natgillin/translations-raw huggingface dataset:
Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton. 
Ena škatla vsebuje eno vialo (20 mg/0,72 ml) zdravila Docetaksel Teva in eno vialo ustreznega vehikla za Docetaksel Teva v škatli.
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. Odklon celotnega telesnega očistka med posamezniki je bil približno 50 %.
Both regimens were administered on day 1 every 3 weeks. 
Obe kombinaciji so aplicirali prvi dan na vsake 3 tedne.
• operable node-positive breast cancer • operable node-negative breast cancer 
• z operabilnim rakom dojke s pozitivnimi bezgavkami • z operabilnim rakom dojke z negativnimi bezgavkami.
The Docetaxel Teva 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 enourni infuziji, pri sobni temperaturi (do 25°C) in običajnih svetlobnih pogojih.
Docetaxel Teva is supplied as single-dose vials. 
Docetaksel Teva je na voljo v vialah z enim odmerkom.
In GEICAM 9805 study, 3 patients (0.6%) in TAC arm and 3 patients (0.6%) in FAC arm developed congestive heart failure during the follow-up period. 
V študiji GEICAM 9805 se je 3 bolnicam (0,6 %) v kraku TAC in 3 bolnicam (0,6 %) v kraku FAC
Pre-Menopausal 
Pred menopavzo Po menopavzi
The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5). 
itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina in vorikonazola) (glejte poglavje 4.5).
• oral candidiasis 
• oralna kandidoza;
Peripheral motor neuropathy (G3/4: 0%) 
periferna motorična nevropatija (S 3/4: 0 %)
Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment. 
Posvetujte se z zdravnikom, če ste odvisni od alkohola,
• shortness of breath 
• težko dihanje;
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4%) in TAC arm and 5 patients (1.0%) 
V študiji GEICAM 9805 so nadaljnjo prisotnost amenoreje, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express 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 prekomerno izražen HER2 in prej še niso dobivale kemoterapije za metastatsko bolezen.
The updated analysis was performed when all patients had reached their 10-year (median follow up time of 10 years and 5 months) follow-up visit (unless they had a DFS event or were lost to follow-up previously). 
(mediani čas spremljanja: 10 let in 5 mesecev) spremljanju (razen če se jim je prej pojavil dogodek
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis) 
Učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno napredovalim
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/m2 (see sections 4.4 and 5.2). 
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočeni odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo referenčnega območja (ZMRO) in alkalno fosfatazo nad 2,5-kratno ZMRO,
G3/4 Blood alkaline phosphatase increased 
povišanje ravni alkalne fosfataze v krvi S 3/4
Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton. 
Ena škatla vsebuje eno vialo (80 mg/2,88 ml) zdravila Docetaksel Teva in eno vialo ustreznega vehikla za Docetaksel Teva v škatli.
Skin reaction (G3/4: 
kožna reakcija (S 3/4:
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4) 
Nevtropenija (4. stopnje) Febrilna nevtropenija
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 so v priporočenem odmerku in režimu 100 mg/m2 na 3 tedne opravili 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.
Docetaxel +Cis+5-FU n=255 
končna točka docetaksel + Cis + 5-FU n = 255
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: 
Podaljšanje preživetja, opaženo v kraku s tedenskim odmerjanjem docetaksela, ni bilo statistično značilno v primerjavi s kontrolnim krakom z mitoksantronom.
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 ga je 69 % bolnic, ki so dobivale TAC, in 72 % bolnic, ki so dobivale FAC.
75 years of age or greater versus less than 65 years. 
bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p=0.01). 
Prejemnice TAC so imele 32 % manjše tveganje recidiva kot prejemnice FAC (razmerje ogroženosti = 0,68, 95 % IZ (0,49-0,93), p = 0,01).
Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%) 
Bolezni živčevja disgevzija (S 3/4: < 1 %), parestezija (S 3/4: < 1 %)
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 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
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2.88 ml per vial. 
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za vialo docetaksela to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 8 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 80 mg/2,88 ml na vialo.
You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines (see section 4 Possible side effects). 
uporabe orodij ali upravljanja strojev (glejte poglavje 4 Možni neželeni učinki).
in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm. 
Na koncu spremljanja (mediani čas spremljanja 10 let in 5 mesecev) so amenorejo še vedno opažali pri 7 bolnicah (1,3 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
Docetaxel in combination with doxorubicin 
Zdravilo Docetaksel Teva v kombinaciji z doksorubicinom
Neutropenic infection; Infection (G3/4: 11.7%) 
Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S 3/4: 11,7 %)
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other diseaserelated medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC. 
Bolniki, ki so se zdravili z docetakselom v odmerku 75 mg/m2, so potrebovali manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in obsevanja (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
Median overall survival (months) (95%CI) 
srednji čas celotnega preživetja (meseci) (95-odstotni interval zaupanja)
Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value 
razmerje tveganja (95-odstotni interval zaupanja) **vrednost p najboljši celotni odziv (CR + PR) na kemoterapijo (%) (95-odstotni interval zaupanja) ***vrednost p najboljši celotni odziv (CR + PR) na raziskovano zdravljenje [kemoterapija +/kemoradioterapija] (%) (95-odstotni interval zaupanja) ***vrednost p
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed. 
Na okončinah (dlaneh in podplatih) so opažali lokalen kožni eritem z edemi in poznejše luščenje.
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) 1,000 mg/m²/day from day 1 to day 4. 
Bolniki v kraku z docetakselom so prvi dan dobili docetaksel (T) 75 mg/m2 v intravenski infuziji, 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.
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3. 
Docetaksel se ne sme uporabljati pri bolnikih, ki imajo izhodiščno število nevtrofilcev < 1500
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg/0.72 ml 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 20 mg/0,72 ml
The severity of adverse events of Docetaxel Teva may be increased when Docetaxel Teva is given in combination with other chemotherapeutic agents. 
Izrazitost neželenih učinkov na zdravilo Docetaksel Teva se lahko poveča, če se zdravilo daje v kombinaciji z drugimi kemoterapevtiki.
Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80. 
Docetaksel Teva 20 mg/0,72 ml koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 27,73 mg docetaksela/ml v polisorbatu 80.
Patients previously treated with chemotherapy with or without radiotherapy 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. 
Bolniki, ki so se predhodno zdravili s kemoterapijo, z obsevanjem ali brez njega V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12,3 tedna v prim.
Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80. 
Docetaksel Teva 80 mg/2,88 ml koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 27,73 mg docetaksela/ml v polisorbatu 80.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.72 ml per vial. 
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za vialo docetaksela to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 20 mg/0,72 ml na vialo.
Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml). 
Vsaka viala z vehiklom vsebuje 1,28 ml vode za injekcije (polnilni volumen: 1,71 ml).
One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years). 
Zaradi AML je med obdobjem spremljanja umrla 1 bolnica v skupini TAC (0,1 %) in 1 bolnica v skupini FAC (0,1 %)
Somnolence (G3/4: 
somnolenca (S3/4;
Docetaxel Teva 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 Teva v kombinaciji s trastuzumabom je indicirano za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo prekomerno izražen HER2 in ki se predhodno niso zdravile s kemoterapijo za metastatsko bolezen.
in TAC arm. No cases were reported in patients in FAC arm. 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.
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%) 
Bolezni prebavil navzeja (S 3/4: 3,3 %), stomatitis (S 3/4: 1,7 %), bruhanje (S 3/4: 0,8 %), driska (S 3/4: 1,7 %)
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel. 
Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila Docetaksel Teva 20 mg/0,72 ml koncentrata za raztopino za infundiranje zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
Infection (G3/4: 3.6%) Neutropenic infection 
Infekcijske in parazitske bolezni okužba (S 3/4: 3,6 %) nevtropenična okužba
• Each vial contains 20 mg/0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml). 
• Ena viala vsebuje 20 mg/0,72 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,88 ml).
• Induction chemotherapy followed by radiotherapy (TAX 323) 
• Indukcijska kemoterapija in nato obsevanje (TAX 323)
• operable node-positive breast cancer 
• z operabilnim rakom dojke s pozitivnimi bezgavkami
2.1 Docetaxel Teva 20 mg/0.72 ml vial: 
2.1 Viala zdravila Docetaksel Teva 20 mg/0,72 ml:
BATCH NUMBER Lot 
* nekorigirani test log-rank
intestinal perforation. 
nevtropenična okužba.
Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap. 
15 ml viala tipa I iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
- If you get any side effects talk to your doctor, hospital pharmacist or nurse. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva premix solution or the Docetaxel Teva infusion solution 
Pomembno je, da pred pripravo osnovne raztopine zdravila Docetaksel Teva ali raztopine za infundiranje Docetaksel Teva v celoti preberete ta navodila.
G3/4 AST increased 
povišanje ravni AST S
Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Zdravilo Docetaksel Teva v kombinaciji s kapecitabinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspeli citotoksični kemoterapiji.
What you need to know before you use Docetaxel Teva 
Kaj morate vedeti, preden boste uporabili zdravilo Docetaksel Teva Zdravila Docetaksel Teva NE smete dobiti:
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 enourni infuziji, ki mu sledi cisplatin 75 mg/m2 v enodo triurni infuziji (oboje samo prvi dan); temu sledi 5-fluorouracil 750 mg/m2 dnevno v 24-urni stalni infuziji 5 dni, z začetkom ob koncu infuzije cisplatina.
Alopecia; Skin reaction (G3/4: 0.8%) 
Bolezni kože in podkožja alopecija, kožna reakcija (S 3/4: 0,8 %)
First episode: reduce 5-FU dose by 20%. 
toksični učinek prilagoditev odmerka driska 3. stopnje prvi pojav: zmanjšajte odmerek 5-FU za 20 % drugi pojav: zmanjšajte odmerek docetaksela za 20 %
Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. 
Zdravilo Docetaksel Teva je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
Peripheral motor neuropathy (G3/4: 
periferna motorična nevropatija (S 3/4:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 80 mg/2,88 ml
Solvent vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap. 
Viala z vehiklom 6 ml viala tipa I iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
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
What the solvent vial contains: 
Ena kartonska škatla vsebuje:
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel. 
Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila Docetaksel Teva 80 mg/2,88 ml koncentrata za raztopino za infundiranje zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01). 
z 11 tedni, p = 0,0004) in podaljšal celotno preživetje (11 mesecev v prim.
Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p=0.002). 
10 letih je bilo značilno povečano v kraku TAC v primerjavi s FAC (76 % proti 69 %), t.j.
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol). 
Pomožne snovi z znanim učinkom: Ena viala koncentrata vsebuje 25,1 % (m/m) brezvodnega etanola (723 mg brezvodnega etanola).
Arrhythmia (G3/4: 1.0%) 
Srčne bolezni aritmija (S 3/4: 1,0 %)
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%) 
Bolezni prebavil navzeja (S 3/4: 9,6 %), bruhanje (S 3/4: 7,6 %), driska (S 3/4: 6,4 %), stomatitis (S 3/4: 2 %)
Nausea (G3/4: 13.9%); Stomatitis (G3/4: 
Bolezni prebavil navzeja (S 3/4: 13,9 %), stomatitis (S 3/4:
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population. 
*: korigirano za več primerjav in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 in combination with trastuzumab 
Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4). 
sakvinavirja, telitromicina in vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
• The Docetaxel Teva 80 mg/2.88 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml. 
• Viala zdravila Docetaksel Teva 80 mg/2,88 ml vsebuje raztopino docetaksela v polisorbatu 80 s koncentracijo 27,73 mg/ml.
Nail discolouration; Onycholysis (G3/4: 1%) 
obarvanje nohtov, oniholiza (S 3/4: 1 %)
Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills 
bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
What Docetaxel Teva looks like and contents of the pack: 
Izgled zdravila Docetaksel Teva in vsebina pakiranja
1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Docetaksel Teva 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
4.1 Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml) 
PRIPRAVA ZA INTRAVENSKO UPORABO 4.1 Priprava osnovne raztopine zdravila Docetaksel Teva (10 mg docetaksela/ml)
Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer 
Opis izbranih neželenih učinkov adjuvantnega zdravljenja z zdravilom Docetaksel Teva 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
Hazard ratio (95% CI) **p-value 
razmerje tveganja (95-odstotni interval zaupanja) **vrednost p
• Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C). 
• Osnovna raztopina: dokazano je, da je osnovna raztopina kemijsko in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 in 8°C ali pri sobni temperaturi (do 25°C).
p= Hazard ratio* 
95-% IZ p = razmerje tveganja*
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR. 
da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC) ali da bi docetaksel vplival na farmakokinetiko 5'-DFUR, pomembnega presnovka kapecitabina.
Myalgia (G3/4: 0.6%) 
aritmija (S 3/4: 0,6 %)
Anorexia (G3/4: 1%); Decreased appetite 
Presnovne in prehranske motnje anoreksija (S 3/4: 1 %), zmanjšan apetit dehidracija (S 3/4: 2 %)
• muscle aches and pains; back pain or bone pain 
• bolečine v mišicah, bolečine v hrbtu ali kosteh;
75 to 60 mg/m². 
20 mg/0,72 ml na vialo.