FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests.
Croatian: Osobito je važno obavijestiti liječnika u slučaju proljeva, ranica u ustima, osjećaja utrnulosti ili bockanja u udovima i povišene temperature te mu pokazati rezultate krvnih pretraga.
English: Preparation for the intravenous administration a)
Croatian: Priprema za primjenu u venu a)
English: Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Croatian: Docetaksel je povećao stopu terapijskog odgovora (33% prema 12%, p<0,0001), produljio vrijeme do progresije bolesti (19 tjedana prema 11 tjedana, p=0,0004) i produljio ukupno preživljenje (11 mjeseci prema 9 mjeseci, p=0,01).
English: In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Croatian: U ispitivanju faze III, vrijeme do progresije bolesti (12,3 tjedna prema 7 tjedana) i ukupno preživljenje bilo je u ranije liječenih bolesnika značajno dulje s docetakselom u dozi od 75 mg/m u usporedbi s najboljom potpornom terapijom (BSC).
English: Contains anhydrous ethanol (see leaflet)
Croatian: Sadrži bezvodni etanol (vidjeti uputu o lijeku)
English: Overall survival was also significantly longer (p = 0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
Croatian: Ukupno preživljenje bilo je također značajno dulje (p=0,0201) u korist TCF skupine s rizikom smanjenja smrtnosti od 22,7%.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m and 113 l, respectively.
Croatian: Srednje vrijednosti ukupnog klirensa i volumena distribucije u stanju dinamičke ravnoteže bile su 21 l/h/m2, odnosno 113 l.
English: Shelf life in infusion bag: see the leaflet.
Croatian: EXP Rok valjanosti lijeka u infuzijskoj vrećici: vidjeti Uputu o lijeku.
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Croatian: Uklonite štrcaljku i iglu te ručno promiješajte okretanjem bočice gore-dolje tijekom najmanje 45 sekundi.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates  10% higher in patients who were 65 years of age or older compared to younger patients.
Croatian: Incidencija sljedećih nuspojava (svi stupnjevi): letargija, stomatitis, neutropenijska infekcija bila je ≥ 10% viša u bolesnika koji su imali 65 ili više godina u odnosu na mlađe bolesnike.
English: • one single-dose vial of concentrate,
Croatian: • jednu jednodoznu bočicu s koncentratom,
English: Menopausal status Pre-Menopausal
Croatian: Menopauzalni status
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Croatian: Opći poremećaji i reakcije na mjestu primjene Medijan kumulativne doze do prekida liječenja bio je veći od 1000 mg/m2, a medijan vremena do reverzibilnosti retencije tekućine bilo je 16,4 tjedana (u rasponu od 0 do 42 tjedna).
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
Croatian: Bez utjecaja na ukupno vrijeme preživljenja (docetaksel 15 mjeseci prema doksorubicinu 14 mjeseci, p= 0,38) ili na vrijeme do progresije bolesti (docetaksel 27 tjedana prema doksorubicinu 23 tjedna, p=0,54), docetaksel je povećao stopu terapijskog odgovora (52% prema 37%, p=0,01) i skratio vrijeme do odgovora (12 tjedana prema 23 tjedna, p=0,007).
English: ** PSA response: Prostate-Specific Antigen response: PSA level <0.2 ng/mL measured for two consecutive measurements at least 4 weeks apart.
Croatian: ** PSA odgovor: odgovor prostata specifičniog antigena: razina PSA <0,2 ng/mL mjerena u dva uzastopna mjerenja odvojena barem 4 tjedna.
English: • one single-dose vial of concentrate and,
Croatian: • jednu jednodoznu bočicu s koncentratom i
English: TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Croatian: TAXOTERE se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, zaštitnom blister pakiranju i bočicama.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE
Croatian: • ako ste alergični (preosjetljivi) na docetaksel ili neki drugi sastojak lijeka TAXOTERE (naveden u dijelu 6).
English: In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate  10% higher in patients who were 65 years of age or greater compared to younger patients.
Croatian: U bolesnika koji su docetaksel primali svaka tri tjedna, incidencija promjena na noktima povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 65 godina ili starijih u usporedbi s mlađim bolesnicima.
English: Each box contains one vial.
Croatian: Jedna kutija sadržava jednu bočicu lijeka.
English: Justification for not including Braille accepted.
Croatian: PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Croatian: Pripremljena otopina koncentrata sadržava 10 mg/ml docetaksela i treba se upotrijebiti odmah nakon priprave.
English: • From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Croatian: • S mikrobiološkog stanovišta, rekonstitucija/razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a infuzijska otopina se mora primijeniti odmah.
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Croatian: S mikrobiološkog stanovišta, rekonstitucija/razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a lijek se mora upotrijebiti odmah.
English: • Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Croatian: • Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN) (pojava mjehurića, guljenje ili krvarenje na bilo kojem dijelu kože (uključujući usne, oči, usta, nos, genitalije, šake ili stopala) sa ili bez osipa.
English: In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Croatian: U pivotalnim SCCHN ispitivanjima bolesnicima kod kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti GCSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
English: Recommendations for the safe handling
Croatian: PREPORUKE ZA SIGURNO RUKOVANJE
English: RECOMMENDATIONS FOR THE SAFE HANDLING
Croatian: Preporuke za sigurno rukovanje
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Croatian: • 1276 bolesnika (744 u TAX 316 i 532 u GEICAM 9805 studiji) koji su primali docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Croatian: Bez utjecaja na primarni ishod, ukupnu stopu odgovora (32% prema 25%, p=0,10), docetaksel je produljio medijan vremena do progresije bolesti (24,6 tjedana prema 15,6 tjedana; p<0,01) i medijan vremena preživljenja (15,3 mjeseca prema 12,7 mjeseci; p=0,03).
English: TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Croatian: TAXOTERE u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
English: SOLVENT for TAXOTERE
Croatian: OTAPALO za TAXOTERE
English: How to use TAXOTERE
Croatian: Kako primjenjivati TAXOTERE
English: • Standard of care alone
Croatian: Samo standard liječenja
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively.
Croatian: Kinetički profil docetaksela neovisan je o dozi i u skladu je s farmakokinetičkim modelom tri odjeljka, s poluvijekom za alfa, beta i gama fazu od 4 minute, 36 minuta i 11,1 sati.
English: What TAXOTERE contains - The active substance is docetaxel (as trihydrate).
Croatian: Što TAXOTERE sadrži - Djelatna tvar je docetaksel (u obliku docetaksel trihidrata).
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in
Croatian: Infekcije i infestacije infekcije (G3/4: 5,7%; uključujući sepsu i pneumoniju, fatalno u
English: You must not breast-feed while you are treated with TAXOTERE.
Croatian: Ne smijete dojiti tijekom liječenja lijekom TAXOTERE.
English: In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST  1.5 times the ULN associated with alkaline phosphatase  2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Croatian: U malog broja bolesnika (n=23), gdje su klinički biokemijski podaci pokazivali lagano ili srednje oštećenje jetrene funkcije (ALT, AST ≥ 1,5 puta od GGN te alkalna fosfataza ≥ 2,5 puta od GGN), ukupni klirens bio je smanjen u prosjeku 27% (vidjeti dio 4.2).
English: The premix solution should be used immediately after preparation.
Croatian: Pripremljenu otopinu koncentrata treba primijeniti odmah nakon priprave.
English: CisplatinClearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Croatian: Klirens docetaksela u kombiniranoj terapiji s cisplatinom bio je sličan onom nakon monoterapije.
English: TAXOTERE in combination with doxorubicin
Croatian: TAXOTERE u kombinaciji s doksorubicinom
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Croatian: Na temelju potrebne doze izražene u mg, aseptički izvucite odgovarajući volumen otopine koncentrata s 10 mg/ml docetaksela iz odgovarajućeg broja bočica s pripremljenom otopinom koncentrata, koristeći graduirane štrcaljke s iglom.
English: • Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml.
Croatian: • Jedna bočica otapala za TAXOTERE 80 mg/2 ml sadrži 7,33 ml.
English: Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 32%); febrilna neutropenija (uključujući neutropeniju povezanu s vrućicom i primjenom antibiotika) ili neutropenijska sepsa
English: - For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.
Croatian: - Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, TAXOTERE se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Croatian: 4.1.2 Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj otapala za TAXOTERE, djelomično okrećući bočicu otapala naopako.
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m².
Croatian: • Bolesnicima u kojih se drugi put pojavila toksičnost stupnja 2, ili u kojih se prvi put pojavila toksičnost stupnja 3, u bilo koje vrijeme liječenja, treba odgoditi terapiju sve dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti liječenje docetakselom 55 mg/m
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m twice daily for 2 weeks followed by 1-week rest period).
Croatian: U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom (1250 mg/m dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
English: It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Croatian: Važno je pročitati cijeli sadržaj upute prije pripreme TAXOTERE otopine koncentrata i TAXOTERE otopine za infuziju
English: Patients with severe liver impairment (see sections 4.2 and 4.4).
Croatian: Bolesnici s teškim oštećenjem jetre (vidjeti dijelove 4.2. i 4.4).
English: • Premix solution: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Croatian: • Pripremljena otopina koncentrata: pripremljena otopina koncentrata sadrži 10 mg/ml docetaksela i treba se upotrijebiti odmah nakon priprave.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Croatian: Ako se otopina ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika, a ne bi smjeli biti duži od 6 sati pri temperaturi ispod 25
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Croatian: Primarni ishod djelotvornosti u ovom ispitivanju, ukupno preživljenje (OS) bilo je značajno duže (log-rank test, p=0,0058) u skupini liječenoj docetakselom u usporedbi s PF (medijan OS: 70,6 prema 30,1 mjesec), s 30 % smanjenja smrtnosti u usporedbi s PF (omjer hazarda (HR) = 0,70, 95% interval pouzdanosti (CI) = 0,54-0,90) uz ukupni medijan praćenja od 41,9 mjeseci.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Croatian: * omjer hazarda manji od 1 ukazuje da je TAC povezan s duljim preživljenjem bez znakova bolesti i ukupnim preživljenjem u usporedbi s FAC-om
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Croatian: Na primjer, za dozu od 140 mg docetaksela potrebno je 7 ml docetaksel koncentrata za otopinu.
English: CAUTION: Dilution required with the entire contents of the solvent vial.
Croatian: UPOZORENJE: koncentrat je potrebno razrijediti cjelokupnim sadržajem bočice s otapalom.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates  10% higher in patients who were 75 years of age or greater versus less than 65 years.
Croatian: Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Croatian: Rijetko su zabilježeni akutni respiratorni distres sindrom te slučajevi intersticijske pneumonije/pneumonitisa, intersticijske bolesti pluća, plućne fibroze i zatajenja disanja, koji su ponekad imali smrtni ishod.
English: This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Croatian: Taj volumen punjenja utvrđen je tijekom razvoja lijeka TAXOTERE kako bi se nadoknadio gubitak tekućine koji nastaje tijekom pripreme otopine koncentrata (vidjeti dio 4), zbog pjenjenja, adhezije za stijenku bočice i neiskoristivog volumena koji zaostaje u bočici.
English: 4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Croatian: 4.1.5 Ostavite bočicu s pripremljenom otopinom koncentrata na sobnoj temperaturi (ispod 25°C) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon 5 minuta zbog polisorbata 80 u sastavu).
English: 4.2 Preparation of the infusion solution
Croatian: 4.2 Priprema otopine za infuziju
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza ''EXP''.
English: Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
Croatian: Prilagođeni omjer hazarda 95% CI p-vrijednosta a p-vrijednost izračunata iz testa omjera vjerojatnosti i prilagođena za sve stratifikacijske faktore (osim za centar i planiranu hormonsku terapiju) i stratificirana prema periodu ispitivanja b Preživljenje bez neuspjeha: vrijeme od randomizacije do prvog dokaza barem jednoga od sljedećeg: biokemijski neuspjeh (definiran kao porast PSA od 50% iznad najniže vrijednosti unutar 24 tjedna i preko 4 ng/mL te potvrđen ponovnim testom ili liječenjem); progresija bolesti, lokalno u limfnim čvorovima ili u udaljenim metastazama; događaj povezan uz kosštani sustav; ili smrt zbog raka prostate.
English: Docetaxel should be administered when the neutrophil count is  1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m to 75 mg/m and/or from 75 to
Croatian: Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m na 75 mg/m i/ili sa 75 mg/m na 60 mg/m
English: You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.
Croatian: Također, istovremeno možete imati simptome nalik gripi, poput vrućice, zimice ili bolnih mišića.
English: - If you have any further questions, ask your doctor, hospital pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Croatian: TAXOTERE u kombinaciji sa cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
English: If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili bolničkom ljekarniku.
English: Solvent vial: ethanol 95% (see leaflet for further information), water for injections.
Croatian: Bočica s otapalom: etanol 95% (za detaljnije informacije vidjeti Uputu o lijeku), voda za injekcije.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m every three weeks, with trastuzumab administered weekly.
Croatian: U kombinaciji s trastuzumabom preporučena doza docetaksela iznosi 100 mg/m svaka tri tjedna, dok se trastuzumab primjenjuje svaki tjedan.
English: 5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days.
Croatian: 75 mg/m te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
English: - The other ingredients are polysorbate 80 and citric acid.
Croatian: - Drugi sastojci su polisorbat 80 i citratna kiselina.
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Croatian: Pomoćne tvari: polisorbat 80, etanol bezvodni (za detaljnije informacije vidjeti Uputu o lijeku) i citratna kiselina.
English: The concentrate is a clear viscous, yellow to brown-yellow solution.
Croatian: Koncentrat je bistra, viskozna, žuta do smeđežuta otopina.
English: Efficacy of docetaxel in combination with prednisone or prednisolone and standard of care in the treatment of patients with metastatic hormone-sensitive prostate cancer (STAMPEDE)
Croatian: Djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom i standardom liječenja u liječenju bolesnika s metastatskim karcinomom prostate osjetljivim na hormone (STAMPEDE)
English: • acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Croatian: • akutna mijeloična leukemija i mijelodisplastični sindrom (vrste raka krvi) mogu se javiti kod bolesnika koji se liječe zajedno s docetakselom i određenim drugim antitumorskim lijekovima
English: - For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
Croatian: - Za liječenje karcinoma prostate TAXOTERE se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
Croatian: (521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).