natgillin/translations-raw huggingface dataset:
b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first. 
b Čas do raka prostate, odpornega proti kastraciji = čas od randomizacije do napredovanja PSA ali kliničnega napredovanja (tj. porast simptomov metastaz v kosteh, napredovanje po merilih RECIST (Response Evaluation Criteria in Solid Tumours) ali klinično poslabšanje zaradi raka po mnenju raziskovalca), kar od tega se pojavi prej.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data). 
Opredelitev pogostnosti je: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10); občasno (≥ 1/1.000 do< 1/100); redko (≥ 1/10.000 do < 1/1.000); zelo redko (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Cautions for use in hormone-sensitive prostate cancer 
Previdnost pri uporabi pri hormonsko občutljivem raku prostate
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2. 
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
Solvent vial: ethanol 95% (see leaflet for further information), water for injections. 
Viala vehikla: 95 % etanol (za dodatne informacije glejte navodilo za uporabo), voda za injekcije.
The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in AC arm. 
V kraku AT je bil celotni delež odziva 59,3 % (95 % IZ: 52,8-65,9) in v kraku AC 46,5 % (95 % IZ: 39,8
More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anaemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years. 
V skupini, ki je prejemala docetaksel, je o preobčutljivostni reakciji, nevtropeniji, anemiji, zadrževanju tekočine, dispneji in spremembi nohtov poročalo več bolnikov, starih ≥ 65 let, kot bolnikov, mlajših od 65 let.
4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml) 
4.1 Priprava osnovne raztopine zdravila TAXOTERA (10 mg docetaksela/ml)
G3/4 Blood bilirubin increased 
S3/4 zvišanje bilirubin v krvi
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone. 
O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samodocetaksel.
For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution. 
Primer: za odmerek 140 mg docetaksela bi potrebovali 14 ml osnovne raztopine docetaksela.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m in monotherapy. 
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m2.
Patients with severe liver impairment (see sections 4.2 and 4.4). 
Bolniki s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
Sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 996 
Deutschland sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 996
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle. 
Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine, ki vsebuje 10 mg docetaksela/ml, iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
• Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25°C). 
• Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25°C).
Solvent vial: 
Viala z vehiklom:
MedDRA system organ classes Very common adverse reactions 
Organski sistemi po MedDRA Zelo pogosti neželeni učinki
• one single-dose vial of concentrate, 
• eno vialo z enim odmerkom koncentrata
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia. 
Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
TAXOTERE in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. 
Zdravilo TAXOTERE je v kombinaciji z zdravljenjem z deprivacijo androgenov (ADT - androgendeprivation therapy) s prednizonom oz. prednizolonom ali brez njega, indicirano za zdravljenje bolnikov z metastatskim, hormonsko občutljivim rakom prostate.
- For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone. 
- Za zdravljenje raka prostate se zdravilo TAXOTERE lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
Of the 545 patients treated with docetaxel every 3 weeks in a hormone-sensitive prostate cancer study (STAMPEDE), 296 patients were 65 years of age or older, and 48 patients were 75 years of age or older. 
Od 545 bolnikov, ki so bili v študiji hormonsko občutljivega raka prostate (študija STAMPEDE) zdravljeni z docetakselom na 3 tedne, je bilo 296 bolnikov starih 65 let ali več in 48 bolnikov 75 let ali več.
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. 
Pri bolnikih, zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih  10 % večja v primerjavi z mlajšimi bolniki.
- For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin. 
- Za zdravljenje pljučnega raka se zdravilo TAXOTERE lahko uporablja sam ali v kombinaciji s cisplatinom.
Patients previously treated with chemotherapy with or without radiotherapy 
Nedrobnocelični pljučni rak Bolniki, predhodno zdravljeni s kemoterapijo z radioterapijo ali brez nje
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C). 
Vendar je osnovna raztopina dokazano kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C).
UNIQUE IDENTIFIER - 2D BARCODE Not applicable 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.) 
Sočasno se lahko pojavijo tudi gripi podobni simptomi, na primer zvišana telesna temperatura, mrzlica ali boleče mišice.)
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. 
Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
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. 
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo), kot so ciklosporin, ketokonazol in eritromicin.
TAXOTERE 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. 
Zdravilo TAXOTERE je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
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). 
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5 %), o katerih so poročali v študiji III faze pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
PSA response** at 12 months - N(%) p-valuea* 
Odziv PSA** po 12 mesecih - N (%) Vrednost pa*
First episode: stop 5-FU only, at all subsequent cycles. 
Prvi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
In these metastatic prostate cancer patients, the median overall survival was significantly longer in docetaxel treatment groups than in the standard of care alone group, with a median overall survival 19 months longer with the addition of docetaxel to standard of care (HR = 0.76, 95% CI = 0.62-0.92, p=0.005). 
Med temi bolniki z metastatskim rakom prostate je bilo mediano celokupno preživetje značilno daljše v skupini, ki je prejemala docetaksel, kot v skupini, ki je bila deležna le standardne oskrbe; mediano celokupno preživetje je bilo z dodatkom docetaksela standardni oskrbi 19 mesecev daljše (ROg = 0,76, 95 % IZ = 0,62-0,92, p = 0,005).
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack. 
Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (80 mg/2 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale. 
Za kombinacijo z ADT in prednizonom ali prednizolonom (študija STAMPEDE) so prikazani neželeni učinki, ki so se pojavili v 6 ciklusih zdravljenja z docetakselom in so imeli v skupini z docetakselom vsaj 2 % večjo pojavnost kot v kontrolni skupini; uporabljena je lestvica stopenj CTCAE.
Based on a population pharmacokinetic analysis, there are no special instructions for use in older people. 
Za uporabo pri starostnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
• Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.) 
• akutna generalizirana eksantemska pustuloza (AGEP) (rdeč, luskast razprostranjen izpuščaj z bulicami pod oteklo kožo (tudi v kožnih gubah, na trupu in zgornjih okončinah) in mehurji, ki jih spremlja zvišana telesna temperatura.)
- For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. 
- Za zdravljenje metastatskega raka želodca se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
TAXOTERE concentrate 
DRUGI PODATKI TAXOTERE koncentrat VEHIKEL za TAXOTERE
Efficacy of docetaxel in combination with prednisone or prednisolone and standard of care in the treatment of patients with metastatic hormone-sensitive prostate cancer (STAMPEDE) 
Učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom ter standardne oskrbe za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija STAMPEDE)
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 koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP) nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack. 
Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (20 mg/0,5 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. 
Ko je zdravilo enkrat dodano v infuzijsko vrečko, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25°C.
PSA response** at 6 months - N(%) p-valuea* 
Odziv PSA** po 6 mesecih - N (%) Vrednost pa*
Data from one multi-centre, 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. 
Podatki multicentrične, randomizirane, kontrolirane kliničnega študije III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
Efficacy results in metastatic prostate cancer patients for docetaxel arm versus control arm are summarized in the following table: 
Rezultate učinkovitosti pri bolnikih z metastatskim rakom prostate v skupini z docetakselom v primerjavi s kontrolno skupino povzema naslednja preglednica:
To be taken into account in pregnant or breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy. 
Vsebnost etanola je treba upoštevati tudi pri nosečnicah, doječih ženskah, otrocih in skupinah z velikim tveganjem, npr. pri bolnikih z boleznijo jeter ali epilepsijo.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial. 
Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo TAXOTERE iz viale tako, da vialo delno obrnete.
One vial contains 20 mg/0.5 ml docetaxel. 
Ena viala vsebuje 20 mg/0,5 ml docetaksela.
Adjusted hazard ratio 
Prilagojeno razmerje ogroženosti
Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint. 
Preživetje brez bolezni (DFS-Disease-free survival) je bilo primarni, celokupno preživetje (OS-Overall survival) pa sekundarni opazovani dogodek učinkovitosti.
TAXOTERE vial: polysorbate 80, citric acid. 
Viala zdravila TAXOTERA: polisorbat 80, citronska kislina.
Vascular disorders Venous thromboembolic events have rarely been reported. 
Redko so poročali o venskih trombembolijah.
A total of 1006 patients with KPS  60 were randomised to the following treatment groups: 
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem  60:
- AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever. 
- Med simptomi AGEP so lahko rdeč, luskast razprostranjen izpuščaj z bulicami pod oteklo kožo (tudi v kožnih gubah, na trupu in zgornjih okončinah) in mehurji, ki jih spremlja zvišana telesna temperatura.
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test 
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test
One vial contains 80 mg/2 ml docetaxel. 
Ena viala vsebuje 80 mg/2 ml docetaksela.
Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with TAXOTERE: - SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. 
Med uporabo zdravila TAXOTERE so poročali o hudih težavah s kožo, kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP): - Med simptomi SJS/TEN so lahko mehurji, lupljenje ali krvavitev na katerem koli predelu kože (tudi na ustnicah, očeh, v ustih, nosu, na spolovilih, dlaneh in stopalih), z izpuščajem ali brez njega.
• Docetaxel 30 mg/m administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. 
• Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
• acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments. 
• akutna mieloična levkemija in mielodisplastični sindrom (vrsti krvnega raka) se lahko pojavita pri bolnikih, ki se zdravijo z docetakselom v kombinaciji z nekatermi drugimi zdravili proti raku.
The median overall survival was significantly longer in docetaxel treatment group than in the ADT alone group, with a median overall survival 13.6 months longer with the addition of docetaxel to ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.47-0.80, p=0.0003). 
Mediano celokupno preživetje je bilo v skupini z docetakselom značilno daljše kot v skupini z ADT samim; mediano celokupno preživetje je bilo z dodatkom docetaksela ADT 13,6 meseca daljše (razmerje ogroženosti (ROg) = 0,61, 95 % interval zaupanja (IZ) = 0,47-0,80, p = 0,0003).
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: 
Zdravilo TAXOTERE je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic z:
• 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively. 
• 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/m² docetaksela, 121 pa jih je prejemalo 75 mg/m².
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills. 
Najpogosteje opisani simptomi so zardevanje, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja in zvišanje telesne temperature ali mrzlica.
- For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil. 
- Za zdravljenje raka glave in vratu se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
Median survival (months) 
Mediano celokupno preživetje (meseci)
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 antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem z njim in med pripravo njegovih raztopin potrebna previdnost.
13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml 
13 % (m/m) 95 % etanol v vodi za injekcije Polnitev: 7,33 ml
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2). 
Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm3 (glejte poglavje 4.2).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m twice daily for 2 weeks followed by 1-week rest period). 
V tej študiji so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
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 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment). 
Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment. 
V povezavi z zdravljenjem z docetakselom so poročali o hudih kožnih neželenih učinkih (SCARsevere cutaneous adverse reactions), kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
G3/4 Blood alkaline phosphatase increased 
zvečanje AST S3/4 zvečanje alkalne fosfataze v krvi S3/4
Disease Free Survival 
Preživetje brez bolezni
Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis 
Pri zdravljenju z docetakselom so poročali o kožnem eritematoznem lupusu, o buloznih erupcijah, npr. o multiformnem eritemu in o hudih kožnih neželenih učinkih kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
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 (eg, day 6-15) in all subsequent cycles. 
V ključni SCCHN študiji pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
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/m 
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75 mg/m2 (glejte poglavji 4.4 in 5.2).
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease. 
Opravljeno je bilo multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
1060 patients were randomised to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m 
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila TAXOTERE 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539