natgillin/translations-raw huggingface dataset:
In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
U kontroliranim kliničkim ispitivanjima, 71,2% bolesnika u skupini Provenge razvilo je akutnu infuzijsku reakciju.
Cerebrovascular disease
Cerebrovaskularne bolesti
Fertility Effect on male fertility is not known.
Plodnost Utjecaj na plodnost u muškaraca nije poznat.
Healthcare professionals are asked to report any suspected adverse reactions.
Zdravstveni djelatnici dužni su prijaviti svaku sumnju na nuspojavu.
Prior to the first leukapheresis proceedure, a complete blood count (CBC) test should be performed.
Prije prvog postupka leukafereze, potrebno je učiniti kompletnu krvnu sliku (KKS).
No interaction studies have been performed with Provenge.
Nisu provedena ispitivanja interakcija s lijekom Provenge.
In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
Prema postmarketinškom iskustvu u više od 5000 liječenih bolesnika, ta incidencija iznosi približno 19% (vidjeti dio 4.2).
Provenge is for use in adult men only.
Provenge je namijenjen isključivo za primjenu u odraslih muškaraca.
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.
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.
A retrospective subgroup analysis has suggested a greater Provenge treatment effect in patients with a baseline PSA < 22.1 ng/mL [HR= 0.521 (95% CI: 0.309, 0.879)].
Retrospektivna analiza 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)].
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.
Uzrok tome može biti nepoštivanje kriterija priprave tijekom proizvodnje, istekao rok valjanosti lijeka ili nemogućnost bolesnika da u određenom trenutku primi infuziju.
Provenge is intended solely for autologous use.
Provenge je namijenjen isključivo za autolognu primjenu.
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.
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.
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.
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.
• 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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Ako imate bilo kakvih dodatnih pitanja o uporabi ovog lijeka, upitajte svog liječnika ili medicinsku sestru.
Control (N=33)
Kontrolna skupina (N=33)
In clinical studies, about one quarter of the patients required more than 3 leukapheresis procedures in order to receive 3 infusions of Provenge.
U kliničkim ispitivanjima, kod približno jedne četvrtine bolesnika bila su potrebna više od 3 postupka leukafereze kako bi se primijenile 3 infuzije lijeka Provenge.
Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
30 minuta prije i 30 minuta poslije svake infuzije.
Atrial fibrillation Myocardial infarction Myocardial ischaemia
Srčani poremećaji fibrilacija atrija infarkt miokarda ishemija miokarda
Neutralising antibody responses to GM-CSF were transient.
Stvaranje protutijela koja neutraliziraju GM-CSF bilo je prolaznog karaktera.
Control (N=45)
Kontrolna skupina (N=45)
In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
U kontroliranim kliničkim ispitivanjima, teške (3. stupnja) akutne infuzijske reakcije prijavljene su u 3,5% bolesnika u skupini Provenge.
Therefore, concurrent use of immunosuppressive agents (such as systemic corticosteroids) should be avoided during Provenge treatment.
Stoga je istodobnu primjenu imunosupresiva (kao što su kortikosteroidi za sustavnu primjenu) i lijeka Provenge potrebno izbjegavati.
• Training completion form as agreed with the national competent authority
• Obrazac o završenoj obuci koji je potvrdilo nadležno državno tijelo
See the end of section 4 for how to report side effects.
Za uputu o tome kako prijaviti nuspojavu, pogledajte završetak dijela 4.
• shortness of breath, wheezing, dizziness, rash, or fever.
• nedostatak zraka, piskanje, omaglicu, osip ili vrućicu.
Your doctor will work with you to schedule new appointments for cell collection and infusion.
Vaš liječnik će Vam ugovoriti nove termine za prikupljanje stanica i infuziju.
The effects of Provenge on male fertility are not known at this time.
Djelovanje lijeka Provenge na plodnost muškaraca zasad nije poznata.
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.
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.
The cellular composition and the cell number per dose of Provenge will vary according to the patient's leukapheresis.
Stanični sastav i broj stanica po dozi lijeka Provenge varira ovisno o učinkovitosti leukafereze u bolesnika.
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.
Provenge je blago mutna disperzija kremaste do ružičaste boje i isporučuje se u plastičnoj vrećici s 3
• 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.
• Ako vrećica s lijekom Provenge propušta, ako je oštećena ili ako su u vrećici i nakon miješanja ostale čestice ili grudice, lijek se ne smije koristiti.
- decrease of platelets in the blood due to the leukapheresis procedure Uncommon side effects (may affect up to 1 in 100 patients - severe infection in the blood from a contaminated catheter (catheter sepsis) - infection from a contaminated catheter (catheter-related infection) - skin infection of the area where the infusion drip was inserted
Rijetke nuspojave (mogu se pojaviti u do 1 na 100 bolesnika): - teška infekcija krvi (sepsa) - teška infekcija krvi zbog kontaminiranog katetera (sepsa povezana s kateterom) - infekcija zbog kontaminiranog katetera (infekcija povezana s kateterom) - kožna infekcija na mjestu igle za infuziju
How to store Provenge
Kako primjenjivati Provenge
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The number of cells in Provenge does not exceed the number of cells from the leukapheresis.
Broj stanica u lijeku Provenge ne prelazi broj stanica dobivenih leukaferezom.
Dispersion for infusion.
OBLIK Disperzija za infuziju.
During or within 24 hours of the infusion, you may develop very common symptoms such as chills, fever, tiredness, feeling weak, headache, feeling sick (nausea), being sick (vomiting), muscle ache, and dizziness,.
Tijekom ili u roku od 24 sata nakon infuzije, moguće je da ćete razviti vrlo česte simptome kao što su zimica, vrućica, umor, osjećaj slabosti, glavobolja, mučnina, povraćanje, tupa bol u mišićima i omaglica.
The first step in your Provenge treatment is to collect your blood cells in order to manufacture your personal infusion of Provenge.
Prvi korak u liječenju lijekom Provenge je prikupljanje Vaših krvnih stanica za proizvodnju
For full instructions on the preparation and handling of Provenge, see section 6.6.
Za potpune upute o pripremi i rukovanju lijekom Provenge, vidjeti dio 6.6. 4.3 Kontraindikacije
PAP-GM-CSF were observed in cells collected from peripheral blood of patients through the follow-up period in the Provenge treatment group but not in controls.
testom kao odgovor na PAP i PAP-GM-CSF zabilježeni su u stanicama prikupljenim iz periferne krvi bolesnika kroz razdoblje praćenja u terapijskoj skupini Provenge, ali ne i u kontrolnim skupinama.
PAP-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, in a sealed, patient-specific polyolefin bag.
CSF-om, suspendiranih u 250 mL Ringerove otopine s laktatom, u zatvorenoj, poliolefinskoj vrećici posebno označenoj za svakog bolesnika.
Do not remove this insulated container from the shipping box, or open the lid of the insulated container, until the patient is ready for
Izolirani spremnik ne smije se izvaditi iz transportne kutije niti se poklopac izoliranog spremnika smije otvarati sve dok bolesnik nije spreman za infuziju.
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.
U kontroliranim kliničkim ispitivanjima, cerebrovaskularni događaji (hemorhagijski i ishemijski moždani udari) zabilježeni su u 3,5% bolesnika u skupini Provenge u usporedbi s 2,6% bolesnika u kontrolnoj skupini.
• Any unused product or waste material should be disposed of in accordance with local
• Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
You can help by reporting any side effects you may get.
I vi možete pridonjeti prijavom svake nuspojave koju primijetite.
Patients should be informed of the possibility of late onset reactions and instructed to contact their physician if symptoms of dyspnoea, bronchospasm, dizziness, rash, or pyrexia occur.
Bolesnike je potrebno obavijestiti o mogućnosti kasnijih reakcija i uputiti ih da se obrate svom liječniku u slučaju pojave dispneje, bronhospazma, omaglice, osipa ili povišene tjelesne temperature.
Provenge treatment checklists
Kontrolni popis liječenja lijekom Provenge
Name and address of the manufacturer of the biological active substance
Naziv i adresa proizvođača biološke djelatne tvari PharmaCell
No Grade 4 or 5 acute infusion reactions were reported in patients in the Provenge group.
Akutne infuzijske reakcije 4. ili 5. stupnja nisu prijavljene u bolesnika u skupini Provenge.
Adverse reactions associated with leukapheresis
Nuspojave povezane s leukaferezom
Eligible patients had metastatic disease in the soft tissue and/or bone with current or historical evidence of disease progression concomitant with surgical or medical castration, as evidenced by progression of serum prostate specific antigen (PSA) and/or bone or soft tissue disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Uključeni bolesnici imali su metastaze u mekom tkivu i/ili kostima s postojećom ili ranije utvrđenom progresijom bolesti nakon kirurške ili medikamentozne kastracije, što je utvrđeno porastom vrijednosti prostatičnog specifičnog antigena (PSA) u serumu i ili progresijom bolesti u kostima ili mekom tkivu te ECOG status 0 ili 1.
Provenge is not tested for transmissible infectious agents.
Provenge nije testiran na prenosive uzročnike zaraznih bolesti.
It must be ensured that the APPROVED Final Product Disposition Notification form has been received from the marketing authorisation holder and the product has not expired (see section 6.6).
Mora se osigurati da je od nositelja odobrenja za stavljanje lijeka u promet zaprimljen ODOBRENI obrazac s Obavijesti o raspolaganju konačnim lijekom te da rok valjanosti lijeka nije istekao (vidjeti dio 6.6).
Preparing the infusion • Take care to ensure aseptic handling when preparing the infusion.
Priprema infuzije • Osigurajte aseptičko rukovanje prilikom pripreme infuzije
Patients should be carefully evaluated to determine whether it is medically appropriate to discontinue immunosuppressive agents prior to treatment with Provenge (see section 4.4).
Potrebno je pažljivo razmotriti je li medicinski prikladno u pojedinog bolesnika prekinuti liječenje imunosupresivima prije započinjanja liječenja lijekom Provenge (vidjeti dio 4.4).
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).
Prije infuzije, mora biti potvrđeno da identitet bolesnika odgovara jedinstvenoj informaciji o bolesniku na vrećici lijeka Provenge i na finalnom Naputku za zbrinjavanje lijeka (vidjeti dio 4.2 i 6.6).
Hypertension Hypotension
Krvožilni poremećaji hipertenzija hipotenzija
Appropriate medical therapy, which could include paracetamol, intravenous H1 and/or H2 blockers, and low dose intravenous pethidine, should be administered as needed.
U slučaju potrebe nužno je primijeniti odgovarajuće simptomatsko liječenje, koje može uključivati paracetamol, intravenske blokatore H1 i/ili H2 receptora te niske doze intravenskog petidina.
It is strongly recommended that upon completion of each Provenge infusion, the patient specific label on the infusion bag, which contains the patient name, product name, and chain of identity (COI) product lot number, is removed and adhered to the patient file in order to maintain a link between the patient and the lot of the product.
Preporučuje se nakon završetka svake infuzije lijeka Provenge, naljepnicu s vrećice infuzije koja sadrži ime bolesnika, naziv lijeka i serijski broj lijeka, ukloniti i zaljepiti na karton bolesnika kako bi postojala poveznica između pojedinog bolesnika i serijskog broja lijeka.
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.
Stupanj povećanja izraženosti CD54 antigena korelira s ukupnim preživljenjem u randomiziranim kontroliranim kliničkim ispitivanjima lijeka Provenge provedenim za metastatski rak prostate rezistentan na kastraciju.
Study D9901 was a randomised, double-blind, controlled, multicentre trial in patients with metastatic castrate resistant prostate cancer and no cancer-related pain.
Studija D9901 provedena je kao randomizirano, dvostruko slijepo, kontrolirano, multicentrično ispitivanje u bolesnika s metastatskim rakom prostate rezistentnim na kastraciju bez bolova povezanih s rakom.
Secondary endpoints included time to objective disease progression, time to clinical progression, and PSA doubling time (PSADT).
Sekundarni ishodi bili su vrijeme objektivne progresije bolesti, vrijeme do kliničke progresije i vrijeme udvostručenja PSA.
Before handling or administering Provenge
Prije rukovanja ili primjene lijeka Provenge
To conduct study P12-1 to evaluate characteristics predictive of a positive imaging study for distant metastases in patients with castrate-resistant prostate cancer.
Provođenje ispitivanja P12-1 za procjenu karakteristika koje predviđaju pozitivno ispitivanje oslikavanja za udaljene metastaze kod bolesnika s rakom prostate rezistentnim na kastraciju.
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%).
Nuspojave koje su najčešće prijavljene ≤ 1 dan nakon postupka leukafereze u kontroliranim kliničkim ispitivanjima uključivale su citratnu toksičnost (14,6%), oralne parestezije
T cell proliferative and γIFN ELISPOT responses to PAP and
Proliferacija T stanica i stvaranje γIFN izmjereno ELISPOT
Acute infusion reactions have been observed in patients treated with Provenge.
Akutne infuzijske reakcije zabilježene su u bolesnika liječenih lijekom Provenge.
Hyperkalaemia should be corrected prior to Provenge administration (see section 4.2).
Hiperkalijemiju je potrebno korigirati prije primjene lijeka Provenge (vidjeti dio 4.2).
• Selection of patients for treatment with Provenge
• Opis odabira bolesnika za liječenje lijekom Provenge
Provenge is an autologous cellular therapy.
Provenge je autologno stanično liječenje.
In controlled clinical trials, 25.4% of patients treated with Provenge required more than 3 leukapheresis procedures in order to receive 3 infusions.
U kontroliranim kliničkim ispitivanjima, u 25,4% bolesnika liječenih lijekom Provenge bilo je potrebno provesti više od 3 postupka leukafereze u svrhu primanja 3 infuzije.
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)].
Intermedijarni rezultati uočeni su u bolesnika s početnom vrijednošću PSA > 22,1-50,1 ng / mL [HR = 0,685 (95% CI: 0,431, 1,088)] i bolesnika s početnom vrijednošću PSA > 50,1-134,1 ng/mL [HR = 0,819 (95% CI
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.