natgillin/translations-raw huggingface dataset:
The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 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.
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days. 
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m2 v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m2, infundiran 1 uro dolgo, prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m2 na dan pet dni.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics. 
Za prilagoditve odmerjanja cisplatina in 5-fluorouracila glejte ustrezen povzetek glavnih značilnosti obeh zdravil.
Headache (G3/4: < 1%); Neuropathy peripheral 
omotica, glavobol (S3/4: < 1 %), periferna nevropatija
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g). 
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 2 ml brezvodnega etanola (1,58 g).
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older. 
fazi študije), ki so jih zdravili z docetakselom v kombinaciji s cisplatinom in 5-fluorouracilom v študiji raka želodca, je bilo 74 bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated. 
Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
A study of 14C-docetaxel has been conducted in three cancer patients. 
Pri treh onkoloških bolnikih so opravili študijo s 14C-docetakselom.
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning. 
Za blage do zmerne senzorične motnje so značilne parestezije, dizestezije ali bolečina s pekočim občutkom.
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy. 
V kombinacijskem kraku s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40 % proti 31 %) in neželenih učinkov stopnje 4 (34 % proti 23 %) v primerjavi z monoterapijo z docetakselom.
- For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil. 
- Za zdravljenje raka glave in vratu se zdravilo DOCETAKSEL KABI uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
1 vial with 180 mg/9 ml 
1 viala s 180 mg/9 ml
Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy. 
Pri bolnikih, ki so sočasno dobivali radioterapijo, so bili opisani primeri radiacijskega pnevmonitisa.
DOCETAXEL KABI in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. 
Zdravilo DOCETAKSEL KABI je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications. 
Za bolnike z okvaro jeter, zdravljene z docetakselom v kombinaciji pri drugih indikacijah, ni podatkov.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported. 
Redko je bilo opisano solzenje s konjunktivitisom ali brez njega ter obstrukcija solzovoda s posledičnim čezmernim solzenjem.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure. 
V študiji TAX316 se je kongestivno srčno popuščanje pojavilo 26 bolnicam (3,5 %) v kraku s TAC in 17 bolnicam (2,3 %) v kraku s FAC.
Both regimens were administered every 3 weeks. 
Obe shemi so aplicirali enkrat na 3 tedne.
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur. 
Ženskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg). 
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
Patients should be monitored for second primary malignancies (see section 4.8). 
Bolnike je treba kontrolirati glede drugih primarnih malignomov (glejte poglavje
1Full analysis set (intent-to-treat) 
1 celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
- For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone. 
- Za zdravljenje raka prostate se zdravilo DOCETAKSEL KABI lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days. 
Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5-fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
For cisplatin dose adjustments, see the corresponding summary of product characteristics. 
Za prilagoditve odmerjanja cisplatina glejte ustrezen povzetek glavnih značilnosti zdravila.
It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits. 
Dokazano je, da je docetaksel pri podganah in kuncih embriotoksičen in fetotoksičen.
Data from a multi-centre open-label randomised trial support the use of DOCETAXEL KABI for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy. 
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila DOCETAKSEL KABI za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days. 
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m2, ki mu je sledil 5-fluorouracil 1000 mg/m2 (F) na dan 5 dni.
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test 
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil.
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table: 
Povečanje v preživetju opazovano pri kraku tedenskega docetaksela ni bilo statistično značilno v primerjavi z mitoksantronovem kontrolnem kraku zdravljenja.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4). 
Pri zdravljenju raka prostate, v primeru sočasne uporabe prednizona ali prednizolona, je priporočena premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (prosimo, glejte poglavje 4.4).
Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%). 
Mielodisplastični sindrom so zabeležili pri 2 od 744 bolnic, ki so prejemale TAC (0,3 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1 %).
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 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 %.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period. 
Bolnice je med terapijo in v obdobju nadzora po terapiji potrebno kontrolirati glede simptomov kongestivnega srčnega popuščanja.
1 vial with 20 mg/1 ml 
1 viala z 20 mg/1 ml
Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g). 
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 3 ml brezvodnega etanola (2,37 g).
In both arms, after the last cycle of chemotherapy, patients with positive oestrogen 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.
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC. 
Dobilo jo je 69 % bolnic, ki so prejemale TAC, in 72 % bolnic, ki so prejemale FAC.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide. 
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnikih starih > 70 let je malo.
• flushing, skin reactions, itching 
• vročinski oblivi, kožne reakcije, srbenje,
What DOCETAXEL KABI looks like and contents of the pack DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution. 
Izgled zdravila DOCETAKSEL KABI in vsebina pakiranja Zdravilo DOCETAKSEL KABI koncentrat za raztopino za infundiranje je bistra, brezbarvna do bledorumena raztopina.
Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g). 
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%) 
Preiskave zvečanje bilirubina v krvi S3/4 (2,1 %), zvečanje ALT S3/4
• alteration in sense of taste 
• spremenjeno okušanje,
Docetaxel is a substance derived from the needles of yew trees. 
Docetaksel je substanca, pridobljena iz iglic tise.
Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe. 
S kalibrirano brizgo aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI.
Skin and subcutaneous tissue 
Bolezni kože in podkožja
The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents. 
Izrazitost neželenih učinkov zdravila DOCETAKSEL KABI se lahko poveča, če dobivate zdravilo DOCETAKSEL KABI v kombinaciji z drugimi kemoterapevtiki.
Neutropenic infection; Infection (G3/4: 11.7%) 
Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S3/4: 11,7 %)
This regimen is administered every 3 weeks for 3 cycles. 
Ta terapevtska shema se uporablja vsake 3 tedne po 3 cikle.
MARKETING AUTHORISATION NUMBER 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
• 92 patients treated with docetaxel in combination with trastuzumab. 
• 92 bolnikih, ki so prejemale docetaksel v kombinaciji s trastuzumabom.
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks. 
Z docetakselom sta bili v priporočenem odmerku in shemi 100 mg/m2 na 3 tedne opravljeni dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%) 
Bolezni živčevja periferna senzorična nevropatija (S3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
Hypersensitivity (no severe) 
Bolezni imunskega sistema preobčutljivost (nobene hude)
Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%) 
Bolezni živčevja disgevzija (S3/4: 0,6 %), periferna senzorična nevropatija (S3/4: < 0,1 %)
DOCETAXEL KABI 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 DOCETAKSEL KABI je v kombinaciji s cisplatinom indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease. 
Docetaksel so v kombinaciji s trastuzumabom raziskali za zdravljenje bolnic z metastatskim rakom dojke, ki so imele na tumorju hiperekspresijo HER2 in prej še niso dobivale kemoterapije za metastatsko bolezen.
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 
Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP)
1 vial with 80 mg/4 ml 
1 viala z 80 mg/4 ml
Constipation (severe: 0.2%); Abdominal pain (severe: 1%); 
zaprtje (hudo: 0,2 %), bolečine v trebuhu (hude: 1 %), gastrointestinalna krvavitev (huda: 0,3 %)
No patient was diagnosed with myelodysplastic syndrome in either treatment groups. 
Ne v eni ne v drugi terapevtski skupini niso odkrili nobenega primera mielodisplastičnega sindroma.
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value 
Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % IZ) ***p-vrednost
At the median follow-up time of 77 months overall survival (OS) was also 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 tudi celokupno preživetje v kraku TAC daljše: tveganje za smrt 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).
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care. 
s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
• indigestion 
• nespečnost,
Cancer pain (G3/4: 1.2%) 
bolečina zaradi raka (S3/4: 1,2 %)
At the median follow-up was 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated. 
Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
Peripheral motor neuropathy (G3/4: 2.5%) 
periferna motorična nevropatija (S3/4: 2,5 %)
• 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 randomised, multi-centre open-label, phase III, study (TAX324). 
• Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
• 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 bolnikih z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous. 
Kaj vsebuje zdravilo DOCETAKSEL KABI: - Učinkovina je brezvodni docetaksel.
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5. 
Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji 1. dan in nato stalno intravensko infuzijo 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 5. dneva.
Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g). 
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4,5 ml brezvodnega etanola (3,55 g).
Skin and subcutaneous Alopecia (G3/4:4.0%) 
Bolezni kože in podkožja alopecija (S3/4: 4,0 %)
Neutropenia is the most frequent adverse reaction of docetaxel. 
Najpogostejši neželeni učinek docetaksela je nevtropenija.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain 
Bolezni prebavil navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
• 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, multi-centre, open-label, randomised study (TAX323). 
• Indukcijska kemoterapija in nato radioterapija (TAX323) Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
Peripheral sensory neuropathy (G3/4: 8.7%) 
Bolezni živčevja periferna senzorična nevropatija (S3/4: 8,7 %)
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed. 
Na udih (dlaneh in podplatih) so opažali lokalen kožni eritem z edemi in poznejšo deskvamacijo.
Infection (G3/4: 6.3%); Neutropenic infection 
Infekcijske in parazitske bolezni okužba (S3/4: 6,3 %), nevtropenična okužba
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%) 
omotica (S3/4: 2,3 %), periferna motorična nevropatija (S3/4: 1,3 %)
• oral candidiasis 
• oralna kandidoza,
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%). 
Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) je v kraku TAC periferne edeme še vedno imelo 19 bolnic (2,6 %), v kraku FAC pa 4 bolnice (0,5
Skin reaction (G3/4: 5.9%); Nail disorders (severe: 2.6%) 
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4: 5,9 %), spremembe nohtov (hude: 2,6 %)
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4. 
Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 4. dneva.
Paraesthesia; Headache; Dysgeusia; Hypoaesthesia 
Bolezni živčevja parestezije, glavobol, disgevzija, hipestezija
- If you get any side effects, talk to your doctor, hospital pharmacist or nurse. 
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
- For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL 
- Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo DOCETAKSEL KABI lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. 
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila 1000 mg/m2/dan od 1. do 4. dneva.
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%). 
Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC (11,7 %).
Reversible cutaneous reactions have been observed and were generally considered as mild to moderate. 
Pojavljale so se reverzibilne, praviloma blage do zmerne kožne reakcije.
TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm. 
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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg brezvodnega docetaksela.
DOCETAXEL KABI in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. 
Zdravilo DOCETAKSEL KABI je v kombinaciji s trastuzumabom indiciran za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%). 
Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 3od 744 bolnic, ki so prejemale TAC (0,4 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1%).