natgillin/translations-raw huggingface dataset:
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 kaţe, da se je incidenca nevtropenije, febrilne nevtropenije in nevtropeničnih okuţb 4. stopnje zmanjšala pri bolnicah, ki so prejemale primarno profilakso z G-CSF, potem ko je ta postala obvezna v kraku TAC - študija GEICAM.
Docetaxel Teva Pharma vials should not be stored above 25°C and should be protected from light.
Viale zdravila Docetaxel Teva Pharma morajo biti shranjene pri temperaturi do 25°C in zaščitene pred svetlobo.
D. CONITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
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.
Če je potrebni odmerek docetaksela večji od 200 mg, uporabite več infuzijskega vehikla, tako da končna koncentracija ne preseţe koncetracije docetaksela 0,74 mg/ml.
What Docetaxel Teva Pharma is and what it is used for
Kaj je zdravilo Docetaxel Teva Pharma in za kaj ga uporabljamo
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Vnetje pljuč se lahko razvije tudi, če se zdravljenje z docetakselom uporablja sočasno z radioterapijo.
2-year Survival (%)
dveletno preţivetje (%)
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Poleg tega so ugotovili, da docetaksel deluje na nekatere, ne pa na vse celične linije z močno izraţenim pglikoproteinom, ki ga kodira gen za odpornost proti več zdravilom.
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 cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Študije in vitro so pokazale, da lahko presnovo docetaksela spremeni sočasna uporaba zdravil, ki inducirajo ali inhibirajo citokrom P4503A ali jih ta presnavlja (in tako lahko kompetitivno inhibirajo encim), kot so ciklosporin, terfenadin, ketokonazol, eritromicin in troleandomicin.
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 neţeleni učinki (≥ 5 %), povezani z zdravljenjem, o katerih so poročali v fazi III preskušanja pri bolnicah z rakom dojke, pri katerih zdravljenje z antraciklini ni uspelo (glejte povzetek glavnih značilnosti kapecitabina).
Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Poročali so o zelo redkih primerih prehodnih motenj vida (bliskanje, bliskajoča svetloba, skotomi), ki so se praviloma pojavili med infundiranjem zdravila in v povezavi s preobčutljivostnimi reakcijami.
Single-use vials.
Viale za enkratno uporabo.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala za ≥ 10 % večkrat pri bolnikih, starejših od 75 let, v primerjavi z mlajšimi od 65 let.
At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Akutno levkemijo so po mediano 77 mesečnem spremljanju zabeleţili pri 1 od 532 (0,2 %) bolnicah, ki so prejemale docetaksel, doksorubicin in ciklofosfamid v študiji GEICAM 9805.
Each ml of concentrate contains 27.73 mg docetaxel.
En ml koncentrata vsebuje 27,73 mg docetaksela.
Solvent Water for injections.
Voda za injekcije.
Docetaxel achieves high intracellular concentrations with a long cell residence time.
Docetaksel doseţe visoko znotrajcelično koncentracijo in se dolgo zadrţuje v celicah.
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
4.2.1 Za odmerek, ki ga potrebuje bolnik, bo morda potrebna več kot ena viala z osnovno raztopino.
Arrhythmia (no severe)
aritmija (ne huda)
How to store Docetaxel Teva Pharma Contents of the pack and other information
Shranjevanje zdravila Docetaxel Teva Pharma Vsebina pakiranja in dodatne informacije
What you need to know before you use Docetaxel Teva Pharma
Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Teva Pharma
In case of white blood cells disturbances, you may experience associated fever or infections.
Če imate spremenjeno število belih krvnih celic, se lahko pojavijo povišana telesna temperatura ali okuţbe.
Cardiac disorders Rare cases of myocardial infarction have been reported.
Srčne bolezni Poročali so o redkih primerih miokardnega infarkta.
When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
V kombinaciji uporabljeni docetaksel ne vpliva na očistek doksorubicina ali na koncentracijo doksorubicinola (presnovka doksorubicina) v plazmi.
Infusion site reaction; Pain
reakcija na mestu infundiranja, bolečina
Without affecting the primary endpoint, overall response rate (32% vs 25%, p=0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p<0.01) and median survival (15.3 months vs 12.7 months; p=0.03).
Docetaksel ni vplival na primarno končno točko, celotni deleţ odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je srednji čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p < 0,01) in srednje trajanje preţivetja (15,3 meseca v primerjavi z 12,7 meseca, p = 0,03).
Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine ni podatkov.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
4.1.4 Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da ponavljate obračanje viale vsaj 45 sekund.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
V primeru hudih reakcij, npr. hude hipotenzije, bronhospazma ali generaliziranega izpuščaja oziroma eritema, je treba zdravljenje z docetakselom takoj prekiniti in uporabiti ustrezno terapijo.
Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% docetaxel dose reduction if patients require coadministration of a strong CYP3A4 inhibitor such as azole antifungals, ritonavir and some macrolides (clarithromycin, telithromycin).
Na podlagi ekstrapolacije iz farmakokinetične študije s ketokonazolom pri 7 bolnikih pride v poštev 50 % zmanjšanje odmerka docetaksela, če bolnik sočasno potrebuje zdravljenje s kakšnim močnim zaviralcem CYP3A4, npr. kakšnim azolskim antimikotikom, ritonavirjem ali nekaterimi makrolidi (klaritromicin, telitromicin).
The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir.
Mehanizem tega medsebojnega delovanja je, da ritonavir zavre CYP3A4, ki je glavni izoencim, vpleten v presnovo docetaksela.
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite katere koli neţelene učinke, ki niso navedeni v tem navodilu.
In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro delovanja jeter (ALT, AST ≥ 1,5-kratna ZMRO hkrati z alkalno fosfatazo ≥ 2,5-kratno ZMRO), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
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).
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).
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.
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.
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Bolniki, ki dobivajo TCF, morajo profilaktično dobivati G-CSF za zmanjšanje tveganja za zapleteno nevtropenijo (febrilno nevtropenijo, dolgotrajno nevtropenijo ali nevtropenično okuţbo).
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.
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.
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).
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).
Cutaneous reactions
Koţne reakcije
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.
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.
For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Primer: za odmerek 140 mg docetaksela potrebujete 14 ml osnovne raztopine docetaksela.
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
300 bolnikih z adenokarcinomom ţelodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
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).
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).
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Zaradi moţnih neţelenih učinkov na dojenčke je treba dojenje med zdravljenjem z docetakselom prekiniti.
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).
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).
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Bolnike s hudim zastajanjem tekočine, npr. plevralnim izlivom, perikardialnim izlivom ali ascitesom, je treba skrbno nadzorovati.
Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Mielodisplastični sindrom so zabeleţili pri 2 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
V primeru blaţjih preobčutljivostnih reakcij, npr. pordelosti ali lokalnih koţnih reakcij, zdravljenja ni treba prekiniti.
• Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
ciklih; mitoksantron 12 mg/m vsake 3 tedne, 10 ciklov.
A total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
V spodnje skupine zdravljenja so naključno razvrstili skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
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.
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.
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Tudi enoletni deleţ preţivetja je bil z docetakselom značilno daljši (40 %) kot z najboljšo podporno oskrbo (16 %).
Docetaxel is highly protein bound (>95%).
Docetaksel se obseţno (> 95 %) veţe na beljakovine.
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.
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.
Cardiac failure; Arrhythmia (no severe)
Srčne bolezni srčno popuščanje, aritmija (ne huda)
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
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).
Recommended dose
Priporočeno odmerjanje
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.
Reakcije na mestu infundiranja so bile praviloma blage; obsegale so hiperpigmentacijo, vnetje, pordelost ali suhost koţe, flebitis ali ekstravazacijo in otekanje vene.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m
Blood and lymphatic system disorders neutropenia associated with fever and antibiotic use) or neutropenic
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
Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Za uporabo pri starejših osebah glede na analizo farmakokinetike na populaciji ni posebnih navodil.
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%).
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 %).
Docetaxel Teva Pharma should not be used after the expiry date shown on the carton and vials.
Zdravila Docetaxel Teva Pharma ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vialah.
The following adverse reactions are frequently observed with docetaxel:
Pri docetakselu so pogosto opaţali naslednje neţelene učinke:
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.
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).
Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
razmerje tveganja: 1,032 [95-% IZ: 0,876; 1,216]
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.
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.
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Docetaksel se ne sme uporabljati pri bolnikih, ki imajo izhodiščno število nevtrofilcev < 1500 celic/mm
Congestive heart failure (CHF)
Zastojno srčno popuščanje(KSP)
Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Teva Pharma.
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.
Zdravilo Docetaxel Teva Pharma ni primerno za uporabo pri pediatrični populaciji za indikacije rak dojke, nedrobnocelični pljučni rak in rak prostate.
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.
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.
Docetaxel concentrate vial: polysorbate 80, anhydrous ethanol.
Viala s koncentratom docetaksela Polisorbat 80, brezvodni etanol.
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.
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.
Docetaxel Teva Pharma will be administered to you by a healthcare professional.
Zdravilo Docetaxel Teva Pharma vam bo dal pristojni zdravstveni delavec.
Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
razmerje tveganja: 1,122 [97,2-% IZ: 0,937; 1,342]*
Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Farmakokinetiko docetaksela v prisotnosti prednizona so preučevali pri bolnikih z metastatskim rakom prostate.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Zdravilo je treba aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Statistično značilnih učinkov prednizona na farmakokinetiko docetaksela niso opazili.
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 pordelost, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja in povišana telesna temperatura ali mrzlica.
When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Pri bolnicah, ki so kandidatke za zdravljenje z docetakselom v kombinaciji s trastuzumabom, je treba opraviti izhodiščne preiskave za oceno srčne funkcije.
No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
V nobeni izmed preiskovanih skupin pri bolnicah ni bil diagnosticiran mielodisplastični sindrom.
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.
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.
6.4 Special precautions for storage and other handling
6.4 Posebni varnostni ukrepi za shranjevanje in ravnanje z zdravilom
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.
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.
Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Presnovne in prehranske motnje Opisani so bili primeri hiponatriemije, večinoma povezani z dehidracijo, bruhanjem in pljučnico.
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".
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«.
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Pri bolnikih, ki se zdravijo z docetakselom, doksorubicinom in ciklofosfamidom (TAC), je zaradi tveganja zapoznele mieolodisplazije ali mieloidne levkemije potrebno hematološko spremljanje.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Za zdravljenje po neuspehu predhodne kemoterapije na podlagi platine je priporočeni odmerek 75 mg/m
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
docetaksel 30 mg/m 2, apliciran tedensko prvih 5 tednov 6-tedenskega cikla, ki se ponovi v 5
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.
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.
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).
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).
4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
4.1.3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Teva Pharma.