FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no obvious mechanistic rationale to explain specifically this malignancy can be established, and taking into account that exposure levels, based on AUC, achieved in the study, for enzalutamide plus its metabolites, were less than or similar to those in prostate cancer patients at the recommended dose of 160 mg/day, urinary bladder carcinogenicity potential of enzalutamide in humans cannot be excluded.
Slovenian: Potenciala enzalutamida za nastanek raka sečnega mehurja pri ljudeh ni mogoče izključiti na podlagi ravni izpostavljenosti (določena glede na AUC enzalutamida in njegovih presnovkov, doseženih v študiji); izpostavljenost je bila manjša ali podobna tisti pri bolnikih z rakom prostate med uporabo priporočenega odmerka enzalutamida 160 mg/dan.
English: Consistent benefit of enzalutamide over bicalutamide on PFS was observed in all pre-specified patient subgroups.
Slovenian: V vseh vnaprej opredeljenih podskupinah bolnikov so v primerjavi z bikalutamidom opažali stalno korist enzalutamida za PFS.
English: Nervous system disorders
Slovenian: MedDRA organski sistemi
English: There have been rare reports of PRES (may affect up to 1 in 1,000 people), a rare, reversible condition involving the brain, in patients treated with Xtandi.
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES) Pri bolnikih, ki so jemali zdravilo Xtandi so redko poročali o PRES (pojavi se lahko pri največ 1 od 1.000 bolnikov), redkem, reverzibilnem stanju, ki vključuje možgane.
English: Iron oxide black (E172) Polyvinyl acetate phthalate
Slovenian: Črnilo: črni železov oksid (E172) polivinilacetatftalat
English: After oral administration of radiolabeled 14C-enzalutamide to rats on day 14 of pregnancy at a dose of 30 mg/kg (~ 1.9 times the maximum dose indicated in humans), the maximum radioactivity in the fetus was reached 4 hours after administration and was lower than that in the maternal plasma with tissue/plasma ratio of 0.27.
Slovenian: Po peroralnem dajanju radioaktivno označenega 14C-enzalutamida podganam v 14. dnevu brejosti v odmerku 30 mg/kg (~1,9 kratnik največjega človeškega odmerka), je najvišja vrednost radioaktivnosti pri plodu dosežena 4 ure po dajanju in je bila nižja od vrednosti v plazmi samice.
English: Rare cases of posterior reversible encephalopathy syndrome have been reported in enzalutamidetreated patients (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili z enzalutamidom, so redko poročali o sindromu posteriorne reverzibilne encefalopatije (glejte poglavje 4.4).
English: Xtandi - 40 mg film-coated tablets Xtandi - 80 mg film-coated tablets
Slovenian: Xtandi - 40 mg filmsko obložene tablete Xtandi - 80 mg filmsko obložene tablete
English: • Betablockers (e.g. bisoprolol, propranolol)
Slovenian: • zaviralci adrenergičnih receptorjev beta (npr. bisoprolol, propranolol)
English: Headache, fall, feeling anxious, dry skin, itching, difficulty remembering, blockage of the arteries in the heart (ischemic heart disease), breast enlargement in men (gynaecomastia), symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg), reduced concentration, forgetfulness
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) glavobol, padci, občutek tesnobe, suha koža, srbenje, težave s spominom, zožitev srčnih arterij (ishemična srčna bolezen), povečanje dojk pri moških (ginekomastija), simptomi sindroma nemirnih nog (siljenje k premikanju delov telesa, običajno nog, ki ga ni mogoče obvladati), slabša zbranost, pozabljivost
English: Not known*: nausea, vomiting, diarrhoea
Slovenian: Bolezni prebavil neznana*: navzea, bruhanje, driska
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET WITHOUT BLUE BOX
Slovenian: PRETISNA ZGIBANKA BREZ MODREGA OKENCA
English: Figure 7: Kaplan-Meier curves of overall survival in the AFFIRM study (intent-to-treat analysis)
Slovenian: Slika 7: Kaplan-Meierjevi krivulji celokupnega preživetja v študiji AFFIRM (analiza z-namenomzdravljenja)
English: Confirmed PSA decline of 50% or 90% were 54.0% and 24.8%, respectively, for patients treated with enzalutamide and 1.5% and 0.9%, respectively, for patients who received placebo (p < 0.0001).
Slovenian: Med prejemniki enzalutamida se je PSA znižal za 50 % pri 54,0 % bolnikov in za 90 % pri 24,8 % bolnikov, med prejemniki placeba pa za 50 % pri 1,5 % in za 90 % pri 0,9 % bolnikov (p < 0,0001).
English: How Xtandi works
Slovenian: Kako deluje zdravilo Xtandi
English: Consistent rPFS benefit was observed across all pre-specified patient subgroups (e.g. age, baseline ECOG performance, baseline PSA and LDH, Gleason score at diagnosis, and visceral disease at screening).
Slovenian: V vseh vnaprej določenih podskupinah bolnikov (npr. starost, status zmogljivosti po ECOG ob izhodišču, vrednosti PSA in LDH ob izhodišču, seštevek po Gleasonu ob diagnozi in visceralna bolezen ob presejanju) je bila dosežena konsistentna korist pri rPFS.
English: MDV3100-09 (STRIVE) study (chemotherapy-naïve patients with non-metastatic/metastatic CRPC)
Slovenian: Študija MDV3100-09 (STRIVE) (bolniki z nemetastatskim/metastatskim KORP, predhodno še nezdravljeni s kemoterapijo)
English: If you are allergic to enzalutamide or any of the other ingredients of this medicine, do not take Xtandi.
Slovenian: Ne jemljite zdravila Xtandi, če ste alergični na enzalutamid ali katero koli drugo sestavino tega zdravila.
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).
Slovenian: Pri bolnikih, ki so dobivali enzalutamid, je bila dokazana značilno višja skupna stopnja odziva PSA (opredeljeno kot ≥ 50 % zmanjšanje od izhodišča), v primerjavi z bolniki, ki so dobivali placebo, 78,0 % v primerjavi s 3,5 % (razlika = 74,5 %, p < 0,0001).
English: The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other.
Slovenian: Porazdelitev po rasah je bila: 93 % belcev, 4 % črncev, 1 % Azijcev in 2 % drugih.
English: Enzalutamide was negative for genotoxicity in a standard battery of in vitro and in vivo tests.
Slovenian: Enzalutamid v standardni skupini preizkusov in vitro in in vivo ni imel genotoksičnih učinkov.
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].
Slovenian: Mediani čas do napredovanja PSA po kriteriju PCWG2 je bil 11,2 meseca za bolnike, zdravljenje z enzalutamidom, in 2,8 meseca za bolnike, ki so dobivali placebo [ROg = 0,17 (95 % IZ: 0,15, 0,20), p < 0,0001].
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte s svojim zdravnikom.
English: Posology The recommended dose is 160 mg enzalutamide (four 40 mg soft capsules) as a single oral daily dose.
Slovenian: Priporočeni odmerek je 160 mg enzalutamida (štiri 40 mg mehke kapsule) v enkratnem peroralnem odmerku na dan.
English: Each soft capsule contains 40 mg of enzalutamide.
Slovenian: Ena mehka kapsula vsebuje 40 mg enzalutamida.
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].
Slovenian: Enzalutamid je v primerjavi s placebom statistično značilno zmanjšal relativno tveganje za radiografsko napredovanje bolezni ali smrt za 71 % [ROg = 0,29 (95 % IZ: 0,24, 0,35), p < 0,0001].
English: The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group.
Slovenian: Mediano preživetje brez radiografsko potrjenega napredovanja bolezni je bilo 19,7 meseca v skupini z enzalutamidom in 5,4 meseca v skupini s placebom.
English: - Do not cut, crush or chew the tablets before swallowing.
Slovenian: Tablete pred zaužitjem ne smete lomiti, drobiti ali žvečiti.
English: If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.
Slovenian: Če se pri bolniku pojavijo toksični učinki ≥ 3. stopnje ali neznosne neželene reakcije, je treba uporabo zdravila prekiniti za en teden oziroma dokler se simptomi ne izboljšajo na ≤ 2. stopnjo.
English: How to take Xtandi
Slovenian: Kako jemati zdravilo Xtandi
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].
Slovenian: Mediani čas do uvedbe citotoksične kemoterapije je bil 28,0 meseca za bolnike, ki so prejemali enzalutamid, in 10,8 meseca za bolnike, ki so prejemali placebo [ROg = 0,35 (95 % IZ: 0,30, 0,40), p < 0,0001].
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).
Slovenian: V kliničnem preskušanju MDV3100-09 (STRIVE) pri bolnikih z nemetastatskim in metastatskim KORP so ugotovili značilno večji celotni potrjeni delež odziva PSA (opredeljen kot ≥ 50-odstotno znižanje od izhodiščne vrednosti) pri prejemnikih enzalutamida (81,3 %) kot pri prejemnikih bikalutamida (31,3 %) (razlika = 50,0 %, p < 0,0001).
English: Median MFS was 36.6 months (95% CI: 33.1, NR) on the enzalutamide arm versus 14.7 months (95% CI: 14.2, 15.0) on the placebo arm.
Slovenian: Mediano MFS v skupini z enzalutamidom je bilo 36,6 meseca (95 % IZ: 33,1, ND) in v skupini s placebom 14,7 meseca (95 % IZ: 14,2, 15,0).
English: The active substance is enzalutamide.
Slovenian: Učinkovina je enzalutamid.
English: Enzalutamide demonstrated a statistically significant 93% reduction in the relative risk of PSA progression compared to placebo [HR = 0.07 (95% CI: 0.05, 0.08), p < 0.0001].
Slovenian: Enzalutamid je v primerjavi s placebom statistično značilno zmanjšal relativno tveganje za napredovanje PSA za 93 % [ROg = 0,07 (95 % IZ: 0,05, 0,08), p < 0,0001].
English: Each film-coated tablet contains 80 mg enzalutamide.
Slovenian: Ena filmsko obložena tableta vsebuje 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)
Slovenian: V kliničnem preskušanju 2. faze (TERRAIN) pri bolnikih, ki se predhodno še niso zdravili s kemoterapijo, so imeli bolniki zdravljeni z enzalutamidom značilno višjo stopnjo odziva PSA (opredeljeno kot ≥ 50 % zmanjšanje od izhodišča), v primerjavi z bolniki, ki so dobivali bikalutamid, 82,1 % v primerjavi z 20,9 % (razlika = 61,2 %, p < 0,0001).
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].
Slovenian: Mediano PFS bolnikov, ki so prejemali enzalutamid, je bilo 15,7 meseca in bolnikov, ki so prejemali bikalutamid, 5,8 meseca [ROg = 0,44 (95 % IZ: 0,34, 0,57), p < 0,0001].
English: Talk to your doctor before taking Xtandi - If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol,
Slovenian: Preden vzamete zdravilo Xtandi, se morate posvetovati z zdravnikom: če jemljete kakšna zdravila za preprečevanje nastajanja krvnih strdkov (npr. varfarin, acenokumarol, klopidogrel) če prejemate kemoterapijo (npr. docetaksel) če imate težave z jetri če imate težave z ledvicami
English: Time to first use of new antineoplastic therapy
Slovenian: Čas do prve uporabe novega antineoplastičnega zdravljenja Število dogodkov (%)
English: Table 2: Summary of efficacy results in the PROSPER study (intent-to-treat analysis) Enzalutamide N = 933
Slovenian: Preglednica 2: Povzetek rezultatov učinkovitosti v študiji PROSPER (analiza z-namenomzdravljenja)
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).
Slovenian: V kliničnem preskušanju MDV3100-14 (PROSPER) pri bolnikih z nemetastatskim KORP so ugotovili značilno večji celotni potrjeni delež odziva PSA (opredeljen kot ≥ 50-odstotno znižanje od izhodiščne vrednosti) pri prejemnikih enzalutamida (76,3 %) kot pri prejemnikih placeba (2,4 %) (razlika = 73,9 %, p <
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.
Slovenian: Ženske-negovalke glejte poglavje 3, "Kako jemati zdravilo Xtandi", za navodila o ravnanju in uporabi.
English: The AFFIRM study excluded patients with medical conditions that may predispose them to seizures (see section 4.8) and medicinal products known to decrease the seizure threshold, as well as clinically significant cardiovascular disease such as uncontrolled hypertension, recent history of myocardial infarction or unstable angina, New York Heart Association class III or IV heart failure (unless ejection fraction was ≥ 45%), clinically significant ventricular arrhythmias or AV block (without permanent pacemaker).
Slovenian: Prav tako ni vključila bolnikov s klinično pomembnimi kardiovaskularnimi boleznimi, npr. z neurejeno hipertenzijo, nedavnim miokardnim infarktom ali nestabilno angino pektoris, srčnim popuščanjem v razredu III ali IV po NYHA (razen če je bil iztisni delež ≥ 45 %), klinično pomembnimi motnjami srčnega ritma ali AV-blokom (brez stalnega srčnega spodbujevalnika).
English: Xtandi - 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide.
Slovenian: Xtandi - 40 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 40 mg enzalutamida
English: Each film-coated tablet contains 40 mg enzalutamide.
Slovenian: Ena filmsko obložena tableta vsebuje 40 mg enzalutamida.
English: Following oral administration of the moderate CYP2C8 and strong CYP3A4 inducer rifampin (600 mg once daily) to healthy male subjects, the AUC of enzalutamide plus the active metabolite decreased by 37% while Cmax remained unchanged.
Slovenian: Po peroralni uporabi rifampicina (600 mg enkrat na dan), zmernega induktorja CYP2C8 in močnega induktorja CYP3A4, pri zdravih moških, se je AUC enzalutamida in aktivnega presnovka zmanjšala za 37 %, Cmax pa je ostala nespremenjena.
English: Seizures
Slovenian: Konvulzije
English: Despite low or even undetectable levels of serum androgen, androgen receptor signalling continues to promote disease progression.
Slovenian: Signaliziranje androgenskih receptorjev še naprej spodbuja napredovanje bolezni, kljub nizki ali nemerljivi koncentraciji androgenov v serumu.
English: Xtandi 40 mg film-coated tablets are yellow round film-coated tablets, debossed with E 40.
Slovenian: Xtandi 40 mg filmsko obložene tablete so rumene filmsko obložene tablete, okrogle oblike z vtisnjeno oznako E 40.
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Astellas Pharma B.V.
English: Xtandi - 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide.
Slovenian: Xtandi - 80 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 80 mg enzalutamida
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].
Slovenian: Mediani čas do prvega z okostjem povezanega dogodka je bil med prejemniki enzalutamida 16,7 meseca in med prejemniki placeba 13,3 meseca [ROg = 0,69 (95 % IZ: 0,57, 0,84), p < 0,0001].
English: CYP2C8 inhibitors
Slovenian: Zaviralci CYP2C8
English: Median MFS
Slovenian: Vistor hf
English: butylhydroxyanisole (E320), and butylhydroxytoluene (E321).
Slovenian: Druge sestavine mehke kapsule so makrogol-8 glicerol kaprilat kaprinat, butilhidroksianizol (E320) in butilhidroksitoluen (E321).
English: 40 mg film-coated tablets
Slovenian: 40 mg filmsko obložene tablete
English: MDV3100-03 (PREVAIL) study (chemotherapy-naïve patients with metastatic CRPC)
Slovenian: Študija MDV3100-03 (PREVAIL) (bolniki z metastatskim KORP, predhodno še nezdravljeni s kemoterapijo)
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.
Slovenian: Mediani čas do napredovanja PSA je bil v skupini z enzalutamidom 37,2 meseca (95 % IZ: 33,1, ND) in v skupini s placebom 3,9 meseca (95 % IZ:
English: Astellas Pharma s.r.o.
Slovenian: Česká republika Astellas Pharma s.r.o.
English: No dose adjustment is necessary when Xtandi is coadministered with inducers of CYP2C8 or CYP3A4.
Slovenian: V primeru sočasne uporabe zdravila Xtandi z induktorji CYP2C8 ali CYP3A4 prilagoditev odmerka ni potrebna
English: A prolonged time to reach steady state concentrations is however anticipated, and the time to maximum pharmacological effect as well as time for onset and decline of enzyme induction (see section 4.5) may be increased.
Slovenian: Predviden je podaljšan čas za dosego stanja dinamičnega ravnovesja in čas do maksimalnega farmakološkega učinka.
English: 80 mg film-coated tablets
Slovenian: 80 mg filmsko obložene tablete
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).
Slovenian: V drugem kliničnem preskušanju 3. faze (PREVAIL) pri bolnikih, ki se predhodno še niso zdravili s kemoterapijo, so imeli bolniki zdravljeni z enzalutamidom značilno višjo stopnjo odziva PSA (opredeljeno kot ≥ 50 % zmanjšanje od izhodišča), v primerjavi z bolniki, ki so dobivali placebo, 78,0 % v primerjavi s 3,5 % (razlika = 74,5 %, p < 0,0001).
English: Pre-specified interim analysis Number of deaths (%) Median survival, months (95% CI)
Slovenian: Vnaprej določena vmesna analiza Število smrti (%)
English: - This medicine has been prescribed for you only.
Slovenian: Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Figure 1: Kaplan-Meier Curves of metastasis-free survival in the PROSPER study (intent-totreat analysis)
Slovenian: Slika 1: Kaplan-Meierjevi krivulji preživetja brez metastaz v študiji PROSPER (analiza z-namenomzdravljenja)
English: Xtandi 40 mg film-coated tablets enzalutamide
Slovenian: Xtandi 40 mg filmsko obložene tablete enzalutamid
English: Each Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
Slovenian: Ena 40-mg filmsko obložena tableta zdravila Xtandi vsebuje 40 mg enzalutamida.
English: - 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) - Treat gout (e.g. colchicine) - Treat stomach disorders (e.g. omeprazole) - Prevent heart conditions or strokes (e.g. dabigatran etexilate) - Prevent organ rejection (e.g. tacrolimus)
Slovenian: To vključuje določena zdravila za: zniževanje holesterola (npr. gemfibrozil, atorvastatin, simvastatin) zdravljenje bolečin (npr. fentanil, tramadol) zdravljenje raka (npr. kabazitaksel) zdravljenje epilepsije (npr. karbamazepin, klonazepam, fenitoin, primidon, valprojska kislina) zdravljenje določenih psihiatričnih motenj, npr. hude anksioznosti ali shizofrenije (npr. diazepam, midazolam, haloperidol) zdravljenje motenj spanja (npr. zolpidem) zdravljenje srčnih bolezni ali za znižanje krvnega tlaka (npr. bisoprolol, digoksin, diltiazem, felodipin, nikardipin, nifedipin, propranolol, verapamil) zdravljenje resnih vnetnih bolezni (npr. deksametazon, prednizolon) zdravljenje okužbe s HIV (npr. indinavir, ritonavir) zdravljenje bakterijskih okužb (npr. klaritromicin, doksiciklin) zdravljenje bolezni ščitnice (npr. levotiroksin) zdravljenje protina (npr. kolhicin) zdravljenje težav z želodcem (npr. omeprazol) preprečevanje srčnih bolezni ali možganske kapi (npr. dabigatran-eteksilat) preprečevanje zavrnitve presajenih organov (npr. takrolimus)
English: - Xtandi soft capsules are white to off-white, oblong soft capsules (approximately 20 mm by
Slovenian: Izgled zdravila Xtandi in vsebina pakiranja mehke kapsule zdravila Xtandi so bele do skoraj bele, podolgovate mehke kapsule (velike približno 20 mm x 9 mm), ki imajo na eni strani natisnjeno oznako "ENZ".
English: Each Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Slovenian: Ena 80-mg filmsko obložena tableta zdravila Xtandi vsebuje 80 mg enzalutamida.
English: Astellas Pharma Europe B.V. Sylviusweg 62
Slovenian: Astellas Pharma Europe B.V.
English: Xtandi 80 mg film-coated tablets enzalutamide
Slovenian: Xtandi 80 mg filmsko obložene tablete enzalutamid
English: Figure 6: Kaplan-Meier curves of radiographic progression-free survival in the PREVAIL study (intent-to-treat analysis)
Slovenian: Slika 6: Kaplan-Meierjevi krivulji preživetja brez radiografsko potrjenega napredovanja bolezni v študiji PREVAIL (analiza z-namenom-zdravljenja)
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).
Slovenian: Študija STRIVE je zajela 396 bolnikov z nemetastatskim ali metastatskim KORP, ki so imeli serološko ali radiografsko napredovanje bolezni kljub primarnemu zdravljenju z odtegnitvijo androgenov.
English: No dose adjustment is necessary for patients with mild, moderate or severe hepatic impairment (ChildPugh Class A, B or C, respectively).
Slovenian: Bolnikom z blago (Child-Pugh A), zmerno (Child-Pugh B) ali hudo (Child-Pugh C) okvaro jeter odmerka ni treba prilagoditi.
English: glycerol, titanium dioxide (E171), and purified water.
Slovenian: Sestavine mehke ovojnice kapsule so želatina, sorbitol in raztopina sorbitanov (glejte poglavje 2), glicerol, titanov dioksid (E171) in prečiščena voda.
English: 112 soft capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 112 mehkih kapsul
English: This includes certain medicines used to: - Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin) - Treat pain (e.g. fentanyl, tramadol) - Treat cancer (e.g. cabazitaxel) - Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam,
Slovenian: To vključuje določena zdravila za: zniževanje holesterola (npr. gemfibrozil, atorvastatin, simvastatin) zdravljenje bolečin (npr. fentanil, tramadol) zdravljenje raka (npr. kabazitaksel) zdravljenje epilepsije (npr. karbamazepin, klonazepam, fenitoin, primidon, valprojska kislina) zdravljenje določenih psihiatričnih motenj, npr. hude anksioznosti ali shizofrenije (npr. diazepam, midazolam, haloperidol) zdravljenje motenj spanja (npr. zolpidem) zdravljenje srčnih bolezni ali za znižanje krvnega tlaka (npr. bisoprolol, digoksin, diltiazem, felodipin, nikardipin, nifedipin, propranolol, verapamil) zdravljenje resnih vnetnih bolezni (npr. deksametazon, prednizolon) zdravljenje okužbe s HIV (npr. indinavir, ritonavir) zdravljenje bakterijskih okužb (npr. klaritromicin, doksiciklin) zdravljenje bolezni ščitnice (npr. levotiroksin) zdravljenje protina (npr. kolhicin) zdravljenje težav z želodcem (npr. omeprazol) preprečevanje srčnih bolezni ali možganske kapi (npr. dabigatran-eteksilat)