natgillin/translations-raw huggingface dataset:
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival 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
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin . 
In vitro ispitivanja pokazala su da metabolizam docetaksela može promijeniti istodobna primjena tvari koji induciraju, inhibiraju ili se metaboliziraju (i tako kompetitivno mogu inhibirati enzim) pomoću citokroma P450-3A, kao što su ciklosporin, ketokonazol i eritromicin.
Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen 
95% CI p-vrijednost * Stratificirani log- rank test * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
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 istovremenu primjenu docetaksela sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, klaritromicinom, indinavirom, nefazodonom, nelfinavirom,. ritonavirom, sakvinavirom, telitromicinom i vorikonazolom) (vidjeti dio 4.5).
At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%). 
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 96 mjeseci), alopecija je i dalje bila prisutna u 29 bolesnika u TAC skupini (3,9%) i 16 bolesnika u FAC skupini (2,2 %).
Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients. 
Mijelodisplastični sindrom zabilježen je u 2 od 744 bolesnika u TAC skupini te u 1 od 736 bolesnika u FAC skupini.
If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion. 
Ako se otopina ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika, a ne bi smjeli biti duži od 6 sati pri temperaturi ispod 25oC, uključujući u to i jednosatnu infuziju.
Docetaxel Mylan contains ethanol 
Docetaxel Mylan sadrži etanol
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported. 
Rijetko su zabilježeni pojava dehidracije kao posljedica gastrointestinalnih poremećaja, gastrointestinalna perforacija, ishemični kolitis, kolitis i neutropenijski enterokolitis.
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.
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor a 
TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti;
From a microbiological point of view, dilution must take place in controlled and aseptic conditions. 
S mikrobiološkog stajališta, priprema za primjenu/razrjeđivanje se mora odvijati u kontroliranim i aseptičkim uvjetima.
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively. 
Srednje vrijednosti ukupnog klirensa i volumena distribucije u stanju dinamičke ravnoteže bile su 21 l/h/m2, odnosno 113 l.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients. 
Nakon 10 godina praćenja u studiji TAX 316, akutna leukemija zabilježena je u 4 od 744 bolesnika u TAC skupini te u 1 od 736 bolesnika u FAC skupini.
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed: 
Podskupine bolesnika koji su liječeni TAC-om analizirane su prema prospektivno definiranim glavnim prognostičkim čimbenicima.
The other ingredients are polysorbate 80, ethanol anhydrous and citric acid. 
Drugi sastojci su polisorbat 80, etanol, bezvodni i citratna kiselina.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3. 
Bolesnici ne bi smjeli primiti sljedeći ciklus docetaksela dok se broj neutrofila ne vrati na razinu od > 1500 stanica/mm3, a broj trombocita na > 100.000 stanica/mm3.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle. 
Na temelju doze potrebne za bolesnika izražene u mg, iz odgovarajućeg broja bočica aseptički izvucite odgovarajući volumen koncentrata za otopinu koja sadržava 20 mg/ml docetaksela, rabeći kalibrirane štrcaljke s pričvršćenom iglom od 21G.
This is because Docetaxel Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect. 
Naime, može se dogoditi da u tom slučaju Docetaxel Mylan ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
Docetaxel Mylan is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Mylan solutions. 
Docetaxel Mylan je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora njime oprezno rukovati u pripremi otopina Docetaxel Mylan.
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/m 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.
Magyarország Mylan Kft Tel: 36 1 8026993 
Magyarország Tel: 36 1 8026993
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy. 
Za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke preporučena doza docetaksela u monoterapiji iznosi 100 mg/m2.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC. 
Manje su se davali morfinski analgetici (p<0,01), nemorfinski analgetici (p<0,01), ostali lijekovi povezani s bolesti (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom 75 mg/m2 nego onima iz skupine BSC.
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 studiji 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.
If you are a man being treated with Docetaxel Mylan 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 Docetaxel Mylan 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.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m². 
Ako se nakon toga pojave epizode komplicirane neutropenije, dozu docetaksela trebalo bi smanjiti sa 60 na 45 mg/m2.
The recommended dose of docetaxel is 75 mg/m². 
Preporučena doza docetaksela iznosi 75 mg/m2.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i etiketi bočice iza 'Rok valjanosti/Valjanost'.
For storage conditions after dilution of the medicinal product, see section 6.3. 
Za uvjete čuvanja razrijeđenog lijeka vidjeti dio 6.3.
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years). 
(521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
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.
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC. 
* omjer hazarda (TAC/FAC) manji od 1 prikazuje da je TAC povezan sa dužim preživljenjem bez znakova bolesti u usporedbi sa FAC-om.
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m². 
U slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316). 
Od 84 bolesnika s perifernom senzornom neuropatijom na kraju kemoterapije, u 10 bolesnika periferna senzorna neuropatija bila je i dalje prisutna tijekom praćenja nakon kemoterapije u kliničkoj studiji karcinoma dojke s pozitivnim limfnim čvorovima (TAX 316).
You must not breast-feed while you are treated with Docetaxel Mylan. 
Ne smijete dojiti tijekom liječenja lijekom Docetaxel Mylan.
Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805) 
Bolesnici s operabilnim karcinomom dojke i negativnim limfnim čvorovima prikladni za primanje kemoterapije (GEICAM 9805)
Grade1 (includes grade not assessed) 
Histološki gradus Gradus 1 (uključujući neodređeni gradus) Gradus 2
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 studiji koja je uključivala bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starijih, a 4 ih je bilo u dobi od 75 godina ili starijih.
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 Docetaxel Mylan, the concentration of docetaxel is 20 mg/ml. 
U bočici Docetaxel Mylan, koncentracija docetaksela iznosi 20 mg/ml.
Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3. 
Općenito Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm3.
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m². 
• 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
Box of 1 vial, or 5 vials. 
Jedna kutija sadržava 1 bočicu ili 5 bočica.
The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents. 
Težina nuspojava lijeka Docetaxel Mylan može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
Age category 2 <35 years ≥35 years 
Dobna skupina 1 <50 godina ≥50 godina Dobna skupina 2 <35 godina ≥35 godina Status hormonskih receptora
Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added to the infusion solution. 
Docetaxel Mylan koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku vrećicu.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m². 
Ako se unatoč primjeni G-CSF pojave epizode febrilne neutropenije, produljene neutropenije ili neutropenijske infekcije, dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
• For patients developing the first appearance of a 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.
5 vials of 1 ml 
5 bočica od 1 ml
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months). 
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous and citric acid. 
Pomoćne tvari: polisorbat 80, etanol bezvodni i citratna kiselina.
As with all parenteral products, Docetaxel Mylan concentrate for solution or diluted solution for infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
Kao što je slučaj sa svim parenteralnim pripravcima, Docetaxel Mylan koncentrat za otopinu ili razrijeđenu otopinu za infuziju treba vizualno provjeriti prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
• Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles. 
• Mitoksantron 12 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
See also section “Docetaxel Mylan contains ethanol” below. 
Također pogledajte ispod dio " Docetaxel Mylan sadrži etanol (alkohol)".
Once added as recommended into the non-PVC infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. 
Nakon dodavanja u ne-PVC infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna je 6 sati pri temperaturi do 25°C.
• From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. 
• S mikrobiološkog stanovišta, rekonstitucija/razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a infuzijsku otopinu treba primijeniti odmah.
Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4: 
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
- 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, docetaxel se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
• Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. 
• Nakon dodavanja u infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna je 6 sati pri temperaturi do 25ºC.
In GEICAM 9805 study, amenorrhoea persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. 
U GEICAM 9805 studiji, amenoreja je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: 
Docetaxel Mylan u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe. 
• Rabeći kalibriranu štrcaljku s aseptički uvucite potrebnu količinu koncentrata za otopinu za infuziju.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. 
Infuzijska otopina docetaksela je prezasićena, stoga tijekom vremena može doći do kristalizacije.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution for infusion. 
Primjerice, za dozu od 140 mg docetaksela bit će potrebno 7 ml docetaksela u obliku koncentrata za otopinu za infuziju..
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m² to 75 mg/m² and/or from 75 to 60 mg/m². 
Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m2 na 75 mg/m2 i/ili sa 75 mg/m2 na 60 mg/m2.
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). 
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).
Docetaxel Mylan 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 Mylan u kombinaciji sa cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm. 
U studiji TAX 316, periferni edem je i dalje bio prisutan u 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
One large randomized 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).
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m² on day 1) in combination with cisplatin (C) (75 mg/m² on day 1) and 5-fluorouracil (F) (750 mg/m² per day for 5 days) or cisplatin (100 mg/m² on day 1) and 5-fluorouracil (1000 mg/m² per day for 5 days). 
Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan) u kombinaciji sa cisplatinom (C) (75 mg/m2 prvi dan) i 5-fluorouracilom (F) (750 mg/m2 dnevno kroz 5 dana) ili cisplatinom (100 mg/m2 prvi dan) i 5-fluorouracilom (1000 mg/m2 dnevno kroz 5 dana).
In first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²). 
U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m u kombinaciji s doksorubicinom (50 mg/m
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study. 
Sigurnost i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranoj multicentričnoj studiji faze III.
Asthenia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. 
Astenija je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 12 bolesnika (2,3%) u TAC skupini i u 4 bolesnika (0,8%) u FAC skupini.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
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/m
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mg/10 ml