FrancophonIA/ELRC3.0 huggingface dataset:
English: During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Croatian: Tijekom infuzije u bolnici mogu se javiti sljedeće alergijske reakcije (mogu se javiti u više od 1 na 10 osoba):
English: The peripheral oedema usually starts at the lower extremities and may become generalised with a weight gain of 3 kg or more.
Croatian: Periferni edem obično počinje na donjim ekstremitetima i može postati generalizirani s povećanjem težine za 3 kg ili više.
English: A final analysis was performed with an actual median follow up of 96 months.
Croatian: Konačna analiza provedena je sa stvarnim medijanom praćenja od 96 mjeseci.
English: Frequency not known (cannot be estimated from the available data):
Croatian: Učestalost nije poznata (ne može se procijeniti iz dostupnih podataka):
English: Median time to progression (weeks):
Croatian: Medijan vremena do progresije (tjedni):
English: • weight gain or loss.
Croatian: • dobitak ili gubitak na težini.
English: The infusion will last approximately one hour during which you will be in the hospital.
Croatian: Infuzija će trajati oko jedan sat i primit ćete je u bolnici.
English: This leaflet was last revised in {MM/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u: {MM/GGGG}
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Croatian: Liječnik će izračunati površinu Vašeg tijela u kvadratnim metrima (m2) i odrediti dozu koju trebate primiti.
English: You should usually receive your infusion once every 3 weeks.
Croatian: Obično ćete primati infuziju jednom svaka tri tjedna.
English: During treatment, you may be given other medicines to maintain the number of your blood cells.
Croatian: Tijekom liječenja možda će Vam se dati lijekovi za održavanje broja krvnih stanica.
English: Your doctor should address them immediately.
Croatian: Vaš bi liječnik trebao odmah reagirati na njih.
English: In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Croatian: U obje skupine kvaliteta života mjerena s pomoću EORTC upitnika bila je usporediva i stabilna tijekom liječenja i praćenja.
English: Ask your doctor for advice before being given any medicine.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete bilo koji lijek.
English: • raised liver enzymes (hence the need for regular blood tests).
Croatian: • povišeni jetreni enzimi (potrebne su redovite krvne pretrage).
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Croatian: Na temelju populacijske farmakokinetičke analize, nema posebnih uputa za primjenu u starijih osoba.
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Croatian: O mogućim nuspojavama će Vaš liječnik razgovarati s Vama i objasniti Vam rizike i koristi liječenja.
English: The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Croatian: Količina alkohola u ovom lijeku može imati učinke na središnji živčani sustav (dio živčanog sustava koji uključuje mozak i leđnu moždinu).
English: Histological grade
Croatian: Histološki gradus
English: Overall survival (Primary end-point):
Croatian: Ukupno preživljenje (primarni ishod):
English: There were a few reports of overdose.
Croatian: Postoji malo izvješća o predoziranju.
English: • change in the colour of your nails, which may detach
Croatian: • promjena boje noktiju koji nakon toga mogu otpasti
English: Results on these end-points were supportive of the primary end-points results.
Croatian: Rezultati tih ishoda podupirali su rezultate primarnih ishoda.
English: Menopausal status
Croatian: Menopauzalni status
English: An effective method of contraception should be used during treatment.
Croatian: Za vrijeme liječenja potrebno je koristiti učinkovitu metodu kontracepcije.
English: Usual dose
Croatian: Uobičajena doza
English: In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Croatian: U slučaju predoziranja bolesnika treba zadržati na specijaliziranom odjelu i strogo kontrolirati vitalne funkcije.
English: Inter individual variation in total body clearance was approximately 50%.
Croatian: Interindividualne varijacije ukupnog klirensa bile su približno 50%.
English: Two interim analyses and one final analysis were performed.
Croatian: Provedene su dvije privremene analize te jedna konačana analiza.
English: Hormonal receptor status
Croatian: Status hormonskih receptora
English: Elderly treated with TCF should be closely monitored.
Croatian: Starije osobe liječene sa TCF trebaju biti pod stalnim nadzorom.
English: These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal.
Croatian: Ovi simptomi mogu biti prvi znakovi ozbiljne toksičnosti u probavnom sustavu koja može biti smrtonosna.
English: The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Croatian: Glavna test metoda za određivanje pozitivnog HER2 u ovoj temeljnoj studiji bila je imunohistokemijska metoda (IHC).
English: Progressive Disease as Best Overall Response (%) *Unstratified logrank test
Croatian: Progresija bolesti kao najbolji ukupni odgovor (%) * nestratificirani log-rank test
English: Docetaxel is more than 95% bound to plasma proteins.
Croatian: Docetaksel se više od 95% vezuje za proteine plazme.
English: Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions.
Croatian: Bolesnike treba pažljivo nadzirati zbog reakcija preosjetljivosti, pogotovo tijekom prve i druge infuzije.
English: • bleeding from the nose
Croatian: • krvarenje iz nosa
English: Cases of permanent alopecia (frequency not known) have been reported.
Croatian: Prijavljeni su slučajevi trajne alopecije (nepoznata učestalost).
English: Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Croatian: Bolesnici moraju primiti terapiju G-CSF što je prije moguće nakon otkrivanja predoziranja.
English: In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Croatian: U slučaju problema s vidom, osobito zamagljenog vida, odmah morate otići na pregled očiju i vida.
English: Once added to the infusion bag
Croatian: Nakon dodavanja u infuzijsku vrećicu
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders).
Croatian: • smanjena razina natrija, kalija, magnezija i/ili kalcija u krvi (poremećaji ravnoteže elektrolita).
English: The binding of docetaxel to microtubules does not alter the number of protofilaments.
Croatian: Vezanje docetaksela za mikrotubule ne mijenja broj protofilamenata.
English: • fever: if this happens you must tell your doctor immediately
Croatian: • vrućica: ako se to dogodi odmah obavijestite svog liječnika
English: Number of patients in TAC group
Croatian: Podskupina bolesnika Broj bolesnika u TAC skupini
English: Eruptions generally occurred within one week after the docetaxel infusion.
Croatian: Erupcije su se općenito pojavile unutar tjedan dana nakon infuzije docetaksela.
English: Very rare: one case of alopecia non-reversible at the end of the study.
Croatian: Vrlo rijetko: jedan slučaj ireverzibilne alopecije na kraju ispitivanja.
English: Grade1 (includes grade not assessed)
Croatian: Gradus 1 (uključujući neodređeni gradus)
English: About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Croatian: Približno 80% radioaktivnosti u stolici izlučilo se prvih 48 sati u obliku glavnog neaktivnog metabolita i tri manja neaktivna metabolita te vrlo male količine nepromijenjenog lijeka.
English: The first interim analysis was planned 3 years after the date when half of study enrolment was done.
Croatian: Prva privremena analiza planirala se provesti 3 godine nakon datuma pri kojem je polovica bolesnika uključena u studiju.
English: Your doctor may stop your treatment immediately.
Croatian: Liječnik će možda odmah prekinuti liječenje.
English: • if the number of white blood cells is too low.
Croatian: - ako imate premali broj bijelih krvnih stanica.
English: Overall response rate (%):
Croatian: Stopa ukupnog odgovora (%):
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Croatian: DFS podaci nisu bili statistički značajni, ali su i dalje bili povezani s pozitivnim trendom u korist TAC skupine.
English: The hospital staff will monitor your condition closely during treatment.
Croatian: Vaše stanje pomno će nadzirati medicinski djelatnici za vrijeme liječenja.
English: • difficulty or painful swallowing
Croatian: • otežano ili bolno gutanje
English: The safety and efficacy of DOCETAXEL KABI in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka DOCETAXEL KABI u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nisu još ustanovljene.
English: Cardiac function should be further monitored during treatment (e.g. every three months) to help identify patients who may develop cardiac dysfunction.
Croatian: Tijekom liječenja treba nastaviti kontrolirati srčanu funkciju (npr. svaka tri mjeseca) kako bi se lakše identificirali bolesnici u kojih se može razviti poremećaj srčane funkcije.
English: • swelling of the hands, feet, legs
Croatian: • oticanje ruku, stopala, nogu
English: In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Croatian: Nadalje, fizikalna i kemijska stabilnost tijekom primjene ovako pripremljene infuzijske otopine dokazana je u 'ne-PVC' vrećicama do 48 sati kada se čuvaju pri temperaturi između 2 do 8°C.
English: The incidence of serious adverse events was higher in older people compared to younger patients.
Croatian: Incidencija ozbiljnih nuspojava bila je veća u starijih osoba u odnosu na mlađe bolesnike.
English: Dose adjustments during treatment
Croatian: Prilagodba doze tijekom liječenja
English: If pregnancy occurs during your treatment, you must immediately inform your doctor.
Croatian: Ako zatrudnite tijekom liječenja, odmah obavijestite svoga liječnika.
English: All except one patient in each arm were diagnosed with CHF more than 30 days after the treatment period.
Croatian: Svim bolesnicima, osim po jednom bolesniku u svakoj skupini, CHF je bio dijagnosticiran nakon više od 30 dana od vremena liječenja.
English: Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Croatian: Farmakokinetički parametri određeni prema modelu bili su vrlo blizu onima iz ispitivanja faze I.
English: Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
Croatian: Retencija tekućine nije bila udružena s akutnim epizodama oligurije ili hipotenzije.
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Croatian: Tijekom liječenja, muškarci i žene moraju primjenjivati kontracepcijska sredstva, a muškarci i još najmanje 6 mjeseci nakon prekida liječenja (vidjeti dio 4.6).
English: Although majority of cases occurred during the first or second cycle of docetaxel containing regimen, enterocolitis could develop at any time, and could lead to death as early as on the first day of onset.
Croatian: Iako se većina slučajeva dogodila tijekom prvog ili drugog ciklusa liječenja koji sadrži docetaksel, enterokolitis se može razviti bilo kada i može dovesti do smrti već prilikom prvog dana pojave.
English: Pain intensity score improved during treatment in both groups indicating adequate pain management.
Croatian: Stupanj intenziteta boli poboljšao se tijekom liječenja u obje skupine što upućuje na primjereni način liječenja boli.
English: The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Croatian: Ciklus liječenja trajao je 3 tjedna za TCF skupinu i 4 tjedna za CF skupinu.
English: Such information will allow her/him to decide whether a dose reduction is needed.
Croatian: Na osnovu tih informacija liječnik će odlučiti je li potrebno smanjiti dozu.
English: If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti koristiti bilo kakve alate ili strojeve prije savjetovanja s Vašim liječnikom, medicinskom sestrom ili bolničkim ljekarnikom.
English: • alteration in sense of taste
Croatian: • promjene osjeta okusa
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22nd May 2012
Croatian: Datum prvog odobrenja: 22. svibnja 2012.
English: It is important that you read the entire contents of this guide prior to the preparation of the DOCETAXEL KABI infusion solution.
Croatian: Važno je pročitati cijeli sadržaj ove upute prije pripreme DOCETAXEL KABI infuzijske otopine.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because DOCETAXEL KABI may be harmful for the unborn baby.
Croatian: Ne smijete zatrudnjeti tijekom liječenja ovim lijekom i morate provoditi učinkovite mjere kontracepcije tijekom liječenja, jer DOCETAXEL KABI može štetno djelovati na nerođeno dijete.
English: The estimated hazard ratio was using Cox proportional hazard model with treatment group as the factor.
Croatian: Omjer hazarda procijenjen je po Cox modelu proporcionalnog rizika s liječenom skupinom kao faktorom.
English: Each box contains one vial.
Croatian: Jedna kutija sadržava jednu bočicu.
English: If you had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which may be more severe.
Croatian: Ako ste imali alergijsku reakciju na paklitaksel, možete također doživjeti alergijsku reakciju na docetaksel, koja može biti teža.
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Croatian: Ovo je također bilo statistički značajno s HR od 0,71; 95% CI 0,56-0,90; log-rang test p=0,004.
English: Median survival (months)
Croatian: Medijan preživljenja (mjeseci)
English: If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
Croatian: Ako se pojave novi ili pogoršaju postojeći plućni simptomi, bolesnike treba pažljivo nadzirati, odmah provesti pretrage i odgovarajuće liječiti.
English: Docetaxel is highly protein bound (> 95%).
Croatian: Docetaksel se izrazito veže za proteine (> 95%).
English: In cases of overdose, exacerbation of adverse events may be expected.
Croatian: U slučajevima predoziranja može se očekivati egzacerbacija štetnih događaja.
English: During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Croatian: Tijekom radioterapije, karboplatin (AUC 1,5) se davao tjedno kao jednosatna intravenska infuzija u maksimalno 7 doza.
English: The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Croatian: Procjena djelotvornosti i sigurnosti primjene isključivo se odnosila na preživljenje kao ishod, dok se na uspješnost očuvanja organa nije formalno odnosila.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Croatian: Općenito, kvaliteta života (QoL) i rezultati kliničke koristi dosljedno su pokazali poboljšanje u korist TCF skupine.
English: Women of childbearing potential/ Contraception in males and females
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena
English: If crystals appear, the solution must no longer be used and shall be discarded.
Croatian: Ako se kristali pojave, otopina se više ne smije koristiti te ju treba baciti.
English: Cisplatin and 5-fluorouracil
Croatian: Cisplatin i 5-fluorouracil
English: Cases of electrolyte imbalance have been reported.
Croatian: Prijavljeni su slučajevi neravnoteže elektrolita.
English: This may be moderate to severe and has been associated with death (see section 4.8).
Croatian: Ono može biti umjereno do teško, a bilo je povezano sa smrtnim ishodom (vidjeti dio 4.8.).
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Croatian: Kao rezultat navedenog, potreban je oprez pri istodobnom liječenju bolesnika tim lijekovima zbog mogućnosti značajne interakcije.
English: A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Croatian: Populacijska farmakokinetička analiza docetaksela provedena je na 577 bolesnika.
English: • swelling caused by faulty lymphatic drainage
Croatian: • oticanje uzrokovano lošom limfnom drenažom
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Croatian: Studijska populacija uključivala je bolesnike s tehnički neoperabilnom bolešću, bolesnike s malom vjerojatnošću kirurškog izlječenja i bolesnike kod kojih se težilo očuvanju organa.
English: Pharmacotherapeutic group: antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD02
Croatian: Farmakoterapijska skupina: antineoplastici, biljni alkaloidi i drugi biljni pripravci, taksani, ATK oznaka: L01CD02.
English: Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Croatian: Kirurška resekcija je dopuštena nakon kemoterapije, prije ili nakon radioterapije.
English: Early use of supportive care measures may help improve the condition.
Croatian: Rano uvođenje mjera suportivne skrbi može pridonijeti poboljšanju bolesnikova stanja.
English: The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Croatian: Primarna analiza napravljena je nakon što su svi bolesnici imali period praćenja duži od 5 godina (medijan vremena praćenja od 77 mjeseci).
English: Grade 2
Croatian: Gradus 2
English: FAC Hazard ratio (TAC/FAC)
Croatian: Omjer hazarda (TAC/FAC)
English: The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Croatian: Sveukupni terapijski odgovor bio je 6,8% u ocijenjenih bolesnika, a medijan trajanja terapijskog odgovora bio je 26,1 tjedan.
English: The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Croatian: Sekundarni ishod ispitivanja, PFS, pokazao je 29% smanjenje rizika od progresije ili smrti i 22 mjeseca poboljšanja u medijanu PFS (35,5 mjeseci za TPF i 13,1 za PF).
English: Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications.
Croatian: Preporuča se oprez u bolesnika s neutropenijom, posebno u onih koji su pod rizikom od razvoja gastrointestinalnih komplikacija.
English: The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Croatian: Ljestvica izvedbenog statusa, odnosno pomoćne ljestvice za glavu i vrat (PSS-HN), koja mjeri razumijevanje govora, sposobnost uzimanja jela u javnosti i normalnost ishrane, bile su značajno u korist TPF u odnosu na PF.
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)
English: Gastrointestinal reactions
Croatian: Gastrointestinalne reakcije
English: Treatment is repeated every three weeks.
Croatian: Liječenje se ponavlja svaka 3 tjedna.
English: A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Croatian: Dopunjena analiza preživljenja provedena s medijanom vremena praćenja od 41,6 mjeseci nije više pokazala statistički značajnu razliku, iako je ta razlika uvijek bila u korist TCF skupine te je pokazala da se korist TCF u usporedbi s CF jasno opaža između 18 i 30 mjeseci praćenja.
English: If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Croatian: Ako se u bolesnika pri primjeni doze od 60 mg/m2 i dalje javljaju ove reakcije, liječenje treba prekinuti.
English: • blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Croatian: • zamagljen vid zbog oticanja mrežnice unutar oka (cistični edem makule)
English: Recommendations for the safe handling
Croatian: Preporuke za sigurno rukovanje
English: If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Croatian: Ako se pojave ili pogoršaju tegobe s plućima (vrućica, nedostatak zraka ili kašalj), odmah o tome obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: Mitoxantrone every 3 weeks
Croatian: Mitoksantron svaka 3 tjedna
English: The concentrate is a clear, colourless to pale yellow solution.
Croatian: Koncentrat je bistra, bezbojna do blijedo žuta otopina.
English: A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Croatian: Ukupna doza od 70 Gy preporučena je za akcelerirane protokole zračenja i 74 Gy za hiperfrakcionirane protokole.
English: Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Croatian: Ograničeni podaci iz jedine nekontrolirane studije upućivali su na interakciju između docetaksela i karboplatina.
English: Second primary malignancies
Croatian: Druge primarne zloćudne bolesti
English: DOCETAXEL KABI will be given by infusion into one of your veins (intravenous use).
Croatian: DOCETAXEL KABI ćete dobiti infuzijom u jednu od vena (intravenska primjena).
English: One primary analysis and one updated analysis were performed.
Croatian: Provedene su jedna primarna i jedna dopunska analiza.
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Croatian: Bolesnici koji su primali docetaksel svaka tri tjedna pokazali su značajno dulje ukupno preživljenje u odnosu na bolesnike liječene mitoksantronom.
English: The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Croatian: Kasna je faza djelomično rezultat relativno sporog izlaska docetaksela iz perifernog odjeljka.
English: Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Croatian: Zabilježeni su vrlo rijetki slučajevi hepatitisa, ponekad fatalnog, prvenstveno u bolesnika s već postojećim poremećajima jetre.
English: After opening of the vial
Croatian: Nakon otvaranja bočice
English: Quality of life parameters
Croatian: Pokazatelji kvalitete života