natgillin/translations-raw huggingface dataset:
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9,805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). 
• 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),
- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide. 
- Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, docetaksel se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (Intent-to-treat analysis) 
Analiza podskupina - adjuvantno liječenje bolesnika s karcinomom dojke s negativnim limfnim čvorovima (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat])
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju NE ZAHTIJEVA prethodno razrjeđivanje s otapalom i spreman je za dodavanje infuzijskoj otopini.
Docetaxel Accord 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. 
Docetaxel Accord u kombinaciji sa cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. 
Docetaksel je antineoplastična tvar te je s njime, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, potreban je oprez prilikom rukovanja i pripreme otopina koje ga sadrže.
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma 
Djelotvornost docetaksela u liječenju bolesnika s adenokarcinomom želuca Ishod
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid anhydrous. 
- Pomoćne tvari su polisorbat 80, etanol bezvodni (vidjeti dio 2) i citratna kiselina, bezvodna.
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin) -containing chemotherapy. 
U bolesnika koji su primali docetaksel u kombinaciji s trastuzumabom, posebice nakon kemoterapije koja je sadržavala antracikline (doksorubicin ili epirubicin), zabilježeno je zatajenje srca.
Patients with hepatic impairment 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). 
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).
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). 
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).
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 a 1-week rest period. 
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 dva tjedna, nakon čega slijedi tjedan dana pauze.
The infusion solution must not be coupled to the infusion set for more than 6 h at 25°C. 
Infuzijska otopina ne smije biti priključena na infuzijski set više od 6 sati na temperaturi od 25C.
Both regimens were administered on day 1 every 3 weeks. 
Oba kemoterapijska protokola primjenjivala su se na dan 1 svaka tri tjedna.
95% CI p-value†* 
95% CI p- vrijednost † *
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents. 
Težina nuspojava docetaksela može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%. 
Prilagodba doze Proljev stupnja 3 Prva epizoda: smanjiti dozu 5-FU za 20%.
One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m2) in combination with docetaxel (75 mg/m2) (AT arm) versus doxorubicin (60 mg/m2) in combination with cyclophosphamide (600 mg/m2) (AC arm). 
U jednom velikom randomiziranom ispitivanju faze III u koje je bilo uključeno 429 ranije neliječenih bolesnika s metastatskom bolesti, primjenjivala se kombinacija doksorubicina (50 mg/m2) s docetakselom (75 mg/m2) (AT skupina) naspram kombinacije doksorubicina (60 mg/m2) i ciklofosfamida (600 mg/m2) (AC skupina).
If Docetaxel Accord concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. 
Ako Docetaxel Accord koncentrat ili infuzijska otopina dođu u dodir s kožom, to mjesto odmah temeljito isprati sapunom i vodom.
Asthenia (severe: 
konstipacija (teška:
Docetaxel Accord concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Docetaxel Accord koncentrat za otopinu za infuziju NE ZAHTIJEVA prethodno razrjeđivanje s otapalom i spreman je za dodavanje infuzijskoj otopini.
All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously. 
Sva tri kemoterapijska protokola primjenjivala su se u kombinaciji s prednizonom ili prednizolonom u dozi od 5 mg dva puta dnevno kontinuirano.
(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). 
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).
- For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone. 
- Za liječenje karcinoma prostate docetaksel se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported. 
Rijetko su zabilježeni akutni respiratorni distres sindrom, intersticijska pneumonija/pneumonitis, intersticijska bolest pluća, plućna fibroza te respiratorno zatajenje, u nekim slučajevima sa smrtnim ishodom.
Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen 
* prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
G3/4 AST increased G3/4 Blood alkaline phosphatase increased 
G3/4 AST povišen G3/4 povećanje alkalne fosfataze u krvi
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomised, multicentre open-label, phase III study (TAX324). 
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
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). 
U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka tri tjedna) i kapecitabinom (1250 mg/m2 dvaput dnevno tijekom dva tjedna nakon čega slijedi jedan tjedan pauze).
EXP: Shelf life in infusion bag: see the leaflet. 
Rok valjanosti lijeka u infuzijskoj vrećici: vidjeti uputu o lijeku.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m2 as a single agent. 
Za liječenje nakon neuspjeha prethodne kemoterapije temeljene na platini, preporučuje se doza od 75 mg/m2 u monoterapiji.
(ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia. 
U bolesnika koji su primali docetaksel u dozi od 100 mg/m2 kao jedinu terapiju te imali vrijednosti transaminaza (ALT i/ili AST) u serumu više od 1,5 puta veće od GGN, te serumsku alkalnu fosfatazu više od 2,5 puta veću od GGN, postoji viši rizik od razvoja teških nuspojava poput toksične smrti uključujući sepsu i gastrointestinalno krvarenje koje može biti fatalno, febrilne neutropenije, infekcije, trombocitopenije, stomatitisa i astenije.
Docetaxel in combination with trastuzumab 
Docetaksel u kombinaciji s trastuzumabom
Constipation (severe: 0.2%); Abdominal pain (severe: 1%); Gastrointestinal haemorrhage (severe: 0.3%) 
0,2%); abdominalna bol (teška: 1%); gastrointestinalno krvarenje (teško 0,3%)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 20 mg docetaksela.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m2 every 3 weeks). 
U bolesnika koji su neuspješno liječeni alkilirajućim agensima, docetaksel se uspoređivao s doksorubicinom (75 mg/m2 svaka tri tjedna).
A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion. 
Ukupno 449 bolesnika dobivalo je ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
Marketing Authorisation Holder Accord Healthcare S.L.U. 
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet Accord Healthcare S.L.U.
A multicentre, 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. 
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.
Docetaxel in combination with doxorubicin 
Docetaksel u kombinaciji s doksorubicinom
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomised study (TAX323). 
• Indukcijska kemoterapija praćena radioterapijom (TAX 323) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
Data from one multicentre, 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. 
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.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C. 
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.
Each box contains one vial of 8 ml concentrate. 
Jedno pakiranje sadrži po jednu bočicu s 8 ml koncentrata.
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-treat analysis) 
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s inoperabilnim lokalno uznapredovalim SCCHN (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat])
Very common (may affect more than 1 in 10 people): 
Vrlo često (javljaju se u više od 1 na 10 osoba):
You must not breast-feed while you are treated with docetaxel. 
Ne smijete dojiti tijekom liječenja docetakselom.
Description of selected adverse reactions for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer 
Opis odabranih nuspojava za adjuvantno liječenje za docetaksel 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel. 
Prijavljeni su slučajevi cistoidnog edema makule u bolesnika koji su liječeni docetakselom.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava prijavljivanja: navedenog u Dodatku V.
More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient. 
Ponekad je potrebno upotrijebiti više od jedne bočice Docetaxel Accorda koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus. 
(uključujući teški sindrom šaka/stopalo), ali i na rukama, licu ili grudnom košu, a često su bile povezane sa svrbežom.
Docetaxel Accord 20 mg/1 ml contains 
Docetaxel Accord 20 mg/1 ml sadrži
• Mix the infusion bag manually using a rocking motion. 
• Promiješajte sadržaj infuzijske vrećice ručno, polukružnim (ljuljajućim) pokretima.
Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%) 
anemija (G3/4: 9,4%); febrilna neutropenija; trombocitopenija (G4: 0,8%)
Docetaxel Accord 160 mg/8 ml contains 
Docetaxel Accord 160 mg/8 ml sadrži
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8ºC.
- For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin. 
- Za liječenje karcinoma pluća docetaksel se primjenjuje sam ili u kombinaciji s cisplatinom.
• Each vial is for single use and should be used immediately after opening. 
• Svaka bočica namijenjena je za jednokratnu primjenu te se treba primijeniti odmah nakon otvaranja.
Read the package leaflet before use Single use vial 
Prije uporabe pročitati uputu o lijeku Bočica za jednokratnu uporabu
Docetaxel Accord 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. 
Docetaxel Accord u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
Mix the infusion bag manually using a rocking motion. 
Promiješajte sadržaj infuzijske vrećice ručno polukružnim (ljuljajućim) pokretima.
Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy. 
U bolesnika koji se istodobno liječe radioterapijom prijavljeni su slučajevi radijacijskog pneumonitisa.
The concentrate is a clear pale yellow to brownish-yellow solution. 
Koncentrat je bistra svijetložuta do smeđežuta otopina.
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment). 
Za adjuvantno liječenje operabilnog karcinoma dojke s pozitivnim i negativnim limfnim čvorovima, preporučena doza docetaksela od 75 mg/m2 primjenjuje se 1 sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 svaka tri tjedna tijekom 6 ciklusa (TAC protokol; vidjeti također
- For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil. 
- Za liječenje metastatskog karcinoma želuca docetaksel se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
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 
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.
Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%) 
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
• 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. 
• Indukcijska kemoterapija nakon koje slijedi radioterapija (TAX 323) Za indukcijsko liječenje neoperabilnog, lokalno uznapredovalog karcinoma skvamoznih stanica glave i vrata (engl. squamous cell carcinoma of the head and neck, SCCHN) preporučena doza docetaksela iznosi 75 mg/m2 u obliku jednosatne infuzije, nakon čega slijedi jednosatna infuzija 75 mg/m2 cisplatina prvi dan.
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 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 
Tablični popis nuspojava za adjuvantno liječenje za docetaksel 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 MedDRA klasifikacija organskih sustava
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%). 
U ispitivanju TAX 316 alopecija koja je i dalje bila prisutna tijekom perioda praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika (92,3%) u TAC skupini i 645 od 736 bolesnika (87,6%) u FAC skupini.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4). 
Za karcinom prostate, uz terapiju prednizonom ili prednizolonom, preporučeni režim premedikacije sadržava oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i jedan sat prije infuzije docetaksela (vidjeti dio 4.4).
Docetaxel in combination with capecitabine 
Docetaksel u kombinaciji s kapecitabinom
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 (0.64-1.08), p=0.1646). 
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).
Use the medicine immediately after it is added into the infusion bag. 
Nakon dodavanja lijeka u infuzijsku vrećicu, odmah upotrijebite pripremljenu otopinu.
In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%). 
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. 
Docetaxel Accord u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4). 
Kod karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma želuca i karcinoma glave i vrata kao premedikacija primjenjuju se oralni kortikosteroidi poput deksametazona, u dozi od 16 mg/dan tijekom 3 dana (primjerice, 8 mg dvaput dnevno), pri čemu premedikaciju treba početi jedan dan prije primjene docetaksela, ako to nije kontraindicirano (vidjeti dio 4.4).