FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p=0.01, using the EORTC QLQ-C30 scale).
Croatian: Bolesnici liječeni s TPF imali su značajno manje pogoršanje ukupnog zdravstvenog stanja prema bolesnicima liječenim s PF (p=0,01, prema EORTC QLQ-C30 ljestvici).
English: MARKETING AUTHORISATION NUMBER EU/1/09/611/002
Croatian: EU/1/09/611/002
English: Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p<0.0001).
Croatian: Vrijeme do progresije bolesti je bilo dulje u skupini koja je primala kombinaciju docetaksel + kapecitabin (p<0,0001).
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Croatian: Docetaksel se metabolizira putemCYP3A4 dok je poznato da prednizon inducira CYP3A4.
English: Deutschland Teva GmbH Tel: +49 731 402 08
Croatian: Teva GmbH Tel: +49 731 402 08
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Croatian: • ako ste alergični (preosjetljivi) na docetaksel ili neki drugi sastojak Docetaksel Teva (naveden u dijelu 6).
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Croatian: 4.1.3 Ubrizgajte cijeli sadržaj štrcaljke u odgovarajuću bočicu Docetaksel Teva.
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: Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Croatian: Prednizon ili prednizolon u dozi od 5 mg oralno dva puta na dan primjenjuje se kontinuirano (vidjeti dio 5.1).
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanost; ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora >5 cm
English: - The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol (see section 2).
Croatian: Drugi sastojci su polisorbat 80 i 25,1%-tni (m/m) bezvodni etanol (vidjeti dio 2).
English: Water for injections.
Croatian: Vodu za injekcije.
English: Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Croatian: Stomatitis/mukozitis stupnja 4 Prva epizoda: prekinuti samo primjenu 5-FU u svim sljedećim ciklusima.
English: Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Croatian: Radioterapija zahvaćene regije provodila se ili konvencionalnim frakcioniranjem (1,8 Gy-2,0 Gy jednom na dan, 5 dana tjedno do ukupne doze od 66 do 70 Gy), ili akceleriranim/hiperfrakcioniranim režimom zračenja (dva puta na dan, s minimalnim razmakom između frakcija od 6 sati, 5 dana tjedno).
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Croatian: Neutropenijske komplikacije u bolesnika koji su primali TAC terapiju s ili bez primarne profilakse s G-CSF (GEICAM 9805)
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p=0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p<0.01) and median survival (15.3 months vs 12.7 months; p=0.03).
Croatian: Bez utjecaja na primarni ishod, ukupnu stopu odgovora (32% prema 25%, p=0,10), docetaksel je produljio medijan vremena do progresije (24,6 tjedana prema 15,6 tjedana; p<0,01) i medijan vremena preživljenja (15,3 mjeseca prema 12,7 mjeseci; p=0,03).
English: 1Full analysis set (intent-to-treat)
Croatian: 1 potpuna analiza (Full analysis set, intent-to-treat) 2 procijenjeni medijan preživljenja
English: Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Croatian: Reakcije preosjetljivosti (nepoznata učestalost) zabilježene su s docetakselom kod pacijenata koji su već imali reakcije preosjetljivosti na paklitaksel.
English: NN: {number]
Croatian: NN:
English: Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Croatian: Docetaksel je povećao stopu terapijskog odgovora (33% prema 12%, p<0,0001), produljio vrijeme do progresije bolesti (19 tjedana prema 11 tjedana, p=0,0004) i produljio ukupno preživljenje (11 mjeseci prema 9 mjeseci, p=0,01).
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Croatian: • nadražen želudac uključujući mučninu, povraćanje i proljev, zatvor
English: What Docetaxel Teva looks like and contents of the pack:
Croatian: Kako Docetaksel Teva izgleda i sadržaj pakiranja
English: p= Hazard ratio*
Croatian: p= Omjer rizika*
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Croatian: Žene u generativnoj dobi koje primaju docetaksel treba savjetovati da ne planiraju trudnoću te da odmah obavijeste svog liječnika ako zatrudne.
English: Docetaxel Teva contains ethanol (alcohol)
Croatian: Docetaksel Teva sadrži etanol (alkohol)
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p=0.002).
Croatian: 10 godina bilo je također značajno poboljšano u TAC skupini u usporedbi s FAC skupinom (76% prema 69%), što znači da je apsolutni rizik od smrti smanjen za 7% (p=0,002).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing docetaxel in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostated 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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja s referentnim lijekom koji sadrži docetaksel u svim podskupinama pedijatrijske populacije za karcinom dojke, karcinom nemalih stanica pluća, karcinom prostate, karcinom želuca i karcinom glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Croatian: Retencija tekućine Bolesnike s teškom retencijom tekućine, poput pleuralnog i perikardijalnog izljeva te ascitesa, treba pažljivo nadzirati.
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva vial.
Croatian: Ubrizgajte cijeli sadržaj štrcaljke u odgovarajuću bočicu Docetaksela Teva.
English: The survival rate was 93.7% in the TAC arm and 91.4% in the FAC arm, at the 8-year follow-up time point, and 91.3% in the TAC arm and 89% in the FAC arm, at the 10-year follow-up time point.
Croatian: Stopa preživljenja bila je 93,7% u TAC skupini i 91,4% u FAC skupini, u točki praćenja od 8 godina te 91,3% u TAC skupini i 89% u FAC skupini, u točki praćenja od 10 godina.
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Croatian: • infekcije, smanjenje broja crvenih krvnih stanica (anemija) ili bijelih krvnih stanica (koje su važne u borbi protiv infekcija) i krvnih pločica • vrućica: ako imate povišenu temperaturu odmah obavijestite svog liječnika
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p=0.0043).
Croatian: Incidencija povrata bolesti u 10 godina smanjena je u bolesnika koji su primili TAC u odnosu na FAC (39% prema 45%), što znači da je apsolutni rizik smanjen za 6% (p=0,0043).
English: • injection site reactions at the site of a previous reaction
Croatian: • reakcije na mjestu primjene injekcije, gdje se već prije pojavljivala ista reakcija
English: Survival was superior in the docetaxel +capecitabine combination arm (p=0.0126).
Croatian: Preživljenje je bilo dulje u skupini koja je primala kombinaciju docetaksela i kapecitabina (p=0,0126).
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Croatian: Primarni ishod djelotvornosti u ovom ispitivanju, ukupno preživljenje (OS) bilo je značajno duže (log-rang test, p=0,0058) u skupini liječenoj docetakselom u usporedbi s PF (medijan OS: 70,6 prema 30,1 mjesec), s 30 % smanjenja smrtnosti u usporedbi s PF (omjer rizika (HR) = 0,70, 95% interval pouzdanosti (CI) = 0,54-0,90) uz ukupni medijan praćenja od 41,9 mjeseci.
English: If you have any further questions on the use of this medicine, ask your doctor or hospital pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili bolničkom ljekarniku.
English: Docetaxel Teva should not be used after the expiry date shown on the carton and vials.
Croatian: Docetaksel Teva se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočicama.
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: Postmenopauza * omjer rizika (TAC/FAC) manji od 1 prikazuje da je TAC povezan sa dužim preživljenjem bez znakova bolesti u usporedbi sa FAC-om.
English: very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
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 zatajivanje srca (CHF).
English: administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m administered on day 1 of cycles repeated every 4 weeks (VCis).
Croatian: do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m2 na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
English: 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.
Croatian: Gastrointestinalne reakcije Simptomi poput rane pojave boli u abdomenu i osjetljivosti na dodir, vrućice, proljeva s ili bez neutropenije, mogu biti rani znaci teške gastrointestinalne toksičnosti koju treba brzo procijeniti i liječiti.
English: Efficacy results are summarized in the following table:
Croatian: Rezulatati djelotvornosti sažeti su u sljedećoj tablici:
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
Croatian: Omjer rizika manji od 1 daje prednost kombinaciji docetaksel + cisplatin + 5-FU * Coxov model (prilagodba prema primarnom mjestu tumora, T i N kliničkim stadijima te PSWHO)
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: The most commonly reported adverse reactions of Docetaxel Teva alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Croatian: Najčešće prijavljivane nuspojave Docetaksel Teva kada se primjenjuje sam su: pad broja crvenih ili bijelih krvnih stanica, alopecija, mučnina, povraćanje, ranice u ustima, proljev i umor.
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Croatian: Prema farmakokinetičkim podacima za monoterapiju docetakselom u dozi od 100 mg/m2, za bolesnike koji imaju povišene vrijednosti transaminaza (ALT i/ili AST) više od 1,5 puta od gornje granice normalnih vrijednosti (GGN) i alkalne fosfataze više od 2,5 puta od GGN, preporučena doza docetaksela je 75 mg/m2 (vidjeti dio 4.4. i 5.2).
English: If you are a man being treated with Docetaxel Teva 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 Docetaksel Teva 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: Docetaxel Teva 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 Teva could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Croatian: Docetaksel Teva 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, Docetaksel Teva se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
English: Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Croatian: Teške promjene na noktima karakterizirali su hipo- ili hiperpigmentacijom ponekad praćene boli i oniholizom.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}
English: In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Croatian: Bolesnicima koji početnu dozu docetaksela od 75 mg/m2 primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25.000 stanica/mm3, u bolesnika koji su imali febrilnu neutropeniju ili u bolesnika s ozbiljnim nehematološkim toksičnim učincima, doza docetaksela u sljedećim ciklusima mora se smanjiti na 65 mg/m2.
English: More than one premix vial may be necessary to obtain the required dose for the patient.
Croatian: Ponekad je potrebno upotrijebiti više od jedne bočice s pripremljenom otopinom koncentrata kako bi se dobila potrebna doza za bolesnika.
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
Croatian: Teva Pharma Belgium N.V./S.A./AG Tél: +32 3 820 73 73
English: How to store Docetaxel Teva
Croatian: Kako čuvati Docetaksel Teva
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/m2.
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Croatian: Docetaksel se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se intravenski na dan 1 svaka tri tjedna.
English: • alteration in sense of taste
Croatian: • glavobolja • promjene osjeta okusa
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Croatian: • crvenilo i oticanje dlanova ili tabana koje može uzrokovati ljuštenje kože (ovo se može također pojaviti na rukama, licu ili tijelu) • promjena boje noktiju koji nakon toga mogu otpasti
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 s 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: Obligation to conduct post-authorisation measures Not applicable
Croatian: • Obaveza provođenja mjera nakon davanja odobrenja
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.
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 liječenje dok se ne postigne stupanj toksičnosti 0-1, a nakon toga nastaviti sa 100% originalne doze.
English: Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Croatian: Karcinom glave i vrata Bolesnici moraju primiti premedikaciju antiemeticima i biti primjereno hidrirani (prije i poslije primjene cisplatina).
English: In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
Croatian: U obje skupine, nakon poslijednjeg ciklusa kemoterapije, bolesnici sa ER+ i/ili PgR+ tumorima, primali su tamoksifen 20 mg jednom na dan u razdoblju do 5 godina.
English: 75 to 60 mg/m².
Croatian: na 60 mg/m2.
English: Dry skin; Desquamation
Croatian: osip praćen svrbežom suha koža; deskvamacija
English: Docetaxel Teva vials should not be stored above 25°C and should be protected from light.
Croatian: Docetaksel Teva bočice treba čuvati na temperaturi do 25°C, zaštićeno od svjetlosti.
English: Docetaxel Teva 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.
Croatian: Docetaksel Teva u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za indukcijsko liječenje bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata.
English: • one vial (5.12 ml) of solvent (water for injections).
Croatian: • jednu bočicu (5,12 ml) s otapalom (voda za injekcije).
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Croatian: Bolesnici koji primaju TCF moraju biti pod stalnim nadzorom (vidjeti dio 4.2 i 4.8).
English: There is no relevant use of Docetaxel Teva 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 Docetaksela Teva 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: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients.
Croatian: Nakon 10 godina praćenja u GEICAM 9805 studiji akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
English: This volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Croatian: Taj volumen punjenja utvrđen je tijekom razvoja docetaksela kako bi se nadoknadio gubitak tekućine koji nastaje tijekom pripreme otopine koncentrata (vidjeti dio 4), zbog pjenjenja, adhezije za stijenku bočice i neiskoristivog volumena koji zaostaje u bočici.
English: One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Croatian: skupini i 1 bolesnik (0,1%) u FAC skupini preminuli su zbog akutne mijeloične leukemije (AML) tijekom perioda praćenja (medijan vremena praćenja iznosio je 8 godina).
English: Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Croatian: Uklonite štrcaljku i iglu te ručno promiješajte okretanjem bočice gore-dolje tijekom najmanje 45
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Croatian: slučaju trombocitopenije stupnja 4 dozu docetaksela treba smanjiti sa 75 na 60 mg/m2.
English: How to use Docetaxel Teva
Croatian: Kako primjenjivati Docetaksel Teva
English: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Croatian: Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm3.
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.
Croatian: Pojava umjerene i teške retencije je odgođena (medijan kumulativne doze: 818,9 mg/m2) u bolesnika koji su primili premedikaciju u odnosu na bolesnike koji nisu primili premedikaciju (medijan kumulativne doze:
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Croatian: Omjer rizika: 1,122 [97,2% CI: 0,937; 1,342]*
English: Headache (G3/4: <1%); Neuropathy peripheral
Croatian: omaglica; glavobolja (G3/4: <1%); periferna neuropatija
English: It is important that you read the entire contents of this guide prior to the preparation of either the Docetaxel Teva premix solution or the Docetaxel Teva infusion solution
Croatian: Važno je pročitati cijeli sadržaj upute prije pripreme Docetaksel Teva otopine koncentrata i