FrancophonIA/ELRC3.0 huggingface dataset:
English: Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Croatian: Reakcije je karakterizirala pojava osipa, uključujući lokalizirane erupcije, najčešće na stopalima i šakama (uključujući teški sindrom šaka i stopalo), ali i na rukama, licu ili grudnom košu, a često su bile povezane sa svrbežom.
English: Therefore, patients should be warned of the potential impact of the amount of alcohol and the side effects of this medicinal product on the ability to drive or use machines, and be advised not to drive or use machines if they experience these side effects during treatment.
Croatian: Stoga, bolesnike treba upozoriti na mogući utjecaj na sposobnost upravljanja vozilima i rada sa strojevima zbog količine alkohola i nuspojava ovog lijeka te im savjetovati da ne upravljaju vozilima niti rade sa strojevima ako dožive ove nuspojave tijekom liječenja.
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Croatian: G-CSF se primjenjivao kao sekundarna profilaksa u 19,3% bolesnika (10,7% ciklusa).
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Croatian: Sekundarni ishodi uključivali su promjenu u stupnju boli, opću procjenu kvalitete života prema EuroQoL-5D, ljestvici simptoma karcinoma pluća (Lung Cancer Symptom Scale) i promjene u Karnofski izvedbenom statusu.
English: Nervous system
Croatian: Živčani sustav
English: These were reversible upon discontinuation of the infusion.
Croatian: Ti su poremećaji bili reverzibilni nakon prekida infuzije.
English: A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
Croatian: Ukupno 1006 bolesnika s KPS > 60 randomizirani su prema liječenju u sljedeće skupine:
English: • inflammation of the eye or increased tearing of the eyes
Croatian: • upala oka ili pojačano suzenje očiju
English: The pharmacokinetics of docetaxel were not altered by the age or sex of the patient.
Croatian: Farmakokinetika docetaksela nije se promijenila zbog dobi ili spola bolesnika.
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Croatian: Rizik smanjenja progresije bio je 32,1% i bio je udružen sa značajnim produljenjem TTP (p=0,0004) u korist TCF skupine.
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Croatian: Za kombinaciju docetaksel/karboplatin nije se mogla dokazati ekvivalentna niti neinferiorna djelotvornost u usporedbi s referentnom kombinacijom liječenja VCis.
English: Prostate cancer
Croatian: Karcinom prostate
English: Second episode: stop 5-FU only, at all subsequent cycles.
Croatian: Druga epizoda: prekinuti samo primjenu 5-FU u svim sljedećim ciklusima.
English: Docetaxel1 n = 94
Croatian: Docetaksel1 n=94
English: Docetaxel plus trastuzumab1 n = 92
Croatian: Docetaksel + trastuzumab1 n=92
English: Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Croatian: Sveukupno, rezultati studije pokazuju pozitivni omjer koristi i rizika za TAC skupinu u usporedbi sa FAC skupinom.
English: permanent hair loss has been observed
Croatian: (nepoznata učestalost) zabilježen je trajni gubitak kose.
English: Tell your doctor, hospital pharmacist or nurse if you have experienced an allergic reaction to previous paclitaxel therapy.
Croatian: Obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru ako ste doživjeli alergijsku reakciju na prethodnu terapiju paklitakselom.
English: The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Croatian: Očekivane primarne komplikacije predoziranja bile bi supresija koštane srži, periferna neurotoksičnost i mukozitis.
English: Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised .
Croatian: Primarna G-CSF profilaksa uvedena je kao obavezna u TAC skupini nakon što je randomizirano 230 bolesnika.
English: The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Croatian: Sljedeće doze docetaksela primjenjivale su se odmah nakon završetka infuzije trastuzumaba, ako se prethodna doza trastuzumaba dobro podnosila.
English: • pneumonia (infection of the lungs)
Croatian: • pneumonija (infekcija pluća)
English: No of positive nodes Overall
Croatian: Broj pozitivnih limfnih čvorova Ukupno
English: DOCETAXEL KABI contains alcohol.
Croatian: DOCETAXEL KABI sadrži alkohol.
English: Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Croatian: Teške reakcije karakterizirali su hipotenzija i/ili bronhospazam ili generalizirani osip/eritem (vidjeti dio 4.4).
English: In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Croatian: U otprilike 20% ovih slučajeva nije bilo faktora rizika za akutno zatajenje bubrega kao što su istodobno primijenjeni nefrotoksični lijek i poremećaji probavnog sustava.
English: Patients previously treated with chemotherapy with or without radiotherapy
Croatian: Bolesnici koji su ranije primali kemoterapiju s ili bez radioterapije
English: Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Croatian: Reakcije preosjetljivosti mogu se pojaviti unutar nekoliko minuta nakon početka primjene infuzije docetaksela pa treba imati dostupnu opremu i sredstva za liječenje hipotenzije i bronhospazma.
English: Docetaxel did not influence the binding of digitoxin.
Croatian: Docetaksel nije utjecao na vezanje digitoksina.
English: Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Croatian: Docetaksel je antineoplastik koji djeluje poticanjem skupljanja tubulina u stabilne mikrotubule i inhibira njihovo razdvajanje što ima za posljedicu značajno smanjenje slobodnog tubulina.
English: Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Croatian: Medijan vremena do prvog pogoršanja, prema WHO izvedbenom statusu, bio je značajno dulji u TPF skupini u odnosu na PF skupinu.
English: The carcinogenic potential of docetaxel has not been studied.
Croatian: Kancerogeni potencijal docetaksela nije bio ispitivan.
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Croatian: Profilaktički treba primijeniti G-CSF kako bi se smanjio rizik hematološke toksičnosti (vidjeti također 'Prilagodba doze tijekom liječenja').
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Croatian: Manji broj bolesnika testiran je primjenom fluorescencijske in situ hibridizacije (FISH).
English: In case of white blood cells disturbances, you may experience associated fever or infections.
Croatian: U slučaju poremećaja broja bijelih krvnih stanica, moguće je da taj poremećaj uzrokuje vrućicu ili infekciju.
English: The benefit of resuming docetaxel treatment must be carefully evaluated.
Croatian: Mora se pažljivo procijeniti korist od nastavka liječenja docetakselom.
English: Grade 3
Croatian: Gradus 3
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Croatian: Taj protokol je primjenjivan svaka tri tjedna tijekom 4 ciklusa u slučaju da je barem minimalni odgovor (≥ 25% smanjenje dvodimenzonalno mjerene veličine tumora) bio primijećen nakon 2 ciklusa.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to DOCETAXEL KABI.
Croatian: Vaš liječnik može mijenjati dozu i učestalost primjene lijeka ovisno o rezultatima Vaših krvnih pretraga, Vašem općem stanju i terapijskom odgovoru na DOCETAXEL KABI.
English: If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Croatian: Ako je potrebna doza veća od 190 mg docetaksela, upotrijebite veći volumen infuzijskog sredstva, tako da koncentracija docetaksela ne prelazi 0,74 mg/ml.
English: DOCETAXEL KABI will be administered to you by a healthcare professional.
Croatian: DOCETAXEL KABI će Vam davati zdravstveni radnik.
English: Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Croatian: Bolesnici u obje liječene skupine su primali CRT 7 tjedana nakon završetka indukcijske kemoterapije s minimalnim intervalom od 3 tjedna i ne kasnijim od 8 tjedana nakon početka posljednjeg ciklusa kemoterapije (od 22. do 56. dana posljednjeg ciklusa).
English: If not used immediately, in-use 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: These results are consistent with the pharmacological activity of docetaxel.
Croatian: Ti su rezultati u skladu s farmakološkom aktivnošću docetaksela.
English: In case of combination with CYP3A4 inhibitors, the occurrence of docetaxel adverse reactions may increase, as a result of reduced metabolism.
Croatian: U slučaju kombinacije s CYP3A4 inhibitorima, učestalost nuspojava docetaksela može se povećati, kao rezultat njegovog smanjenog metabolizma.
English: • if you have a severe liver disease.
Croatian: - ako bolujete od teške bolesti jetre.
English: • injection site reactions at the site of a previous reaction.
Croatian: • reakcije na mjestu injektiranja na mjestu gdje se prethodno javila reakcija
English: Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Croatian: Razlika u liječenju: 5,4% [95% CI: -1,1; 12,0]
English: Discontinue treatment if these toxicities persist (see section 4.4).
Croatian: Liječenje se mora prekinuti ako toksičnost potraje (vidjeti dio 4.4).
English: The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Croatian: Druga privremena analiza provedena je nakon što je ukupno prijavljeno 400 DFS događaja (preživljenje bez znakova bolesti), što znači da je medijan praćenja iznosio 55 mjeseci.
English: Dehydration and pulmonary oedema have rarely been reported.
Croatian: Dehidracija i plućni edem rijetko su zabilježeni.
English: p = Hazard ratio*
Croatian: p= Omjer hazarda*
English: During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Croatian: Tijekom tih dvaju ispitivanja faze III, profil sigurnosti primjene docetaksela odgovarao je profilu sigurnosti zapaženom u ispitivanjima faze II (vidjeti dio 4.8).
English: Between infusions of DOCETAXEL KABI the following may occur, and the frequency may vary with the combinations of medicines that are received
Croatian: Između infuzija lijeka DOCETAXEL KABI mogu se pojaviti sljedeće nuspojave, a učestalost može varirati ovisno o kombinacijama lijekova koje ste primili.
English: Docetaxel achieves high intracellular concentrations with a long cell residence time.
Croatian: Docetaksel postiže visoku intracelularnu koncentraciju s dugim vremenom zadržavanja u stanicama.
English: Previous therapy should have included an anthracycline.
Croatian: Prethodna terapija morala je uključivati antraciklin.
English: The positive benefit risk ratio for TAC compared to FAC remained unchanged.
Croatian: Pozitivan omjer koristi i rizika za TAC u odnosu na FAC ostao je nepromijenjen.
English: Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Croatian: Docetaksel se metabolizira putem CYP3A4 dok je poznato da prednizon inducira CYP3A4.
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Croatian: Najčešće prijavljene nuspojave samog docetaksela su: neutropenija (koja je bila reverzibilna i nije bila kumulativna; medijan javljanja najnižih vrijednosti je bio 7 dana, a medijan trajanja teške neutropenije (500 stanica/mm3) je bio 7 dana), anemija, alopecija, mučnina, povraćanje, stomatitis, proljev i astenija.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Croatian: Od 333 bolesnika koji su docetaksel primali svaka tri tjedna u studiji liječenja karcinoma prostate, 209 bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
English: • sores in the mouth
Croatian: • ranice u ustima
English: Patients who have previously experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction.
Croatian: Bolesnici koji su prethodno doživjeli reakciju preosjetljivosti na paklitaksel mogu biti pod rizikom razvoja reakcije preosjetljivosti na docetaksel, uključujući i teže reakcije preosjetljivosti.
English: Acute leukaemia / Myelodysplastic syndrome
Croatian: Akutna leukemija/mijelodisplastični sindrom
English: The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive or use machines (see sections 4.4 and 4.8).
Croatian: Količina alkohola u ovom lijeku i nuspojave lijeka mogu smanjiti sposobnost upravljanja vozilima ili rada sa strojevima (vidjeti dijelove 4.4 i 4.8).
English: • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Croatian: • Za svaku sljedeću pojavu toksičnosti, ili bilo koju pojavu toksičnosti 4. stupnja, potrebno je prekinuti terapiju docetakselom.
English: Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Croatian: Zbog činjenice da je docetaksel primijenjen svaki tjedan pokazao bolji profil sigurnosti primjene u odnosu na docetaksel primijenjen svaka 3 tjedna, moguće je da određeni bolesnici mogu imati koristi od primanja docetaksela svaki tjedan.
English: Fluid retention is cumulative in incidence and severity (see section 4.4).
Croatian: Retencija tekućine kumulativna je po incidenciji i težini (vidjeti dio 4.4).
English: You may experience side effects of this medicine that may impair your ability to drive, use tools or operate machines (see section 4 Possible side effects).
Croatian: Mogu Vam se javiti nuspojave ovog lijeka koje mogu smanjiti vašu sposobnost upravljanja vozilima, korištenja alata ili upravljanja strojevima (vidjeti dio 4. Moguće nuspojave).
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).
Croatian: Odzivna upalna reakcija na mjestu iniciranja (ponovna pojava kožne reakcije na mjestu prethodne ekstravazacije nakon primjene docetaksela na drugom mjestu) zapažena je na mjestu prethodne ekstravazacije (učestalost nije poznata).
English: The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Croatian: Stopa jednogodišnjeg preživljenja bila je, također, značajno dulja u skupini s docetakselom (40%) nego u skupini s BSC (16%).
English: A study of 14C-docetaxel has been conducted in three cancer patients.
Croatian: Provedeno je ispitivanje 14C-docetaksela na tri osobe s karcinomom.
English: • interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Croatian: • intersticijska bolest pluća (upala pluća koja izaziva kašalj i otežano disanje.
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Croatian: Nisu zabilježene statističke razlike u općoj kvaliteti života između liječenih skupina bolesnika.
English: Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Croatian: Ukupno preživljenje bilo je također značajno dulje (p=0,0201) u korist TCF skupine s rizikom smanjenja smrtnosti od 22,7%.
English: Ischemia myocardial
Croatian: ishemija miokarda
English: †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Croatian: † Stratificirani log- rank test * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
English: However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
Croatian: Međutim, kod pojave teških reakcija poput teške hipotenzije, bronhospazma ili generaliziranog osipa/eritema potrebno je odmah prekinuti primjenu docetaksela i primijeniti odgovarajuće liječenje.
English: In some cases concomitant factors may have contributed to the development of these effects.
Croatian: U nekim su slučajevima razvoju tih učinaka mogli, uz docetaksel, doprinijeti i drugi istodobni čimbenici.
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Croatian: Profilaktički se može primijeniti G-CSF kako bi se smanjio rizik hematološke toksičnosti.
English: Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Croatian: Podaci o reverzibilnosti dostupni su među 35,3% bolesnika u kojih se razvila neurotoksičnost nakon liječenja docetakselom 100 mg/m2 u monoterapiji.
English: 6.3 Shelf life Unopened vial 2 years.
Croatian: 6.3 Rok valjanosti Neotvorena bočica 2 godine
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: Druge primarne zloćudne bolesti (uključujući akutnu mijeloičnu leukemiju, mijelodisplastični sindrom i ne-Hodgkinov limfom) mogu se javiti nekoliko mjeseci ili godina nakon terapije koja uključuje docetaksel.
English: The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Croatian: Količina alkohola u ovom lijeku može smanjiti sposobnost upravljanja vozilima ili strojevima.
English: Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Croatian: Bolesnici moraju primiti premedikaciju antiemeticima i biti primjereno hidrirani (prije i poslije primjene cisplatina).
English: Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Croatian: Potrebna je učestala kontrola kompletne krvne slike u svih bolesnika koji primaju docetaksel.
English: Neutropenic infection
Croatian: neutropenijska infekcija
English: Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Croatian: Bolesnike treba pažljivo nadzirati radi ranih manifestacija ozbiljne gastrointestinalne toksičnosti (vidjeti dio 4.2, 4.4 Hematologija i 4.8).
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Croatian: Incidencija sljedećih nuspojava (svi stupnjevi): letargija, stomatitis, neutropenijska infekcija bila je ≥10% viša u bolesnika koji su imali 65 ili više godina u odnosu na mlađe bolesnike.
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: Cases of hyponatraemia have been reported, mostly associated with dehydration, vomiting and pneumonia.
Croatian: Prijavljeni su slučajevi hiponatrijemije, najčešće povezani s dehidracijom, povraćanjem i pneumonijom.
English: Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Croatian: Docetaksel pripada skupini antitumorskih lijekova, koji se nazivaju taksani.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Croatian: PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: • feeling of numbness or pins and needles or pain in the joints or muscles
Croatian: • osjećaj utrnulosti ili bockanja ili bol u zglobovima i mišićima
English: If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Croatian: Ako se reakcije preosjetljivosti pojave u obliku blažih simptoma, poput crvenila praćenog osjećajem vrućine ili lokalnih reakcija na koži, to ne zahtijeva prekid terapije.
English: Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Croatian: Zabilježene su reverzibilne kožne reakcije koje su općenito bile blage ili umjerene.
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Croatian: Za kombinaciju s trastuzumabom prikazane su nuspojave (svi stupnjevi) zabilježene u ≥ 10% bolesnika.
English: Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Croatian: Bolesnici liječeni s TCF imali su do 5% dulje vrijeme do definitivnog pogoršanja zdravstvenog statusa prema upitniku QLQ-C30 (p=0,0121) i dulje vrijeme do definitivnog pogoršanja prema Karnofsky izvedbenom statusu (p=0,0088) u usporedbi s bolesnicima liječenim s CF.
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: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili bolničkog ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i lijekove koje ste nabavili bez recepta.
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Croatian: Docetaksel se, stoga, ne smije primjenjivati tijekom trudnoće osim ako to nije striktno indicirano.