natgillin/translations-raw huggingface dataset:
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).
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).
PSA response** at 12 months - N(%) p-valuea*
Odziv PSA** po 12 mesecih - N (%) Vrednost pa*
First episode: stop 5-FU only, at all subsequent cycles.
Prvi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
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).
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).
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (80 mg/2 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
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.
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.
Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Za uporabo pri starostnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
• 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.)
• 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.)
- For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje metastatskega raka želodca se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
TAXOTERE concentrate
DRUGI PODATKI TAXOTERE koncentrat VEHIKEL za TAXOTERE
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)
Učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom ter standardne oskrbe za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija STAMPEDE)
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.
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.
Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Vsaka škatla vsebuje eno vialo zdravila TAXOTERE (20 mg/0,5 ml) in eno vialo ustreznega vehikla za zdravilo TAXOTERE v pretisnem omotu.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Ko je zdravilo enkrat dodano v infuzijsko vrečko, je raztopina docetaksela stabilna 6 ur pri temperaturi do 25°C.
PSA response** at 6 months - N(%) p-valuea*
Odziv PSA** po 6 mesecih - N (%) Vrednost pa*
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.
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.
Efficacy results in metastatic prostate cancer patients for docetaxel arm versus control arm are summarized in the following table:
Rezultate učinkovitosti pri bolnikih z metastatskim rakom prostate v skupini z docetakselom v primerjavi s kontrolno skupino povzema naslednja preglednica:
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.
Vsebnost etanola je treba upoštevati tudi pri nosečnicah, doječih ženskah, otrocih in skupinah z velikim tveganjem, npr. pri bolnikih z boleznijo jeter ali epilepsijo.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za zdravilo TAXOTERE iz viale tako, da vialo delno obrnete.
One vial contains 20 mg/0.5 ml docetaxel.
Ena viala vsebuje 20 mg/0,5 ml docetaksela.
Adjusted hazard ratio
Prilagojeno razmerje ogroženosti
Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
Preživetje brez bolezni (DFS-Disease-free survival) je bilo primarni, celokupno preživetje (OS-Overall survival) pa sekundarni opazovani dogodek učinkovitosti.
TAXOTERE vial: polysorbate 80, citric acid.
Viala zdravila TAXOTERA: polisorbat 80, citronska kislina.
Vascular disorders Venous thromboembolic events have rarely been reported.
Redko so poročali o venskih trombembolijah.
A total of 1006 patients with KPS  60 were randomised to the following treatment groups:
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem  60:
- 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.
- 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.
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test
One vial contains 80 mg/2 ml docetaxel.
Ena viala vsebuje 80 mg/2 ml docetaksela.
Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with TAXOTERE: - SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Med uporabo zdravila TAXOTERE so poročali o hudih težavah s kožo, kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP): - Med simptomi SJS/TEN so lahko mehurji, lupljenje ali krvavitev na katerem koli predelu kože (tudi na ustnicah, očeh, v ustih, nosu, na spolovilih, dlaneh in stopalih), z izpuščajem ali brez njega.
• Docetaxel 30 mg/m administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Docetaksel 30 mg/m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
• acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
• akutna mieloična levkemija in mielodisplastični sindrom (vrsti krvnega raka) se lahko pojavita pri bolnikih, ki se zdravijo z docetakselom v kombinaciji z nekatermi drugimi zdravili proti raku.
The median overall survival was significantly longer in docetaxel treatment group than in the ADT alone group, with a median overall survival 13.6 months longer with the addition of docetaxel to ADT (hazard ratio (HR) = 0.61, 95% confidence interval (CI) = 0.47-0.80, p=0.0003).
Mediano celokupno preživetje je bilo v skupini z docetakselom značilno daljše kot v skupini z ADT samim; mediano celokupno preživetje je bilo z dodatkom docetaksela ADT 13,6 meseca daljše (razmerje ogroženosti (ROg) = 0,61, 95 % interval zaupanja (IZ) = 0,47-0,80, p = 0,0003).
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Zdravilo TAXOTERE je v kombinaciji z doksorubicinom in ciklofosfamidom indiciran za adjuvantno zdravljenje bolnic z:
• 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
• 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/m² docetaksela, 121 pa jih je prejemalo 75 mg/m².
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Najpogosteje opisani simptomi so zardevanje, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja in zvišanje telesne temperature ali mrzlica.
- For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje raka glave in vratu se zdravilo TAXOTERE uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
Median survival (months)
Mediano celokupno preživetje (meseci)
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Docetaksel je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem z njim in med pripravo njegovih raztopin potrebna previdnost.
13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml
13 % (m/m) 95 % etanol v vodi za injekcije Polnitev: 7,33 ml
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2).
Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm3 (glejte poglavje 4.2).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m twice daily for 2 weeks followed by 1-week rest period).
V tej študiji so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
V povezavi z zdravljenjem z docetakselom so poročali o hudih kožnih neželenih učinkih (SCARsevere cutaneous adverse reactions), kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
G3/4 Blood alkaline phosphatase increased
zvečanje AST S3/4 zvečanje alkalne fosfataze v krvi S3/4
Disease Free Survival
Preživetje brez bolezni
Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis
Pri zdravljenju z docetakselom so poročali o kožnem eritematoznem lupusu, o buloznih erupcijah, npr. o multiformnem eritemu in o hudih kožnih neželenih učinkih kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
V ključni SCCHN študiji pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75 mg/m2 (glejte poglavji 4.4 in 5.2).
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravljeno je bilo multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
1060 patients were randomised to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila TAXOTERE 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Pharyngitis (G3: 0%)
faringitis (3. st.: 0 %)
The infusion solution should be used within 4 hours at room temperature (below 25°C).
Raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25°C).
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions.
Zdravilo TAXOTERE je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je pri ravnanju in pripravi raztopin zdravila TAXOTERE potrebna previdnost.
This volume has been established based on the fill volume of the TAXOTERE 20 mg/0.5 ml vial.
Ta količina je določena glede na polnilni volumen viale zdravila TAXOTERE 20 mg/0,5 ml.
4.1.1 If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.
4.1.1 Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila TAXOTERE 5 minut stati na sobni temperaturi (do 25°C).
In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m
Kot zdravljenje prvega izbora se docetaksel 75 mg/m2 daje v kombinaciji z doksorubicinom (50 mg/m2).
Infection (G3/4: 7.8%)
Okužba (S3/4):7,8%
This volume has been established based on the fill volume of the TAXOTERE 80 mg/2 ml vial.
Ta količina je določena glede na polnilni volumen viale zdravila TAXOTERE 80 mg/2 ml.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Opaziti ni bilo nobenih učinkov prednizona na farmakokinetiko docetaksela.
Efficacy results or the docetaxel arm versus the control arm are summarized in the following table:
Končna učinkovitost docetakselovih rok v primerjavi s kontrolno roko je povzeta v spodnji tabeli:
What TAXOTERE concentrate vial contains - The active substance is docetaxel (as trihydrate).
Kaj vsebuje viala zdravila TAXOTERE koncentrat: - Zdravilna učinkovina je docetaksel (kot trihidrat).
• 332 patients (TAX327) who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolnikih (TAX327), ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
Dobilo jo je 57,3% bolnic, ki so prejemale TAC, in 51,2% bolnic, ki so prejemale FAC.
Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
driska 4. stopnje Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
Headache (G3/4: < 1%); Neuropathy peripheral
glavobol (S3/4: < 1 %), periferna nevropatija
Median (months) 95% CI
Mediana (meseci) 95 % IZ
FAC patients (0.1%).
z 1,1 %).
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p = 0.007).
doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa zvečal delež odziva (52 % v prim.
Data from a multi-centre open label randomised trial support the use of TAXOTERE for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila TAXOTERE za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information) and citric acid.
Pomožne snovi: polisorbat 80, brezvodni etanol (za dodatne informacije glejte navodilo za uporabo) in citronska kislina.
More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje zdravila TAXOTERE.
No of positive nodes
št. pozitivnih bezgavk celotno
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Varnost in učinkovitost docetaksela med sočasno uporabo s standardno oskrbo (ADT) so pri bolnikih z lokalno napredovalim ali metastatskim hormonsko občutljivim rakom prostate z velikim tveganjem ovrednotili v randomizirani, multicentrični večstopenjski študiji z več skupinami (MAMS - multi-arm multi-stage) z zveznim, adaptivnim načrtom II./III.
Solvent vial
Neodprta viala
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM STUDY.
Spodnja preglednica kaže, da se je incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okužb 4. stopnje zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF, potem ko je ta postala obvezna v kraku TAC - študija GEICAM.
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
V redkih primerih so bili opisani akutni respiracijski distres sindrom in primeri intersticijske pljučnice/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so bili včasih usodni.
Docetaxel must not be used in patients with baseline neutrophil count of < 1,500 cells/mm
Docetaksela se ne sme uporabljati pri bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Metastatic hormone-sensitive prostate cancer
Metastatski hormonsko občutljiv rak prostate
4.2.5 As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
4.2.5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje zdravila TAXOTERE pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning.
Za blage do zmerne senzorične motnje so značilne parestezije, dizestezije ali bolečina s pekočim občutkom.
This medicine should not be used after the expiry date shown on the carton, blister pack and vials.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli, pretisnem omotu in vialah.
A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v