natgillin/translations-raw huggingface dataset:
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other diseaserelated medications (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), ne morfinski analgetici (p<0,01), ostali lijekovi povezani s bolesti (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol). 
Jedna bočica koncentrata sadrži 25,1%-tni (m/m) bezvodni etanol (723 mg bezvodnog etanola).
Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor. 
Docetaksel Teva NE smije primati ako ste trudni, osim ako to liječnik nije izričito propisao.
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). 
Poremećaji krvi i limfnog sustava 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).
Mix the infusion bag or bottle manually using a rocking motion. 
Promiješajte sadržaj infuzijske vrećice ili bočice polukružnim (ljuljajućim) pokretima.
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 je randomizirano kako bi primili ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
Treatment difference: 5.4% [95% CI: -1.1; 12.0] 
[95% CI: -1,1; 12,0]
See also section ”Docetaxel Teva contains ethanol (alcohol)” below. 
Pogledajte također dio „Docetaksel Teva sadrži etanol (alkohol)“
See also section “Docetaxel Teva contains ethanol (alcohol)” below. 
Pogledajte također dio "Docetaksel Teva sadrži etanol (alkohol)"
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis. 
U bolesnika liječenih docetakselom u kombinaciji s doksorubicinom i ciklofosfamidom (TAC), febrilna neutropenija i/ili neutropenijska infekcija rijeđe su zabilježene ako su bolesnici dobivali primarnu G-CSF profilaksu.
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol). 
Jedna bočica koncentrata sadrži 25,1 %-tni (m/m) bezvodni etanol (181 mg bezvodnog etanola).
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated. 
Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST > 1,5 x GGN te alkalnom fosfatazom > 2,5 x GGN i bilirubinom > 1 x GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
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 u TAC skupini bolesnika značajno poduljenje preživljenja bez znakova bolesti u usporedbi s bolesnicima iz FAC skupine.
This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume". 
Ovaj volumen punjenja utvrđen je tijekom razvoja docetaksela kako bi se nadoknadio gubitak tekućine kod pripreme otopine koncentrata zbog pjenjenja, adhezije na stijenku bočice i neiskoristivog volumena koji zaostaje u bočici.
5-fluorouracil (clinically important treatment related adverse events are presented). 
(prikazani su klinički značajni štetni događaji povezani s liječenjem),
Diarrhoea grade 4 
Stomatitis/mukozitis stupnja 4
Docetaxel Teva 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. 
Docetaksel Teva 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.
Docetaxel + Cis+5-FU n=177 
Docetaksel + Cis + 5-FU n = 177
(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 koji mogu biti fatalni, febrilne neutropenije, infekcije,
First episode: reduce docetaxel and 5-FU doses by 20%. 
Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 %
• one vial of 1.28 ml solvent (water for injections). 
• jednu bočicu s 1,28 ml otapala (voda za injekcije).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm). 
Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (TAC skupina) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
This is because Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect. 
Teva ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
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 pneumonija/pneumonitisa, intersticijska bolesti plućna, plućne fibroze i zatajenja disanja, koji su ponekad imali smrtni ishod.
b) Preparation of the infusion solution 
b) Priprema otopine za infuziju
• Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). 
• Jedna bočica otapala sadrži 1,28 ml vode za injekcije (volumen punjenja: 1,71 ml).
[chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value 
[kemoterapija +/- radioterapija] (%) (95% CI) ***p- vrijednost
A hazard ratio of less than 1 favours docetaxel + 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 
**Neprilagođeni log-rang test, nije prilagođen višestrukim usporedbama *** Hi-kvadrat test, nije prilagođen višestrukim usporedbama
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia. 
Rijetko: epizode krvarenja povezane s trombocitopenijom stupnja 3/4.
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills. 
Najčešće zabilježeni simptomi bili su crvenilo praćeno osjećajem vrućine, osip sa/bez svrbeža, stezanje u prsištu, bol u leđima, dispneja, vrućica ili zimica.
Each ml of concentrate contains 27.73 mg docetaxel. 
Jedan ml koncentrata sadrži 27,73 mg docetaksela.
Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%) 
dispneja (G3/4: 1%); kašalj (G3/4: <1%); epistaksa (G3/4: <1%)
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 anemia (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 (LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4). 
CYP3A4 inhibitora (npr. ketokonazola, itrakonzola, klaritromicina, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola), nužan je poman klinički nadzor, a može biti potrebna i prilagodba doze docetaksela za vrijeme terapije snažnim inhibitorom CYP3A4
Inject the required premix volume into a non-PVC 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Ubrizgajte potrebni volumen pripremljene otopine koncentrata u ne-PVC infuzijsku vrećicu od 250 ml, koja sadrži 5 %-tnu otopinu glukoze ili 0,9 %-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
Docetaxel +Cis+5-FU n=255 
Docetaksel + Cis + 5-FU n = 255
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study. 
Karcinom prostate 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.
• one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent. 
• jednu prozirnu staklenu bočicu od 15 ml s "flip-off" zatvaračem koja sadržava 5,12 ml otapala.
The Docetaxel Teva infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions. 
Docetaksel Teva infuzijska otopina mora se upotrijebiti unutar 4 sata nakon priprave i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
• one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent. 
• jednu prozirnu staklenu bočicu od 6 ml s "flip-off" zatvaračem koja sadržava 1,28 ml otapala.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 80 mg/2,88 ml
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 BID) 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 na dan), pri čemu premedikaciju treba početi jedan dan prije primjene docetaksela, ako to nije kontraindicirano (vidjeti dio 4.4).
4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
4.2.2 Ubrizgajte potrebni volumen pripremljene otopine koncentrata u ne-PVC infuzijsku vrećicu od 250 ml, koja sadrži 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
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
Single-use vials. 
Bočice za jednokratnu uporabu.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia. 
Najčešće prijavljene nuspojave samog docetaksela su: neutropenija (koja je bila reverzibilna i nije bila kumulativna; medijan javljanja najnižih vrijednosti je bio 7 dana, a medijan trajanja teške neutropenije
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days. 
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 nakon čega je slijedio cisplatin (P) 75 mg/m2 te 5-fluorouracil (F) 750 mg/m2 na dan u obliku kontinuirane infuzije tijekom 5 dana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg/0.72 ml 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 20 mg/0,72 ml
Grade 3 
Proljev stupnja 3
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents. 
Težina nuspojava Docetaksel Teva može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml). 
Bočica s otapalom sadržava 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis) 
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN
4.2.4 The Docetaxel Teva infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions. 
4.2.4 Docetaksel Teva infuzijska otopina mora se upotrijebiti unutar 4 sata nakon pripreme i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
Kao što je slučaj sa svim parenteralnim pripravcima, pripremljena otopina koncentrata i otopina za infuziju Docetaksel Teva moraju biti vizualno provjerene prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
- For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil. 
- Za liječenje uznapredovalog karcinoma želuca Docetaksel Teva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%) 
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
2.1 Docetaxel Teva 20 mg/0.72 ml vial: 
2.1 Docetaksel Teva 20 mg/0,72 ml bočica:
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days. 
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m2 nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m2 na dan tijekom 5 dana.
Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). 
Bočica s otapalom sadržava 1,28 ml vode za injekcije (volumen punjenja 1,71 ml).
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.72 ml per vial. 
Ovo punjenje u suvišku osigurava da, nakon razrjeđivanja s cjelokupnim sadržajem priloženog otapala za docetaksel, minimalni iskoristivi volumen pripremljene otopine koncentrata od 2 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 20 mg/0,72 ml po bočici.
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 studiji TAX 316, alopecija koja je i dalje bila prisutna tijekom 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.
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 (11.7%). 
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
Hepatic impairment 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 jetrene funkcije (ALT, AST ≥ 1,5 puta od GGN te alkalna fosfataza ≥ 2,5 puta od GGN),
Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. 
Docetaksel Teva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
Name and address of the manufacturer(s) responsible for batch release 
Naziv i adrese proizvođača odgovornih za puštanje serije lijeka u promet
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5. 
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m2 kao 30-minutnu do trosatnu intravensku infuziju na dan 1, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m2 na dan od dana 1 do dana 5.
Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4: 
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml) 
Priprema za primjenu u venu a) Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml) 
Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01). 
U bolesnika liječenih u TAC skupini, rizik povrata bolesti smanjio se za 32% u odnosu na bolesnike u FAC skupini (omjer rizika = 0,68, 95% CI (0,49-0,93), p = 0,01).
Data from a multi-centre open-label randomised trial support the use of Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy. 
Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu Docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
Combination therapy 
Kombinirana terapija Doksorubicin
What the solvent vial contains: 
Što bočica s otapalom sadrži:
Tabulated list of 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 - 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
1.28 ml (Fill: 1.71 ml) 
voda za injekcije 1,28 ml (Punjenje: 1,71 ml)
At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16.5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646). 
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).
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2.88 ml per vial. 
Ovo punjenje u suvišku osigurava da, nakon razrjeđivanja s cjelokupnim sadržajem priloženog otapala, minimalni iskoristivi volumen pripremljene otopine koncentrata od 8 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 80 mg po bočici.
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4%) in TAC arm and 5 patients (1.0%) 
U ispitivanju GEICAM 9805 amenoreja koja je počela tijekom perioda liječenja i bila prisutna u periodu praćenja zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics). 
Najčešće nuspojave (≥ 5%) povezane s kombiniranim liječenjem s kapecitabinom zabilježene su u ispitivanju faze III u bolesnika s karcinomom dojke nakon neuspješnog liječenja antraciklinima
Diarrhoea grade 3 
Stomatitis/mukozitis stupnja 3
Treatment difference: 6.2% [95% CI: 0.2; 12.3] 
[95% CI: 0,2; 12,3]
Hypertension; Haemorrhage 
disgeuzija; hipoestezija
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
Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills 
Opći poremećaji i reakcije na mjestu primjene astenija; periferni edem; pireksija; umor; upala sluznice; bol; bolest slična gripi; bol u prsnom košu;
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
Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%); 
Poremećaji probavnog sustava proljev (G 3/4: 19,7%); mučnina (G 3/4: 16%);