natgillin/translations-raw huggingface dataset:
• Premix solution: The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
• Osnovna raztopina: Osnovna raztopina vsebuje 10 mg docetaksela/ml in jo je treba uporabiti takoj po pripravi.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m in phase I studies.
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I.
• one single-dose vial of concentrate and,
• eno eno-odmerno vialo koncentrata in
Number of patients Median overall survival (months) All patients
Mediano celokupno preživetje (meseci) Vsi bolniki
• Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (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.
• Stevens-Johnsonov sindrom (SJS) in toksična epidermalna nekroliza (TEN) (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.
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m every three weeks, with trastuzumab administered weekly.
Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Raztopino za infundiranje v infuzijski vrečki je treba uporabiti v 6 urah na temperaturi do 25°C, to vključuje tudi 1 uro infundiranja bolniku.
See also section “TAXOTERE contains ethanol (alcohol)” below.
Glejte tudi poglavje "Zdravilo TAXOTERE vsebuje etanol (alkohol)" spodaj.
Neutropenia (Grade 4)
Nevtropenija (4. stopnje)
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8).
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
*a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
*a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem zdravila TAXOTERE za nadomestitev izgube tekočine, do katere pride med pripravo osnovne mešanice zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
Stomatitis/mucositis grade 4
Stomatitis/mukoziti s 4. stopnje
Docetaxel +ADT
Docetaksel + ADT ADT samo
- For the treatment of early breast cancer with or without lymph node involvement, TAXOTERE could be administered in combination with doxorubicin and cyclophosphamide.
- Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo TAXOTERE lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
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 vialo ponavljaje obračate vsaj 45 sekund.
(ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
(ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
• tiredness; or flu-like symptoms
• utrujenost ali gripi podobni simptomi
1 vial of solvent for TAXOTERE
1 viala vehikla za zdravilo TAXOTERE
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  10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
Treatment difference: 6.2% [95% CI: 0.2; 12.3]
razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
Treatment difference: 5.4% [95% CI: -1.1; 12.0]
razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0]
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Zdravilo TAXOTERE je v kombinaciji s cisplatinom in 5-fluorouracilom indiciran za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
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 jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
• 3 years.
• 3 leta
• stomach upsets including nausea, vomiting and diarrhoea, constipation
• draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje
It should be used within 6 hours (including the one hour infusion intravenous administration).
Porabiti jo je potrebno v 6 urah (to vključuje tudi 1 uro infundiranja bolniku).
2-year Survival (%)
2-letno preživetje (%)
256 patients were randomised to treatment with docetaxel alone (100 mg/m as a 1 hour intravenous infusion every 3 weeks).
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila TAXOTERE se lahko poveča, če dobivate zdravilo TAXOTERE v kombinaciji z drugimi kemoterapevtiki.
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, utegne biti potrebna več kot ena viala z osnovno raztopino.
Docetaxel plus trastuzumab1 n = 92
Docetaksel in trastuzumab1 n = 92
You must not breast-feed while you are treated with TAXOTERE.
Med zdravljenjem z zdravilom TAXOTERE ne smete dojiti.
Contains anhydrous ethanol (see leaflet)
Vsebuje brezvodni etanol (glejte navodilo za uporabo)
Each vial is of single use and should be used immediately.
Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
s 6,1 %), absolutno zmanjšanje LVEF ≥ 30 % (6,2 % v prim.
It is important that you read the entire contents of this guide prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Pomembno je, da pred pripravo osnovne raztopine zdravila TAXOTERE ali raztopine za infundiranje zdravila TAXOTERE v celoti preberete ta navodila.
CAUTION: Dilution required with the entire contents of the solvent vial.
OPOZORILO: Razredčite s celotno vsebino viale z vehiklom.
c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion).
c Čas do kliničnega napredovanja = čas od randomizacije do kliničnega napredovanja (tj. porasta simptomov metastaz v kosteh, napredovanje po merilih RECIST ali klinično poslabšanje zaradi raka po mnenju raziskovalca).
Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT.
Operacija na primarnem mestu bolezni in/ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
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Rare cases of myocardial infarction have been reported.
Opisani so bili redki primeri miokardnega infarkta.
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 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).
Hazard ratio*
Razmerje ogroženosti*
The solvent is a colourless solution.
Vehikel je brezbarvna raztopina.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Zdravilo je potrebno aplicirati pod nadzorom zdravnika, izkušenega na področju uporabe citotoksičnih zdravil.
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).
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.
Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
• Each solvent for TAXOTERE 80 mg/2 ml vial contains 7.33 ml.
• Vsaka viala z vehiklom za zdravilo TAXOTERE 80 mg/2 ml vsebuje 7,33 ml vehikla.
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]*
Number of metastatic prostate cancer patients
Število bolnikov z metastatskim rakom prostate
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).
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).
Amenorrhoea (G3/4: NA)
Amenoreja (S 3/4: NA)
In addition, dexamethasone did not affect protein binding of docetaxel.
Poleg tega deksametazon ni vplival na vezavo docetaksela na beljakovine.
• ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
• ADT + docetaksel 75 mg/m2, uporabljen na začetku ADT in uporabljan na 3 tedne 6 ciklusov,
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).
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).
• Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml.
• Vsaka viala z vehiklom za zdravilo TAXOTERE 20 mg/0,5 ml vsebuje 1,98 ml vehikla.
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.
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.
Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED)
Učinkovitost docetaksela in ADT za zdravljenje bolnikov z metastatskim hormonsko občutljivim rakom prostate (študija CHAARTED)
Patients with operable node-positive breast cancer (TAX 316)
Bolnice z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316)
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.
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.
Acute myeloid leukaemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
O akutni mieloični levkemiji in mielodisplastičnem sindromu so (s pogostnostjo "občasno") poročali v ključnih kliničnih študijah pri raku dojke s shemo TAC.
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PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
(G3/4: 0.2%)
(S3/4: 0,2 %)
In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels
Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi
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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.
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).
• 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).
• 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).
Neutropenic infection (Grade 3-4)
Nevtropenična okužba (3.-4. stopnja)
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Primer: za odmerek 140 mg docetaksela bi potrebovali 7 ml koncentrata docetaksela za raztopino.
In case of
Ne Da
TAXOTERE in combination with doxorubicin
Zdravilo TAXOTERE v kombinaciji z doksorubicinom
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.
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.
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).
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).
Cautions for use in hormone-sensitive prostate cancer
Previdnost pri uporabi pri hormonsko občutljivem raku prostate
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
Solvent vial: ethanol 95% (see leaflet for further information), water for injections.
Viala vehikla: 95 % etanol (za dodatne informacije glejte navodilo za uporabo), voda za injekcije.
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.
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
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.
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.
4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
4.1 Priprava osnovne raztopine zdravila TAXOTERA (10 mg docetaksela/ml)
G3/4 Blood bilirubin increased
S3/4 zvišanje bilirubin v krvi
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
O simptomatskem srčnem popuščanju so poročali pri 2,2 % bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0 % bolnikov, ki so dobivali samodocetaksel.
For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Primer: za odmerek 140 mg docetaksela bi potrebovali 14 ml osnovne raztopine docetaksela.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m in monotherapy.
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m2.
Patients with severe liver impairment (see sections 4.2 and 4.4).
Bolniki s hudo okvaro jeter (glejte poglavji 4.2 in 4.4).
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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 (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.
• Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25°C).
• Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25°C).
Solvent vial:
Viala z vehiklom:
MedDRA system organ classes Very common adverse reactions
Organski sistemi po MedDRA Zelo pogosti neželeni učinki
• one single-dose vial of concentrate,
• eno vialo z enim odmerkom koncentrata
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Redki: krvavitve povezane s trombocitopenijo stopnje 3/4.
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.
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.
- For the treatment of prostate cancer, TAXOTERE is administered in combination with prednisone or prednisolone.
- Za zdravljenje raka prostate se zdravilo TAXOTERE lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
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.
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.
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, 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.
- For the treatment of lung cancer, TAXOTERE could be administered either alone or in combination with cisplatin.
- Za zdravljenje pljučnega raka se zdravilo TAXOTERE lahko uporablja sam ali v kombinaciji s cisplatinom.
Patients previously treated with chemotherapy with or without radiotherapy
Nedrobnocelični pljučni rak Bolniki, predhodno zdravljeni s kemoterapijo z radioterapijo ali brez nje
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).
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).
UNIQUE IDENTIFIER - 2D BARCODE Not applicable
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)
Sočasno se lahko pojavijo tudi gripi podobni simptomi, na primer zvišana telesna temperatura, mrzlica ali boleče mišice.)
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.
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.
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.
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.
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.
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.