natgillin/translations-raw huggingface dataset:
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.
In patients that receive a subsequent stem cell transplantation, SPRYCEL can be administered for an additional year post-transplantation.
Pri bolnikih z naknadno presaditvijo krvotvornih matičnih celic se zdravilo SPRYCEL lahko uporablja še dodatno leto po presaditvi.
Results are shown in Table 15.
Rezultati so prikazani v preglednici 15.
In a supportive study, of 55 paediatric patients, 35 received SPRYCEL in combination with chemotherapy on a discontinuous dosing regimen (two weeks on treatment followed by one to two weeks off) and 20 received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
V podporni študiji s 55 pediatričnimi bolniki je 35 bolnikov prejemalo zdravilo SPRYCEL v kombinaciji s kemoterapijo po režimu prekinjenega odmerjanja (dva tedna zdravljenja, nato pa eden do dva tedna brez zdravljenja), 20 bolnikov pa je prejemalo zdravilo SPRYCEL v kombinaciji s kemoterapijo po režimu neprekinjenega odmerjanja.
Median duration of treatment was approximately 6 months (range 0.03-31 months).
Zdravljenje je v povprečju trajalo približno 6 mesecev (razpon od 0,03 do 31 mesecev).
2 year follow-up
2-letno obdobje spremljanja
By 1 year 5%, p<.2394
V 1 letu 5%, p<0,2394
b Haematologic response criteria (all responses confirmed after 4 weeks): Major haematologic response (MaHR) = complete haematologic response (CHR) + no evidence of leukaemia (NEL).
b Kriteriji hematološkega odziva (vsi odzivi potrjeni po 4 tednih): Dober hematološki odziv (MaHR) = popoln hematološki odziv (CHR) + brez znakov levkemije (NEL).
Before each use, make sure the syringe plunger is pushed to the bottom of the syringe barrel.
Pred vsako uporabo poskrbite, da bo bat brizge potisnjen do spodnjega dela brizge.
The recommended starting daily dosage of SPRYCEL tablets in paediatric patients is shown in Table 1.
Priporočeni začetni dnevni odmerek zdravila SPRYCEL v obliki tablet pri pediatričnih bolnikih je prikazan v preglednici 1.
DO NOT USE A DISHWASHER
NE UPORABLJAJTE POMIVALNEGA STROJA
The mean terminal half-life of dasatinib is 3 hours to 5 hours.
Srednji končni razpolovni čas dasatiniba znaša 3 ure do 5 ur.
If neutropaenia and/or thrombocytopaenia persist and the next block of treatment is delayed another 7 days, a bone marrow assessment should be performed to assess cellularity and percentage of blasts.
Če nevtropenija in/ali trombocitopenija vztrajata in se naslednji blok zdravljenja odloži še za dodatnih 7 dni, je treba ovrednotiti kostni mozeg in določiti celularnost in odstotek blastov.
No studies have been performed to evaluate dasatinib interaction with other protein-bound medicinal products.
Študije, ki bi ovrednotile medsebojno delovanje med dasatinibom in drugimi zdravili, ki se vežejo na proteine, niso bile izvedene.
• Do not take the syringe apart in order to avoid damaging it.
• Brizge ne razstavljajte, da preprečite morebitne poškodbe.
In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma.
Pri zdravih osebah, ki so prejele s [14C] označeni dasatinib v odmerku 100 mg, je nespremenjeni dasatinib predstavljal 29% cirkulirajoče radioaktivnosti v plazmi.
Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Ker je ledvični očistek dasatiniba in njegovih presnovkov manjši od 4%, pri bolnikih z insuficienco ledvic zmanjšanja skupnega telesnega očistka ne pričakujemo.
Results described below are based on a minimum of 2 years and 7 years follow-up after the start of dasatinib therapy.
Rezultati, navedeni v nadaljevanju, temeljijo na najmanj 2-letnem in 7-letnem obdobju spremljanja bolnikov po uvedbi zdravljenja z dasatinibom.
In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months.
V randomiziranem preskušanju pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju je mediana trajanja zdravljenja znašala približno 60 mesecev.
If neutropaenia and/or thrombocytopaenia result in delay of the next block of treatment by more than 14 days, SPRYCEL should be interrupted and resumed at the same dose level once the next block of treatment is started.
Če zaradi nevtropenije in/ali trombocitopenije pride do odložitve naslednjega bloka zdravljenja za več kot 14 dni, je treba zdravljenje z zdravilom SPRYCEL prekiniti in ga nato znova uvesti v enakem odmerku, ko se začne naslednji blok zdravljenja.
Cytogenetic response within 12 months cCCyRa p< 0.007*
Citogenetski odziv v 12 mesecih cCCyRa p < 0,007*
Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4.
Dasatinib je substrat in zaviralec citokroma P450 (CYP) 3A4.
Paediatric patients with CML
Pediatrični bolniki s KML
b Complete cytogenetic response (CCyR) is based on a single bone marrow cytogenetic evaluation.
b Popolni citogenetski odziv (CCyR) temelji na enem citogenetskem vrednotenju kostnega mozga.
The outcome of patients with bone marrow transplantation after dasatinib treatment has not been fully evaluated.
Izid presaditve kostnega mozga po zdravljenju z dasatinibom ni bil popolnoma ovrednoten.
Remove the syringe from the bottle being careful not to depress the plunger.
Brizgo odstranite iz plastenke, pri tem pa pazite, da ne boste pritisnili na bat.
CTC grades: neutropaenia (Grade 3 ≥ 0.5- < 1.0 × 109/l, Grade 4 < 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - < 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - < 80 g/l, Grade 4 < 65 g/l).
Stopnje po CTC: nevtropenija (stopnja 3 ≥ 0,5 - < 1,0 × 109/l, stopnja 4 < 0,5 × 109/l); trombocitopenija (stopnja 3 ≥ 25< 50 × 109/l, stopnja 4 < 25 × 109/l); anemija (hemoglobin; stopnja 3 ≥ 65 - < 80 g/l, stopnja 4 < 65 g/l).
Physicians and other healthcare providers should counsel male patients of appropriate age about possible effects of SPRYCEL on fertility, and this counseling may include consideration of semen deposition.
Zdravniki in drugi zdravstveni delavci morajo bolnikom moškega spola ustrezne starosti pojasniti možne učinke zdravila SPRYCEL na plodnost, vključno z morebitno shranitvijo semena.
Rare pulmonary embolism, acute respiratory distress syndrome
Redki pljučna embolija, akutni respiratorni distresni sindrom
Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
Učinkovitost zdravila SPRYCEL je bila konsistentna in dokazana v različnih podskupinah glede na starost, spol in izhodiščno oceno po Hasfordu.
The time to MMR is displayed graphically in Figure 1.
Čas do MMR je grafično prikazan na sliki 1.
Use with caution in patients with hepatic or renal impairment, as benzyl alcohol may accumulate over time and cause metabolic acidosis.
Uporabljajte previdno pri bolnikih z okvaro jeter ali ledvic, saj se benzilalkohol lahko sčasoma nakopiči in povzroči metabolično acidozo.
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).
Bolnike z dejavniki tveganja ali s predhodno boleznijo srca je treba skrbno nadzirati glede pojava znakov in simptomov srčne disfunkcije in jih ustrezno ovrednotiti ter zdraviti (glejte poglavje 4.4).
In accordance with recommendations for management of non-haematologic adverse reactions (see section 4.2) the dose of dasatinib should be reduced or therapy interrupted during this evaluation.
V skladu s priporočili za ukrepanje v primeru pojava nehematoloških neželenih učinkov (glejte poglavje 4.2) je treba v času trajanja teh preiskav odmerek dasatiniba zmanjšati ali zdravljenje prekiniti.
SPRYCEL inhibits the growth of these leukaemic cells.
Zdravilo SPRYCEL zavira deljenje teh levkemičnih celic.
Dasatinib is associated with fluid retention.
Dasatinib je bil povezan z zastajanjem tekočin.
If cytopaenia recurs, repeat marrow aspirate/biopsy and resume treatment at a reduced dose.
Če se citopenija ponovi, ponovite aspiracijo/biopsijo kostnega mozga in nato ponovno uvedite zdravljenje z zmanjšanim odmerkom.
Dose (maximum dose per day) Original starting dose
Odmerek (največji odmerek na dan) Običajni začetni odmerek
This dose represents 30% lower exposure compared to the recommended dose (see section 5.2. of Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Ta odmerek predstavlja 30% manjšo izpostavljenost v primerjavi s priporočenim odmerkom (glejte poglavje 5.2 povzetka glavnih značilnosti zdravila SPRYCEL prašek za peroralno suspenzijo).
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE06
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), Zaviralci proteinskih kinaz, oznaka ATC: L01XE06