FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common reactions (≥ 20%) were chills, fever, and fatigue.
Croatian: Najčešće reakcije (≥ 20%) bile su zimica, vrućica i umor.
English: Conventional toxicology, carcinogenicity, mutagenicity, and reproductive toxicity studies have not been performed.
Croatian: Uobičajena ispitivanja toksičnosti, karcinogenosti, mutagenosti i reproduktivne toksičnosti nisu provedena.
English: The most severe side effects are described below:
Croatian: Najteže nuspojave opisane su u nastavku:
English: Eighty-two percent of patients had an ECOG performance status of 0; 75% had a Gleason sum ≤ 7; 44% had bone and soft tissue disease; 48% had bone-only disease; 7% had soft tissue-only disease; and 43% had greater than ten bony metastases.
Croatian: Osamdeset dva posto bolesnika imalo je ECOG status 0; 75% bolesnika imalo je Gleason zbroj ≤ 7; 44% bolesnika imalo je bolest kostiju i mekog tkiva , 48% ih je imalo samo bolest kostiju, 7% ih je imalo samo bolest mekog tkiva, a 43% ih je imalo više od deset koštanih metastaza.
English: Fevers and chills generally resolved within 2 days (71.9% and 89.0%, respectively).
Croatian: Vrućica i zimica općenito su nestale u roku od dva dana (u 71,9% odnosno 89,0% bolesnika).
English: If you need a vaccination whilst receiving Provenge, you should first discuss this with your doctor.
Croatian: Ukoliko trebate primiti cjepivo u vrijeme dok se liječite lijekom Provenge, najprije se konzultirajte sa svojim liječnikom.
English: Pregnancy, breast-feeding and fertility Provenge is for use in men only.
Croatian: Trudnoća, dojenje i plodnost Provenge je namijenjen isključivo muškarcima.
English: Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
Croatian: Neke ozbiljne infekcije i sepsa bile su povezane s korištenjem centralnih venskih katetera.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Provenge Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: After the infusion
Croatian: Nakon infuzije
English: Patients should be observed for at least 30 minutes following each infusion.
Croatian: Bolesnike je potrebno promatrati najmanje 30 minuta nakon svake infuzije.
English: In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Croatian: Osim antigen prezentirajućih stanica (APC), konačni proizvod također sadrži T stanice, B stanice, stanice prirodne ubojice (NK stanice) i druge stanice.
English: These immune cells are then mixed with an antigen (a protein, which is able to stimulate your immune system) at a specific manufacturing facility.
Croatian: Te imunološke stanice se zatim miješaju s antigenom (proteinom koji ima sposobnost poticanja Vašeg imunološkog sustava) u određenom proizvodnom laboratoriju.
English: Tell your doctor or nurse if you develop any of these symptoms, as the infusion may need to be slowed down or stopped.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ukoliko primijetite bilo koji od ovih simptoma, s obzirom da će možda biti potrebno usporiti ili zaustaviti infuziju.
English: Some (1.2%) patients in the Provenge group were hospitalized within 1 day of infusion for management of acute infusion reactions.
Croatian: Neki (1,2%) bolesnici u skupini Provenge bili su hospitalizirani unutar 1 dana nakon infuzije radi pojave akutnih infuzijskih reakcija.
English: If the final results show that your medicine was not sterile, your doctor will be notified and you will be monitored closely for any signs of infection and will be treated accordingly.
Croatian: Ako konačni rezultati pokažu da Vaš lijek nije bio sterilan, Vaš liječnik će biti obaviješten i pažljvo vas pratiti radi mogućnosti razvoja infekcije, sukladno čemu ćete onda biti liječeni.
English: Date {DD month YYYY}, Exp. Time {hh:mm}, Time Zone
Croatian: Datum isteka roka valjanosti {DD mjesec GGGG}, vrijeme isteka roka valjanosti {hh: mm}, vremenska zona
English: Patient Alert card to record the scheduled leukapheresis and infusion dates
Croatian: 6. Karticu s upozorenjima za bolesnika za zapisivanje planiranih datuma leukafereze i infuzije
English: In the post-marketing setting, serious acute infusion reactions involving hypotension and syncope have been reported.
Croatian: U postmarketinškom razdoblju, prijavljene su ozbiljne akutne infuzijske reakcije koje se uključivale hipotenziju i sinkopu.
English: Small clumps of cellular material should disperse with gentle manual mixing.
Croatian: Sitne nakupine staničnog materijala raspršit će se laganim ručnim miješanjem.
English: Supportive studies
Croatian: Suportivne studije
English: Neither endpoint met statistical significance.
Croatian: Niti jedan ishod nije pokazao statistički značajne razlike.
English: Practical information for handling and administration of Provenge for the doctor or nurse can be found at the end of this leaflet.
Croatian: Praktične informacije o rukovanju i primjeni lijeka Provenge namijenjene liječniku ili medicinskoj sestri mogu se naći na kraju ove upute.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Provenge in all subsets of the paediatric population in the treatment of prostate cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odrekao obvezu podnijeti rezultate istraživanja lijeka Provenge u svim podskupinama pedijatrijske populacije u liječenju raka prostate (vidjeti dio 4.2 za informacije o primjeni u pedijatrijskoj populaciji).
English: Cases in which Provenge cannot be infused
Croatian: Slučajevi u kojima se Provenge ne može primijeniti
English: The physician should monitor and/or treat the patient as appropriate.
Croatian: Liječnik treba pratiti i/ili liječiti bolesnika u skladu s novonastalom situacijom.
English: • The need to provide patients with the educational material and explain the use of the patient
Croatian: • Objašnjenje potrebe da se bolesnicima osigura edukacijski materijal i objasni uporaba kartice s upozorenjima za bolesnika
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:
Croatian: Možda će biti potreban jedan ili više dodatnih dolazaka zbog provođenja krvnih pretraga prije postupka leukafereze (ovisno o lokalnoj praksi u bolnici u kojoj se provodi liječenje), ili krvne pretrage mogu biti napravljene tijekom Vaših postupaka leukafereze:
English: The nature of Provenge is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Croatian: Priroda lijeka Provenge je takva da uobičajena ispitivanja farmakokinetike, apsorpcije, distribucije, metabolizma i eliminacije nisu primjenjive.
English: • high temperature, chills, breathing difficulties
Croatian: • visoka temperatura, zimica, otežano disanje
English: If you miss an appointment and you cannot be given your Provenge infusion, it will no longer be usable.
Croatian: Ako ste propustili termin i ne možete primiti svoju infuziju lijeka Provenge, ona više neće biti upotrebljiva.
English: The MAH shall ensure that all healthcare professionals who are expected to prescribe or use Provenge are provided with the following items:
Croatian: Nositelj odobrenja mora se pobrinuti da svi zdravstveni djelatnici koji bi trebali propisivati ili primjenjivati Provenge imaju sljedeće materijale:
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.
Croatian: Prije ili na dan kad su Vaše krvne stanice prikupljene, morat ćete dati uzorak krvi za kompletnu krvnu sliku (KKS).
English: Immunocompromised patients and patients taking systemic immunosuppressive therapy were excluded from controlled clinical trials.
Croatian: Imunokompromitirani bolesnici i bolesnici u kojih je u tijeku sistemsko imunosupresivno liječenje isključeni su iz kontroliranih kliničkih ispitivanja.
English: Once the infusion is complete you will be observed and monitored for at least 30-60 minutes, after which, you may go home.
Croatian: Bit ćete pod nadzorom najmanje 30-60 minuta po završetku infuzije, nakon čega ćete moći otići kući.
English: Acute infusion reactions
Croatian: Akutne infuzijske reakcije
English: Therefore, vaccinations with live attenuated or inactivated vaccines whilst receiving Provenge should be carefully considered.
Croatian: Stoga je cijepljenje živim atenuiranim ili inaktiviranim cjepivom istodobno uz primjenu lijeka Provenge potrebno pažljivo razmotriti.
English: All patients had baseline testosterone levels < 50 ng/mL.
Croatian: Početna razina testosterona u svih bolesnika bila je <50 ng / ml.
English: Concurrent use of immunosuppressive agents (such as systemic corticosteroids) may alter its efficacy and/or safety.
Croatian: Istodobna primjena imunosupresiva (kao što su kortikosteroidi za sustavnu primjenu) može utjecati na njegovu učinkovitost i/ili sigurnost.
English: Dose and course of treatment
Croatian: Doza i tijek liječenja
English: Additionally, there have been reports of thrombocytopenia received in spontaneous post-marketing reporting that have been temporally associated with leukapheresis.
Croatian: Također postoje izvješća o trombocitopeniji zaprimljena tijekom spontanog postmarketinškog izvješćivanja, a koja su privremeno povezana s leukaferezom.
English: • Provenge is infused over a period of approximately 60 minutes through a large bore needle appropriate for transfusion of red blood cells.
Croatian: • Provenge se primijenjuje tijekom otprilike 60 minuta kroz iglu s velikim otvorom prikladnu za transfuziju crvenih krvnih stanica.
English: • Provenge is shipped directly to the medical facility where the infusion will be administered.
Croatian: • Provenge se isporučuje izravno u zdravstvenu ustanovu u kojoj će se infuzija primijeniti.
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.
Croatian: Provenge je potrebno primijenjivati s oprezom u svih imunokompromitiranih bolesnika, uključujući bolesnike u kojih je u tijeku sustavno imunosupresivno liječenje, a nakon pažljivog razmatranja potencijalnog rizika i koristi na individiualnoj osnovi.
English: • The outer shipping box should be opened to verify the product and patient-specific labels located on the top of the insulated container.
Croatian: • Vanjsku transportnu kutiju potrebno je otvoriti kako bi se provjerilo lijek i naljepnice s podacima o bolesniku koje se nalaze na vrhu izoliranog spremnika.
English: • The expiration date and time have passed.
Croatian: • je istekao datum i vrijeme roka valjanosti
English: • 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.
Croatian: • oštećenje lijeka pri prispijeću u bolnicu, na primjer, vrećica koja sadrži lijek propušta ili su stanice formirale nakupine koje nije moguće raspršiti.
English: - increase in a type of white blood cells called eosinophils - infusion site reaction (a reaction of the skin area where the infusion drip was inserted)
Croatian: - povećanje jedne vrste bijelih krvnih stanica koje se nazivaju eozinofili - reakcija na mjestu infuzije (kožna reakcija na mjestu igle na infuziju)
English: Figure 1 Kaplan-Meier overall survival curve, IMPACT study
Croatian: Kaplan-Meier krivulja ukupnog preživljenja, IMPACT ispitivanje
English: Older people No dose adjustment is required in the elderly population.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/867/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/867/001
English: Your Provenge treatment will be given by a drip (infusion) into one of your veins (intravenous use).
Croatian: Provenge ćete primiti putem infuzije u jednu od vena (intravenska primjena).
English: What Provenge is and what it is used for What you need to know before you are given Provenge
Croatian: Što je Provenge i za što se koristi Što morate znati prije nego počnete primati Provenge Kako primjenjivati Provenge
English: 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%).
Croatian: Najčešće ozbiljne infekcije u skupini Provenge bile su kateterska sepsa (0,7%), stafilokokna bakterijemija (0,7%), sepsa (0,7%), stafilokokna sepsa
English: If you are allergic (hypersensitive) to the active substances or any of the ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični (preosjetljivi) na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: • a delay in Provenge reaching the clinic where you will be given your treatment.
Croatian: • kašnjenje u isporuci lijeka Provenge u kliniku u kojoj ćete biti liječeni.
English: As Provenge is made from your own blood cells, your cells will be collected approximately 3 days before each scheduled infusion.
Croatian: Budući da se Provenge priprema od Vaših krvnih stanica, Vaše stanice će se prikupljati oko 3 dana prije svake planirane infuzije.
English: Do not administer if the bag leaks during handling or if particles or clumps remain in the bag.
Croatian: Nemojte primijenjivati lijek ukoliko vrećica propušta tijekom rukovanja ili ako su u vrećici ostale čestice ili grudice.
English: ▼ This medicine is subject to additional monitoring.
Croatian: Ovaj je lijek predmet dodatnog ispitivanja.
English: Each Provenge bag contains one individual infusion treatment and the container will only be opened when you are ready to receive your treatment.
Croatian: Svaka vrećica lijeka Provenge sadrži lijek za jednu individualnu infuziju i spremnik koji će biti otvoren tek kada ste Vi spremni primiti lijek.
English: • An infection which affects your whole body (e.g., sepsis, seen as high temperature, increased heart rate or breathing)
Croatian: • infekcija koja utječe na cijelo tijelo (npr. sepsa, što se očituje kao visoka temperatura,
English: Your blood will be tested before it is collected (see section “Tests” below).
Croatian: Vašu će krv testirati prije postupka prikupljanja (vidjeti dio "Krvne pretrage" u nastavku).
English: Provenge is used as treatment for prostate cancer that has spread outside of the prostate but not to the liver, lung or brain, and no longer responds to medicines that lower the levels of the male hormone testosterone in patients who are not considered appropriate for treatment with chemotherapy.
Croatian: Provenge se primjenjuje za liječenje raka prostate koji se proširio izvan prostate, ali ne na jetru, pluća ili mozak, i više ne reagira na lijekove koji snizuju razinu muškog hormona testosterona u bolesnika koje se ne smatra prikladnima za liječenje kemoterapijom.
English: Submission of study protocol within 1 month of authorisation
Croatian: Predavanje protokola ispitivanja unutar 1 mjeseca od odobrenja Godišnje ažuriranje rezultata ispitivanja
English: • 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).
Croatian: • je proizvod oštećen na bilo koji način (oštećena vrećica infuzije, propuštanje ili čestice/grudice koje su ostale u vrećici i nakon blagog ručnog miješanja).
English: 250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
Croatian: Disperzija od 250 mL u vrećici (prozračna troslojna poliolefinska vrećica s 3 otvora za uzorkovanje (2 otvora za iglu i 1 otvor sa zapečaćenom cjevčicom )).
English: Patients with cardiac or pulmonary conditions should be closely monitored (see section 4.8).
Croatian: Bolesnike sa srčanim i plućnim tegobama potrebno je pažljivo pratiti (vidjeti dio 4.8).
English: CD54 is an adhesion and costimulatory molecule essential in the formation of the immunological synapse between an APC and a T cell.
Croatian: CD54 je adhezija i kostimulacijska molekula nužna za stvaranje imunološke veze između antigen prezentirajućih stanica i T stanica.
English: 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.
Croatian: Treća studija, D9902A, sličnog dizajna kao studija D9901, obustavljena je prije planiranog završetka uključivanja bolesnika, zbog podataka o vremenu do progresije bolesti iz studije D9901.
English: In the pivotal randomised controlled study (D9902B, IMPACT, see section 5.1) Provenge was discontinued in 1.5% of patients due to adverse reactions.
Croatian: U ključnom randomiziranom kontroliranom ispitivanju (D9902B, IMPACT, vidjeti dio 5.1) liječenje lijekom Provenge bilo je prekinuto u 1,5% bolesnika zbog nuspojava.
English: To establish and keep an observational EU-based registry of men with mCRPC to evaluate overall survival, the risk of ischemic stroke or myocardial infarction following treatment with Provenge and other identified and potential risks (observational study P13-1)
Croatian: Uspostavljanje i održavanje registra EU-a koji se temelji na praćenju muškaraca s mCRPC-om kako bi se procijenilo ukupno preživljenje, rizik od ishemijskog moždanog udara ili infarkta miokarda nakon liječenja lijekom Provenge te ostale prepoznate i potencijalne rizike (opažajno ispitivanje P13-1)
English: Provenge is used to control your prostate cancer.
Croatian: Provenge se primjenjuje za liječenje vašeg raka prostate.
English: The primary endpoint was time to disease progression and the secondary endpoint was overall survival.
Croatian: Primarni ishod bilo je vrijeme do progresije bolesti, a sekundarni ishod ukupno preživljenje.
English: There are no known instances of overdose from either a single infusion or a full course of therapy with Provenge.
Croatian: Nema poznatih slučajeva predoziranja niti pojedinačnom infuzijom niti sveukupnom dozom lijeka Provenge.
English: • increased heart rate, high blood pressure, low blood pressure, fainting.
Croatian: • umor • ubrzani rad srca, visoki krvni tlak, niski krvni tlak, nesvjestica.
English: Prior to launch of Provenge in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational materials with the National Competent Authority.
Croatian: Prije stavljanja lijeka Provenge u promet u svakoj državi članici, nositelj odobrenja mora potvrditi sadržaj i oblik edukacijskih materijala pri nadležnom državnom tijelu.
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.
Croatian: Odmah kontaktirajte liječnika ako primijetite bol u prsima, bol u lijevoj ruci i/ili nedostatak zraka jer su ovo znakovi srčanog udara.
English: Control (N=171)
Croatian: Kontrolna skupina (N=171)
English: 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.
Croatian: 2. U drugom koraku se Vaše prikupljene stanice šalju u posebni laboratorij gdje se miješaju s antigenom i pripremaju za infuziju.
English: Submission of study protocol with first PSUR
Croatian: Predavanje protokola ispitivanja s prvim PSURom
English: 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.
Croatian: Provenge je odobren za infuziju na temelju rezultata nekoliko mikrobioloških ispitivanja: određivanja kontaminacije mikroorganizmima metodom bojanja po Gramu, mjerenja sadržaja endotoksina, te ispitivanjem sterilnosti postupka dvodnevnom inkubacijom u svrhu potvrđivanja odsutnosti rasta mikroorganizama.
English: Physicians must provide the educational materials to the patient as well as the package leaflet and the Patient Alert Card.
Croatian: Liječnici također moraju osigurati edukacijske materijale za bolesnika, kao i uputu o lijeku i karticu s upozorenjima za bolesnika.
English: The risks and benefits of vaccinating patients during the course of treatment with Provenge have not been studied.
Croatian: Rizici i koristi od cijepljenja bolesnika tijekom liječenja lijekom Provenge nisu ispitani.
English: The entire volume of the infusion bag should be used.
Croatian: Potrebno je iskoristiti cijeli sadržaj vrećice za infuziju.
English: 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.
Croatian: Sažetak sigurnosnog profila Sigurnosna procjena lijeka Provenge temelji se na podacima prikupljenim od 601 bolesnika s rakom prostate u četiri randomizirana, kontrolirana klinička ispitivanja (3 studije metastatskog raka prostate rezistentnog na kastraciju i jedno ispitivanje androgenski ovisnog raka prostate) i postmarketinškom praćenju.
English: Table 1 Adverse reactions from clinical studies and post-marketing reports System organ class
Croatian: Tablica 1 Nuspojave iz kliničkih ispitivanja i postmarketinških izvješća
English: Final study report by 31 December 2020
Croatian: Završno izvješće o ispitivanju do 31. prosinca
English: Provenge has moderate influence on the ability to drive and use machines, as it may cause fatigue, dizziness, syncope, chills, and headache.
Croatian: Provenge ima umjeren utjecaj na sposobnost upravljanja vozilima i rada sa strojevima, jer može izazvati umor, omaglicu, sinkopu, zimicu i glavobolju.
English: Warnings and precautions Tell your doctor if you have any of the conditions listed below as you will have to be closely monitored during and after your infusion:
Croatian: Obavijestite svog liječnika ako se na Vas odnosi bilo koje od stanja navedenih u nastavku budući da će Vas pažljivo pratiti tijekom i nakon infuzije:
English: * Primarily associated with the leukapheresis procedure
Croatian: proceduralne komplikacije * Primarno povezano s postupkom leukafereze
English: Forty-eight percent of patients were receiving bisphosphonates and 18% had received prior chemotherapy, including docetaxel.
Croatian: Četrdeset osam posto bolesnika primalo je bisfosfonate, a 18% ih je primalo kemoterapiju, uključujući docetaksel.
English: Steps before Provenge treatment
Croatian: Koraci prije primjene lijeka Provenge
English: 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.
Croatian: 36-mjesečno preživljenje a Omjer rizika i p-vrijednost temeljeni na Cox modelu prilagođenom za PSA (ln) i LDH (ln) i stratificirani po uporabi bisfosfonata, broju koštanih presadnica i primarnom Gleason stupnju.
English: You may need to have further CBC tests during your treatment in line with local or country-wide practices.
Croatian: Možda će tijekom liječenja biti potrebne dodatne krvne pretrage KKS-a u skladu s lokalnom ili nacionalnom praksom.
English: 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.
Croatian: Tijekom ex vivo uzgoja u kulturi pomoću PAP-GM-CSF-a, aktivirane antigen prezentirajuće stanice preuzimaju i pretvaraju rekombinantne ciljne antigene u peptide koji se tada prezentiraju T stanicama.
English: Do not use this medicine after the expiration date and time, which is stated on the insulated container and the infusion bag.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka datuma i vremena roka valjanosti navedenog na izoliranom spremniku i vrećici za infuziju..