FrancophonIA/ELRC3.0 huggingface dataset:
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Croatian: • jednu bočicu (2,88 ml) s koncentratom (80 mg docetaksela),
English: CAUTION: Dilution of concentrate required using the entire contents of the solvent vial.
Croatian: UPOZORENJE: koncentrat je potrebno razrijediti cjelokupnim sadržajem bočice s otapalom.
English: H-2100 Gödöllő, Táncsics Mihály út 82
Croatian: TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő, Táncsics Mihály út 82
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: Docetaxel Teva concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
Croatian: Docetaksel Teva koncentrat za otopinu za infuziju je prozirna, viskozna, žuta do smeđežuta otopina.
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
Croatian: Za intravensku primjenu
English: 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Croatian: 4.1.1 Ako su bočice pohranjene u hladnjaku, izvadite potreban broj kutija Docetaksel Teva iz hladnjaka i ostavite ih na sobnoj temperaturi (ispod 25°C) 5 minuta.
English: PF).
Croatian: PSWHO)
English: You must not breast-feed while you are treated with Docetaxel Teva.
Croatian: Ne smijete dojiti tijekom liječenja Docetaksel Teva.
English: Both regimens were administered on day 1 every 3 weeks.
Croatian: Oba kemoterapijska protokola primjenjivala su se na dan 1 svaka 3 tjedna.
English: Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Croatian: Ostavite bočicu s pripremljenom otopinom koncentrata na sobnoj temperaturi (ispod 25 oC) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon 5 minuta zbog polisorbata 80 u sastavu).
English: If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Croatian: Ako su bočice pohranjene u hladnjaku, izvadite potreban broj kutija Docetaksel Teva iz hladnjaka i ostavite ih na sobnoj temperaturi (ispod 25 oC) 5 minuta.
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.
Croatian: Docetaksel se pokazao mutagenim u in vitro mikronukleusnom testu i testu kromosomske aberacije na
English: - For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Teva could be administered in combination with doxorubicin and cyclophosphamide.
Croatian: Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, Docetaksel Teva se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
English: A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1,000 mg/m2 per day for 5 days).
Croatian: Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m2 prvi dan) u kombinaciji s cisplatinom (C) (75 mg/m2 prvi dan) i 5-fluorouracilom (F) (750 mg/m2 na dan kroz 5 dana) ili cisplatinom (100 mg/m2 prvi dan) i 5-fluorouracilom (1000 mg/m2 na dan kroz 5 dana).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Croatian: Nakon 10 godina praćenja u studiji TAX 316, akutna leukemija zabilježena je u 43 od 744 bolesnika (0.4%) u TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
English: • Infusion solution: Chemical and physical in-use stability has been demonstrated for 4 hours at room temperature (below 25°C).
Croatian: • Infuzijska otopina: Dokazana kemijska i fizikalna stabilnost u primjeni je 4 sata na sobnoj temperaturi (ispod 25°C).
English: 4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Croatian: 4.1.4 Uklonite štrcaljku i iglu te ručno promiješajte okretanjem bočice gore-dolje najmanje 45
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1,250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Croatian: U kombinaciji s kapecitabinom, preporučena doza docetaksela je 75 mg/m2 svaka tri tjedna u kombinaciji s kapecitabinom u dozi od 1250 mg/m2 dvaput na dan (unutar pola sata nakon obroka) u trajanju od 2 tjedna, nakon čega slijedi tjedan dana pauze.
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Croatian: Poremećaji živčanog sustava Razvoj teške periferne neurotoksičnosti zahtijeva smanjenje doze (vidjeti dio 4.2 i 4.4).
English: Docetaxel Teva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Teva solutions.
Croatian: Teva je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine Docetaksela.
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.
Croatian: Sljedeća tablica prikazuje da je incidencija neutropenije stupnja 4, febrilne netropenije i neutropenijske infekcije smanjena u bolesnika koji su primali primarnu profilaksu s G-CSF nakon što je ona uvedena kao obavezna u TAC skupini - GEICAM studija.
English: • one vial of 0.72 ml concentrate (20 mg of docetaxel),
Croatian: • jednu bočicu s 0,72 ml koncentrata (20 mg docetaksela),
English: Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF, (see section 4.2).
Croatian: bolesnika koji su profilaktički primali G-CSF i u 15,6% i 12,9% bolesnika koji nisu profilaktički primali G-CSF (vidjeti dio 4.2).
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
Croatian: Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m2 na 75 mg/m2 i/ili sa 75 mg/m2
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Croatian: Za liječenje nakon neuspjeha prethodne kemoterapije temeljene na platini, preporučuje se doza od 75 mg/m2 u monoterapiji.
English: Second primary malignancies (including acute myeloid leukemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Croatian: mijelodisplastični sindrom i ne-Hodgkinov limfom) mogu se javiti nekoliko mjeseci ili godina nakon terapije koja uključuje docetaksel.
English: There is no information on the use of docetaxel in pregnant women.
Croatian: Nema podataka o primjeni docetaksela u trudnica.
English: in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Croatian: Niti jednom bolesniku u obje skupine nije dijagnosticiran mijelodisplastični sindrom.
English: One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Croatian: U jednom velikom randomiziranom ispitivanju faze III u koje je bilo uključeno 429 ranije neliječenih bolesnika s metastatskom bolesti, primjenjivala se kombinacija doksorubicina (50 mg/m2) s docetakselom (75 mg/m2) (AT skupina) naspram kombinacije doksorubicina (60 mg/m2) i ciklofosfamida (600 mg/m2) (AC skupina).
English: • one 15 ml clear glass vial with a flip-off cap containing 2.88 ml concentrate and,
Croatian: • jednu prozirnu staklenu bočicu od 15 ml s "flip-off" zatvaračem koja sadržava 2,88 ml koncentrata i
English: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Croatian: Docetaksel se ne smije primjenjivati u bolesnika s početnim brojem neutrofila < 1500 stanica/mm3.
English: Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study (Intent-toTreat Analysis)
Croatian: Analiza podskupina - adjuvantno liječenje bolesnika s karcinomom dojke s negativnim limfnim čvorovima ("Intent-to-Treat" analiza)
English: • one 6 ml clear glass vial with a flip-off cap containing 0.72 ml concentrate and,
Croatian: • jednu prozirnu staklenu bočicu od 6 ml s "flip-off" zatvaračem koja sadržava 0,72 ml koncentrata i
English: Method of administration For instructions on preparation and administration of the product, see section 6.6.
Croatian: Za upute o pripremi i primjeni lijeka, vidjeti dio 6.6.
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Croatian: 4.1.2 Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj otapala za Docetaksel Teva, djelomično okrećući bočicu otapala naopako.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva.
Croatian: Vaš liječnik može mijenjati dozu i učestalost primjene lijeka ovisno o rezultatima krvnih pretraga,
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1,250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Croatian: U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom (1250 mg/m2 dvaput dnevno tijekom 2 tjedna nakon čega slijedi 1 tjedan pauze).
English: • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p=0.009.
Croatian: • Ukupna stopa terapijskog odgovora (ORR) bila je značajno veća u AT skupini naspram AC
English: Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Croatian: Karcinom dojke Docetaksel Teva u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Croatian: Akutna mijeloična leukemija i mijelodisplastični sindrom su prijavljeni (manje česta učestalost) u pivotalnim kliničkim ispitivanjima raka dojke u kojima se primjenjivao docetaksel,
English: There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other diseaserelated medications (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), ne morfinski analgetici (p<0,01), ostali lijekovi povezani s bolesti (p=0,06) i radioterapija (p<0,01) bolesnicima koji su se liječili docetakselom
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol).
Croatian: Jedna bočica koncentrata sadrži 25,1%-tni (m/m) bezvodni etanol (723 mg bezvodnog etanola).
English: Docetaxel Teva must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Croatian: Docetaksel Teva NE smije primati ako ste trudni, osim ako to liječnik nije izričito propisao.
English: 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).
Croatian: Poremećaji krvi i limfnog sustava Vrlo često: Hematološka toksičnost bila je povećana u bolesnika koji su primali trastuzumab i docetaksel u usporedbi s bolesnicima koji su primali docetaksel u monoterapiji (32% neutropenija stupnja 3/4 u odnosu na 22%, prema kriterijima NCI-CTC).
English: Mix the infusion bag or bottle manually using a rocking motion.
Croatian: Promiješajte sadržaj infuzijske vrećice ili bočice polukružnim (ljuljajućim) pokretima.
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Croatian: Ukupno 449 bolesnika je randomizirano kako bi primili ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Croatian: [95% CI: -1,1; 12,0]
English: See also section ”Docetaxel Teva contains ethanol (alcohol)” below.
Croatian: Pogledajte također dio „Docetaksel Teva sadrži etanol (alkohol)“
English: See also section “Docetaxel Teva contains ethanol (alcohol)” below.
Croatian: Pogledajte također dio "Docetaksel Teva sadrži etanol (alkohol)"
English: CF n=224
Croatian: n = 224
English: In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Croatian: U bolesnika liječenih docetakselom u kombinaciji s doksorubicinom i ciklofosfamidom (TAC), febrilna neutropenija i/ili neutropenijska infekcija rijeđe su zabilježene ako su bolesnici dobivali primarnu G-CSF profilaksu.
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
Croatian: Jedna bočica koncentrata sadrži 25,1 %-tni (m/m) bezvodni etanol (181 mg bezvodnog etanola).
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Croatian: Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST > 1,5 x GGN te alkalnom fosfatazom > 2,5 x GGN i bilirubinom > 1 x GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
English: At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Croatian: Pri medijanu vremena praćenja od 77 mjeseci dokazano je u TAC skupini bolesnika značajno poduljenje preživljenja bez znakova bolesti u usporedbi s bolesnicima iz FAC skupine.
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Croatian: Ovaj volumen punjenja utvrđen je tijekom razvoja docetaksela kako bi se nadoknadio gubitak tekućine kod pripreme otopine koncentrata zbog pjenjenja, adhezije na stijenku bočice i neiskoristivog volumena koji zaostaje u bočici.
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Croatian: (prikazani su klinički značajni štetni događaji povezani s liječenjem),
English: Diarrhoea grade 4
Croatian: Stomatitis/mukozitis stupnja 4
English: Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Croatian: Docetaksel Teva u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: Docetaxel + Cis+5-FU n=177
Croatian: Docetaksel + Cis + 5-FU n = 177
English: (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/m2 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 koji mogu biti fatalni, febrilne neutropenije, infekcije,
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Croatian: Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 %
English: • one vial of 1.28 ml solvent (water for injections).
Croatian: • jednu bočicu s 1,28 ml otapala (voda za injekcije).
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Croatian: Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (TAC skupina) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
English: This is because Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Croatian: Teva ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Croatian: Rijetko su zabilježeni akutni respiratorni distres sindrom te slučajevi intersticijske pneumonija/pneumonitisa, intersticijska bolesti plućna, plućne fibroze i zatajenja disanja, koji su ponekad imali smrtni ishod.
English: b) Preparation of the infusion solution
Croatian: b) Priprema otopine za infuziju
English: • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Croatian: • Jedna bočica otapala sadrži 1,28 ml vode za injekcije (volumen punjenja: 1,71 ml).
English: [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Croatian: [kemoterapija +/- radioterapija] (%) (95% CI) ***p- vrijednost
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: **Neprilagođeni log-rang test, nije prilagođen višestrukim usporedbama *** Hi-kvadrat test, nije prilagođen višestrukim usporedbama
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Croatian: Rijetko: epizode krvarenja povezane s trombocitopenijom stupnja 3/4.
English: The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Croatian: Najčešće zabilježeni simptomi bili su crvenilo praćeno osjećajem vrućine, osip sa/bez svrbeža, stezanje u prsištu, bol u leđima, dispneja, vrućica ili zimica.
English: Each ml of concentrate contains 27.73 mg docetaxel.
Croatian: Jedan ml koncentrata sadrži 27,73 mg docetaksela.
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Croatian: dispneja (G3/4: 1%); kašalj (G3/4: <1%); epistaksa (G3/4: <1%)
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1 % versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Croatian: S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/611/001
Croatian: EU/1/09/611/001
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).
Croatian: CYP3A4 inhibitora (npr. ketokonazola, itrakonzola, klaritromicina, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola), nužan je poman klinički nadzor, a može biti potrebna i prilagodba doze docetaksela za vrijeme terapije snažnim inhibitorom CYP3A4
English: Inject the required premix volume into a non-PVC 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Ubrizgajte potrebni volumen pripremljene otopine koncentrata u ne-PVC infuzijsku vrećicu od 250 ml, koja sadrži 5 %-tnu otopinu glukoze ili 0,9 %-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
English: Docetaxel +Cis+5-FU n=255
Croatian: Docetaksel + Cis + 5-FU n = 255
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Croatian: Karcinom prostate Sigurnost i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranoj multicentričnoj studiji faze III.
English: • one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.
Croatian: • jednu prozirnu staklenu bočicu od 15 ml s "flip-off" zatvaračem koja sadržava 5,12 ml otapala.