natgillin/translations-raw huggingface dataset:
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
• 300 bolesnika s adenokarcinomom želuca (221 bolesnik u ispitivanju faze III i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
Mix the infusion bag or bottle manually using a rocking motion.
Promiješajte sadržaj infuzijske vrećice ili boce polukružnim (ljuljajućim) pokretima.
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%).
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 this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized 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.
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
• Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, Taxespira se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
Taxespira in combination with doxorubicin
Taxespira u kombinaciji s doksorubicinom
Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Taxespira koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje s otapalom te se može odmah dodati u infuzijsku vrećicu.
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
• pain in the joints or muscles
• osjećaj utrnulosti ili bockanja ili bol u zglobovima i mišićima
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
(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).
5 dana) ili cisplatinom (100 mg/m2 prvi dan) i 5-fluorouracilom (1000 mg/m2 dnevno kroz 5 dana).
General Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm
Općenito Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm
A multicenter, open-label, randomized 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.
Provedeno je multicentrično, randomizirano ispitivanje otvorenog tipa kako bi se procijenile sigurnost i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Taxespira u kombinaciji s doksorubicinom i ciklofosfamidom indicirana je za adjuvantno liječenje bolesnika s:
Pfizer AS Tlf: +47 67 52 61 00
Tlf: +47 67 52 61 00
• 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent
• 1312 bolesnika koji su primali 100 mg/m2 i 121 bolesnika koji su primali 75 mg/m docetaksela kao monoterapiju,
At the median follow-up time of 77 months, OS was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Pri medijanu vremena praćenja od 77 mjeseci ukupno preživljenje (OS) bilo je dulje u bolesnika u TAC skupini, uz 24%-tno smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini (omjer hazarda = 0,76, 95% CI (0,46-1,26), p = 0,29).
First episode: reduce docetaxel and 5-FU doses by 20%.
Prva epizoda: smanjiti doze docetaksela i 5-FU za 20%.
Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Bočice koje sadrže 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml i 160 mg/8 ml dostupne su u pakiranjima koja sadrže jednu bočicu.
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
U ispitivanjima TAX 323 i TAX 324, svi bolesnici u skupinama koje su primile docetaksel, profilaktički su primali i antibiotike.
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 vrijeme i primjenu bolesniku jednosatnom intravenskom infuzijom, uz čuvanje na temperaturi ispod 25°C.
20mg/1 ml contains 1 ml of concentrate.
20 mg/1 ml sadrži 1 ml koncentrata.
A total of 449 patients were randomized 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 dobivalo je ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m u trosatnoj infuziji.
• If you have any further questions, ask your doctor, hospital pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.
Pfizer, spol.
Pfizer Kft.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Rijetko je zabilježena pojava suzenja s/bez konjunktivitisa, poput slučajeva opstrukcije suznog kanala što rezultira prekomjernim suzenjem.
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 se mora provesti u kontroliranim i aseptičkim uvjetima i otopina za infuziju se mora odmah primijeniti.
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 što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora oprezno rukovati u pripremi otopine.
160mg/8 ml contains 8 ml of concentrate.
160 mg/8 ml sadrži 8 ml koncentrata.
• 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 randomized, multicenter open-label, phase III study (TAX324).
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
Taxespira 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.
Taxespira u kombinaciji s cisplatinom i 5-fluorouracilom indicirana je za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Rezultati jednog multicentričnog, randomiziranog, kontroliranog, kliničkog ispitivanja faze III podupiru primjenu docetaksela u kombinaciji s kapecitabinom za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspješne citotoksične terapije koja je uključivala i antracikline.
Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
trombocitopenija (G3/4: 0,6%); febrilna neutropenija
Each vial is of single use and should be used immediately.
Bočice su za jednokratnu primjenu i moraju se odmah primijeniti.
140mg/7 ml contains 7 ml of concentrate.
140 mg/7 ml sadrži 7 ml koncentrata.
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Bolesnici koji primaju TAC moraju biti pod stalnim nadzorom (vidjeti dijelove 4.2 i 4.8).
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).
Lacrimation increased; Conjunctivitis
Poremećaji oka pojačano suzenje; konjunktivitis
50 mg/m2 (TAC arm), or doxorubicin 50 mg/m 2 followed by fluorouracil 500 mg/m2 (FAC arm).
50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
U bolesnika koji su neuspješno liječeni alkilirajućim agensima, docetaksel se uspoređivao s doksorubicinom (75 mg/m svaka 3 tjedna).
Myocardial ischemia (G3/4:1.7%)
Srčani poremećaji ishemija miokarda (G3/4:1,7%)
• For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.
• Za liječenje uznapredovalog karcinoma želuca Taxespira se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
• Indukcijska kemoterapija praćena radioterapijom (TAX 323) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentričnog, randomiziranog ispitivanja otvorenog tipa (TAX323).
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 na peti dan svakog ciklusa, ili ekvivalentnim antibiotikom.
Patients with hepatic impairment 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 2 (see sections 4.4 and 5.2).
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/m2 (vidjeti dijelove 4.4. i 5.2).
If Taxespira concentrate should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako Taxespira koncentrat dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolesnici u TAC skupini primali su antibiotsku profilaksu s ciprofloksacinom 500 mg peroralno dvaput dnevno u trajanju od 10 dana, počevši od petog dana svakog ciklusa, ili ekvivalentni antibiotik.
Description of selected adverse reactions for adjuvant therapy with Taxespira 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 Taxespira 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Jedan ml koncentrata sadrži 20 mg docetaksela (u obliku docetaksel trihidrata).
Infections and infestations Blood and lymphatic system disorders
Infekcije i infestacije Poremećaji krvi i limfnog sustava febrilna neutropenija
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) 1,000 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 1. dan, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/ m dnevno od 1. do 5. dana.
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m immediately followed by cisplatin 75 mg/m 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.
Taxespira in combination with capecitabine
Taxespira u kombinaciji s kapecitabinom
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Rizik smanjenja progresije bio je 32,1% i bio je udružen sa značajnim produljenjem TTP (p=0,0004) u korist TCF skupine.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500cells/mm 3 and platelets recover to a level >100,000 cells/mm 3.
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).
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Taxespira 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 Taxespira 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
• operable node-negative breast cancer.
• operabilnim karcinomom dojke i negativnim limfnim čvorovima.
• muscle aches and pains; back pain or bone pain
• bolovi u mišićima; bol u leđima ili bol u kostima
120mg/6 ml contains 6 ml of concentrate.
120 mg/ 6 ml sadrži 6 ml koncentrata.
Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Taxespira u kombinaciji s prednizonom ili prednizolonom indicirana je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
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 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.
Without affecting OS time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
27 tjedana prema doksorubicinu 23 tjedna, p=0,54), docetaksel je povećao stopu terapijskog odgovora (52% prema 37%, p=0,01) i skratio vrijeme do odgovora (12 tjedana prema 23 tjedna, p=0,007).
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
Amenoreja je i dalje bila prisutna na kraju perioda praćenja (medijan vremena praćenja iznosio je 8 godina) u 121 od 744 bolesnica (16,3%) u TAC skupini i 86 bolesnica (11,7%) u FAC skupini.
Peripheral motor neuropathy (G3/4:
periferna motorna neuropatija (G3/4:
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 sadrži oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.4).
Data from a multicenter open label randomized trial support the use of Taxespira 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 Taxespira za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
Vial label
Naljepnica bočice
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
omaglica (G3/4: 2,3%); periferna motorna neuropatija (G3/4: 1,3%)
In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
U bočicama Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml i 160 mg/8 ml koncentracija docetaksela je 20 mg/ml.
If this happens, you must tell your doctor immediately.
Odmah obavijestite svog liječnika ako se to dogodi.
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
U ovom ispitivanju randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST >1.5 × ULN associated with alkaline phosphatase >2.5 × ULN, and bilirubin >1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST više od 1,5 puta većim od GGN te alkalnom fosfatazom više od 2,5 puta većom od GGN i bilirubinom više od 1 puta većim od GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
Taxespira in combination with platinum agents in chemotherapy-naïve patients 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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Taxespira u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju Ispitivanje faze III provedeno je na 1218 bolesnika s neoperabilnim karcinomom nemalih stanica pluća stadija IIIB ili IV s KPS od 70% ili više, koji nisu ranije primali kemoterapiju za tu bolest.
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%).
140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg).
140 mg/7 ml Jedna bočica sa 7 ml koncentrata sadrži 3,5 ml bezvodnog etanola (2765 mg).
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).
120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
120 mg/6 ml Jedna bočica sa 6 ml koncentrata sadrži 3 ml bezvodnog etanola (2370 mg).
75 mg/m2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
75 mg/m2 cisplatine u trajanju od 1 do 3 sata (oboje samo na 1. dan), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5 dana.
Each ml of solution contains 20 mg of docetaxel (as trihydrate).
Jedan ml otopine sadrži 20 mg docetaksela (u obliku docetaksel trihidrata).
Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
omaglica (G3/4:2,0%) periferna motorna neuropatija (G3/4:0,4%)
Both regimens were administered once every 3 weeks for 6 cycles.
Oba kemoterapijska protokola primjenjivala su se svaka 3 tjedna, tijekom 6 ciklusa.
20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
20 mg/1 ml Jedna bočica s 1 ml koncentrata sadrži 0,5 ml bezvodnog etanola (395 mg).
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Provedeno je multicentrično randomizirano ispitivanje faze III otvorenog tipa kako bi se usporedile monoterapija docetakselom i terapija paklitakselom u liječenju uznapredovalog karcinoma dojke kod bolesnika prethodno liječenih antraciklinima.
Lacrimation increased (G3/4: <0.1%)
pojačano suzenje (G3/4: <0,1%)
Rare (may affect up to 1 in 1,000 people): inflammation of the colon, small intestine, which could be fatal (frequency not known);
• upala debelog crijeva, tankog crijeva, koja može biti smrtonosna (nepoznata učestalost);