FrancophonIA/ELRC3.0 huggingface dataset:
English: The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Slovenian: Tudi enoletni delež preživetja je bil z docetakselom značilno daljši (40 %) kot z najboljšo podporno oskrbo (16 %).
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/m².
Slovenian: • Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom55 mg/m2.
English: For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Slovenian: Pri zdravljenju raka dojke in nedrobnoceličnega pljučnega raka lahko 3-dnevna premedikacija s peroralnim kortikosteroidom, npr. deksametazonom 16 mg na dan (npr. 8 mg 2-krat na dan), ki se začne 1 dan pred aplikacijo docetaksela, zmanjša pogostnost in izrazitost zastajanja tekočine ter izrazitost preobčutljivostnih reakcij, če ni kontraindicirana.
English: Other medicines and DOCETAXEL KABI
Slovenian: Druga zdravila in zdravilo DOCETAKSEL KABI
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Slovenian: Pri bolnicah, kandidatkah za zdravljenje z docetakselom v kombinaciji s trastuzumabom, je potrebno opraviti temeljne preiskave za oceno srčne funkcije.
English: The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Slovenian: Pri bolnikih, zdravljenih s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/nevtropenične sepse (23 % v primerjavi s 17 % pri bolnikih, ki so dobivali samo docetaksel).
English: • Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
Slovenian: • Docetaksel 75 mg/m2 vsake 3 tedne, 10 ciklov.
English: All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Slovenian: Vsi bolniki v kraku z docetakselom so profilaktično dobili antibiotike.
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Slovenian: V študiji GEICAM 9805 se je 3 bolnicam (0,6 %) v kraku TAC in 3 bolnicam (0,6 %) v kraku FAC med obdobjem spremljanja pojavilo kongestivno srčno popuščanje.
English: Discuss with your doctor if you suffer from alcohol dependency epilepsy or liver impairment.
Slovenian: Posvetujte se s svojim zdravnikom, če ste odvisni od alkohola, imete epilepsijo ali okvaro jeter.
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Slovenian: • 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
English: Hazard ratio (95% CI) **p-value n = 128
Slovenian: Razmerje tveganja (95 % IZ) **p-vrednost n = 128
English: Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Slovenian: Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial with 160 mg/8 ml METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala s 120 mg/6 ml POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljeno za dodajanje raztopini za infundiranje.
English: The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.436.0) in AC arm.
Slovenian: 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).
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Primarna profilaksa z G-CSF pride v poštev pri bolnicah, ki prejemajo adjuvantno zdravljenje s TAC za raka dojke, za zmanjšanje tveganja zapletene nevtropenije (febrilne nevtropenije, dolgotrajne nevtropenije ali nevtropenične okužbe).
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Slovenian: Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavji 4.2 in 4.4).
English: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Slovenian: Prednizon ali prednizolon v odmerku 5 mg dvakrat na dan dajemo nepretrgoma (prosimo, glejte poglavje 5.1).
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/m2 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/m2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
English: Diarrhoea grade 3
Slovenian: Prilagoditev odmerka driska 3. stopnje
English: You must not be given DOCETAXEL KABI:
Slovenian: Zdravila DOCETAKSEL KABI ne smete dobiti:
English: The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Slovenian: Najpogosteje opisani simptomi so vročinski oblivi, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja ter povišanje telesne temperature ali mrzlica.
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Slovenian: Opisani so redki primeri enterokolitisa, vključno s kolitisom, ishemičnim kolitisom in nevtropeničnim enterokolitisom, s potencialnim smrtnim izidom (pogostnost neznana).
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Slovenian: Opisani so bili akutni respiracijski distres sindrom (dihalna stiska), intersticijska pljučnica/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so lahko bili usodni.
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Slovenian: Redkeje so poročali o hudih simptomih, npr. izpuščajih s poznejšo deskvamacijo, zaradi katerih je bilo treba v redkih primerih zdravljenje z docetakselom prekiniti (glejte poglavji 4.2 in 4.4).
English: 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).
Slovenian: 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).
English: A multi-centre, open-label, randomised 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.
Slovenian: 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.
English: Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Slovenian: Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
English: Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Slovenian: In vitro je ugotovljeno, da docetaksel v klonogenih preizkusih deluje citotoksično proti različnim linijam mišjih in človeških tumorskih celic in proti sveže odstranjenim človeškim tumorskim celicam.
English: • hair loss: in most cases normal hair growth should return.
Slovenian: • izguba las in dlak (večinoma se obnovi njihova normalna rast), v nekaterih primerih (neznana pogostnost) so bili opisani primeri trajne izgube las in dlak,
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Slovenian: Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm3 (see section 4.2).
Slovenian: Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm3 (glejte poglavje 4.2).
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Slovenian: Pogostost recidiva pri 10 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (39 % proti 45 %) t.j.
English: Pre-Menopausal
Slovenian: Pred menopavzo
English: These were reversible upon discontinuation of the infusion.
Slovenian: Po prekinitvi infundiranja so bili reverzibilni.
English: TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Slovenian: Prejemnice TAC so imele 32 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti 0,68, 95 % IZ (0,49-0,93), p = 0,01).
English: 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).
Slovenian: 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.
English: Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Slovenian: Tudi mediano celotno preživetje (OS) je bilo signifikantno daljše na kraku TPF kot na kraku PF (mediano OS: 18,6 proti 14,5 mesecev) z 28 % zmanjšanjem tveganja smrti, p = 0,0128.
English: • 258 patients who received docetaxel in combination with doxorubicin.
Slovenian: • 258 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom.
English: Contraindications for other medicinal products also apply, when combined with docetaxel.
Slovenian: Če se v kombinaciji z docetakselom uporabljajo še druga zdravila, veljajo tudi kontraindikacije zanje.
English: Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Slovenian: Pred aplikacijo cisplatina morajo bolniki dobiti premedikacijo z antiemetiki in ustrezno hidracijo.
English: • blood clots.
Slovenian: • krvni strdki.
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 enkrat dodano v infuzijsko vrečo, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25 °C.
English: Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Slovenian: Prednizon Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Slovenian: Za zmanjšanje tveganja za hematološke toksične učinke je treba profilaktično uporabiti G-CSF (glejte Prilagajanje odmerjanja med zdravljenjem).
English: • non-Hodgkin lymphoma (a cancer affecting the immune system) and other cancers may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Slovenian: • ne-Hodgkinov limfom (rak, ki napade imunski sistem) in druge vrste raka se lahko pojavijo pri bolnikih, ki se zdravijo z docetakselom v kombinaciji z nekatermi drugimi zdravili proti raku.
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Slovenian: V kraku z docetakselom in trastuzumabom je 64 % bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta delež 55 %.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Slovenian: Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja)
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Slovenian: V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32,1 %, ČDN pa je bil ob tem značilno daljši (p = 0,0004).
English: 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 1-week rest period.
Slovenian: V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m2 na tri tedne, kombiniran s kapecitabinom 1.250 mg/m2 dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Slovenian: Pri bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom so opazovali srčno popuščanje, še posebno, če je zdravljenje sledilo kemoterapiji z antraciklinom (doksorubicin ali epirubicin).
English: 1060 patients were randomised to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).).
Slovenian: 1060 bolnic je bilo naključno razporejenih na prejemanje zdravila DOCETAKSEL KABI 75 mg/m2 1-uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Slovenian: V redkih primerih so bili opisani akutni respiracijski distres sindrom, primeri intersticijske pljučnice/pnevmonitisa, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, včasih s smrtnim izidom.
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Slovenian: • Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v
English: 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).
Slovenian: V tej študiji so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
English: One large randomised 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).
Slovenian: 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).
English: • inflammation of the colon, small intestine, which could be fatal (frequency not known); intestinal perforation.
Slovenian: • vnetje debelega črevesa, tankega črevesa, ki je lahko smrtno (pogostnost ni znana) predrtje črevesa.
English: • chest tightness; difficulty in breathing
Slovenian: • tiščanje v prsih, težko dihanje,
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Slovenian: Izrazitost neželenih učinkov docetaksela se lahko poveča, če se zdravilo daje v kombinaciji z drugimi kemoterapevtiki.
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 AC
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: Docetaxel infusion solution is supersaturated, therefore may cristallize over time.
Slovenian: Raztopina docetaksela je prenasičena raztopina, ki lahko čez čas kristalizira.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Slovenian: Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/m2 v monoterapiji.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Slovenian: Med monoterapijo z docetakselom so zabeležili več neželenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Slovenian: • Za prilagoditve odmerka kapecitabina glejte povzetek glavnih značilnosti kapecitabina.
English: Patient subset
Slovenian: Podskupina bolnic
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Slovenian: Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3-urni infuziji.
English: Tumor response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Slovenian: število bolnikov odzivnost na bolečino (%) 95% IZ p- vrednost* število bolnikov odzivnost tumorja (%) 95% IZ p- vrednost* †stratificiran log-rang test *prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
English: Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Slovenian: Opisani so hudi simptomi, npr. izpuščaji s poznejšo deskvamacijo, zaradi katerih je bilo treba zdravljenje z docetakselom prekiniti ali opustiti (glejte poglavje 4.2).
English: In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Slovenian: Med bolniki, ki so docetaksel prejemali v kombinaciji s cisplatinom in 5-fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okužba redkeje pojavili pri bolnikih, ki so profilaktično prejemali G-CSF.
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Slovenian: Vse tri načine zdravljenja so dajali nepretrgoma v kombinaciji s prednizonom ali prednizolonom 5 mg dvakrat na dan.
English: • Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
Slovenian: • S kalibrirano brizgo aseptično odvzemite potrebno količino koncentrata za raztopino za injiciranje.
English: • 1,312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Slovenian: • 1.312 bolnikih, ki so v monoterapiji prejemali 100 mg/m2 docetaksela, 121 pa jih je prejemalo 75 mg/m2.
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
Slovenian: Pri bolnicah z neuspelim alkilirajočim zdravljenjem so docetaksel primerjali z doksorubicinom (75 mg/m2 na 3 tedne).
English: MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Fresenius Kabi Deutschland GmbH
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
Slovenian: Imetnik dovoljenja za promet z zdravilom Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
Slovenian: V kraku s TCF je bilo mediano število ciklov na bolnika 6 (razpon: od 1 do 16), v kraku s CF pa 4 (razpon: od 1 do 12).
English: Gastric adenocarcinoma
Slovenian: Adenokarcinom želodca
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL
Slovenian: • če ste alergični na docetaksel ali katero koli sestavino zdravila DOCETAKSEL KABI
English: The following adverse reactions are frequently observed with docetaxel:
Slovenian: Z docetakselom so pogosto opažali naslednje neželene učinke: