FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to lack of steady-state data, control of warfarin pharmacodynamic markers (INR or PT) following initiation of nilotinib therapy (at least during the first 2 weeks) is recommended.
Croatian: Zbog nedostatka podataka u stanju dinamičke ravnoteže, preporučuje se nadzor farmakodinamičkih parametara varfarina (INR ili PV) nakon početka terapije nilotinibom (najmanje tijekom prva 2 tjedna).
English: dihydroergotamine).
Croatian: dihidroergotamin).
English: Most responders achieved their MCyR rapidly within 3 months (median 2.8 months) of starting nilotinib treatment and these were sustained.
Croatian: Većina bolesnika u kojih je postignut odgovor dosegli su svoj MCyR brzo unutar 3 mjeseca (medijan 2,8 mjeseca) nakon početka liječenja nilotinibom i to se zadržalo.
English: The bioavailability of nilotinib is increased by food.
Croatian: Bioraspoloživost nilotiniba povećava se uzimanjem hrane.
English: If transient interruption of treatment is not possible, close monitoring of the individual for prolongation of the QT interval is indicated (see sections 4.2, 4.5 and 5.2).
Croatian: Ako se ne može privremeno prekinuti liječenje, potrebno je pažljivo pratiti svakog pojedinog bolesnika zbog mogućeg produženja QT intervala (vidjeti dijelove 4.2, 4.5 i 5.2).
English: Nilotinib absorption following oral administration was approximately 30%.
Croatian: Apsorpcija nilotiniba nakon peroralne primjene je približno 30%.
English: - Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the last dose.
Croatian: - Dojenje se ne preporučuje tijekom liječenja Tasignom i tijekom dva tjedna nakon posljednje doze.
English: In a pre- and postnatal development study in rats, maternal exposure to nilotinib caused reduced pup body weight with associated changes in physical development parameters as well as reduced mating and fertility indices in the offspring.
Croatian: U pre- i postnatalnim ispitivanjima u štakora, izloženost majke nilotinibu uzrokovala je sniženje tjelesne težine mladunčadi povezane s promjenama u parametrima fizičkog razvoja, kao i smanjeno parenje i plodnost potomaka.
English: There is no experience with treatment of paediatric patients below 2 years of age.
Croatian: Nema iskustva s liječenjem pedijatrijskih bolesnika mlađih od 2 godine.
English: It is therefore crucial to perform frequent monitoring of BCR-ABL transcript levels and complete blood count with differential in order to detect possible loss of remission (see section 4.2).
Croatian: Stoga je presudno obavljati učestalo praćenje razina BCR-ABL transkripcija i kompletne krvne slike s diferencijalnom krvnom slikom kako bi se otkrio mogući gubitak remisije (vidjeti dio 4.2).
English: Imatinib intolerance included patients who discontinued imatinib because of toxicity and were not in major cytogenetic response at time of study entry.
Croatian: Intolerancija na imatinib obuhvaćala je bolesnike koji su prestali uzimati imatinib zbog toksičnosti te koji nisu postigli veliki citogenetski odgovor u vrijeme ulaska u ispitivanje.
English: The primary endpoint was the percentage of patients in MMR at 48 weeks after starting the TFR phase (considering any patient who required re-initiation of treatment as non-responder).
Croatian: Mjera primarnog ishoda bila je postotak bolesnika s MMR-om u 48. tjednu nakon početka TFR faze (pri čemu se svaki bolesnik kojem je bilo potrebno ponovno započinjanje liječenja smatrao bolesnikom bez odgovora).
English: No major differences were observed for safety and efficacy in patients ≥65 years of age as compared to adults aged 18 to 65 years.
Croatian: Sigurnost i djelotvornost u bolesnika u dobi od ≥65 godina u usporedbi s odraslima u dobi od 18 do 65 godina nije se značajno razlikovala.
English: It may be given with hydroxyurea or anagrelide if clinically indicated.
Croatian: Može se primijeniti s hidroksiurejom ili anagrelidom ako je klinički indicirano.
English: If a HMG-CoA reductase inhibitor (a lipid-lowering agent) is required, please refer to section 4.5 before initiating treatment since certain HMG-CoA reductase inhibitors are also metabolised by the CYP3A4 pathway.
Croatian: Ako je potreban inhibitor HMG-CoA reduktaze (lijek za snižavanje lipida), vidjeti dio 4.5 prije početka liječenja budući da se određeni inhibitori HMG-CoA reduktaze također metaboliziraju putem CYP3A4.
English: MMR rates by different time points (including patients who achieved MMR at or before those time points as responders) are presented in the cumulative incidence of MMR (see Figure 1).
Croatian: Stope MMR-a prema različitim vremenskim točkama (uključujući bolesnike koji su postigli MMR u vrijeme ili prije spomenutih vremenskih točaka kao osobe s odgovorom) prikazane su u kumulativnoj incidenciji MMR-a (vidjeti Sliku 1).
English: Forty-eight of these 51 patients (94.1%) regained MR4.0 and 47 patients (92.2%) regained MR4.5 by the time of the cut-off date.
Croatian: Četrdeset osam od tih 51 bolesnika (94,1%) ponovo je postiglo MR4,0, a 47 bolesnika (92,2%) ponovo je postiglo MR4,5 do isključnog datuma.
English: The primary endpoint was the proportion of patients without confirmed loss of MR4.0 or loss of MMR within 48 weeks following treatment discontinuation.
Croatian: Mjera primarnog ishoda bila je udio bolesnika bez potvrđenog gubitka MR4,0 ili gubitka MMR-a unutar 48 tjedana nakon prekida liječenja.
English: Patients must have typical BCR-ABL transcripts to allow quantitation of BCR-ABL, evaluation of the depth of molecular response, and determination of a possible loss of molecular remission after discontinuation of treatment with nilotinib.
Croatian: Bolesnici moraju imati tipične BCR-ABL transkripcije kako bi bila moguća kvantifikacija BCR-ABL, ocjenjivanje dubine molekularnog odgovora i utvrđivanje mogućeg gubitka molekularne remisije nakon prekida liječenja nilotinibom.
English: Nilotinib has little or no effect against the majority of other protein kinases examined, including Src, except for the PDGF, KIT and Ephrin receptor kinases, which it inhibits at concentrations within the range achieved following oral administration at therapeutic doses recommended for the treatment of CML (see Table 6).
Croatian: Nilotinib ima mali ili nikakav učinak na većinu ispitivanih protein kinaza, uključujući Src, osim na PDGF, Kit i Ephrin receptor kinaze, koje inhibira u koncentracijama unutar raspona koji se postiže nakon peroralne primjene terapijskih doza preporučenih za liječenje KML-a (vidjeti Tablicu 6).
English: Nilotinib absorption (relative bioavailability) might be reduced by approximately 48% and 22% in patients with total gastrectomy and partial gastrectomy, respectively.
Croatian: Apsorpcija nilotiniba (relativna bioraspoloživost) mogla je biti snižena za otprilike 48% u bolesnika s potpunom gastrektomijom i 22% u bolesnika s djelomičnom gastrektomijom.
English: If you are told to discontinue Tasigna, your doctor will continue to carefully monitor your CML before, during and after you have discontinued Tasigna and may tell you to re-start Tasigna if your condition indicates that this is necessary.
Croatian: Ako Vam kaže da prestanete uzimati Tasignu, liječnik će nastaviti pažljivo pratiti Vaš KML prije, za vrijeme i nakon što prestanete uzimati Tasignu i može Vam reći da ponovo počnete uzimati Tasignu ako Vaše stanje bude ukazivalo da je to potrebno.
English: Besides standard study parameters, evaluations of developmental landmarks, CNS effects, mating and fertility were performed.
Croatian: Uz standardne parametre ispitivanja, napravljene su procjene razvojnih oznaka, učinaka na središnji živčani sustav, parenje i plodnost.
English: No episodes of torsade de pointes were observed in clinical studies.
Croatian: Nisu zapažene epizode torsade de pointes u kliničkim ispitivanjima.
English: Total gastrectomy
Croatian: Potpuna gastrektomija
English: Hyperbilirubinaemia (including blood bilirubin increased)
Croatian: Hiperbilirubinemija (uključujući povišenje bilirubina u krvi)
English: Due to possible occurrence of tumour lysis syndrome (TLS) correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiating nilotinib therapy (see section 4.8).
Croatian: Zbog mogućeg nastanka sindroma lize tumora preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline prije početka liječenja nilotinibom (vidjeti dio 4.8).
English: Steady-state conditions were essentially achieved by day 8.
Croatian: Stanje dinamičke ravnoteže je u biti postignuto do 8. dana.
English: Clinical studies have not been performed in patients with impaired renal function.
Croatian: Nisu provedena klinička ispitivanja u bolesnika s oštećenom funkcijom bubrega.
English: The long-term effects of prolonged treatment with nilotinib in paediatric patients are unknown.
Croatian: Dugoročni učinci produljenog liječenja nilotinibom u pedijatrijskih bolesnika nisu poznati.
English: If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive or use any tools or machines after taking this medicine, you should refrain from these activities until the effect has disappeared.
Croatian: U slučaju da ste nakon uzimanja ovog lijeka imali nuspojave (kao što su omaglica ili poremećaj vida) koje mogu utjecati na sposobnost sigurnog upravljanja vozilima ili strojevima ili korištenja nekog alata, trebate se suzdržati od tih aktivnosti dok taj utjecaj ne nestane.
English: Should treatment with any of these agents be required, it is recommended that nilotinib therapy be interrupted if possible (see section 4.5).
Croatian: Ako je potrebno liječenje bilo kojim od ovih lijekova, preporučuje se prekinuti primjenu nilotiniba ako je moguće (vidjeti dio 4.5).
English: Serious cardiovascular events including problems with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been reported in patients taking Tasigna.
Croatian: Ozbiljni srčanožilni događaji, uključujući probleme s dotokom krvi u nogu (okluzivna bolest periferne arterije), ishemijsku bolest srca i probleme s dotokom krvi u mozak (ishemijska cerebrovaskularna bolest), zabilježeni su u bolesnika koji su uzimali Tasignu.
English: Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong the QT interval, and/or food (see section 4.5).
Croatian: Značajno produženje QT intervala može se pojaviti ako se nilotinib primjenjuje na neodgovarajući način zajedno sa snažnim CYP3A4 inhibitorima i/ili lijekovima za koje se zna da produžuju QT interval i/ili s hranom (vidjeti dio 4.5).
English: Nilotinib may be used concurrently with esomeprazole or other proton pump inhibitors as needed.
Croatian: Nilotinib se može istodobno koristiti s esomeprazolom ili drugim inhibitorima protonske pumpe ako je potrebno.
English: For all Sokal risk groups, the MMR rates at all time points remained consistently higher in the two nilotinib groups than in the imatinib group.
Croatian: Za sve rizične skupine prema Sokalu, stope MMR-a u svim su vremenskim točkama ostale dosljedno više u dvjema skupinama koje su primale nilotinib nego u skupini koja je primala imatinib.
English: Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Croatian: Produženje QT intervala može povećati rizik od smrtnog ishoda.
English: Therefore, absorption and subsequent elimination of systemically absorbed nilotinib may be influenced by substances that affect CYP3A4 and/or P-gp.
Croatian: Radi toga, na apsorpciju i posljedičnu eliminaciju sistemski apsorbiranog nilotiniba mogu utjecati tvari koje djeluju na CYP3A4 i/ili P-gp.
English: The safety and efficacy of nilotinib in paediatric patients with Ph+ CML in chronic phase have been investigated in two studies.
Croatian: Sigurnost i djelotvornost nilotiniba u pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi istraživane su u dva ispitivanja.
English: The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established (see sections 4.8, 5.1 and 5.2).
Croatian: Ustanovljene su sigurnost i djelotvornost Tasigne u pedijatrijskih bolesnika s KML-om s pozitivnim Philadelphia kromosomom u kroničnoj fazi u dobi od 2 do manje od 18 godina (vidjeti dijelove 4.8, 5.1 i 5.2).
English: Biochemical adverse drug reactions include alanine aminotransferase increased (24%), hyperbilirubinaemia (16%), aspartate aminotransferase increased (12%), lipase increased (11%), blood bilirubin increased (10%), hyperglycaemia (4%), hypercholesterolaemia (3%) and hypertriglyceridaemia (<1%).
Croatian: Biokemijske nuspojave na lijek uključuju povišenje alanin aminotransferaze (24%), hiperbilirubinemiju (16%), povišenje aspartat aminotransferaze (12%), povišenje lipaze (11%), povišenje bilirubina u krvi (10%), hiperglikemiju (4%), hiperkolesterolemiju (3%) i hipertigliceridemiju (<1%).
English: Serum lipase levels should be tested monthly or as clinically indicated (see section 4.4).
Croatian: Razine serumske lipaze treba mjeriti jednom mjesečno ili kad je klinički indicirano (vidjeti dio 4.4).
English: Laboratory abnormalities of mild to moderate transient elevations of aminotransferases and total bilirubin have been observed in children at a higher frequency than in adults, indicating a higher risk of hepatotoxicity in the paediatric population (see section 4.8).
Croatian: Laboratorijske abnormalnosti blagih do umjerenih prolaznih povećanja vrijednosti aminotransferaza i ukupnog bilirubina opažene su u djece s većom učestalošću nego u odraslih, ukazujući na povišeni rizik hepatotoksičnosti u pedijatrijskoj populaciji (vidjeti dio 4.8).
English: In vitro cardiac safety studies demonstrated a preclinical signal for QT prolongation, based upon block of hERG currents and prolongation of the action potential duration in isolated rabbit hearts by nilotinib.
Croatian: In vitro ispitivanja sigurnosti srčanih parametara pokazala su pretklinički signal za produženje QT intervala, temeljeno na blokiranju hERG protoka i produženju trajanja akcijskog potencijala u izoliranim zečjim srcima pod djelovanjem nilotiniba.
English: Pleural and pericardial effusions as well as complications of fluid retention occurred in <1% of patients receiving Tasigna.
Croatian: Pleuralni i perikardijalni izljevi, kao i komplikacije vezane uz retenciju tekućine pojavile su se u <1% bolesnika liječenih Tasignom.
English: Among the 53 patients who discontinued the TFR phase due to confirmed loss of MR4.0 or loss of MMR, 51 patients restarted nilotinib and 2 patients discontinued the study.
Croatian: Od 53 bolesnika koji su prekinuli TFR fazu zbog potvrđenog gubitka MR4,0 ili gubitka MMR-a, 51 bolesnik ponovo je započeo terapiju nilotinibom, a 2 bolesnika prekinula su ispitivanje.
English: Concomitant administration of nilotinib with imatinib (a substrate and moderator of P-gp and CYP3A4), had a slight inhibitory effect on CYP3A4 and/or P-gp.
Croatian: Istodobna primjena nilotiniba s imatinibom (supstrat i moderator P-gp i CYP3A4) imala je blagi inhibitorni učinak na CYP3A4 i/ili P-gp.
English: - taking anti-arrhythmic medicinal products or other substances that lead to QT prolongation.
Croatian: - koji uzimaju antiaritmike ili druge tvari koje dovode do produženja QT intervala.
English: Accelerated phase (n=137)*
Croatian: Ubrzana faza (n=137)*
English: What Tasigna is Tasigna is a medicine containing an active substance called nilotinib.
Croatian: Što je Tasigna Tasigna je lijek koji sadrži djelatnu tvar zvanu nilotinib.
English: If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.
Croatian: U tom slučaju, možete istresti sadržaj svake tvrde kapsule u jednu čajnu žličicu kaše od jabuke i odmah ju uzeti.
English: Eighty-eight patients (46.3%) discontinued the TFR phase due to loss of MMR, and 1 (0.5%), 1 (0.5%), and 3 patients (1.6%) due to death from unknown cause, physician decision and subject decision, respectively.
Croatian: Osamdeset osam bolesnika (46,3%) prekinulo je TFR fazu zbog gubitka MMR-a, 1 (0,5%) zbog smrti od nepoznatog uzroka, 1 (0,5%) zbog liječničke odluke i 3 bolesnika (1,6%) zbog ispitanikove odluke.
English: Haematological Response (%) Overall (95%CI) Complete NEL
Croatian: Hematološki odgovor (%) Ukupno (95%CI) Kompletan NEL
English: The dose was 400 mg twice daily and dose escalation to 600 mg twice daily was allowed.
Croatian: Doza je iznosila 400 mg dva puta na dan i povećanje doze do 600 mg dva puta na dan je bilo dozvoljeno.
English: BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation (see sections 4.2 and 5.1).
Croatian: Razine BCR-ABL transkripcija moraju se ocijeniti prije i za vrijeme prekida liječenja (vidjeti dijelove 4.2 i 5.1).
English: Patients with a CHR at baseline achieved a MCyR faster (1.9 versus 2.8 months).
Croatian: Bolesnici s CHR-om na početku su brže postigli MCyR (1,9 u odnosu na 2,8 mjeseci).
English: However, percentages with one decimal precision are used to identify terms with a frequency of at least 5% and to classify terms according to frequency categories.
Croatian: Međutim, postotci s točnošću od jedne decimale koriste se za navođenje nuspojava s učestalošću od najmanje 5% te za klasifikaciju nuspojava prema kategorijama učestalosti.
English: There is no experience with the use of Tasigna in newly diagnosed children below 10 years of age and limited experience in patients below 6 years of age who are no longer benefiting from previous treatment for CML.
Croatian: Nema iskustva s primjenom Tasigne u novodijagnosticirane djece mlađe od 10 godina, a iskustvo je ograničeno u bolesnika mlađih od 6 godina kojima više ne pomaže prethodna terapija za KML.
English: If you are told to discontinue this medicine, your doctor will continue to monitor your CML and may tell you to re-start Tasigna if your condition indicates that this is necessary.
Croatian: Ako Vam kaže da prestanete uzimati ovaj lijek, liječnik će nastaviti pratiti Vaš KML i može Vam reći da ponovo počnete uzimati Tasignu ako Vaše stanje bude ukazivalo da je to potrebno.
English: Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Croatian: Kompletni hematološki odgovor (CHR - engl. complete hematological response) u bolesnika u kroničnoj fazi procjenjivao se kao sekundarni ishod.
English: Figure 1 Cumulative incidence of MMR
Croatian: Slika 1 Kumulativna incidencija MMR-a
English: The predicted steady-state Cmax of nilotinib showed an increase of 29%, 18% and 22%, respectively.
Croatian: Predviđeni Cmax nilotiniba u stanju dinamičke ravnoteže pokazao je povećanje od 29%, 18%, odnosno 22%.
English: The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to <35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
Croatian: Primarni ishod u bolesnika u kroničnoj fazi bio je veliki citogenetski odgovor (MCyR), definiran kao eliminacija (CCyR, kompletni citogenetski odgovor) ili značajno smanjenje na <35% Ph+ metafaza (djelomični citogenetski odgovor) Ph+ hematopoetskih stanica.
English: Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone and moxifloxacin (see section 4.4).
Croatian: Nilotinib se treba oprezno primjenjivati u bolesnika koji imaju ili mogu razviti produženi QT interval, uključujući one bolesnike koji uzimaju antiaritmike, kao što su amiodaron, dizopiramid, prokainamid, kinidin i sotalol ili ostale lijekove koji mogu dovesti do produženja QT intervala, kao što su klorokin, halofantrin, klaritromicin, haloperidol, metadon i moksifloksacin (vidjeti dio 4.4).
English: The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
Croatian: Primarni ishod u bolesnika u ubrzanoj fazi bio je cjelokupni potvrđeni hematološki odgovor (HR - engl. hematological response), definiran bilo kao kompletan hematološki odgovor, nemogućnost dokazivanja leukemije ili kao povratak u kroničnu fazu.
English: There are no or limited amount of data from the use of nilotinib in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni nilotiniba u trudnica ograničeni.
English: Among newly diagnosed patients, the percentage of patients who achieved MR4.0 was 32%, while 28.0% achieved MR4.5.
Croatian: Među novodijagnosticiranim bolesnicima, postotak bolesnika koji su postigli MR4,0 bio je 32%, dok ih je 28,0% postiglo MR4,5.
English: What Tasigna contains - The active substance is nilotinib.
Croatian: Što Tasigna sadrži - Djelatna tvar je nilotinib.
English: Appropriate therapy should be prescribed to manage cardiovascular risk factors (see section 4.2 for instructions on managing non-haematological toxicities).
Croatian: Za zbrinjavanje čimbenika kardiovaskularnog rizika treba propisati odgovarajuću terapiju (vidjeti dio 4.2 za upute o zbrinjavanju nehematoloških toksičnosti).
English: There is no experience in paediatric patients below 2 years of age or in paediatric patients with Philadelphia chromosome positive CML in accelerated phase or blast crisis.
Croatian: Nema iskustva u pedijatrijskih bolesnika mlađih od 2 godine ili u pedijatrijskih bolesnika s KML-om s pozitivnim Philadelphia kromosomom u ubrzanoj fazi ili blastičnoj krizi.
English: In healthy subjects receiving esomeprazole at 40 mg once daily for 5 days, gastric pH was markedly increased, but nilotinib absorption was only decreased modestly (27% decrease in Cmax and 34% decrease in AUC0-∞).
Croatian: U zdravih ispitanika koji su primali esomeprazol u dozi od 40 mg jedanput na dan tijekom 5 dana, želučani pH je bio značajno povećan, ali je apsorpcija nilotiniba bila umjereno snižena (27% sniženje u Cmax i 34% sniženje AUC0-∞).
English: Nilotinib has pH dependent solubility, with lower solubility at higher pH.
Croatian: Topljivost nilotiniba ovisna je o pH, uz nižu topljivost pri višem pH.
English: Figure 5 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Croatian: Slika 5 Kaplan-Meierova procjena preživljenja bez liječenja nakon početka TFR-a (potpuni skup podataka za analizu)
English: The hard capsules should be swallowed whole with water.
Croatian: Tvrde kapsule se trebaju uzimati s vodom i progutati cijele.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tasigna: - if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina), problems with the blood supply to your brain (stroke) or problems with the blood flow to your leg (claudication) or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid disorders).
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Tasignu: - ako ste ranije imali srčanožilne događaje, kao što su srčani udar, bol u prsnom košu (angina), problemi s dotokom krvi u mozak (moždani udar) ili problemi s dotokom krvi u nogu (klaudikacija), ili ako imate rizične čimbenike za srčanožilne bolesti kao što su visoki krvni tlak (hipertenzija), šećerna bolest ili problemi s razinom masnoća u krvi (poremećaji lipida).