FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Croatian: Zabilježeni su teški simptomi kao što su erupcije praćene deskvamacijom koji su doveli do prekida ili prestanka terapije docetakselom (vidjeti dio 4.2).
English: Age category 1 <50 years ≥50 years
Croatian: Dobna skupina 1 <50 godina ≥50 godina
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: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Croatian: • Kao i svi parenteralni pripravci, otopina za infuziju mora se vizualno provjeriti prije uporabe, a otopine koje sadrže precipitat ne smiju se koristiti.
English: DOCETAXEL KABI was administered as a 1-hour infusion, all other medicinal product were given intraveinously on day 1 every three weeks.
Croatian: DOCETAXEL KABI se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se intravenski 1. dan svaka tri tjedna.
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 trnaca i bockanja u udovima i vrućice te mu pokazati rezultate krvnih pretraga.
English: What DOCETAXEL KABI is and what it is used for
Croatian: Što je DOCETAXEL KABI i za što se koristi
English: Docetaxel infusion solution is supersaturated, therefore may cristallize over time.
Croatian: Infuzijska otopina docetaksela je prezasićena, stoga tijekom vremena može doći do kristalizacije.
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Croatian: Simptomatsko zatajivanje srca zabilježeno je u 2,2% bolesnika koji su primili docetaksel i trastuzumab u usporedbi s 0% bolesnika koji su primili docetaksel kao monoterapiju.
English: MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Fresenius Kabi Deutschland GmbH
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC
Croatian: ORR je bio 59,3 % (95% CI: 52,8-65,9) u AT skupini u odnosu na 46,5% (95% CI: 39,8-53,2) u AC skupini.
English: Docetaxel every week
Croatian: Docetaksel svaki tjedan
English: Hazard ratio*
Croatian: Omjer hazarda*
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Croatian: Ako se nakon toga pojave epizode komplicirane neutropenije, dozu docetaksela trebalo bi smanjiti sa 60 na 45 mg/m2.
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Croatian: G-CSF se primjenjivao kao sekundarna profilaksa u bolesnika koji su imali kompliciranu neutropeniju (febrilnu neutropeniju, produljenu neutropeniju ili infekciju).
English: G3/4 AST increased G3/4 ALT increased
Croatian: G3/4 AST povišen G3/4 ALT povišen
English: Patients with severe liver impairment (see sections 4.2 and 4.4).
Croatian: Bolesnici s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2. i 4.4).
English: The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Croatian: Najčešće zabilježeni simptomi bili su crvenilo praćeno osjećajem vrućine, osip sa ili bez svrbeža, stezanje u prsima, bol u leđima, dispneja, vrućica ili zimica.
English: DOCETAXEL KABI has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, DOCETAXEL KABI could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Croatian: DOCETAXEL KABI Vam je propisao liječnik za liječenje karcinoma dojke, posebnih oblika karcinoma pluća (karcinom nemalih stanica pluća), karcinoma prostate, karcinoma želuca ili karcinoma glave i vrata: - Za liječenje uznapredovalog karcinoma dojke, DOCETAXEL KABI se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
English: Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Croatian: Primijećen je lokalizirani eritem na koži ekstremiteta (na dlanovima i tabanima) s edemom popraćenim deskvamacijom.
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Croatian: U studiji faze I u kojoj se evaluirao učinak kapecitabina na farmakokinetiku docetaksela i obrnuto, pokazano je da kapecitabin nema učinka na farmakokinetiku docetaksela (Cmax i AUC) te da nema učinka docetaksela na farmakokinetiku 5'-DFUR-a, relevantnog metabolita kapecitabina.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL
Croatian: - ako ste alergični (preosjetljivi) na docetaksel ili neki drugi sastojak lijeka DOCETAXEL KABI (naveden u dijelu 6).
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Croatian: Razgovarajte sa svojim liječnikom ako ste ovisni o Alkoholu, imate epilepsiju ili oštećenje funkcije jetre.
English: Its common name is docetaxel.
Croatian: Uobičajeni naziv je docetaksel.
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomised to one of two treatment arms.
Croatian: U ovoj je studiji 358 bolesnika s inoperabilnim, lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1, bilo randomizirano u jednu od dvije liječene skupine.
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Croatian: Incidencija neutropenije stupnja 4, febrilne neutropenije i neutropenijske infekcije smanjena je u bolesnika koji su primali primarnu profilaksu s G-CSF (vidjeti dio 4.8.).
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: The recommended dose of docetaxel is 75 mg/m2.
Croatian: Preporučena doza docetaksela iznosi 75 mg/m2.
English: DOCETAXEL KABI contains ethanol (alcohol).
Croatian: DOCETAXEL KABI sadrži etanol (alkohol)
English: There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Croatian: Zabilježena je povećana incidencija ozbiljnih štetnih događaja (40% prema 31%) i štetnih događaja stupnja 4 (34% prema 23%) u kombinaciji s trastuzumabom u odnosu na monoterapiju docetakselom.
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Croatian: Vrlo rijetko, pri primjeni docetaksela, zabilježeni su kožni lupus eritematodes i bulozne erupcije poput eritema multiforme, Stevens-Johnsonovog sindroma i toksične epidermalne nekrolize.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly.
Croatian: U kombinaciji s trastuzumabom preporučena doza docetaksela iznosi 100 mg/m2 svaka tri tjedna, dok se trastuzumab primjenjuje svaki tjedan.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Croatian: Podskupine bolesnika koji su liječeni TAC-om analizirane su prema prospektivno definiranim glavnim prognostičkim čimbenicima.
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Croatian: Za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke preporučena doza docetaksela u monoterapiji iznosi 100 mg/m2.
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: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Croatian: U slučaju trombocitopenije 4. stupnja dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
English: Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Croatian: Sukladno navedenom, zbog mogućih nuspojava u dojenčeta, za vrijeme liječenja docetakselom dojenje se mora prekinuti.
English: First episode: reduce 5-FU dose by 20%.
Croatian: Prva epizoda: smanjiti dozu 5-FU za 20%.
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Croatian: Zabilježeni su rijetki slučajevi konvulzija ili prolaznog gubitka svijesti pri primjeni docetaksela.
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: No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Croatian: Niti jednom bolesniku u obje skupine nije dijagnosticiran mijelodisplastični sindrom.
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: The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs. 29.7% (docetaxel alone); p = 0.0058.
Croatian: Ukupna objektivna stopa terapijskog odgovora u svih randomiziranih bolesnika (prema procjeni ispitivača) bila je 41,6% (docetaksel + kapecitabin) u odnosu na 29,7% (samo docetaksel); p=0,0058.
English: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Croatian: Bolesnicima koji početnu dozu docetaksela od 75 mg/m2 primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25.000 stanica/mm3, u bolesnika koji su imali febrilnu neutropeniju ili u bolesnika s ozbiljnim nehematološkim toksičnim učincima doza docetaksela u sljedećim ciklusima mora se smanjiti na 65 mg/m2.
English: Discuss with your doctor if you suffer from alcohol dependency epilepsy or liver impairment.
Croatian: Razgovarajte sa svojim liječnikom ako ste ovisni o alkoholu imate epilepsiju ili oštečenje funkcije jetre.
English: Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Croatian: Stoga, preporučena doza docetaksela u tih bolesnika s povišenim vrijednostima testova jetrene funkcije iznosi 75 mg/m2, a testove funkcije jetre treba učiniti prije početka terapije i prije svakog sljedećeg ciklusa (vidjeti dio 4.2).
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 upućuje da je TAC povezan s duljim preživljenjem bez znakova bolesti i ukupnim preživljenjem u usporedbi s FAC-om
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Croatian: • Indukcijska kemoterapija praćena kemoradioterapijom (TAX 324) MedDRA klasifikacija organskih sustava
English: Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Croatian: Klirens docetaksela nije bio promijenjen u bolesnika s blagom do umjerenom retencijom tekućine, odnosno nema podataka o bolesnicima s teškom retencijom tekućine.
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8).
Croatian: Bolesnicima u kojih se pojavi febrilna neutropenija i/ili neutropenijska infekcija u svim sljedećim ciklusima treba smanjiti dozu docetaksela na 60 mg/m2 (vidjeti dio 4.4 i 4.8).
English: Docetaxel is a substance derived from the needles of yew trees.
Croatian: Docetaksel je tvar koja se dobiva iz iglica drveta tise.
English: Patients should be monitored for second primary malignancies (see section 4.8).
Croatian: Bolesnike je potrebno nadzirati zbog pojave drugih primarnih zloćudnih bolesti (vidjeti dio 4.8).
English: Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Croatian: Rijetko je zabilježena pojava suzenja sa ili bez konjunktivitisa, poput slučajeva opstrukcije suznog kanala što rezultira prekomjernim suzenjem.
English: Cardiac toxicity
Croatian: Srčana toksičnost
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Croatian: U ispitivanju TAX 316, 26 bolesnika (3,5%) u TAC skupini te 17 bolesnika (2,3%) u FAC skupini doživjelo je kongestivno zatajenje srca (CHF).
English: Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Croatian: Teške promjene na noktima karakterizirale su hipo- ili hiperpigmentacija ponekad praćene boli i oniholizom.
English: The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Croatian: Incidencija febrilne neutropenije/neutropenijske sepse također je bila povećana u bolesnika koji su liječeni Herceptinom i docetakselom (23% u odnosu na 17% bolesnika koji su liječeni samo docetakselom).
English: Meeting relative indication for chemotherapya
Croatian: Zadovoljena relativna indikacija za kemoterapiju a
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Croatian: U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m2 u kombinaciji s doksorubicinom (50 mg/m2).
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Croatian: Na završetku kemoterapije, s minimalnim intervalom od 4 tjedna i maksimalnim intervalom od 7 tjedana, bolesnici čija bolest nije napredovala liječeni su radioterapijom (RT) prema smjernicama ustanove u kojoj su liječeni kroz 7 tjedana (TPF/RT).
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Croatian: Medijan vremena do progresije bolesti bio je 186 dana (docetaksel + kapecitabin) u usporedbi sa 128 dana (samo docetaksel).
English: A hazard ratio of less than 1 favoursdocetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Croatian: Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + fluorouracil *neprilagođeni log-rank test **neprilagođeni log-rank test, nije prilagođen višestrukim usporedbama *** Hi-kvadrat test, nije prilagođen višestrukim usporedbama
English: Second primary malignancies have been reported when docetaxel was given in combination with anticancer treatments known to be associated with second primary malignancies.
Croatian: Druge primarne zloćudne bolesti su prijavljene kada se docetaksel primjenjivao u kombinaciji s drugim antitumorskim lijekovima za koje je poznato da su povezani s pojavom drugih primarnih zloćudnih bolesti.
English: • chest tightness; difficulty in breathing
Croatian: • stezanje u prsima, otežano disanje
English: Doxorubicin
Croatian: Doksorubicin
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Croatian: Prema farmakokinetičkim podacima za monoterapiju docetakselom u dozi od 100 mg/m2 za bolesnike koji imaju povišene vrijednosti transaminaza (ALT i/ili AST) više od 1,5 puta od gornje granice normalnih vrijednosti (GGN) i alkalne fosfataze više od 2,5 puta od GGN, preporučena doza docetaksela je 75 mg/m2 (vidjeti dio 4.4. i 5.2).
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Druge primarne zloćudne bolesti (nepoznata učestalost) uključujući ne-Hodgkinov limfom su prijavljene kao povezane s docetakselom u slučajevima kada se on primjenjivao u kombinaciji s drugim antitumorskim lijekovima za koje je poznato da su povezani sa pojavom drugih primarnih zloćudnih bolesti.
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Croatian: Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + 5-FU * Coxov model (prilagodba prema primarnom tumorskom mjestu, T i N kliničkom stupnju te PSWHO)
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Croatian: Način primjene Za upute o pripremi i primjeni lijeka, vidjeti dio 6.6.
English: Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Croatian: Ukupni medijan preživljenja također je bio značajno dulji u TPF skupini u odnosu na PF skupinu (medijan OS: 18,6 prema 14,5 mjeseci) s rizikom smanjenja smrtnosti od 28%, p=0,0128.
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Croatian: Preživljenje bez znakova bolesti (DFS) bio je primarni ishod djelotvornosti, a ukupno preživljenje (OS) sekundarni ishod djelotvornosti.
English: 1-year Survival (%)
Croatian: jednogodišnje preživljenje (%)
English: Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Croatian: Bolesnici s operabilnim karcinomom dojke i negativnim limfnim čvorovima prikladni za primanje kemoterapije (GEICAM 9805)
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Croatian: • 332 bolesnika koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Croatian: Na kraju kemoterapije, s minimalnim intervalom od 4 tjedna i maksimalnim intervalom od 7 tjedana, bolesnici čija bolest nije napredovala liječeni su radioterapijom (RT) u skladu sa smjernicama ustanove u kojoj su liječeni kroz 7 tjedana (PF/RT).
English: • Mix the infusion bag or bottle manually using a rocking motion.
Croatian: • Promiješajte sadržaj infuzijske vrećice ili boce ručno, polukružnim (ljuljajućim) pokretima.
English: It should be used within 6 hours (including the one hour infusion intravenous administration).
Croatian: Infuzijska otopina treba se upotrijebiti unutar 6 sati (uključujući u to i jednosatnu intravensku infuziju bolesniku).
English: • heart failure
Croatian: • zatajenje srca
English: • 1,276 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: Cardiac failure; Arrhythmia (no severe)
Croatian: Srčani poremećaji zatajivanje srca, aritmija (ne teška)
English: • 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Croatian: • 1312 bolesnika koji su primali 100 mg/m2 i 121 bolesnika koji su primali 75 mg/m2 docetaksela kao monoterapiju,
English: 61352 Bad Homburg v.d.Höhe Germany
Croatian: 61352 Bad Homburg v.d.Höhe Njemačka
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Croatian: Razlika u liječenju: 6,2% [95% CI: 0,2; 12,3]