FrancophonIA/ELRC3.0 huggingface dataset:
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: • 1276 bolnikih (744 pri TAX 316 in 532 GEICAM 9805), ki so dobivali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki);
English: There is no relevant use of Docetaxel Teva in the paediatric population in the indications 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 Docetaksel Teva 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: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Slovenian: TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor *Izpolnjena relativna indikacija za kemoterapijo
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Slovenian: EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: • difficulty or painful swallowing
Slovenian: • težave ali bolečine pri požiranju;
English: To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Slovenian: Na vsebnost alkohola morajo biti pozorne nosečnice in doječe matere, otroci in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Slovenian: Benigne in maligne novotvorbe (vključno s cistami in polipi) O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
English: Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Slovenian: Zelo redko so pri zdravljenju z docetakselom poročali o kožnem eritematoznem lupusu in buloznih erupcijah, npr. o multiformnem eritemu, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi.
English: Patients should be monitored for second primary malignancies (see section 4.8).
Slovenian: Bolnike je treba kontrolirati glede drugih primarnih malignomov (glejte poglavje 4.8).
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Slovenian: primeru blažjih preobčutljivostnih reakcij, npr. pordelosti ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Slovenian: • pljučna fibroza (brazgotinjenje in zadebelitve v pljučih s težkim dihanjem);
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 tudi Prilagajanje odmerjanja med zdravljenjem).
English: Docetaxel Teva 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 Docetaksel Teva v kombinaciji s cisplatinom in 5-fluorouracilom je indicirano za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
English: If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Slovenian: Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaksel Teva 5 minut stati na sobni temperaturi (do 25°C).
English: • one vial (5.12 ml) of solvent (water for injections).
Slovenian: • eno vialo (5,12 ml) z vehiklom (voda za injekcije).
English: • swelling of the hands, feet, legs
Slovenian: • otekanje dlani, stopal, nog;
English: Following chemotherapy, patients should receive chemoradiotherapy.
Slovenian: Po kemoterapiji morajo bolniki dobiti še kemoradioterapijo.
English: Cough; Rhinorrhoea
Slovenian: kašelj, rinoreja
English: Cardiac failure; Arrhythmia (no severe)
Slovenian: Srčne bolezni aritmija (ne huda)
English: 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 (eg, day 6-15) in all subsequent cycles.
Slovenian: V ključnem preskušanju pri bolnikih s SCCHN, pri katerih se je pojavila zapletena nevtropenija (ki vključuje dolgotrajno nevtropenijo, febrilno 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.
English: In both arms, after the last cycle of chemotherapy, patients with positive oestrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Slovenian: V obeh krakih so bolnice s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji po zadnjem ciklu kemoterapije do 5 let dobivale 20 mg tamoksifena dnevno.
English: No of positive nodes Overall
Slovenian: št. pozitivnih bezgavk skupaj
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Slovenian: Srčne bolezni O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samo docetaksel.
English: Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Slovenian: Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila Docetaksel Teva (10 mg docetaksela/ml)
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, apliciran tedensko prvih 5 tednov 6-tedenskega cikla, ki se ponovi v 5
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
Slovenian: Bolniki ne smejo prejeti poven cikel docetaksela, dokler se število nevtrofilcev ne poveča na > 1500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
English: • decrease in blood pressure; irregular or rapid heart beat
Slovenian: • znižanje krvnega tlaka, nereden ali hiter srčni utrip; • srčno popuščanje;
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients.
Slovenian: Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
English: • nasal drainage; inflammation of the throat and nose; cough
Slovenian: • izcedek iz nosu, vnetje žrela in nosu, kašelj;
English: Hepatic impairment 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 delovanja jeter (ALT, AST ≥ 1,5-kratna ZMRO hkrati z alkalno fosfatazo ≥ 2,5-kratno ZMRO), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
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 0 ali 1, nato pa zdravljenje nadaljujte z docetakselom v odmerku 55 mg/m2.
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
Slovenian: Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
English: In combination with cisplatin 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.
Slovenian: Bolnikom, ki uvodoma dobijo docetaksel v odmerku 75 mg/m2 v kombinaciji s cisplatinom in imajo v predhodnem krogu 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 krogih zmanjšati na 65 mg/m2.
English: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Slovenian: Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1500 celic/mm3.
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Slovenian: Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so se bolniki, pri katerih bolezen ni napredovala, 7 tednov zdravili z obsevanjem (RT) skladno s smernicami ustanove (TPF/RT).
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Slovenian: • eno vialo (2,88 ml) s koncentratom (80 mg docetaksela),
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intraveinously on day 1 every three weeks.
Slovenian: Zdravilo Docetaksel Teva je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
English: Docetaxel Teva should not be used after the expiry date shown on the carton and vials.
Slovenian: Zdravila Docetaksel Teva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vialah.
English: Docetaxel is highly protein bound (>95%).
Slovenian: Docetaksel se obsežno (> 95 %) veže na beljakovine.
English: very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000
Slovenian: Kategorije pogostosti so opredeljene tako: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100),
English: 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
Slovenian: Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 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 oziroma s 75 na 60 mg/m2.
English: 4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: 4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250 ml infuzijsko vrečko (ne iz PVC-ja) ali steklenico, v kateri je 5 % raztopina glukoze ali 9 mg/ml (0,9 %) raztopina natrijevega klorida za infundiranje.
English: • sores in the mouth
Slovenian: • razjede v ustih;
English: • one vial of 0.72 ml concentrate (20 mg of docetaxel),
Slovenian: • eno vialo z 0,72 ml koncentrata (20 mg docetaksela),
English: How to store Docetaxel Teva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Docetaksel Teva Vsebina pakiranja in dodatne informacije
English: Febrile neutropenia (G3/4: NA)
Slovenian: febrilna nevtropenija (S 3/4: NA)
English: 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Slovenian: 4.1.1 Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaksel Teva 5 minut stati na sobni temperaturi (do 25°C).
English: • 406 patients who received docetaxel in combination with cisplatin.
Slovenian: • 406 bolnikih, ki so dobivali docetaksel v kombinaciji s cisplatinom;
English: At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
Slovenian: Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so se bolniki, pri katerih bolezen ni napredovala, 7 tednov zdravili z obsevanjem (RT) skladno s smernicami ustanove (PF/RT).
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Slovenian: Priporočene prilagoditve odmerka v primeru toksičnih učinkov pri bolnikih, ki dobivajo docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (5-FU):
English: • one 15 ml clear glass vial with a flip-off cap containing 2.88 ml concentrate and,
Slovenian: • eno 15 ml vialo iz prozornega stekla s pokrovčkom Flip Off, ki vsebuje 2,88 ml koncentrata in
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, je treba odmerek zmanjšati na 60 mg/m2.
English: 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.
Slovenian: Po aplikaciji odmerka 100 mg/m2 v enourni infuziji je bila povprečna največja koncentracija v plazmi 3,7 µg/ml, ustrezna vrednost AUC pa 4,6 hµg/ml.
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
English: • chest tightness; difficulty in breathing
Slovenian: • tiščanje v prsih, težko dihanje;
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Slovenian: • pordelost in otekanje dlani ali podplatov, ki lahko povzroči lupljenje kože (to se lahko pojavi tudi na rokah, obrazu ali telesu); • sprememba barve nohtov, ki lahko odstopijo;
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 723 mg ethanol, anhydrous per concentrate vial, equivalent to 18.3 ml beer or 7.6 ml wine.
Slovenian: Zdravilo vsebuje 25,1 % (m/m) brezvodnega etanola (alkohola), tj. do 723 mg brezvodnega etanola na vialo koncentrata; to ustreza 18,3 ml piva ali 7,6 ml vina.
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Slovenian: Srednji čas do napredovanja je bil 186 dni (docetaksel + kapecitabin) v prim.
English: Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Slovenian: Povprečno preživetje je bilo 442 dni (docetaksel + kapecitabin)
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: 10 letih je bila zmanjšana pri bolnicah, ki so dobivale TAC, v primerjavi s tistimi, ki so dobivale FAC (39 % proti 45 %) t.j.
English: 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.
Slovenian: *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
English: Both regimens were administered every 3 weeks.
Slovenian: Oba režima so aplicirali enkrat na 3 tedne.
English: Inject the required premix volume into a non-PVC 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Potrebno količino osnovne raztopine vbrizgajte v 250 ml infuzijsko vrečko (ne iz PVC-ja) ali steklenico, v kateri je 5 % raztopina glukoze ali 0,9 % (9 mg/ml) raztopina natrijevega klorida za infundiranje.
English: Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Slovenian: Zdravilo Docetaksel Teva v kombinaciji z doksorubicinom in ciklofosfamidom je indicirano za adjuvantno zdravljenje bolnic:
English: As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Slovenian: Bolnice s 4+ bezgavkami Za preživetje brez bolezni (DFS - disease-free survival) in celokupno preživetje (OS - overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
English: Meeting relative indication for chemotherapy a
Slovenian: Izpolnjena relativna indikacija za kemoterapijo* Ne
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 dobivali v kombinaciji s cisplatinom in 5-fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okužba redkeje pojavili pri bolnikih, ki so profilaktično dobivali G-CSF.
English: • loss of appetite (anorexia)
Slovenian: • alergijske reakcije, ki so opisane zgoraj; • izguba apetita (anoreksija);
English: Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Slovenian: Do smrti zaradi zastrupitve je prišlo pri eni bolnici v kraku AT (zastojno srčno popuščanje) in štirih bolnicah v kraku AC (pri eni zaradi septičnega šoka, pri treh zaradi kongestivnega srčnega popuščanja).
English: Fluid retention (severe: Asthenia (severe: Pain
Slovenian: zastajanje tekočine (hudo: bolečina
English: This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine.
Slovenian: Zdravilo vsebuje 25,1 % (m/m) brezvodnega etanola (alkohola), tj. do 181 mg brezvodnega etanola na vialo koncentrata; to ustreza 4,6 ml piva ali 1,9 ml vina.
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Slovenian: • draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtost;
English: • inflammation of the eye or increased tearing of the eyes
Slovenian: • vnetje oči ali močnejše solzenje;
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 opazili več neželenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
English: The survival rate was 93.7% in the TAC arm and 91.4% in the FAC arm, at the 8-year follow-up time point, and 91.3% in the TAC arm and 89% in the FAC arm, at the 10-year follow-up time point.
Slovenian: 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 %.
English: Docetaxel Teva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions.
Slovenian: Docetaksel Teva je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med ravnanjem in pripravo raztopin zdravila Docetaksel Teva potrebna previdnost.
English: The solvent for Docetaxel Teva is water for injections.
Slovenian: Vehikel za Docetaksel Teva je voda za injekcije.
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: ** nekorigirani test log-rank, nekorigiran za več primerjav *** test hi-kvadrat, nekorigiran za več primerjav
English: Overall survival was also significantly longer (p=0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Slovenian: V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
English: An open-label, multi-centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Slovenian: Opravili so odprto multicentrično randomizirano študijo III. faze za primerjavo monoterapije z docetakselom in paklitaksela pri zdravljenju napredovalega raka dojke pri bolnicah, katerih predhodno zdravljenje je moralo vključevati antraciklin.
English: 4.2.5 As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovenian: 4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docetaksel Teva pred uporabo pregledati; če vsebuje oborino, jo je treba zavreči.
English: • 258 patients who received docetaxel in combination with doxorubicin.
Slovenian: • 258 bolnikih, ki so dobivali docetaksel v kombinaciji z doksorubicinom;
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 terapije je bilo preživetje brez bolezni v kraku TAC dokazano značilno daljše kot v kraku FAC.
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p=0.0121) and a longer time to definitive worsening of Karnofsky performance status (p=0.0088) compared to patients treated with CF.
Slovenian: 5 % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja indeksa zmogljivosti po Karnofskem (p = 0,0088).