FrancophonIA/ELRC3.0 huggingface dataset:
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
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 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
English: Concentrate vial: Polysorbate 80 Citric acid.
Slovenian: Viala koncentrata: Polisorbat 80 citronska kislina
English: 15 ml clear glass (type I) vial with a blue aluminium seal and blue plastic flip-off cap containing 8 ml of concentrate.
Slovenian: 15 ml viala iz prozornega stekla tipa I z modro aluminijasto zaporko in modro dvižno zaporko z 8 ml koncentrata.
English: 75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Slovenian: Priporočeni odmerek docetaksela je 75 mg/m2 v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m2 v 1- do 3-urni infuziji (oboje samo 1. dan); temu sledi 5-fluorouracil 750 mg/m2 na dan v 24-urni stalni infuziji 5 dni, z začetkom ob koncu infuzije cisplatina.
English: The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Slovenian: Aplicirati jo je treba aseptično v 1-urni infuziji, pri sobni temperaturi (do 25°C) in v pogojih običajne svetlobe.
English: At the median follow-up time of 77 months, overall survival (OS) was 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: Po mediano 77 mesecih spremljanja je bilo dokazano, da je bilo celotno preživetje 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: Docetaxel regimen was administered in combination with prednisone or prednisolone 5 mg twice daily continuously.
Slovenian: Shema z docetakselom je bila uporabljena v kombinaciji z nepretrgano uporabo 5 mg prednizona ali prednizolona dvakrat na dan.
English: • Mix the infusion bag or bottle manually using a rocking motion.
Slovenian: • Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m and 113 l, respectively.
Slovenian: Povprečni celotni telesni očistek je bil 21 l/h/m2, volumen porazdelitve v stanju dinamičnega ravnovesja pa 113 l. Interindividualno variiranje celotnega telesnega očistka je bilo približno 50 %.
English: Dose adjustment Diarrhoea 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: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu.
English: Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml).
Slovenian: Viala z vehiklom vsebuje 6 ml 13 % (m/m) raztopine 95 % etanola v vodi za injekcije (polnilni volumen: 7,33 ml).
English: Metastatic castration-resistant prostate cancer
Slovenian: Metastatski, proti kastraciji odporen rak prostate
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor
Slovenian: TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor
English: Nail disorders (severe: 0.8%)
Slovenian: spremembe nohtov (hude 0,8 %)
English: Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Slovenian: 1 ml koncentrata vsebuje 20 mg docetaksela v obliki trihidrata.
English: G3/4 Blood bilirubin increased (2.1%);
Slovenian: S3/4 zvišanje bilirubina v krvi (2,1 %), S3/4 zvišanje ALT
English: TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Slovenian: Zdravilo TAXOTERE v kombinaciji s cisplatinom je indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
English: Common adverse reactions disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje anoreksija Psihiatrične motnje nespečnost
English: Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous).
Slovenian: Ena viala z enim odmerkom zdravila TAXOTERE 20/0,5 ml mg koncentrat vsebuje docetaksel (kot trihidrat), ki ustreza 20 mg brezvodnega docetaksela.
English: The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study (CHAARTED).
Slovenian: Varnost in učinkovitost docetaksela, uporabljenega na začetku androgenskega deprivacijskega zdravljenja (ADT) pri bolnikih z metastatskim hormonsko občutljivim rakom prostate, so ovrednotili v randomizirani multicentrični študiji III. faze (študija CHAARTED).
English: For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4).
Slovenian: Za metastatskega, hormonsko občutljivega raka prostate je ne glede na sočasno uporabo prednizona ali prednizolona priporočena premedikacija z 8 mg deksametazona peroralno 12 ur, 3 ure in 1 uro pred infundiranjem docetaksela (glejte poglavje 4.4).
English: TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Slovenian: Zdravilo TAXOTERE v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: In both arms, after the last cycle of chemotherapy, patients with positive eostrogen 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 tamoksifen 20 mg na dan. Adjuvantna radioterapija je bila predpisana v skladu z veljavnimi smernicami v sodelujočih ustanovah.
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Slovenian: V študiji III. faze so 1.218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, randomizirali v tri skupine.
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with metastatic castration-resistant prostate cancer were evaluated in a randomised multi-centre phase III study (TAX 327).
Slovenian: Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim proti kastraciji odpornim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III (TAX 327).
English: Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Slovenian: Bolezni živčevja parestezije, glavobol, disgevzija, hipestezija
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Slovenian: Vsaka škatla vsebuje 1 vialo z 1 ml koncentrata (20 mg docetaksela).
English: Fluid retention (severe:
Slovenian: spremembe nohtov (hude:
English: Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia
Slovenian: Bolezni prebavil driska (3. st.: 3 %) stomatitis (3. st.: 0 %) zaprtost (3. st.: 0 %) navzea (3. st.: 1 %) dispepsija bolečine v trebuhu (3. st.: 0 %) flatulenca bruhanje (3. st.: 1 %)
English: p =
Slovenian: Vrednost p*
English: There is no relevant use of TAXOTERE 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 TAXOTERE ni primerno za uporabo pri pediatrični populaciji nima 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: Solvent vial contains 1.5 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 1.98 ml).
Slovenian: Viala z vehiklom vsebuje 1,5 ml 13 % (m/m) raztopine 95 % etanola v vodi za injekcije (polnilni volumen: 1,98 ml).
English: If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Slovenian: Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže 0,74 mg docetaksela/ml.
English: TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Slovenian: Zdravilo TAXOTERE je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim proti kastraciji odpornim rakom prostate.
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Slovenian: Zdravilo TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 40 mg brezvodnega docetaksela/ml v polisorbatu 80 in citronsko kislino.
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Slovenian: Zdravilo TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 40 mg brezvodnega docetaksela/ml v polisorbatu 80 in citronsko kislino.
English: Time to castration-resistant prostate cancerb
Slovenian: Čas do raka prostate, odpornega proti kastracijib
English: Mix the infusion bag or bottle manually using a rocking motion.
Slovenian: Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
English: 1 vial of TAXOTERE 80 mg/2 ml concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ml) Fill: 94.4 mg/2.36 ml
Slovenian: 1 viala zdravila TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje 80 mg docetaksela v 2 ml polisorbata 80 (40 mg/ml) Polnitev: 94,4 mg/2,36 ml
English: TAXOTERE in combination with trastuzumab
Slovenian: Zdravilo TAXOTERE v kombinaciji s trastuzumabom
English: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v).
Slovenian: Ena viala z enim odmerkom vehikla vsebuje 13 % (m/m) 95 % (v/v) etanola v vodi za injekcije (252 mg 95% (v/v) etanola).
English: The required volume of TAXOTERE concentrate for solution for infusion must be injected via a single injection (one shot) into a 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 koncentrata za raztopino za infundiranje zdravila TAXOTERE je treba vbrizgati preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: combined with capecitabine at 1250 mg/m 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-tedenski premor.
English: 4.2 Preparation of the infusion solution
Slovenian: 4.2 Priprava raztopine za infundiranje
English: 1 vial of TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ml) Fill: 24.4 mg/0.61 ml
Slovenian: 1 viala zdravila TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje 20 mg docetaksela v 0,5 ml polisorbata 80 (40 mg/ml) Polnitev: 24,4 mg/0,61 ml
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76%versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Slovenian: Tudi celotno preživetje pri 10 letih je bilo značilno povečano pri TAC v primerjavi z FAC (76 % proti 69 %) t.j.
English: The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.
Slovenian: Vehikel za zdravilo TAXOTERE je 13 % (m/m) raztopina 95 % etanola v vodi za injekcije.
English: TAXOTERE is supplied as single-dose vials.
Slovenian: Zdravilo TAXOTERE je na voljo v vialah z enim odmerkom.
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m as a 1 hour infusion followed by cisplatin 75 mg/m over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m per day for five days.
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m2 v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m2, infundiran 1 uro dolgo prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m2 na dan pet dni.
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Slovenian: Vsaka škatla vsebuje 1 vialo z 8 ml koncentrata (160 mg docetaksela).
English: TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Slovenian: Zdravilo TAXOTERE je indiciran v kombinaciji s trastuzumabom za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
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: Peripheral motor neuropathy (G3/4:
Slovenian: periferna motorična nevropatija (S3/4:
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m on day 1) in combination with cisplatin (C) (75 mg/m on day 1) and 5-fluorouracil (F)
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: 7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.
Slovenian: 7 ml viala iz prozornega stekla tipa I z zeleno aluminijasto zaporko in zeleno dvižno zaporko z 1 ml koncentrata.
English: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v).
Slovenian: Ena viala z enim odmerkom vehikla vsebuje 13% (m/m) 95 % (v/v) etanola v vodi za injekcije (932 mg 95 % (v/v) etanola).
English: 15 ml clear glass Type I vial with a red flip-off cap.
Slovenian: 15-ml viala iz prozornega stekla tipa I z rdečo dvižno zaporko.
English: Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study(TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Slovenian: Od 333 bolnikov z rakom prostate v študiji, ki so bili zdravljeni z docetakselom vsake tri tedne, je bilo 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih nad 75 let.
English: What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections.
Slovenian: Kaj vsebuje viala z vehiklom: 13 % (m/m) 95 % etanola (glejte poglavje 2) v vodi za injekcije
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
English: Overall survival (Primary end-point):
Slovenian: statistična analiza celotno preživetje (primarna končna točka) mediana preživetja (meseci)
English: VIAL LABEL / TAXOTERE 160 mg/8 ml
Slovenian: NALEPKA NA VIALI/TAXOTERE 160 mg/8 ml
English: Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous).
Slovenian: Ena viala z enim odmerkom zdravila TAXOTERE 80 mg/2 ml koncentrat vsebuje docetaksel (kot trihidrat), ki ustreza 80 mg brezvodnega docetaksela.
English: Patients with baseline neutrophil count of < 1,500 cells/mm
Slovenian: Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Slovenian: Bolezni prebavil navzea (S3/4: 13,9 %), stomatitis (S3/4:
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Slovenian: Vsaka škatla vsebuje 1 vialo s 4 ml koncentrata (80 mg docetaksela).
English: • Docetaxel 75 mg/m every 3 weeks for 10 cycles.
Slovenian: • Docetaksel 75 mg/m2 vsake 3 tedne, 10 ciklov.
English: Cautions for use in adjuvant treatment of breast cancer There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
English: Prednisone or prednisolone 5 mg orally twice daily may be administered continuously.
Slovenian: Nepretrgano je mogoče uporabljati 5 mg prednizona ali prednizolona peroralno dvakrat na dan.
English: - The other ingredients are polysorbate 80 and citric acid.
Slovenian: - Pomožni snovi sta polisorbat 80 in citronska kislina.
English: • The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Slovenian: • Viala zdravila TAXOTERE 80 mg/2 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
English: The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Slovenian: Koncentrat je opremljen v 15-ml prozorni brezbarvni viali iz stekla tipa I z modro aluminijasto zaporko in z modro dvižno zaporko.
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Slovenian: Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ali poslabšanja sluha.
English: • operable node-negative breast cancer .
Slovenian: • operabilnim rakom dojke z negativnimi bezgavkami.
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovenian: Namen tega je minimaliziranje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila TAXOTERE, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests.
Slovenian: Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
English: Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
Slovenian: biokemičnega neuspeha (opredeljenega kot zvišanje PSA za 50 % nad 24-tedensko obdobje znotraj najnižje vrednosti in nad 4 ng/ml ter potrjenega s ponovnim testiranjem ali z zdravljenjem); napredovanja bodisi lokalno, v bezgavkah ali oddaljenih metastaz; skeletnega dogodka; smrti zaradi raka prostate.
English: 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: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: VIAL/TAXOTERE 20 mg/0.5 ml
Slovenian: VIALA/TAXOTERE 20 mg/0,5 ml
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 3,16 g brezvodnega etanola na vialo; kar ustreza 80 ml piva ali 33 ml vina.
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid.
Slovenian: - Pomožni snovi sta polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina.