natgillin/translations-raw huggingface dataset:
Patients developing grade 3 or 4 hypocalcaemia often had recovery with oral calcium supplementation. 
Bolesnici koji su razvili hipokalcijemiju 3. ili 4. stupnja često bi se oporavili uz uzimanje oralnih pripravaka za nadoknadu kalcija.
In these cases, PAH was reported after initiation of dasatinib therapy, including after more than one year of treatment. 
U ovim je slučajevima PAH bio zabilježen nakon početka terapije dasatinibom, uključujući i nakon više od jedne godine liječenja.
The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients. 
Ukupni prosječni terminalni poluvijek dasatiniba u bolesnika iznosi oko 5-6 sati.
Among dasatinib-treated CML-CP paediatric patients previously exposed to imatinib, the mutations detected at the end of treatment were: T315A, E255K and F317L. 
Među pedijatrijskim bolesnicima s KML u kroničnoj fazi liječenima dasatinibom koji su prethodno bili izloženi imatinibu, na kraju razdoblja liječenja utvrđene su sljedeće mutacije: T315A, E255K i F317L.
Rare leukocytoclastic vasculitis, skin fibrosis 
Rijetko leukocitoklastični vaskulitis, kožna fibroza
The pharmacokinetics of dasatinib have been evaluated in 104 paediatric patients with leukaemia or solid tumours (72 who received the tablet formulation and 32 who received the powder for oral suspension). 
Farmakokinetika dasatiniba ocjenjivala se u 104 pedijatrijska bolesnika s leukemijom ili solidnim tumorima (72 su primala lijek u obliku tablete, a 32 u obliku praška za oralnu suspenziju).
QT Prolongation 
Produženje QT intervala
The starting dose of SPRYCEL is calculated by body weight as shown below: 
Početna doza lijeka SPRYCEL izračunava se na temelju tjelesne težine kako je prikazano u nastavku:
Rare pulmonary embolism, acute respiratory distress syndrome 
Rijetko plućna embolija, akutni respiratorni distres sindrom
If you are pregnant or may be pregnant, tell your doctor immediately. 
Ako ste trudni ili biste mogli biti trudni, odmah o tome obavijestite liječnika.
Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related pleural effusions. 
Manje od 10% bolesnika s pleuralnim izljevom imalo je teške pleuralne izljeve (3. ili 4. stupnja) uzrokovane primjenom dasatiniba.
Imatinib-resistant patients n=124 
Bolesnici otporni na imatinib n=124
SPRYCEL can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2). 
SPRYCEL se može uzimati uz obrok ili bez njega, ali se mora uzimati uvijek dosljedno ili ujutro ili navečer (vidjeti dio 5.2).
At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%). 
U 60. mjesecu, transformacija u ubrzanu ili blastnu fazu javila se u manje bolesnika liječenih dasatinibom (n=8; 3%) u usporedbi s bolesnicima liječenim imatinibom (n=15; 5,8%).
2 year follow-up 
2 godine praćenja
• Do not wash in a dishwasher. 
• Nemojte je prati u perilici posuđa.
The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated. 
Učinak prekida liječenja na dugoročan ishod bolesti nakon postizanja citogenetskog ili molekularnog odgovora [uključujući potpun citogenetski odgovor (engl. complete cytogenetic response, CCyR), značajan molekularni odgovor (engl. major molecular response, MMR) i MR4,5] nije ispitivan.
This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age. 
Ovaj lijek koristi se za liječenje kronične mijeloične leukemije (KML) u odraslih, adolescenata i djece u dobi od najmanje godinu dana.
Monitor patients less than 3 years of age for respiratory symptoms. 
Bolesnike mlađe od 3 godine treba pratiti zbog moguće pojave dišnih simptoma.
b Complete cytogenetic response (CCyR) is based on a single bone marrow cytogenetic evaluation. 
b Potpuni citogenetski odgovor (CCyR) temelji se na samo jednoj citogenetskoj pretrazi koštane srži.
Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent. 
Neklinički podaci pokazuju da topljivost dasatiniba ovisi o pH.
Chronic phase (n= 165)b 
Kronična faza (n= 165)b
In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months. 
U ispitivanju faze I zabilježen je hematološki i citogenetski odgovor u svim fazama KML i Ph+ ALL u prva 84 liječena bolesnika, koji su bili praćeni do 27 mjeseci.
ANC: absolute neutrophil count 
ABN: apsolutni broj neutrofila.
SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg. 
SPRYCEL je dostupan i u obliku tableta za primjenu u odraslih i djece u dobi od najmanje godinu dana koja teže više od 10 kg.
The efficacy of dasatinib is based on haematological and cytogenetic response rates. 
Djelotvornost dasatiniba određuje se na temelju stopa hematoloških i citogenetskih odgovora.
Lymphoid blast phase and Ph+ ALL (n= 168)c 
Limfoidna blastna kriza i Ph+ ALL (n= 168)c
In a single-dose study in healthy subjects, the administration of famotidine 10 hours prior to a single dose of SPRYCEL reduced dasatinib exposure by 61%. 
U ispitivanju pojedinačne doze u zdravih ispitanika, primjenom famotidina 10 sati prije pojedinačne doze lijeka SPRYCEL smanjila se izloženost dasatinibu za 61%.
d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively. 
d Isključuje gastrointestinalno krvarenje i krvarenje u središnji živčani sustav; ove su nuspojave prijavljene prema organskom sustavu pod poremećajima probavnog sustava odnosno poremećajima živčanog sustava.
The diagnostic approach should follow standard practice guidelines. 
Dijagnostička obrada mora slijediti i biti u skladu sa standardnim smjernicama.
Patients who develop dyspnoea and fatigue after initiation of therapy should be evaluated for common etiologies including pleural effusion, pulmonary oedema, anaemia, or lung infiltration. 
U bolesnika koji razviju dispneju i umor nakon početka terapije mora se razmotriti uobičajena etiologija tih simptoma, uključujući pleuralni izljev, plućni edem, anemiju ili infiltraciju pluća.
Dasatinib was studied in a randomised clinical study of 519 patients with newly diagnosed CML in chronic phase which included patients with prior cardiac disease. 
Dasatinib je ispitivan u randomiziranom kliničkom ispitivanju u 519 bolesnika s novodijagnosticiranom KML u kroničnoj fazi u koje su bili uključeni bolesnici s postojećom srčanom bolešću.
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2). 
Uz tu je dozu postignuta 30% manja izloženost od one koja se postiže uz preporučenu dozu (vidjeti dio 5.2).
SPRYCEL contains benzyl alcohol 
SPRYCEL sadrži benzilni alkohol
Paediatric patients with ALL 
Pedijatrijski bolesnici s ALL
Common contusion a Includes decreased appetite, early satiety, increased appetite. 
Često kontuzije a Uključuje smanjen apetit, brz nastup osjećaja sitosti, pojačan apetit.
Haematopoietic growth factor has been used in patients with resistant myelosuppression. 
Hematopoetski faktor rasta primjenjivan je u bolesnika s rezistentnom mijelosupresijom.
• A small container filled with water to use to rinse the syringe. 
• malu posudu napunjenu vodom za ispiranje štrcaljke
Accelerated (n= 174) 
ubrzanje (n= 174)
The rates of MCyR at 2 years were similar whether patients had any baseline BCR-ABL mutation, P-loop mutation, or no mutation (63%, 61% and 62%, respectively). 
Stope MCyR nakon 2 godine bile su slične bez obzira na to jesu li bolesnici imali osnovnu BCR-ABL mutaciju (63%), mutaciju P-petlje (61%) ili nisu imali mutaciju (62%).
Therefore, there is a potential for interaction with other concomitantly administered medicinal products that are metabolised primarily by or modulate the activity of CYP3A4 (see section 4.5). 
Stoga postoji mogućnost interakcije s drugim istodobno primijenjenim lijekovima koji se metaboliziraju primarno preko CYP3A4 ili moduliraju aktivnost tog enzima (vidjeti dio 4.5).
In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system. 
In vivo, u posebnim pokusima na mišjem modelu KML, dasatinib je zaustavio progresiju kronične KML do blastne krize i produžio preživljenje miša u kojem su uzgojene kulture stanica KML-a bolesnika u različitim organima, uključujući i središnji živčani sustav.
There was no difference in OS (HR 1.01, 95% CI: 0.58-1.73, p= 0.9800) and PFS (HR 1.00, 95% CI: 0.58-1.72, p = 0.9998) between dasatinib and imatinib. 
Nije primijećena razlika u OS (HR 1,01, 95% CI: 0,58-1,73, p=0,9800) ni PFS (HR 1,00, 95% CI: 0,58-1,72, p=0,9998) između dasatiniba i imatiniba.
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. 
Liječenje treba započeti liječnik s iskustvom u dijagnosticiranju i liječenju bolesnika s leukemijom.
Platelet transfusion and red cell transfusion were used as appropriate. 
Transfuzija trombocita i transfuzija eritrocita primjenjivane su po potrebi.
Patients with risk factors or a history of cardiac disease should be monitored carefully for signs or symptoms consistent with cardiac dysfunction and should be evaluated and treated appropriately (see section 4.4). 
Bolesnike s rizičnim faktorima ili srčanom bolešću u anamnezi mora se pažljivo pratiti na znakove i simptome poremećaja srčane funkcije te ih se mora dijagnostički obraditi i liječiti na odgovarajući način (vidjeti dio 4.4).
However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2). 
Ipak, SPRYCEL se mora koristiti s oprezom u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
See the "Instructions for administration to the patient" at the end of the package leaflet for how to give a dose of SPRYCEL oral suspension. 
Pogledajte "Upute za primjenu bolesniku" na kraju upute o lijeku za informacije o tome kako primijeniti dozu SPYRCEL oralne suspenzije.
Very common side effects (may affect more than 1 in 10 people) Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) Infekcije (uključujući bakterijske, virusne i gljivične) Srce i pluća: nedostatak zraka
It binds to both the inactive and active conformations of the BCR-ABL enzyme. 
Dasatinib se veže i za aktivni i za neaktivni oblik BCR-ABL enzima.
See section 4.4 for further information on patients with chronic phase CML and advanced phase CML or Ph+ ALL. 
Vidjeti dio 4.4 za više informacija o bolesnicima s KML u kroničnoj fazi i KML u uznapredovaloj fazi ili Ph+ ALL.
Dasatinib over imatinib 
Dasatinib prema imatinibu
Adverse reactions reported in these two paediatric studies at a frequency of 10% in patients on a continuous dosing regimen are shown in Table 7. 
Nuspojave prijavljene u ta dva pedijatrijska ispitivanja s učestalošću od  10% u bolesnika liječenih prema režimu kontinuirane primjene prikazane su u Tablici 7.
How to split a dose that is greater than 11 mL Total prescribed dose (mL) 
Kako podijeliti dozu koja je veća od 11 ml
Gastrointestinal toxicity was dose-limiting in rats and monkeys, as the intestine was a consistent target organ. 
Toksični učinci na probavni sustav ograničavaju doziranje u štakora i majmuna, budući da je crijevo redovito bilo ciljni organ.
The rate of major molecular response at 24 months was 45% (35% for imatinib-resistant patients and 74% for imatinib-intolerant patients). 
Stopa značajnog molekularnog odgovora (MMR) nakon 24 mjeseca iznosila je 45% (35% za bolesnike otporne na imatinib i 74% za bolesnike koji ne podnose imatinib).
In addition to imatinib, 35% of patients had received prior cytotoxic chemotherapy, 65% had received prior interferon, and 10% had received a prior stem cell transplant. 
Uz imatinib, 35% bolesnika prethodno je primilo citotoksičnu kemoterapiju, 65% interferon, a 10% transplantaciju matičnih stanica.
The powder for oral suspension consists of powder blend with the active substance plus excipients, contained within a bottle for constitution. 
Prašak za oralnu suspenziju sastoji se od praškaste mješavine koja sadrži djelatnu tvar i pomoćne tvari, a dolazi u boci za rekonstituciju.
In people with CML, white cells called granulocytes start growing out of control. 
U osoba s KML, bijele krvne stanice koje se zovu granulociti nekontrolirano se počnu umnažati.
If cytopaenia persists for more than 3 weeks, check if cytopaenia is related to leukaemia (marrow aspirate or biopsy). 
Ako citopenija potraje dulje od 3 tjedna, provjeriti je li povezana s leukemijom (aspirat ili biopsija koštane srži).
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with SPRYCEL should not be resumed. 
Ako je razina protutijela na ADAMTS13 povišena, a aktivnost enzima ADAMTS13 niska, liječenje lijekom SPRYCEL ne smije se nastaviti.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction. 
Nakon toga može se nastaviti s liječenjem na odgovarajući način uz manju dozu, ovisno o početnoj težini nuspojave.
A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and of prostate adenoma in low-dose males was noted. 
Zabilježeno je statistički značajno povećanje kombinirane incidencije karcinoma pločastih stanica i papiloma maternice i cerviksa u ženki koje su dobivale visoke doze i adenoma prostate u mužjaka koji su primali niske doze.
Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib. 
Četrdeset i dva posto bolesnika otpornih na imatinib koji prethodno nisu postigli MCyR na imatinib (n=188) postigli su MCyR na dasatinib.
Secondary endpoints included time in cCCyR (measure of durability of response), time to cCCyR, major molecular response (MMR) rate, time to MMR, progression free survival (PFS) and overall survival (OS). 
Sekundarne mjere ishoda uključivale su vrijeme cCCyR (mjera trajanja odgovora), vrijeme do nastupa cCCyR, stopa značajnog molekularnog odgovora (MMR), vrijeme do MMR, preživljenje bez progresije bolesti (PFS) i ukupno preživljenje (OS).
SPRYCEL must be administered orally. 
SPRYCEL se mora primijeniti peroralno.
In patients that receive a subsequent stem cell transplantation, SPRYCEL can be administered for an additional year post-transplantation. 
U bolesnika koji se zatim podvrgnu presađivanju matičnih stanica SPRYCEL se može primjenjivati još godinu dana nakon presađivanja.
Pleural effusion was usually reversible and managed by interrupting SPRYCEL treatment and using diuretics or other appropriate supportive care measures (see sections 4.2 and 4.4). 
Pleuralni izljev obično je bio reverzibilan te se zbrinjavao privremenim prekidom liječenja lijekom SPRYCEL i primjenom diuretika ili drugim prikladnim mjerama potpornog liječenja (vidjeti dijelove 4.2 i 4.4).
If you have accidentally taken too much SPRYCEL, talk to your doctor immediately. 
Ako ste slučajno uzeli previše lijeka SPRYCEL odmah se javite liječniku.
Once constituted, the bottle contains 99 mL of oral suspension, of which 90 mL is intended for dosing and administration. 
Nakon rekonstitucije boca sadrži 99 ml oralne suspenzije, od čega je 90 ml predviđeno za doziranje i primjenu.
Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4. 
Dasatinib je supstrat i inhibitor citokroma P450 (CYP) 3A4.
Pharmacokinetics of the tablet formulation of dasatinib were evaluated for 72 paediatric patients with relapsed or refractory leukaemia or solid tumours at oral doses ranging from 60 to 120 mg/m2 once daily and 50 to 110 mg/m2 twice daily. 
Farmakokinetika dasatiniba u obliku tablete ocjenjivala se u 72 pedijatrijska bolesnika s relapsnom ili refraktornom leukemijom ili solidnim tumorima u peroralnim dozama u rasponu od 60 do 120 mg/m2 jedanput dnevno te od 50 do 110 mg/m2 dvaput dnevno.
if you experience bruising, bleeding, fever, fatigue and confusion when taking SPRYCEL, contact your doctor. 
ako se tijekom liječenja lijekom SPRYCEL jave modrice, krvarenje, vrućica, umor i smetenost, obratite se svom liječniku.
Response rates are presented in Table 14. 
Stope odgovora prikazane su u Tablici 14.
Responses were durable across all phases of CML and Ph+ ALL. 
Odgovor je trajao tijekom svih faza KML i Ph+ ALL.
The cumulative rate of dasatinib-related pleural effusion (all grades) over time was 10% at 12 months, 14% at 24 months, 19% at 36 months, 24% at 48 months and 28% at 60 months. 
Kumulativna stopa pleuralnog izljeva (svih stupnjeva) uzrokovana primjenom dasatiniba tijekom vremena iznosila je 10% nakon 12 mjeseci, 14% nakon 24 mjeseca, 19% nakon 36 mjeseci, 24% nakon 48 mjeseci i 28% nakon 60 mjeseci.
70 mg at least 45 kg 
70 mg najmanje 45 kg
Based on the patient population PK analysis, variability in dasatinib exposure was estimated to be mainly due to inter-occasion variability in bioavailability (44% CV) and, to a lesser extent, due to inter-individual variability in bioavailability and inter-individual variability in clearance (30% and 32% CV, respectively). 
Prema analizi populacijske farmakokinetike u populaciji bolesnika procijenjeno je da je varijabilnost u izloženosti dasatinibu prvenstveno posljedica intraindividualne varijabilnosti u bioraspoloživosti u pojedinim vremenskim točkama (44% CV) te u manjoj mjeri interindividualne varijabilnosti u bioraspoloživosti i interindividualne varijabilnosti u klirensu (30% odnosno 32% CV).
The median duration of therapy in the 100 mg once daily group was 37 months (range 1-91 months). 
Medijan trajanja liječenja u skupini liječenoj dozom od 100 mg jedanput dnevno iznosio je 37 mjeseci (raspon: 1-91 mjesec).
Dose increase or reduction is recommended based on individual patient response and tolerability. 
Preporučuje se povećati ili smanjiti dozu na temelju odgovora i podnošljivosti lijeka kod pojedinog bolesnika.
4 If cytopaenia is related to leukaemia, consider dose escalation to 180 mg once daily. 
Ako je citopenija povezana s leukemijom, razmotriti postupno povećanje doze na 180 mg jedanput dnevno.
n/a Duration of MaHR (%; Kaplan-Meier estimates) 1 year n/a 
n/p Trajanje značajnog hematološkog odgovora (%; procjena po Kaplan-Meieru) 1 godina n/p
These data should be considered if patients are to switch from tablets to powder for oral suspension or vice versa. 
Te podatke treba uzeti u obzir ako se bolesnike planira prebaciti s tableta na prašak za oralnu suspenziju ili obrnuto.
In adult and paediatric patients with chronic phase CML, complete blood counts should be performed every 2 weeks for 12 weeks, then every 3 months thereafter or as clinically indicated. 
U odraslih i pedijatrijskih bolesnika s KML u kroničnoj fazi, kompletnu krvnu sliku treba raditi svaka 2 tjedna tijekom 12 tjedana, a zatim svaka 3 mjeseca nakon toga ili prema kliničkoj indikaciji.
Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions. 
Varijabilnost u izloženosti dasatinibu izraženija je nakon primjene natašte (47% CV) nego nakon primjene uz obrok s malim udjelom masnoća (39% CV) ili obrok bogat masnoćama (32% CV).
The main secondary endpoint was MCyR by total daily dose level in the imatinib-resistant patients. 
Glavni sekundarni ishodi bili su značajan citogenetski odgovor prema ukupnoj razini dnevne doze u bolesnika otpornih na imatinib.
SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib (see section 4.6). 
SPRYCEL se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje dasatinibom (vidjeti dio 4.6).
2 Resume treatment at the original starting dose. 
2 Nastaviti liječenje dozom kojom je i započelo.
Prior imatinib (N = 46)b 
Prethodno liječenje imatinibom (N = 46)b
• If a second dose is needed to complete the total prescribed dose, repeat steps 3 through 10. 
• Ako za primjenu cijele propisane količine lijeka treba primijeniti još jednu dozu, ponovite korake
A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other. 
Možda će trebati promijeniti dozu lijeka pri prelasku s jednog oblika lijeka na drugi (tj. tablete i prašak za oralnu suspenziju), stoga nemojte prelaziti s jednog oblika na drugi.
Due to the limitations of this clinical study, caution is recommended when administering dasatinib to patients with hepatic impairment. 
Zbog ograničenja ovog kliničkog ispitivanja, oprez je potreban pri primjeni dasatiniba kod bolesnika s oštećenom jetrenom funkcijom.
A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib. 
Obrok siromašan mastima 30 minuta prije primjene dasatiniba rezultirao je 21%-tnim povećanjem prosječne AUC dasatiniba.
Carefully prepare the SPRYCEL oral suspension for administration, measure the dose, and fill the syringe, like this: 
Pažljivo pripremite SPRYCEL oralnu suspenziju za primjenu, odmjerite dozu i napunite štrcaljku na sljedeći način:
Other relevant efficacy results included CCyR and complete molecular response (CMR) rates. 
Ostali važni rezultati mjerenja djelotvornosti uključivali su stope CCyR i potpunog molekularnog odgovora (CMR).
Not known nephrotic syndrome Pregnancy, puerperium and perinatal conditions 
Nepoznato nefrotski sindrom Stanja vezana uz trudnoću, babinje i perinatalno razdoblje
If laboratory or clinical findings associated with TMA occur in a patient receiving SPRYCEL, treatment with SPRYCEL should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed. 
Ako laboratorijski ili klinički nalazi u bolesnika koji prima SPRYCEL upućuju na TMA, potrebno je prekinuti liječenje lijekom SPRYCEL i provesti temeljitu ocjenu radi utvrđivanja TMA, uključujući određivanje aktivnosti enzima ADAMTS13 i prisutnosti protutijela na ADAMTS13.
Thus, antacids may be administered up to 2 hours prior to or 2 hours following SPRYCEL (see section 4.4). 
Stoga se antacidi mogu primijeniti najmanje 2 sata prije ili 2 sata poslije primjene lijeka SPRYCEL (vidjeti dio 4.4).
MCyR (0%-35%) combines both complete and partial responses. 
(0%-35%) obuhvaća i potpun i djelomičan odgovor.
In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. 
U kliničkim je ispitivanjima mijelosupresija obuzdavana preskakanjem doze, smanjenjem doze ili prekidom ispitivanja lijeka.
Step 5: Dispense the bottle with inserted PIBA, package leaflet, and oral dosing syringe in the original carton to the patient or caregiver. 
5. korak: Bocu s umetnutim nastavkom, uputom o lijeku i štrcaljkom za peroralnu primjenu stavite u originalno pakiranje i dajte bolesniku ili njegovatelju.
The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment. 
Postupno povećavanje doze prikazano u Tablici 2 preporučuje se za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi koji ne postignu hematološki, citogenetski i molekularni odgovor u preporučenim vremenskim točkama prema trenutno važećim smjernicama za liječenje i koji podnose liječenje.