FrancophonIA/ELRC3.0 huggingface dataset:
English: A multi-centre, open-label, randomised study, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Croatian: Provedena je multicentrična, randomizirana studija otvorenog tipa da bi se procijenila sigurnost primjene i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
English: Bone marrow suppression and other haematologic adverse reactions have been reported.
Croatian: Zabilježene su supresija koštane srži i ostale hematološke nuspojave.
English: Description of selected adverse reactions for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Croatian: Opis odabranih nuspojava za adjuvantno liječenje za DOCETAXEL KABI 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
English: - For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje karcinoma glave i vrata DOCETAXEL KABI se primjenjuje u kombinaciji s cisplatinom i 5-fluorouracilom.
English: Intravenous use.
Croatian: Način primjene.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Croatian: Pripremljena infuzijska otopina mora se upotrijebiti unutar 6 sati nakon priprave, uključujući u to i jednosatnu intravensku infuziju bolesniku, uz čuvanje na temperaturi ispod 25°C.
English: Hazard ratio
Croatian: Omjer hazarda
English: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Croatian: Najčešće nuspojave (≥ 5%) povezane s kombiniranim liječenjem s kapecitabinom zabilježene su u ispitivanju faze III u bolesnika s karcinomom dojke nakon neuspješnog liječenja antraciklinima (vidjeti sažetak opisa svojstava lijeka za kapecitabin).
English: Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Croatian: Jedna bočica koncentrata sadržava 4,5 ml (3,55 g) etanola, bezvodnog.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 nakon čega je slijedio cisplatin (P) 75 mg/m2 te 5-fluorouracil (F) 750 mg/m2 dnevno u obliku kontinuirane infuzije tijekom 5 dana.
English: • nasal drainage; inflammation of the throat and nose; cough
Croatian: • curenje iz nosa, upala grla i nosa, kašalj
English: Gastric adenocarcinoma
Croatian: Adenokarcinom želuca
English: DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Croatian: DOCETAXEL KABI je u kombinaciji s cisplatinom i 5-fluorouracilom indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Croatian: Što DOCETAXEL KABI sadrži - Djelatna tvar je docetaksel bezvodni.
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Croatian: Zabilježeno je značajno duže preživljenje bez znakova bolesti u skupini TAC u usporedbi sa skupinom FAC.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadržava 20 mg docetaksela, bezvodnog.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Croatian: U bolesnika liječenih s TAC adjuvantnom terapijom treba razmotriti primjenu primarne G-CSF profilakse da bi se smanjio rizik od komplicirane neutropenije (febrilna neutropenija, produljena neutropenija ili neutropenijska infekcija).
English: DOCETAXEL KABI in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Croatian: DOCETAXEL KABI je u kombinaciji s prednizonom ili prednizolonom indiciran za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
English: • blood clots.
Croatian: • krvni ugrušci
English: Both regimens were administered every 3 weeks.
Croatian: Obje vrste liječenja primjenjivane su svaka 3 tjedna.
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 stajališta, rekonstitucija/razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a lijek se treba upotrijebiti odmah.
English: DOCETAXEL KABI in combination with trastuzumab
Croatian: DOCETAXEL KABI u kombinaciji s trastuzumabom
English: DOCETAXEL KABI in combination with doxorubicin
Croatian: DOCETAXEL KABI u kombinaciji s doksorubicinom
English: Second episode: then reduce docetaxel dose by 20%.
Croatian: Druga epizoda: zatim smanjiti dozu docetaksela za 20%.
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4: 20.7%); Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 12.0%);
Croatian: Poremećaji probavnog sustava mučnina (G 3/4: 13,9%), stomatitis (G3/4: 20,7%), povraćanje (G3/4: 8,4%), proljev (G3/4: 6,8%);, ezofagitis/disfagija/odinof agija (G3/4: 12,0%), konstipacija (G3/4: 0,4%)
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/m2 u usporedbi s najboljom potpornom terapijom (BSC).
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Croatian: Akutna mijeloična leukemija i mijelodisplastični sindrom su prijavljeni (manje česta učestalost) u pivotalnim kliničkim ispitivanjima raka dojke u kojima se primjenjivao docetaksel, doksorubicin i ciklofosfamid (TAC režim).
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Croatian: Preporučena doza docetaksela je 75 mg/m2 u obliku jednosatne infuzije nakon čega slijedi infuzija 75 mg/m2 cisplatina u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5 dana.
English: G3/4 Blood alkaline phosphatase increased
Croatian: G3/4 AST povišen G3/4 povećanje alkalne fosfataze u krvi
English: More severe reactions may occur.
Croatian: Također se mogu javiti i teže nuspojave.
English: Response rate (95% CI)
Croatian: Stopa terapijskog odgovora (95% CI)
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Croatian: Tablični popis nuspojava za adjuvantno liječenje za DOCETAXEL KABI 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Croatian: Za modifikaciju doze trastuzumaba pogledati sažetak opisa svojstava lijeka za trastuzumab.
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Croatian: U bolesnika liječenih u TAC skupini, rizik povrata bolesti smanjio se za 32% u odnosu na bolesnike u FAC skupini (omjer hazarda = 0,68, 95% CI (0,49-0,93), p = 0,01).
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Croatian: Za prilagodbu doze cisplatina vidjeti odgovarajući sažetak opisa svojstava lijeka.
English: Number of patients Tumor response rate (%) 95% CI p-value*
Croatian: Stopa tumorskog odgovora (%) 95% CI p-vrijednost*
English: In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Croatian: Ako se dijagnosticira cistični edem makule, potrebno je prekinuti primjenu docetaksela i uvesti odgovarajuće liječenje (vidjeti dio 4.8).
English: Infection (G3/4: 6.3%); Neutropenic infection
Croatian: Infekcije i infestacije infekcija (G3/4: 6,3%), neutropenijska infekcija
English: Neutropenic infection; Infection (G3/4: 11.7%)
Croatian: Infekcije i infestacije neutropenijska infekcija, infekcija (G3/4: 11,7%)
English: What you need to know before you use DOCETAXEL KABI 3.
Croatian: Što morate znati prije nego počnete primati DOCETAXEL KABI 3. Kako primjenjivati DOCETAXEL KABI 4. Moguće nuspojave
English: No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Croatian: Nema podataka o primjeni docetaksela u kombiniranoj terapiji u bolesnika s oštećenom funkcijom jetre u ostalim indikacijama.
English: Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe.
Croatian: Koristeći kalibriranu štrcaljku, aseptički uvucite potrebnu količinu DOCETAXEL KABI koncentrata za otopinu za infuziju.
English: How to store DOCETAXEL KABI
Croatian: Kako čuvati DOCETAXEL KABI
English: Lacrimation increased (G3/4: < 0.1%)
Croatian: pojačano suzenje (G3/4: <0,1%)
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Croatian: • Za prilagodbu doziranja kapecitabina pogledati sažetak opisa svojstava tog lijeka.
English: Median duration of response (months) (95% CI)
Croatian: Medijan trajanja odgovora (mjeseci) (95% CI)
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Croatian: Poremećaji živčanog sustava disgeuzija (G3/4: <1%), parestezija (G3/4: <1%)
English: DOCETAXEL KABI in combination with capecitabine
Croatian: DOCETAXEL KABI u kombinaciji s kapecitabinom
English: Overall Age category 1 <50 years ≥50 years Age category 2 <35 years ≥35 years
Croatian: Dobna skupina 1 <50 godina ≥50 godina Dobna skupina 2 <35 godina ≥35 godina Status hormonskih receptora
English: Single-use vial.
Croatian: Bočica za jednokratnu uporabu.
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), limfedem je i dalje bio prisutan u 6 bolesnika (0,8%) u TAC skupini te u 1 bolesnika (0,1%) u FAC skupini.
English: For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Croatian: U bolesnika s razinama serumskog bilirubina >GGN i/ili ALT i AST > 3,5 puta većim od GGN te serumskom alkalnom fosfatazom > 6 puta od GGN nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
English: Venous disorder
Croatian: Krvožilni poremećaji venski poremećaji
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Croatian: 0,2%), abdominalna bol (teška: 1%), gastrointestinalno krvarenje (teško 0,3%)
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: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Croatian: Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m2 kao 30-minutnu do trosatnu intravensku infuziju 1. dan, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m2 dnevno od 1. do 5. dana.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Croatian: U ovom je ispitivanju u dvije skupine bio randomiziran 501 bolesnik s lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1.
English: G3/4 Blood bilirubin increased (< 2.5%);
Croatian: G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
English: Or
Croatian: CI
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Croatian: Najbolji ukupni odgovor na liječenje tijekom studije [kemoterapija +/- radioterapija] (%) (95% CI) ***p- vrijednost
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Croatian: Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda = 0 ,84, 95% CI (0,65-1,08), p=0,1646).
English: • muscle aches and pains; back pain or bone pain
Croatian: • tupi bolovi u mišićima, bol u leđima ili bol u kostima
English: • hearing impaired
Croatian: • oštećenje sluha
English: If DOCETAXEL KABI concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako DOCETAXEL KABI koncentrat ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Croatian: U ispitivanju TAX 316 amenoreja koja je počela tijekom perioda liječenja te je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije zabilježena je u 202 od 744 bolesnice (27,2%) u TAC skupini te u 125 od 736 bolesnica (17,0%) u FAC skupini.
English: Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica koncentrata sadržava 3 ml (2,37 g) etanola, bezvodnog.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Croatian: • Indukcijska kemoterapija nakon koje slijedi radioterapija (TAX 323) Za indukcijsko liječenje neoperabilnog, lokalno uznapredovalog karcinoma skvamoznih stanica glave i vrata preporučena doza docetaksela iznosi 75 mg/m2 u obliku jednosatne infuzije nakon čega slijedi jednosatna infuzija 75 mg/m2 cisplatina prvi dan.
English: Lethargy; Pain
Croatian: letargija, bol
English: Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Croatian: Česte nuspojave konstipacija (G3/4: 1%), abdominalna bol (G3/4: 2%), dispepsija
English: One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Croatian: Jedna bočica s 9 ml koncentrata sadržava 180 mg docetaksela.
English: Data from one multi-centre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Croatian: Rezultati jedne multicentrične, randomizirane, kontrolirane, kliničke studije faze III podupiru primjenu docetaksela u kombinaciji s kapecitabinom za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspješne citotoksične terapije koja je uključivala i antracikline.
English: Data from a multi-centre open-label randomisedtrial support the use of DOCETAXEL KABI for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Croatian: Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu DOCETAXEL KABI za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima prikladnih za liječenje kemopterapijom.
English: Second episode: reduce docetaxel dose by 20%.
Croatian: Druga epizoda: smanjiti dozu docetaksela za 20%
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Croatian: Težina nuspojava docetaksela može se povećati kada se docetaksel daje u kombinaciji s drugim citostaticima.
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%)
Croatian: Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/- kemoradioterapija] (%) (95% CI)
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Croatian: Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik od smrti smanjio se za 9% u odnosu na bolesnike u FAC skupini (omjer hazarda= 0,91, 95% CI (0,63-1,32)).
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), periferni edem je i dalje bio prisutan u 19 bolesnika (2,6%) u TAC skupini, odnosno u 4 bolesnika (0,5%) u FAC skupini.
English: 1Full analysis set (intent-to-treat)
Croatian: 1potpuna analiza (podataka bolesnika predviđenih za liječenje [intent-to-treat]) 2 procijenjeni medijan preživljenja
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (teška: 12,4%), retencija tekućine (teška: 0,8%), bol
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Croatian: Djelotvornost docetaksela u indukcijskom liječenju bolesnika s inoperabilnim lokalno uznapredovalim SCCHN (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat)
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Croatian: Provedena su dva randomizirana, komparativna ispitivanja faze III u kojima su sudjelovali bolesnici s metastatskim karcinomom dojke, od kojih je 326 bilo neuspješno liječeno alkilirajućim agensima, a 392 antraciklinima.
English: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica koncentrata sadržava 2 ml (1,58 g) etanola, bezvodnog.
English: Peripheral motor neuropathy (G3/4: 2.5%)
Croatian: periferna motorna neuropatija (G3/4: 2,5%)
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Croatian: Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
English: Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Croatian: bol u udovima (G3/4: <1%), bol u leđima (G3/4: 1%)
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Croatian: Jedna bočica s 8 ml koncentrata sadržava 160 mg docetaksela.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC.
Croatian: Nakon 10 godina praćenja u ispitivanju GEICAM 9805, akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%)u TAC skupini.
English: At the median follow-up time of 77 months overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Croatian: Pri medijanu vremena praćenja od 77 mjeseci ukupno preživljenje (OS) također je bilo duže u bolesnika u TAC skupini, uz 24%-tno smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini (omjer hazarda = 0,76, 95% CI (0,46-1,26), p = 0,29).
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Croatian: Sigurnost primjene i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomizirano multicentričnoj studiji faze III.
English: Vascular disorders Lymphoedema Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica koncentrata sadržava 4 ml (3,16 g) etanola, bezvodnog.
English: Patients with liver impairment
Croatian: Bolesnici s oštećenom funkcijom jetre
English: Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Croatian: trombocitopenija (G3/4: 0,6%), febrilna neutropenija
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 intravenskom infuzijom 1. dan nakon čega je slijedio cisplatin (P) 100 mg/m2 primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5-fluorouracila (F) 1000 mg/m2 dnevno od 1. do 4. dana.
English: At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Croatian: Pri medijanu vremena praćenja od 77 mjeseci ukupno preživljenje (OS) bilo je duže u bolesnika u TAC skupini, uz 24%-tno smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini (omjer hazarda = 0,76, 95% CI (0,46-1,26), p = 0,29).