FrancophonIA/ELRC3.0 huggingface dataset:
English: Radiographic progression-free survival as assessed by the investigator using RECIST v 1.1 for soft tissue and appearance of 2 or more bone lesions in bone scan was 8.3 months for patients treated with enzalutamide and 2.9 months for patients who received placebo [HR = 0.40 (95% CI: 0.35, 0.47), p < 0.0001].
Croatian: Preživljenje bez radiološke progresije bolesti prema procjeni ispitivača pomoću RECIST kriterija verzija 1.1 za meko tkivo i pojave 2 ili više koštanih lezija na snimci kostiju iznosilo je 8,3 mjeseca u bolesnika liječenih enzalutamidom i 2,9 mjeseci u bolesnika koji su primali placebo [HR = 0,40 (95% CI: 0,35; 0,47), p < 0,0001].
English: Iron oxide black (E172) Polyvinyl acetate phthalate
Croatian: Tinta za označavanje željezov oksid, crni (E172) poli(vinilacetat) ftalat
English: nicardipine, nifedipine, propranolol, verapamil) - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine)
Croatian: felodipin, nikardipin, nifedipin, propranolol, verapamil) - liječenje ozbiljnih bolesti povezanih s upalom (npr. deksametazon, prednizolon) - liječenje HIV-infekcije (npr. indinavir, ritonavir) - liječenje bakterijskih infekcija (npr. klaritromicin, doksiciklin) - liječenje poremećaja štitne žlijezde (npr. levotiroksin) - liječenje gihta (npr. kolhicin) - liječenje želučanih poremećaja (npr. omeprazol) - sprječavanje srčanih bolesti ili moždanog udara (dabigatran eteksilat)
English: Patients with a history of mild to moderate heart failure (NYHA Class I or II), and patients taking medicinal products associated with lowering the seizure threshold were allowed.
Croatian: U ispitivanju su mogli sudjelovati bolesnici koji su u anamnezi imali blago do umjereno zatajenje srca (NYHA stupanj I ili II) i oni koji su uzimali lijekove povezane sa sniženjem praga za napadaje.
English: How to store Xtandi
Croatian: Kako čuvati Xtandi
English: For the 145 patients who had no previous chemotherapy, median rPFS was 8.1 months (95% CI: 5.7, 8.3).
Croatian: Za 145 bolesnika koji nisu ranije primili kemoterapiju, medijan rPFS je bio 8,1 mjeseci (95% CI: 5,7; 8,3).
English: The exposure levels achieved in this study in male rats at Week 26 at 100 mg/kg per day for enzalutamide plus its active metabolites M1 and M2 (AUC24: enzalutamide ~457 µg·h/mL, M1 ~321 µg·h/mL, M2 ~35 µg·h/mL) were less than or similar to those in prostate cancer patients at the recommended dose (160 mg/day) of enzalutamide (AUC24: enzalutamide ~322 µg·h/mL, M1 ~193 µg·h/mL, M2 ~278 µg·h/mL).
Croatian: U ovom su ispitivanju uz primjenu doze od 100 mg/kg na dan kod mužjaka štakora u 26. tjednu postignute razine izloženosti enzalutamidu i njegovim aktivnim metabolitima M1 i M2 (AUC24: enzalutamid ~457 µg·h/ml, M1 ~321 µg·h/ml, M2 ~35 µg·h/ml) bile niže ili slične onima koje se postižu u bolesnika s rakom prostate kod primjene preporučene doze (160 mg na dan) enzalutamida (AUC24: enzalutamid ~322 µg·h/ml, M1 ~193 µg·h/ml, M2 ~278 µg·h/ml).
English: Xtandi 40 mg soft capsules enzalutamide
Croatian: Xtandi 40 mg meke kapsule enzalutamid
English: No formal renal impairment study for enzalutamide has been completed.
Croatian: Nije završeno nijedno službeno ispitivanje enzalutamida kod oštećenja funkcije bubrega.
English: Psychiatric disorders
Croatian: KLINIČKI PODACI
English: Discontinuation of Xtandi in patients who develop PRES is recommended.
Croatian: U bolesnika u kojih se razvije PRES, preporučuje se prekid liječenja lijekom Xtandi.
English: Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamidetreated patients (see section 4.4).
Croatian: Kod bolesnika koji su liječeni enzalutamidom prijavljeni su rijetki slučajevi sindroma posteriorne reverzibilne encefalopatije (vidjeti dio 4.4).
English: Patient demographics and baseline disease characteristics were balanced between the treatment arms.
Croatian: Demografski podaci bolesnika i početne karakteristike bolesti bili su uravnoteženi između ispitivanih skupina.
English: Median time to PSA progression was 37.2 months (95% CI: 33.1, NR) on the enzalutamide arm versus 3.9 months (95% CI: 3.8, 4.0) on the placebo arm.
Croatian: Medijan vremena do progresije PSA iznosio je 37,2 mjeseca (95% CI: 33,1; ND) u skupini liječenoj enzalutamidom naspram 3,9 mjeseci (95% CI: 3,8; 4,0) u skupini koja je primala placebo.
English: MDV3100-09 (STRIVE) study (chemotherapy-naïve patients with non-metastatic/metastatic CRPC)
Croatian: Ispitivanje MDV3100-09 (STRIVE) (bolesnici s nemetastatskim/metastatskim CRPC-om koji prethodno nisu primali kemoterapiju)
English: Xtandi - 40 mg soft capsules
Croatian: Xtandi 40 mg meke kapsule
English: Enzalutamide demonstrated a statistically significant delay in the time to first use of new antineoplastic therapy compared to placebo [HR = 0.21 (95% CI: 0.17, 0.26), p < 0.0001].
Croatian: U usporedbi s placebom, enzalutamid je statistički značajno odgodio prvu primjenu nove antineoplastične terapije [HR = 0,21 (95% CI: 0,17; 0,26); p < 0,0001].
English: Patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Croatian: Bolesnici koji su primali enzalutamid pokazali su značajno višu stopu odgovora ukupnog PSA (definirano kao ≥ 50%-tno smanjenje u odnosu na početne vrijednosti), u usporedbi s bolesnicima koji su primali placebo, 78,0% naspram 3,5% (razlika = 74,5%, p < 0,0001).
English: Tabulated list of adverse reactions Adverse reactions observed during clinical studies are listed below by frequency category.
Croatian: Nuspojave primijećene tijekom kliničkih ispitivanja navedene su niže prema kategorijama učestalosti.
English: Median PFS was 15.7 months for patients on enzalutamide versus 5.8 months for patients on bicalutamide [HR = 0.44 (95% CI: 0.34, 0.57), p < 0.0001].
Croatian: Medijan PFS-a iznosio je 15,7 mjeseci u bolesnika liječenih enzalutamidom naspram 5,8 mjeseci u onih liječenih bikalutamidom [HR = 0,44 (95% CI: 0,34; 0,57), p < 0,0001].
English: EU/1/13/846/001 112 soft capsules
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/846/001 112 mekih kapsula
English: PFS was the primary endpoint defined as the time from randomisation to the earliest objective evidence of radiographic progression, PSA progression, or death on study.
Croatian: Mjera primarnog ishoda bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS), koji se definirao kao vrijeme od randomizacije do prvog objektivnog dokaza radiografske progresije, progresije PSA ili smrti tijekom ispitivanja.
English: Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete hipromelozaacetat sukcinat mikrokristalična celuloza silicijev dioksid, koloidni, bezvodni umrežena karmelozanatrij magnezijev stearat
English: The active substance is enzalutamide.
Croatian: Djelatna tvar je enzalutamid.
English: Each soft capsule contains 40 mg of enzalutamide.
Croatian: Jedna meka kapsula sadrži 40 mg enzalutamida.
English: Xtandi - 40 mg soft capsules Each soft capsule contains 40 mg of enzalutamide.
Croatian: Xtandi 40 mg meke kapsule Jedna meka kapsula sadrži 40 mg enzalutamida.
English: A total of 1199 patients were randomised 2:1 to receive either enzalutamide orally at a dose of 160 mg once daily (N = 800) or placebo once daily (N = 399).
Croatian: Ukupno je bilo randomizirano 1199 bolesnika u omjeru 2:1 u skupinu koja je primala enzalutamid peroralno u dozi od 160 mg jedanput na dan (N = 800) i skupinu koja je primala placebo jedanput na dan (N = 399).
English: In the MDV3100-14 clinical trial (PROSPER) of non-metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher confirmed PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 76.3% versus 2.4% (difference = 73.9%, p < 0.0001).
Croatian: U kliničkom ispitivanju MDV3100-14 (PROSPER) provedenom kod nemetastatskog CRPC-a, bolesnici liječeni enzalutamidom ostvarili su značajno višu stopu potvrđenog odgovora PSA (definiranog kao smanjenje za ≥ 50% od početne vrijednosti) u usporedbi s bolesnicima koji su primali placebo (76,3% naspram 2,4%; razlika = 73,9%; p < 0,0001).
English: The median time to PSA progression per PCWG2 criteria was 11.2 months for patients treated with enzalutamide and 2.8 months for patients who received placebo [HR = 0.17 (95% CI: 0.15, 0.20), p < 0.0001].
Croatian: Medijan vremena do progresije PSA prema kriterijima PCWG2 iznosio je 11,2 mjeseci u bolesnika liječenih enzalutamidom i 2,8 mjeseci u bolesnika koji su primali placebo [HR = 0,17, (95% CI: 0,15; 0,20), p < 0,0001].
English: Patients were required to have a PSA doubling time ≤ 10 months, PSA ≥ 2 ng/mL, and confirmation of non-metastatic disease by blinded independent central review (BICR).
Croatian: U bolesnika je vrijeme do udvostručenja vrijednosti PSA moralo iznositi ≤ 10 mjeseci te su morali imati PSA ≥ 2 ng/ml i nemetastatsku bolest potvrđenu zaslijepljenom neovisnom središnjom ocjenom.
English: The median time to first skeletal-related event was 16.7 months for patients treated with enzalutamide and 13.3 months for patients who received placebo [HR = 0.69 (95% CI: 0.57, 0.84), p < 0.0001].
Croatian: Medijan vremena do prvog koštanog događaja iznosio je 16,7 mjeseci u bolesnika liječenih enzalutamidom i 13,3 mjeseca u bolesnika koji su primali placebo [HR = 0,69 (95% CI: 0,57; 0,84), p < 0,0001].
English: A review of concomitant medicinal products should therefore be conducted when initiating enzalutamide treatment.
Croatian: Stoga je prilikom započinjanja liječenja enzalutamidom potrebno napraviti pregled svih lijekova koje bolesnik istovremeno uzima.
English: In the MDV3100-09 clinical trial (STRIVE) of non-metastatic and metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher total confirmed PSA response rate (defined as a ≥ 50% reduction from baseline) compared with patients receiving bicalutamide, 81.3% versus 31.3% (difference = 50.0%, p < 0.0001).
Croatian: U kliničkom ispitivanju MDV3100-09 (STRIVE) provedenom kod nemetastatskog i metastatskog CRPC-a, bolesnici liječeni enzalutamidom ostvarili su značajno višu stopu potvrđenog odgovora ukupnog PSA (definiranog kao smanjenje za ≥ 50% od početne vrijednosti) u usporedbi s bolesnicima koji su primali bikalutamid (81,3% naspram 31,3%; razlika = 50,0%; p < 0,0001).
English: Figure 7: Kaplan-Meier curves of overall survival in the AFFIRM study (intent-to-treat analysis)
Croatian: Slika 7: Kaplan-Meierove krivulje ukupnog preživljenja u ispitivanju AFFIRM (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: Xtandi 40 mg film-coated tablets are yellow round film-coated tablets, debossed with E 40.
Croatian: Xtandi 40 mg filmom obložene tablete su žute okrugle filmom obložene tablete s utisnutom oznakom E 40.
English: butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
Croatian: - Drugi sastojci meke kapsule su kaprilokaproil makrogol-8 gliceridi, butilhidroksianizol (E320) i butilhidroksitoluen (E321).
English: Figure 4: Kaplan-Meier curves of overall survival based on updated survival analysis in the PREVAIL study (intent-to-treat analysis)
Croatian: Slika 4: Kaplan-Meierove krivulje ukupnog preživljenja na temelju analize ažuriranih podataka o preživljenju u ispitivanju PREVAIL (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: The phase 3 studies excluded patients with recent myocardial infarction (in the past 6 months) or unstable angina (in the past 3 months), New York Heart Association Class (NYHA) III or IV heart failure except if Left Ventricular Ejection Fraction (LVEF) ≥ 45%, bradycardia or uncontrolled hypertension.
Croatian: Ispitivanja faze III nisu uključivala bolesnike s nedavnim infarktom miokarda (u zadnjih 6 mjeseci) ili nestabilnom anginom (u zadnja 3 mjeseca), NYHA (eng.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Astellas Pharma B.V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON WITH BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Figure 6: Kaplan-Meier curves of radiographic progression-free survival in the PREVAIL study (intent-to-treat analysis)
Croatian: Slika 6: Kaplan-Meierove krivulje preživljenja bez radiografske progresije bolesti u ispitivanju PREVAIL (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: Seizure
Croatian: Apsorpcija
English: Each film-coated tablet contains 40 mg enzalutamide.
Croatian: Jedna filmom obložena tableta sadrži 40 mg enzalutamida.
English: B. PACKAGE LEAFLET
Croatian: Tablični popis nuspojava
English: Each film-coated tablet contains 80 mg enzalutamide.
Croatian: Jedna filmom obložena tableta sadrži 80 mg enzalutamida.
English: In a phase 2 clinical trial (TERRAIN) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving bicalutamide, 82.1% versus 20.9% (difference = 61.2%, p < 0.0001)
Croatian: U kliničkom ispitivanju faze II (TERRAIN) kod bolesnika koji nisu ranije primali kemoterapiju, bolesnici liječeni enzalutamidom pokazali su značajno višu stopu odgovora ukupnog PSA (definiranog kao smanjenja ≥ 50% od početne vrijednosti), u usporedbi s bolesnicima koji su primali bikalutamid, 82,1% naspram 20,9% (razlika=61,2%, p < 0,0001).
English: Each Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
Croatian: Jedna Xtandi 40 mg filmom obložena tableta sadrži 40 mg enzalutamida.
English: Figure 1: Kaplan-Meier Curves of metastasis-free survival in the PROSPER study (intent-totreat analysis)
Croatian: Slika 1: Kaplan-Meierove krivulje preživljenja bez metastaza u ispitivanju PROSPER (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: Each Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Croatian: Jedna Xtandi 80 mg filmom obložena tableta sadrži 80 mg enzalutamida.
English: MDV3100-03 (PREVAIL) study (chemotherapy-naïve patients with metastatic CRPC)
Croatian: Ispitivanje MDV3100-03 (PREVAIL) (bolesnici s metastatskim CRPC-om koji prethodno nisu primali kemoterapiju)
English: If you have a seizure during treatment: See your doctor as soon as possible.
Croatian: Ako doživite napadaj tijekom liječenja:
English: Astellas Pharma Europe B.V. Sylviusweg 62
Croatian: Astellas Pharma Europe B.V.
English: Median MFS
Croatian: Vistor hf
English: If you are having sex with a pregnant woman, use a condom to protect the unborn child. - Female caregivers see section 3 ‘How to take Xtandi' for handling and use.
Croatian: Ako imate spolne odnose s trudnicom, koristite prezervativ kako biste zaštiti nerođeno dijete.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN (ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Placebo (N = 399)
Croatian: Enzalutamid (N = 800) Placebo (N = 399)
English: Seizures
Croatian: Doziranje
English: • Thyroid agents (e.g. levothyroxine)
Croatian: • hormone štitne žlijezde (npr. levotiroksin)
English: At the pre-specified rPFS analysis, a statistically significant improvement was demonstrated between the treatment groups with an 81.4% reduction in risk of radiographic progression or death [HR = 0.19 (95% CI: 0.15, 0.23), p < 0.0001].
Croatian: U unaprijed planiranoj analizi rPFS-a, pokazano je statistički značajno poboljšanje između ispitivanih skupina s 81,4%-tnim smanjenjem rizika od radiografske progresije ili smrti HR = 0,19 (95% CI: 0,15; 0,23), p < 0,0001]. 118 (14%) bolesnika liječenih enzulatamidom i 321 (40%) bolesnik liječen placebom imali su događaj.
English: Xtandi 80 mg film-coated tablets enzalutamide
Croatian: Xtandi 80 mg filmom obložene tablete enzalutamid
English: Common: headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome Uncommon: cognitive disorder, seizure¥ Not known*: posterior reversible encephalopathy syndrome
Croatian: Poremećaji probavnog sustava nepoznata učestalost*: mučnina, povraćanje, proljev Poremećaji kože i potkožnog tkiva često: suha koža, pruritus nepoznata učestalost*: osip
English: Xtandi 40 mg film-coated tablets enzalutamide
Croatian: Xtandi 40 mg filmom obložene tablete enzalutamid
English: The median time to initiation of cytotoxic chemotherapy was 28.0 months for patients receiving enzalutamide and 10.8 months for patients receiving placebo [HR = 0.35 (95% CI: 0.30, 0.40), p < 0.0001].
Croatian: Medijan vremena do započinjanja citotoksične kemoterapije iznosio je 28,0 mjeseci u bolesnika koji, su primali enzalutamid i 10,8 mjeseci u bolesnika koji su primali placebo [HR = 0,35 (95% CI: 0,30; 0,40), p < 0,0001].
English: In another phase 3 clinical trial (PREVAIL) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Croatian: U drugom kliničkom ispitivanju faze III (PREVAIL) kod bolesnika koji nisu ranije primali kemoterapiju, bolesnici liječeni enzalutamidom pokazali su značajno višu stopu odgovora ukupnog PSA (definiranog kao smanjenja ≥ 50% od početne vrijednosti), u usporedbi s bolesnicima koji su primali placebo, 78,0% naspram 3,5% (razlika=74,5%, p < 0,0001).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET WITHOUT BLUE BOX
Croatian: KARTONSKI OMOT BEZ PLAVOG OKVIRA
English: The median time to PSA progression was 8.3 months for patients treated with enzalutamide and 3.0 months for patients who received placebo [HR = 0.25 (95% CI: 0.20, 0.30), p < 0.0001].
Croatian: Medijan vremena do progresije bolesti prema PSA iznosio je 8,3 mjeseca u bolesnika liječenih enzalutamidom i 3,0 mjeseca u bolesnika koji su primali placebo [HR = 0,25 (95% CI: 0,20; 0,30), p < 0,0001].
English: Table 3: Overall survival of patients treated with either enzalutamide or placebo in the PREVAIL study (intent-to-treat analysis)
Croatian: Tablica 3: Ukupno preživljenje bolesnika liječenih enzalutamidom ili placebom u ispitivanju PREVAIL (analiza podataka prikupljenih u bolesnika predviđenih za liječenje) Enzalutamid (N = 872)
English: Tel: +386 14011 400
Croatian: Astellas Pharma d.o.o. Tel: + 386 14011 400
English: Astellas Pharma B.V. Tel: + 31 (0)71 5455745
Croatian: Tel: + 31 (0)71 5455745
English: Xtandi - 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide.
Croatian: Xtandi 80 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 80 mg enzalutamida.
English: Table 2: Summary of efficacy results in the PROSPER study (intent-to-treat analysis) Enzalutamide N = 933
Croatian: Tablica 2: Sažetak rezultata za djelotvornost u ispitivanju PROSPER (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: xtandi 40 mg film-coated tablets
Croatian: xtandi 40 mg filmom obložene tablete
English: Xtandi - 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide.
Croatian: Xtandi 40 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 40 mg enzalutamida.
English: The TERRAIN study enrolled 375 chemo- and antiandrogen-therapy naïve patients with metastatic CRPC who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 184) or bicalutamide at a dose of 50 mg once daily (N = 191).
Croatian: Bolesnici su bili randomizirani za primanje enzalutamida u dozi od 160 mg jedanput na dan (N = 184) ili bikalutamida u dozi od 50 mg jedanput na dan (N = 191).
English: Xtandi - 80 mg film-coated tablets Yellow oval - film-coated tablets, debossed with E 80.
Croatian: Xtandi 80 mg filmom obložene tablete Žute ovalne filmom obložene tablete s utisnutom oznakom E 80.
English: Xtandi - 40 mg film-coated tablets Yellow round - film-coated tablets, debossed with E 40.
Croatian: Filmom obložena tableta.Xtandi 40 mg filmom obložene tablete Žute okrugle filmom obložene tablete s utisnutom oznakom E 40.
English: Figure 3: Kaplan-Meier Curves of progression-free survival in the STRIVE study (intent-totreat analysis)
Croatian: Slika 3: Kaplan-Meierove krivulje preživljenja bez progresije bolesti u ispitivanju STRIVE (analiza podataka prikupljenih u bolesnika predviđenih za liječenje)
English: The STRIVE study enrolled 396 non-metastatic or metastatic CRPC patients who had serologic or radiographic disease progression despite primary androgen deprivation therapy who were randomised to receive either enzalutamide at a dose of 160 mg once daily (N = 198) or bicalutamide at a dose of 50 mg once daily (N = 198).
Croatian: U ispitivanje STRIVE bilo je uključeno 396 bolesnika s nemetastatskim ili metastatskim CRPC-om u kojih je nastupila serološka ili radiografska progresija bolesti unatoč primarnom liječenju androgenom deprivacijom.
English: P-value is derived from an unstratified log-rank test.
Croatian: P-vrijednost dobivena je pomoću nestratificiranog log-rang testa 2. Omjer hazarda dobiven je pomoću nestratificiranog modela proporcionalnih hazarda.
English: Xtandi - 40 mg film-coated tablets Xtandi - 80 mg film-coated tablets
Croatian: Xtandi 40 mg filmom obložene tablete Xtandi 80 mg filmom obložene tablete enzalutamid
English: Astellas Pharma Ltd. Tel: +44 (0)203 379 8700
Croatian: Tel: + 44 (0)203 379 8700
English: E.J.
Croatian: Ltd.
English: Xtandi 80 mg film-coated tablets are yellow oval film-coated tablets, debossed with E 80 Each carton contains 56 tablets in 4 blister wallets of 14 tablets each.
Croatian: Xtandi 80 mg filmom obložene tablete su žute ovalne filmom obložene tablete s utisnutom oznakom E 80.
English: glycerol, titanium dioxide (E171), and purified water.
Croatian: Ovojnica kapsule želatina otopina sorbitola sorbitana glicerol titanijev dioksid (E171) pročišćena voda
English: Not known*: myalgia, muscle spasms, muscular weakness, back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često: prijelomi‡** nepoznata učestalost*: mialgija, mišićni spazmi, mišićna slabost, bol u leđima
English: Reproductive system and breast disorder
Croatian: Poremećaji reproduktivnog sustava i dojki često: ginekomastija
English: A condom is required during and for 3 months after treatment with enzalutamide if the patient is engaged in sexual activity with a pregnant woman.
Croatian: Ako bolesnik ima spolne odnose s trudnicom, treba upotrebljavati prezervative za vrijeme i tijekom 3 mjeseca nakon liječenja enzalutamidom.
English: Package leaflet: Information for the patient Xtandi 40 mg film-coated tablets
Croatian: PODACI NA BRAILLEOVOM PISMU xtandi 40 mg filmom obložene tablete
English: 40 mg film-coated tablets
Croatian: Filmom obložene tablete od 40 mg
English: 80 mg film-coated tablets
Croatian: Filmom obložene tablete od 80 mg
English: Astellas Pharma Kft. Tel.: + 36 1 577 8200
Croatian: Tel.: +36 1 577 8200
English: Enzalutamide demonstrated a statistically significant 71% reduction in the relative risk of radiographic progression or death compared to placebo [HR = 0.29 (95% CI: 0.24, 0.35), p < 0.0001].
Croatian: Enzalutamid je ostvario statistički značajno smanjenje relativnog rizika od radiografske progresije bolesti ili smrti, koje je iznosilo 71% u odnosu na placebo [HR = 0,29 (95% CI: 0,24; 0,35), p < 0,0001]. Medijan MFS-a iznosio je 36,6 mjeseci (95% CI: 33,1; ND) u skupini liječenoj enzalutamidom naspram 14,7 mjeseci (95% CI: 14,2; 15,0) u skupini koja je primala placebo.
English: Pre-specified interim analysis Number of deaths (%) Median survival, months (95% CI)
Croatian: Unaprijed planirana interim analiza Broj smrti (%)
English: Busuttil Ltd. Tel: +356 21 447184
Croatian: Tel: + 356 21 447184
English: Uncommon: leucopenia, neutropenia Not known*: thrombocytopenia
Croatian: Poremećaji krvi i limfnog sustava manje često: leukopenija, neutropenija nepoznata učestalost*: trombocitopenija