natgillin/translations-raw huggingface dataset:
Post-Menopausal * a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC. 
Po menopavzi *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
Tell your doctor or nurse immediately during or shortly after the infusion, you notice any of the following symptoms of allergic reactions (very common): - flushing, skin reactions, itching - chest tightness, difficulty in breathing - fever or chills - back pain - low blood pressure. 
Zdravnika ali medicinsko sestro nemudoma med ali po infuziji obvestite, če opazite katerega izmed naslednjih simptomov alergijske reakcije (zelo običajno): - rdečica, kožne reakcije, srbenje; - občutek utesnjenosti v prsih, težave z dihanjem; - vročica ali mrzlica; - bolečine v hrbtu;
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.
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 12 patients out of the 83 patients with peripheral sensory neuropathy at the end of the chemotherapy. 
Še prisotno periferno senzorično nevropatijo so pri spremljanju zabeležili pri 12 od 83 bolnicah, ki so imeli periferno senzorično nevropatijo ob koncu kemoterapije.
Hazard ratio* 
Razmerje tveganj*
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hrs at 2 to 8°C, unless reconstitution and further dilution has taken place in controlled and validated aseptic conditions. 
Če raztopine ne uporabimo takoj, moramo zagotoviti ustrezen čas roka uporabe in pogoje shranjevanja pred uporabo, po navadi je to do 24 ur pri temperaturi od 2 do 8 °C, razen če je bila v nadzorovanih in ustreznih aseptičnih pogojih raztopina znova pripravljena in razredčena.
Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8). 
Bolnike, ki prejemajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).
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.
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin. 
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo), kot so ciklosporin, terfenadin, ketokonazol, eritromicin in troleandomicin.
Important information about some of the ingredients of Docefrez 
Pomembne informacije o sestavinah v Docefrez
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection 
Nevtropenija (4. stopnje) Febrilna nevtropenija
Neutropenic infection 
nevtropenična okužba
In the node positive study (TAX316) one patient in each treatment arm died because of cardiac failure. 
V študijah pri bolnicah s pozitivnimi bezgavkami (TAX 316), je zaradi srčnega popuščanja umrla po ena bolnica v vsakem kraku.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported. 
Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
(G3/4 2.7%). 
(S3/4 2.7%).
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4. 
Docetaksel se metabolizira s CYP3A4, za prednizon pa je znano, da inducira
Age category 1 <50 years 
Starostna kategorija 1 < 50 let ≥ 50 let
• decreased number of white blood cells (may make you more prone to infections) 
• znižano število belih krvnih celic (dovzetnost za infekcije);
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly. 
Starostniki Za uporabo pri starostnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
There is no relevant use of docetaxel 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 docetaksel ni primerno za uporabo pri pediatrični populaciji 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.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART terms 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.
Solvent: Polysorbate 80 and ethanol, anhydrous 
Polisorbat 80 in etanol, brez vode
Additional cautions for use in adjuvant treatment of breast cancer For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2). 
Dodatna opozorila pri uporabi adjuvantne terapije raka dojke Pri bolnicah, ki doživijo komplicirano nevtropenijo (podaljšano nevtropenijo, febrilno nevtropenijo ali okužbo) je potrebno razmisliti o G-CSF in zmanjšanju odmerka (glejte poglavje 4.2).
WHAT DOCEFREZ IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO DOCEFREZ IN ZA KAJ GA UPORABLJAMO
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomized to one of two treatment arms. 
V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001). 
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126). 
Preživetje je bilo boljše v kraku s kombinacijo docetaksel + kapecitabin (p = 0,0126).
• pain in the joints or muscles 
• bolečine v mišičnih sklepih;
Docetaxel 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. 
Docefrez je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
Alopecia was observed to be ongoing during follow-up in 25 patients out of the 736 patients with alopecia at the end of the chemotherapy. 
Še prisotno alopecijo so pri spremljanju zabeležili pri 25 od 736 bolnicah, ki so imeli alopecijo ob koncu kemoterapije.
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).
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed (see table below): 
Podskupine bolnic, zdravljenih s TAC,so analizirali po prospektivno opredeljenih prognostičnih dejavnikih (glejte spodnjo preglednico):
Therefore, docetaxel must not be used during pregnancy unless clearly indicated. 
Zato se docetaksela med nosečnostjo ne sme uporabljati, razen če se jasno ne indicira.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy. 
primeru blažjih preobčutljivostnih reakcij, npr. pordevanja ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
METHOD OF ADMINISTRATION Read the package leaflet before use EXPIRY DATE 
POSTOPEK UPORABE Pred uporabo preberite brošuro v embalaži DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
Intravenous use 
Docetaksel Intravenska uporaba
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 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).
Myalgia (severe: 1.4%) Arthralgia 
Mialgija (huda: 1,4 %) Artralgija
Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported. 
V redkih primerih so bili opisani akutni respiracijski distres sindrom, intersticijska pljučnica in pljučna fibroza.
Ethanol This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose. 
Ta medicinski izdelek vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
of patients 
bolnikov
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO
The Netherlands tel: +31-23-5685501 fax: +31-23-5685505 
Nizozemska tel: +31-23-5685501 faks: +31-23-5685505
Peripheral oedema was observed to be ongoing during follow-up time in 18 patients out of the 112 patients with peripheral oedema at the end of the chemotherapy in study TAX 316, whereas lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy in the study GEICAM 9805. 
Še prisotne periferne edeme so pri spremljanju zabeležili pri 18 od 112 bolnicah, ki so imeli periferne edeme ob koncu kemoterapije v študiji TAX 316, limfedem pa je še trajal pri 4 od 5 bolnicah z limfedemom na koncu kemoterapije v študiji GEICAM 9805.
Median duration of response to chemotherapy ± radiotherapy (months) (95%CI) 
Mediano trajanje odziva na kemoterapijo ± radioterapijo (meseci) (95 % IZ)
Using a syringe with a needle, the entire contents of the correct vial of solvent for Docefrez is to be withdrawn and injected into the respective Docefrez powder vials. 
Z injekcijsko brizgo z nameščeno iglo izvlecite celotno vsebino ustrezne viale z vehiklom za Docefrez in jo vbrizgajte v ustrezne viale s praškom Docefrez.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138. 
• Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
total of 1006 patients with KPS≥60 were randomized to the following treatment groups: 
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
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).
Docetaxel every week Mitoxantrone every 3 weeks 
Mitoksantron vsake 3 tedne
Any solution containing a precipitate should be discarded. 
Če raztopina vsebuje precipitat, jo je treba zavreči.
This volume of concentrate should be injected into a 250 ml infusion bag or bottle containing either glucose 50 mg/ml (5%) solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
To količino koncentrata je treba injicirati v 250-mililitrsko infuzijsko vrečko ali steklenico, v kateri je bodisi 5-odstotna raztopina glukoze (50 mg/ml) ali 0,9-odstotna raztopina natrijevega klorida (9 mg/ml) za infundiranje.
Keep the vial in the outer carton in order to protect from light. 
Vialo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
(TAX 316) 
III (TAX323).
You must not use Docefrez if you are pregnant unless clearly indicated by your doctor. 
Docefrez NE smete dobiti, če ste noseči, razen čav vam zdravnik tako izrecno naloži.
No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide. 
Nobenih sprememb niso zabeležili pri bolnicah, ki so prejemale fluorouracil, doksorubicin in ciklofosfamid.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze a 4 minute, P 36 minut in y 11,1 ure.
Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemoterapy agents and/or radiotherapy. 
Poročali so o zelo redkih primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
Powder vial: 
Viala z vehiklom:
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics). 
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (> 5 %), o katerih so poročali v fazi III klinične študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
For example, a dose of 140 mg docetaxel would require one 80 mg pack and three 20 mg packs. 
Na primer, za odmerek od 140 mg docetaksela bo potreben en 80 miligramskoi pakiranje in tri 20 miligramska pakiranja.
Keep out of the reach and sight of children. 
Hranite izven dosega otrok.
Infusion site reaction 
Reakcija na mestu infundiranja
The Netherlands. 
Nizozemska.
• For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel / capecitabine treatment, delay treatment until resolved to Grade 0- 1, and resume at 100% of the original dose. 
• Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 ter znova uporabite 100 % izvirnega odmerka.
Docetaxel, derived from yew-tree needles, belongs to a group of anti-cancer medicines called taxanes. 
Docetaksel se pridobiva iz iz iglic tise in spada v skupino zdravil proti raku, imenovanih taksoidi.
Pain response rate (%) 
Odzivnost na bolečino (%)
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009. 
• Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0,009.
Keep the vial in the outer carton in order to protect from light 
Vialo hranite v zunanji embalaži, da jo zaščitite pred svetlobo
Overall 
celotno
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docefrez vial by partially inverting the vial. 
4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docefrez iz viale tako, da vialo delno obrnete.
Abdominal pain upper; Dry mouth 
Bolečine v zgornjem delu trebuha, suha usta
The docetaxel infusion solution should be used within 4 hours and should be aseptically administered as a 1 hour infusion under room temperature and normal lighting conditions. 
Infuzijsko raztopino docetaksela je treba uporabiti v 4 urah, odmeriti pa jo je treba aseptično v 1 uri pri sobni temperaturi in pri normalni osvetlitvi.
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported. 
Opisani so redki primeri dehidracije zaradi prebavnih motenj, gastrointestinalne perforacije, ishemični kolitis, kolitis in nevtropenični enterokolitis.
Overall survival was also significantly longer (p=0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%. 
V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
• decreased number of red bloods cells (anaemia, with symptoms of such as paleness, weakness) 
• okužbe, vključno s pljučnico in krvno zastrupitvijo • znižano število rdečih krvnih celic (slabokrvnost s simptomi kot so bledica, slabotnost);
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). 
ULN hkrati z alkalno fosfatazo > 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
Excipients: the solvent contains 35.4% (w/w) ethanol. 
Pomožne snovi: vehikel vsebuje 35,4 % (m/m) etanola.
Paresthesia; Headache; Dysgeusia; Hypoaesthesia 
Parestezije, glavobol, disgevzija, hipestezija
Arrhythmia (no severe) 
aritmija (nobene hude)
Do not use Docefrez after the expiry date which is stated on the carton and vial after EXP. 
Zdravila Docefrez ne uporabljajte po preteku roka uporabe, ki je naveden na embalaži in steklenički po POTEKU.
4.2.2 Inject the required volume of reconstituted solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali raztopina natrijevega klorida 9 mg/ml (0.9%) za infundiranje.
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 shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (> 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
The solvent contains small amounts of ethanol (alcohol), less than 100 mg per dose. 
To zdravilo vsebuje majhne količnine etanola (alkohola), manj kot 100 mg na odmerek.
The reconstituted solution should be used immediately after preparation. 
Pripravljeno raztopino uporabite nemudoma po pripravi.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: 
4.8 Neželeni učinki Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri:
Special handling precautions. 
Posebni previdnosti ukrepi ob uporabi.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. 
• Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3. 
Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p=0.0042 (median PFS: 11.4 vs. 8.3 months respectively) with an overall median follow up time of 33.7 months. 
Primarni končni cilji v tej študiji, preživetje brez napredovanja bolezni (PFS), je bilo signifikantno daljše na kraku TPF kot na kraku PF, p = 0,0042 (mediano PFS: 11,4 proti 8,3 meseca), celotni mediani čas spremljanja pa je bil 33,7 meseca.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docefrez 20 mg 
IME ZDRAVILA IN POT(I) UPORABE VEHIKEL za Docefrez 20 mg
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). 
Docetaksel ni vplival na celotni čas preživetja (docetaksel 15 mesecev, 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.
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills 
Astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica
• one single-dose solvent vial with 1 ml solvent for Docefrez 
• viala z enim odmerkom vehikla, to je 1 ml vehikla za zdravilo Docefrez
In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, 
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST > 1,5-kratna
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3. 
Docetaksela se ne sme uporabljati pri bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Docefrez is used, either alone or in combination with other medicines, for the treatment of the following kinds of cancer: - advanced breast cancer, alone or with doxorubicin, or trastuzumab, or capecitabine - early breast cancer with or without lymph node involvement, with doxorubicin and cyclophosphamide - non-small cell lung cancer (NSCLC), alone or with cisplatin - prostate cancer, with prednisone or prednisolone - metastatic gastric cancer, with cisplatin and 5-fluorouracil - head and neck cancer, with cisplatin and 5-fluorouracil. 
Docefrez se uporablja bodisi samostojno bodisi v kombinaciji z drugimi zdravili za zdravljenje naslednjih oblik raka: - za zdravljenje napredovalega raka dojke se lahko uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom; - za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se lahko uporablja v kombinaciji z doksorubicinom in ciklofosfamidom; - za zdravljenje pljučnega raka se lahko uporablja sam ali v kombinaciji s cisplatinom; - za zdravljenje raka prostate se lahko uporablja v kombinaciji s prednizonom ali prednizolonom; - za zdravljenje metastatskega raka želodca se uporablja v kombinaciji s cisplatinom in 5fluorouracilom; - za zdravljenje raka glave in vratu se zdravilo uporablja v kombinaciji s cisplatinom in 5fluorouracilom.
Special handling precautions 
Posebni previdnosti ukrepi ob uporabi
Hypotension; Hypertension; Haemorrhage 
Hipotenzija, hipertenzija, krvavitev
Docefrez contains the active substance docetaxel. 
Zdravilo Docefrez vsebuje aktivno substanco docetaksel.
PREPARATION FOR INTRAVENOUS ADMINISTRATION Do not use any PVC equipment or device. 
PRIPRAVA ZA INTRAVENSKO APLIKACIJO Ne uporabljajte PVC opreme ali naprav.
Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm. 
Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF.
Disease free survival 
Preživetje brez bolezni
It is important that you read the entire contents of this procedure prior to the preparation of either the Docefrez reconstituted solution or the Docefrez solution for infusion. 
Pomembno je, da pred pripravo osnovne raztopine Docefrez ali raztopine za infundiranje Docefrez v celoti preberete ta navodila.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years. 
209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih nad 75 let.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m2. 
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
No of positive nodes 
Št. pozitivnih bezgavk