natgillin/translations-raw huggingface dataset:
30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis). 
(TCis), ili docetaksel 75 mg/m u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m 2 primijenjen tijekom 6 do 10 minuta na 1., 8., 15. i 22. dan, nakon čega je slijedilo davanje cisplatine 100 mg/m 2 na 1. dan ciklusa koji se ponavljao svaka 4 tjedna (VCis).
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath) 
• plućna fibroza (ožiljci i zadebljanja na plućima, praćeni nedostatkom zraka)
G3/4 Blood bilirubin increased (<2%) 
G3/4 povećanje bilirubina u krvi (< 2%)
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/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 primjene i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranojm multicentričnom ispitivanju faze III.
50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 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).). 
1060 bolesnika randomizirano je u skupine koje su primale ili Taxespira 75 mg/m2 primijenjenu jedan sat nakon doksorubicina 50 mg/m ciklofosfamida 500 mg/m 2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg/m2 (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).
Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure. 
skupini i 4 bolesnika u FAC skupini preminula su zbog zatajenja srca.
Dyspnoea (severe: 
disgeuzija (teška:
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours. 
Antitumorska aktivnost docetaksela je in vivo neovisna o rasporedu doziranja te ima širok spektar eksperimentalne antitumorske aktivnosti na uznapredovale tumore u mišjih i ljudskih tumorskih presadaka.
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions. 
S mikrobiološkog stajališta, priprema za primjenu/razrjeđivanje se mora provesti u kontroliranim i aseptčkim uvjetima.
Weight decreased; G3/4 Blood bilirubin increased 
Pretrage gubitak tjelesne težine; G3/4 povećanje bilirubina u krvi
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. 
Docetaksel se pokazao citotoksičnim in vitro prema raznim linijama mišjih i ljudskih tumorskih Stanica te prema svježe izdvojenim ljudskim tumorskim stanicama u klonogenim ispitivanjima.
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). 
• 1276 bolesnika (744 u TAX 316 i 532 u GEICAM 9805 ispitivanju) koji su primali docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm 
Bolesnicima koji početnu dozu docetaksela od 75 mg/m2 primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25 000 stanica/mm
Use immediately the medicine once added into the infusion bag. 
Nakon dodavanja lijeka u infuzijsku vrećicu, odmah ga primijenite.
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 kako je preporučeno, otopina docetaksela za infuziju stabilna je 6 sati ako se čuva na temperaturi ispod 25°C.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies. 
Farmakokinetička svojstva docetaksela ispitivala su se u kliničkim ispitivanjima faze I u bolesnika s karcinomom nakon primjene 20 - 115 mg/m2.
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/m 2) (AT skupina) naspram kombinacije doksorubicina (60 mg/m 2) i ciklofosfamida (600 mg/m 2) (AC skupina).
In addition, physical and chemical in-use stability of the infusion solution prepared with sodium chloride 9 mg/ml (0.9%) or 5% glucose infused solution in non-PVC bags or with 5% glucose in glass bottles has been demonstrated for up to 48 hours when stored between 2°C to 8°C and for up to 
Osim toga, kemijska i fizikalna stabilnost infuzijske otopine pripremljene s 0,9% -tnom otopinom natrijevog klorida (9 mg/ml) ili 5%-tnom otopinom glukoze za infuziju u ne-PVC vrećici ili 5%-tnom otopinom glukoze u staklenoj boci dokazana je tijekom najviše 48 sati kada se čuva na temperaturi od 2°C do 8°C i tijekom najviše 6 sati kada se čuva na temperaturi ispod 25°C.
Patients with operable node-positive breast cancer (TAX 316) Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥80%, between 18 and 70 years of age. 
Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
Taxespira in combination with trastuzumab 
Taxespira u kombinaciji s trastuzumabom
Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8). 
Bolesnici koji primaju TCF moraju biti pod stalnim nadzorom (vidjeti dijelove 4.2 i 4.8).
• For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. 
• Za liječenje uznapredovalog karcinoma dojke, Taxespira se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
Hypotension; Hypertension; Haemorrhage 
Krvožilni poremećaji hipotenzija; hipertenzija; krvarenje
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 (Intent-to-Treat analiza)
As the benefit observed in patients with 4 + nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4 + nodes was not fully demonstrated at the final analysis. 
S obzirom na to da korist liječenja uočena u bolesnika s 4 i više pozitivnih limfnih čvorova nije bila statistički značajna u pogledu DFS i OS, pozitivan omjer rizika i koristi TAC liječenja u bolesnika s 4 i više pozitivnih limfnih čvorova nije potpuno dokazan u konačnoj analizi rezultata studije.
The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents. 
Težina nuspojava lijeka Taxespira može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF. 
U bolesnika liječenih docetakselom u kombinaciji s cisplatinom i 5-fluorouracilom (TCF), febrilna neutropenija i neutropenijska infekcija javljale su se s manjom učestalošću kad su bolesnici profilaktički primali G-CSF.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. 
• Docetaksel 30 mg/m2 primijenjen tjedno prvih 5 tjedana u ciklusu liječenja od 6 tjedana,
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 prsima, bol u leđima, dispneja, vrućica ili zimica.
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 (Intent-to-treat analiza)
As with all parenteral products, docetaxel 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 docetaksela za infuziju mora se vizualno provjeriti prije primjene, a otopine koje sadrže precipitat trebaju se baciti.
In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m 
U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m 2 u kombinaciji s doksorubicinom (50 mg/m
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/m 2 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/m ciklofosfamida 500 mg/m 2 svaka 3 tjedna tijekom 6 ciklusa (TAC protokol; vidjeti također 'Prilagodba doze tijekom liječenja').
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). 
• 300 bolesnika s adenokarcinomom želuca (221 bolesnik u ispitivanju faze III i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
Mix the infusion bag or bottle manually using a rocking motion. 
Promiješajte sadržaj infuzijske vrećice ili boce polukružnim (ljuljajućim) pokretima.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%). 
Nakon 10 godina praćenja u ispitivanju TAX 316, akutna leukemija zabilježena je u 3 od 744 bolesnika (0,4%) u TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two arms. 
U ovom je ispitivanju, u dvije skupine bio randomiziran 501 bolesnik s lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1.
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2. 
slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide. 
• Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, Taxespira se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
Taxespira in combination with doxorubicin 
Taxespira u kombinaciji s doksorubicinom
Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Taxespira koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje s otapalom te se može odmah dodati u infuzijsku vrećicu.
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis) 
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
• pain in the joints or muscles 
• osjećaj utrnulosti ili bockanja ili bol u zglobovima i mišićima
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%) 
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
(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). 
5 dana) ili cisplatinom (100 mg/m2 prvi dan) i 5-fluorouracilom (1000 mg/m2 dnevno kroz 5 dana).
General Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm 
Općenito Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm
A multicenter, open-label, randomized 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. 
Provedeno je multicentrično, randomizirano ispitivanje otvorenog tipa kako bi se procijenile sigurnost i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: 
Taxespira u kombinaciji s doksorubicinom i ciklofosfamidom indicirana je za adjuvantno liječenje bolesnika s:
Pfizer AS Tlf: +47 67 52 61 00 
Tlf: +47 67 52 61 00
• 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent 
• 1312 bolesnika koji su primali 100 mg/m2 i 121 bolesnika koji su primali 75 mg/m docetaksela kao monoterapiju,
At the median follow-up time of 77 months, 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 dulje 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).
First episode: reduce docetaxel and 5-FU doses by 20%. 
Prva epizoda: smanjiti doze docetaksela i 5-FU za 20%.
Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial. 
Bočice koje sadrže 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml i 160 mg/8 ml dostupne su u pakiranjima koja sadrže jednu bočicu.
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics. 
U ispitivanjima TAX 323 i TAX 324, svi bolesnici u skupinama koje su primile docetaksel, profilaktički su primali i antibiotike.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient. 
Pripremljena infuzijska otopina mora se upotrijebiti unutar 6 sati nakon priprave, uključujući u to vrijeme i primjenu bolesniku jednosatnom intravenskom infuzijom, uz čuvanje na temperaturi ispod 25°C.
20mg/1 ml contains 1 ml of concentrate. 
20 mg/1 ml sadrži 1 ml koncentrata.
A total of 449 patients were randomized 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/m u trosatnoj infuziji.
• If you have any further questions, ask your doctor, hospital pharmacist or nurse. 
- Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
Pfizer, spol. 
Pfizer Kft.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported. 
Rijetko je zabilježena pojava suzenja s/bez konjunktivitisa, poput slučajeva opstrukcije suznog kanala što rezultira prekomjernim suzenjem.
From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately. 
• S mikrobiološkog stajališta, rekonstitucija/razrjeđivanje se mora provesti u kontroliranim i aseptičkim uvjetima i otopina za infuziju se mora odmah primijeniti.
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 se njime, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora oprezno rukovati u pripremi otopine.
160mg/8 ml contains 8 ml of concentrate. 
160 mg/8 ml sadrži 8 ml koncentrata.
• 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 randomized, multicenter 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).
Taxespira 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. 
Taxespira u kombinaciji s cisplatinom i 5-fluorouracilom indicirana je za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
Data from one multicenter, 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 jednog multicentričnog, randomiziranog, kontroliranog, kliničkog ispitivanja 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.
Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia 
trombocitopenija (G3/4: 0,6%); febrilna neutropenija
Each vial is of single use and should be used immediately. 
Bočice su za jednokratnu primjenu i moraju se odmah primijeniti.
140mg/7 ml contains 7 ml of concentrate. 
140 mg/7 ml sadrži 7 ml koncentrata.
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8). 
Bolesnici koji primaju TAC moraju biti pod stalnim nadzorom (vidjeti dijelove 4.2 i 4.8).
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 (vidjeti sažetak opisa svojstava lijeka za kapecitabin).
Lacrimation increased; Conjunctivitis 
Poremećaji oka pojačano suzenje; konjunktivitis
50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm). 
50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
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/m svaka 3 tjedna).
Myocardial ischemia (G3/4:1.7%) 
Srčani poremećaji ishemija miokarda (G3/4:1,7%)
• For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil. 
• Za liječenje uznapredovalog karcinoma želuca Taxespira se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
• 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, randomized 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 multicentričnog, randomiziranog ispitivanja otvorenog tipa (TAX323).
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent. 
Bolesnici u TPF skupini primali su antibiotsku profilaksu ciprofloksacinom 500 mg oralno dva puta dnevno tijekom 10 dana koju su počeli uzimati na peti dan svakog ciklusa, ili ekvivalentnim antibiotikom.
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 2 (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 dijelove 4.4. i 5.2).
If Taxespira concentrate should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Ako Taxespira koncentrat dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent. 
Bolesnici u TAC skupini primali su antibiotsku profilaksu s ciprofloksacinom 500 mg peroralno dvaput dnevno u trajanju od 10 dana, počevši od petog dana svakog ciklusa, ili ekvivalentni antibiotik.