FrancophonIA/ELRC3.0 huggingface dataset:
English: Fluid retention adverse reactions were typically managed by supportive care measures that include diuretics and short courses of steroids (see sections 4.2 and 4.8).
Croatian: Nuspojave zadržavanja tekućine uglavnom su bilezbrinute uvođenjem potpornih mjera koje su uključivale primjenu diuretika i kratkotrajnu primjenu steroida (vidjeti dijelove 4.2 i 4.8).
English: In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Croatian: U pivotalnom je ispitivanju sudjelovalo 106 pedijatrijskih bolesnika koji su primali SPRYCEL u kombinaciji s kemoterapijom prema režimu kontinuirane primjene.
English: SPRYCEL 10 mg/mL powder for oral suspension
Croatian: SPRYCEL 10 mg/ml prašak za oralnu suspenziju
English: Contains 0.29 g of sucrose per mL of oral suspension.
Croatian: Sadrži 0,29 g saharoze po ml oralne suspenzije.
English: One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Croatian: Jedna plastična boca od 120 ml (sa zatvaračem sigurnim za djecu) sadrž 33 g praška za oralnu suspenziju.
English: After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Croatian: Nakon najmanje 60 mjeseci praćenja kumulativna stopa trajnog prekida liječenja zbog mijelosupresije 3. ili 4. stupnja bila je 2,3%.
English: Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Croatian: Nositelje virusa HBV kojima je potrebno liječenje SPRYCELOM, potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
English: h Frequency reported as common in paediatric studies.
Croatian: h Prijavljeno često u pedijatrijskim ispitivanjima.
English: Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Croatian: Ph+ akutne limfoblastične leukemije (ALL) i limfoidne blastične KML uz nepodnošenje ili otpornost na prethodnu terapiju.
English: The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Croatian: Stopa značajnog molekularnog odgovora (definiranog kao BCR-ABL/kontrolni transkripti ≤0,1% po RQ-PCR u uzorcima periferne krvi) prije prelaska u drugu terapijsku skupinu iznosila je 29% za dasatinib i 12% za imatinib.
English: Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Croatian: Vrlo često infekcije (uključujući bakterijske, virusne, gljivične, nespecificirane)
English: Following resolution of a subsequent episode, dasatinib at one dose level reduction should be reintroduced.
Croatian: Nakon povlačenja naredne epizode, treba ponovno uvesti dasatinib u dozi nižoj za jednu razinu.
English: SPRYCEL will only be prescribed to you by a doctor with experience in treating leukaemia.
Croatian: SPRYCEL će Vam propisati samo liječnik s iskustvom u liječenju leukemije.
English: But if they do, persons other than the patient should use gloves when handling SPRYCEL.
Croatian: Ali ako jesu, osobe koje dolaze u kontakt s tabletama, a nisu bolesnici moraju koristiti rukavice za jednokratnu uporabu.
English: Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Croatian: Dasatinib nije pokazao mutageno djelovanje na bakterijske kulture in vitro (Ames test) niti je imao genotoksične učinke u in vivo provedenom mikronukleusnom testu u štakora.
English: In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
Croatian: U štakora je dasatinib inhibirao agregaciju trombocita in vitro i produžio krvarenje iz kutikule in vivo, ali nije izazivao spontana krvarenja.
English: Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Croatian: U bolesnika koji razviju simptome koji upućuju na pleuralni izljev, kao što su dispneja ili suhi kašalj, mora se napraviti rendgensku snimku pluća.
English: After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Croatian: Nakon najmanje 60 mjeseci praćenja, kumulativna stopa pojave neutropenije bila je 29%, trombocitopenije 22% i anemije 13%.
English: Two-level dose reduction
Croatian: Smanjenje doze za dvije razine
English: SPRYCEL 10 mg/mL powder for oral suspension dasatinib
Croatian: SPRYCEL 10 mg/ml prašak za oralnu suspenziju dasatinib
English: Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Croatian: Rijetko hipertireoza, tireoiditis Poremećaji metabolizma i prehrane
English: The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Croatian: Medijan vremena do nastupa prvog pleuralnog izljeva ≥ 3. stupnja uzrokovanog primjenom dasatiniba iznosio je 175 tjedana (raspon: 114-274 tjedna).
English: • 12-mL oral syringe provided with the bottle.
Croatian: • štrcaljku za usta volumena 12 ml koja dolazi s bocom
English: No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Croatian: Nisu provedena klinička ispitivanja SPRYCELA u bolesnika sa smanjenom funkcijom bubrega (ispitivanje u bolesnika s novodijagnosticiranom KML u kroničnoj fazi isključilo je bolesnike s koncentracijom kreatinina u serumu koja je bila >3 puta veća od gornje granice normalnog raspona, a ispitivanja u bolesnika s KML u kroničnoj fazi koji ne podnose ili su otporni na prethodnu terapiju imatinibom isključila su bolesnike s koncentracijom kreatinina u serumu koja je bila >1,5 puta veća od gornje granice normalnog raspona).
English: 56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
Croatian: 56 filmom obloženih tableta 60 x 1 filmom obložena tableta 60 filmom obloženih tableta
English: b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death.
Croatian: b Progresija se definirala povećanjem broja leukocita, gubitkom potpunog hematološkog odgovora ili MCyR, povećanjem Ph+ metafaza od ≥30%, potvrđenom AP/BP bolešću ili smrću.
English: PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib treatment (see section 4.8).
Croatian: Prijavljen je PAH (prekapilarna plućna arterijska hipertenzija potvrđena kateterizacijom desne strane srca) povezan s liječenjem dasatinibom (vidjeti dio 4.8).
English: Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Croatian: Pomoćne tvari: sadrži saharozu, natrij, natrijev benzoat, benzoatnu kiselinu, benzilni alkohol i sumporov dioksid (E220).
English: The starting dose was 70 mg dasatinib twice daily.
Croatian: Početna doza dasatiniba iznosila je 70 mg dvaput dnevno.
English: There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.
Croatian: Bila su 33 pedijatrijska bolesnika s novodijagnosticiranim KML u kroničnoj fazi koja su primala SPRYCEL prašak za oralnu suspenziju u dozi od 72 mg/m2.
English: The concomitant use of strong CYP3A4 inhibitors and grapefruit juice with SPRYCEL should be avoided (see section 4.5).
Croatian: Potrebno je izbjegavati istodobnu primjenu snažnih inhibitora CYP3A4 i uzimanje soka od grejpa zajedno s lijekom SPRYCEL (vidjeti dio 4.5).
English: Constituted oral suspension mixed with milk, yogurt, apple juice, or applesauce may be stored at or below 25°C for up to 1 hour.
Croatian: Rekonstituirana oralna suspenzija pomiješana s mlijekom, jogurtom ili bistim/gustim sokom od jabuke može se čuvati na temperaturi od 25°C ili nižoj tijekom najviše sat vremena.
English: Preferred term
Croatian: Preporučen naziv
English: Patients with risk factors (e.g. hypertension, hyperlipidaemia, diabetes) or a history of cardiac disease (e.g. prior percutaneous coronary intervention, documented coronary artery disease) should be monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction such as chest pain, shortness of breath, and diaphoresis.
Croatian: Bolesnici s rizičnim faktorima (npr. hipertenzija, hiperlipidemija, šećerna bolest) ili srčanom bolešću u anamnezi (npr. prethodna perkutana koronarna intervencija, potvrđena bolest koronarnih arterija) moraju se pažljivo nadzirati zbog kliničkih znakova i simptoma koji upućuju na disfunkciju srca, kao što su bol u prsištu, nedostatak zraka i dijaforeza.
English: The median changes in QTcF from baseline were 3.0 msec in dasatinib-treated patients compared to 8.2 msec in imatinib-treated patients.
Croatian: Medijan promjene QTcF u odnosu na početnu vrijednost iznosio je 3,0 msek u bolesnika liječenih dasatinibom u odnosu na 8,2 msek u bolesnika liječenih imatinibom.
English: Grade 3 or 4 gastrointestinal haemorrhage occurred in 6% of patients with advanced phase CML and generally required treatment interruptions and transfusions.
Croatian: Gastrointestinalno krvarenje 3. ili 4. stupnja nastupilo je u 6% bolesnika s KML u uznapredovaloj fazi i općenito je zahtijevalo prekid liječenja i primjenu transfuzije.
English: In animal studies, the fertility of male and female rats was not affected by treatment with dasatinib (see section 5.3).
Croatian: U ispitivanjima na životinjama liječenje dasatinibom nije utjecalo na plodnost mužjaka ni ženki štakora (vidjeti dio 5.3).
English: Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds.
Croatian: Snažno tresite zatvorenu bocu 30 sekundi da biste promiješali SPRYCEL oralnu suspenziju.
English: Diarrhoea Fluid retention Superficial oedema Pleural effusion Generalised oedema Pericardial effusion Pulmonary hypertension Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported in recommended starting dose of 100 mg once daily (n=165) population
Croatian: Zadržavanje tekućine površinski edem 18 pleuralni izljev generalizirani edem 3 perikardijalni izljev plućna hipertenzija Krvarenje gastrointestinalno krvarenje a Rezultati ispitivanja optimizacije doze faze 3 prijavljeni u populaciji liječenoj preporučenom početnom dozom od 100 mg jedanput dnevno (n=165)
English: If there are still visible clumps, continue shaking until no clumps are visible.
Croatian: Ako u boci i dalje ima vidljivih grudica, nastavite je tresti sve dok one ne nestanu.
English: After a minimum of 60 months follow-up the cumulative rate of grade 3 or 4 hypophosphataemia was 7%, grade 3 or 4 elevations of creatinine and bilirubin was 1% and grade 3 or 4 elevations of transaminases remained 1%.
Croatian: Nakon najmanje 60 mjeseci praćenja kumulativna stopa pojave hipofosfatemije 3. ili 4. stupnja bila je 7%, povišenja kreatinina 3. ili 4. stupnja bila je 1%, a povišenja transaminaza 3. ili 4. stupnja je ostala 1%.
English: Very common diarrhoea, vomiting, nausea, abdominal pain
Croatian: Vrlo često proljev, povraćanje, mučnina, bol u abdomenu
English: An international open-label, multicentre, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
Croatian: Međunarodno, otvoreno, multicentrično, randomizirano, komparativno ispitivanje faze III provedeno je u odraslih bolesnika s novodijagnosticiranom KML u kroničnoj fazi.
English: Figure 4: Landmark plot for overall survival for dasatinib by BCR-ABL level (≤ 10% or > 10%) at 3 months in a phase 3 study of newly diagnosed patients with chronic phase CML
Croatian: Grafikon ključnih vremenskih točaka za ukupno preživljenje uz primjenu dasatiniba prema razini BCR-ABL (≤ 10% ili > 10%) u 3. mjesecu u ispitivanju faze 3 provedenom u novodijagnosticiranih bolesnika s KML u kroničnoj fazi
English: Common tinnitus
Croatian: Često tinitus
English: The median time to first dasatinib-related grade 1 or 2 pleural effusion was 114 weeks (range: 4 to 299 weeks).
Croatian: Medijan vremena do nastupa prvog pleuralnog izljeva 1. ili 2. stupnja uzrokovanog primjenom dasatiniba iznosio je 114 tjedana (raspon: 4 - 299 tjedana).
English: If SPRYCEL is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt SPRYCEL until the inhibitor is discontinued.
Croatian: Ako bolesnik ne podnosi SPRYCEL nakon smanjenja doze, treba obustaviti primjenu snažnog inhibitora CYP3A4 ili privremeno prekinuti primjenu lijeka SPRYCEL do prestanka liječenja inhibitorom.
English: Among dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions and 30 (41%) had dose reductions.
Croatian: Među bolesnicima liječenima dasatinibom koji su imali pleuralni izljev uzrokovan primjenom lijeka (n=73), u njih 45 (62%) privremeno je prekinuta primjena lijeka, dok je u 30 bolesnika (41%) smanjena doza.
English: Common visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased Ear and labyrinth disorders
Croatian: Često poremećaji vida (uključujući smetnje vida, zamagljen vid i smanjena oštrina vida), suhoća oka Manje često smetnje vida, konjunktivitis, fotofobija, pojačano suzenje Poremećaji uha i labirinta
English: Dose escalation is not recommended for paediatric patients with Ph+ ALL, as SPRYCEL is administered in combination with chemotherapy in these patients.
Croatian: Postupno povećavanje doze za pedijatrijske bolesnike s Ph+ ALL se ne preporučuje jer se u tih bolesnika SPRYCEL primjenjuje u kombinaciji s kemoterapijom.
English: Total prescribed dose (mL)
Croatian: Ukupna propisana doza (ml)
English: In clinical studies in patients with advanced phase CML receiving the recommended dose of SPRYCEL (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients.
Croatian: U kliničkim ispitivanjima u bolesnika s KML u uznapredovaloj fazi koji su primali preporučenu dozu lijeka SPRYCEL (n=304), teško krvarenje u središnji živčani sustav (CNS) nastupilo je u 1% bolesnika.
English: Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Croatian: Manje često infarkt miokarda (uključujući smrtni ishod)*, elektrokardiografski vidljivo produženje QT intervala*, perikarditis, ventrikularna aritmija (uključujući ventrikularnu tahikardiju), angina pektoris, kardiomegalija, abnormalnosti T-vala na elektrokardiogramu, povišene vrijednosti troponina
English: In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Croatian: U kliničkim je ispitivanjima u odraslih bolesnika s KML i Ph+ ALL povećanje doze na 140 mg jedanput dnevno (kronična faza KML) ili 180 mg jedanput dnevno (uznapredovala faza KML ili Ph+ ALL) bilo dopušteno u bolesnika koji nisu postigli hematološki ili citogenetski odgovor na preporučenu početnu dozu.
English: Swallow the tablets whole.
Croatian: Tablete treba progutati cijele.
English: The recommended starting daily dosage of SPRYCEL tablets in paediatric patients is shown in Table 1.
Croatian: Preporučena početna dnevna doza SPRYCEL tableta u pedijatrijskih bolesnika prikazana je u Tablici
English: Unchanged dasatinib accounted for 0.1% and 19% of the dose in urine and faeces, respectively, with the remainder of the dose as metabolites.
Croatian: Neizmijenjeni dasatinib činio je 0,1% doze u mokraći i 19% doze u stolici, dok su ostatak doze činili metaboliti.
English: In this multicenter, historically-controlled Phase II study of dasatinib added to standard chemotherapy, 106 paediatric patients with newly diagnosed Ph+ ALL, of whom 104 patients had confirmed Ph+ ALL, received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to
Croatian: U tom multicentričnom ispitivanju faze II kontroliranom podacima iz prethodnih ispitivanja, u kojem se ispitivao dasatinib kao dodatak standardnoj kemoterapiji, 106 pedijatrijskih bolesnika s novodijagnosticiranim Ph+ ALL, od kojih su njih 104 imala potvrđen Ph+ ALL, primalo je dasatinib u dnevnoj dozi od 60 mg/m2 prema režimu kontinuirane primjene tijekom najviše 24 mjeseca, u kombinaciji s kemoterapijom.
English: Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs
Croatian: Bol: bol u mišićima (tijekom liječenja ili nakon njegova prekida), bol u trbuhu Pretrage mogu pokazati: snižen broj krvnih pločica, snižen broj bijelih krvnih stanica (neutropenija), anemija, tekućina oko pluća
English: MMR rates by specific time point are displayed graphically in Figure 2.
Croatian: Stope MMR u specifičnim vremenskim točkama grafički su prikazane na Slici 2.
English: Musculoskeletal and connective tissue: delayed fusion of the rounded ends that form joints (epiphyses); slower or delayed growth
Croatian: Mišićno-koštani sustav i vezivno tkivo: zakašnjelo srastanje zaobljenih dijelova koji tvore zglobove (epifize); sporiji rast ili zastoj u rastu
English: Haematology parameters Neutropaenia Thrombocytopaenia Anaemia a Phase 3 dose optimisation study results reported at 2 year study follow up.
Croatian: Hematološki parametri Neutropenija Trombocitopenija Anemija a Rezultati ispitivanja optimizacije doze faze 3 prijavljeni nakon 2 godine praćenja u sklopu ispitivanja.
English: Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag.
Croatian: Svako pakiranje sadrži i nastavak za bocu od polietilena niske gustoće i dozirnu štrcaljku za usta od 12 ml (polipropilensko tijelo štrcaljke i potisnik klipa od polietilena visoke gustoće) u zatvorenoj plastičnoj vrećici.
English: Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Croatian: Dasatinib je imao fototoksični potencijal u jednom in vitro ispitivanju na mišjim fibroblastima pomoću testa preuzimanja neutralne crvene boje (engl. neutral red uptake phototoxicity assay).
English: if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection.
Croatian: ako imate ili ste imali problema s jetrom ili srcem ako počnete otežano disati, osjetite bol u prsištu ili počnete kašljati dok uzimate SPRYCEL: to može biti znak da se u plućima ili prsištu zadržava voda (što se zna češće javljati u bolesnika u dobi od 65 godina i starijih) ili znak promjena na krvnim žilama koje opskrbljuju pluća ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B.
English: OUTER CARTON AND LABEL FOR BOTTLE PACK OUTER CARTON FOR BLISTER PACK
Croatian: KUTIJA I NALJEPNICA BOCE KUTIJA ZA BLISTER PAKIRANJE
English: CCyRb within 24 months cCCyRa CCyRb within 36 months cCCyRa CCyRb within 48 months cCCyRa CCyRb within 60 months cCCyRa CCyRb Major molecular responsec
Croatian: CCyRb unutar 48 mjeseci cCCyRa CCyRb unutar 60 mjeseci cCCyRa
English: Table 4: Dose reduction for concomitant use of strong CYP3A4 inhibitors in paediatric patients
Croatian: Tablica 4: Smanjenje doze kod istodobne primjene snažnih inhibitora CYP3A4 u pedijatrijskih bolesnika
English: Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder
Croatian: Često neuropatija (uključujući perifernu neuropatiju), omaglica, disgeuzija, somnolencija Manje često krvarenje u središnji živčani sustav*b, sinkope, tremor, amnezija, poremećaj ravnoteže
English: Dasatinib is administered orally once daily in the form of either SPRYCEL powder for oral suspension or film-coated tablets (see Summary of Product Characteristics for SPRYCEL film-coated tablets).
Croatian: Dasatinib se primjenjuje peroralno jedanput dnevno u obliku SPRYCEL praška za oralnu suspenziju ili SPRYCEL filmom obloženih tableta (vidjeti sažetak opisa svojstava lijeka za SPRYCEL filmom obložene tablete).
English: Selected adverse reactions that were reported in the recommended starting dose of 140 mg once daily are shown in Table 6b.
Croatian: Odabrane nuspojave prijavljene uz primjenu preporučene početne doze od 140 mg jedanput dnevno prikazane su u Tablici 6b.
English: d Major molecular response criteria: Defined as BCR-ABL/control transcripts ≤0.1% by RQ-PCR in peripheral blood samples
Croatian: d Kriteriji značajnog molekularnog odgovora: Definiran kao BCR-ABL/kontrolni transkripti ≤ 0,1% po RQ-PCR u uzorcima periferne krvi.
English: Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date).
Croatian: Medijan trajanja liječenja iznosio je 23 mjeseca za dasatinib (s time da je do tada 44% bolesnika bilo liječeno >24 mjeseca), a 3 mjeseca za imatinib (s time da je do tada 10% bolesnika bilo liječeno >24 mjeseca).
English: In a study of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 4-day, 40-mg omeprazole dose at steady state reduced the AUC of dasatinib by 43% and the Cmax of dasatinib by 42%.
Croatian: U ispitivanju 14 zdravih ispitanika, jednokratna primjena doze lijeka SPRYCEL od 100 mg 22 sata nakon četverodnevne primjene doze omeprazola od 40 mg u stanju dinamičke ravnoteže smanjila je AUC dasatiniba za 43%, a Cmax dasatiniba za 42%.
English: The once daily schedule demonstrated comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MaHR 0.8%; 95% confidence interval [-7.1% - 8.7%]); however, the 140 mg once daily regimen demonstrated improved safety and tolerability.
Croatian: Raspored doziranja jedanput dnevno imao je usporedivu djelotvornost (nije bio inferioran) s doziranjem dvaput dnevno s obzirom na primarni ishod ocjenjivanja djelotvornosti (razlika u značajnom hematološkom odgovoru 0,8%; 95% interval pouzdanosti [-7,1% - 8,7%]); međutim, režim liječenja dozom od 140 mg jedanput dnevno pokazao je bolju sigurnosti i podnošljivost.
English: Accelerated phase (n= 157)c
Croatian: Faza ubrzanja (n= 157)c