natgillin/translations-raw huggingface dataset:
Disposal Any unused product or waste material should be disposed of in accordance with local requirements. 
Neiskorišteni lijek ili otpadni materijal treba zbrinuti sukladno lokalnim propisima.
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. 
Kao dio puštanja serije u promet, svaki lijek podliježe ispitivanju kako bi se utvrdila aktivacija antigen prezentirajućih stanica na temelju povećanog izražavanja CD54 antigena nakon uzgoja s PAP
Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator. 
Mononuklearne stanice periferne krvi prikupljene od bolesnika uzgojene su u kulturi pomoću PAP-GM-CSF-a, složenog proteina koji se sastoji od PAP antigena povezanog s čimbenikom poticanja kolonija granulocita i makrofaga (GM-CSF) koji aktivira imunološke stanica.
What you need to know before you are given Provenge 
Što morate znati prije nego počnete primati Provenge Nemojte primjenjivati Provenge
In clinical study D9902B (IMPACT), 237 out of the 512 patients randomized were evaluated for the development of humoral or cellular immune responses (T cell proliferation and gamma-interferon 
U kliničkom ispitivanju D9902B (IMPACT), 237 od ukupno 512 randomiziranih bolesnika evaluirano je u odnosu na razvoj humoralnog ili staničnog imunološkog odgovora (proliferacija T stanica i mjerenje interferona gama (γIFN) ELISPOT testom) na ciljne antigene na početku liječenja te u 6., 14. i 26. tjednu liječenja.
c p-value based on a log-rank test. 
b Omjer rizika temeljen na Cox modelu. c p-vrijednost temeljena na log rank testu.
Other side effects with Provenge include: 
Ostale nuspojave lijeka Provenge uključuju:
If the sterility results become positive for microbial contamination after Provenge has been approved for infusion, the marketing authorisation holder will notify the treating physician and may request additional information from the physician in order to determine the source of contamination. 
Provenge odobren za infuziju, nositelj odobrenja za stavljanje lijeka u promet će obavijestiti liječnika, od kojeg može zatražiti dodatne informacije kako bi se utvrdio izvor kontaminacije.
IMPACT study 
IMPACT ispitivanje
The most commonly reported adverse reactions are chills, fatigue, pyrexia, nausea, arthralgia, headache, and vomiting. 
Najčešće prijavljene nuspojave su zimica, umor, pireksija, mučnina, artralgija, glavobolja i povraćanje.
To submit the results from study P-11, a randomised, double-blind trial evaluating Provenge versus placebo in patients with non-metastatic prostate cancer who experience PSA elevation following radical prostatectomy 
Dostavljanje rezultata ispitivanja P-11, randomiziranog, dvostruko slijepog ispitivanja procjene lijeka Provenge nasuprot placebu kod bolesnika s nemetastatskim rakom prostate u kojih vrijednost PSA poraste nakon radikalne prostatektomije
This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion. 
Ovaj lijek sadrži približno 800 mg natrija i 45 mg kalija po infuziji.
• Specific handling and administration requirements for Provenge 
• Posebne propise za rukovanje i primjenu lijeka Provenge
The IMPACT study was a randomised, double-blind, controlled, multicentre trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. 
IMPACT ispitivanje provedeno je kao randomizirano, dvostruko slijepo, kontrolirano i multicentično ispitivanje u bolesnika s asimptomatskim ili minimalno simptomatskim metastatskim rakom prostate rezistentnim na kastraciju.
Therefore, patient leukapheresis material and Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to healthcare professionals handling the product. 
Stoga, uzorak dobiven leukaferezom i Provenge mogu nositi rizik od prenošenja zaraznih virusa (HIV 1 i 2, hepatitisa B i C) na zdravstvene djelatnike koji rukuju lijekom.
The dispersion is slightly cloudy, with a cream-to-pink colour. 
Disperzija je blago mutna, kremaste do ružičaste boje.
The recommended course of treatment is 3 doses at approximately 2 week intervals. 
Preporučeni protkol liječenja uključuje 3 doze u intervalima od otprilike 2 tjedna.
A smaller treatment effect was observed in those with baseline PSA > 134.1 ng/mL [HR=0.853 (95% CI: 0.554, 1.315)]. 
134,1 ng/mL [HR = 0,853 (95% CI: 0,554, 1,315)].
• Infusion must begin prior to the expiration date and time indicated on the Final Product Disposition Notification form and bag label. 
• Infuzija mora započeti prije isteka datuma i vremena roka valjanosti naznačenog na finalnom Naputku za zbrinjavanje lijeka i na naljepnici vrećice.
• The disposition form verifying the product has been APPROVED has been provided 
• Dostavljen je obrazac za raspolaganje koji potvrđuje da je lijek ODOBREN
• Contents of the bag will be slightly cloudy, with a cream to pink colour. 
• Sadržaj vrećice će biti blago mutan, kremaste do ružičaste boje.
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to 
(≥ 1/10), često (≥ 1/100 do <1/10), manje često (≥ 1/1000 do <1/100), rijetko (≥ 1/10 000 do
Reporting of suspected adverse reactions 
Prijava sumnje na nuspojavu
If you have severe reactions during the infusion your doctor may either slow down the infusion or stop it. You may also be given other medicines if needed. 
Ako iskusite teške reakcije tijekom infuzije, Vaš liječnik može usporiti ili zaustaviti infuziju.
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. 
Vaš liječnik može Vam predložiti uzimanje paracetamola i antihistaminika oko 30 minuta prije početka infuzije, a u svrhu ublažavanja moguće reakcije na Provenge.
Pregnancy Provenge is not intended for use in women. 
Provenge nije namijenjen za primjenu u žena.
Embolic and thrombotic events Provenge should be used with caution in patients with a history of embolic and thrombotic disorders. 
Provenge je potrebno primjenjivati s oprezom u bolesnika s embolijskim i trombotičkim poremećajima u anamnezi.
Do not initiate infusion of expired Provenge. 
Nemojte započinjati infuziju lijeka Provenge kojem je istekao rok valjanosti.
You can also report any side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Svaku nuspojavu također možete prijaviti i putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Patients with renal impairment and/or hyperkalaemia The content of sodium and potassium per infusion should be taken into account if administered in patients with cardiovascular diseases and/or renal impairment. 
Bolesnici s oštećenjem funkcije bubrega i/ili hiperkalijemijom Sadržaj natrija i kalija po infuziji potrebno je kontrolirati u bolesnika s kardiovaskularnim bolestima i/ili oštećenjem funkcije bubrega.
Additional CBC tests may be performed in accordance with local requirements. 
Dodatna ispitivanja KKS mogu se provedesti ovisno o zahtjevima ustanove.
Provenge should be delayed in patients with active systemic infection until resolution. 
Primjenu lijeka Provenge potrebno je odgoditi u bolesnika s aktivnom sustavnom infekcijom sve do stabilizacije stanja.
The bag should be removed from the insulated polyurethane container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots. 
Vrećicu je potrebno izvaditi iz izoliranog poliuretanskog spremnika i provjeriti propušta li, ima li vanjskih oštećenja te sadrži li strane čestice ili grudice/ugruške.
• approximately 45 mg potassium per infusion. 
• oko 45 mg kalija po infuziji.
See section 4.8 for how to report adverse reactions. 
Za uputu o tome kako prijaviti nuspojavu, vidjeti dio 4.8.
Serious adverse reactions include acute infusion reactions, catheter sepsis, staphylococcal bacteraemia, myocardial infarction, and cerebrovascular events. 
Ozbiljne nuspojave uključuju akutne infuzijske reakcije, katetersku sepsu, stafilokoknu bakterijemiju,
Therefore patient leukapheresis material and Provenge may carry the risk of transmitting infectious diseases to healthcare professionals handling the product. 
Stoga kod uzorka dobivenog leukaferezom i lijeka Provenge postoji rizik od prenošenja zaraznih bolesti na zdravstvene djelatnike koji rukuju lijekom.
• Upon completion of the infusion, the patient specific label on the infusion bag should be removed and adhered to the patient file. 
• Po završetku infuzije, personaliziranu naljepnicu bolesnika potrebno je ukloniti s infuzijske vrećice i zalijepiti na karton bolesnika
For intravenous infusion. 
Za infuziju u venu.
Appropriate medical therapy should be administered as needed. 
U slučaju potrebe potrebno je primijeniti odgovarajuće simptomatsko liječenje.
Accordingly, healthcare professionals should employ appropriate precautions when handling leukapheresis material or Provenge. 
Prema tome, zdravstveni djelatnici se trebaju pridržavati odgovarajućih mjera opreza prilikom rukovanja uzorkom dobivenim leukaferezom ili lijekom Provenge.
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. 
U kontrolnoj skupini bolesnika, 64% ih je primilo eksperimentalnu autolognu staničnu imunoterapiju dobivenu od stanica krioprezerviranih u trenutku kada je kontrolni lijek proizveden;
Provenge has not been investigated in patients with hepatic impairment. 
Provenge nije ispitan u bolesnika s oštećenom funkcijom bubrega.
• The Final Product Disposition Notification form is marked REJECTED. 
• je finalni Naputak o zbrinjavanju lijeka označen kao ODBIJEN
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. 
uključujući PSA i vrijeme udvostručenja PSA-a, broj bolesnika kod kojih se razvila metastatska bolest, liječenje primjenjeno nakon dijagnoze metastatske bolesti i parametre djelotvornosti nakon primijenjenih metoda liječenja, uključujući porast vrijednosti PSA-a,
Reports of serious infection have been received in post-marketing surveillance including devicerelated infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection. 
Unutar razdoblja postmarketinškog praćenja zaprimljene su prijave ozbiljnih infekcija, uključujući infekcije povezane s uređajem, sepse povezane s uređajem, upalu pluća, sepsu, bakterijemiju i infekciju mokraćnog sustava.
• approximately 800 mg sodium per infusion. 
• oko 800 mg natrija po infuziji.
Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T). 
Autologne mononuklearne stanice periferne krvi aktivirane PAP-GM-CSF-om (Sipuleucel-T).
Appropriate precautions should be employed when handling Provenge (see section 4.4). 
Potrebno je pridržavati se odgovarajućih mjera opreza pri rukovanju lijekom Provenge (vidjeti dio 4.4).
If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours (see section 6.3). 
U slučaju da je potrebno zaustaviti infuziju lijeka Provenge, infuziju se ne smije nastaviti ako je infuzijska vrećica bila držana na sobnoj temperaturi (25°C) dulje od 3 sata (vidjeti dio 6.3).
Each dose of Provenge requires a standard leukapheresis procedure approximately 3 days prior to the infusion. 
Svaka doza lijeka Provenge zahtijeva provođenje standardnog postupka leukafereze oko 3 dana prije infuzije.
Preparing the infusion Take care to ensure aseptic handling when preparing the infusion. 
Priprema infuzije Osigurajte aseptičko rukovanje prilikom pripreme infuzije.
To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion. 
Za ublažavanje takvih reakcija, u kliničkim ispitivanjima prije infuzije primijenjivana je premedikacija koje je sadržavala paracetamol i antihistaminike.
Contents of the bag will be slightly cloudy, with a cream to pink colour. 
Sadržaj vrećice će biti blago mutan, kremaste do ružičaste boje.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INFUSION BAG 
PODACI KOJI SE MORAJU NALAZITI UNUTARNJEM PAKIRANJU
Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion. 
Moguće je da ćete se nakon primjene infuzije osjećati umorno i omamljeno ili imati vrtoglavicu, glavobolju ili zimicu.
Hypoxia Wheezing Dyspnoea Bronchospasm 
prsišta i sredoprsja hipoksija piskanje dispneja bronhospazam
In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group. 
U kontroliranim kliničkim ispitivanjima, infekcija se razvila u 27,5% ispitanika u skupini Provenge i
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. 
Nema relevantne primjene lijeka Provenge u pedijatrijskoj populaciji u djece i adolescenata u dobi do 18 godina u indikaciji asimptomatskog ili minimalno simptomatskog metastatskog (nevisceralnog)
The product also contains approximately 45 mg potassium per infusion. 
Pripravak također sadrži oko 45 mg kalija po infuziji.
If you get any side effects, talk to your doctor or nurse. 
Ako primijetite bilo koju nuspojavu, obratite se svom liječniku ili medicinskoj sestri.
Sodium chloride Sodium lactate Potassium chloride Calcium chloride 
natrijev klorid natrijev laktat kalijev klorid kalcijev klorid
In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C). 
HIV-1, HIV-2, hepatitis B i hepatitis C).
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. 
U kontroliranim kliničkim ispitivanjima, infarkt miokarda zabilježen je u 0,8% bolesnika u skupini
Your doctor will give you a schedule for your cell collection and infusion appointments. 
Liječnik će Vam dati raspored prikupljanja krvnih stanica i planiranih infuzija.
Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group. 
Ozbiljne infekcije pojavile su se u 4,7% ispitanika u skupini
However, as it is an autologous product, a positive test does not preclude the manufacture of the product. 
pozitivan test ujedno ne isključuje njegovu proizvodnju.
This medicinal product contains approximately 800 mg sodium per infusion. 
Ovaj lijek sadrži oko 800 mg natrija po infuziji.
Thrombocytopenia* 
često trombocitopenija*
Each leukapheresis was followed approximately 3 days later by infusion of Provenge or control. 
Nakon svake leukafereze slijedila je infuzija lijeka Provenge ili kontrolnog lijeka oko 3 dana nakon leukafereze.
A statistically significant improvement in overall survival was seen in patients treated with Provenge, with a 22.5% reduction in the risk of death compared with control (see Table 2 and Figure 1). 
Provenge, uz 22,5% smanjen rizik od smrti u usporedbi s kontrolnom skupinom (vidjeti tablicu 2. i sliku 1).
Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD United Kingdom 
41 Chalton Street London, NW1 1JD Ujedinjeno Kraljevstvo
Gently mix and re-suspend the contents of the bag, inspecting for particles, clumps or clots. 
Laganim miješanjem i resuspendiranjem sadržaja vrećice potrebno je provjeriti ima li čestica, grudica ili ugrušaka.
If not used immediately, in-use storage times and conditions should not exceed 3 hours at room temperature (25°C). 
Ako se ne primijeni odmah , vrijeme i uvjeti čuvanja ne smiju prijeći 3 sata na sobnoj temperaturi (25 °C).
• You are on a controlled sodium/potassium diet or you have reduced kidney function. 
• prehrana s ograničenim unosom natrija/kalija ili smanjena bubrežna funkcija
• It must be ensured that the Final Product Disposition Notification form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), has been received from the market authorisation holder. 
• Mora se osigurati da je od nositelja odobrenja za stavljanje lijeka u promet zaprimljen finalni Naputak za zbrinjavanje lijeka koji sadrži podatke o bolesniku, datum i vrijeme isteka roka valjanosti i status raspolaganja (odobren za infuziju ili odbijen).
Injury, poisoning and procedural complications 
Ozljede, trovanja i vrlo često citratna toksičnost*
A machine is used to take blood from one arm, extract the white blood cells and return the rest of the blood to you, usually in the other arm. 
Vam se vraća ostatak krvi, obično u drugu ruku.
• If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours. 
• U slučaju da se infuzija lijeka Provenge mora prekinuti, ista se ne smije nastaviti ako je infuzijska vrećica bila držana na sobnoj temperaturi (25 °C) više od 3 sata.
Gently mix and re-suspend the contents of the bag. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Lagano miješati i resuspendirati sadržaj vrećice.
In controlled clinical trials, 23.8% of patients in the Provenge group required opioids (a single dose of pethidine) on the day of infusion for infusion reactions compared with 2.4% of patients in control group (see sections 4.2 and 4.4). 
U kontroliranim kliničkim ispitivanjima, u 23,8% bolesnika u skupini Provenge bila je potrebna primjena opijata (jedna doza petidina) na dan infuzije u odnosu na 2,4% bolesnika u kontrolnoj skupini (vidjeti dio 4.2 i 4.4).
Reactions included chills, fever, fatigue, asthenia, dyspnoea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. 
hipoksiju, bronhospazam, omaglicu, glavobolju, hipertenziju, bol u mišićima, mučninu i povraćanje.
• The essential unique patient information on the infusion bag does not match that of the 
• jedinstveni podaci o bolesniku na vrećici infuzije ne odgovaraju bolesniku kojem je potrebno primijeniti lijek.
Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion. 
Čuvati vrećicu u izoliranom spremniku radi održavanja ispravne temperature čuvanja (2°C-8°C) do infuzije.
Gently mix and resuspend the contents of the bag, inspecting for clumps and clots. 
Lagano miješajte i resuspendirajte sadržaj vrećice provjeravajući sadrži li grudice ili ugruške.
NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion. 
NAZIV LIJEKA PROVENGE 50 x 106 CD54+ stanica/250 mL disperzija za infuziju.
- anaemia (decrease in number of red blood cells) due tothe leukapheresis procedure 
- anemija (smanjenje broja crvenih krvnih zrnaca) zbog postupka leukafereze Česte nuspojave (mogu se pojaviti u do 1 na 10 bolesnika):
Catheter sepsis Catheter related infection Catheter site infection Sepsis 
Infekcije i infestacije često bakterijemija rijetko kateterska sepsa infekcija povezana s kateterom infekcija na mjestu uvođenja katetera sepsa
Patient leukapheresis material is tested for transmissible infectious agents in line with applicable member state requirements. 
Uzorak dobiven leukaferezomi testira se na prenosive uzročnike zaraznih bolesti u skladu s važećim propisima zemalja članica.
Provenge 50 x 106 CD54+ cells/250mL dispersion for infusion. 
NAZIV LIJEKA Provenge 50 x 106 CD54+ stanica/250 mL disperzija za infuziju.
If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours. 
U slučaju da se infuzija lijeka Provenge mora prekinuti, ne smije se nastavljati ako je infuzijska vrećica bila držana na sobnoj temperaturi (25°C) dulje od 3 sata.
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva osip hiperhidroza svrbež urtikarija
Update on study outcome annually Final study report by 31 December 2019 
Završno izvješće o ispitivanju do 30. rujna
To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. 
To trebaju uzeti u obzir u bolesnici sa smanjenom bubrežnom funkcijom ili bolesnici na prehrani s kontroliranim unosom kalija.
Each dose of Provenge is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date. 
Svakom doziranju lijeka Provenge prethodi standardni postupak leukafereze otprilike 3 dana prije predviđenog datuma infuzije.
Handling precautions for control of infectious disease Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents. 
Provenge se priprema od ljudske krvi pojedinog bolesnika i nije testiran na prenosive uzročnike zaraznih bolesti.
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava vrlo često anemija*
Posology One dose of Provenge contains a minimum of 50 x 106 autologous CD54+ cells activated with 
Jedna doza lijeka Provenge sadrži najmanje 50 x 106 autolognih CD54+ stanica aktiviranih PAP-GM
Before 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. 
Prije infuzije, mora biti potvrđeno da bolesnikov identitet odgovara jedinstvenoj informaciji o bolesniku na vrećici lijeka Provenge i na finalnom Naputku za zbrinjavanje lijeka.
Provenge contains sodium and potassium This medicine contains: 
Provenge sadrži natrij i kalij
• 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. 
ODOBRENOM raspolaganju konačnim lijekom, vrećicu s lijekom Provenge potrebno je izvaditi iz izoliranog spremnika i pregledati kako bi se uočilo eventualno propuštanje, vanjska oštećenja, prisutnost stranih čestica ili grudice/ugrušci.
In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.2 and 4.8). 
U kontroliranim kliničkim ispitivanjima, u 23,8% bolesnika liječenih lijekom Provenge zbog infuzijskih reakcija bilo je potrebno primijeniti opioide (jedna doza petidina) na dan infuzije (vidjeti dio 4.2 i 4.8).
- tingling, numbness or abnormal sensation (paraesthesia) around lips, in mouth, or in the arms and/or legs during the leukapheresis procedure - muscle spasms, chest pain, and low blood pressure during the leukapheresis procedure 
Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 bolesnika): - bol - bol u zglobovima ili bol (artralgija) - trnci, utrnulost ili abnormalni osjeti (parestezije) oko usana, u ustima ili u rukama i/ili nogama tijekom postupka leukafereze - grčevi u mišićima, bol u prsima i nizak krvni tlak tijekom postupka leukafereze (uzrokovani lijekom (citrat) koji se koristi za sprječavanje zgrušavanja krvi)