natgillin/translations-raw huggingface dataset:
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Od 84 bolesnika s perifernom senzornom neuropatijom na kraju kemoterapije, u 10 bolesnika periferna senzorna neuropatija bila je i dalje prisutna tijekom praćenja nakon kemoterapije u kliničkoj studiji karcinoma dojke s pozitivnim limfnim čvorovima (TAX 316).
You must not breast-feed while you are treated with Docetaxel Mylan.
Ne smijete dojiti tijekom liječenja lijekom Docetaxel Mylan.
Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Bolesnici s operabilnim karcinomom dojke i negativnim limfnim čvorovima prikladni za primanje kemoterapije (GEICAM 9805)
Grade1 (includes grade not assessed)
Histološki gradus Gradus 1 (uključujući neodređeni gradus) Gradus 2
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji sa cisplatinom i 5-fluoruracilom u studiji koja je uključivala bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starijih, a 4 ih je bilo u dobi od 75 godina ili starijih.
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m² and LFTs should be measured at baseline and before each cycle (see section 4.2).
Stoga preporučena doza docetaksela u tih bolesnika s povišenim vrijednostima testova jetrene funkcije iznosi 75 mg/m2, a testove funkcije jetre treba učiniti prije početka terapije i prije svakog sljedećeg ciklusa (vidjeti dio 4.2).
In Docetaxel Mylan, the concentration of docetaxel is 20 mg/ml.
U bočici Docetaxel Mylan, koncentracija docetaksela iznosi 20 mg/ml.
Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Općenito Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm3.
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m².
• Bolesnicima u kojih se drugi put pojavila toksičnost stupnja 2, ili u kojih se prvi put pojavila toksičnost stupnja 3, u bilo koje vrijeme liječenja, treba odgoditi terapiju sve dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti liječenje docetakselom 55 mg/m
Box of 1 vial, or 5 vials.
Jedna kutija sadržava 1 bočicu ili 5 bočica.
The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents.
Težina nuspojava lijeka Docetaxel Mylan može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
Age category 2 <35 years ≥35 years
Dobna skupina 1 <50 godina ≥50 godina Dobna skupina 2 <35 godina ≥35 godina Status hormonskih receptora
Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added to the infusion solution.
Docetaxel Mylan koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku vrećicu.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m².
Ako se unatoč primjeni G-CSF pojave epizode febrilne neutropenije, produljene neutropenije ili neutropenijske infekcije, dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
• For patients developing the first appearance of a 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 stupnja 2, 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.
5 vials of 1 ml
5 bočica od 1 ml
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
U GEICAM 9805 studiji limfedem je i dalje bio prisutan u 4 od 5 bolesnika u TAC skupini i u 1 od 2 bolesnika u FAC skupini na kraju kemoterapije i nije se povukao tijekom perioda praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci).
LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous and citric acid.
Pomoćne tvari: polisorbat 80, etanol bezvodni i citratna kiselina.
As with all parenteral products, Docetaxel Mylan concentrate for solution or diluted solution for infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Kao što je slučaj sa svim parenteralnim pripravcima, Docetaxel Mylan koncentrat za otopinu ili razrijeđenu otopinu za infuziju treba vizualno provjeriti prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
• Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.
• Mitoksantron 12 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
See also section “Docetaxel Mylan contains ethanol” below.
Također pogledajte ispod dio " Docetaxel Mylan sadrži etanol (alkohol)".
Once added as recommended into the non-PVC infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Nakon dodavanja u ne-PVC infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna je 6 sati pri temperaturi do 25°C.
• From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
• S mikrobiološkog stanovišta, rekonstitucija/razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a infuzijsku otopinu treba primijeniti odmah.
Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide.
- Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, docetaxel se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
• 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 25ºC.
In GEICAM 9805 study, amenorrhoea persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm.
U GEICAM 9805 studiji, amenoreja je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
Docetaxel Mylan in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Docetaxel Mylan u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
• Rabeći kalibriranu štrcaljku s aseptički uvucite potrebnu količinu koncentrata za otopinu za infuziju.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Infuzijska otopina docetaksela je prezasićena, stoga tijekom vremena može doći do kristalizacije.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution for infusion.
Primjerice, za dozu od 140 mg docetaksela bit će potrebno 7 ml docetaksela u obliku koncentrata za otopinu za infuziju..
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm 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.
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/m2 na 75 mg/m2 i/ili sa 75 mg/m2 na 60 mg/m2.
At the median follow-up time of 77 months, overall survival (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 duže 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).
Docetaxel Mylan 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.
Docetaxel Mylan u kombinaciji sa cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
U studiji TAX 316, periferni edem je i dalje bio prisutan u 19 bolesnika od 119 bolesnika s perifernim edemom u TAC skupini, odnosno u 4 bolesnika od 23 bolesnika s perifernim edemom u FAC skupini.
One large randomized 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 bolesti, 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).
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).
Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan) u kombinaciji sa cisplatinom (C) (75 mg/m2 prvi dan) i 5-fluorouracilom (F) (750 mg/m2 dnevno kroz 5 dana) ili cisplatinom (100 mg/m2 prvi dan) i 5-fluorouracilom (1000 mg/m2 dnevno kroz 5 dana).
In first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²).
U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m u kombinaciji s doksorubicinom (50 mg/m
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Sigurnost i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranoj multicentričnoj studiji faze III.
Asthenia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm.
Astenija je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 12 bolesnika (2,3%) u TAC skupini i u 4 bolesnika (0,8%) u FAC skupini.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
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).
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
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mg/10 ml
- For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
- Za liječenje karcinoma prostate docetaxel se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
5 vials of 4 ml
5 bočica od 4 ml
C-docetaxel has been conducted in three cancer patients.
Provedeno je ispitivanje 14C-docetaksela na tri osobe s karcinomom.
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.
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 od 75 mg/m2 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').
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 na dan 1.
Infusion site reaction; Pain
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu primjene infuzije; bol
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 jedne multicentrične, randomizirane, kontrolirane, kliničke studije 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.
What Docetaxel Mylan 200 mg/10 ml is and what it is used for What you need to know before you use Docetaxel Mylan 200 mg/10 ml How to use Docetaxel Mylan 200 mg/10 ml Possible side effects
Što je Docetaxel Mylan 200 mg/10 ml i za što se koristi Što morate znati prije nego počnete primjenjivati Docetaxel Mylan 200 mg/10 ml Kako primjenjivati Docetaxel Mylan 200 mg/10 ml Moguće nuspojave
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 80 mg/4 ml
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m² every three weeks, with trastuzumab administered weekly.
U kombinaciji s trastuzumabom preporučena doza docetaksela iznosi 100 mg/m svaka tri tjedna, dok se trastuzumab primjenjuje svaki tjedan.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m² 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.
• Docetaxel 75 mg/m² every 3 weeks for 10 cycles.
• Docetaksel 75 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
- For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.
- Za liječenje karcinoma pluća docetaxel se primjenjuje sam ili u kombinaciji s cisplatinom.
Docetaxel Mylan 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.
Docetaxel Mylan 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.
Arrhythmia (G3/4: 0.7%) Cardiac failure
Srčani poremećaji aritmija (G3/4: 0,7%) zatajivanje srca
Unopened vial 12 months.
12 mjeseci
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 20 mg/1 ml
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2°C do 8°C.
One vial of 4 ml of concentrate contains 1.58 g of ethanol anhydrous.
Jedna bočica od 4 ml koncentrata sadržava 1,58 g etanola, bezvodnog.
95% CI p-value*
95% CI p- vrijednost † *
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8ºC.
What Docetaxel Mylan 80 mg/4 ml is and what it is used for What you need to know before you use Docetaxel Mylan 80 mg/4 ml How to use Docetaxel Mylan 80 mg/4 ml Possible side effects
Što je Docetaxel Mylan 80 mg/4 ml i za što se koristi Što morate znati prije nego počnete primjenjivati Docetaxel Mylan 80 mg/4 ml Kako primjenjivati Docetaxel Mylan 80 mg/4 ml Moguće nuspojave
Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
U studiji TAX 316, od 202 bolesnice koje su imale amenoreju na kraju kemoterapije, amenoreja je i dalje bila prisutna u njih 121 tijekom praćenja nakon kemoterapije.
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.
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.
Each vial contains 1 ml of concentrate.
Jedna bočica sadržava 1 ml koncentrata.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m² every three weeks, combined with capecitabine at 1250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
U kombinaciji s kapecitabinom, preporučena doza docetaksela je 75 mg/m svaka tri tjedna u kombinaciji s kapecitabinom u dozi od 1250 mg/m2 dvaput dnevno (unutar pola sata nakon obroka) u trajanju od 2 tjedna, nakon čega slijedi tjedan dana pauze.
The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.
Pakiranje sadrži koncentrat u prozirnoj staklenoj bočici s gumenim čepom i plastičnim "flip-off" zatvaračem.
What Docetaxel Mylan 20 mg/1 ml is and what it is used for What you need to know before you use Docetaxel Mylan 20 mg/1 ml How to use Docetaxel Mylan 20 mg/1 ml Possible side effects
Što je Docetaxel Mylan 20 mg/1 ml i za što se koristi Što morate znati prije nego počnete primjenjivati Docetaxel Mylan 20 mg/1 ml Kako primjenjivati Docetaxel Mylan 20 mg/1 ml Moguće nuspojave
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna ml koncentrata za otopinu za infuziju sadržava 20 mg docetaksela (u obliku bezvodnog docetaksela).
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin
1060 bolesnika randomizirano je u skupine koje su primale ili docetaksela 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil
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/m2 u trosatnoj infuziji.
- If you have any further questions, ask your doctor or hospital pharmacist.
- Ako imate dodatnih pitanja, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj sestri.
Without primary G-CSF prophylaxis
Bez primarne profilakse s
Each vial contains 4 ml of concentrate.
Jedna bočica sadržava 4 ml koncentrata.
Infection associated with G4 neutropenia (G3/4: 4.6%)
Infekcije i infestacije infekcije udružene s G4 neutropenijom (G3/4: 4,6%)
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).
U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom (1250 mg/m dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
• Docetaxel 30 mg/m² administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Docetaksel 30 mg/m2 primijenjen tjedno prvih 5 tjedana u ciklusu liječenja od 6 tjedana,
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Mylan concentrate for solution for infusion, which contains only 1 vial).
Uz ovaj lijek (Docetaxel Mylan koncentrat za otopinu za infuziju) koji uključuje samo 1 bočicu NEMOJTE KORISTITI druge lijekove koji sadrže docetaksel i uključuju 2 bočice (koncentrat i otapalo).
The active substance is docetaxel.
Djelatna tvar je docetaksel.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
Marketing Authorisation Holder and Manufacturer
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač: