natgillin/translations-raw huggingface dataset:
TAXOTERE 80 mg/2 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 80 mg/2 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.
Time to castration-resistant prostate cancerb 
Čas do raka prostate, odpornega proti kastracijib
Mix the infusion bag or bottle manually using a rocking motion. 
Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
1 vial of TAXOTERE 80 mg/2 ml concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ml) Fill: 94.4 mg/2.36 ml 
1 viala zdravila TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje 80 mg docetaksela v 2 ml polisorbata 80 (40 mg/ml) Polnitev: 94,4 mg/2,36 ml
TAXOTERE in combination with trastuzumab 
Zdravilo TAXOTERE v kombinaciji s trastuzumabom
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v). 
Ena viala z enim odmerkom vehikla vsebuje 13 % (m/m) 95 % (v/v) etanola v vodi za injekcije (252 mg 95% (v/v) etanola).
The required volume of TAXOTERE concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Potrebno količino koncentrata za raztopino za infundiranje zdravila TAXOTERE je treba vbrizgati preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
combined with capecitabine at 1250 mg/m twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period. 
V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m2 na tri tedne, kombiniran s kapecitabinom 1.250 mg/m2 dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
4.2 Preparation of the infusion solution 
4.2 Priprava raztopine za infundiranje
1 vial of TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ml) Fill: 24.4 mg/0.61 ml 
1 viala zdravila TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje 20 mg docetaksela v 0,5 ml polisorbata 80 (40 mg/ml) Polnitev: 24,4 mg/0,61 ml
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). 
Tudi celotno preživetje pri 10 letih je bilo značilno povečano pri TAC v primerjavi z FAC (76 % proti 69 %) t.j.
The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections. 
Vehikel za zdravilo TAXOTERE je 13 % (m/m) raztopina 95 % etanola v vodi za injekcije.
TAXOTERE is supplied as single-dose vials. 
Zdravilo TAXOTERE je na voljo v vialah z enim odmerkom.
• 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/m as a 1 hour infusion followed by cisplatin 75 mg/m over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m 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.
Each box contains one vial of 8 ml concentrate (160 mg docetaxel). 
Vsaka škatla vsebuje 1 vialo z 8 ml koncentrata (160 mg docetaksela).
TAXOTERE 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 TAXOTERE je indiciran v kombinaciji s trastuzumabom 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 GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups. 
Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
Peripheral motor neuropathy (G3/4: 
periferna motorična nevropatija (S3/4:
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m on day 1) in combination with cisplatin (C) (75 mg/m on day 1) and 5-fluorouracil (F) 
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/m2 1. dan) in 5-fluorouracilom (F) (750 mg/m2 na dan, 5 dni), bodisi cisplatin (100 mg/m2 1. dan) in 5fluorouracil (1000 mg/m2 na dan, 5 dni).
7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate. 
7 ml viala iz prozornega stekla tipa I z zeleno aluminijasto zaporko in zeleno dvižno zaporko z 1 ml koncentrata.
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v). 
Ena viala z enim odmerkom vehikla vsebuje 13% (m/m) 95 % (v/v) etanola v vodi za injekcije (932 mg 95 % (v/v) etanola).
15 ml clear glass Type I vial with a red flip-off cap. 
15-ml viala iz prozornega stekla tipa I z rdečo dvižno zaporko.
Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study(TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years. 
Od 333 bolnikov z rakom prostate v študiji, ki so bili zdravljeni z docetakselom vsake tri tedne, je bilo 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih nad 75 let.
What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections. 
Kaj vsebuje viala z vehiklom: 13 % (m/m) 95 % etanola (glejte poglavje 2) v vodi za injekcije
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm. 
V kraku s TCF je ciklus zdravljenja trajal 3 tedne, v kraku s
Overall survival (Primary end-point): 
statistična analiza celotno preživetje (primarna končna točka) mediana preživetja (meseci)
VIAL LABEL / TAXOTERE 160 mg/8 ml 
NALEPKA NA VIALI/TAXOTERE 160 mg/8 ml
Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous). 
Ena viala z enim odmerkom zdravila TAXOTERE 80 mg/2 ml koncentrat vsebuje docetaksel (kot trihidrat), ki ustreza 80 mg brezvodnega docetaksela.
Patients with baseline neutrophil count of < 1,500 cells/mm 
Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Nausea (G3/4: 13.9%); Stomatitis (G3/4: 
Bolezni prebavil navzea (S3/4: 13,9 %), stomatitis (S3/4:
Each box contains one vial of 4 ml concentrate (80 mg docetaxel). 
Vsaka škatla vsebuje 1 vialo s 4 ml koncentrata (80 mg docetaksela).
• Docetaxel 75 mg/m every 3 weeks for 10 cycles. 
• Docetaksel 75 mg/m2 vsake 3 tedne, 10 ciklov.
Cautions for use in adjuvant treatment of breast cancer 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 bolnicah starih > 70 let je malo.
Prednisone or prednisolone 5 mg orally twice daily may be administered continuously. 
Nepretrgano je mogoče uporabljati 5 mg prednizona ali prednizolona peroralno dvakrat na dan.
- The other ingredients are polysorbate 80 and citric acid. 
- Pomožni snovi sta polisorbat 80 in citronska kislina.
• The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml. 
• Viala zdravila TAXOTERE 80 mg/2 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap. 
Koncentrat je opremljen v 15-ml prozorni brezbarvni viali iz stekla tipa I z modro aluminijasto zaporko in z modro dvižno zaporko.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported. 
Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
• operable node-negative breast cancer . 
• operabilnim rakom dojke z negativnimi bezgavkami.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain). 
Namen tega je minimaliziranje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila TAXOTERE, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests. 
Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer. 
biokemičnega neuspeha (opredeljenega kot zvišanje PSA za 50 % nad 24-tedensko obdobje znotraj najnižje vrednosti in nad 4 ng/ml ter potrjenega s ponovnim testiranjem ali z zdravljenjem); napredovanja bodisi lokalno, v bezgavkah ali oddaljenih metastaz; skeletnega dogodka; smrti zaradi raka prostate.
FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years). 
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).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial). 
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
VIAL/TAXOTERE 20 mg/0.5 ml 
VIALA/TAXOTERE 20 mg/0,5 ml
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine. 
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 3,16 g brezvodnega etanola na vialo; kar ustreza 80 ml piva ali 33 ml vina.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid. 
- Pomožni snovi sta polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina.
VIAL LABEL / TAXOTERE 20 mg/1 ml 
NALEPKA NA VIALI/TAXOTERE 20 mg/1 ml
• oral candidiasis 
• oralna kandidoza
The concentrate is supplied in a 7 ml clear colourless glass vial with a green aluminium seal and a green plastic flip-off cap. 
Koncentrat je opremljen v 7-ml prozorni brezbarvni viali iz stekla tipa I z zeleno aluminijasto zaporko in z zeleno dvižno zaporko.
SOLVENT for TAXOTERE 
Shranjevanje zdravila TAXOTERE
Each ml of concentrate for solution for infusion contains 20 mg docetaxel. 
En ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela.
• Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml). 
• Ena viala zdravila TAXOTERE 80 mg/2 ml vsebuje 2,0 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 94,4 mg/2,36 ml).
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C. 
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
• The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap. 
• Viala zdravila TAXOTERE 80 mg/2 ml je 15-ml viala iz prozornega stekla z rdečo dvižno zaporko.
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills 
Splošne težave in spremembe na mestu aplikacije astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. 
Zdravilo TAXOTERE je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
FAC patients (17.0%). 
in pri 5 bolnicah (1,0 %) v kraku FAC.
• Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml). 
• Ena viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje 0,5 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,61 ml).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial). 
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
• The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap. 
• Viala zdravila TAXOTERE 20 mg/0,5 ml je 7-ml viala iz prozornega stekla z zeleno dvižno zaporko.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 
Bolezni živčevja periferna senzorična nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
TAXOTERE in combination with platinum agents in chemotherapy-naïve patients 
Zdravilo TAXOTERE v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
• The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml. 
• Viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
- If you get any side effects talk to your doctor, hospital pharmacist or nurse. 
- Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test 
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test ***Hi - kvadrat test
Peripheral sensory neuropathy (≥G3: 2%) 
Bolezni živčevja periferna senzorična nevropatija (≥ 3. st.: 2 %)a glavobol omotica
If you get any side effects talk to your doctor, hospital pharmacist or nurse. 
Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
• Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion. 
• Potem jo vbrizgajte preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
VIAL/TAXOTERE 80 mg/2 ml 
VIALA/TAXOTERE 80 mg/2 ml
Vomiting (G3/4: 3%) 
trombocitopenija (S3/4: 3 %)
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval 
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid
For metastatic castration-resistant 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 metastatskega, proti kastraciji odpornega 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).
TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. 
Zdravilo TAXOTERE v kombinaciji z doksorubicinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
Following the administration of a 100 mg/m dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml. 
3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Adjusted hazard ratio 95% CI p-valuea 
Prilagojeno razmerje ogroženosti 95 % IZ
TAXOTERE 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Zdravilo TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle. 
• S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za injiciranje.
• haemorrhage 
• vnetje požiralnika
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial). 
NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2. 
Priporočeno odmerjanje docetaksela je 75 mg/m2.
In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml. 
V zdravilu TAXOTERE 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
Myalgia (severe: 1.4%) Arthralgia 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (huda: 1,4 %) artralgija
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine. 
Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 1,58 g brezvodnega etanola na vialo; kar ustreza 40 ml piva ali 17 ml vina.
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%) 
Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
VIAL LABEL / TAXOTERE 80 mg/4 ml 
NALEPKA NA VIALI/TAXOTERE 80 mg/4 ml
Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value 
Najboljši celotni odziv (CR + PR) na raziskovano terapijo [kemoterapija +/kemoradioterapija] (%) (95 % IZ) ***Vrednost p
Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml) 
Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila TAXOTERE (10 mg docetaksela/ml)
Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains: 
En pretisni omot zdravila TAXOTERE 20 mg/0,5 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
• 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/m as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m 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
2 ml (Fill 2.36 ml) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 ml (polnitev 2,36 ml)
• operable node-positive breast cancer 
• operabilnim rakom dojke s pozitivnimi bezgavkami
Anorexia (G3/4: 1%); Decreased appetite 
Presnovne in prehranske motnje anoreksija (S3/4: 1 %), zmanjšan apetit dehidracija (S3/4: 2 %),
95% CI p-valuea 
95 % IZ p =
• 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).
Cautions for use in gastric adenocarcinoma cancer 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.
Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains: 
En pretisni omot zdravila TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
• blood clots 
• krvni strdki
Venous disorder (G3/4: 
Žilne bolezni venske motnje (S3/4: