croatian: U kontroliranim kliničkim ispitivanjima, teške (3. stupnja) akutne infuzijske reakcije prijavljene su u 3,5% bolesnika u skupini Provenge.
English: Therefore, concurrent use of immunosuppressive agents (such as systemic corticosteroids) should be avoided during Provenge treatment.
Croatian: Stoga je istodobnu primjenu imunosupresiva (kao što su kortikosteroidi za sustavnu primjenu) i lijeka Provenge potrebno izbjegavati.
English: • Training completion form as agreed with the national competent authority
Croatian: • Obrazac o završenoj obuci koji je potvrdilo nadležno državno tijelo
English: See the end of section 4 for how to report side effects.
Croatian: Za uputu o tome kako prijaviti nuspojavu, pogledajte završetak dijela 4.
English: • shortness of breath, wheezing, dizziness, rash, or fever.
Croatian: • nedostatak zraka, piskanje, omaglicu, osip ili vrućicu.
English: Your doctor will work with you to schedule new appointments for cell collection and infusion.
Croatian: Vaš liječnik će Vam ugovoriti nove termine za prikupljanje stanica i infuziju.
English: The effects of Provenge on male fertility are not known at this time.
Croatian: Djelovanje lijeka Provenge na plodnost muškaraca zasad nije poznata.
English: Patients with positive serology tests for human immunodeficiency virus [HIV] 1 and 2, human T cell lymphotropic virus [HTLV] 1, and hepatitis B and C were excluded from controlled clinical trials.
Croatian: Bolesnici čiji su serološki testovi pozitivni na virus humane imunodeficijencije (HIV) 1 i 2, humani T-limfotropni virus (HTLV) 1 te hepatitis B i C, isključeni su iz kontroliranih kliničkih ispitivanja i za te bolesnike nema dostupnih podataka.
English: The cellular composition and the cell number per dose of Provenge will vary according to the patient's leukapheresis.
Croatian: Stanični sastav i broj stanica po dozi lijeka Provenge varira ovisno o učinkovitosti leukafereze u bolesnika.
English: What Provenge looks like and contents of the pack Provenge is a slightly cloudy dispersion of cream-to-pink colour and is supplied in a plastic bag with 3 sample ports.
Croatian: Provenge je blago mutna disperzija kremaste do ružičaste boje i isporučuje se u plastičnoj vrećici s 3