natgillin/translations-raw huggingface dataset:
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.
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v III. fazi randominizirane multicentrične študije.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m².
Če se pojavijo nadaljnje epizode zapletene nevtropenije, je treba odmerek docetaksela zmanjšati s 60 na 45 mg/m².
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala ≥ 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
• Mitoxantrone 12 mg/m² every 3 weeks for 10 cycles.
• Mitoksantron 12 mg/m² vsake 3 tedne, 10 ciklov.
The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m²) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m²); however, it has been reported in some patients during the early courses of therapy.
Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek: 818,9 mg/m²), kot pri tistih, ki je ne (mediani kumulativni odmerek: 489,7 mg/m²); vendar je pri nekaterih bolnikih opisan med zgodnjimi ciklusi zdravljenja.
The amount of alcohol in this medicine may impair your ability to drive or use machines.
Vsebnost alkohola v zdravilu lahko zmanjša vozniške sposobnosti in sposobnosti upravljanja z orodji in s stroji.
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
• 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
• 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.
• Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 ter znova uporabite 100 % izvirnega odmerka.
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m in all subsequent cycles (see sections 4.4 and 4.8).
Pri bolnicah, pri katerih se je razvila febrilna nevtropenija in/ali nevtropenična okužba je treba odmerek docetaksela zmanjšati na 60 mg/m² v vseh naslednjih ciklusih zdravljenja (glejte poglavji 4.4 in 4.8).
The recommended dose of docetaxel is 75 mg/m².
Priporočeno odmerjanje docetaksela je 75 mg/m².
Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Bolnice z operabilnim rakom dojke z negativnimi bezgavkami, primerne za prejemanje kemoterapije (GEICAM 9805)
The infusion bag solution should be used within 6 hours below 25°C and normal lighting conditions including the one hour infusion to the patient.
Raztopino za infundiranje v infuzijski vrečki je treba uporabiti v 6 urah na temperaturi do 25°C in pri normalnih pogojih osvetljenosti, to vključuje tudi 1 uro infundiranja bolniku .
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin .
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo); mednje spadajo npr. ciklosporin, ketokonazol in eritromicin.
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
• 174 in 251 bolnikov z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m².
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m².
Preparation of the intravenous administration:
Priprava za intravensko uporabo:
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m² every three weeks, with trastuzumab administered weekly.
Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m² vsake tri tedne, s tedensko aplikacijo trastuzumaba.
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/m² na 6 tednov in 6 mg/m² na tedne).
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy.
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m².
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0]
razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]* razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0] razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan infusion solution.
Pomembno je, da pred pripravo Docetaxel Mylan raztopine za infundiranje v celoti preberete ta navodila.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Primarna profilaktična uporaba G-CSF je priporočena pri bolnikih, ki dobivajo docetaksel, doksorubicin in ciklofosfamid (TAC) adjuvantno terapijo pri raku dojke.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 4 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
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 in kemična stabilnost tako pripravljene infuzijske raztopine je bila dokazana v vrečkah, ki ne vsebujejo PVC do 48 ur, pri shranjevanju pri temperaturi med 2°C in 8°C.
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).
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5 %), o katerih so poročali v fazi III. študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
256 patients were randomised to treatment with docetaxel alone (100 mg/m² as a 1 hour intravenous infusion every 3 weeks).
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m² v 1-urni intravenski infuziji na 3 tedne).
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups:
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
The median TTP was 37.3 weeks (95% CI: 33.4-42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Mediana časa do napredovanja je bila v kraku AT 37,3 tedna (95 % IZ: 33,4-42,1) in v kraku AC 31,9 tedna (95 % IZ: 27,4-36,0).
At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Na koncu obdobja spremljanja (dejanski mediani čas spremljanja 96 mesecev) so še trajajočo alopecijo zabeležili pri 29 bolnicah (3,9 %), ki so prejemale TAC, in pri 16 bolnicah (2,2 %), ki so prejemale FAC.
Docetaxel Mylan has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Zdravnik vam je zdravilo Docetaxel Mylan predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu: - Za zdravljenje napredovalega raka dojke se lahko docetaksel uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.
Stomatitis/mucositis grade 4
stomatitis/mukozitis 4. stopnje
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89% in the FAC arm, at the 10-year follow-up timepoint.
Po 8 letih spremljanja je bil delež preživetja v kraku TAC 93,7 % in v kraku FAC 91,4 %, po 10 letih spremljanja pa je bil v kraku TAC 91,3 % in v kraku FAC 89 %.
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).
Še prisotno periferno senzorično nevropatijo so pri spremljanju zabeležili pri 10 od 84 bolnic, ki so imele periferno senzorično nevropatijo ob koncu kemoterapije, v študiji pri bolnicah z rakom dojk s pozitivnimi bezgavkami (TAX316).
The concentrate is supplied in a clear colourless glass vial with a rubber stopper and a plastic flip-off cap.
Koncentrat je na voljo v viali iz prozornega, brezbarvnega stekla z gumijasto zaporko in plastično dvižno zaporko.
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.
Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m² v kombinaciji s cisplatinom in imajo v predhodnem ciklusu zdravljenja najmanjše število trombocitov < 25.000 celic/mm3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklusih zmanjšati na 65 mg/m².
Inject the required volume of concentrate for solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Potrebno količino koncentrata za raztopino za infundiranje je treba vbrizgati v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous and citric acid.
Pomožne snovi: polisorbat 80, brezvodni etanol in citronska kislina.
The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila Docetaxel Mylan se lahko poveča, če dobivate zdravilo Docetaxel Mylan v kombinaciji z drugimi kemoterapevtiki.
Cardiac disorders Rare cases of myocardial infarction have been reported.
Srčne bolezni Opisani so bili redki primeri miokardnega infarkta.
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test ***Hi-kvadrat test
To be taken into account if you are pregnant or if you are breast-feeding women, in children and highrisk groups such as patients with liver disease, or epilepsy.
Na vsebnost etanola (alkohola) morate biti pozorni, če ste nosečnica ali doječa mater, pri otrocih in skupinah bolnikov z velikim tveganjem, npr. pri bolnikih z jetrnimi obolenji ali epilepsijo.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3.
Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm in število trombocitov na > 100.000 celic/mm 3.
• nasal drainage; inflammation of the throat and nose; cough
• izcedek iz nosu, vnetje žrela in nosu; kašelj
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Pri bolnikih, zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih ≥ 10 % večja v primerjavi z mlajšimi bolniki.
• 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.
• Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom 55 mg/m².
In patients treated with docetaxel at 100 mg/m² as single agent who have serum transaminase levels (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Pri bolnikih, zdravljenih s 100 mg docetaksela/m² v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5-kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
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.
Če se kljub uporabi G-CSF pojavi febrilna nevtropenija, dolgotrajna nevtropenija ali nevtropenična okužba, je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m².
Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Mielodisplastični sindrom so zabeležili pri 2 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
• As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
• Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino za infundiranje pred uporabo pregledati; če vsebuje oborino, jo je treba zavreči.
Congestive heart failure (CHF)
Kongestivno srčno popuščanje(KSP)
Once added as recommended into the non-PVC infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Ko je zdravilo enkrat dodano v ne-PVC infuzijsko vrečko, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25°C.
• Docetaxel 75 mg/m² every 3 weeks for 10 cycles.
• Docetaksel 75 mg/m² vsake 3 tedne, 10 ciklov.
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.
Zdravilo Docetaxel Mylan je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
Docetaxel Mylan is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Mylan solutions.
Zdravilo Docetaxel Mylan je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Docetaxel Mylan potrebna previdnost.
5 vials of 1 ml
5 vial z 1 ml
Psychiatric disorders Nervous system disorders Eye disorders Cardiac disorders
Psihiatrične motnje Bolezni živčevja Očesne bolezni Srčne bolezni srčno popuščanje
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).
Opravljena je bila ena velika randomizirana študija III. faze, ki je vključevala 429 predhodno nezdravljenih bolnic z metastatsko boleznijo; v njej so kombinacijo doksorubicina (50 mg/m²) in docetaksela (75 mg/m²) (krak AT) primerjali s kombinacijo doksorubicina (60 mg/m²) in ciklofosfamida (600 mg/m²) (krak AC).
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m².
A Hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin +fluorouracil *Nekorigirani log-rang test **Nekorigirani log-rang test, nekorigiran za multiple primerjave ***Test hi-kvadrat, nekorigiran za multiple primerjave NP-ni podatka
In first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²).
Kot zdravljenje prvega izbora se docetaksel 75 mg/m² daje v kombinaciji z doksorubicinom (50 mg/m²).
- if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Zdravila Docetaxel Mylan ne smete dobiti: - če ste alergični (preobčutljivi za) na docetaksel ali katero koli sestavino zdravila Docetaxel
- If you have any further questions, ask your doctor or hospital pharmacist.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali z bolnišničnim farmacevtom.
• Docetaxel 30 mg/m² administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Docetaksel 30 mg/m² aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
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).
Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m², apliciran eno uro po doksorubicinu 50 mg/m² in ciklofosfamidu 500 mg/m² vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
*Prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
Following the administration of a 100 mg/m² dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Po aplikaciji odmerka 100 mg/m² v enourni infuziji je bila povprečna največja koncentracija v plazmi 3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Immune system
Bolezni imunskega sistema
- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide.
- Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se docetaksel lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
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.
Opravljena je bila multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Glede na zahtevan odmerek za bolnika, izražen v mg, aseptično odvzemite potreben volumen koncentrata za raztopino, ki vsebuje 20 mg/ml docetaksela z graduirano brizgo z iglo 21G iz ustreznega števila vial.
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.
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m² na 75 mg/m² oz. s 75 na 60 mg/m².
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).
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m² je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75 mg/m² (glejte poglavji 4.4 in 5.2).
Without affecting overall survival 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).
Docetaksel ni vplival na celotni čas preživetja (docetaksel 15 mesecev, doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa zvečal delež odziva (52 % v prim.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Raztopina docetaksela je prenasičena raztopina, ki lahko čez čas kristalizira.