natgillin/translations-raw huggingface dataset:
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Pharyngitis (G3: 0%) 
faringitis (3. st.: 0 %)
The infusion solution should be used within 4 hours at room temperature (below 25°C). 
Raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25°C).
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. 
Zdravilo TAXOTERE je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je pri ravnanju in pripravi raztopin zdravila TAXOTERE potrebna previdnost.
This volume has been established based on the fill volume of the TAXOTERE 20 mg/0.5 ml vial. 
Ta količina je določena glede na polnilni volumen viale zdravila TAXOTERE 20 mg/0,5 ml.
4.1.1 If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes. 
4.1.1 Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila TAXOTERE 5 minut stati na sobni temperaturi (do 25°C).
In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m 
Kot zdravljenje prvega izbora se docetaksel 75 mg/m2 daje v kombinaciji z doksorubicinom (50 mg/m2).
Infection (G3/4: 7.8%) 
Okužba (S3/4):7,8%
This volume has been established based on the fill volume of the TAXOTERE 80 mg/2 ml vial. 
Ta količina je določena glede na polnilni volumen viale zdravila TAXOTERE 80 mg/2 ml.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed. 
Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
Efficacy results or the docetaxel arm versus the control arm are summarized in the following table: 
Končna učinkovitost docetakselovih rok v primerjavi s kontrolno roko je povzeta v spodnji tabeli:
What TAXOTERE concentrate vial contains - The active substance is docetaxel (as trihydrate). 
Kaj vsebuje viala zdravila TAXOTERE koncentrat: - Zdravilna učinkovina je docetaksel (kot trihidrat).
• 332 patients (TAX327) who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). 
• 332 bolnikih (TAX327), ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC. 
Dobilo jo je 57,3% bolnic, ki so prejemale TAC, in 51,2% bolnic, ki so prejemale FAC.
Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%. 
driska 4. stopnje Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies. 
O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
Headache (G3/4: < 1%); Neuropathy peripheral 
glavobol (S3/4: < 1 %), periferna nevropatija
Median (months) 95% CI 
Mediana (meseci) 95 % IZ
FAC patients (0.1%). 
z 1,1 %).
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007). 
doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa zvečal delež odziva (52 % v prim.
Data from a multi-centre open label randomised trial support the use of TAXOTERE for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy. 
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila TAXOTERE za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid. 
Pomožne snovi: polisorbat 80, brezvodni etanol (za dodatne informacije glejte navodilo za uporabo) in citronska kislina.
More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient. 
Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje zdravila TAXOTERE.
No of positive nodes 
št. pozitivnih bezgavk celotno
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08). 
Varnost in učinkovitost docetaksela med sočasno uporabo s standardno oskrbo (ADT) so pri bolnikih z lokalno napredovalim ali metastatskim hormonsko občutljivim rakom prostate z velikim tveganjem ovrednotili v randomizirani, multicentrični večstopenjski študiji z več skupinami (MAMS - multi-arm multi-stage) z zveznim, adaptivnim načrtom II./III.
Solvent vial 
Neodprta viala
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM STUDY. 
Spodnja preglednica kaže, da se je incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF, potem ko je ta postala obvezna v kraku TAC - študija GEICAM.
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported. 
V redkih primerih so bili opisani akutni respiracijski distres sindrom in primeri intersticijske pljučnice/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so bili včasih usodni.
Docetaxel must not be used in patients with baseline neutrophil count of < 1,500 cells/mm 
Docetaksela se ne sme uporabljati pri bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Metastatic hormone-sensitive prostate cancer 
Metastatski hormonsko občutljiv rak prostate
4.2.5 As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje zdravila TAXOTERE pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning. 
Za blage do zmerne senzorične motnje so značilne parestezije, dizestezije ali bolečina s pekočim občutkom.
This medicine should not be used after the expiry date shown on the carton, blister pack and vials. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli, pretisnem omotu in vialah.
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. 
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v
Docetaxel should be administered when the neutrophil count is  1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m to 75 mg/m and/or from 75 to 
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration. 
Sočasna uporaba docetaksela, doksorubicina in ciklofosfamida ni vplivala na njihovo farmakokinetiko.
What TAXOTERE contains - The active substance is docetaxel (as trihydrate). 
Kaj vsebuje zdravilo TAXOTERE - Zdravilna učinkovina je docetaksel (kot trihidrat).
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/mm 
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 
sinkopa (S3/4: 0 %), nevrotoksičnost (S3/4:
You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles. 
Pojavijo se vam lahko tudi gripi podobni simptomi, na primer zvišana telesna temperatura, mrzlica ali boleče mišice.
• The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections. 
• Vehikel za zdravilo TAXOTERE sestavlja 13 % (m/m) raztopina 95 % etanola v vodi za injekcije.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes 
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Organski sistemi po
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath) 
• pljučna fibroza (brazgotinjenje in zadebelitve v pljučih, težko dihanje/kratka sapa)
Data from a multi-centre open label randomised 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. 
Podatki multicentrične, odprte randomizirane študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem  80 %.
Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation). 
Nato preverite, ali je raztopina homogena in bistra (zaradi polisorbata 80, ki je v pripravku, je penjenje tudi še po 5 minutah normalno).
Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 
Infekcijske in parazitske bolezni okužbe (S3/4: 5,7 %; vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
If the vials are stored under refrigeration, allow the required number of boxes of TAXOTERE concentrate for solution for infusion to stand below 25°C for 5 minutes before use. 
Če so viale shranjene v hladilniku, pustite potrebno število škatel koncentrata za raztopino za infundiranje zdravilo TAXOTERE pred uporabo 5 minut stati na temperaturi do 25°C.
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m². 
• Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom 55 mg/m2.
Single-use vial. 
• eno vialo vehikla.
Ethanol 95% Water for injections. 
Viala z vehiklom: 95 % etanol voda za injekcije.
4.2.3 Mix the infusion bag or bottle manually using a rocking motion. 
4.2.3 Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes. 
Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila TAXOTERE 5 minut stati na sobni temperaturi (do 25°C).
Patients on the docetaxel arm received docetaxel (T) 75 mg/m followed by cisplatin (P) 75 mg/m followed by 
Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5
Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). 
Ena vila koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
Excipient with known effect: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g). 
Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION 
PRIPRAVA ZA INTRAVENSKO APLIKACIJO
TAXOTERE in combination with capecitabine 
Zdravilo TAXOTERE v kombinaciji s kapecitabinom
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na zunanji ovojnini in na nalepki poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m 
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
Concentrate vial: Polysorbate 80 Citric acid. 
Viala koncentrata: Polisorbat 80 citronska kislina
15 ml clear glass (type I) vial with a blue aluminium seal and blue plastic flip-off cap containing 8 ml of concentrate. 
15 ml viala iz prozornega stekla tipa I z modro aluminijasto zaporko in modro dvižno zaporko z 8 ml koncentrata.
75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion. 
Priporočeni odmerek docetaksela je 75 mg/m2 v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m2 v 1- do 3-urni infuziji (oboje samo 1. dan); temu sledi 5-fluorouracil 750 mg/m2 na dan v 24-urni stalni infuziji 5 dni, z začetkom ob koncu infuzije cisplatina.
The TAXOTERE 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. 
Aplicirati jo je treba aseptično v 1-urni infuziji, pri sobni temperaturi (do 25°C) in v pogojih običajne svetlobe.
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29). 
Po mediano 77 mesecih spremljanja je bilo dokazano, da je bilo celotno preživetje v kraku TAC daljše: tveganje smrti je bilo med prejemnicami TAC za 24 % manjše kot med prejemnicami FAC (razmerje ogroženosti = 0,76, 95 % IZ (0,46-1,26), p = 0,29).
Docetaxel regimen was administered in combination with prednisone or prednisolone 5 mg twice daily continuously. 
Shema z docetakselom je bila uporabljena v kombinaciji z nepretrgano uporabo 5 mg prednizona ali prednizolona dvakrat na dan.
• Mix the infusion bag or bottle manually using a rocking motion. 
• Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m and 113 l, respectively. 
Povprečni celotni telesni očistek je bil 21 l/h/m2, volumen porazdelitve v stanju dinamičnega ravnovesja pa 113 l. Interindividualno variiranje celotnega telesnega očistka je bilo približno 50 %.
Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%. 
Prilagoditev odmerka driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu.
Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml). 
Viala z vehiklom vsebuje 6 ml 13 % (m/m) raztopine 95 % etanola v vodi za injekcije (polnilni volumen: 7,33 ml).
Metastatic castration-resistant prostate cancer 
Metastatski, proti kastraciji odporen rak prostate
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor 
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor
Nail disorders (severe: 0.8%) 
spremembe nohtov (hude 0,8 %)
Each ml of concentrate contains 20 mg docetaxel as trihydrate. 
1 ml koncentrata vsebuje 20 mg docetaksela v obliki trihidrata.
G3/4 Blood bilirubin increased (2.1%); 
S3/4 zvišanje bilirubina v krvi (2,1 %), S3/4 zvišanje ALT
TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. 
Zdravilo TAXOTERE v kombinaciji s cisplatinom je indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Common adverse reactions disorders Nervous system disorders 
Presnovne in prehranske motnje anoreksija Psihiatrične motnje nespečnost
Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous). 
Ena viala z enim odmerkom zdravila TAXOTERE 20/0,5 ml mg koncentrat vsebuje docetaksel (kot trihidrat), ki ustreza 20 mg brezvodnega docetaksela.
The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study (CHAARTED). 
Varnost in učinkovitost docetaksela, uporabljenega na začetku androgenskega deprivacijskega zdravljenja (ADT) pri bolnikih z metastatskim hormonsko občutljivim rakom prostate, so ovrednotili v randomizirani multicentrični študiji III. faze (študija CHAARTED).
For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4). 
Za metastatskega, hormonsko občutljivega raka prostate je ne glede na sočasno uporabo prednizona ali prednizolona priporočena premedikacija z 8 mg deksametazona peroralno 12 ur, 3 ure in 1 uro pred infundiranjem docetaksela (glejte poglavje 4.4).
TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Zdravilo TAXOTERE v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
In both arms, after the last cycle of chemotherapy, patients with positive eostrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years. 
V obeh krakih so bolnice s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji po zadnjem ciklu kemoterapije do 5 let dobivale tamoksifen 20 mg na dan. Adjuvantna radioterapija je bila predpisana v skladu z veljavnimi smernicami v sodelujočih ustanovah.
In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over 
V študiji III. faze so 1.218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, randomizirali v tri skupine.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with metastatic castration-resistant prostate cancer were evaluated in a randomised multi-centre phase III study (TAX 327). 
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim proti kastraciji odpornim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III (TAX 327).
Paresthesia; Headache; Dysgeusia; Hypoaesthesia 
Bolezni živčevja parestezije, glavobol, disgevzija, hipestezija
Each box contains one vial of 1 ml concentrate (20 mg docetaxel). 
Vsaka škatla vsebuje 1 vialo z 1 ml koncentrata (20 mg docetaksela).
Fluid retention (severe: 
spremembe nohtov (hude:
Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia 
Bolezni prebavil driska (3. st.: 3 %) stomatitis (3. st.: 0 %) zaprtost (3. st.: 0 %) navzea (3. st.: 1 %) dispepsija bolečine v trebuhu (3. st.: 0 %) flatulenca bruhanje (3. st.: 1 %)
p = 
Vrednost p*
There is no relevant use of TAXOTERE in the paediatric population in the indications 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. 
Zdravilo TAXOTERE ni primerno za uporabo pri pediatrični populaciji nima za indikacije rak dojke, nedrobnocelični pljučni rak, rak prostate, karcinom želodca in rak glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III.
Solvent vial contains 1.5 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 1.98 ml). 
Viala z vehiklom vsebuje 1,5 ml 13 % (m/m) raztopine 95 % etanola v vodi za injekcije (polnilni volumen: 1,98 ml).
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded. 
Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže 0,74 mg docetaksela/ml.
TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 
Zdravilo TAXOTERE je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim proti kastraciji odpornim rakom prostate.
TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid. 
Zdravilo TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 40 mg brezvodnega docetaksela/ml v polisorbatu 80 in citronsko kislino.