natgillin/translations-raw huggingface dataset:
Dose increase or reduction is recommended based on patient response and tolerability.
Preporučuje se povećanje ili smanjenje doze na temelju kliničkog odgovora bolesnika i podnošljivosti lijeka.
MR4.5 rates over time are displayed graphically in Figure 3.
Stope MR4,5 tijekom vremena grafički su prikazane na Slici 3.
Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction.
Mijelosupresija je obično reverzibilna i najčešće se zbrinjava privremenim prekidom primjene ili smanjenjem doze dasatiniba.
Dasatinib was considered to be non-phototoxic in vivo after a single oral administration to female hairless mice at exposures up to 3-fold the human exposure following administration of the recommended therapeutic dose (based on AUC).
Dasatinib se nije smatrao fototoksičnim in vivo nakon primjene pojedinačne doze u ženki bezdlakog miša, pri čemu je njihova izloženost bila trostruko veća od izloženosti ljudi nakon primjene preporučene terapijske doze (na temelju AUC).
The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Drugi sastojci su: Jezgra tablete: laktoza hidrat (vidjeti dio 2 "SPRYCEL sadrži laktozu"); mikrokristalična celuloza; umrežena karmelozanatrij; hidroksipropilceluloza; magnezijev stearat Film ovojnica: hipromeloza; titanijev dioksid (E171); makrogol 400
In a paediatric pharmacokinetics study, dose-normalized dasatinib exposure (Cavg, Cmin and Cmax) appears similar between 21 patients with CP-CML and 16 patients with Ph+ ALL.
U ispitivanju farmakokinetike u pedijatrijskih bolesnika izloženost dasatinibu normalizirana za dozu (Cavg, Cmin i Cmax) činila se sličnom u 21 bolesnika s KML u kroničnoj fazi i 16 bolesnika s Ph+ ALL.
There is no experience with SPRYCEL treatment in children under 1 year of age.
Nema iskustva s liječenjem lijekom SPRYCEL u djece mlađe od godinu dana.
The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
Procijenjena 60-mjesečna stopa PFS bila je 88,9% (CI: 84% - 92,4%) i u skupini liječenoj dasatinibom i u skupini liječenoj imatinibom.
Following a single oral dose of [14C]-labelled dasatinib, approximately 89% of the dose was eliminated within 10 days, with 4% and
Nakon peroralne primjene pojedinačne doze dasatiniba obilježenog sa [14C], oko 89% doze eliminiralo se u roku od 10
Ninety-seven of the 130 paediatric patients with CML-CP were treated with SPRYCEL tablets 60 mg/m2 once daily (maximum dose of 100 mg once daily for patients with high
Devedeset i sedam od 130 pedijatrijskih bolesnika s KML u kroničnoj fazi bilo je liječenoj SPRYCEL tabletama u dozi od 60 mg/m2 jedanput dnevno (maksimalna doza od 100 mg jedanput dnevno za bolesnike koji su imali veliku tjelesnu površinu).
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
What SPRYCEL looks like and contents of the pack SPRYCEL is supplied as a white to off-white powder for oral suspension which forms a white to yellow opaque suspension after constitution with water.
SPRYCEL dolazi kao bijeli do bjelkasti prašak za oralnu suspenziju koji nakon miješanja s vodom tvori bijelu do žutu neprozirnu suspenziju.
The effect of hepatic impairment on the single-dose pharmacokinetics of dasatinib was assessed in 8 moderately hepatic-impaired subjects who received a 50 mg dose and 5 severely hepatic-impaired subjects who received a 20 mg dose compared to matched healthy subjects who received a 70 mg dose of dasatinib.
Učinak na farmakokinetiku dasatiniba u jednostrukoj dozi procjenjivan je kod 8 bolesnika s umjerenim oštećenjem jetre koji su primali dozu od 50 mg i 5 bolesnika sa teškim oštećenjem jetre koji su primali dozu od 20 mg u odnosu na odgovarajuće zdrave ljude koji su primali dozu od 70 mg dasatiniba.
In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage.
U bolesnika s KML u kroničnoj fazi (n=548), 5 bolesnika (1%) koji su primali dasatinib imali su 3. ili 4. stupanj krvarenja.
The safety profile of SPRYCEL administered in combination with chemotherapy in paediatric patients with Ph+ ALL was consistent with the known safety profile of SPRYCEL in adults and the expected effects of chemotherapy, with the exception of a lower pleural effusion rate in paediatric patients as compared to adults.
Sigurnosni profil lijeka SPRYCEL koji se primjenjuje u kombinaciji s kemoterapijom u pedijatrijskih bolesnika s Ph+ ALL bio je u skladu s poznatim sigurnosnim profilom lijeka SPRYCEL u odraslih i očekivanim učincima kemoterapije, uz izuzetak niže stope pleuralnog izljeva u pedijatrijskih bolesnika u odnosu na odrasle.
Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Vrlo često mijelosupresija (uključujući anemiju, neutropeniju, trombocitopeniju)
Common weight decreased, weight increased
Često smanjenje tjelesne težine, povećanje tjelesne težine
Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Dasatinib se može nastaviti primjenjivati u prethodnoj dozi u slučaju da su nuspojave bile blage/umjerene (≤2 stupnja) ili u smanjenoj dozi u slučaju teških nuspojava (≥3 stupnja) (vidjeti dio 4.2).
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 hematološkog odgovora (svi odgovori potvrđeni nakon 4 tjedna): Značajan hematološki odgovor (MaHR) = potpun hematološki odgovor (CHR) + nema znakova leukemije (NEL, engl no evidence of leukaemia).
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults
Tablica 3: Prilagodbe doze zbog neutropenije i trombocitopenije u odraslih
Cutaneous haemorrhage was observed in an acute, single-dose oral study in monkeys but was not observed in repeat-dose studies in either monkeys or rats.
Krvarenja u kožu zabilježena su u akutnom ispitivanju pojedinačne peroralne doze u majmuna, ali nisu zabilježena u ispitivanjima ponovljene doze ni u majmuna ni u štakora.
SPRYCEL tablets are not recommended for patients weighing less than 10 kg.
SPRYCEL tablete ne preporučuju se za bolesnike tjelesne težine manje od 10 kg.
Two clinical studies were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these studies was Major Cytogenetic Response (MCyR).
Dva klinička ispitivanja provedena su u bolesnika koji su otporni na imatinib ili ga ne podnose; primarni ishod za procjenu djelotvornosti u ovim je ispitivanjima bio značajni citogenetski odgovor
For paediatric patients with Ph+ ALL, no dose modification is recommended in cases of haematologic Grade 1 to 4 toxicities.
U pedijatrijskih bolesnika s Ph+ ALL ne preporučuje se prilagođavanje doze u slučaju hematoloških toksičnosti 1. - 4. stupnja.
Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce i kutiji iza oznake “EXP".
The frequency of grade 3 and 4 haematological abnormalities is presented in Table 8.
Učestalost hematoloških poremećaja 3. ili 4. stupnja prikazana je u Tablici 8.
Table 7: Adverse reactions reported in ≥10% of paediatric patients with Ph+ ALL treated with SPRYCEL on a continuous dosing regimen in combination with chemotherapy (N=126)a
Tablica 7: Nuspojave prijavljene u ≥ 10% pedijatrijskih bolesnika s Ph+ ALL liječenih lijekom SPRYCEL prema režimu kontinuirane primjene u kombinaciji s kemoterapijom (N=126)a
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.
Liječnici i drugi zdravstveni radnici trebaju savjetovati muškarce odgovarajuće dobi o mogućim učincima lijeka SPRYCEL na plodnost.
Elimination is predominantly in the faeces, mostly as metabolites.
Dasatinib se pretežno eliminira putem stolice, uglavnom u obliku metabolita.
A total of 519 patients were randomised to a treatment group: 259 to SPRYCEL and 260 to imatinib.
Ukupno je 519 bolesnika bilo randomizirano u dvije terapijske skupine: 259 u skupinu koja je primala SPRYCEL i 260 u skupinu koja je primala imatinib.
While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4).
Dok je sigurnosni profil lijeka SPRYCEL u starijih osoba bio sličan onome u mlađoj populaciji, u bolesnika u dobi od 65 i više godina veća je vjerojatnost nastupa često prijavljenih nuspojava poput umora, pleuralnog izljeva, dispneje, kašlja, krvarenja u donjem dijelu gastrointestinalnog sustava i poremećaja apetita, kao i manje često prijavljenih nuspojava poput distenzije abdomena, omaglice, perikardijalnog izljeva, kongestivnog zatajenja srca i smanjenja tjelesne težine, pa stoga starije osobe moraju biti strogo nadzirane (vidjeti dio 4.4).
Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Farmakokinetika dasatiniba pokazala je proporcionalnost dozi, a u pedijatrijskih je bolesnika opaženo povećanje izloženosti povezano s dozom.
At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
Nakon 3 mjeseca, značajni citogenetski odgovor je bio češći u skupini koja je primala dasatinib (36%) nego u skupini koja je primala imatinib (29%).
The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets.
Prašak za oralnu suspenziju treba primijeniti u bolesnika koji teže manje od 10 kg i koji ne mogu gutati tablete.
Brain: stroke, temporary episode of neurologic dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
Mozak: moždani udar, privremena epizoda poremećaja neurološke funkcije uzrokovana gubitkom krvi, paraliza živca lica, demencija
An open-label, single-arm, multicentre study was conducted in patients resistant or intolerant to imatinib (i.e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
Multicentrično ispitivanje otvorenog tipa u jednoj skupini provedeno je u bolesnika koji su otporni na imatinib ili ga ne podnose (tj. bolesnici u kojih su značajni toksični učinci nastali tijekom liječenja imatinibom onemogućili daljnje liječenje).
To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets and powder for oral suspension (10 mg/mL suspension upon constitution).
Da bi se postigla preporučena doza, SPRYCEL je dostupan u obliku filmom obloženih tableta od 20 mg, 50 mg, 70 mg, 80 mg, 100 mg i 140 mg te u obliku praška za oralnu suspenziju (koncentracija suspenzije nakon rekonstitucije iznosi 10 mg/ml).
Stevens-Johnson syndromef Musculoskeletal and connective tissue disorders Very common musculoskeletal paing
Stevens-Johnson sindromf Poremećaji mišićno-koštanog sustava i veznog tkiva
SPRYCEL will only be prescribed by a doctor with experience in treating leukaemia.
SPRYCEL će propisati samo liječnik s iskustvom u liječenju leukemije.
Table 15: Efficacy of SPRYCEL in paediatric patients with CML-CP Cumulative response over time by minimum follow-up period 3 months
Tablica 15: Djelotvornost lijeka SPRYCEL u pedijatrijskih bolesnika s KML u kroničnoj fazi Kumulativni odgovor tijekom vremena prema minimalnom razdoblju praćenja 3 mjeseca
A total of 43% of the patients in the dasatinib arm, and 82% in the imatinib arm had treatment failure, defined as disease progression or cross-over to the other treatment (lack of response, intolerance of study medicinal product, etc.).
Liječenje nije uspjelo u 43% bolesnika u skupini koja je primala dasatinib i u 82% u skupini koja je primala imatinib, a neuspjeh liječenja definirao se kao progresija bolesti ili prelazak u drugu terapijsku skupinu (izostanak odgovora, nepodnošenje ispitivanog lijeka, itd.).
Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Među bolesnicima liječenima dozom od 100 mg jednom dnevno kumulativna incidencija citopenije 3. ili 4. stupnja bila je slična u 2. i 5. godini, uključujući: neutropeniju (35% nasuprot 36%), trombocitopeniju (23% nasuprot 24%) i anemiju (13% nasuprot 13%).
Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
Jedna filmom obložena tableta sadrži 20 mg, 50 mg, 70 mg, 80 mg,100 mg ili 140mg dasatiniba (u obliku hidrata).
Your doctor will decide the right dose based on age and weight.
Liječnik će odrediti pravu dozu na temelju dobi i tjelesne težine.
c Major molecular response (at any time) was defined as BCR ABL ratios ≤ 0.1% by RQ PCR in peripheral blood samples standardised on the International scale.
c Značajni molekularni odgovor (u bilo kojem trenutku) definirao se kao BCR-ABL omjer ≤ 0,1% na RQ-PCR u uzorcima periferne krvi standardiziran prema Međunarodnoj ljestvici.
Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
Dasatinib nije utjecao na plodnost mužjaka i ženki štakora u konvencionalnom ispitivanju plodnosti niti na rani embrionalni razvoj u štakora, ali je izazvao embrioletalne učinke pri dozama sličnim kliničkim dozama u ljudi.
The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Stopa negativnih nalaza na minimalnu rezidualnu bolest (engl. minimal residual disease, MRD), utvrđena prema prerazmještaju baza u genu za Ig/TCR do kraja konsolidacije, iznosila je 71,7% u svih liječenih bolesnika.
If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Ako se SPRYCEL mora primjenjivati istodobno sa snažnim inhibitorom CYP3A4, potrebno je razmotriti smanjenje doze na:
In healthy subjects, the concomitant use of aluminium hydroxide/magnesium hydroxide antacids with SPRYCEL reduced the AUC of a single dose of SPRYCEL by 55% and the Cmax by 58%.
U zdravih je ispitanika istodobna primjena antacida od aluminijevog hidroksida ili magnezijevog hidroksida i lijeka SPRYCEL smanjila AUC lijeka SPRYCEL nakon pojedinačne doze za 55% te Cmax za 58%.
Do not use this medicine after the expiry date which is stated on the bottle label, blister or carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce, blisteru ili kutiji iza oznake “EXP".
In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarisation (QT Interval) (see section 5.3).
Podaci iz ispitivanja in vitro pokazuju da dasatinib može produžiti repolarizaciju srčane klijetke (QT interval) (vidjeti dio 5.3).
In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.
U ispitivanju optimizacije doze faze III u bolesnika u uznapredovaloj fazi KML i Ph+ ALL, medijan trajanja liječenja bio je 14 mjeseci za fazu ubrzanja KML, 3 mjeseca za mijeloidnu blastnu krizu KML, 4 mjeseca za limfoidnu blastnu krizu KML i 3 mjeseca za Ph+ ALL.
Therefore, concomitant use of potent CYP3A4 inducers with dasatinib is not recommended.
Stoga se ne preporučuje istodobna primjena potentnih induktora CYP3A4 i dasatiniba.
b CA180-034 study results in recommended starting dose of 100 mg once daily.
b Rezultati ispitivanja CA180-034 uz preporučenu početnu dozu od 100 mg jedanput dnevno.
Fluid retention adverse reactions were typically managed by supportive care measures that include diuretics and short courses of steroids (see sections 4.2 and 4.8).
Nuspojave zadržavanja tekućine uglavnom su bilezbrinute uvođenjem potpornih mjera koje su uključivale primjenu diuretika i kratkotrajnu primjenu steroida (vidjeti dijelove 4.2 i 4.8).
In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
U pivotalnom je ispitivanju sudjelovalo 106 pedijatrijskih bolesnika koji su primali SPRYCEL u kombinaciji s kemoterapijom prema režimu kontinuirane primjene.
SPRYCEL 10 mg/mL powder for oral suspension
SPRYCEL 10 mg/ml prašak za oralnu suspenziju
Contains 0.29 g of sucrose per mL of oral suspension.
Sadrži 0,29 g saharoze po ml oralne suspenzije.
One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Jedna plastična boca od 120 ml (sa zatvaračem sigurnim za djecu) sadrž 33 g praška za oralnu suspenziju.
After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Nakon najmanje 60 mjeseci praćenja kumulativna stopa trajnog prekida liječenja zbog mijelosupresije 3. ili 4. stupnja bila je 2,3%.
Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Nositelje virusa HBV kojima je potrebno liječenje SPRYCELOM, potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
h Frequency reported as common in paediatric studies.
h Prijavljeno često u pedijatrijskim ispitivanjima.
Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Ph+ akutne limfoblastične leukemije (ALL) i limfoidne blastične KML uz nepodnošenje ili otpornost na prethodnu terapiju.
The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Stopa značajnog molekularnog odgovora (definiranog kao BCR-ABL/kontrolni transkripti ≤0,1% po RQ-PCR u uzorcima periferne krvi) prije prelaska u drugu terapijsku skupinu iznosila je 29% za dasatinib i 12% za imatinib.
Infections and infestations Very common infection (including bacterial, viral, fungal, non-specified)
Vrlo često infekcije (uključujući bakterijske, virusne, gljivične, nespecificirane)
Following resolution of a subsequent episode, dasatinib at one dose level reduction should be reintroduced.
Nakon povlačenja naredne epizode, treba ponovno uvesti dasatinib u dozi nižoj za jednu razinu.
SPRYCEL will only be prescribed to you by a doctor with experience in treating leukaemia.
SPRYCEL će Vam propisati samo liječnik s iskustvom u liječenju leukemije.
But if they do, persons other than the patient should use gloves when handling SPRYCEL.
Ali ako jesu, osobe koje dolaze u kontakt s tabletama, a nisu bolesnici moraju koristiti rukavice za jednokratnu uporabu.
Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Dasatinib nije pokazao mutageno djelovanje na bakterijske kulture in vitro (Ames test) niti je imao genotoksične učinke u in vivo provedenom mikronukleusnom testu u štakora.
In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
U štakora je dasatinib inhibirao agregaciju trombocita in vitro i produžio krvarenje iz kutikule in vivo, ali nije izazivao spontana krvarenja.
Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
U bolesnika koji razviju simptome koji upućuju na pleuralni izljev, kao što su dispneja ili suhi kašalj, mora se napraviti rendgensku snimku pluća.
After a minimum of 60 months follow-up, the cumulative rates of neutropaenia, thrombocytopaenia, and anaemia were 29%, 22% and 13%, respectively.
Nakon najmanje 60 mjeseci praćenja, kumulativna stopa pojave neutropenije bila je 29%, trombocitopenije 22% i anemije 13%.
Two-level dose reduction
Smanjenje doze za dvije razine
SPRYCEL 10 mg/mL powder for oral suspension dasatinib
SPRYCEL 10 mg/ml prašak za oralnu suspenziju dasatinib
Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Rijetko hipertireoza, tireoiditis Poremećaji metabolizma i prehrane
The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Medijan vremena do nastupa prvog pleuralnog izljeva ≥ 3. stupnja uzrokovanog primjenom dasatiniba iznosio je 175 tjedana (raspon: 114-274 tjedna).
• 12-mL oral syringe provided with the bottle.
• štrcaljku za usta volumena 12 ml koja dolazi s bocom
No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Nisu provedena klinička ispitivanja SPRYCELA u bolesnika sa smanjenom funkcijom bubrega (ispitivanje u bolesnika s novodijagnosticiranom KML u kroničnoj fazi isključilo je bolesnike s koncentracijom kreatinina u serumu koja je bila >3 puta veća od gornje granice normalnog raspona, a ispitivanja u bolesnika s KML u kroničnoj fazi koji ne podnose ili su otporni na prethodnu terapiju imatinibom isključila su bolesnike s koncentracijom kreatinina u serumu koja je bila >1,5 puta veća od gornje granice normalnog raspona).
56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
56 filmom obloženih tableta 60 x 1 filmom obložena tableta 60 filmom obloženih tableta
b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death.
b Progresija se definirala povećanjem broja leukocita, gubitkom potpunog hematološkog odgovora ili MCyR, povećanjem Ph+ metafaza od ≥30%, potvrđenom AP/BP bolešću ili smrću.
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib treatment (see section 4.8).
Prijavljen je PAH (prekapilarna plućna arterijska hipertenzija potvrđena kateterizacijom desne strane srca) povezan s liječenjem dasatinibom (vidjeti dio 4.8).
Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Pomoćne tvari: sadrži saharozu, natrij, natrijev benzoat, benzoatnu kiselinu, benzilni alkohol i sumporov dioksid (E220).
The starting dose was 70 mg dasatinib twice daily.
Početna doza dasatiniba iznosila je 70 mg dvaput dnevno.
There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.
Bila su 33 pedijatrijska bolesnika s novodijagnosticiranim KML u kroničnoj fazi koja su primala SPRYCEL prašak za oralnu suspenziju u dozi od 72 mg/m2.