FrancophonIA/ELRC3.0 huggingface dataset:
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Mylan administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Croatian: Od Vas će se tražiti da uzmete premedikaciju koja se sastoji od oralnih kortikosteroida, poput deksametazona, dan prije primjene lijeka Docetaxel Mylan te još dan ili dva nakon toga, kako bi se smanjile određene nuspojave, koje se mogu pojaviti nakon infuzije lijeka Docetaxel Mylan, osobito alergijske reakcije i zadržavanje tekućine u tijelu (oticanje ruku, stopala, nogu ili povećanje tjelesne težine).
English: In case of white blood cells disturbances, you may experience associated fever or infections.
Croatian: slučaju poremećaja broja bijelih krvnih stanica, moguće je da taj poremećaj uzrokuje vrućicu ili infekciju.
English: Docetaxel Mylan must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Croatian: Docetaxel Mylan NE SMIJETE primati ako ste trudni, osim ako to liječnik nije izričito propisao.
English: Withdraw the required amount of this docetaxel concentrate (20 mg/ml) from the vial and add it directly into the infusion solution.
Croatian: Izvucite potrebnu količinu ovog koncentrata docetaksela (20 mg/ml) iz bočice i izravno ju dodajte u infuzijsku otopinu.
English: Between infusions of Docetaxel Mylan the following may occur, and the frequency may vary with the combinations of medicines that are received.
Croatian: Između infuzija lijeka Docetaxel Mylan mogu se pojaviti sljedeće nuspojave, a učestalost može varirati ovisno o kombinacijama lijekova koje ste primili:
English: Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility
Croatian: Neželjeni učinci na testisima, zamijećeni u ispitivanjima toksičnosti na glodavcima, pokazuju da bi docetaksel mogao oštetiti plodnost u muškaraca.
English: 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.
Croatian: Treba uzeti u obzir da su ti podaci vjerojatno podcijenjeni jer je poznato da monoterapija docetakselom u dozi od 100 mg/m2 uzrokuje neutropeniju u 97% bolesnika, u 76% stupnja 4, baziranu na najnižim vrijednostima broja krvnih stanica.
English: The amount of alcohol in this medicinal product may impair the patients ability to drive or use machines.
Croatian: Količina alkohola u ovom lijeku može oslabiti bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima.
English: 50 mg/m and cyclosphosphamide 500 mg/m
Croatian: 500 mg/m i ciklofosfamid 500 mg/m
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized to one of two treatment arms.
Croatian: U ovoj je studiji 358 bolesnika s inoperabilnim, lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1, bilo randomizirano u jednu od dvije liječene skupine.
English: 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.
Croatian: Medijan TTP bio je 37,3 tjedna (95% CI: 33,4-42,1) u AT skupini i 31,9 tjedna (95% CI: 27,4-36,0) u AC skupini.
English: A Hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Croatian: Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + fluorouracil *neprilagođeni log-rank test **neprilagođeni log-rank test, nije prilagođen višestrukim usporedbama *** Hi-kvadrat test, nije prilagođen višestrukim usporedbama
English: There is no relevant use of docetaxel in the paediatric population in the indications 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.
Croatian: Nema relevantne primjene lijeka docetaksela u pedijatrijskoj populaciji za indikacije karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma prostate, karcinoma želuca i karcinoma glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III.
English: The most commonly reported adverse reactions of Docetaxel Mylan alone are: decrease in the number of red blood cells or white blood cells, hair loss, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Croatian: Najčešće prijavljivane nuspojave lijeka Docetaxel Mylan kada se primjenjuje sam su: pad broja crvenih ili bijelih krvnih stanica, gubitak kose, mučnina, povraćanje, ranice u ustima, proljev i umor.
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).
Croatian: Medijan kumulativne doze do prekida liječenja bio je veći od 1000 mg/m2, a medijan vremena do reverzibilnosti retencije tekućine bilo je 16,4 tjedana (u rasponu od 0 do 42 tjedna).
English: Docetaxel Mylan has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Croatian: Docetaxel Mylan Vam je propisao liječnik za liječenje karcinoma dojke, posebnih oblika karcinoma pluća (karcinom nemalih stanica pluća), karcinoma prostate, karcinoma želuca ili karcinoma glave i vrata: - Za liječenje uznapredovalog karcinoma dojke, docetaxel se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately.
Croatian: S mikrobiološkog stanovišta, razrijeđivanje mora se odvijati u kontroliranim i aseptičkim uvjetima, a lijek se mora upotrijebiti odmah.
English: The concentrate is pale yellow to brownish-yellow.
Croatian: Koncentrat je blijedo žuta do smeđežuta otopina.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
Croatian: U studiji TAX 316, alopecija koja je i dalje bila prisutna tijekom praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika u TAC skupini i 645 od 736 bolesnika u FAC skupini.
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Croatian: U studiji TAX 316, 26 bolesnika (3,5%) u TAC skupini te 17 bolesnika (2,3%) u FAC skupini doživjelo je kongestivno zatajenje srca (CHF).
English: Cardiac disorders Rare cases of myocardial infarction have been reported.
Croatian: Rijetko su zabilježeni slučajevi infarkta miokarda.
English: The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Croatian: Medijan vremena do progresije bolesti bio je 186 dana (docetaksel + kapecitabin) u usporebdi sa 128 dana (samo docetaksel).
English: Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Croatian: Poremećaji imunološkog sustava Zabilježeno je nekoliko slučajeva anafilaktičkog šoka, ponekad sa smrtnim ishodom.
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Croatian: • Kao što je slučaj sa svim parenteralnim pripravcima, otopinu za infuziju treba vizualno provjeriti prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC.
Croatian: * omjer hazarda manji od 1 ukazuje da je TAC povezan s duljim preživljenjem bez znakova bolesti i ukupnim preživljenjem u usporedbi s FAC-om
English: 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 .
Croatian: In vitro ispitivanja pokazala su da metabolizam docetaksela može promijeniti istodobna primjena tvari koji induciraju, inhibiraju ili se metaboliziraju (i tako kompetitivno mogu inhibirati enzim) pomoću citokroma P450-3A, kao što su ciklosporin, ketokonazol i eritromicin.
English: Tumor response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Croatian: 95% CI p-vrijednost * Stratificirani log- rank test * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
English: The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Croatian: Treba izbjegavati istovremenu primjenu docetaksela sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, klaritromicinom, indinavirom, nefazodonom, nelfinavirom,. ritonavirom, sakvinavirom, telitromicinom i vorikonazolom) (vidjeti dio 4.5).
English: At the end of the follow-up period (actual median follow-up time of 96 months), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 96 mjeseci), alopecija je i dalje bila prisutna u 29 bolesnika u TAC skupini (3,9%) i 16 bolesnika u FAC skupini (2,2 %).
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients and in 1 of 736 FAC patients.
Croatian: Mijelodisplastični sindrom zabilježen je u 2 od 744 bolesnika u TAC skupini te u 1 od 736 bolesnika u FAC skupini.
English: If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Croatian: Ako se otopina ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika, a ne bi smjeli biti duži od 6 sati pri temperaturi ispod 25oC, uključujući u to i jednosatnu infuziju.
English: Docetaxel Mylan contains ethanol
Croatian: Docetaxel Mylan sadrži etanol
English: Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Croatian: Rijetko su zabilježeni pojava dehidracije kao posljedica gastrointestinalnih poremećaja, gastrointestinalna perforacija, ishemični kolitis, kolitis i neutropenijski enterokolitis.
English: One hundred eighty six patients were randomized to receive docetaxel (100 mg/m²) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Croatian: Randomizirano je 186 bolesnika koji su primali docetaksel (100 mg/m2) s trastuzumabom ili bez trastuzumaba; 60% bolesnika ranije je primalo adjuvantnu terapiju temeljenu na antraciklinima.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor a
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti;
English: From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
Croatian: S mikrobiološkog stajališta, priprema za primjenu/razrjeđivanje se mora odvijati u kontroliranim i aseptičkim uvjetima.
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively.
Croatian: Srednje vrijednosti ukupnog klirensa i volumena distribucije u stanju dinamičke ravnoteže bile su 21 l/h/m2, odnosno 113 l.
English: 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.
Croatian: Nakon 10 godina praćenja u studiji TAX 316, akutna leukemija zabilježena je u 4 od 744 bolesnika u TAC skupini te u 1 od 736 bolesnika u FAC skupini.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Croatian: Podskupine bolesnika koji su liječeni TAC-om analizirane su prema prospektivno definiranim glavnim prognostičkim čimbenicima.
English: The other ingredients are polysorbate 80, ethanol anhydrous and citric acid.
Croatian: Drugi sastojci su polisorbat 80, etanol, bezvodni i citratna kiselina.
English: 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.
Croatian: Bolesnici ne bi smjeli primiti sljedeći ciklus docetaksela dok se broj neutrofila ne vrati na razinu od > 1500 stanica/mm3, a broj trombocita na > 100.000 stanica/mm3.
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Croatian: Na temelju doze potrebne za bolesnika izražene u mg, iz odgovarajućeg broja bočica aseptički izvucite odgovarajući volumen koncentrata za otopinu koja sadržava 20 mg/ml docetaksela, rabeći kalibrirane štrcaljke s pričvršćenom iglom od 21G.
English: This is because Docetaxel Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Croatian: Naime, može se dogoditi da u tom slučaju Docetaxel Mylan ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
English: Docetaxel Mylan is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Mylan solutions.
Croatian: Docetaxel Mylan je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora njime oprezno rukovati u pripremi otopina Docetaxel Mylan.
English: In patients treated with docetaxel at 100 mg/m² as single agent who have serum transaminase levels (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.
Croatian: U bolesnika koji su primali docetaksel u dozi od 100 mg/m kao jedinu terapiju te imali vrijednosti transaminaza (ALT i/ili AST) u serumu više od 1,5 puta veće od GGN, te serumsku alkalnu fosfatazu više od 2,5 puta veću od GGN, postoji viši rizik od razvoja teških nuspojava poput toksične smrti uključujući sepsu i gastrointestinalno krvarenje koje može biti fatalno, febrilne neutropenije, infekcije, trombocitopenije, stomatitisa i astenije.
English: Magyarország Mylan Kft Tel: 36 1 8026993
Croatian: Magyarország Tel: 36 1 8026993
English: For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy.
Croatian: Za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke preporučena doza docetaksela u monoterapiji iznosi 100 mg/m2.
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Croatian: Manje su se davali morfinski analgetici (p<0,01), nemorfinski analgetici (p<0,01), ostali lijekovi povezani s bolesti (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom 75 mg/m2 nego onima iz skupine BSC.
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Croatian: U studiji GEICAM 9805, 3 bolesnika (0,6%) u TAC skupini i 3 bolesnika (0,6 %) u FAC skupini razvilo je kongestivno zatajenje srca tijekom perioda praćenja.
English: If you are a man being treated with Docetaxel Mylan 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.
Croatian: Muškarcima koji primaju Docetaxel Mylan savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon prestanka terapije te da potraže savjet o konzervaciji sperme prije liječenja, jer docetaksel može utjecati na plodnost muškarca.
English: If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m².
Croatian: Ako se nakon toga pojave epizode komplicirane neutropenije, dozu docetaksela trebalo bi smanjiti sa 60 na 45 mg/m2.
English: The recommended dose of docetaxel is 75 mg/m².
Croatian: Preporučena doza docetaksela iznosi 75 mg/m2.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i etiketi bočice iza 'Rok valjanosti/Valjanost'.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja razrijeđenog lijeka vidjeti dio 6.3.
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).
Croatian: (521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
English: 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.
Croatian: Nakon primjene doze od 100 mg/m2 putem jednosatne infuzije, dobivena je srednja vrijednost vršne razine lijeka u plazmi od 3,7 μg/ml s odgovarajućim AUC-om od 4,6 h μg/ml.
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Croatian: * omjer hazarda (TAC/FAC) manji od 1 prikazuje da je TAC povezan sa dužim preživljenjem bez znakova bolesti u usporedbi sa FAC-om.
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m².
Croatian: U slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
English: 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).
Croatian: Od 84 bolesnika s perifernom senzornom neuropatijom na kraju kemoterapije, u 10 bolesnika periferna senzorna neuropatija bila je i dalje prisutna tijekom praćenja nakon kemoterapije u kliničkoj studiji karcinoma dojke s pozitivnim limfnim čvorovima (TAX 316).
English: You must not breast-feed while you are treated with Docetaxel Mylan.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Docetaxel Mylan.
English: Patients with operable nodenegative breast cancer eligible to receive chemotherapy (GEICAM 9805)
Croatian: Bolesnici s operabilnim karcinomom dojke i negativnim limfnim čvorovima prikladni za primanje kemoterapije (GEICAM 9805)
English: Grade1 (includes grade not assessed)
Croatian: Histološki gradus Gradus 1 (uključujući neodređeni gradus) Gradus 2
English: Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Croatian: Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji sa cisplatinom i 5-fluoruracilom u studiji koja je uključivala bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starijih, a 4 ih je bilo u dobi od 75 godina ili starijih.
English: Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m² and LFTs should be measured at baseline and before each cycle (see section 4.2).
Croatian: Stoga preporučena doza docetaksela u tih bolesnika s povišenim vrijednostima testova jetrene funkcije iznosi 75 mg/m2, a testove funkcije jetre treba učiniti prije početka terapije i prije svakog sljedećeg ciklusa (vidjeti dio 4.2).
English: In Docetaxel Mylan, the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici Docetaxel Mylan, koncentracija docetaksela iznosi 20 mg/ml.
English: Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Croatian: Općenito Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm3.
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m².
Croatian: • Bolesnicima u kojih se drugi put pojavila toksičnost stupnja 2, ili u kojih se prvi put pojavila toksičnost stupnja 3, u bilo koje vrijeme liječenja, treba odgoditi terapiju sve dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti liječenje docetakselom 55 mg/m
English: Box of 1 vial, or 5 vials.
Croatian: Jedna kutija sadržava 1 bočicu ili 5 bočica.
English: The severity of adverse events of Docetaxel Mylan may be increased when Docetaxel Mylan is given in combination with other chemotherapeutic agents.
Croatian: Težina nuspojava lijeka Docetaxel Mylan može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
English: Age category 2 <35 years ≥35 years
Croatian: Dobna skupina 1 <50 godina ≥50 godina Dobna skupina 2 <35 godina ≥35 godina Status hormonskih receptora
English: Docetaxel Mylan concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to be added to the infusion solution.
Croatian: Docetaxel Mylan koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku vrećicu.
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m².
Croatian: Ako se unatoč primjeni G-CSF pojave epizode febrilne neutropenije, produljene neutropenije ili neutropenijske infekcije, dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
English: • For patients developing the first appearance of a 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.
Croatian: • Bolesnicima u kojih se prvi put pojavila toksičnost stupnja 2, a prisutna je i u vrijeme sljedećeg ciklusa liječenja kombinacijom docetaksel/kapecitabin, treba odgoditi sljedeći ciklus dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti sa 100% originalne doze.