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 okuţba 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: This is because Docetaxel Teva Pharma or other medicine may not work as well as expected and you may be more likely to get a side effect.
Slovenian: Zdravilo Docetaxel Teva Pharma ali drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neţelen učinek.
English: Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Bolniki, ki dobivajo TCF, morajo profilaktično dobivati G-CSF za zmanjšanje tveganja za zapleteno nevtropenijo (febrilno nevtropenijo, dolgotrajno nevtropenijo ali nevtropenično okuţbo).
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Slovenian: Študija I. faze za oceno učinka kapecitabina na farmakokinetiko docetaksela in nasprotno ni odkrila, da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC) ali da bi docetaksel vplival na farmakokinetiko 5'-DFUR, pomembnega presnovka kapecitabina.
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Slovenian: Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/m na 6 tednov in 6 mg/m na 3 tedne).
English: Cutaneous reactions
Slovenian: Koţne reakcije
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
Slovenian: V študiji TAX316 je alopecija trajala v obdobje spremljanja po koncu kemoterapije pri 687 bolnicah, ki so prejemale TAC, in 645 bolnicah, ki so prejemale FAC.
English: For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Slovenian: Primer: za odmerek 140 mg docetaksela potrebujete 14 ml osnovne raztopine docetaksela.
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Slovenian: 300 bolnikih z adenokarcinomom ţelodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
English: The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Slovenian: Srednji kumulativni odmerek do prekinitve zdravljenja je bil več kot 1000 mg/m in srednji čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
English: Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Slovenian: Zaradi moţnih neţelenih učinkov na dojenčke je treba dojenje med zdravljenjem z docetakselom prekiniti.
English: Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Slovenian: Primarna profilaksa z G-CSF pride v poštev pri bolnicah, ki prejemajo adjuvantno zdravljenje s TAC za raka dojke, za zmanjšanje tveganja zapletene nevtropenije (febrilne nevtropenije, dolgotrajne nevtropenije ali nevtropenične okuţbe).
English: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Slovenian: Bolnike s hudim zastajanjem tekočine, npr. plevralnim izlivom, perikardialnim izlivom ali ascitesom, je treba skrbno nadzorovati.
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Slovenian: Mielodisplastični sindrom so zabeleţili pri 2 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Slovenian: V primeru blaţjih preobčutljivostnih reakcij, npr. pordelosti ali lokalnih koţnih reakcij, zdravljenja ni treba prekiniti.
English: • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
Slovenian: ciklih; mitoksantron 12 mg/m vsake 3 tedne, 10 ciklov.
English: A total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Slovenian: V spodnje skupine zdravljenja so naključno razvrstili skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
English: A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Slovenian: Skupaj 449 bolnic so naključno razvrstili na monoterapijo z docetakselom 100 mg/m v enourni infuziji ali na paklitaksel 175 mg/m v triurni infuziji.
English: The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Slovenian: Tudi enoletni deleţ preţivetja je bil z docetakselom značilno daljši (40 %) kot z najboljšo podporno oskrbo (16 %).
English: Docetaxel is highly protein bound (>95%).
Slovenian: Docetaksel se obseţno (> 95 %) veţe na beljakovine.
English: Very rare cases of cutaneous lupus erythematous and bullous eruptions such as erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Slovenian: Zelo redko so pri zdravljenju z docetakselom poročali o koţnem eritematoznem lupusu in buloznih erupcijah, npr. o multiformnem eritemu, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi.
English: Cardiac failure; Arrhythmia (no severe)
Slovenian: Srčne bolezni srčno popuščanje, aritmija (ne huda)
English: Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Slovenian: Pri bolnicah, ki so dobivale docetaksel v kombinaciji s trastuzumabom, so opazili srčno popuščanje, še posebno, če je zdravljenje sledilo kemoterapiji z antraciklinom (doksorubicin ali epirubicin).
English: Recommended dose
Slovenian: Priporočeno odmerjanje
English: Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasations and swelling of the vein.
Slovenian: Reakcije na mestu infundiranja so bile praviloma blage; obsegale so hiperpigmentacijo, vnetje, pordelost ali suhost koţe, flebitis ali ekstravazacijo in otekanje vene.
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Slovenian: Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m
English: Blood and lymphatic system disorders neutropenia associated with fever and antibiotic use) or neutropenic
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija (vključuje nevtropenijo, povezano s povišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa Presnovne in prehranske motnje anoreksija
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Slovenian: Za uporabo pri starejših osebah glede na analizo farmakokinetike na populaciji ni posebnih navodil.
English: At the end of the follow-up period, alopecia was observed to be ongoing in 29 TAC patients (4.2%) and 16 FAC patients (2.4%).
Slovenian: Na koncu obdobja spremljanja so še trajajočo alopecijo zabeleţili pri 29 bolnicah (4,2 %), ki so prejemale TAC, in pri 16 bolnicah, ki so prejemale FAC (2.4 %).
English: Docetaxel Teva Pharma should not be used after the expiry date shown on the carton and vials.
Slovenian: Zdravila Docetaxel Teva Pharma ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vialah.
English: The following adverse reactions are frequently observed with docetaxel:
Slovenian: Pri docetakselu so pogosto opaţali naslednje neţelene učinke:
English: If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma 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 Docetaxel Teva Pharma 5 minut stati na sobni temperaturi (do 25°C).
English: Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Slovenian: razmerje tveganja: 1,032 [95-% IZ: 0,876; 1,216]
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 (izraţen 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: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Slovenian: Docetaksel se ne sme uporabljati pri bolnikih, ki imajo izhodiščno število nevtrofilcev < 1500 celic/mm
English: Congestive heart failure (CHF)
Slovenian: Zastojno srčno popuščanje(KSP)
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Slovenian: Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Teva Pharma.
English: There is no relevant use of Docetaxel Teva Pharma in the paediatric population in the indications breast cancer, non-small cell lung cancer and prostate cancer.
Slovenian: Zdravilo Docetaxel Teva Pharma ni primerno za uporabo pri pediatrični populaciji za indikacije rak dojke, nedrobnocelični pljučni rak in rak prostate.
English: Hungary
Slovenian: Magyarország
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/m v enourni infuziji je bila povprečna največja koncentracija v plazmi 3,7 µg/ml, ustrezna vrednost AUC pa 4,6 hµg/ml.
English: Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol.
Slovenian: Viala s koncentratom docetaksela Polisorbat 80, brezvodni etanol.
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, ki so se zdravili z docetakselom vsake tri tedne in so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih za ≥ 10 % večja v primerjavi z mlajšimi bolniki.
English: Docetaxel Teva Pharma will be administered to you by a healthcare professional.
Slovenian: Zdravilo Docetaxel Teva Pharma vam bo dal pristojni zdravstveni delavec.
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Slovenian: razmerje tveganja: 1,122 [97,2-% IZ: 0,937; 1,342]*
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Slovenian: Farmakokinetiko docetaksela v prisotnosti prednizona so preučevali pri bolnikih z metastatskim rakom prostate.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Slovenian: Zdravilo je treba aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Slovenian: Statistično značilnih učinkov prednizona na farmakokinetiko docetaksela niso opazili.
English: The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Slovenian: Najpogosteje opisani simptomi so pordelost, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja in povišana telesna temperatura ali mrzlica.
English: When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Slovenian: Pri bolnicah, ki so kandidatke za zdravljenje z docetakselom v kombinaciji s trastuzumabom, je treba opraviti izhodiščne preiskave za oceno srčne funkcije.
English: No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Slovenian: V nobeni izmed preiskovanih skupin pri bolnicah ni bil diagnosticiran mielodisplastični sindrom.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
Slovenian: Benigne in maligne novotvorbe (vključno s cistami in polipi) Poročali so o primerih akutne mieloidne levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali obsevanjem.
English: 6.4 Special precautions for storage and other handling
Slovenian: 6.4 Posebni varnostni ukrepi za shranjevanje in ravnanje z zdravilom
English: Therefore, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
Slovenian: Moškim, ki prejemajo docetaksel je zato potrebno svetovati, naj med zdravljenjem in do šest mesecev po zdravljenju ne zaplodijo otroka in da naj se pred zdravljenjem posvetujejo o zamrznitvi semena.
English: Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Slovenian: Presnovne in prehranske motnje Opisani so bili primeri hiponatriemije, večinoma povezani z dehidracijo, bruhanjem in pljučnico.
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Slovenian: Ta polnilni volumen je bil določen med razvojem docetaksela za nadomestitev tekočine, ki se izgubi med pripravo osnovne raztopine (glejte poglavje 4) zaradi penjenja, adhezije na stene viale in »mrtvega volumna«.
English: In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Slovenian: Pri bolnikih, ki se zdravijo z docetakselom, doksorubicinom in ciklofosfamidom (TAC), je zaradi tveganja zapoznele mieolodisplazije ali mieloidne levkemije potrebno hematološko spremljanje.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Slovenian: Za zdravljenje po neuspehu predhodne kemoterapije na podlagi platine je priporočeni odmerek 75 mg/m
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Slovenian: docetaksel 30 mg/m 2, apliciran tedensko prvih 5 tednov 6-tedenskega cikla, ki se ponovi v 5
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART and the MedRA terms.
Slovenian: Neţelene učinke so opisali po merilih NCI Common Toxicity Criteria (3. stopnja = S 3, 3.- 4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
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, ki so se zdravili s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/nevtropenične sepse (23 % v primerjavi s 17 % pri bolnikih, ki so dobivali samo docetaksel).
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Slovenian: 4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Teva Pharma.
English: 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Slovenian: 95-% IZ vrednost p†* število bolnikov delež odziva PSA** (%) 95-% IZ vrednost p* število bolnikov delež odziva bolečine (%) 95-% IZ vrednost p* število bolnikov delež odziva tumorja (%) 95-% IZ vrednost p* † stratificirani test log-rank * prag statistične značilnosti = 0,0175 ** PSA: prostatični specifični antigen
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 neţelenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Slovenian: V študiji TAX 316 se je kongestivno srčno popuščanje pojavilo 26 bolnicam (3.5 %) v kraku s TAC in 17 bolnicam (2.3 %) v kraku s FAC.
English: Other medicines and Docetaxel Teva Pharma
Slovenian: Druga zdravila in zdravilo Docetaxel Teva Pharma
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION 4.1 Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml) 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Slovenian: Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila Docetaxel Teva Pharma (10 mg docetaksela/ml) Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaxel Teva Pharma 5 minut stati na sobni temperaturi (do 25°C).
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Slovenian: V kraku z docetakselom in trastuzumabom je 64 % bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta deleţ 55 %.
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Slovenian: Ta polnilni volumen je bil določen med razvojem docetaksela za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine zaradi penjenja, adhezije na stene viale in »mrtvega volumna«.
English: For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Slovenian: Pri zdravljenju raka prostate je premedikacija peroralni deksametazon v odmerku 8 mg 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (glejte poglavje 4.2).
English: The name of this medicine is Docetaxel Teva Pharma.
Slovenian: To zdravilo se imenuje Docetaxel Teva Pharma.
English: Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Slovenian: Redkeje so poročali o hudih simptomih, npr. izpuščajih s poznejšim luščenjem, zaradi katerih je bilo treba v redkih primerih zdravljenje z docetakselom prekiniti (glejte poglavji 4.2 in 4.4).
English: Solvent vial: water for injections.
Slovenian: Vehikel: voda za injekcije.
English: For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Slovenian: Pri zdravljenju raka dojke in nedrobnoceličnega pljučnega raka lahko tridnevna premedikacija s peroralnim kortikosteroidom, npr. deksametazonom 16 mg dnevno (npr. 8 mg dvakrat dnevno), ki se začne en dan pred aplikacijo docetaksela, zmanjša pogostost in izrazitost zastajanja tekočine ter izrazitost preobčutljivostnih reakcij, če ni kontraindicirana.
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 okuţba redkeje pojavili pri bolnikih, ki so profilaktično dobivali G-CSF.
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 UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: V ključnem kliničnem preskušanju docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom ţelodca so izključili bolnike z ALT in/ali AST > 1,5 × ZMRO ter hkrati alkalno fosfatazo > 2,5 × ZMRO in bilirubinom > 1 × ZMRO; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksel se ne sme uporabljati, če ni izrecno indiciran.
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Slovenian: Splošne težave in spremembe na mestu aplikacije Srednji kumulativni odmerek do prekinitve zdravljenja je bil več kot 1000 mg/m in srednji čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
English: Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Slovenian: Zdravilo Docetaxel Teva Pharma v kombinaciji s prednizonom ali prednizolonom je indicirano za zdravljenje bolnikov z metastatskim, hormonsko neodzivnim rakom prostate.
English: Ischemia myocardial
Slovenian: miokardna ishemija
English: CYTOTOXIC.
Slovenian: C-docetakselom.
English: Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Slovenian: Vsem bolnikom, ki dobivajo docetaksel, je treba pogosto pregledovati celotno krvno sliko.
English: See leaflet for further information.
Slovenian: Dodatne informacije preberite v navodilu za uporabo.
English: What Docetaxel Teva Pharma looks like and contents of the pack: Docetaxel Teva Pharma concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Slovenian: Izgled zdravila Docetaxel Teva Pharma in vsebina pakiranja Zdravilo Docetaxel Teva Pharma koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina.
English: Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Slovenian: Prednizon Opazili niso nobenih učinkov prednizona na farmakokinetiko docetaksela.
English: MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Teva Pharma B.V.
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.
Slovenian: Pomoţne snovi z znanim učinkom: Ena viala koncentrata vsebuje 25,1 % (m/m) brezvodnega etanola.
English: Neutropenic infection Neutropenic infection (Grade 3-4)
Slovenian: Nevtropenična okuţba Nevtropenična okuţba (stopnje 3-4)