natgillin/translations-raw huggingface dataset:
At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm. 
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 10 godina i 5 mjeseci), niti jedan bolesnik u TAC skupini nije imao CHF, 1 bolesnik u TAC skupini preminuo je zbog dilatacijske kardiomiopatije, a CHF je i dalje bio prisutan u 1 bolesnika (0,2%) u FAC skupini.
Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m every 3 weeks for 6 cycles. 
Metastatski karcinom prostate osjetljiv na hormone Preporučena doza docetaksela iznosi 75 mg/m svaka 3 tjedna u 6 ciklusa.
• Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml. 
• Jedna bočica otapala za TAXOTERE 20 mg/0,5 ml sadrži 1,98 ml.
TAXOTERE vial: polysorbate 80, citric acid. 
TAXOTERE bočica: polisorbat 80, citratna kiselina.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. 
4.1.4 Uklonite štrcaljku i iglu te ručno promiješajte okretanjem bočice gore-dolje najmanje 45 sekundi.
There is no relevant use of TAXOTERE 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. 
Nema relevantne primjene lijeka TAXOTERE u pedijatrijskoj populaciji za indikacije karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma prostate, karcinoma želuca i karcinoma glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III.
Concentrate and solvent for solution for infusion. 
OBLIK Koncentrat i otapalo za otopinu za infuziju.
*a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC. 
* omjer hazarda (TAC/FAC) manji od 1 prikazuje da je TAC povezan sa dužim preživljenjem bez znakova bolesti u usporedbi sa FAC-om.
What TAXOTERE concentrate vial contains - The active substance is docetaxel (as trihydrate). 
Što TAXOTERE bočica s koncentratom sadrži - Djelatna tvar je docetaksel (u obliku trihidrata).
Headache (G3/4: < 1%); Neuropathy peripheral 
omaglica; glavobolja (G3/4: <1%); periferna neuropatija
Efficacy results in metastatic prostate cancer patients for docetaxel arm versus control arm are summarized in the following table: 
Rezultati za djelotvornost kod bolesnika s metastatskim karcinomom prostate u skupini liječenoj docetakselom u odnosu na kontrolnu skupinu prikazani su u sljedećoj tablici:
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). 
Sveukupno preživljenje nakon 10 godina bilo je također značajno poboljšano u TAC skupini u usporedbi sa FAC skupinom (76% prema 69%), što znači da je apsolutni rizik od smrti smanjen za 7% (p=0,002).
• 545 patients (STAMPEDE study) who received docetaxel in combination with prednisone or prednisolone and ADT. 
• 545 bolesnika (studija STAMPEDE) koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom i terapijom deprivacije androgena (ADT).
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. 
Docetaksel se pokazao citotoksičnim in vitro prema raznim linijama mišjih i ljudskih tumorskih stanica, te prema svježe izdvojenim ljudskim tumorskim stanicama u klonogenim ispitivanjima.
If the vials are stored under refrigeration, allow the required number of boxes of TAXOTERE concentrate for solution for infusion to stand below 25°C for 5 minutes before use. 
Ako su bočice pohranjene u hladnjaku, izvadite potreban broj kutija TAXOTERE koncentrata za otopinu za infuziju iz hladnjaka i ostavite ih na temperaturi ispod 25°C 5 minuta prije primjene.
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents. 
Težina nuspojava lijeka TAXOTERE može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
TAXOTERE in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. 
TAXOTERE u kombinaciji s terapijom deprivacije androgena (engl. androgen deprivation therapy, ADT), s ili bez prednizona ili prednizolona, indiciran je za liječenje bolesnika s metastatskim karcinomom prostate osjetljivim na hormone.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial. 
Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj bočice otapala za TAXOTERE djelomično okrećući bočicu otapala naopako.
This medicine should not be used after the expiry date shown on the carton, blister pack and vials. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, zaštitnom blister pakiranju i bočicama.
Docetaxel n = 94 
Docetaksel n=94
Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, France 
Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, Francuska
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient. 
4.2.1 Ponekad je potrebno upotrijebiti više od jedne bočice s pripremljenom otopinom koncentrata kako bi se dobila potrebna doza za bolesnika.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC. 
Manje su se davali morfinski analgetici (p<0,01), ne morfinski analgetici (p<0,01), ostali lijekovi povezani s bolesti (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom 75 mg/m nego onima iz skupine BSC.
PSA response** at 6 months - N(%) p-valuea* 
PSA odgovor** u 6. mjesecu - N(%) p-vrijednosta*
This volume has been established based on the fill volume of the TAXOTERE 80 mg/2 ml vial. 
Taj volumen utvrđen je na temelju volumena punjenja bočice TAXOTERE 80 mg/2 ml.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent. 
Za liječenje nakon neuspjeha prethodne kemoterapije temeljene na platini, preporučuje se doza od 75 mg/m u monoterapiji.
TAXOTERE is supplied as single-dose vials. 
TAXOTERE je dostupan u jednodoznim bočicama.
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/m every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment). 
Za adjuvantno liječenje operabilnog karcinoma dojke s pozitivnim i negativnim limfnim čvorovima, preporučena doza docetaksela od 75 mg/m primjenjuje se 1 sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m svaka 3 tjedna tijekom 6 ciklusa (TAC protokol; vidjeti također 'Prilagodba doze tijekom liječenja').
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis. 
Teške promjene noktiju karakterizirali su hipo- ili hiperpigmentacija ponekad praćene boli i oniholizom.
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume". 
Ovaj volumen punjenja utvrđen je tijekom razvoja lijeka TAXOTERE kako bi se nadoknadio gubitak tekućine kod pripreme otopine koncentrata zbog pjenjenja, adhezije na stijenku bočice i neiskoristivog volumena koji zaostaje u bočici.
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm 
Bolesnicima koji početnu dozu docetaksela od 75 mg/m primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25.000 stanica/mm
This volume has been established based on the fill volume of the TAXOTERE 20 mg/0.5 ml vial. 
Taj volumen utvrđen je na temelju volumena punjenja bočice TAXOTERE 20 mg/0,5 ml.
50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m 
50 mg/m nakon kojeg slijedi fluorouracil 500 mg/m i ciklofosfamid 500 mg (FAC skupina).
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack. 
Jedna kutija sadrži jednu bočicu TAXOTERE (80 mg/2 ml) i jednu bočicu otapala za TAXOTERE u zaštitnom blister pakiranju.
Constipation (severe: 
konstipacija (teška:
Ethanol 95% Water for injections. 
Bočica s otapalom: etanol 95% voda za injekciju.
Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%. 
Prilagodba doze Proljev stupnja 3 Prva epizoda: smanjiti dozu 5-FU za 20%.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. 
Nakon dodavanja u infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna je 6 sati pri temperaturi do 25°C.
The viscous solution contains 40 mg/ml docetaxel (anhydrous). 
Viskozna otopina sadrži 40 mg/ml docetaksela (bezvodnog).
Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml) 
Priprema Taxotere otopine koncentrata (10 mg docetaksela / ml)
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. 
TAXOTERE u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m 
U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m u kombinaciji s doksorubicinom (50 mg/m
In these metastatic prostate cancer patients, the median overall survival was significantly longer in docetaxel treatment groups than in the standard of care alone group, with a median overall survival 19 months longer with the addition of docetaxel to standard of care (HR = 0.76, 95% CI = 0.62-0.92, p=0.005). 
U navedenih bolesnika s metastatskim karcinomom prostate, medijan ukupnog preživljenja bio je značajno duži u skupinama liječenima docetakselom u odnosu na skupinu liječenu samo standardom liječenja, s 19 mjeseci dužim medijanom ukupnog preživljenja uz dodatak docetaksela standardu liječenja (omjer hazarda = 0,76, 95%CI= 0,62-0,92, p=0,005).
TAXOTERE in combination with capecitabine 
TAXOTERE u kombinaciji s kapecitabinom
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2. 
slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m
Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack. 
Jedna kutija sadrži jednu bočicu TAXOTERE (20 mg/0,5 ml) i jednu bočicu otapala za TAXOTERE u zaštitnom blister pakiranju.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m 
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
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m in phase I studies. 
Farmakokinetička svojstva docetaksela ispitivala su se u kliničkim ispitivanjima faze I u bolesnika s karcinomom nakon primjene 20 - 115 mg/m2.
Adjusted hazard ratio 95% CI p-valuea 
Prilagođeni omjer hazarda 95% CI p-vrijednosta
30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m 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/m 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).
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills 
Opći poremećaji i reakcije na mjestu primjene astenija; periferni edem; pireksija; umor; upala sluznice; bol; bolest slična gripi; bol u prsima; zimica letargija
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis) 
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
The European Medicines Agency has waived the obligation to submit the results of studies with TAXOTERE in all subsets of the paediatric population in 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 (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove izuzela obvezu podnošenja rezultata ispitivanja lijeka TAXOTERE u svim podskupinama pedijatrijske populacije za karcinom dojke, karcinom nemalih stanica pluća, karcinom prostate, karcinom želuca i karcinom glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Prostate cancer Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2. 
Metastatski karcinom prostate rezistentan na kastraciju Preporučena doza docetaksela iznosi 75 mg/m2.
Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide. 
Ventrikularna aritmija uključujući i ventrikularnu tahikardiju (učestalost nije poznata),ponekad smrtonosnu, prijavljena je u bolesnika liječenih docetakselom u kombiniranim režimima koji uključuju doksorubicin, 5-fluorouracil i/ili ciklofosfamid.
Single-use vial. 
Bočica za jednokratnu upotrebu.
Docetaxel regimen was administered in combination with prednisone or prednisolone 5 mg twice daily continuously. 
Režim s docetakselom primjenjivao se u kombinaciji s prednizonom ili prednizolonom 5 mg dva puta dnevno, kontinuirano.
Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis) 
Analiza podskupina - adjuvantno liječenje bolesnika s karcinomom dojke s negativnim limfnim čvorovima ("Intent-to-Treat" analiza)
1060 patients were randomised to receive either TAXOTERE 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m 
1060 bolesnika randomizirano je u skupine koje su primale ili TAXOTERE 75 mg/m primijenjen jedan sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m
See also section “ TAXOTERE contains ethanol (alcohol)” below. 
Pogledajte također dio „TAXOTERE sadrži etanol (alkohol)“ dalje u tekstu.
See also section “TAXOTERE contains ethanol (alcohol)” below. 
Pogledajte također dio "TAXOTERE sadrži etanol (alkohol)" dalje u tekstu.
(750 mg/m per day for 5 days) or cisplatin (100 mg/m on day 1) and 5-fluorouracil (1000 mg/m per day for 5 days). 
5 dana) ili cisplatinom (100 mg/m prvi dan) i 5-fluorouracilom (1000 mg/m dnevno kroz 5 dana).
Both regimens were administered on day 1 every 3 weeks. 
Oba kemoterapijska protokola primjenjivala su se na dan jedan svaka 3 tjedna.
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. 
TAXOTERE je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine TAXOTERE.
- For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin. 
- Za liječenje karcinoma pluća TAXOTERE se primjenjuje sam ili u kombinaciji s cisplatinom.
• 332 patients (TAX327) who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). 
• 332 bolesnika (TAX 327) koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
• Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25°C). 
• Infuzijska otopina: infuzijska otopina mora se upotrijebiti unutar 4 sata nakon priprave, uz čuvanje na sobnoj temperaturi (ispod 25°C).
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 
Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + 5-FU * Coxov model (prilagodba prema primarnom mjestu tumora, T i N kliničkim stadijima te PSWHO)
c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion). 
povećani simptomi metastaza u kostima; progresija prema RECIST kriterijima; ili pogoršanje kliničke slike zbog raka prema mišljenju ispitivača)
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm 
Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration. 
Istodobna primjena docetaksela, doksorubicina i ciklofosfamida ne utječe na njihovu farmakokinetiku.
One vial contains 20 mg/0.5 ml docetaxel. 
Jedna bočica sadržava 20 mg/0,5 ml docetaksela.
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). 
oC) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon 5 minuta zbog polisorbata 80 u sastavu).
A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion. 
Ukupno 449 bolesnika je randomizirano kako bi primili ili docetaksel 100 mg/m u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m u trosatnoj infuziji.
Median (months) 95% CI 
Medijan (mjeseci) 95% CI
95% CI p-valuea 
95% CI p-vrijednosta
• operable node-negative breast cancer . 
• operabilnim karcinomom dojke i negativnim limfnim čvorovima.
Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%) 
Infekcije i infestacije infekcija (G3/4: 2,4%); neutropenijska infekcija (G3/4: 2,6%)
The median overall survival was significantly longer in docetaxel treatment group than in the ADT alone group, with a median overall survival 13.6 months longer with the addition of docetaxel to ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.47-0.80, p=0.0003). 
Medijan ukupnog preživljenja bio je značajno duži u skupini liječenoj docetakselom nego u skupini liječenoj samo terapijom deprivacije androgena (ADT), s medijanom ukupnog preživljenja dužim za 13,6 mjeseci uz dodatak docetaksela terapiji deprivacije androgena (ADT) (omjer hazarda = 0,61; 95% interval pouzdanosti (CI) = 0,47-0,80; p=0,0003).
Pharyngitis (G3: 0%) 
faringitis (G3: 0%)
Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment. 
Prijavljene su ozbiljne kožne nuspojave poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantemozne pustuloze (AGEP) povezane s liječenjem docetakselom.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m². 
Bolesnicima u kojih se pojavi stomatitis stupnja 3 ili 4 treba smanjiti dozu na 60 mg/m Kombinacija s cisplatinom
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease. 
Provedena je multicentrična, randomizirana studija otvorenog tipa da bi se procijenila sigurnost i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%). 
U ispitivanju TAX 316 alopecija koja je i dalje bila prisutna tijekom perioda praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika (92,3%) u TAC skupini i 645 od 736 bolesnika (87,6%) u FAC skupini.
• Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.) 
• Akutna generalizirana egzantematozna pustuloza (AGEP) (crveni, ljuskasti široko rasprostranjeni osip s izbočinama ispod otečene kože (uključujući pregibe na koži, trup i gornje ekstremitete) i mjehuriće praćene vrućicom.)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/TAXOTERE 80 mg/2 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KONCENTRAT i OTAPALO/TAXOTERE 80 mg/2 ml
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms. 
U ovom je ispitivanju, u dvije skupine bio randomiziran 501 bolesnik s lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1.
Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT. 
U bilo koje vrijeme nakon završetka CRT, mogla se razmotriti operacija primarnog sijela bolesti i/ili vrata.
Prednisone or prednisolone 5 mg orally twice daily may be administered continuously. 
Prednizon ili prednizolon u dozi od 5 mg oralno dva puta dnevno mogu se primjenjivati kontinuirano.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) 
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324)
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5. 
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m kao 30-minutnu do trosatnu intravensku infuziju na dan 1, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m dnevno od dana 1 do dana 5.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/TAXOTERE 20 mg/0.5 ml 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP KONCENTRAT i OTAPALO/TAXOTERE 20 mg/0,5 ml