natgillin/translations-raw huggingface dataset:
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Incidenca naslednjih neželenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več, ≥ 10 % večja kot pri mlajših bolnikih.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies.
Absorpcija Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I. faze.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Mediano trajanje odziva na kemoterapijo radioterapijo(meseci) (95 % IZ)
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Z mikrobiološkega vidika morata rekonstitucija/redčenje potekati v nadzorovanih in aseptičnih pogojih.
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• na mestu injiciranja, kožne reakcije, flebitis (vnetje vene) ali otekanje
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Če zdravilo ni uporabljeno takoj, je za čas in pogoje hranjenja med uporabo odgovoren uporabnik in ne sme biti daljši kot 6 ur pri temperaturi do 25°C, pri čemer je ena ura infundiranja všteta v ta čas.
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
• zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem)
2-year estimate (%)
2-letno preživetje (%)
• swelling caused by faulty lymphatic drainage
• otekanje zaradi nepravilnelimfatične drenaže
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.
A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Starost in spol Farmakokinetične analize docetaksela na populaciji so opravili pri 577 bolnikih.
Cases of permanent alopecia (frequency not known) have been reported.
Opisani so bili primeri trajne plešavosti (pogostnost neznana).
• tiredness or flu-like symptoms
• utrujenost ali gripi podobni simptomi
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.-4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
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 klinične študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
The most commonly reported adverse reactions of Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Najpogosteje poročani neželeni učinki zdravila Taxespira samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija (izguba las), siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.
• difficulty or painful swallowing
• težave ali bolečine pri požiranju
PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION
NAVODILA ZA UPORABO ZDRAVILA TAXESPIRA KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11,1 ure.
Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (intent-to-treat analysis)
Analize podskupine - adjuvantno zdravljenje bolnic v študiji raka dojke z negativnimi bezgavkami (analiza z-namenom-zdravljenja)
5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Po menopavzi *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
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 randominizirani multicentrični študiji faze III.
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g., day 6-15) in all subsequent cycles.
V ključnih SCCHN študijah pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
How to use Taxespira
Kako uporabljati zdravilo Taxespira
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
Zato je priporočljivo, da moški, ki se zdravijo z docetakselom, ne zaplodijo otroka med zdravljenjem in v obdobju šestih mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščejo nasvet glede ohranitve sperme.
Overall
Celotno
Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Na mestu prejšnje ekstravazacije so opažali reakcijo pomnjenja na mestu injiciranja (ponovitev kožne reakcije na mestu predhodne ekstravazacije med dajanjem docetaksela na drugem mestu) (pogostnost ni znana).
The concentrate is a pale yellow to brownish-yellow solution.
Koncentrat je bledo rumena do rjavo-rumena raztopina.
Taxespira 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:
Zdravnik vam je zdravilo Taxespira predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu:
Ready to add to infusion solution.
Pripravljeno za dodajanje raztopini za infundiranje.
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
• 1.276 bolnikih (744 pri TAX 316 in 532 GEICAM 9805), ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
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.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC
*Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJAZA PROMET Z
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Možna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, a medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatom - in vitro ni vplivalo na vezavo docetaksela na beljakovine.
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
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVEV ZVEZI Z VARNO IN UČINKOVITOUPORABO ZDRAVILA
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1.000 mg/m2 in mediani čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
The cycles were repeated every 3 weeks for 3 cycles.
Cikluse so ponavljali 3 cikluse vsake 3 tedne.
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.
V tej študiji so 501 bolnika z lokalno napredovalim SCCHN in stanjem zmogljivosti 0 ali 1 po WHO randomizirali v enega od dveh krakov.
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6).
• če ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Taxespira
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
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/m 2.
5.2 Pharmacokinetic properties
5.2 Farmakokinetičnelastnosti
Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint.
Preživetje brez bolezni (DFS) je bilo primarni, celokupno preživetje (OS) pa sekundarni opazovani dogodek učinkovitosti.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Raztopina docetaksela je supernasičena in sčasoma lahko kristalizira.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Starejši bolniki Za uporabo pri starejših bolnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
There is no relevant use of Taxespira in the paediatric population for the indication of breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Zdravilo Taxespira ni primerno za uporabo pri pediatrični populaciji za indikacije rak dojke, nedrobnocelični pljučni rak, rak prostate, karcinom želodca in rak glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Dokazano je, da je docetaksel pri kuncih in podganah embriotoksičen in fetotoksičen ter da pri podganah zmanjšuje plodnost.
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF. Ponovna analiza preživetja, narejena pri medianem času spremljanja 41,6 mesecev, ni več pokazala statistično značilne razlike, čeprav je bila shema s TCF še vedno ugodnejša; pokazala pa je, da so koristi TCF v primerjavi s CF jasno opazne med 18. in 30. mesecem spremljanja.
Taxespira 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 Taxespira je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Z mikrobiološkega vidika morata rekonstutucija/redčenje potekati v nadzorovanih in aseptičnih pogojih in je zdravilo treba uporabiti takoj.
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 antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin tega zdravila potrebna previdnost.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm 3 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/m 2 to 75 mg/m 2 and/or from 75 to
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm 3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m 2 na 75 mg/m 2 oz. s 75 na 60
Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
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]
Use immediately the medicine once added into the infusion bag.
Ko je zdravilo dodano v infuzijsko vrečko, ga je treba uporabiti takoj.
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
• Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjobezgavk se zdravilo Taxespira lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
V kraku s TCF je ciklus zdravljenja trajal 3 tedne, v kraku s CF pa 4 tedne.
The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in
V kraku AT je bil celotni delež odziva 59,3 % (95 % IZ: 52,8-65,9) in v kraku AC 46,5 % (95 % IZ: 39,8-53,2).
3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p <0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Docetaksel ni vplival na primarno končno točko, celotni delež odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je mediani čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p < 0,01) in mediano preživetje (15,3 meseca v primerjavi z 12,7 meseca, p = 0,03).
Pack size:
Velikost pakiranja:
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-ranktest ***Hi-kvadrattest
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:
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Ko je zdravilo skladno s priporočili dodano v infuzijsko vrečo, je infuzijska raztopina docetaksela pri temperaturi do 25°C stabilna 6 ur.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.
- Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina monohidrat.
• swelling of the hands, feet, legs
• otekanje dlani, stopal, nog
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
• Čas do napredovanjaje bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice in doječe matere, otroci in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
Epistaxis (G3/4: <1%)
epistaksa (S3/4: < 1 %)
For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion.
Na primer, za odmerek 140 mg docetaksela bi bilo potrebnih 7 ml zdravila Taxespira 20 mg/ 1 ml koncentrat za raztopino za infundiranje.
Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions.
Zdravilo Taxespira je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Taxespira potrebna previdnost.
• sores in the mouth
• razjede v ustih
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če ni uporabljena takoj, je za čas in pogoje hranjenja odgovoren uporabnik.
You must not breast-feed while you are treated with Taxespira.
Med zdravljenjem z zdravilom Taxespira ne smete dojiti.
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/m 2 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/m 2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
• stomach upsets including nausea, vomiting and diarrhoea, constipation
• draženje želodca, vključno s slabostjo, bruhanjemin drisko, zaprtje
Patients with liver impairment 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.
Bolniki z okvaro jeter 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.
• inflammation of the eye or increased tearing of the eyes
• vnetje oči ali močnejše solzenje
• 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/m
• 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 in nato zdravljenje nadaljujte z docetakselom 55 mg/m
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4 % of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z GCSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).