FrancophonIA/ELRC3.0 huggingface dataset:
English: These patients should be closely monitored during initiation of docetaxel therapy.
Slovenian: Takšne bolnike je treba med uvedbo zdravljenja z docetakselom natančno spremljati.
English: DOCETAXEL KABI contains alcohol.
Slovenian: Zdravilo DOCETAKSEL KABI vsebuje alkohol.
English: DOCETAXEL KABI was administered as a 1-hour infusion, all other medicinal product were given intraveinously on day 1 every three weeks.
Slovenian: Zdravilo DOCETAKSEL KABI je bilo uporabljeno v 1-urni infuziji, vsa druga zdravila pa intravensko 1. dan na tri tedne.
English: (19.3-NA)
Slovenian: (19,3-NP)
English: Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Slovenian: Dokazano je, da je docetaksel mutagen v mikronukleusnem in kromosomskem aberacijskem testu na celicah CHO-K1 in vitro ter v mikronukleusnem testu pri miših in vivo.
English: Congestive heart failure (CHF)
Slovenian: Kongestivno srčno popuščanje (KSP)
English: With primary G-CSF prophylaxis (n = 421) n (%)
Slovenian: S primarno profilakso z G-CSF (n = 421) n (%)
English: If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Slovenian: Če se sočasni uporabi močnega zaviralca CYP3A4 (npr. ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
English: Some cases of anaphylactic shock, sometimes fatal, have been reported.
Slovenian: Poročali so o nekaj primerih anafilaktičnega šoka, včasih usodnega.
English: However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Slovenian: V primeru hudih reakcij, npr. hude hipotenzije, bronhospazma ali generaliziranega izpuščaja oz. eritema, pa je treba zdravljenje z docetakselom takoj prekiniti in uporabiti ustrezno terapijo.
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions.
Slovenian: Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
English: Efficacy results are presented in the table below:
Slovenian: Rezultati učinkovitosti so predstavljeni v spodnji tabeli:
English: Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Slovenian: Opisani so bili primeri hiponatriemije, večinoma povezani z dehidracijo, bruhanjem in pljučnico.
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-to-Treat Analysis)
Slovenian: Analize podskupine - adjuvantno zdravljenje bolnic v študiji raka dojke z negativnimi bezgavkami (analiza z-namenom-zdravljenja)
English: Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Slovenian: Možna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, a 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.
English: Acute leukaemia / Myelodysplastic syndrome
Slovenian: Akutna levkemija/mielodisplastični sindrom:
English: General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Slovenian: Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1.000 mg/m2 in mediani čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
English: 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.
Slovenian: 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 cikli zdravljenja.
English: Previous chemotherapy should have included an anthracycline or an alkylating agent.
Slovenian: Predhodna kemoterapija bi morala vključevati antraciklin ali alkilirajočo učinkovino.
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Slovenian: V primeru blažjih preobčutljivostnih reakcij, npr. pordevanja ali lokalnih kožnih reakcij, zdravljenja ni treba prekiniti.
English: 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.
Slovenian: V ključnih študijah SCCHN pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, febrilno 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.
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Slovenian: Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, ß 36 minut in γ 11,1 ure.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Slovenian: • zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem),
English: • feeling of numbness or pins and needles or pain in the joints or muscles
Slovenian: • občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah,
English: Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Slovenian: Zaradi možnih neželenih učinkov na dojenčke je treba dojenje med zdravljenjem z docetakselom prekiniti.
English: Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known).
Slovenian: Na mestu prejšnje ekstravazacije so opažali reakcijo pomnjenja na mestu injiciranja (ponovitev kožne reakcije na mestu predhodne ekstravazacije med dajanjem docetaksela na druge mestu) (pogostnost ni znana).
English: If you are a man being treated with DOCETAXEL KABI 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.
Slovenian: Če ste moški, ki se zdravi z zdravilom DOCETAKSEL KABI 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.
English: Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Slovenian: Bolnice z operabilnim rakom dojke z negativnimi bezgavkami, primerne za prejemanje kemoterapije (GEICAM 9805)
English: 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.
Slovenian: Opisani so bili zelo redki primeri prehodnih motenj vida (bliskanje, bliskajoča svetloba, skotomi), ki so se praviloma pojavili med infundiranjem zdravila in v povezavi s preobčutljivostnimi reakcijami.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Slovenian: Za uporabo pri starejših bolnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
English: In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by
Slovenian: V farmakokinetični študiji s 7 bolnicami je sočasna uporaba docetaksela in močnega zaviralca CYP3A4 ketokonazola zmanjšala očistek docetaksela za 49 %.
English: Renal insufficiency and renal failure have been reported.
Slovenian: Opisani sta bili ledvična insuficienca in odpoved ledvic.
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovenian: • Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino za infundiranje pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
English: 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.
Slovenian: Incidenca z zdravljenjem povezane povišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala ≥ 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions.
Slovenian: Docetaksel je antineoplastična učinkovina in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem z njim in med pripravo njegovih raztopin potrebna previdnost.
English: • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
Slovenian: • Mitoksantron 12 mg/m2 vsake 3 tedne, 10 ciklov.
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m2.
Slovenian: Če se pojavijo nadaljnje epizode zapletene nevtropenije, je treba odmerek docetaksela zmanjšati s 60 na 45 mg/m2.
English: Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Slovenian: Mediani čas do prvega poslabšanja stanja zmogljivosti po WHO je bil signifikantno daljši v kraku TPH kot v kraku PF.
English: • dehydration
Slovenian: • dehidracija,
English: In patients treated with the TAC regimen for node positive breast cancer, the risk of CHF has been shown to be higher during the first year after treatment (see sections 4.8 and 5.1).
Slovenian: Bolnice, ki so bile zaradi raka dojke s pozitivnimi bezgavkami zdravljene s shemo TAC, so imele v prvem letu po zdravljenju večje tveganje kongestivnega srčnega popuščanja (glejte poglavji 4.8 in 5.1).
English: Your doctor may stop your treatment immediately.
Slovenian: Vaš zdravnik se bo morda odločil prekiniti zdravljenje.
English: What you need to know before you use DOCETAXEL KABI
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo DOCETAKSEL KABI
English: If the vials are stored under refrigeration, allow the required number of boxes of DOCETAXEL KABI concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Slovenian: Če so viale shranjene v hladilniku, pustite potrebno število škatel koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI pred uporabo 5 minut stati na temperaturi do 25°C.
English: 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.
Slovenian: Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajanjem tekočine podatkov ni.
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: • Potem jo vbrizgajte preko ene injekcije (en odmerek) v 250 ml infuzijsko vrečo ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: • inflammation of the eye or increased tearing of the eyes
Slovenian: • vnetje oči ali močnejše solzenje,
English: Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Slovenian: Do smrti zaradi zastrupitve je prišlo pri 1 bolnici v kraku AT (kongestivno srčno popuščanje) in 4 bolnicah v kraku AC (pri 1 zaradi septičnega šoka, pri 3 zaradi kongestivnega srčnega popuščanja).
English: Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Slovenian: Bolniki, ki so doživeli hudo preobčutljivostno reakcijo, ne smejo več dobiti docetaksela.
English: Neutropenic infection
Slovenian: Nevtropenična okužba
English: • For patients developing the first appearance of Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
Slovenian: • Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 ter znova uporabite 100 % izvirnega odmerka.
English: DOCETAXEL KABI contains ethanol (alcohol).
Slovenian: Zdravilo DOCETAKSEL KABI vsebuje etanol (alkohol).
English: Efficacy results are summarized in the following table:
Slovenian: Rezultate o učinkovitosti povzema naslednja tabela:
English: • From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Slovenian: • Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in raztopino za infundiranje je treba uporabiti takoj.
English: • 1,276 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).
Slovenian: • 1.276 bolnikih (744 v 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).
English: Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Slovenian: Očistek docetaksela v kombinaciji s cisplatinom je bil podoben kot po monoterapiji.
English: In combination with capecitabine
Slovenian: V kombinaciji s kapecitabinom
English: The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Slovenian: Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20 mg/m2-115 mg/m2 v študijah I. faze.
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Slovenian: Infekcijske in parazitske bolezni okužbe (S3/4: 5,7 %; vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride v stik s sluznico, jo nemudoma in temeljito umijte z vodo.
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Slovenian: Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m2.
English: Each vial is for single use and should be used immediately.
Slovenian: Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj.
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany
Slovenian: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d. Höhe Nemčija
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Slovenian: Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
English: Both regimens were administered on day 1 every 3 weeks.
Slovenian: Obe kombinaciji so aplicirali 1. dan vsakega 3. tedna.
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Slovenian: Če med zdravljenjem zanosite, o tem nemudoma obvestite svojega zdravnika.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Slovenian: • pljučna fibroza (brazgotinjenje in zadebelitve v pljučih s težkim dihanjem/kratko sapo),
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Slovenian: V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
English: A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
Slovenian: V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
English: Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Slovenian: Preživetje je bilo boljše v kraku s kombinacijo docetaksel + kapecitabin (p = 0,0126).
English: Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
Slovenian: Opazili so hipokaliemijo, hipomagneziemijo in hipokalciemijo, običajno v povezavi z boleznimi prebavil, zlasti z drisko.
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Slovenian: Za zmanjšanje tveganja za hematološke toksične učinke se lahko profilaktično uporabi G-CSF.
English: 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.
Slovenian: 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.
English: Complicated neutropenia
Slovenian: Komplicirana nevtropenija
English: 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).
Slovenian: 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).
English: The cycles were repeated every 3 weeks for 3 cycles.
Slovenian: Cikle so ponavljali 3 cikle vsake 3 tedne.
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Slovenian: Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/m2 na 6 tednov in 6 mg/m2 na 3 tedne).
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Slovenian: 256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/m2 v 1-urni intravenski infuziji na 3 tedne).
English: Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
Slovenian: Študija I. faze za oceno učinka kapecitabina na farmakokinetiko docetaksela in obratno ni odkrila, da bi kapecitabin vplival na farmakokinetiko docetaksela (Cmax in AUC), ali da bi docetaksel vplival na farmakokinetiko 5'-DFUR, pomembnega presnovka kapecitabina.
English: The most commonly reported adverse reactions of DOCETAXEL KABI alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Slovenian: Najpogosteje poročani neželeni učinki zdravila DOCETAKSEL KABI samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija, slabost, bruhanje, razjede v ustih, driska in utrujenost.
English: In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Slovenian: V kombinaciji s kapecitabinom je priporočljivo začetni odmerek kapecitabina pri bolnikih, starejših od 60 let, zmanjšati na 75 % (glejte povzetek glavnih značilnosti kapecitabina).
English: • sores in the mouth
Slovenian: • razjede v ustih,
English: In non clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3).
Slovenian: V predkliničnih študijah so opazili genotoksične učinke docetaksela in lahko prizadene moško plodnost (glejte poglavje 5.3).
English: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting).
Slovenian: • prekatne motnje srčnega ritma ali prekatna tahikardija (ki se kaže z nerednim in/ali hitrim bitjem srca, zelo težkim dihanjem, omotico in/ali omedlevico).
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Slovenian: Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih v primarni analizi (po mediano 77 mesecih spremljanja (glejte spodnjo preglednico):
English: From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča mora biti rekonstitucija/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih in zdravilo je potrebno uporabiti takoj.
English: Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Slovenian: Reakcije na mestu infundiranja so bile praviloma blage; obsegale so hiperpigmentacijo, vnetje, pordelost ali suhost kože, flebitis ali ekstravazacijo oz. otekanje vene.
English: There is no information on the use of docetaxel in pregnant women.
Slovenian: O uporabi docetaksela pri nosečnicah ni podatkov.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
Slovenian: • Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
English: Second primary malignancies
Slovenian: Drugi primarni malignomi