natgillin/translations-raw huggingface dataset:
Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml). 
• Jedna bočica otapala sadrži 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
Best overall response (CR + PR) to chemotherapy (%) (95%CI) ***p-value 
Najbolji ukupni odgovor (CR + PR) na kemoterapiju (%) (95% CI) ***p- vrijednost
For patients with serum bilirubin levels >ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated. 
U bolesnika s razinama serumskog bilirubina > GGN i/ili ALT i AST > 3,5 x GGN te serumskom alkalnom fosfatazom > 6 x GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
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 otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 27,73 mg/ml docetaksela u polisorbatu 80.
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 kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), periferni edem je i dalje bio prisutan u 19 bolesnika (2,6%) u TAC skupini, odnosno u 4 bolesnika (0,5%) u FAC skupini.
Solvent vial: Water for injections 
Otapalo voda za injekcije
Hazard ratio: 1.032 [95% CI: 0.876; 1.216] 
Omjer rizika: 1,032 [95% CI: 0,876; 1,216]
Median PFS (months) (95% CI) 
Medijan PFS (mjeseci) (95% CI)
Vomiting (G3/4: 8.4%); 
povraćanje (G3/4: 8,4%);
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. 
Ako Docetaksel Teva koncentrat, pripremljena otopina koncentrata ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah treba dobro i temeljito isprati sapunom i vodom.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 
Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
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. 
GGN i/ili vrijednostima ALT i AST > 3,5 većim puta od GGN te alkalnom fosfatazom > 6 puta većom od GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
Lacrimation increased Conjunctivitis 
Poremećaji oka pojačano suzenje konjuktivitis
For those patients with serum bilirubin >ULN and/or 
Za bolesnike s vrijednostima serumskog bilirubina >
Neoplasms benign, 
docetaksela kao monoterapiju,
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone 
Tablični popis nuspojava kod karcinoma prostate za Docetaksel 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
Grade 2 
Gradus 2 Gradus 3
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) ODGOVORNAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
2.1 Docetaxel Teva 80 mg/2.88 ml vial: 
2.1 Docetaksel Teva 80 mg/2,88 ml bočica:
This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine. 
Ovaj lijek sadrži 50 vol% bezvodnoga etanola (alkohola), odnosno do 395 mg bezvodnoga etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina po bočici.
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 otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 27,73 mg/ml docetaksela u polisorbatu 80.
Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%) 
promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
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. 
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 intravenskom infuzijom na dan 1 nakon čega je slijedio cisplatin (P) 100 mg/m2 primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5-fluorouracila (F) 1000 mg/m2 na dan od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg/0.72 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - KONCENTRAT 20 mg/0,72 ml
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment). 
preporučena doza docetaksela od 75 mg/m2 primjenjuje se 1 sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 svaka 3 tjedna tijekom 6 ciklusa (TAC protokol) (vidjeti također
Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton. 
Jedna kutija sadrži jednu bočicu Docetaksel Teva (80 mg/2,88 ml) i jednu bočicu otapala za
Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton. 
Jedna kutija sadrži jednu bočicu Docetaksel Teva (20 mg/0,72 ml) i jednu bočicu otapala za
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). 
Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial. 
Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj bočice otapala za Docetaksel
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. 
Dodatkom cijelog sadržaja bočice otapala sadržaju bočice Docetaksel Teva 20 mg/0,72 ml koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
This vial contains 2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml). 
Bočica sadrži 2,88 ml otopine docetaksela u polisorbatu 80, koncentracije 27,73 mg/ml (volumen punjenja 94,4 mg/3,40 ml).
PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm 
ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora >5 cm Omjer rizika procijenjen je po Cox modelu proporcionalnog rizika s liječenom skupinom kao faktorom.
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. 
Za karcinome dojke i karcinome nemalih stanica pluća premedikacija se sastoji od oralnog kortikosteroida, poput 16 mg deksametazona na dan (primjerice, 8 mg dvaput na dan) tijekom 3 dana s početkom primjene jedan dan prije primjene docetaksela, osim u slučaju kad je to kontraindicirano.
Lacrimation increased; Conjunctivitis 
Poremećaji oka pojačano suzenje; konjuktivitis
Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel. 
Jedna bočica Docetaksel Teva 20 mg/0,72 ml koncentrata sadrži 20 mg docetaksela.
3 weeks for 4 cycles. 
tijekom 5 ciklusa.
Docetaxel Teva 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. 
Docetaksel Teva u kombinaciji s cisplatinom indiciran je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138. 
• Vrijeme do progresije bolesti (TTP) bilo je značajno dulje u AT skupini naspram AC skupine,
In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm. 
U ispitivanju TAX 316 periferna senzorna neuropatija počela je tijekom perioda liječenja te je bila prisutna i tijekom perioda praćenja u 84 bolesnika (11,3%) u TAC skupini i 15 bolesnika (2%) u FAC skupini.
Concentrate vial: 
Ako Docetaksel koncentrat,
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles. 
(uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G-CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel. 
Jedna bočica Docetaksel Teva 80 mg/2,88 ml koncentrata sadrži 80 mg docetaksela.
3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. 
Nakon završetka infuzije ciplatina slijedi kontinuirana infuzija 5-fluorouracilom 1000 mg/m2/dan od prvog do četvrtog dana.
Blood and lymphatic Neutropenia (G3/4: 
Poremećaji krvi i limfnog sustava neutropenija (G4:
• 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). 
• Pripremljena otopina koncentrata: Dokazana kemijska i fizikalna stabilnost u primjeni je 8 sati uz čuvanje na temperaturi od 2°C do 8° C ili pri sobnoj temperaturi (ispod 25°C).
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mijalgija
Solvent vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap. 
Prozirna staklena bočica od 6 ml (staklo tip I), s čepom od bromobutilne gume i s "flip-off" zatvaračem.
4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation). 
4.1.5 Ostavite bočicu s pripremljenom otopinom koncentrata na sobnoj temperaturi (ispod 25°C) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml) 
0,72 ml (Punjenje: 0,88 ml)
You must NOT be given Docetaxel Teva: 
Docetaksel Teva se NE smije primijeniti
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. 
Docetaksel Teva u kombinaciji s trastuzumabom indiciran je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
DODATAK II A. PROIZVOĐAČ(I) ODGOVORNA(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
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. 
Dodatkom cijelog sadržaja bočice otapala sadržaju bočice Docetaksel Teva 80 mg koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. 
Teva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
Gastrointestinal pain (G3/4: 1.2%); Gastrointestinal haemorrhage (G3/4: 
gastrointestinalna bol (G3/4: 1,2%); gastrointestinalno krvarenje (G3/4:
Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 
proljev (G3/4: 6,8%); ezofagitis/disfagija/ odinofagija (G3/4:
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. 
Docetaksel Teva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
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). 
Bez utjecaja na ukupno vrijeme preživljenja (docetaksel 15 mjeseci prema doksorubicinu 14 mjeseci, p= 0,38) ili na vrijeme do progresije bolesti (docetaksel
Constipation (G3/4: 0.4%) 
konstipacija (G3/4: 0,4%)
Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia 
konstipacija (G3/4: 1%); abdominalna bol (G3/4: 2%); dispepsija bol u gornjem abdomenu suhoća usta
Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm. 
Astenija koja je počela u periodu liječenja i bila prisutna u periodu praćenja zabilježena je u 12 bolesnika (2,3%) u TAC skupini i u 4 bolesnika (0,8%) u FAC skupini.
Best overall response to chemotherapy (%) (95%CI) ***p-value 
Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
• flushing, skin reactions, itching 
• navale crvenila, kožne reakcije, svrbež • stezanje u prsima, otežano disanje
Dyspepsia; Abdominal pain 
konstipacija; stomatitis; dispepsija; abdominalna bol
Number of patients Pain response rate (%) 95% CI p-value* 
Stopa smanjenja boli (%) 95% CI p-vrijednost *
Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap. 
Prozirna staklena bočica od 15 ml (staklo tip I), s čepom od bromobutilne gume i sa "flip-off" zatvaračem.
Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. 
Docetaksel Teva kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
• The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml. 
• Docetaksel Teva 20 mg/0,72 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide. 
Starije osobe Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
Median overall survival (months) (95%CI) 
Ukupni medijan preživljenja (mjeseci) (95% CI)
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent 
Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m2 u monoterapiji
5.12 ml (Fill: 6.29 ml) 
voda za injekcije 5,12 ml (Punjenje 6,29 ml)
Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%); 
Poremećaji krvi i limfnog sustava neutropenija (G3/4: 83,5%); anemija (G3/4: 12,4%); trombocitopenija (G3/4:
2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial: 
2.2 Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml:
• The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap. 
• Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml je prozirna staklena bočica od 6 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.
Doxorubicin 
Docetaksel
Docetaxel Teva 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. 
Docetaksel Teva u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
• oesophagitis 
• Otapalo za Docetaksel
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab 
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
• 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. 
• Docetaksel Teva 80 mg/2,88 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration. 
Poremećaji živčanog sustava Zabilježeni su rijetki slučajevi konvulzija ili prolaznog gubitka svijesti pri primjeni docetaksela.
Weight increased 
pojačano suzenje
Fever (G3/4: 1.2%) 
vrućica (G3/4: 1,2%)
75 years of age or greater versus less than 65 years. 
bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
• 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 praćena radioterapijom (TAX 323) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Ako Docetaksel Teva koncentrat, otopina koncentrata ili otopina za infuziju dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
- For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin. 
Za liječenje uznapredovalog karcinoma dojke, Docetaksel Teva se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 in combination with trastuzumab 
Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
General disorders and administration site conditions Radiation recall phenomena have rarely been reported. 
Rijetko je bio zabilježen fenomenodzivne reakcijske upalne reakcije.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported. 
Rijetko je zabilježena pojava suzenja s ili bez konjunktivitisa,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 80 mg/2.88 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO 80 mg/2,88 ml
VIAL LABEL - CONCENTRATE 80 mg/2.88 ml 
Teva 80 mg/2,88 ml
Dysgeusia (G3/4: 0%) 
limfedem (G3/4: 0%)
Esophagitis/dysphagia/odynophagia (G3/4: 12.0%); 
Poremećaji metabolizma i prehrane anoreksija (G3/4: 12,0%)
Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age. 
Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent. 
Bolesnici u TAC skupini primali su antibiotsku profilaksu s ciprofloksacinom 500 mg peroralno dvaput na dan u trajanju od 10
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. 
75 mg/m2 cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin 
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s doksorubicinom
G3/4 AST increased G3/4 Blood alkaline phosphatase increased 
G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
Cough (G3/4: 0%) 
sinkopa (G3/4: 0%)
• operable node-positive breast cancer • operable node-negative breast cancer 
• operabilnim karcinomom dojke i negativnim limfnim čvorovima.
• The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap. 
• Docetaksel Teva 20 mg/0,72 ml bočica je prozirna staklena bočica od 6 ml, s čepom od bromobutilne gume i "flip-off" zatvaračem.
Baseline cardiac assessment is recommended. 
Karnofski izvedbenom statusu.
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u kombinaciji s cisplatinom
TCF n=221 
n = 221
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 višestruku usporedbu i prilagođeno faktorima stratifikacije (stadij bolesti i regija liječenja) na osnovu podataka iz populacije bolesnika koji su se mogli procijeniti.
• The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap. 
• Docetaksel Teva 80 mg/2,88 ml bočica je prozirna staklena bočica od 15 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.