FrancophonIA/ELRC3.0 huggingface dataset:
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
Slovenian: Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z G-CSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
English: Hazard ratio*
Slovenian: Razmerje ogroženosti*
English: The solvent is a colourless solution.
Slovenian: Vehikel je brezbarvna raztopina.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Slovenian: Zdravilo je potrebno aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
English: In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anaemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher).
Slovenian: Bolniki, stari 75 let ali več, so imeli v primerjavi z mlajšimi bolniki večjo (vsaj 10 % večjo) pojavnost nevtropenije, anemije, driske, dispneje in okužb zgornjih dihal.
English: Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
English: • Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml.
Slovenian: • Vsaka viala z vehiklom za zdravilo TAXOTERE 80 mg/2 ml vsebuje 7,33 ml vehikla.
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Slovenian: razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]*
English: Number of metastatic prostate cancer patients
Slovenian: Število bolnikov z metastatskim rakom prostate
English: The European Medicines Agency has waived the obligation to submit the results of studies with TAXOTERE in all subsets of the paediatric population in 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 (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij z zdravilom TAXOTERE za vse skupine pediatrične populacije za raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, karcinom želodca in raka glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Amenorrhoea (G3/4: NA)
Slovenian: Amenoreja (S 3/4: NA)
English: In addition, dexamethasone did not affect protein binding of docetaxel.
Slovenian: Poleg tega deksametazon ni vplival na vezavo docetaksela na beljakovine.
English: • ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
Slovenian: • ADT + docetaksel 75 mg/m2, uporabljen na začetku ADT in uporabljan na 3 tedne 6 ciklusov,
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Slovenian: Incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje se je zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF (glejte poglavje 4.8).
English: • Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml.
Slovenian: • Vsaka viala z vehiklom za zdravilo TAXOTERE 20 mg/0,5 ml vsebuje 1,98 ml vehikla.
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Slovenian: 4.1.2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo TAXOTERE iz viale tako, da vialo delno obrnete.
English: Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED)
Slovenian: Učinkovitost docetaksela in ADT za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija CHAARTED)
English: Patients with operable node-positive breast cancer (TAX 316)
Slovenian: Bolnice z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316)
English: The onset of moderate and severe retention is delayed (median cumulative dose: 818.9 mg/m2) in patients with premedication compared with patients without premedication (median cumulative dose: 489.7 mg/m2); however, it has been reported in some patients during the early courses of therapy.
Slovenian: Zmeren oz. hud zastoj se kasneje pojavi pri bolnikih, ki dobijo premedikacijo (mediani kumulativni odmerek: 818,9 mg/m2), kot pri tistih, ki je ne (mediani kumulativni odmerek: 489,7 mg/m2); vendar je pri nekaterih bolnikih opisan med zgodnjimi ciklusi zdravljenja.
English: Acute myeloid leukaemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Slovenian: O akutni mieloični levkemiji in mielodisplastičnem sindromu so (s pogostnostjo "občasno") poročali v ključnih kliničnih študijah pri raku dojke s shemo TAC.
English: Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Slovenian: Sanofi Mature IP 54 rue La Boétie 75008 Pariz Francija
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Slovenian: PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
English: (G3/4: 0.2%)
Slovenian: (S3/4: 0,2 %)
English: In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels
Slovenian: Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi
English: Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, France
Slovenian: Sanofi Mature IP, 54 rue La Boétie, 75008 Pariz, Francija
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: 27,4-36,0).
English: • 1276 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 prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
English: Neutropenic infection (Grade 3-4)
Slovenian: Nevtropenična okužba (3.-4. stopnja)
English: For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Slovenian: Primer: za odmerek 140 mg docetaksela bi potrebovali 7 ml koncentrata docetaksela za raztopino.
English: In case of
Slovenian: Ne Da
English: TAXOTERE in combination with doxorubicin
Slovenian: Zdravilo TAXOTERE v kombinaciji z doksorubicinom
English: b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first.
Slovenian: b Čas do raka prostate, odpornega proti kastraciji = čas od randomizacije do napredovanja PSA ali kliničnega napredovanja (tj. porast simptomov metastaz v kosteh, napredovanje po merilih RECIST (Response Evaluation Criteria in Solid Tumours) ali klinično poslabšanje zaradi raka po mnenju raziskovalca), kar od tega se pojavi prej.
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 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 < 1/1.000); zelo redko (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Cautions for use in hormone-sensitive prostate cancer
Slovenian: Previdnost pri uporabi pri hormonsko občutljivem raku prostate
English: Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Slovenian: V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
English: Solvent vial: ethanol 95% (see leaflet for further information), water for injections.
Slovenian: Viala vehikla: 95 % etanol (za dodatne informacije glejte navodilo za uporabo), voda za injekcije.
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 arm.
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
English: More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anaemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years.
Slovenian: V skupini, ki je prejemala docetaksel, je o preobčutljivostni reakciji, nevtropeniji, anemiji, zadrževanju tekočine, dispneji in spremembi nohtov poročalo več bolnikov, starih ≥ 65 let, kot bolnikov, mlajših od 65 let.
English: 4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Slovenian: 4.1 Priprava osnovne raztopine zdravila TAXOTERA (10 mg docetaksela/ml)
English: G3/4 Blood bilirubin increased
Slovenian: S3/4 zvišanje bilirubin v krvi
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: O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samodocetaksel.
English: For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Slovenian: Primer: za odmerek 140 mg docetaksela bi potrebovali 14 ml osnovne raztopine docetaksela.
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m in monotherapy.
Slovenian: Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m2.
English: Patients with severe liver impairment (see sections 4.2 and 4.4).
Slovenian: Bolniki s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
English: Sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 996
Slovenian: Deutschland sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 996
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Slovenian: Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine, ki vsebuje 10 mg docetaksela/ml, iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
English: • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25°C).
Slovenian: • Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25°C).
English: Solvent vial:
Slovenian: Viala z vehiklom:
English: MedDRA system organ classes Very common adverse reactions
Slovenian: Organski sistemi po MedDRA Zelo pogosti neželeni učinki
English: • one single-dose vial of concentrate,
Slovenian: • eno vialo z enim odmerkom koncentrata
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Slovenian: Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
English: TAXOTERE in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.
Slovenian: Zdravilo TAXOTERE je v kombinaciji z zdravljenjem z deprivacijo androgenov (ADT - androgendeprivation therapy) s prednizonom oz. prednizolonom ali brez njega, indicirano za zdravljenje bolnikov z metastatskim, hormonsko občutljivim rakom prostate.
English: - For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
Slovenian: - Za zdravljenje raka prostate se zdravilo TAXOTERE lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
English: Of the 545 patients treated with docetaxel every 3 weeks in a hormone-sensitive prostate cancer study (STAMPEDE), 296 patients were 65 years of age or older, and 48 patients were 75 years of age or older.
Slovenian: Od 545 bolnikov, ki so bili v študiji hormonsko občutljivega raka prostate (študija STAMPEDE) zdravljeni z docetakselom na 3 tedne, je bilo 296 bolnikov starih 65 let ali več in 48 bolnikov 75 let ali več.
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: - For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.
Slovenian: - Za zdravljenje pljučnega raka se zdravilo TAXOTERE lahko uporablja sam ali v kombinaciji s cisplatinom.
English: Patients previously treated with chemotherapy with or without radiotherapy
Slovenian: Nedrobnocelični pljučni rak Bolniki, predhodno zdravljeni s kemoterapijo z radioterapijo ali brez nje
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: Vendar je osnovna raztopina dokazano kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2°C in 8°C ali pri sobni temperaturi (do 25°C).
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)
Slovenian: Sočasno se lahko pojavijo tudi gripi podobni simptomi, na primer zvišana telesna temperatura, mrzlica ali boleče mišice.)
English: Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3.
Slovenian: Bolniki ne smejo znova dobiti ciklusov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
English: In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, ketoconazole and erythromycin.
Slovenian: Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P450-3A ali se z njim presnavljajo (in ga tako lahko kompetitivno inhibirajo), kot so ciklosporin, ketokonazol in eritromicin.
English: TAXOTERE 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: Zdravilo TAXOTERE 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: For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Slovenian: Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5 %), o katerih so poročali v študiji III faze pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
English: PSA response** at 12 months - N(%) p-valuea*
Slovenian: Odziv PSA** po 12 mesecih - N (%) Vrednost pa*
English: First episode: stop 5-FU only, at all subsequent cycles.
Slovenian: Prvi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
English: In these metastatic prostate cancer patients, the median overall survival was significantly longer in docetaxel treatment groups than in the standard of care alone group, with a median overall survival 19 months longer with the addition of docetaxel to standard of care (HR = 0.76, 95% CI = 0.62-0.92, p=0.005).
Slovenian: Med temi bolniki z metastatskim rakom prostate je bilo mediano celokupno preživetje značilno daljše v skupini, ki je prejemala docetaksel, kot v skupini, ki je bila deležna le standardne oskrbe; mediano celokupno preživetje je bilo z dodatkom docetaksela standardni oskrbi 19 mesecev daljše (ROg = 0,76, 95 % IZ = 0,62-0,92, p = 0,005).
English: Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Slovenian: Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (80 mg/2 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Slovenian: Za kombinacijo z ADT in prednizonom ali prednizolonom (študija STAMPEDE) so prikazani neželeni učinki, ki so se pojavili v 6 ciklusih zdravljenja z docetakselom in so imeli v skupini z docetakselom vsaj 2 % večjo pojavnost kot v kontrolni skupini; uporabljena je lestvica stopenj CTCAE.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Slovenian: Za uporabo pri starostnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
English: • Acute Generalized Exanthematous Pustulosis (AGEP) (red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.)
Slovenian: • akutna generalizirana eksantemska pustuloza (AGEP) (rdeč, luskast razprostranjen izpuščaj z bulicami pod oteklo kožo (tudi v kožnih gubah, na trupu in zgornjih okončinah) in mehurji, ki jih spremlja zvišana telesna temperatura.)
English: - For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje metastatskega raka želodca se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
English: TAXOTERE concentrate
Slovenian: DRUGI PODATKI TAXOTERE koncentrat VEHIKEL za TAXOTERE
English: Efficacy of docetaxel in combination with prednisone or prednisolone and standard of care in the treatment of patients with metastatic hormone-sensitive prostate cancer (STAMPEDE)
Slovenian: Učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom ter standardne oskrbe za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija STAMPEDE)
English: At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP) nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
English: Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Slovenian: Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (20 mg/0,5 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
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 vrečko, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25°C.
English: PSA response** at 6 months - N(%) p-valuea*
Slovenian: Odziv PSA** po 6 mesecih - N (%) Vrednost pa*
English: Data from one multi-centre, 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 kliničnega 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: Efficacy results in metastatic prostate cancer patients for docetaxel arm versus control arm are summarized in the following table:
Slovenian: Rezultate učinkovitosti pri bolnikih z metastatskim rakom prostate v skupini z docetakselom v primerjavi s kontrolno skupino povzema naslednja preglednica:
English: To be taken into account in pregnant or breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy.
Slovenian: Vsebnost etanola je treba upoštevati tudi pri nosečnicah, doječih ženskah, otrocih in skupinah z velikim tveganjem, npr. pri bolnikih z boleznijo jeter ali epilepsijo.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Slovenian: Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo TAXOTERE iz viale tako, da vialo delno obrnete.
English: One vial contains 20 mg/0.5 ml docetaxel.
Slovenian: Ena viala vsebuje 20 mg/0,5 ml docetaksela.
English: Adjusted hazard ratio
Slovenian: Prilagojeno razmerje ogroženosti
English: Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Slovenian: Preživetje brez bolezni (DFS-Disease-free survival) je bilo primarni, celokupno preživetje (OS-Overall survival) pa sekundarni opazovani dogodek učinkovitosti.
English: TAXOTERE vial: polysorbate 80, citric acid.
Slovenian: Viala zdravila TAXOTERA: polisorbat 80, citronska kislina.
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Slovenian: Redko so poročali o venskih trombembolijah.
English: A total of 1006 patients with KPS  60 were randomised to the following treatment groups:
Slovenian: V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem  60:
English: - AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
Slovenian: - Med simptomi AGEP so lahko rdeč, luskast razprostranjen izpuščaj z bulicami pod oteklo kožo (tudi v kožnih gubah, na trupu in zgornjih okončinah) in mehurji, ki jih spremlja zvišana telesna temperatura.