FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Croatian: Kombinacija s cisplatinom 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 3, u bolesnika koji su imali febrilnu neutropeniju ili u bolesnika s ozbiljnim nehematološkim toksičnim učincima, doza docetaksela u sljedećim ciklusima mora se smanjiti na 65 mg/m
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Croatian: U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom (1250 mg/m dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Docetaxel Zentiva 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Docetaxel Zentiva 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).
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly.
Croatian: U kombinaciji s trastuzumabom preporučena doza docetaksela iznosi 100 mg/m svaka tri tjedna, dok se trastuzumab primjenjuje svaki tjedan.
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Croatian: Rijetke pojave dehidracije zabilježene su kao posljedica gastrointestinalnih poremećaja, uključujući enterokolitis i gastrointestinalnu perforaciju.Rijetko su zabilježeni ileus i intestinalna opstrukcija.
English: You must not breast-feed while you are treated with Docetaxel Zentiva.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Docetaxel Zentiva.
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Croatian: slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m
English: 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).
Croatian: 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').
English: Docetaxel Zentiva in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Croatian: Docetaxel Zentiva u kombinaciji sa cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Croatian: Prema farmakokinetičkim podacima za monoterapiju docetakselom u dozi od 100 mg/m2, za bolesnike koji imaju povišene vrijednosti transaminaza (ALT i/ili AST) više od 1,5 puta od gornje granice normalnih vrijednosti (GGN) i alkalne fosfataze više od 2,5 puta od GGN, preporučena doza docetaksela je 75 mg/m
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Croatian: Analiza podskupina - adjuvantno liječenje bolesnika s karcinomom dojke s negativnim limfnim čvorovima (Intent-to-Treat analiza)
English: 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) **Log rank test *** Chi-square test
Croatian: Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + 5-FU * Coxov model (prilagodba prema primarnom tumorskom mjestu, T i N kliničkom stupnju te PSWHO)
English: Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m2 every 3 weeks for 6 cycles.
Croatian: Metastatski karcinom prostate osjetljiv na hormone Preporučena doza docetaksela iznosi 75 mg/m svaka 3 tjedna u 6 ciklusa.
English: How to use Docetaxel Zentiva
Croatian: Kako primjenjivati Docetaxel Zentiva
English: - If you have any further questions, ask your doctor, your hospital pharmacist or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
English: OTHER Contains anhydrous ethanol (see leaflet)
Croatian: Sadrži bezvodni etanol (vidjeti uputu o lijeku)
English: Discard unused contents appropriately in accordance with local requirements.
Croatian: Neiskorišteni lijek treba odgovarajuće zbrinuti u skladu s lokalnim propisima.
English: - AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
Croatian: - Simptomi akutne generalizirane egzantematozne pustuloze (AGEP) mogu uključivati crveni, ljuskasti široko rasprostranjen osip s izbočinama ispod otečene kože (uključujući pregibe na koži, trup i gornje ekstremitete) i mjehuriće praćene vrućicom.
English: LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Croatian: Pomoćne tvari: polisorbat 80, etanol bezvodni (za detaljnije informacije vidjeti uputu o lijeku) i citratna kiselina.
English: 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.
Croatian: Prijavljene su teške kožne nuspojave poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantemozne pustuloze (AGEP) kod liječenja docetakselom.
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Croatian: U kabelovny 130, 102 37 Prague 10, Češka Republika
English: How to store Docetaxel Zentiva
Croatian: Kako čuvati Docetaxel Zentiva
English: MARKETING AUTHORISATION HOLDER Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Češka Republika
English: Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by20%.
Croatian: Prilagodba doze Proljev stupnja 3 Prva epizoda: smanjiti dozu 5-FU za 20%.
English: A total of 1776 male patients were allocated to the treatment armss of interest:
Croatian: Ukupno 1776 muških bolesnika bilo je raspodijeljeno u sljedeće terapijske skupine:
English: - For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Zentiva could be administered in combination with doxorubicin and cyclophosphamide.
Croatian: - Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, Docetaxel Zentiva se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
English: Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding must be discontinued for the duration of docetaxel therapy.
Croatian: Sukladno navedenom, zbog mogućih nuspojava u dojenčeta, za vrijeme liječenja docetakselom dojenje se mora prekinuti.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Croatian: Najčešće prijavljene nuspojave samog docetaksela su: neutropenija (koja je bila reverzibilna i nije bila kumulativna; medijan javljanja najnižih vrijednosti je bio 7 dana, a medijan trajanja teške neutropenije (<500 stanica/mm
English: More than one vial of Docetaxel Zentiva concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Croatian: Ponekad je potrebno upotrijebiti više od jedne bočice Docetaxel Zentiva koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Croatian: Docetaxel Zentiva u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
English: 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.
Croatian: 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.
English: - For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with prednisone or prednisolone.
Croatian: - Za liječenje karcinoma prostate Docetaxel Zentiva se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Croatian: Nakon 10 godina praćenja u ispitivanju TAX 316, akutna leukemija zabilježena je u 3 od 744 bolesnika u (0,4%) TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
English: • flushing, skin reactions, itching
Croatian: • naleti vrućine, kožne reakcije, svrbež
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Croatian: Bolesnici koji su kandidati za liječenje docetakselom u kombinaciji s trastuzumabom trebaju na početku liječenja obaviti osnovne pretrage srčane funkcije.
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (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).
Croatian: Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan) u kombinaciji sa cisplatinom (C) (75 mg/m prvi dan) i 5-fluorouracilom (F) (750 mg/m dnevno kroz 5
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Croatian: U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m u kombinaciji s doksorubicinom (50 mg/m
English: If Docetaxel Zentiva concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Croatian: Ako Docetaxel Zentiva koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
English: Docetaxel Zentiva 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.
Croatian: Docetaxel Zentiva 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.
English: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Croatian: Jedna bočica koncentrata sadržava 2 ml (1,58 g) etanola, bezvodnog.
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Croatian: Za kombinaciju s terapijom deprivacije androgena (ADT) i prednizonom ili prednizolonom (studija STAMPEDE), korištenjem CTCAE ljestvice ocjenjivanja, prikazani su štetni događaji koji su se javljali tijekom 6 ciklusa liječenja docetakselom i koji su imale barem 2% veću incidenciju u skupini liječenoj docetakselom u odnosu na kontrolnu skupinu.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Croatian: Docetaxel Zentiva u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Croatian: Jedna bočica koncentrata sadržava 4 ml (3,16 g) etanola, bezvodnog.
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Croatian: konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
English: In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
Croatian: Za bolesnike koji nisu prethodno primali kemoterapiju za karcinom nemalih stanica pluća preporučeni režim doziranja iznosi 75 mg/m docetaksela, nakon čega odmah slijedi infuzija 75 mg/m cisplatina u trajanju od 30 do 60 minuta.
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T)
Croatian: Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan)
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Croatian: 2. Bolesnici ne bi smjeli primiti sljedeći ciklus docetaksela dok se broj neutrofila ne vrati na razinu od > 1500 stanica/mm 3, a broj trombocita na > 100 000 stanica/mm 3. Liječenje se mora prekinuti ako toksičnost potraje (vidjeti dio 4.4).
English: 95% CIAdjusted hazard ratio
Croatian: 95% CI Prilagođeni omjer hazarda
English: 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.
Croatian: 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.
English: Docetaxel Zentiva in combination with trastuzumab
Croatian: Docetaxel Zentiva u kombinaciji s trastuzumabom
English: 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.
Croatian: 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.
English: 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).
Croatian: 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
English: - For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in combination with cisplatin.
Croatian: - Za liječenje karcinoma pluća Docetaxel Zentiva se primjenjuje sam ili u kombinaciji s cisplatinom.
English: 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.
Croatian: 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.
English: • Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
Croatian: Standard liječenja + docetaksel 75 mg/m2, primijenjen svaka 3 tjedna u 6 ciklusa
English: 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.
Croatian: 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
English: 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.
Croatian: 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.
English: - For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje karcinoma glave i vrata Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Croatian: 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.
English: If Docetaxel Zentiva concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako Docetaxel Zentiva koncentrat, ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: 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.
Croatian: 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.
English: Oedema (G3/4: 1.2%)
Croatian: edem (G3/4: 1,2%)
English: G3/4 AST increased
Croatian: G3/4 ALT povišen
English: 95% CI p-valuea*
Croatian: 95% CI p-vrijednosta*
English: Docetaxel Zentiva in combination with capecitabine
Croatian: Docetaxel Zentiva u kombinaciji s kapecitabinom
English: If this happens, you must tell your doctor immediately
Croatian: Odmah obavijestite svog liječnika ako se to dogodi
English: 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).
Croatian: 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).
English: 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
Croatian: 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
English: Docetaxel Zentiva in combination with doxorubicin
Croatian: Docetaxel Zentiva u kombinaciji s doksorubicinom
English: 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
Croatian: 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
English: 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).
Croatian: 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).
English: 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.
Croatian: 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).
English: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Croatian: ezofagitis/disfagija/odinofagija (G3/4: 0,7%)