natgillin/translations-raw huggingface dataset:
The relevance of the findings from the rat carcinogenicity study for humans is not known. 
Pomen ugotovitev študije karcinogenosti pri podganah za ljudi ni znan.
a Confirmed complete cytogenetic response (cCCyR) is defined as a response noted on two consecutive occasions (at least 
a Potrjen popolni citogenetski odziv (cCCyR) je opredeljen kot odziv, opažen pri dveh zaporednih vrednotenjih (z vsaj
% with MMR 
% z MMR
• If the amount needed is greater than 11 mL, it must be split into 2 doses as indicated in Table 16. 
• Če je potrebna količina večja od 11 ml, jo morate razdeliti na 2 odmerka, kot je prikazano v preglednici 16.
If there are still visible clumps, continue shaking until no clumps are visible. 
Če so še vedno vidne grudice, nadaljujte s stresanjem, dokler grudice niso več vidne.
• Store the constituted oral suspension in a refrigerator (2°C - 8°C). 
• Rekonstituirano peroralno suspenzijo shranjujte v hladilniku (2 °C - 8 °C).
Do not give this medicine to children younger than one year of age. 
Tega zdravila ne smete dajati otrokom, mlajšim od enega leta.
Patients were treated until disease progression or unacceptable toxicity. 
Bolnike so zdravili do napredovanja bolezni ali pojava nesprejemljive toksičnosti.
Wash the outside and the inside of the syringe with water and allow to air dry after each use to reuse for the next day. 
Zunanjost in notranjost brizge po vsaki uporabi izperite z vodo in pustite, da se pred uporabo naslednji dan posuši na zraku.
The majority of the patients (53%) had received prior imatinib treatment for more than 3 years. 
Večina bolnikov (53%) se je pred tem več kot 3 leta zdravila z imatinibom.
Most patients continued treatment without further evidence of myelosuppression. 
Pri večini bolnikov se je zdravljenje nadaljevalo brez nadaljnjih znakov mielosupresije.
Figure 1: Kaplan-Meier estimate of time to major molecular response (MMR) 
Slika 1: Kaplan-Meierjeva ocena časa do dobrega molekularnega odziva (MMR)
The primary efficacy endpoint was 3-year event-free survival (EFS), which was 65.5% (55.5, 73.7). 
Ključni opazovani dogodek učinkovitosti je bilo 3-letno preživetje brez dogodkov (EFS), katerega delež je znašal 65,5% (55,5; 73,7).
Take SPRYCEL daily until your doctor tells you to stop. 
Zdravilo SPRYCEL jemljite vsak dan, dokler vam zdravnik ne naroči, da prenehajte z jemanjem zdravila.
It could not be determined whether these mucocutaneous adverse reactions were directly related to SPRYCEL or to concomitant medicinal product. 
Ni bilo mogoče ugotoviti, ali so bili ti mukokutani neželeni učinki neposredno povezani z zdravilom SPRYCEL ali s sočasno uporabljenimi zdravili.
SPRYCEL contains sulphur dioxide (E220) May rarely cause severe hypersensitivity reactions and bronchospasm. 
Zdravilo SPRYCEL vsebuje žveplov dioksid (E220) Redko lahko povzroči resne preobčutljivostne reakcije in bronhospazem.
What SPRYCEL is and what it is used for 2. 
Kaj je zdravilo SPRYCEL in za kaj ga uporabljamo 2.
Unopened bottle 2 years. 
Neodprta plastenka 2 leti
For details on preparation and administration of this medicinal product and instructions for use, see section 6.6. 
Za podrobnosti o pripravi in dajanju zdravila ter navodila za uporabo glejte poglavje 6.6.
Certain medicines may interfere with the effect of SPRYCEL when taken together. 
Določena zdravila lahko vplivajo na delovanje zdravila SPRYCEL, če jih jemljete skupaj.
Leukaemia is a cancer of white blood cells. 
Levkemija je rakava bolezen belih krvnih celic.
If you forget to take SPRYCEL 
Če ste pozabili vzeti zdravilo SPRYCEL
The mean apparent oral clearance is 363.8 L/hr (CV% 81.3%). 
Srednji navidezni peroralni očistek znaša 363,8 l/uro (KV% 81,3%).
Film-coated tablets should not be dispersed as the exposure in patients receiving a dispersed tablet is lower than in those swallowing a whole tablet. 
Filmsko obloženih tablet se ne sme razdrobiti, saj je izpostavljenost pri bolnikih, ki prejmejo razdrobljeno tableto, manjša kot pri tistih, ki pogoltnejo celo tableto.
*Adjusted for Hasford Score and indicated statistical significance at a pre-defined nominal level of significance. 
* Prilagojeno glede na oceno po Hasfordu in kaže statistični pomen po vnaprej določeni nominalni vrednosti pomena.
For storage conditions after constitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
• Hold plunger to prevent it from moving. 
• Držite bat, da preprečite njegovo morebitno premikanje.
• If the amount needed is greater than 11 mL, it must be split into 2 doses as shown below: 
• Če je potrebna količina večja od 11 ml, jo morate razdeliti na 2 odmerka, kot je prikazano v nadaljevanju:
With the patient in an upright position, place the tip of the syringe into the mouth between the side of the mouth and the tongue. 
Medtem, ko je bolnik v pokončnem položaju, namestite konico brizge v usta med notranjo stran lica in jezik.
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. 
Izkušnje s prevelikim odmerjanjem zdravila SPRYCEL v kliničnih študijah so omejene na posamezne primere.
Most resistant patients (72%) had received > 600 mg imatinib. 
Bolniki z največjo rezistenco (72%) so prejemali > 600 mg imatiniba.
If marrow cellularity is >10%, resumption of treatment with SPRYCEL may be considered. 
Če je celularnost kostnega mozga >10%, se lahko razmisli o nadaljevanju zdravljenja z zdravilom SPRYCEL.
Discard any unused suspension 60 days after constitution. 
Neuporabljeno suspenzijo zavrzite 60 dni po rekonstituciji.
Mean Tmax was observed between 0.5 and 6 hours and mean half-life ranged from 2 to 5 hours across all dose levels and age groups. 
Srednja vrednost Tmax je bila opažena med 0,5 in 6 urami, srednji razpolovni čas pa se je gibal v razponu od 2 do 5 ur pri vseh odmerkih in starostnih skupinah.
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2). 
Ta odmerek predstavlja 30% manjšo izpostavljenost v primerjavi s priporočenim odmerkom (glejte poglavje 5.2).
Do not take SPRYCEL if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). 
če ste alergični na dasatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy. 
Zdravnik vam bo pojasnil možna tveganja, ki so povezana z jemanjem zdravila SPRYCEL med nosečnostjo.
Additionally, 34 (47%) received diuretics, 23 (32%) received corticosteroids, and 20 (27%) received both corticosteroids and diuretics. 
Dodatno je 34 (47%) bolnikov prejemalo diuretike, 23 (32%) bolnikov kortikosteroide, 20 (27%) bolnikov pa je prejemalo kortikosteroide in diuretike.
The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients. 
Farmakokinetične lastnosti dasatiniba so bile ovrednotene pri 229 zdravih odraslih osebah in 84 bolnikih.
• Put closure back on the bottle and close tightly. 
• Namestite zaporko nazaj na plastenko in jo tesno zaprite.
If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered. 
Če za pojav stanja ni ustreznega pojasnila, ali če po prekinitvi zdravljenja ali zmanjšanju odmerka ne pride do izboljšanja, je treba razmisliti o diagnozi PAH.
• Shake well before each use. 
• Pred vsako uporabo dobro pretresite.
If PAH is confirmed, dasatinib should be permanently discontinued. 
Če je PAH potrjena, je treba zdravljenje z dasatinibom trajno prekiniti.
Major molecular response All patients 
Dober molekularni odziv Vsi bolniki
Monitor patients less than 3 years of age for respiratory symptoms. 
Bolnike, mlajše od 3 let, je treba nadzirati glede pojava respiratornih simptomov.
One case was fatal and was associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopaenia. 
En primer se je končal smrtno in je bil povezan s trombocitopenijo stopnje 4 po lestvici toksičnosti CTC (“Common Toxicity Criteria”).
2 Resume treatment at the original starting dose. 
2 Ponovno uvedite zdravljenje, in sicer s prvotnim začetnim odmerkom.
______ Dasatinib 100 mg once daily --------- Imatinib 400 mg once daily 
______ Dasatinib 100 mg enkrat na dan --------- Imatinib 400 mg enkrat na dan
This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA). 
To so lahko znaki poškodb krvnih žil imenovane trombotična mikroangiopatija (TMA).
SPRYCEL has minor influence on the ability to drive and use machines. 
Zdravilo SPRYCEL ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Table 16: How to split a dose of oral suspension that is greater than 11 mL 
Preglednica 16: Razdelitev odmerka peroralne suspenzije, ki je večji od 11 ml
Efficacy was also assessed in patients who were intolerant to imatinib. 
Učinkovitost je bila ovrednotena tudi pri bolnikih, ki niso prenašali imatiniba.
MONTHS 
MESECI
Tell your doctor if you are taking medicines to thin the blood or prevent clots. 
Obvestite zdravnika, če jemljete zdravila za redčenje krvi ali preprečevanje nastanka krvnih strdkov.
Less than 10% of patients with pleural effusion had severe (grade 3 or 4) dasatinib-related pleural effusions. 
Manj kot 10% bolnikov s plevralnim izlivom je imelo resne (stopnja 3 ali 4) z dasatinibom povezane plevralne izlive.
At the request of the European Medicines Agency, Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
2 year n/a 
2 leti n/a
In patients, dasatinib has a large apparent volume of distribution (2,505 L), coefficient of variation (CV% 93%), suggesting that the medicinal product is extensively distributed in the extravascular space. 
Dasatinib ima pri bolnikih velik navidezni volumen porazdelitve (2.505 l), koeficient variacije (KV% 93%), kar kaže na ekstenzivno porazdelitev zdravila v ekstravaskularni prostor.
Bleeding in the stomach or bowels that can cause death Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection) 
Krvavitev v želodcu ali črevesu, ki se lahko konča s smrtjo Ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter)
Common contusion a Includes decreased appetite, early satiety, increased appetite. 
Pogosti kontuzije a Vključuje zmanjšan apetit, zgodnji občutek sitosti in povečan apetit.
Disease progression was defined as increasing white blood cells despite appropriate therapeutic management, loss of CHR, partial CyR or CCyR, progression to accelerated phase or blast phase, or death. 
Napredovanje bolezni je bilo opredeljeno kot naraščanje števila belih krvnih celic kljub primernemu zdravljenju, izguba CHR, delni CyR ali CCyR, napredovanje do faze pospešenega poteka ali blastne preobrazbe ali smrt.
Hazard ratio (HR) within 12 months (99.99% CI) 
Razmerje ogroženosti (HR) v 12 mesecih (99,99% IZ)
Add 77.0 mL of purified water all at once to the bottle and close tightly with closure. 
V plastenko naenkrat dodajte 77,0 ml prečiščene vode in plastenko tesno zaprite z zaporko.
How to take SPRYCEL 4. 
Kako jemati zdravilo SPRYCEL 4.
SPRYCEL oral suspension is taken once daily. 
Zdravilo SPRYCEL peroralna suspenzija se jemlje enkrat na dan.
Changes in the gastrointestinal, haematopoietic and lymphoid systems were reversible following cessation of treatment. 
Spremembe v gastrointestinalnem, hematopoetskem in limfoidnem sistemu so bile po prekinitvi dajanja zdravila reverzibilne.
For higher or lower doses, you may need to take combinations of the different tablet strengths. 
Če vam zdravnik predpiše večji ali manjši odmerek, boste morda morali jemati kombinacijo tablet različnih jakosti.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from available post-marketing data). 
Pogostnost je definirana kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); neznana pogostnost (pogostnosti iz razpoložljivih podatkov po pridobitvi dovoljenja za promet ni mogoče oceniti).
How long to take SPRYCEL 
Kako dolgo jemati zdravilo SPRYCEL
Use of SPRYCEL is not recommended during pregnancy. 
Uporaba zdravila SPRYCEL med nosečnostjo ni priporočljiva.
These effects occurred at doses that did not produce maternal toxicity, indicating that dasatinib is a selective reproductive toxicant from implantation through the completion of organogenesis. 
Ti učinki so se pojavili pri odmerkih, ki niso bili toksični za mater, kar kaže, da je dasatinib selektivno toksičen v obdobju reprodukcije, in sicer v obdobju od vgnezditve do zaključka organogeneze.
Slowly withdraw the amount of SPRYCEL oral suspension prescribed by pulling the syringe plunger until it reaches the marking of the dose prescribed. 
Počasi izvlecite predpisano količino peroralne suspenzije zdravila SPRYCEL s potegom bata brizge, dokler le-ta ne doseže oznake predpisanega odmerka.
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. 
Neželeni učinki, o katerih so poročali v teh dveh pediatričnih študijah s pogostnostjo 10% pri bolnikih z neprekinjenim režimom odmerjanja, so prikazani v preglednici 7.
Slowly push the plunger down until all of the dose has been given. 
Počasi potiskajte bat navzdol, dokler ne iztisnete celotnega odmerka.
Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year 
Preživetje (%; Kaplan-Meierjeva ocena) Brez progresije 1 leto 2 leti Skupno 1 leto 2 leti
All patients were extensively pretreated. 
Vsi bolniki so bili predhodno intenzivno zdravljeni.
The backbone chemotherapy regimen was the same as used in the AIEOP-BFM ALL 2000 trial (chemotherapeutic standard multi-agent chemotherapy protocol). 
Režim osnovne kemoterapije je bil enak kot v preskušanju AIEOP-BFM ALL 2000 (standardni protokol kemoterapije z več kemoterapevtiki).
Dosing for children and adolescents is on the basis of body weight (see Table 1). 
Pri otrocih in mladostnikih odmerjanje temelji na telesni masi (glejte preglednico 1).
g Musculoskeletal pain reported during or after discontinuing treatment. 
g Mišično-skeletne bolečine o katerih so poročali med zdravljenjem ali po prekinitvi zdravljenja.
Film-coating Hypromellose Titanium dioxide (E171) Macrogol 400 
Filmska obloga hipromeloza titanov dioksid (E171) makrogol 400
Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor. 
Dasatinib zavira aktivnost BCR-ABL kinaze in kinaz iz družine SRC skupaj s številnimi drugimi izbranimi onkogenimi kinazami, vključno s c-KIT, kinazami efrinskih (EPH) receptorjev in PDGFβ receptorjev.
It cannot be excluded that the effect is larger after multiple doses of dasatinib. 
Večjega učinka po večkratnih odmerkih dasatiniba ni možno izključiti.
The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8. 
Pogostnost hematoloških nepravilnosti stopnje 3 in 4 je prikazana v preglednici 8.
These white cells usually help the body to fight infection. 
Bele krvne celice sodelujejo pri obrambi organizma pred okužbami.
QT interval was corrected for heart rate by Fridericia's method. 
Interval QT je bil glede na srčno frekvenco prilagojen z metodo po Fridericiju.
Step 4: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 60 days from the date of constitution). 
4. korak: Na nalepko plastenke zapišite datum izteka roka uporabnosti rekonstituirane peroralne suspenzije (datum izteka roka uporabnosti rekonstituirane peroralne suspenzije je 60 dni od datuma rekonstitucije).
These 6 cases included cases of epiphyses delayed fusion, osteopaenia, growth retardation, and gynecomastia (see section 5.1). 
Teh 6 primerov vključuje primere zapoznelega zaprtja epifiz, osteopenije, zaostanka v rasti in ginekomastije (glejte poglavje 5.1).
At the maximum daily dose of 16 mL oral suspension, this is equivalent to 1.7% of the WHO recommended maximum daily dietary intake of 2 g sodium for an adult. 
Pri največjem dnevnem odmerku 16 ml peroralne suspenzije to po priporočilih SZO ustreza 1,7% priporočenega največjega dnevnega vnosa 2 g natrija za odraslo osebo.
Pregnant or breast-feeding women should avoid exposure to SPRYCEL powder for oral suspension. 
Nosečnice ali doječe matere se morajo izogibati izpostavljenosti zdravilu SPRYCEL prašek za peroralno suspenzijo.
Congestive heart failure/cardiac dysfunction and pulmonary oedema were reported in < 2% of patients. 
O kongestivnem srčnem popuščanju/srčni disfunkciji in pljučnem edemu so poročali pri < 2% bolnikov.
What SPRYCEL is and what it is used for 
Kaj je zdravilo SPRYCEL in za kaj ga uporabljamo
PHARMACEUTICAL FORM Film-coated tablet (tablet). 
FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta)
In general, there was no association of decreased calcium with clinical symptoms. 
Zmanjšane vrednosti kalcija na splošno niso bile povezane s kliničnimi simptomi.
The mutations detected among the dasatinib-treated patients were T315I, F317I/L and V299L. 
Pri bolnikih, ki so se zdravili z dasatinibom, so poročali o pojavu mutacij T315I, F317I/L in V299L.
A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib. 
V skupine zdravljenja je bilo randomiziranih skupaj 519 bolnikov: 259 bolnikov na zdravilo SPRYCEL in 260 bolnikov na imatinib.
In rats, minimal to mild decreases in erythrocyte parameters were accompanied by bone marrow changes; similar changes occurred in monkeys at a lower incidence. 
Pri podganah so minimalno do blago zmanjšane eritrocitne parametre spremljale spremembe v kostnem mozgu; podobne spremembe so se z manjšo pojavnostjo pojavile tudi pri opicah.
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly. 
V skladu z odzivom na zdravljenje vam lahko zdravnik odmerek poveča ali zmanjša ali pa zdravljenje celo za krajši čas prekine.
In patients in whom rifampicin or other CYP3A4 inducers are indicated, alternative medicinal products with less enzyme induction potential should be used. 
Pri bolnikih, pri katerih je indicirana uporaba rifampicina ali drugih induktorjev CYP3A4, je treba uporabljati alternativna zdravila z manjšim potencialom za indukcijo encima.
In vitro, dasatinib is active in leukaemic cell lines representing variants of imatinib-sensitive and resistant disease. 
In vitro dasatinib učinkuje na linijah levkemičnih celic, ki predstavljajo različici za imatinib občutljive in na imatinib odporne bolezni.
Step 1: Tap bottom of each bottle (containing 33 g SPRYCEL powder for oral suspension) gently to loosen the powder. 
1. korak: Rahlo udarite po dnu vsake plastenke (vsebuje 33 g SPRYCEL praška za peroralno suspenzijo), da razrahljate prašek.
SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib. 
Zdravila SPRYCEL ne smete uporabljati med nosečnostjo, razen če klinično stanje nosečnice zahteva zdravljenje z dasatinibom.
However, when antacids were administered 2 hours prior to a single dose of SPRYCEL, no relevant changes in dasatinib concentration or exposure were observed. 
Če so osebe antacide prejele 2 uri pred enkratnim odmerkom zdravila SPRYCEL, pomembnih sprememb koncentracije ali izpostavljenosti dasatinibu niso opazili.
CYP3A4 is a major enzyme responsible for the metabolism of dasatinib. 
CYP3A4 je glavni encim, ki je odgovoren za presnovo dasatiniba.
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. 
Sedemnajst bolnikov je imelo 2 ločena neželena učinka, 6 bolnikov 3 neželene učinke, 18 bolnikov od 4 do 8 neželenih učinkov, 5 bolnikov pa > 8 epizod plevralnega izliva.
A bioequivalence study evaluating the powder for oral suspension to the reference tablet formulation in 77 adult patients showed that the exposure for the powder for oral suspension was 19% less than that of reference tablets. 
Bioekvivalenčna študija, s katero so vrednotili prašek za peroralno suspenzijo z referenčno farmacevtsko obliko v obliki tablet pri 77 odraslih bolnikih, je pokazala, da je izpostavljenost pri prašku za peroralno suspenzijo bila za 19% manjša kot pri referenčni tableti.
If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected. 
Če je mogoče, je treba izbrati drugo sočasno zdravilo, ki nima ali ima minimalen potencial za zaviranje encima.
A total of 2,712 patients were evaluated in clinical studies; of these 23% were ≥ 65 years of age and 5% were ≥ 75 years of age. 
V kliničnih študijah je bilo vsega skupaj ovrednotenih 2.712 bolnikov, od katerih je bilo 23% bolnikov starih 65 let ali starejših, 5% bolnikov pa starih 75 let ali starejših.
If the episode does not improve within approximately one week, a course of diuretics or corticosteroids or both concurrently should be considered (see sections 4.4 and 4.8). 
Če se stanje v približno enem tednu ne izboljša, je treba razmisliti o zdravljenju z diuretiki ali s kortikosteroidi ali s kombinacijo obeh sočasno (glejte poglavji 4.4 in 4.8).
In these cases, PAH was reported after initiation of dasatinib therapy, including after more than one year of treatment. 
O pojavu PAH so poročali po uvedbi zdravljenja z dasatinibom in sicer tudi več kot eno leto po uvedbi zdravljenja.
Following a single oral dose of [14C]-labelled dasatinib, approximately 89% of the dose was eliminated within 10 days, with 4% and 
Po enem samem peroralnem odmerku s [14C] označenega dasatiniba se je približno 89% odmerka izločilo v 10 dneh.
Based on human experience, dasatinib is suspected to cause congenital malformations including neural tube defects, and harmful pharmacological effects on the foetus when administered during pregnancy. 
Na podlagi izkušenj pri ljudeh se sumi, da dasatinib povzroča kongenitalne malformacije, vključno z okvarami nevralne cevi, in škodljive farmakološke učinke na plod, če ga jemljejo nosečnice.
In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults. 
V pediatričnih študijah KML so bili deleži laboratorijskih odstopanj skladni z znanim profilom za laboratorijske parametre pri odraslih.
Time-to cCCyR Time-to MMR Durability of cCCyR 
Čas do cCCyR Čas do MMR Trajanje cCCyR
In vitro data indicate a potential risk for interaction with CYP2C8 substrates, such as glitazones. 
Podatki, pridobljeni in vitro, kažejo na možno tveganje za interakcije s substrati za CYP2C8, kot so glitazoni.
SPRYCEL film-coated tablets and SPRYCEL powder for oral suspension are not bioequivalent. 
Zdravili SPRYCEL filmsko obložene tablete in SPRYCEL prašek za peroralno suspenzijo nista bioekvivalentni.
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with SPRYCEL should not be resumed. 
V primeru zvišanja vrednosti protiteles anti-ADAMTS13 s sočasno nizko aktivnostjo ADAMTS13 se zdravljenja z zdravilom SPRYCEL ne sme ponovno uvesti.
4 If cytopaenia is related to leukaemia, consider dose escalation to 180 mg once daily. 
4 Če je citopenija povezana z levkemijo, presodite o povečanju odmerka na 180 mg enkrat na dan.