FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/ m2 to 75 mg/m2 and/or from 75 to 60 mg/ m2.
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 oz. s 75 na 60 mg/m2.
English: Nail disorders (severe 0.8%)
Slovenian: Spremembe nohtov (hude 0,8 %)
English: Both the reconstituted concentrate and the solution for infusion should be visually inspected prior to use.
Slovenian: Pred uporabo je treba pripravljen koncentrat in raztopino za infundiranje pregledati.
English: No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Slovenian: Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/10/630/001
English: Overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Slovenian: Tudi celotno preživetje je bilo v kraku TAC daljše: tveganje smrti je bilo med prejemnicami TAC za 24 % manjše kot med prejemnicami FAC (razmerje ogroženosti = 0,76, 95 % IZ (0,46-1,26), p = 0,29).
English: Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i.e. an absolute risk reduction by 7% (p=0.001).
Slovenian: Pogostost recidiva pri 5 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (25 % proti 32 %) t.j.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite brošuro v embalaži.
English: Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Slovenian: najkrajši presledek je bil 3 tedne in ne več kot 8 tednov po začetku zadnjega ciklusa (22. do 56. dan zadnjega ciklusa).
English: Median overall survival was also significantly longer in favor 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: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Slovenian: • V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4. stopnje,
English: The median TTP was 37.3 weeks (95%CI : 33.4 - 42.1) in AT arm and 31.9 weeks (95%CI : 27.4 - 36.0) in AC arm.
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:
English: • at the injection site; skin reactions, inflammation of the vein or swelling
Slovenian: • omedlevica; • na mestu vboda, kožne reakcije, vnetje žil ali otekanje;
English: Not applicable.
Slovenian: Navedba ni smiselno potrebna.
English: Docefrez powder and solvent for concentrate for solution for infusion is for single use only.
Slovenian: Prašek in raztopilo docefrez za koncentrat infuzijske tekočine je za enkratno uporabo.
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: Response rate (95% CI)
Slovenian: Delež odziva (95 % IZ)
English: Alopecia; Skin reaction (G3/4: 0.8%)
Slovenian: Alopecija, kožna reakcija (S3/4: 0,8 %)
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Slovenian: Zvečanje AST S3/4 zvečanje alkalne fosfataze v krvi S3/4
English: Hypersensitivity (no severe)
Slovenian: Preobčutljivost (nobene hude)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/002
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/10/630/002
English: PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA Prašek in vehikel za pripravo koncentrata za raztopino za infundiranje.
English: Efficacy results are presented in the table below: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Slovenian: Rezultate učinkovitosti prikazuje spodnja tabela: Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja )
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Slovenian: *Meja statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data)
Slovenian: Opredelitev pogostnosti je: zelo pogosto (1/10), pogosto (1/100, do < 1/10); občasno (1/1.000, do < 1/100); redko (1/10.000, do <
English: If a dose greater than 200 mg docetaxel is required, a larger volume of the infusion vehicle should be used, so that a concentration of 0.74 mg/ml docetaxel is not exceeded in the final solution for infusion.
Slovenian: Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncentracije docetaksela 0,74 mg /ml.
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: % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0,0088).
English: Myalgia (severe: 0.5%)
Slovenian: Mialgija (huda 0,5%)
English: Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Slovenian: Docefrez je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
English: Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Slovenian: Podatki multicentrične, randomizirane, kontrolirane klinične študije III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Slovenian: Prilagoditev odmerka Driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
English: A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil
Slovenian: Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU
English: Alopecia (G3/4:
Slovenian: Alopecija (S3/4:
English: Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
Slovenian: periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
English: Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Slovenian: Febrilna nevtropenija se je pojavila pri 17,2 % bolnikov, nevtropenična okužba pa pri 13,5 %
English: All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/CRT).
Slovenian: Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili kemoradioterapijo (KRT) po protokolu
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 ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom 55 mg/m2.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (od 2°C do 8°C).
English: Amenorrhoea was observed to be ongoing during follow-up in 140 patients out of the 251 patients with amenorrhoea at the end of the chemotherapy.
Slovenian: Še prisotno amenorejo so pri spremljanju zabeležili pri 140 od 251 bolnicah, ki so imele amenorejo ob koncu kemoterapije.
English: Alopecia; Nail disorders (no severe)
Slovenian: Alopecija, spremembe nohtov (nobenih hudih)
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 a 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
English: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Slovenian: Splošno Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95%CI) ***p-value
Slovenian: Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % IZ) ***p-vrednost
English: The reconstituted solution contains approximately 24 mg/ml docetaxel and should be used immediately after preparation.
Slovenian: Pripravljena raztopina vsebuje približno 24 mg/ml docetaxela in jo je treba uporabiti nemudoma po pripravi.
English: ≥50 years
Slovenian: <50 let
English: No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Slovenian: nobeni izmed preiskovanih skupin pri bolnicah ni bil diagnosticiran mielodisplastični sindrom.
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Slovenian: Med zdravljenjem morata in moški in ženska uporabljati kontracepcijsko zaščito, moški pa jo mora mora uporabljati še vsaj šest mesece po zdravljanja.
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 x ULN ter hkrati alkalno fosfatazo > 2,5 x ULN in bilirubinom > 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
English: A
Slovenian: s
English: 1Full analysis set (intent-to-treat)
Slovenian: 1celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM POGOJI ALI OMEJITVE GLEDE OBSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: The solution in the infusion bag or bottle should be allowed to mix manually using a rocking motion.
Slovenian: Raztopino v infuzijski vrečki ali steklenici lahko ročno premešate z nagibanjem sem in tja.
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Slovenian: Docefrez v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
English: In combination with capecitabine
Slovenian: kombinaciji s kapecitabinom
English: Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Slovenian: Docefrez je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
English: 1060 patients were randomized to receive either docetaxel 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: 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: Lacrimation increased
Slovenian: Močnejše solzenje
English: A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Slovenian: Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/m2 1. dan) in 5-fluorouracilom (F) (750 mg/m2 na dan, 5 dni), bodisi cisplatin (100 mg/m2 1. dan) in 5fluorouracil (1000 mg/m2 na dan, 5 dni).
English: Lacrimation increased Conjunctivitis
Slovenian: Močnejše solzenje, konjunktivitis
English: Dyspnoea (severe 2.7%)
Slovenian: Dispneja (huda: 2,7 %)
English: Neutropenia (G4:76.4%) Anaemia (G3/4: 8.9%); Febrile neutropenia
Slovenian: Nevtropenija (S4: 76,4 anemija (S3/4: 8,9 %), febrilna nevtropenija
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,
English: Docetaxel+Cis+5-FU n=177
Slovenian: Docetaksel+ Cis+5-FU n = 177
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docefrez may be harmful for the unborn baby.
Slovenian: Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito.
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Slovenian: EuroQoL-5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
English: Best overall response to chemotherapy (%) (95%CI) ***p-value
Slovenian: Najboljši celotni odziv na kemoterapijo (%) (95 % IZ) ***p-vrednost
English: The volume of concentrate (24 mg/ml docetaxel) corresponding to the required dose (mg) for the patient should be withdrawn (from the appropriate number of vials) using graduated syringes fitted with a needle.
Slovenian: Z graduiranimi injekcijskimi brizgami z iglo izvlecite količino koncentrata (24 mg/ml docetaksela), ki ustreza potrebnemu odmerku (mg) za bolnika (iz ustreznega števila vial).
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 <
English: Anorexia (G3/4: 1%); Decreased appetite
Slovenian: Presnovne in prehranske motnje Anoreksija (S3/4: 1 %), zmanjšan apetit
English: Docetaxel 75 mg/m² in combination with capecitabine
Slovenian: Docetaksel 75 mg/m2 v kombinaciji s kapecitabinom
English: 3 HOW TO USE DOCEFREZ
Slovenian: Kako uporabljati zdravilo Docefrez
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Slovenian: Navzea (S3/4: 13,9 %), stomatitis (S3/4:
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Slovenian: Povprečni celotni telesni očistek je bil 21 l/h/m2, volumen
English: You must not breast-feed while using Docefrez.
Slovenian: Med zdravljenjem s Docefrezom NE smete dojiti.
English: Number of patients Median survival (months) 95% CI
Slovenian: Število bolnikov Mediana preživetja (meseci) 95 % IZ
English: There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease-related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Slovenian: Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Slovenian: Za zmanjšanje tveganja za hematološke toksične učinke se lahko profilaktično uporabi GCSF.
English: Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i.e. an absolute reduction of the risk of death by 6% (p=0.008).
Slovenian: Tudi celotno preživetje pri 5 letih je bilo značilno povečano pri TAC v primerjavi z FAC (87 % proti 81 %) t.j.
English: Non-small Cell Lung Cancer
Slovenian: Nedrobnocelični pljučni rak
English: Infection (G3/4: 3.6%) Neutropenic infection
Slovenian: Okužba (S3/4: 3,6 %) Nevtropenična okužba
English: Headache (G3/4: <1%); Neuropathy peripheral
Slovenian: Omotica, glavobol (S3/4: < 1 %), periferna nevropatija
English: For those patients with serum bilirubin >ULN and/or ALT and AST >3.5 times the ULN associated with alkaline phosphatase >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
English: Radiation recall phenomena have rarely been reported.
Slovenian: Redko so poročali o pojavu pomnjenja obsevanja.
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Slovenian: Sicer pa je s preizkusom dokazano, da se kemična in fizična obstojnost pripravljene raztopine ohrani 8 ur, če je shranjena med 2°C in 8°C ali na sobni temperaturi (manj kot 25°C).
English: Docetaxel in combination with capecitabine
Slovenian: Docefrez v kombinaciji s kapecitabinom
English: Reconstituted solution The reconstituted solution contains 24 mg/ml docetaxel and should be used immediately after preparation.
Slovenian: Pripravljena raztopina Pripravljena raztopina vsebuje 24 mg/ml docetaksela in jo je treba uporabiti takoj po pripravi.
English: • one single-dose solvent vial with 4 ml solvent for docefrez (35.4% (w/w) ethanol in polysorbate 80) .
Slovenian: • ena viala za vehikel z enim odmerkom s 4 ml vehikla za zdravilo Docefrez (35,4 % (m/m) etanola v polisorbatu 80).
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Slovenian: Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m2, ki mu je sledil 5-fluorouracil (F) 1000 mg/m2 na dan 5 dni.
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
English: Docetaxel every 3 weeks
Slovenian: Docetaksel vsake 3 tedne
English: Dehydration (G3/4: 2%);
Slovenian: Dehidracija (S3/4: 2 %),
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg docetaxel (anhydrous)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 80 mg docetaxel (brez vode)
English: Docetaxel + Cis + 5-FU n = 255
Slovenian: Docetaksel + Cis + 5FU n = 255
English: The overfill ensures that after dilution with the entire extractable volume of the accompanying solvent vial for Docefrez, there is a minimal extractable reconstituted solution of 0.84 ml containing 20 mg docetaxel (anhydrous).
Slovenian: Prenapolnjenje zagotavlja, da je po razredčitvi s celotnim izločljivim volumnom raztopine viale z vehiklom za Docefrez, minimalen izločljivi volumen 0,84 ml, ki vsebuje 20 mg docetaksela (brez vode).
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Slovenian: Reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude
English: The overfills are included to ensure that, after dilution with the entire volume of the accompanying solvent vial, the minimum extractable volume of reconstituted concentrate containing 20 mg or 80 mg docetaxel, respectively, may be withdrawn from the vial.
Slovenian: Dodatek vsebine v viali zagotavlja, da je mogoče po razredčenju s celotno vsebino priložene viale z vehiklom iz viale izvleči najmanjšo prostornino pripravljenega koncentrata z 20 mg oziroma 80 mg docetaksela, ki jo je mogoče ekstrahitati.
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced
Slovenian: Učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno
English: After reconstitution, each vial contains an extractable volume of approx 0.84 ml concentrate, corresponding to approximately 20 mg docetaxel.
Slovenian: Po pripravi vsebuje vsaka viala izvlečeno količino koncentrata, približno 0,84 ml, kar ustreza približno
English: Patients on the docetaxel arm received docetaxel 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days .
Slovenian: Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5-fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.