natgillin/translations-raw huggingface dataset:
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
U ispitivanju GEICAM 9805, 3 bolesnika (0,6%) u TAC skupini i 3 bolesnika (0,6 %) u FAC skupini razvilo je kongestivno zatajenje srca tijekom perioda praćenja.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4
Medijan TTP bio je 37,3 tjedna (95% CI: 33,4-42,1) u AT skupini i 31,9 tjedna (95% CI: 27,4-36,0) u AC skupini.
- For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone.
- Za liječenje karcinoma prostate DOCETAXEL KABI se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits.
Dokazana je embriotoksičnost i fetotoksičnost docetaksela u štakora i kunića.
• 255 patients who received docetaxel in combination with capecitabine.
• 255 bolesnika koji su primali docetaksel u kombinaciji s kapecitabinom,
If you are a man being treated with DOCETAXEL KABI you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
Muškarcima koji primaju DOCETAXEL KABI savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon prestanka terapije te da potraže savjet o konzervaciji sperme prije liječenja, jer docetaksel može utjecati na plodnost muškarca.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
U skupini koja je primala docetaksel i trastuzumab 64% bolesnika prethodno je primalo antraciklin kao adjuvantno liječenje, dok je u skupini koja je primala samo docetaksel takvih bolesnika bilo 55%.
There is no information on the use of docetaxel in pregnant women.
Nema podataka o primjeni lijeka u trudnica.
Nail disorders (severe: 0.8%)
poremećaji noktiju (teški: 0,8%)
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.
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 (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat])
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Docetaksel se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se u intravenskom bolusu 1. dan.
Anhydrous citric acid (pH adjustment)
citratna kiselina bezvodna (za podešavanje pH).
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Jedna bočica koncentrata sadržava 0,5 ml (395 mg) etanola, bezvodnog.
Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Mijelodisplastični sindrom zabilježen je u 2 od 744 bolesnika (0,3%) u TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), anhydrous citric acid (for pH adjustment).
Pomoćne tvari: polisorbat 80, etanol bezvodni (za dodatne informacije vidjeti uputu o lijeku), citratna kiselina bezvodna (za podešavanje pH).
Infection associated with G4 neutropenia (G3/4: 4.6%)
infekcije udružene s G4 neutropenijom (G3/4: 4,6%)
• stomach upsets including nausea, vomiting and diarrhoea, constipation
• nelagoda u trbuhu uključujući mučninu, povraćanje i proljev, zatvor
Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
anemija (G3/4: 9,4%), febrilna neutropenija, trombocitopenija (G4: 0,8%)
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Svaki ml koncentrata za otopinu za infuziju sadrži 20 mg docetaksela.
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.
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.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
• Koristeći kalibriranu štrcaljku aseptički izvucite potrebnu količinu koncentrata za otopinu za infuziju.
Median TTP (months) (95% CI)
Medijan TTP (mjeseci) (95% CI)
Docetaxel + Cis + 5-FU n = 177
Docetaksel + Cis + 5-FU n = 177
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Bolesnici koji primaju TAC moraju biti pod stalnim nadzorom (vidjeti dio 4.2 i 4.8).
Weight decreased; G3/4 Blood bilirubin increased
Pretrage gubitak tjelesne težine, G3/4 povećanje bilirubina u krvi
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Prednizon Nije zabilježen utjecaj prednizona na farmakokinetiku docetaksela.
DOCETAXEL KABI is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing the solution.
DOCETAXEL KABI je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine DOCETAXEL KABI.
• 92 patients treated with docetaxel in combination with trastuzumab.
• 92 bolesnika koji su primali docetaksel u kombinaciji s trastuzumabom,
Therefore, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
Stoga se muškarcima liječenim docetakselom savjetuje da ne začinju dijete do 6 mjeseci nakon završetka liječenja i da potraže savjet o konzervaciji sperme prije početka liječenja.
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide: adjuvant therapy
DOCETAXEL KABI u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje
Patients on the TPF 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 TPF skupini primali su antibiotsku profilaksu ciprofloksacinom 500 mg oralno dva puta dnevno tijekom 10 dana koju su počeli uzimati peti dan svakog ciklusa, ili ekvivalentnim antibiotikom.
For more details see summary of product characteristics of trastuzumab.
Detaljnije informacije pogledati u sažetku opisa svojstava lijeka za trastuzumab.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
- Drugi sastojci su polisorbat 80, etanol bezvodn (vidjeti dio 2) i citratna kiselina bezvodna (za podešavanje pH).
Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Docetaksel se eliminirao urinom i stolicom nakon metaboliziranja s pomoću citokroma P450 putem oksidacije tercijarne butil esterske skupine, tijekom sedam dana.
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
U bolesnika liječenih docetakselom u kombinaciji s doksorubicinom i ciklofosfamidom (TAC), febrilna neutropenija i/ili neutropenijska infekcija rjeđe su zabilježene ako su bolesnici dobivali primarnu G-CSF profilaksu.
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 ciprofloksacinom 500 mg peroralno dvaput dnevno u trajanju od 10 dana, počevši od petog dana svakog ciklusa, ili ekvivalentni antibiotik.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Nakon 10 godina praćenja u ispitivanju TAX 316, akutna leukemija zabilježena je u 3 od 744 bolesnika (0,4%) u TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
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.
Za bolesnike koji nisu prethodno primali kemoterapiju za karcinom nemalih stanica pluća preporučeni režim doziranja iznosi 75 mg/m2 docetaksela, nakon čega odmah slijedi infuzija 75 mg/m2 cisplatina u trajanju od 30 do 60 minuta.
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 randomizirano je te su dobivali ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Docetaksel je antineoplastična tvar te se njime, kao i sa svim ostalim potencijalno toksičnim spojevima, mora oprezno rukovati u pripremi otopine.
Use immediately the medicine once added into the infusion bag.
Nakon dodavanja lijeka u infuzijsku vrećicu, odmah upotrijebite pripremljenu otopinu.
G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
G3/4 povećanje alkalne fosfataze u krvi (<4%), G3/4 povećanje AST
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
DOCETAXEL KABI je u kombinaciji s doksorubicinom i ciklofosfamidom indiciran za adjuvantno liječenje bolesnika s:
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).
Za adjuvantno liječenje operabilnog karcinoma dojke s pozitivnim i negativnim limfnim čvorovima, preporučena doza docetaksela je 75 mg/m2, a primjenjuje se 1 sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 svaka 3 tjedna tijekom 6 ciklusa (TAC protokol; vidjeti također 'Prilagodba doze tijekom liječenja').
Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
U bolesnika koji su istodobno primali radioterapiju prijavljeni su slučajevi radijacijskog pneumonitisa.
• For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
• Bolesnicima u kojih se prvi put pojavila toksičnost 2. stupnja a prisutna je i u vrijeme sljedećeg ciklusa liječenja kombinacijom docetaksel/kapecitabin, treba odgoditi sljedeći ciklus dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti sa 100% originalne doze.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Za karcinom prostate, uz terapiju prednizonom ili prednizolonom, preporučeni režim premedikacije sadržava oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.4).
Both regimens were administered once every 3 weeks for 6 cycles.
Oba kemoterapijska protokola primjenjivala su se svaka 3 tjedna tijekom 6 ciklusa.
Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Prilagodba doze Proljev 3.stupnja Prva epizoda: smanjiti dozu 5-FU za 20%.
If DOCETAXEL KABI concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Ako DOCETAXEL KABI koncentrat ili infuzijska otopina dođu u dodir s kožom, to mjesto odmah treba dobro i temeljito isprati sapunom i vodom.
How to use DOCETAXEL KABI
Kako primjenjivati DOCETAXEL KABI
Patients with 4+ nodes
Bolesnici s 4 i više pozitivnih limfnih čvorova
Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
U bilo koje vrijeme nakon završetka CRT, mogla se razmotriti operacija primarnog sijela bolesti i/ili vrata.
Docetaxel + Cis + 5-FU n = 255
Docetaksel + Cis + 5-FU n = 255
95% CI p-value† *
95% CI p- vrijednost† *
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Potrebno je uzeti u obzir kod trudnica ili dojilja, djece i visoko rizičnih skupina, kao što su bolesnici s bolešću jetre ili epilepsijom.
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%)
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
omaglica (G3/4: 2,3%), periferna motorna neuropatija (G3/4: 1,3%)
More than one vial of DOCETAXEL KABI concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Ponekad je potrebno upotrijebiti više od jedne bočice DOCETAXEL KABI koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
• From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
• S mikrobiološkog stajališta, rekonstitucija/razrjeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a infuzijska otopina se mora primijeniti odmah.
One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
U jednom velikom randomiziranom ispitivanju faze III u koje je bilo uključeno 429 ranije neliječenih bolesnika s metastatskom bolešću primjenjivala se kombinacija doksorubicina (50 mg/m2) s docetakselom (75 mg/m2) (AT skupina) naspram kombinacije doksorubicina (60 mg/m2) i ciklofosfamida (600 mg/m2) (AC skupina).
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti; ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora >5 cm
Third episode: reduce docetaxel dose by 20%.
Treća epizoda: smanjiti dozu docetaksela za 20%.
- For the treatment of lung cancer, DOCETAXEL KABI could be administered either alone or in combination with cisplatin.
- Za liječenje karcinoma pluća DOCETAXEL KABI se primjenjuje sam ili u kombinaciji s cisplatinom.
You must not breast-feed while you are treated with DOCETAXEL KABI.
Ne smijete dojiti tijekom liječenja lijekom DOCETAXEL KABI .
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Za izmjene u doziranju cisplatina i 5-fluorouracila vidjeti sažetke opisa svojstava lijeka tih lijekova.
For breast, non-small cell lung, gastric, and head and neck 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 be used (see section 4.4).
Kod karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma želuca i karcinoma glave i vrata kao premedikacija primjenjuju se oralni kortikosteroidi poput deksametazona u dozi od 16 mg/dan tijekom 3 dana (primjerice, 8 mg dvaput dnevno), pri čemu premedikaciju treba početi jedan dan prije primjene docetaksela, ako to nije kontraindicirano (vidjeti dio 4.4).
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 736FAC patients(87.6%).. At the end of the follow-up period actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
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.Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), alopecija je i dalje bila prisutna u 29 bolesnika u TAC skupini (3,9%) i 16 bolesnika u FAC skupini (2,2%).
Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Za primjenu cisplatina bolesnici moraju primiti premedikaciju antiemeticima i biti primjereno hidrirani.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Za indukcijsko liječenje bolesnika s lokalno uznapredovalim (tehnički neresektabilnim, male vjerojatnosti kirurške izlječivosti, a s ciljem očuvanja organa) karcinomom skvamoznih stanica glave i vrata preporučena doza docetaksela iznosi 75 mg/m2 i daje se kao jednosatna intravenska infuzija na prvi dan, nakon čega slijedi cisplatin 100 mg/m2 primijenjen kao 30-minutna do 3satna infuzija.
Skin and subcutaneous Alopecia (G3/4:4.0%)
Poremećaji kože i potkožnog tkiva alopecija (G3/4: 4,0%)
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below
Provedene su eksploracijske analize preživljenja bez znakova bolesti u podskupini bolesnika koji zadovoljavaju kriterije za kemoterapiju po kriterijima iz St. Gallena, 2009. (ITT populacija) - rezultati su prikazani u sljedećoj tablici:
Diarrhoea grade 3
Stomatitis/mukozitis 3. stupnja
In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Farmakokinetička svojstva docetaksela ispitivala su se u ispitivanjima faze I u bolesnika s karcinomom nakon primjene 20 - 115 mg/m2.
- For the treatment of metastatic gastric cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje metastatskog karcinoma želuca DOCETAXEL KABI se primjenjuje u kombinaciji s cisplatinom i 5-fluorouracilom.
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/m2 nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m2 dnevno tijekom 5 dana.
Cough; Rhinorrhoea
Česte nuspojave rinoreja
Myocardial ischemia (G3/4: 1.7%)
Srčani poremećaji ishemija miokarda (G3/4: 1,7%)
• operable node-positive breast cancer
• operabilnim karcinomom dojke s pozitivnim limfnim čvorovima
Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
U bolesnika koji su istodobno primali radioterapiju, zabilježeni su rijetki slučajevi radijacijskog pneumonitisa.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Za prilagodbu doza cisplatine i 5-fluorouracila vidjeti sažetak opisa svojstava tih lijekova.
Rare (may affect up to 1 in 1,000 people):
Rijetko (mogu se javiti manje od 1 na 1000 osoba):
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 primjene i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
Bone marrow suppression and other haematologic adverse reactions have been reported.
Zabilježene su supresija koštane srži i ostale hematološke nuspojave.
Description of selected adverse reactions for adjuvant therapy with DOCETAXEL KABI 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 KABI 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
- For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje karcinoma glave i vrata DOCETAXEL KABI se primjenjuje u kombinaciji s cisplatinom i 5-fluorouracilom.
Intravenous use.
Način primjene.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Pripremljena infuzijska otopina mora se upotrijebiti unutar 6 sati nakon priprave, uključujući u to i jednosatnu intravensku infuziju bolesniku, uz čuvanje na temperaturi ispod 25°C.
Hazard ratio
Omjer hazarda
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Najčešće nuspojave (≥ 5%) povezane s kombiniranim liječenjem s kapecitabinom zabilježene su u ispitivanju faze III u bolesnika s karcinomom dojke nakon neuspješnog liječenja antraciklinima (vidjeti sažetak opisa svojstava lijeka za kapecitabin).
Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Jedna bočica koncentrata sadržava 4,5 ml (3,55 g) etanola, bezvodnog.