FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Croatian: Infekcije i infestacije infekcije (G3/4: 5,7%; uključujući sepsu i pneumoniju, fatalno u 1,7% slučajeva)
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Croatian: Postmenopauza * omjer hazarda (TAC/FAC) manji od 1 prikazuje da je TAC povezan sa dužim preživljenjem bez znakova bolesti u usporedbi sa FAC-om.
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Croatian: • 300 bolesnika s adenokarcinomom želuca (221 bolesnik u fazi III studije i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
English: As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis.
Croatian: S obzirom na to da korist liječenja uočena u bolesnika s 4 i više pozitivnih limfnih čvorova nije bila statistički značajna u pogledu DFS i OS, pozitivan omjer rizika i koristi TAC liječenja u bolesnika s 4 i više pozitivnih limfnih čvorova nije potpuno dokazan u konačnoj analizi rezultata studije.
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm3 (see section 4.2).
Croatian: Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm3 (vidjeti dio 4.2).
English: The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents.
Croatian: Težina nuspojava može se povećati kada se DOCETAXEL KABI daje u kombinaciji s drugim kemoterapijskim lijekovima.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Croatian: Za liječenje nakon neuspjeha prethodne kemoterapije temeljene na platini, preporučuje se doza od 75 mg/m2 kao monoterapija.
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: Diarrhoea grade 4
Croatian: Stomatitis/mukozitis 4. stupnja
English: • 406 patients who received docetaxel in combination with cisplatin.
Croatian: • 406 bolesnika koji su primali docetaksel u kombinaciji s cisplatinom,
English: • oral candidiasis
Croatian: • oralna kandidijaza
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Croatian: Za karcinom prostate premedikacija se provodi s peroralnim deksametazonom od 8 mg, 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.2).
English: Following chemotherapy, patients should receive chemoradiotherapy.
Croatian: Nakon kemoterapije bolesnici se moraju liječiti kemoradioterapijom.
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Croatian: Ako se unatoč primjeni G-CSF pojave epizode febrilne neutropenije, produljene neutropenije ili neutropenijske infekcije, dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Croatian: Ove su reakcije opisane prema kriterijima «NCI Common Toxicity Criteria» (stupanj 3 = G 3, stupanj 3-4 = G 3/4, stupanj 4 = G 4) i pojmovima COSTART i MedDRA.
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 liječniku ili bolničkom ljekarniku.
English: Mix the infusion bag or bottle manually using a rocking motion.
Croatian: Promiješajte sadržaj infuzijske vrećice ili boce ručno, polukružnim (ljuljajućim) pokretima.
English: • Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
Croatian: • Docetaksel 75 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Croatian: • plućna fibroza (ožiljci i zadebljanja na plućima, praćeni nedostatkom zraka)
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Croatian: Bolesnici koji primaju TCF moraju biti pod stalnim nadzorom (vidjeti dio 4.2 i 4.8).
English: In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Croatian: Osim toga, pokazalo se da je docetaksel aktivan samo na nekim linijama stanica koje imaju pojačanu ekspresiju p-glikoproteina kodiranog genom za višestruku rezistenciju na lijekove.
English: There are no data available in patients with severely impaired renal function treated with docetaxel.
Croatian: Ne postoje dostupni podaci o liječenju docetakselom bolesnika s teško oštećenom funkcijom bubrega.
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Croatian: Žene reproduktivne dobi koje primaju docetaksel treba savjetovati da izbjegavaju trudnoću te da odmah obavijeste svog liječnika ako zatrudne.
English: • Each vial is for single use and should be used immediately after opening.
Croatian: • Bočice su namijenjene za jednokratnu primjenu te se trebaju upotrijebiti odmah nakon otvaranja.
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
Croatian: U kombinaciji s kapecitabinom, preporučena doza docetaksela je 75 mg/m2 svaka tri tjedna u kombinaciji s kapecitabinom u dozi od 1250 mg/m2 dvaput dnevno (unutar pola sata nakon obroka) u trajanju od 2 tjedna, nakon čega slijedi tjedan dana pauze.
English: Infusion site reaction; Pain
Croatian: reakcije na mjestu primjene infuzije, bol
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Croatian: U bolesnika koji su primali docetaksel u kombinaciji s trastuzumabom, posebice nakon kemoterapije koja je sadržavala antracikline (doksorubicin ili epirubicin), zabilježeno je zatajenje srca.
English: Additional cautions for use in adjuvant treatment of breast cancer
Croatian: Dodatna upozorenja za primjenu u adjuvantnom liječenju karcinoma dojke
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Croatian: Neutropenijske komplikacije u bolesnika koji su primali TAC terapiju sa ili bez profilakse s G-CSF (GEICAM 9805)
English: Rare cases of ileus and intestinal obstruction have been reported.
Croatian: Rijetko su zabilježeni ileus i intestinalna opstrukcija.
English: Both regimens were administered on day 1 every 3 weeks.
Croatian: Oba kemoterapijska protokola primjenjivala su se 1. dan svaka 3 tjedna.
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Croatian: bol reakcija na mjestu primjene infuzije, bol u prsima nekardiološke etiologije (teška: 0,4%)
English: As with all parenteral products, DOCETAXEL KABI infusion solution should be visually inspected prior to use, and solutions containing a precipitate should be discarded.
Croatian: Kao i svi parenteralni pripravci, DOCETAXEL KABI otopina za infuziju mora se vizualno provjeriti prije primjene, a otopine koje sadrže precipitat potrebno je baciti.
English: Prednisone and dexamethasone
Croatian: Prednizon i deksametazon
English: 2 year Survival (%)
Croatian: dvogodišnje preživljenje (%)
English: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Croatian: Docetaksel se pokazao citotoksičnim in vitro prema raznim linijama mišjih i ljudskih tumorskih stanica te prema svježe izdvojenim ljudskim tumorskim stanicama u klonogenim ispitivanjima.
English: 1 vial with 120 mg/6 ml
Croatian: 1 bočica s 120 mg/6 ml
English: DOCETAXEL KABI 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: DOCETAXEL KABI je u kombinaciji sa cisplatinom i 5-fluorouracilom indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
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, stopu ukupnog 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: Nail disorders (severe: 2.6%)
Croatian: poremećaji noktiju (teški: 2,6%)
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM study.
Croatian: Sljedeća tablica prikazuje da je incidencija neutropenije stupnja 4, febrilne neutropenije i neutropenijske infekcije smanjena u bolesnika koji su primali primarnu profilaksu s G-CSF nakon što je ona uvedena kao obavezna u TAC skupini - GEICAM studija.
English: Hypersensitivity (no severe)
Croatian: Poremećaji imunološkog sustava preosjetljivost (ne teška)
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental anti-tumour activity against advanced murine and human grafted tumours.
Croatian: Antitumorska aktivnost docetaksela je in vivo neovisna o rasporedu doziranja te ima širok spektar eksperimentalne antitumorske aktivnosti na uznapredovale tumore u mišjih i ljudskih tumorskih presadaka.
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/ or cyclophosphamide (see section 4.8).
Croatian: Ventrikularna aritmija, uključujući i ventrikularnu tahikardiju (ponekad smrtonosnu), prijavljena je u bolesnika liječenih docetakselom u kombiniranim režimima koji uključuju doksorubicin, 5fluorouracil i/ili ciklofosfamid (vidjeti dio 4.8).
English: Efficacy results are presented in the table below:
Croatian: Rezultati djelotvornosti prikazani su u donjoj tablici:
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: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Croatian: U bolesnika koji su neuspješno liječeni alkilirajućim agensima, docetaksel se uspoređivao s doksorubicinom (75 mg/m2 svaka 3 tjedna).
English: For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Croatian: Za izračunavanje doze kapecitabina prema površini tijela, pogledati sažetak opisa svojstava lijeka za kapecitabin.
English: 1 vial with 80 mg/4 ml
Croatian: 1 bočica s 80 mg/4 ml
English: Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
Croatian: Hipokalemija, hipomagnezijemija i hipokalcemija su uočene, obično povezane s gastrointestinalnim poremećajima, a posebice s proljevom.
English: Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Croatian: Docetaksel s trastuzumabom bio je efikasan neovisno o tome jesu li bolesnici prije toga primali adjuvantnu terapiju antraciklinima.
English: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Croatian: U bolesnika liječenih docetakselom u kombinaciji s cisplatinom i 5-fluorouracilom (TCF) febrilna neutropenija i neutropenijska infekcija javljale su se s manjom učestalošću kad su bolesnici profilaktički primali G-CSF.
English: 6.4 Special precautions for storage Do not store above 25°C.
Croatian: Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 25°C.
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Croatian: Bolesnicima u kojih se pojavi stomatitis stupnja 3 ili 4 treba smanjiti dozu na 60 mg/m2.
English: Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Croatian: Nakon dodavanja u infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna je 6 sati pri temperaturi do 25ºC.
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Croatian: • Docetaksel 30 mg/m2 primijenjen tjedno prvih 5 tjedana u ciklusu liječenja od 6 tjedana, tijekom 5
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Croatian: U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom (1250 mg/m2 dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Croatian: Djelotvornost docetaksela u liječenju bolesnika s adenokarcinomom želuca
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Croatian: Sva 3 kemoterapijska protokola primjenjivala su se u kombinaciji s prednizonom ili prednizolonom u dozi od 5 mg dva puta dnevno kontinuirano.
English: All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Croatian: U ispitivanjima TAX 323 i TAX 324 svi bolesnici u skupinama koje su primile docetaksel, profilaktički su primali i antibiotike.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Croatian: Podskupine bolesnika liječenih TAC-om analizirane su u primarnoj analizi (pri medijanu vremena praćenja od 77 mjeseci) prema unaprijed definiranim glavnim prognostičkim čimbenicima (vidjeti tablicu):
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 2. stupnja, ili u kojih se prvi put pojavila toksičnost 3. stupnja, 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/m2,
English: and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Croatian: 87% bolesnika imalo je IHC 3+, a 95% uključenih bolesnika imalo je IHC 3+ i/ili FISH pozitivne rezultate.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Croatian: Bolesnici liječeni s TCF moraju profilaktički primati G-CSF da bi se smanjio rizik od komplicirane neutropenije (febrilna neutropenija, produljena neutropenija ili neutropenijska infekcija).
English: Without primary G-CSF prophylaxis (n = 111) n (%)
Croatian: Bez primarne profilakse s G-CSF (n = 111) n (%)
English: In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 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/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Croatian: Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm3 dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom dozu docetaksela treba smanjiti sa 100 mg/m2 na 75 mg/m2 i/ili sa 75 mg/m2 na 60 mg/m2.
English: • non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Croatian: • ne-Hodgkinov limfom (rak koji pogađa imunološki sustav) i druge vrste raka mogu se javiti u bolesnika koji se liječe zajedno s docetakselom i određenim drugim antitumorskim lijekovima
English: With primary G-CSF prophylaxis (n = 421) n (%)
Croatian: Uz primarnu profilaksu s G-CSF (n = 421) n (%)
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).
Croatian: Amenoreja je i dalje bila prisutna na kraju perioda praćenja (medijan vremena praćenja iznosio je 8 godina) u 121 od 744 bolesnica (16,3%) u TAC skupini i 86 bolesnica (11,7%) u FAC skupini.
English: However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
Croatian: Docetaksel, međutim, nije izazvao mutagenost u Ames testu ni u pokusu CHO/HGPRT mutacije gena.
English: Efficacy results are summarized in the following table:
Croatian: Rezultati djelotvornosti sažeti su u sljedećoj tablici:
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Croatian: Bolesnici koji su kandidati za liječenje docetakselom u kombinaciji s trastuzumabom trebaju na početku liječenja obaviti procjenu srčane funkcije.
English: Head and neck cancer
Croatian: Karcinom glave i vrata
English: • operable node-negative breast cancer.
Croatian: • operabilnim karcinomom dojke s negativnim limfnim čvorovima.
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Croatian: Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (TAC skupina) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
English: Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Croatian: Retencija tekućine uključuje pojave kao periferni edem i rjeđe pleuralni izljev, perikardijalni izljev, ascites te povećanje tjelesne težine.
English: • 258 patients who received docetaxel in combination with doxorubicin.
Croatian: • 258 bolesnika koji su primali docetaksel u kombinaciji s doksorubicinom,
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Croatian: Farmakokinetika docetaksela u prisustvu prednizona ispitivala se u bolesnika s metastatskim karcinomom prostate.
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Croatian: Poremećaji probavnog sustava mučnina; proljev; povraćanje; konstipacija; stomatitis; dispepsija; abdominalna bol
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Croatian: S mikrobiološkog stajališta, priprema za primjenu/razrjeđivanje se mora odvijati u kontroliranim i aseptičkim uvjetima.
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Croatian: Prijavljeni su akutni respiratorni distres sindrom, intersticijska pneumonija/pneumonitis, intersticijska bolest pluća, plućna fibroza i zatajenje disanja, koji mogu biti povezani sa smrtnim ishodima.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Croatian: Istodobna primjena docetaksela, doksorubicina i ciklofosfamida ne utječe na njihovu farmakokinetiku.
English: Adjuvant therapy for breast cancer
Croatian: Adjuvantno liječenje karcinoma dojke
English: Each vial is for single use and should be used immediately after opening.
Croatian: Svaka bočica namijenjena je za jednokratnu primjenu te se treba primijeniti odmah nakon otvaranja.
English: Non-small cell lung cancer
Croatian: Karcinom nemalih stanica pluća
English: In combination with capecitabine
Croatian: Kombinacija s kapecitabinom
English: Hazard Ratio: 1.032 [95% CI: 0.876; 1.216]
Croatian: Omjer hazarda: 1,032 [95% CI: 0,876; 1,216]
English: Cutaneous reactions
Croatian: Kožne reakcije
English: Headache (G3/4: < 1%); Neuropathy peripheral
Croatian: glavobolja (G3/4: <1%), periferna neuropatija
English: 1060 patients were randomised to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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: 1060 bolesnika randomizirano je u skupine koje su primale ili DOCETAXEL KABI 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg/m2 (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).