FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines are not to be used with SPRYCEL: ketoconazole, itraconazole - these are antifungal medicines erythromycin, clarithromycin, telithromycin - these are antibiotics ritonavir - this is an antiviral medicine phenytoin, carbamazepine, phenobarbital - these are treaments for epilepsy rifampicin - this is a treatment for tuberculosis famotidine, omeprazole - these are medicines that block stomach acids St. John's wort - a herbal preparation obtained without a prescription, used to treat depression and other conditions (also known as Hypericum perforatum)
Croatian: Sljedeći se lijekovi ne smiju uzimati zajedno s lijekom SPRYCEL: ketokonazol, itrakonazol - to su lijekovi protiv gljivica eritromicin, klaritromicin, telitromicin - to su antibiotici ritonavir - to je antivirusni lijek fenitoin, karbamazepin, fenobarbital - koriste se za liječenje epilepsije rifampicin - koristi se u liječenju tuberkuloze famotidin, omeprazol - to su lijekovi koji blokiraju kiselinu u želucu gospina trava - biljni pripravak koji se izdaje bez liječničkog recepta i koristi se u liječenju depresije i drugih bolesti (biljka poznata i pod imenom Hypericum perforatum)
English: An echocardiography should be performed at treatment initiation in every patient presenting symptoms of cardiac disease and considered in patients with risk factors for cardiac or pulmonary disease.
Croatian: Na početku liječenja mora se napraviti ultrazvuk srca u svakog bolesnika u kojeg postoje simptomi bolesti srca te razmotriti potrebu ultrazvuka srca u bolesnika u kojih postoje rizični faktori za bolesti srca ili pluća.
English: The oral suspension should not be taken with grapefruit or grapefruit juice (see section 4.5).
Croatian: Oralna suspenzija ne smije se uzimati s grejpom ni sokom od grejpa (vidjeti dio 4.5).
English: One patient (< 1%) in each group experienced a QTcF > 500 msec.
Croatian: Po jedan bolesnik (<1%) u svakoj skupini imao je QTcF >500 msek.
English: Median time to MMR after 60 months of follow-up was 9.3 months in the SPRYCEL group and 15.0 months in the imatinib group in patients with a MMR.
Croatian: Medijan vremena do MMR nakon 60 mjeseci praćenja bio je 9,3 mjeseca u skupini koja je primala SPRYCEL i 15,0 mjeseci u skupini koja je primala imatinib u bolesnika s MMR.
English: Dasatinib activity in vitro in hERG and Purkinje fiber assays suggested a potential for prolongation of cardiac ventricular repolarisation (QT interval).
Croatian: Djelovanje dasatiniba in vitro na hERG i Purkinjeova vlakna pokazuje da dasatinib ima potencijal produljenja faze repolarizacije srčanih klijetki (QT interval).
English: Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Croatian: Dvadeset jedan (1%) bolesnik imao je QTcF > 500 msek (vidjeti dio 4.4).
English: SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib.
Croatian: SPRYCEL se ne smije uzimati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje dasatinibom.
English: Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders
Croatian: Manje često anksioznost, konfuzno stanje, afektivna labilnost, smanjeni libido Poremećaji živčanog sustava
English: HDPE bottle with a polypropylene child-resistant closure.
Croatian: HDPE boca s polipropilenskim zatvaračem sigurnim za djecu.
English: Common side effects (may affect up to 1 in 10 people) Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) Infekcije: upala pluća, infekcija virusom herpesa (uključujući citomegalovirus - CMV), infekcija gornjih dišnih putova, ozbiljne infekcije krvi ili tkiva (uključujući manje česte slučajeve sa smrtnim ishodima)
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukraza-izomaltaza ne bi trebali uzimati ovaj lijek.
English: Follow up should be performed according to standard practice guidelines.
Croatian: Praćenje bolesnika mora biti u skladu sa standardnim smjernicama.
English: Dose reduction for concomitant use of strong CYP3A4 inhibitors
Croatian: Smanjenje doze kod istodobne primjene snažnih inhibitora CYP3A4
English: (PPK) analysis, which showed that the exposure of the powder for oral suspension (as measured by time-averaged concentration at steady state [Cavgss]) at 72 mg/m2 was approximately 30% lower than that of the tablet at 60 mg/m2.
Croatian: objedinjeni su s podacima za tablete radi provedbe analize populacijske farmakokinetike, koja je pokazala da je izloženost kod primjene praška za oralnu suspenziju (mjerena vremenski uprosječenom koncentracijom u stanju dinamičke ravnoteže [Cavgss]) u dozi od 72 mg/m2 bila približno 30% manja nego kod primjene tableta u dozi od 60 mg/m2.
English: Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Croatian: Takvom se rekonstitucijom dobiva 90 ml (volumen koji se može primijeniti) SPRYCEL oralne suspenzije koncentracije 10 mg/ml.
English: Rare protein-losing gastroenteropathy, ileus, anal fistula
Croatian: Rijetko gastroenteropatija s gubitkom proteina, ileus, analna fistula
English: Carton containing one bottle with 30 film-coated tablets.
Croatian: Kutija sadrži jednu bocu s 30 filmom obloženih tableta.
English: Key efficacy endpoints were: complete cytogenetic response (CCyR), major cytogenetic response (MCyR) and major molecular response (MMR).
Croatian: Ključne mjere ishoda za djelotvornost bile su potpuni citogenetski odgovor (CCyR), značajni citogenetski odgovor (MCyR) i značajni molekularni odgovor (MMR).
English: In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated.
Croatian: U pedijatrijskih bolesnika s Ph+ ALL liječenih dasatinibom u kombinaciji s kemoterapijom kompletnu krvnu sliku treba napraviti prije početka svakog bloka kemoterapije i prema kliničkoj indikaciji.
English: The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population.
Croatian: Cjelokupan sigurnosni profil lijeka SPRYCEL u pedijatrijskoj populaciji s Ph+ KML u kroničnoj fazi bio je sličan onome u odrasloj populaciji, neovisno o formulaciji, s time da u pedijatrijskih bolesnika nisu prijavljeni slučajevi perikardijalnog izljeva, pleuralnog izljeva, plućnog edema ni plućne hipertenzije.
English: Use with caution in patients with hepatic or renal impairment, as benzyl alcohol may accumulate over time and cause metabolic acidosis.
Croatian: Lijek treba primjenjivati uz oprez u bolesnika s oštećenjem funkcije jetre ili bubrega, jer se benzilni alkohol s vremenom može nakupljati i uzrokovati metaboličku acidozu.
English: Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Croatian: Rijetko moždani udar, tranzitorna ishemijska ataka, konvulzije, optički neuritis, paraliza VII moždanog živca, demencija, ataksija
English: The primary toxicities occurred in the gastrointestinal, haematopoietic, and lymphoid systems.
Croatian: Primarni toksični učinci nastupili su u probavnom, hematopoetskom i limfnom sustavu.
English: Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Croatian: Često alopecija, dermatitis (uključujući ekcem), pruritus, akne, suha koža, urtikarija, hiperhidroza
English: Eighty-two patients received dasatinib tablets exclusively and 24 patients received dasatinib powder for oral suspension at least once, 8 of whom received dasatinib powder for oral suspension exclusively.
Croatian: Osamdeset i dva bolesnika primala su isključivo tablete dasatiniba, dok su 24 bolesnika primila dasatinib u obliku praška za oralnu suspenziju najmanje jedanput, a njih 8 primalo je dasatinib isključivo u obliku praška za oralnu suspenziju.
English: The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated with SPRYCEL used as single-agent therapy in clinical studies and post-marketing experience (Table 5).
Croatian: Sljedeće su nuspojave, osim promjena u laboratorijskim nalazima, bile prijavljene u bolesnika liječenih lijekom SPRYCEL kao monoterapijom u kliničkim ispitivanjima te nakon stavljanja lijeka u promet (Tablica 5).
English: The mean terminal half-life of dasatinib is 3 hours to 5 hours.
Croatian: Srednja vrijednost terminalnog poluvremena eliminacije dasatiniba kreće se u rasponu od 3 sata do 5 sati.
English: They are also available in bottles with child-resistant closure containing 30 film-coated tablets.
Croatian: Također su dostupne u bocama sa zatvaračem sigurnim za djecu koje sadrže 30 filmom obloženih tableta.
English: In patients who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 5% of patients.
Croatian: U bolesnika koji su razvili mijelosupresiju 3. ili 4. stupnja, oporavak je općenito nastupio nakon kratkih prekida davanja lijeka i/ili smanjenja doze, dok je liječenje trajno prekinuto u 5% bolesnika.
English: In this population of patients who received 100 mg once daily, MCyR was achieved in 77% and CCyR in 67%.
Croatian: U toj populaciji bolesnika koji su primali dasatinib u dozi od 100 mg jedanput dnevno, značajan citogenetski odgovor postigao se u 77% i potpun citogenetski odgovor u 67%.
English: Two randomised, open-label Phase III studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Croatian: Provedena su dva randomizirana, otvorena ispitivanja faze III za procjenu djelotvornosti dasatiniba kad se primjenjuje jedanput dnevno u usporedbi s primjenom dasatiniba dvaput dnevno.
English: Do not take dispersed tablets.
Croatian: Tablete se ne smiju otapati.
English: Four single-arm, uncontrolled, open-label Phase II clinical studies were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib.
Croatian: Provedena su četiri nekontrolirana otvorena klinička ispitivanja faze II s jednom skupinom ispitanika da bi se utvrdila djelotvornost i sigurnost primjene dasatiniba u bolesnika s KML u kroničnoj fazi, fazi ubrzanja ili mijeloidnoj blastnoj krizi, koji su otporni na imatinib ili ga ne podnose.
English: Outer Carton: sprycel 10 mg/mL
Croatian: Kutija: sprycel 10 mg/ml
English: Seventeen patients had 2 separate adverse reactions, 6 had 3 adverse reactions, 18 had 4 to 8 adverse reactions and 5 had > 8 episodes of pleural effusions.
Croatian: U 17 bolesnika zabilježene su 2 odvojene nuspojave, u njih 6 zabilježene su 3 nuspojave, u 18 bolesnika zabilježeno je 4 - 8 nuspojava, dok je u 5 bolesnika zabilježeno > 8 epizoda pleuralnog izljeva.
English: In all SPRYCEL treated patients with chronic phase CML, severe fluid retention occurred in 32 patients (6%) receiving SPRYCEL at the recommended dose (n=548).
Croatian: Među svim bolesnicima s KML u kroničnoj fazi liječenima lijekom SPRYCEL, teško zadržavanje tekućine primijećeno je u 32 bolesnika (6%) koja su SPRYCEL primala u preporučenoj dozi (n=548).
English: 7 years
Croatian: 7 godina
English: They are also available in bottles with child-resistant closure containing 60 film-coated tablets.
Croatian: Također su dostupne u bocama sa zatvaračem sigurnim za djecu koje sadrže 60 filmom obloženih tableta.
English: In patients with CML with resistance or intolerance to prior imatinib therapy, cytopaenias (thrombocytopaenia, neutropaenia, and anaemia) were a consistent finding.
Croatian: U bolesnika s KML koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib, citopenije (trombocitopenija, neutropenija i anemija) su bile konzistentan nalaz.
English: Rare gait disturbance
Croatian: Rijetko poremećaj hoda
English: It is unlikely that the SPRYCEL tablets will get broken.
Croatian: Posebne upute za rukovanje lijekom SPRYCEL Nije vjerojatno da bi SPRYCEL tablete bile zdrobljene.
English: Patients should be advised that they may experience adverse reactions such as dizziness or blurred vision during treatment with dasatinib.
Croatian: Bolesnike se mora upozoriti na nuspojave poput omaglice ili zamagljenog vida, koje se mogu javiti tijekom liječenja dasatinibom.
English: For patients with chronic phase CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended.
Croatian: U bolesnika s KML u kroničnoj fazi koji su primali 100 mg jedanput dnevno, preporučuje se smanjiti dozu na 80 mg jedanput dnevno uz daljnje smanjenje doze od 80 mg jedanput dnevno na 50 mg jedanput dnevno, ukoliko je preporučeno.
English: If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you or your child, ask your doctor.
Croatian: Ako imate dodatnih pitanja o načinu djelovanja lijeka SPRYCEL ili razlogu zašto je taj lijek propisan Vama ili Vašem djetetu, obratite se liječniku.
English: Holding the syringe tip firmly in the bottle, turn the bottle with the syringe upright again.
Croatian: Držeći vrh štrcaljke čvrsto u boci, ponovno preokrenite bocu i štrcaljku.
English: c CA180-035 study results in recommended starting dose of 140 mg once daily.
Croatian: Rezultati ispitivanja CA180-035 uz preporučenu početnu dozu od 140 mg jedanput dnevno.
English: Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you.
Croatian: Prije nego što Vam izda lijek, Vaš će ljekarnik ili kvalificirani zdravstveni radnik pripremiti (pomiješati) SPRYCEL prašak za oralnu suspenziju tako da dobije SPRYCEL oralnu suspenziju.
English: In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
Croatian: U ispitivanju optimizacije doze faze III u bolesnika s KML u kroničnoj fazi koji ne podnose ili su otporni na prethodnu terapiju imatinibom (medijan trajanja liječenja bio je 30 mjeseci), incidencija pleuralnog izljeva i kongestivnog zatajenja srca/srčana disfunkcija bila je manja u skupini koja je primala SPRYCEL u dozi od 100 mg jedanput dnevno nego u skupini koja je primala SPRYCEL u dozi od 70 mg dvaput dnevno.
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic (n= 387)
Croatian: Tablica 11: Djelotvornost lijeka SPRYCEL u kliničkim ispitivanjima faze II s jednom skupinoma kronična (n= 387)
English: The rates of MMR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (8% and 0.4%), 6 months (27% and 8%), 9 months (39% and 18%), 12 months (46% and 28%), 24 months (64% and 46%) , 36 months (67% and 55%), 48 months (73% and 60%) and 60 months (76% and 64%)were also consistent with the primary endpoint.
Croatian: Stope MMR u terapijskoj skupini koja je primala SPRYCEL odnosno imatinib unutar 3 mjeseca (8% odnosno 0,4%), 6 mjeseci (27% odnosno 8%), 9 mjeseci (39% odnosno 18%), 12 mjeseci (46% odnosno 28%), 24 mjeseca (64% i 46%), 36 mjeseci (67% i 55% ), 48 mjeseci (73% i 60%) i 60 mjeseci (76% i 64%) također su bile dosljedne primarnoj mjeri ishoda.
English: Daily dose, mL (mg)
Croatian: Dnevna doza, ml (mg)
English: Uncommon neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome, hair disorder
Croatian: Manje često neutrofilna dermatoza, fotosenzibilnost, poremećaj pigmentacije, panikulitis, kožni ulkus, bulozna stanja, poremećaj noktiju, sindrom palmarno plantarne eritrodizestezije (sindrom šake i stopala), poremećaj kose
English: Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML.
Croatian: Njihova je pojava ranija i češća u bolesnika u uznapredovaloj fazi KML ili Ph+ ALL nego u onih u kroničnoj fazi KML.
English: In severely hepatic-impaired subjects, the mean Cmax and AUC adjusted for the 70 mg dose were decreased by 43% and 28%, respectively, compared to subjects with normal hepatic function (see sections 4.2 and 4.4).
Croatian: Kod bolesnika sa teškim oštećenjem jetre, srednja vrijednost Cmax i AUC prilagođena dozi od 70 mg smanjena je za 43% u odnosu na bolesnike s normalnom funkcijom jetre, kod kojih je smanjenje bilo 28% (vidjeti dio 4.2. i 4.4.).
English: In 865 patients with leukaemia treated with dasatinib in Phase II clinical studies, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Croatian: U 865 bolesnika s leukemijom koji su bili liječeni dasatinibom u kliničkim ispitivanjima faze II, prosječne promjene od početnih vrijednosti QTc intervala prema Fridericija metodi (QTcF) iznosile su 4-6 msek; gornje granice 95% intervala pouzdanosti za sve prosječne promjene u odnosu na početne vrijednosti bile su <7 msek (vidjeti dio 4.8).
English: Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
Croatian: Istodobna primjena dasatiniba i supstrata CYP3A4 može povećati izloženost supstratu CYP3A4.
English: 1 Check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Croatian: 1 Provjeriti povezanost citopenije s leukemijom (aspirat ili biopsija koštane srži).
English: Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia.
Croatian: Liječenje lijekom SPRYCEL povezano je s anemijom, neutropenijom i trombocitopenijom.
English: Patients were randomised to receive either SPRYCEL 100 mg once daily or imatinib 400 mg once daily.
Croatian: Bolesnici su bili randomizirani u skupinu koja je primala SPRYCEL 100 mg jedanput dnevno ili imatinib 400 mg jedanput dnevno.
English: No additional patients were reported to have QTcF > 500 msec after a minimum of 60 months follow-up.
Croatian: Nakon najmanje 60 mjeseci praćenja nije bilo dodatnih bolesnika s QTcF >500 msek.
English: Paediatric population (Ph+ CML-CP and Ph+ ALL)
Croatian: Pedijatrijska populacija (Ph+ KML u kroničnoj fazi i Ph+ ALL)
English: Grade 3 or 4 hypocalcaemia, hypokalaemia, and hypophosphataemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL.
Croatian: Hipokalcijemija, hipokalijemija i hipofosfatemija 3. ili 4. stupnja prijavljene su u bolesnika u svim fazama KML, ali češće u bolesnika u mijeloidnoj ili limfoidnoj blastnoj krizi KML i Ph+ ALL.
English: Table 6b: Selected adverse reactions reported in phase III dose-optimisation study: Advanced phase CML and Ph+ ALLa
Croatian: Tablica 6b: Odabrane nuspojave prijavljene u ispitivanju optimizacije doze faze III: uznapredovala faza KML i Ph+ ALLa
English: Among 130 patients with chronic phase CML (CML-CP) treated in two paediatric studies, a Phase I, open-label, nonrandomized dose-ranging trial and a Phase II, open-label, nonrandomized trial, 84 patients (exclusively from the Phase II trial) were newly diagnosed with CML-CP and 46 patients (17 from the Phase I trial and 29 from the Phase II trial) were resistant or intolerant to previous treatment with imatinib.
Croatian: Među130 bolesnika s KML u kroničnoj fazi liječenih u dvama pedijatrijskim ispitivanjimaotvorenom, nerandomiziranom ispitivanju faze I za utvrđivanje raspona doze i otvorenom, nerandomiziranom ispitivanju faze II - 84 bolesnika (isključivo iz ispitivanja faze II) imalo je novodijagnosticiran KML u kroničnoj fazi, a 46 bolesnika (17 iz ispitivanja faze I i 29 iz ispitivanja faze II) bilo je otporno na prethodno liječenje imatinibom ili ga nije podnosilo.
English: For patients with advanced phase CML or Ph+ ALL who received 140 mg once daily, dose reduction to 100 mg once daily with further reduction from 100 mg once daily to 50 mg once daily, if needed, is recommended.
Croatian: U bolesnika s KML u uznapredovaloj fazi ili s Ph+ ALL koji primaju 140 mg jedanput dnevno, preporučuje se smanjiti dozu na 100 mg jedanput dnevno uz daljnje smanjenje sa 100 mg jedanput dnevno na 50 mg jedanput dnevno, ako je potrebno.
English: Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Croatian: Stoga je potreban oprez kada se dasatinib primjenjuje istodobno sa supstratima CYP3A4 koji imaju uzak terapijski indeks, kao što su astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil ili ergot alkaloidi (ergotamin, dihidroergotamin) (vidjeti dio 4.5).
English: In embryofoetal development studies, dasatinib likewise induced embryolethality with associated decreases in litter size in rats, as well as foetal skeletal alterations in both rats and rabbits.
Croatian: U ispitivanjima embriofetalnog razvoja, dasatinib je imao embrioletalne učinke s posljedičnim smanjenjem veličine okota u štakora i izazvao promjene u fetalnom kosturu kako štakora, tako i kunića.
English: Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
Croatian: Rijetko plućno srce, miokarditis, akutni koronarni sindrom, srčani zastoj, produljenje PR intervala na elektrokardiogramu, bolest koronarnih arterija, pleuroperikarditis
English: First dose (mL)
Croatian: Prva doza (ml)
English: Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months
Croatian: Tablica 10: Bolesnici liječeni dasatinibom koji su imali BCR-ABL ≤ 10% i > 10% u 3. mjesecu
English: Adults with chronic phase CML (starting dose 100 mg once daily)
Croatian: Odrasli u kroničnoj fazi KML (početna doza od 100 mg jedanput dnevno)
English: Once constituted by your pharmacist or healthcare professional, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Croatian: Nakon što Vaš ljekarnik ili kvalificirani zdravstveni radnik pripremi oralnu suspenziju za primjenu, ona se smije primijeniti samo štrcaljkom za usta koja dolazi u svakom pakiranju lijeka.
English: Powder: Store below 25°C.
Croatian: Prašak: Čuvati na temperaturi ispod 25°C.
English: Step 3: Remove the closure, insert the press-in bottle adapter (PIBA) into the bottle neck, and close the bottle tightly with the child-resistant closure.
Croatian: 3. korak: Skinite zatvarač, gurnite nastavak za bocu u grlo boce i čvrsto je zatvorite zatvaračem sigurnim za djecu.
English: Saturday Sunday
Croatian: Nedjelja