natgillin/translations-raw huggingface dataset:
Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Zentiva: - SJS/TEN sympoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. 
Teške kožne tegobe poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantematozne pustuloze (AGEP) prijavljene su kod primjene lijeka Docetaxel Zentiva: - Simptomi Stevens-Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize TEN) mogu uključivati pojavu mjehurića, guljenje ili krvarenje bilo kojeg dijela kože (uključujući usne, oči, usta, nos, genitalije, šake ili stopala) sa ili bez pojave osipa.
Docetaxel Zentiva in combination with trastuzumab 
Docetaxel Zentiva u kombinaciji s trastuzumabom
Docetaxel Zentiva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Zentiva solutions. 
Docetaxel Zentiva je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine lijeka Docetaxel Zentiva.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm). 
Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m primijenjen jedan sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m
- For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in combination with cisplatin. 
- Za liječenje karcinoma pluća Docetaxel Zentiva se primjenjuje sam ili u kombinaciji s cisplatinom.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days. 
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P) 75 mg/m te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
• Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles 
Standard liječenja + docetaksel 75 mg/m2, primijenjen svaka 3 tjedna u 6 ciklusa
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m². 
Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m na 75 mg/m i/ili sa 75 mg/m na 60 mg/m
b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first. 
b Vrijeme do karcinoma prostate rezistentnog na kastraciju = vrijeme od randomizacije do povećanja PSA ili kliničke progresije bolesti (npr. porast simptomatskih metastaza u kostima, progresija bolesti prema Kriterijima ocjene odgovora kod solidnih tumora [eng.
- For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil. 
- Za liječenje karcinoma glave i vrata Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days. 
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
If Docetaxel Zentiva concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Ako Docetaxel Zentiva koncentrat, ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
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 bolesnika koji su docetaksel primali svaka tri tjedna u studiji liječenja karcinoma prostate, 209 bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
Oedema (G3/4: 1.2%) 
edem (G3/4: 1,2%)
G3/4 AST increased 
G3/4 ALT povišen
95% CI p-valuea* 
95% CI p-vrijednosta*
Docetaxel Zentiva in combination with capecitabine 
Docetaxel Zentiva u kombinaciji s kapecitabinom
If this happens, you must tell your doctor immediately 
Odmah obavijestite svog liječnika ako se to dogodi
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08). 
Sigurnost i djelotvornost docetaksela primijenjenog istovremeno sa standardom liječenja (terapija deprivacije androgena, ADT) u bolesnika s visokorizičnim lokalno uznapredovalim ili metastatskim karcinomom prostate osjetljivim na hormone ocijenjene su u randomiziranoj multicentričnoj studiji s više skupina i više stupnjeva (engl. multi-arm multi-stage, MAMS) s dizajnom bez prijelaza faza II/III (engl. seamless phase II/III design)(STAMPEDE - MRC PR08).
Description of selected adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer 
Opis odabranih nuspojava za adjuvantno liječenje za Docetaxel Zentiva 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
Docetaxel Zentiva in combination with doxorubicin 
Docetaxel Zentiva u kombinaciji s doksorubicinom
Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data 
Tablični popis nuspojava za adjuvantno liječenje za Docetaxel Zentiva 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646). 
Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda=0 ,84, 95% CI (0,65-1,08), p=0,1646).
Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel. 
Pri primjeni docetaksela, zabilježeni su kožni lupus eritematodes, bulozne erupcije poput eritema multiforme i teških kožnih nuspojava poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) ) i akutne generalizirane egzantemozne pustuloze (AGEP).
Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%) 
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 
Docetaxel Zentiva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju.
3 years 
svaka 3 tjedna.
Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone 
Tablični popis nuspojava kod metastatskog karcinoma prostate rezistentnog na kastraciju za Docetaxel Zentiva 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy. 
Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu lijeka Docetaxel Zentiva za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
Efficacy of docetaxel in the induction treatment of patientswith locally advanced SCCHN (Intent-toTreat Analysis) 
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
Aseptically withdraw the required amount of Docetaxel Zentiva concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle. 
Rabeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu Docetaxel Zentiva koncentrata za otopinu za infuziju.
In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis). 
(TCis), ili docetaksel 75 mg/m u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m primijenjen tijekom 6 do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
• 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 nakon koje slijedi kemoradioterapija (TAX 324) Sigurnost 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).
- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil. 
- Za liječenje uznapredovalog karcinoma želuca Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4: 
Poremećaji živčanog sustava disgeuzija (G3/4: periferna senzorna neuropatija (G3/4:
A study of 14C-docetaxel has been conducted in three cancer patients. 
C-docetaksela na tri osobe s karcinomom.
MARKETING AUTHORISATION NUMBER EU/1/07/384/005 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/005
Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%) 
astenija (G3: 0%) retencija tekućine vrućica (G3: 1%) oralna kandidijaza hipokalcijemija (G3: 0%) hipofosfatemija (G3-4: 1%) hipokalijemija (G3: 0%)
Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for DOCETAXEL 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study) 
Tablični popis nuspojava kod visokorizičnog lokalno uznapredovalog ili metastatskog karcinoma prostate osjetljivog na hormone za DOCETAXEL ZENTIVA 75 mg/m u kombinaciji s prednizonom ili prednizolonom i terapijom deprivacije androgena (ADT) (studija STAMPEDE)
In some cases (frequency not known) 
U pojedinim slučajevima (nepoznata učestalost) primijećen je trajan gubitak kose
Docetaxel Zentiva 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. 
Docetaxel Zentiva 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.
For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dosereduction 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 puta od GGN te serumskom alkalnom fosfatazom > 6 puta od GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate. 
NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadržava 20 mg docetaksela u obliku docetaksel trihidrata.
MARKETING AUTHORISATION NUMBER EU/1/07/384/004 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/004
Rare cases of ileus and intestinal obstruction have been reported. 
Zabilježeni su slučajevi insuficijencije bubrega i zatajenja bubrega.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 160 mg/8 ml
MARKETING AUTHORISATION NUMBER EU/1/07/384/003 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/003
Package leaflet: Information for the patient Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel 
Uputa o lijeku: Informacije za bolesnika Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 160 mg/8 ml sterilni koncentrat docetaksel
Adjusted hazard ratio 95% CI p-value* 
Prilagođeni omjer hazarda 95% CI p-vrijednost*
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/m 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/m po danu u trajanju od 5 dana.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 20 mg/1 ml
Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy. 
Docetaxel Zentiva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml. 
U bočici Docetaxel Zentiva 160 mg/8 ml, koncentracija docetaksela iznosi 20 mg/ml.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
In addition, 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. 
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.
Docetaxel Zentiva 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. 
Docetaxel Zentiva 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.
Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients 
Docetaxel Zentiva u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 20 mg/1 ml sterilni koncentrat docetaksel
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 %) 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. 
U GEICAM 9805 studiji, amenoreja je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION 
UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 160 mg/8 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Docetaxel Zentiva 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. 
Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 80 mg/4 ml
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion. 
NAZIV LIJEKA Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion 
NAZIV LIJEKA Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%) 
hipotenzija (G3/4: flebitis (G3/4: 0%)
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom, koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion 
NAZIV LIJEKA Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju
Docetaxel Zentiva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Docetaxel Zentiva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
Alopecia; Skin reaction (G3/4: 
Poremećaji kože i potkožnog tkiva alopecija; kožna reakcija (G 3/4:
Skin reaction (G3/4: 
Manje česte nuspojave kožna reakcija (G3/4:
Peripheral sensory neuropathy (≥G3: 2%)a 
Poremećaji živčanog sustava periferna senzorna neuropatija (≥G3: 2%)
Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab 
Opis odabranih nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
(75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days). 
u kombinaciji sa cisplatinom (C) (75 mg/m prvi dan) i 5-fluorouracilom (F) (750 mg/m dnevno kroz
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 80 mg/4 ml sterilni koncentrat docetaksel
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 160 mg/8 ml
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2). 
Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
Docetaxel Zentiva 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. 
Docetaxel Zentiva u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION 
UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 20 mg/1 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab 
Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 20 mg/1 ml