natgillin/translations-raw huggingface dataset:
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany 
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Nemčija
TAXOTERE contains ethanol (alcohol) 
Zdravilo TAXOTERE vsebuje etanol (alkohol)
Stomatitis/mucositis grade 3 
Stomatitis/mukoziti s 3. stopnje
Inject the entire contents of the syringe into the corresponding TAXOTERE vial. 
Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila TAXOTERE.
CAUTION: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution. 
OPOZORILO: Odvzemite potrebno količino tega koncentrata docetaksela (20 mg/ml) iz viale in ga dodajte neposredno v raztopino za infundiranje.
Each blister pack contains: 
En pretisni omot vsebuje:
Menopausal status Pre-Menopausal Post-Menopausal 
Menopavzalno stanje Pred menopavzo Po menopavzi
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because TAXOTERE may be harmful for the unborn baby. 
Med zdravljenjem z zdravilom TAXOTERE ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo TAXOTERE lahko škoduje vašemu nerojenemu otroku.
The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation. 
Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
How to use TAXOTERE 
Kako uporabljati zdravilo TAXOTERE
Docetaxel + standard of care Standard of care alone 
Docetaksel + standardna oskrba
Second primary malignancies (including acute myeloid leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy. 
Drugi primarni malignomi (vključno z akutno mieloično levkemijo, mielodisplastičnim sindromom in ne-Hodgkinovim limfomom) se lahko pojavijo več mesecev ali let po zdravljenju, ki vključuje docetaksel.
If you are a man being treated with TAXOTERE 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. 
Če ste moški, ki se zdravi z zdravilom TAXOTERE je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
Full analysis set (intent-to-treat) Estimated median survival 
1celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
1000 mg/m per day for 5 days. 
1000 mg/m2/dan od 1. do 4. dneva.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. 
Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles. 
To terapevtsko shemo so uporabljali vsake tri tedne za 4 cikle, če so po 2 ciklih opazili vsaj manjši odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
Median duration of response to chemotherapy  radiotherapy (months) (95% CI) 
Mediano trajanje odziva na kemoterapijo  radioterapijo (meseci) (95 % IZ)
TAXOTERE was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks. 
Zdravilo TAXOTERE je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
2-year estimate (%) 
2-letna ocena (%)
In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab. 
V ključni študiji so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Tako kot vsa druga zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Method of administration For instructions on preparation and administration of the product, see section 6.6. 
Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
5-fluorouracil (F) 750 mg/m per day as a continuous infusion for 5 days. 
fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates  10% higher in patients who were 65 years of age or older compared to younger patients. 
Incidenca naslednjih neželenih učinkov (vse stopnje)letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več,  10 % večja kot pri mlajših bolnikih.
The most commonly reported adverse reactions of TAXOTERE alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness. 
Najpogosteje poročani neželeni učinki zdravila TAXOTERE samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.
• 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone and ADT. 
• 545 bolnikov (študija STAMPEDE), ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom in ADT.
In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2). 
Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
Acute leukaemia / Myelodysplastic syndrome. 
Akutna levkemija / mielodisplastični sindrom
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. 
Zdravnik vam je zdravilo TAXOTERE predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu: - Za zdravljenje napredovalega raka dojke se lahko zdravilo TAXOTERE uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
This volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume". 
Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine (glejte poglavje 4) zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
Discard unused contents appropriately in accordance with local requirements. 
Neporabljeno vsebino ustrezno zavrzite v skladu z lokalnimi zahtevami.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively. 
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11,1 ure.
• feeling of numbness or pins and needles or pain in the joints or muscles 
• občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah
Docetaxel belongs to the group of anti-cancer medicines called taxoids. 
Docetaksel spada v skupino zdravil proti raku, imenovanih taksoidi.
• Standard of care alone 
• standardna oskrba sama.
• Premix solution: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation. 
• Osnovna raztopina: Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m in phase I studies. 
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
• one single-dose vial of concentrate and, 
• eno eno-odmerno vialo koncentrata in
Number of patients Median overall survival (months) All patients 
Mediano celokupno preživetje (meseci) Vsi bolniki
• Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (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. 
• Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN) (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.
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m every three weeks, with trastuzumab administered weekly. 
Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient. 
Raztopino za infundiranje v infuzijski vrečki je treba uporabiti v 6 urah na temperaturi do 25°C, to vključuje tudi 1 uro infundiranja bolniku.
See also section “TAXOTERE contains ethanol (alcohol)” below. 
Glejte tudi poglavje "Zdravilo TAXOTERE vsebuje etanol (alkohol)" spodaj.
Neutropenia (Grade 4) 
Nevtropenija (4. stopnje)
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8). 
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
*a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC. 
*a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume". 
Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne mešanice zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
Stomatitis/mucositis grade 4 
Stomatitis/mukoziti s 4. stopnje
Docetaxel +ADT 
Docetaksel + ADT ADT samo
- For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide. 
- Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo TAXOTERE lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. 
4.1.4 Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
(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. 
(ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
• tiredness; or flu-like symptoms 
• utrujenost ali gripi podobni simptomi
1 vial of solvent for TAXOTERE 
1 viala vehikla za zdravilo TAXOTERE
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates  10% higher in patients who were 75 years of age or greater versus less than 65 years. 
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala  10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
Treatment difference: 6.2% [95% CI: 0.2; 12.3] 
razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
Treatment difference: 5.4% [95% CI: -1.1; 12.0] 
razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0]
TAXOTERE 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. 
Zdravilo TAXOTERE je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
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). 
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
• 3 years. 
• 3 leta
• stomach upsets including nausea, vomiting and diarrhoea, constipation 
• draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje
Docetaxel1 n = 94 
Docetaksel1 n = 94
It should be used within 6 hours (including the one hour infusion intravenous administration). 
Porabiti jo je potrebno v 6 urah (to vključuje tudi 1 uro infundiranja bolniku).
2-year Survival (%) 
2-letno preživetje (%)
256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks). 
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents. 
Izrazitost neželenih učinkov zdravila TAXOTERE se lahko poveča, če dobivate zdravilo TAXOTERE v kombinaciji z drugimi kemoterapevtiki.
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient. 
4.2.1 Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala z osnovno raztopino.
Docetaxel plus trastuzumab1 n = 92 
Docetaksel in trastuzumab1 n = 92
You must not breast-feed while you are treated with TAXOTERE. 
Med zdravljenjem z zdravilom TAXOTERE ne smete dojiti.
Contains anhydrous ethanol (see leaflet) 
Vsebuje brezvodni etanol (glejte navodilo za uporabo)
Each vial is of single use and should be used immediately. 
Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms. 
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%). 
s 6,1 %), absolutno zmanjšanje LVEF ≥ 30 % (6,2 % v prim.
It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution 
Pomembno je, da pred pripravo osnovne raztopine zdravila TAXOTERE ali raztopine za infundiranje zdravila TAXOTERE v celoti preberete ta navodila.
CAUTION: Dilution required with the entire contents of the solvent vial. 
OPOZORILO: Razredčite s celotno vsebino viale z vehiklom.
c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion). 
c Čas do kliničnega napredovanja = čas od randomizacije do kliničnega napredovanja (tj. porasta simptomov metastaz v kosteh, napredovanje po merilih RECIST ali klinično poslabšanje zaradi raka po mnenju raziskovalca).
Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT. 
Operacija na primarnem mestu bolezni in/ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00 
Ireland sanofi-aventis Ireland Ltd. Tel: +353 (0) 1 403 56 00
Rare cases of myocardial infarction have been reported. 
Opisani so bili redki primeri miokardnega infarkta.
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2). 
Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z G-CSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
Hazard ratio* 
Razmerje ogroženosti*
The solvent is a colourless solution. 
Vehikel je brezbarvna raztopina.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents. 
Zdravilo je potrebno aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anaemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher). 
Bolniki, stari 75 let ali več, so imeli v primerjavi z mlajšimi bolniki večjo (vsaj 10 % večjo) pojavnost nevtropenije, anemije, driske, dispneje in okužb zgornjih dihal.
Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis 
Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
• Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml. 
• Vsaka viala z vehiklom za zdravilo TAXOTERE 80 mg/2 ml vsebuje 7,33 ml vehikla.
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* 
razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]*
Number of metastatic prostate cancer patients 
Število bolnikov z metastatskim rakom prostate
The European Medicines Agency has waived the obligation to submit the results of studies with TAXOTERE in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij z zdravilom TAXOTERE za vse skupine pediatrične populacije za raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, karcinom želodca in raka glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Amenorrhoea (G3/4: NA) 
Amenoreja (S 3/4: NA)
In addition, dexamethasone did not affect protein binding of docetaxel. 
Poleg tega deksametazon ni vplival na vezavo docetaksela na beljakovine.
• ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles 
• ADT + docetaksel 75 mg/m2, uporabljen na začetku ADT in uporabljan na 3 tedne 6 ciklusov,
The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8). 
Incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje se je zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF (glejte poglavje 4.8).
• Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml. 
• Vsaka viala z vehiklom za zdravilo TAXOTERE 20 mg/0,5 ml vsebuje 1,98 ml vehikla.
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial. 
4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo TAXOTERE iz viale tako, da vialo delno obrnete.
Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED) 
Učinkovitost docetaksela in ADT za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija CHAARTED)
Patients with operable node-positive breast cancer (TAX 316) 
Bolnice z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316)
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy. 
Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek: 818,9 mg/m2), kot pri tistih, ki je ne (mediani kumulativni odmerek: 489,7 mg/m2); vendar je pri nekaterih bolnikih opisan med zgodnjimi ciklusi zdravljenja.
Acute myeloid leukaemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen. 
O akutni mieloični levkemiji in mielodisplastičnem sindromu so (s pogostnostjo "občasno") poročali v ključnih kliničnih študijah pri raku dojke s shemo TAC.
Sanofi Mature IP 54 rue La Boétie 75008 Paris France 
Sanofi Mature IP 54 rue La Boétie 75008 Pariz Francija
PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm 
PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
(G3/4: 0.2%) 
(S3/4: 0,2 %)
In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels 
Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi
Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, France 
Sanofi Mature IP, 54 rue La Boétie, 75008 Pariz, Francija
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm. 
Mediana časa do napredovanja je bila v kraku AT 37,3 tedna (95 % IZ: 33,4-42,1) in v kraku AC 31,9 tedna (95 % IZ: 27,4-36,0).
• 1276 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 bolnikih (744 pri TAX 316 in 532 GEICAM 9805), ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Neutropenic infection (Grade 3-4) 
Nevtropenična okužba (3.-4. stopnja)
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution. 
Primer: za odmerek 140 mg docetaksela bi potrebovali 7 ml koncentrata docetaksela za raztopino.
In case of 
Ne Da
TAXOTERE in combination with doxorubicin 
Zdravilo TAXOTERE v kombinaciji z doksorubicinom