natgillin/translations-raw huggingface dataset:
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy. 
Randomizirano je 186 bolesnika koji su primali docetaksel (100 mg/m2) s trastuzumabom ili bez trastuzumaba; 60% bolesnika ranije je primalo adjuvantnu terapiju temeljenu na antraciklinima.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI) 
Medijan trajanja odgovora na kemoterapiju ± radioterapiju (mjeseci) (95% CI)
It should be used within 6 hours (including the one hour infusion intravenous administration). 
Mora se primijeniti unutar 6 sati (to uključuje i 1 sat primjene intravenske infuzije).
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known). 
Zabilježeni su rijetki slučajevi enterokolitisa, uključujući kolitis, ishemijski kolitis i neutropenijski enterokolitis s potencijalno smrtnim ishodom (nepoznata učestalost).
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69 % of patients who received TAC and 72% of patients who received FAC. 
Adjuvantno radioterapijsko liječenje provođeno je sukladno smjernicama ustanova u kojima je provođeno ispitivanje i provedeno je u 69% bolesnika koji su primili TAC i u 72% bolesnika koji su primili FAC.
In combination with cisplatin and 5-fluorouracil 
Kombinacija s cisplatinom i 5-fluoruracilom
The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5). 
Treba izbjegavati istodobnu primjenu docetaksela sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, klaritromicinom, indinavirom, nefazodonom, nelfinavirom, ritonavirom, sakvinavirom, telitromicinom i vorikonazolom) (vidjeti dio 4.5).
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated. 
Pri medijanu vremena praćenja od 77 mjeseci dokazano je značajno produljenje preživljenja bez znakova bolesti u TAC skupini u usporedbi sa bolesnicima iz FAC skupine.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4). 
Rjeđe su zabilježeni teški simptomi poput erupcija praćenih deskvamacijom što je rijetko dovelo do prekida ili prestanka liječenja docetakselom (vidjeti dijelove 4.2 i 4.4).
Disposal 
Eliminacija
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). 
Bez utjecaja na primarni ishod, ukupnu stopu odgovora (32% prema 25%, p=0,10), docetaksel je produljio medijan vremena do progresije bolesti (24,6 tjedana prema 15,6 tjedana; p<0,01) i medijan vremena preživljenja (15,3 mjeseca prema 12,7 mjeseci; p=0,03).
Pack size: 
Veličina pakiranja:
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years. 
U obje skupine, nakon posljednjeg ciklusa kemoterapije, bolesnici sa ER+ i/ili PgR+ tumorima, primali su tamoksifen 20 mg jednom dnevno u razdoblju do 5 godina.
Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3] 
Omjer hazarda: 1,122 [97.2% CI: 0.937; 1,342]* Razlika u liječenju: 5,4% [95% CI: -1,1; 12,0] Razlika u liječenju: 6.2% [95% CI: 0,2; 12,3]
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria). 
Vrlo često: Hematološka toksičnost bila je povećana u bolesnika koji su primali trastuzumab i docetaksel u usporedbi s bolesnicima koji su primali docetaksel u monoterapiji (32% neutropenija stupnja 3/4 u odnosu na 22%, prema kriterijima NCI-CTC).
There is no relevant use of Taxespira in the paediatric population for the indication of breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma. 
Nema relevantne primjene lijeka Taxespira u pedijatrijskoj populaciji za indikacije karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma prostate, karcinoma želuca i karcinoma glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III.
The most commonly reported adverse reactions of Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness. 
Najčešće prijavljivane nuspojave lijeka Taxespira kada se primjenjuje sam su: pad broja crvenih ili bijelih krvnih stanica, gubitak kose, mučnina, povraćanje, ranice u ustima, proljev i umor.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m 
Bolesnicima u kojih se pojavi stomatitis stupnja 3 ili 4 treba smanjiti dozu na 60 mg/m
Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions. 
Taxespira je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine Taxespira.
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805) 
Neutropenijske komplikacije u bolesnika koji su primali TAC terapiju s ili bez profilakse s G-CSF (GEICAM 9805)
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. 
Fizikalna i kemijska stabilnost infuzijske otopine, pripremljene kako je preporučeno, dokazana je tijekom najviše 48 sati u ne-PVC vrećicama uz čuvanje na temperaturi od 2°C do 8°C.
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). 
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).
If you are a man being treated with Taxespira you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility. 
Muškarcima koji primaju Taxespira savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon prestanka terapije te da potraže savjet o konzervaciji sperme prije liječenja, jer docetaksel može utjecati na plodnost muškarca.
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. 
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.
Docetaxel n = 94 
Docetaksel n = 94
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older. 
Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji sa cisplatinom i 5-fluoruracilom u ispitivanju koje je uključivalo bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starije, a 4 ih je bilo u dobi od 75 godina ili starije.
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 (e.g., day 6-15) in all subsequent cycles. 
U pivotalnim SCCHN ispitivanjima bolesnicima u kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti GCSF u svim sljedećim ciklusima (npr. od 6. do 15. dana), kako bi se osigurala profilaktička zaštita.
The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Potrebni volumen Taxespira koncentrata za otopinu za infuziju mora se injicirati jednokratnom injekcijom (jedno injiciranje) u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks). 
U bolesnika koji su neuspješno liječeni antraciklinima, docetaksel se uspoređivao s kombinacijom mitomicina C i vinblastina (12 mg/m svakih 6 tjedana i 6 mg/m svaka 3 tjedna).
OS at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002). 
Sveukupno preživljenje nakon 10 godina bilo je također značajno poboljšano u TAC skupini u usporedbi sa FAC skupinom (76% prema 69%), što znači da je apsolutni rizik od smrti smanjen za 7% (p=0,002).
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one. 
Docetaksel se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se u intravenskom bolusu na 1. dan.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10 % higher in patients who were 75 years of age or greater versus less than 65 years. 
Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3 % of patients who received TAC and 51.2 % of patients who received FAC. 
Adjuvantna radioterapija provedena je prema važećim smjernicama ustanova u kojima je provođeno ispitivanje u 57,3% bolesnika koji su primali TAC terapiju i 51,2% bolesnika koji su primali FAC terapiju.
Patients with liver impairment In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (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.
You must not breast-feed while you are treated with Taxespira. 
Ne smijete dojiti tijekom liječenja lijekom Taxespira.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA
Cardiac failure; Arrhythmia (no severe) 
Srčani poremećaji zatajivanje srca; aritmija (ne teška)
If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili bolničkom ljekarniku.
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. 
Vrlo rijetko pri primjeni docetaksela zabilježeni su kožni lupus eritematodes i bulozne erupcije poput multiformnog eritema, Stevens-Johnsonovog sindroma i toksične epidermalne nekrolize.
Dizziness; Headache (G3/4: <1%); Neuropathy peripheral 
omaglica; glavobolja (G3/4: <1%); periferna neuropatija
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2). 
Zabilježeni su teški simptomi kao što su erupcije praćene deskvamacijom koji su uzrokovali prekid ili prestanak terapije docetakselom (vidjeti dio 4.2).
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%. 
Stomatitis/mukozitis stupnja 3 Prva epizoda: smanjiti dozu 5-FU za 20%.
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). 
Ventrikularna aritmija, uključujući i ventrikularnu tahikardiju (ponekad smrtonosnu), prijavljena je u bolesnika liječenih docetakselom u kombiniranim režimima koji uključuju doksorubicin, 5-fluorouracil i/ili ciklofosfamid (vidjeti dio 4.8).
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis. 
Teške promjene na noktima karakterizirali su hipo- ili hiperpigmentacija ponekad praćene boli i oniholizom.
• Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle. 
• Potrebnu dozu (u mg) injicirajte jednokratnom injekcijom (jedno injiciranje) u infuzijsku ne-PVC vrećicu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju ili u staklenu bocu koja sadrži 5%-tnu otopinu glukoze.
Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805) 
Bolesnici s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladni za primanje kemoterapije (GEICAM 9805)
Distribution Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml. 
Nakon primjene doze od 100 mg/m2 putem jednosatne infuzije, dobivena je srednja vrijednost vršne razine lijeka u plazmi od 3,7 μg/ml s odgovarajućim AUC-om od 4,6 h μg/ml.
Docetaxel increased response rate (33% vs. 12%, p <0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged OS (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 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/m 
• Bolesnicima u kojih se drugi put pojavila toksičnost stupnja 2, ili u kojih se prvi put pojavila toksičnost stupnja 3, u bilo koje vrijeme liječenja, treba odgoditi terapiju sve dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti liječenje docetakselom 55 mg/m
For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion. 
Npr. za dozu od 140 mg docetaksela potrebno je 7 ml Taxespira 20 mg/1 ml koncentrata za otopinu za infuziju.
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. 
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 ispitivanje.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC 
* omjer hazarda manji od 1 ukazuje da je TAC povezan s duljim preživljenjem bez znakova bolesti i ukupnim preživljenjem u usporedbi s FAC-om
Taxespira 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. 
Taxespira u kombinaciji sa cisplatinom i 5-fluorouracilom indicirana je za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
General disorders and administration site conditions Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein. 
Reakcije na mjestu primjene infuzije općenito su bile blage i sastojale su se od hiperpigmentacije, upale, crvenila ili suhoće kože, flebitisa ili ekstravazacije te otoka vene.
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period. 
U ispitivanju GEICAM 9805, 3 bolesnika (0,6%) u TAC skupini i 3 bolesnika (0,6%) u FAC skupini razvilo je kongestivno zatajenje srca tijekom perioda praćenja.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORNI ZA PUŠTANJE SERIJE
If Taxespira concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. 
Ako Taxespira koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah treba dobro i temeljito isprati sapunom i vodom.
Median OS 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. 
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.
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). 
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).
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). 
U malog broja bolesnika (n=23), gdje su klinički biokemijski podaci pokazivali lagano ili srednje oštećenje jetre (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).
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately. 
S mikrobiološkog stajališta, rekonstitucija/otapanje mora se provesti u kontroliranim i aseptičkim uvjetima, a lijek se mora odmah primijeniti.
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 te slučajevi intersticijske pneumonije/pneumonitisa, intersticijske bolesti pluća, plućne fibroze i zatajenja disanja, koji su ponekad imali smrtni ishod.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended in non-PVC bags or bottles has been demonstrated up to 48 hours when stored between 2°C to 8°C, and for up to 6 hours when stored below 25°C. 
Osim toga, fizikalna i kemijska stabilnost infuzijske otopine, pripremljene kako je preporučeno, u ne-PVC vrećicama ili bocama dokazana je tijekom najviše 48 sati, uz čuvanje na temperaturi od 2°C do 8°C i tijekom najviše 6 sati uz čuvanje na temperaturi ispod 25°C.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm 3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m 2 to 75 mg/m 2 and/or from 75 to 
Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm 3 dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m 2 na 75 mg/m 2 i/ili sa 75 mg/m na 60 mg/m
Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer. 
Farmakokinetika docetaksela u prisutnosti prednizona ispitivala se u bolesnika s metastatskim karcinomom prostate.
Taxespira in combination with doxorubicin and cyclophosphamide: adjuvant therapy 
Taxespira u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje
• For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose. 
• Bolesnicima u kojih se prvi put pojavila toksičnost stupnja 2, a prisutna je i u vrijeme sljedećeg ciklusa liječenja kombinacijom docetaksel/kapecitabin, treba odgoditi sljedeći ciklus dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti sa 100% originalne doze.
At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm. 
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 10 godina i 5 mjeseci) nijedan bolesnik u TAC skupini nije imao CHF, 1 bolesnik u TAC skupini preminuo je zbog dilatacijske kardiomiopatije, a CHF je i dalje bio prisutan u 1 bolesnika (0,2%) u FAC skupini.
Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide. 
Ventrikularna aritmija, uključujući i ventrikularnu tahikardiju (nepoznate učestalosti), ponekad sa smrtnim ishodom, prijavljena je u bolesnika liječenih docetakselom u kombiniranim režimima koji uključuju doksorubicin, 5-fluorouracil i/ili ciklofosfamid.
As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
• Kao što je slučaj sa svim parenteralnim lijekovima, otopina za infuziju mora se vizualno provjeriti prije primjene, a otopine koje sadrže precipitat treba baciti.