FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: The concentrate is a pale yellow to brownish-yellow solution.
Slovenian: Koncentrat je bledo rumena do rjavo-rumena raztopina.
English: 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:
Slovenian: 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:
English: Ready to add to infusion solution.
Slovenian: Pripravljeno za dodajanje raztopini za infundiranje.
English: Docetaxel n = 94
Slovenian: Docetaksel n = 94
English: • 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).
Slovenian: • 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).
English: 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.
Slovenian: 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.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC
Slovenian: *Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJAZA PROMET Z
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVEV ZVEZI Z VARNO IN UČINKOVITOUPORABO ZDRAVILA
English: 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).
Slovenian: 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).
English: The cycles were repeated every 3 weeks for 3 cycles.
Slovenian: Cikluse so ponavljali 3 cikluse vsake 3 tedne.
English: 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.
Slovenian: V tej študiji so 501 bolnika z lokalno napredovalim SCCHN in stanjem zmogljivosti 0 ali 1 po WHO randomizirali v enega od dveh krakov.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6).
Slovenian: • če ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Taxespira
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Slovenian: Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Slovenian: Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m 2.
English: 5.2 Pharmacokinetic properties
Slovenian: 5.2 Farmakokinetičnelastnosti
English: Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint.
Slovenian: Preživetje brez bolezni (DFS) je bilo primarni, celokupno preživetje (OS) pa sekundarni opazovani dogodek učinkovitosti.
English: Docetaxel infusion solution is supersaturated, therefore may crystallize over time.
Slovenian: Raztopina docetaksela je supernasičena in sčasoma lahko kristalizira.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Slovenian: Starejši bolniki Za uporabo pri starejših bolnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
English: 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.
Slovenian: 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.
English: Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Slovenian: Dokazano je, da je docetaksel pri kuncih in podganah embriotoksičen in fetotoksičen ter da pri podganah zmanjšuje plodnost.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zdravilo Taxespira je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
English: 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).
Slovenian: 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).
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega vidika morata rekonstutucija/redčenje potekati v nadzorovanih in aseptičnih pogojih in je zdravilo treba uporabiti takoj.
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Slovenian: 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.
English: 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
Slovenian: 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
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Slovenian: 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]
English: Use immediately the medicine once added into the infusion bag.
Slovenian: Ko je zdravilo dodano v infuzijsko vrečko, ga je treba uporabiti takoj.
English: • For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide.
Slovenian: • Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjobezgavk se zdravilo Taxespira lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Slovenian: V kraku s TCF je ciklus zdravljenja trajal 3 tedne, v kraku s CF pa 4 tedne.
English: The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in
Slovenian: 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).
English: 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Slovenian: tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Pack size:
Slovenian: Velikost pakiranja:
English: 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
Slovenian: 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
English: A total of 1006 patients with KPS ≥60 were randomized to the following treatment groups:
Slovenian: V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
English: Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Slovenian: Ko je zdravilo skladno s priporočili dodano v infuzijsko vrečo, je infuzijska raztopina docetaksela pri temperaturi do 25°C stabilna 6 ur.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.
Slovenian: - Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina monohidrat.
English: • swelling of the hands, feet, legs
Slovenian: • otekanje dlani, stopal, nog
English: 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.
Slovenian: Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Slovenian: • Čas do napredovanjaje bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Slovenian: 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.
English: Epistaxis (G3/4: <1%)
Slovenian: epistaksa (S3/4: < 1 %)
English: For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion.
Slovenian: Na primer, za odmerek 140 mg docetaksela bi bilo potrebnih 7 ml zdravila Taxespira 20 mg/ 1 ml koncentrat za raztopino za infundiranje.
English: Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions.
Slovenian: 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.
English: • sores in the mouth
Slovenian: • razjede v ustih
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Slovenian: Če ni uporabljena takoj, je za čas in pogoje hranjenja odgovoren uporabnik.
English: Hospira Enterprises B.V. Randstad 22-11
Slovenian: Randstad 22-11
English: You must not breast-feed while you are treated with Taxespira.
Slovenian: Med zdravljenjem z zdravilom Taxespira ne smete dojiti.
English: 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).
Slovenian: 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).
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Slovenian: • draženje želodca, vključno s slabostjo, bruhanjemin drisko, zaprtje
English: 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.
Slovenian: 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.
English: • inflammation of the eye or increased tearing of the eyes
Slovenian: • vnetje oči ali močnejše solzenje
English: • 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
Slovenian: • 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
English: 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
Slovenian: 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
English: 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).
Slovenian: 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).
English: • 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).
Slovenian: • 174 in 251 bolnikih 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).
English: Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Slovenian: Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
English: Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Slovenian: Aseptično izvlecite ustrezno količino zdravila Taxespira koncentrat za raztopino za infundiranje in uporabite kalibrirane injekcijske brizge z iglo velikosti 21G.
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m
Slovenian: Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m
English: Docetaxel + Cis + 5-FU n = 177
Slovenian: Docetaksel+ Cis+5-FU n = 177
English: As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovenian: Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino docetaksela za infundiranje pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
English: Second episode: stop 5-FU only, at all subsequent cycles.
Slovenian: Drugi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
English: If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Slovenian: ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Slovenian: Benigne in maligne neoplazme (vključno s cistami in polipi) Poročali so o primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Slovenian: • Docetaksel 30 mg/m 2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
English: If Taxespira concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje Taxespira v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: 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.
Slovenian: 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.
English: Nervous system The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
Slovenian: Živčevje Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavje 4.2).
English: Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Slovenian: Pomožne snovi: polisorbat 80, brezvodni etanol (opozorila so navedena v navodilu za uporabo), citronska kislina monohidrat.
English: versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Slovenian: Ob tem so pri shemi z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95 % interval zaupanja (IZ) = 0,54-0,90); celotni mediani čas spremljanja je bil 41,9 meseca.
English: Docetaxel is highly protein bound (>95%).
Slovenian: Docetaksel je v veliki meri (> 95 %) vezan na beljakovine.
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Slovenian: Raztopino v infuzijski vrečki je treba uporabiti v 6 urah, če je hranjena pri temperaturi do 25°C, ena ura infundiranja zdravila bolniku je všteta v ta čas.