natgillin/translations-raw huggingface dataset:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite skladno z lokalnimi predpisi.
The incidence of serious adverse events was higher in older people compared to younger patients.
Incidenca resnih neţelenih učinkov je bila pri starejših osebah večja kot pri mlajših.
Obligation to conduct post-authorisation measures
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Zato je med sočasnim zdravljenjem s temi zdravili potrebna previdnost, saj obstaja moţnost pomembnega medsebojnega delovanja.
For more details see Summary of Product Characteristics of trastuzumab.
Za več podrobnosti glejte povzetek glavnih značilnosti trastuzumaba.
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Pribliţno 80 % radioaktivnosti v blatu se izloči v prvih 48 urah v obliki enega pomembnega in treh manj pomembnih neaktivnih presnovkov; zelo malo zdravila se izloči nespremenjenega.
Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Glede na to, da je tedensko odmerjanje docetaksela pokazalo nekoliko boljši varnostni profil kot odmerjanje docetaksela vsake tri tedne, je moţno, da bi nekaterim bolnikom koristilo tedensko odmerjanje docetaksela.
Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia
Dodatna opozorila pri uporabi v adjuvantni terapiji raka dojke Zapletena nevtropenija
Pharmacokinetic parameters estimated by the model were very close to those estimated from Phase I studies.
Z modelom dobljeni farmakokinetični parametri so bili zelo blizu parametrom, ocenjenim v študijah I. faze.
CAUTION: Dilution of concentrate required using the entire contents of the solvent vial.
OPOZORILO: koncentrat je treba razredčiti s celotno vsebino viale z vehiklom.
The carcinogenic potential of docetaxel has not been studied.
Kancerogenega potenciala docetaksela niso raziskali.
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 the available data).
Kategorije pogostosti so opredeljene tako: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana ( ni mogoče oceniti iz razpoloţljivih podatkov).
Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Med zdravljenjem morajo tako moški kot ţenske, moški pa še vsaj šest mesecev po njegovem koncu uporabljati kontracepcijsko zaščito (glejte poglavje 4.6).
Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Profilaktični G-CSF (granulocitne kolonije stimulirajoči faktor) se lahko uporabi, da se ublaţi tveganje za hematološko toksičnost.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomoţno snov, navedeno v poglavju 6.1.
Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Najmanjše število nevtrofilcev se je pojavilo po mediani 7 dni, vendar je ta čas lahko krajši pri bolnikih, ki so se ţe intenzivno zdravili.
This medicine should not be used after the expiry date which is stated on the carton and vials.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli in vialah.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V vsaki kategoriji pogostosti so neţeleni učinki navedeni po padajoči resnosti.
Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti ţivljenja z EuroQoL-5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Upoštevajte, da je to verjetno podcenjen deleţ, kajti znano je, da sam docetaksel v odmerku 100 mg/m povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najniţjega števila celic v krvi.
The safety and efficacy of Docetaxel Teva Pharma in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Docetaxel Teva Pharma za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
Read the package leaflet before use.
Pred uporabo preberite priloţeno navodilo.
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
razlika zdravljenj: 7,1 % [95-% IZ: 0,7; 13,5] *: korigirano za več primerjav in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.
Če imate glede uporabe tega zdravila še kakšna vprašanja, vprašajte zdravnika ali bolnišničnega farmacevta.
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Pri ocenljivih bolnikih je bil celotni deleţ odziva 6,8 %, srednje trajanje odziva pa 26,1 tednov.
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Simptomi, kot so abdominalne bolečine in občutljivost, zvišana telesna temperatura, driska z nevtropenijo ali brez nje, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Docetaksel se ne sme uporabljati pri bolnikih s hudo okvaro jeter, ker o uporabi pri njih ni podatkov (glejte poglavji 4.2 in 4.4).
Before each treatment with Docetaxel Teva Pharma, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva Pharma.
Pred vsako uporabo zdravila Docetaxel Teva Pharma boste opravili preiskave krvi, da bo zdravnik preveril, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Docetaxel Teva Pharma.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Če se pojavijo akutne teţave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, teţko dihanje ali kašelj), takoj obvestite svojega zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Od 333 bolnikov z rakom prostate v študiji, ki so se zdravili z docetakselom vsake tri tedne, je bilo 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih več kot 75 let.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Bolezni imunskega sistema Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Docetaksel presnavlja CYP3A4, za prednizon pa je znano, da inducira CYP3A4.
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Za te reakcije je bil značilen izpuščaj, vključno z lokaliziranimi izbruhi, predvsem na dlaneh in stopalih (vključno z resnim sindromom roka/noga), pa tudi na rokah, obrazu in prsnem košu; pogosto jih je spremljalo srbenje.
Discard unused contents appropriately
Neporabljeno vsebino ustrezno zavrzite.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate so ocenili v randomizirani multicentrični študiji faze III.
1-year Survival (%)
enoletno preţivetje (%)
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Podatki o preţivetju, srednji čas do napredovanja bolezni in deleţ odziva v dveh krakih te raziskave so prikazani v naslednji razpredelnici:
Between infusions of Docetaxel Teva Pharma the following may occur, and the frequency may vary with the combinations of medicines that are received:
Med infuzijami zdravila Docetaxel Teva Pharma se lahko pojavi naslednje in pogostost se lahko razlikuje glede na kombinacijo uporabljenih zdravil.
For cisplatin dose adjustments, see the corresponding summary of product characeteristics.
Za prilagoditve odmerkov cisplatina glejte ustrezni povzetek glavnih značilnosti zdravila.
Docetaxel is administered as a one-hour infusion every three weeks.
Docetaksel se aplicira v enourni infuziji vsake tri tedne.
In cases of overdose, exacerbation of adverse events may be expected.
Pri prevelikih odmerkih je mogoče pričakovati eksacerbacijo neţelenih učinkov.
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Tri bolnice (2 %), ki so dobivale docetaksel, so zdravljenje prekinile zaradi zastajanja tekočine, 15 prejemnic (9 %) doksorubicina pa je prekinilo zdravljenje zaradi kardiotoksičnih učinkov (trije primeri usodnega zastojnega srčnega popuščanja).
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali odpovedjo več organov.
Each carton contains:
Kaj vsebuje navodilo:
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Opisali so zelo redke primere hepatitisa, včasih s smrtnim izidom, pri bolnikih z ţe prej obstoječo boleznijo jeter.
In about 20% of these cases there were no risk factors for acute renal failure concomitant nephrotoxic medicinal products and gastro-intestinal disorders.
V pribliţno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, sočasnih nefrotoksičnih zdravil in bolezni prebavil.
No cases were reported in patients who received fluorouracil, doxorubicin and cyclophosphamide.
Nobenih sprememb niso zabeleţili pri bolnicah, ki so prejemale fluorouracil, doksorubicin in ciklofosfamid.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
V kombinaciji z docetakselom je bil očistek karboplatina za pribliţno 50 % večji od vrednosti, opisanih med monoterapijo s karboplatinom.
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Podatki o reverzibilnosti so na voljo za 35,3 % bolnikov, pri katerih so se po zdravljenju z docetakselom kot samostojno učinkovino v odmerku 100 mg/m pojavili nevrotoksični učinki.
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients with lymphoedema at the end of the chemotherapy.
V študiji GEICAM 9805 so še trajajoč limfedem zabeleţili pri 4 od 5 bolnic z limfedemom na koncu kemoterapije.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Podatke o neţelenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so zbrali pri:
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Pri bolnikih, ki doţivijo zapleteno nevtropenijo (podaljšano nevtropenijo, febrilno nevtropenijo ali okuţbo) je treba razmisliti o uporabi G-CSF in zmanjšanju odmerka (glejte poglavje 4.2).
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
Docetaksel se sme uporabljati samo v enotah, specializiranih za citotoksično kemoterapijo in samo pod nadzorom zdravnika, izkušenega v uporabi onkološke kemoterapije (glejte poglavje 6.6).
An effective method of contraception should be used during treatment.
Kontracepcija pri moških in ţenskah Med zdravljenjem se mora uporabljati učinkovita metoda kontracepcije.
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Prednizon ali prednizolon v peroralnem odmerku 5 mg dvakrat dnevno se daje neprekinjeno (glejte poglavje 5.1).
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Pri bolnikih, ki so dobivali docetaksel vsake 3 tedne, so ugotovili značilno daljše celotno preţivetje v primerjavi s tistimi, ki so se zdravili z mitoksantronom.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Incidenca naslednjih neţelenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okuţbeje bila pri bolnikih, starih 65 let ali več, za ≥ 10 % večja kot pri mlajših bolnikih.
Reconstituted solution must be further diluted in the infusion diluent before administration.
Rekonstituirano raztopino je treba pred uporabo dodatno razredčiti v vehiklu.
The concentrate is a clear viscous, yellow to brown-yellow solution.
Koncentrat je bistra, viskozna, rumena do rjavorumena raztopina.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
In vitro docetaksel dokazano zmoti celično mikrotubulno mreţje, nujno za mitotično in interfazno celično delovanje.
Docetaxel Teva Pharma will be given by infusion into one of your veins (intravenous use).
Zdravilo Docetaxel Teva Pharma boste dobili v infuziji v eno od ven (intravenska uporaba).
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Febrilna nevtropenija se je pojavila pri 17,2 % bolnikov, nevtropenična okuţba pa pri 13,5 % bolnikov, ne glede na uporabo G-CSF.
Patients with impaired vision should undergo a prompt and complete ophthalmologic examiniation.
Bolniki z okvaro vida morajo takoj opraviti popoln oftalmološki pregled.
What Docetaxel Teva Pharma is and what it is used for What you need to know before you use Docetaxel Teva Pharma How to use Docetaxel Teva Pharma Possible side effects
Kaj je zdravilo Docetaxel Teva Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Docetaxel Teva Pharma Kako uporabljati zdravilo Docetaxel Teva Pharma Moţni neţeleni učinki
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
In vivo docetaksel ni odvisen od reţima in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Bolezni krvi in limfatičnega sistema Redki: krvavitve, povezane s trombocitopenijo stopnje 3/4.
In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatement initiated (see section 4.8).
Če je diagnosticiran CMO, je treba zdravljenje z docetakselom prekiniti in uvesti ustrezno zdravljenje (glejte poglavje 4.8).
If you are a man being treated with Docetaxel Teva Pharma you 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 because docetaxel may alter male fertility.
Če ste moški, ki se zdravi z zdravilom Docetaxel Teva Pharma je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Učinek prednizona na farmakokinetiko docetaksela, ki so ga aplicirali s standardno premedikacijo z deksametazonom, so študirali pri 42 bolnikih.
In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Docetaksel je imel v nekliničnih raziskavah genotoksične učinke in lahko vpliva na plodnost pri moških (glejte poglavje 5.3).
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Neţeleni učinki na moda, opisani v študijah toksičnosti na glodalcih, nakazujejo, da lahko docetaksel prizadene moško plodnost.
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Opravili so odprto multicentrično randomizirano študijo III. faze za primerjavo monoterapije z docetakselom in paklitaksela pri zdravljenju napredovalega raka dojke pri bolnicah, katerih predhodno zdravljenje je moralo vključevati antraciklin.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da ponavljate obračanje viale vsaj 45 sekund.
You must not become pregnant during treatment with this medicine and you must use an effective method of contraception during therapy because Docetaxel Teva Pharma may be harmful for the unborn baby.
Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati zanesljivo metodo kontracepcije, saj lahko zdravilo Docetaxel Teva Pharma škoduje nerojenemu otroku.
The solvent for Docetaxel Teva Pharma is water for injections.
Vehikel za zdravilo Docetaxel Teva Pharma je voda za injekcije.
- The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
- Pomoţni snovi sta polisorbat 80 in 25,1 % (m/m) brezvodnega etanola.
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Še prisotno periferno senzorično nevropatijo so pri spremljanju zabeleţili pri 10 od 84 bolnicah, ki so imele periferno senzorično nevropatijo ob koncu kemoterapije, v študiji pri bolnicah z rakom dojk s pozitivnimi bezgavkami (TAX316).
The most commonly reported adverse reactions of Docetaxel Teva Pharma alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Najpogosteje opisani neţeleni učinki na samo zdravilo Docetaxel Teva Pharma so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
Docetaxel is more than 95% bound to plasma proteins.
Več kot 95 % docetaksela se veţe na beljakovine v plazmi.
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Zelo pogosti: hematoloških toksičnih učinkov je bilo več pri bolnikih, ki so dobivali trastuzumab in docetaksel kot pri tistih, ki so dobivali samo docetaksel (32 % nevtropenije stopnje 3/4 v primerjavi z 22 % po merilih NCI-CTC).
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in Phase I studies.
Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m v študijah I.
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis (see section 5.1).
Za preţivetje brez bolezni (DFS - disease-free survival) in celokupno preţivetje (OS - overall survival) ugotovljena korist pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+ (glejte poglavje 5.1).
All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Vse tri načine zdravljenja so dajali neprekinjeno v kombinaciji s prednizonom ali prednizolonom 5 mg dvakrat dnevno.
Treatment difference: 5.4% [95% CI: -1.1; 12.0]
razlika zdravljenj: 5,4 % [95-% IZ: -1,1; 12,0]
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeleţili pri 4 od 744 bolnic, ki so prejemale TAC, in pri 1 od 736 bolnic, ki so prejemale FAC.
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 oziroma hud zastoj se pozneje pojavi pri bolnikih, ki dobijo premedikacijo (srednji kumulativni odmerek: 818,9 mg/m 2), kot pri tistih, ki je ne (srednji kumulativni odmerek: 489,7 mg/m 2); vendar so ga pri nekaterih bolnikih opisali med zgodnjimi cikli zdravljenja.
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal products has not been investigated formally, in vitro interactions with tightly protein-bound drugs such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Moţna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, vendar medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatomin vitro ni vplivalo na vezavo docetaksela na beljakovine.
Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Bolniki, ki so doţiveli hudo preobčutljivostno reakcijo, ne smejo več dobiti docetaksela.
Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Bolnike, ki dobivajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).