natgillin/translations-raw huggingface dataset:
If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline.
Ako se dijagnosticira pleuralni izljev, treba prekinuti primjenu dasatiniba sve dok se bolesnika ne pregleda, do povlačenja simptoma ili do povratka na početno stanje.
Patients with BCR-ABL ≤ 10% at 3 months
Bolesnici koji su imali BCR-ABL ≤ 10% u 3. mjesecu
Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Rijetko anafilaktički šok Endokrini poremećaji Manje često hipotireoza
Based on the Kaplan-Meier estimates, 95% (95% CI: [92%-98%]) of the patients maintained MCyR for 1 year and 88% (95% CI: [83%-93%]) maintained MCyR for 2 years.
Na temelju procjene preživljenja po Kaplan-Meieru, 95% (95% CI: [92%-98%]) bolesnika održalo je MCyR tijekom 1 godine, dok je 88% (95% CI: [83%-93%]) održalo MCyR tijekom 2 godine.
Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia
Često poremećaji apetitaa, hiperuricemija Manje često sindrom lize tumora, dehidracija, hipoalbuminemija, hiperkolesterolemija
Additionally, in vitro and in vivo platelet assays suggest that SPRYCEL treatment reversibly affects platelet activation.
Dodatno, određivanje trombocita in vitro i in vivo sugerira da liječenje lijekom SPRYCEL reverzibilno utječe na aktivaciju trombocita.
Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased.
Nakon prekida liječenja inhibitorom potrebno je razdoblje ispiranja od približno 1 tjedna prije nego što se poveća doza lijeka SPRYCEL.
In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
U 2712 odraslih bolesnika s KML u kroničnoj fazi, KML u uznapredovaloj fazi ili Ph+ ALL, medijan trajanja liječenja iznosio je 19,2 mjeseca (raspon 0-93,2 mjeseca).
The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Medijan trajanja liječenja u 1618 odraslih bolesnika s KML u kroničnoj fazi iznosio je 29 mjeseci (raspon 0-92,9 mjeseci).
MEDIAN (95% CI)
MEDIJAN (95% CI)
• 40 mg daily for patients taking SPRYCEL 140 mg tablet daily.
• 40 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 140 mg dnevno
Shake bottle repeatedly for 30 seconds.
Tresite bocu neprekidn o tijekom sekundi.
In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months.
U tih je bolesnika CCyR nakon 12 mjeseci iznosio 87,9% [95% CI: (71,8 - 96,6)], a MMR 45,5% [95% CI: (28,1 63,6)].
One randomised non-comparative study was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib.
Jedno randomizirano nekomparativno ispitivanje provedeno je u bolesnika s KML u kroničnoj fazi u kojih prethodno liječenje imatinibom u dozi od 400 ili 600 mg nije bilo uspješno.
Grade 3/4
3./4. stupanj
A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant).
Ukupno je 387 bolesnika primilo dasatinib u dozi od 70 mg dvaput dnevno (288 s rezistencijom i 99 s nepodnošljivošću).
Myeloid blast (n= 109)
mijeloidna blastna (n= 109)
Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a
Tablica 1: Doza SPRYCEL tableta za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi ili Ph+ ALL Tjelesna težina (kg)a
SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Nakon rekonstitucije s vodom, SPRYCEL prašak za oralnu suspenziju sadrži približno 0,29 g/ml saharoze.
In the Phase III dose-optimisation study in advanced phase CML and Ph+ALL, grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% to 5% of patients across treatment groups.
U ispitivanju optimizacije doze faze III u uznapredovaloj fazi KML i Ph+ ALL, povišene vrijednosti transaminaza ili bilirubina 3. ili 4. stupnja bile su zabilježene u 1% do 5% bolesnika u svim terapijskim skupinama.
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure.
Prijavljena je PAH (prekapilarna plućna arterijska hipertenzija potvrđena desnostranom kateterizacijom srca) povezana s izloženošću dasatinibu.
In adult patients with advanced phase CML or Ph+ ALL treated with dasatinib as monotherapy, complete blood counts (CBCs) should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated.
U odraslih bolesnika u uznapredovaloj fazi KML ili Ph+ ALL liječenih dasatinibom u monoterapiji, potrebno je raditi kompletnu krvnu sliku svakog tjedna tijekom prva 2 mjeseca liječenja, a nakon toga jedanput mjesečno ili prema kliničkoj indikaciji.
The active substance is dasatinib.
Djelatna tvar je dasatinib.
With a minimum of 12 months follow-up, 85% of patients randomised to the SPRYCEL group and 81% of patients randomised to the imatinib group were still receiving first-line treatment.
Uz najmanje 12 mjeseci praćenja, 85% bolesnika randomiziranih u skupinu koja je primala SPRYCEL i 81% bolesnika randomiziranih u skupinu koja je primala imatinib i dalje je primalo terapiju prve linije.
SPRYCEL contains benzoic acid and sodium benzoate SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension.
SPRYCEL sadrži benzoatnu kiselinu i natrijev benzoat SPRYCEL sadrži 0,25 mg benzoatne kiseline u jednom ml oralne suspenzije i 0,25 mg natrijeva benzoata u jednom ml oralne suspenzije.
Tests may show: abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver)
Pretrage mogu pokazati: abnormalni rezultati krvnih pretraga i moguća oslabljena funkcija bubrega uzrokovana otpadnim proizvodima od umirućeg tumora (sindrom lize tumora), niske razine albumina u krvi, niske razine limfocita (jedne vrste bijelih krvnih stanica) u krvi, visoke razine kolesterola u krvi, otečene limfne žlijezde, krvarenje u mozgu, nepravilna električna aktivnost srca, prošireno srce, upala jetre, proteini u urinu, povećana kreatin fosfokinaza (enzim koji se većinom nalazi u srcu, mozgu i skeletnim mišićima), povišene razine troponina (enzima koji se pretežno nalazi u srcu i mišićima kostura), povišene razine gama-glutamiltransferaze (enzima koji se pretežno nalazi u jetri)
In clinical studies in patients with advanced phase CML or Ph+ ALL receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
U kliničkim ispitivanjima u bolesnika s KML u uznapredovaloj fazi ili Ph+ ALL koji su primali SPRYCEL u preporučenoj dozi (n=304), zadržavanje tekućine 3. ili 4. stupnja bilo je prijavljeno u 8% bolesnika, uključujući pleuralni izljev 3. ili 4. stupnja u 7% i perikardijalni izljev 3.ili 4.stupnja u 1% bolesnika.
SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters.
SPRYCEL filmom obložene tablete od 80 mg, 100 mg ili 140 mg dostupne su u kutijama s 30 x 1 filmom obloženom tabletom u perforiranim blisterima djeljivima na jedinične doze.
Among 188 patients in paediatric studies, the median duration of therapy was 26.3 months (range 0 to 99.6 months).
Medijan trajanja liječenja među 188 bolesnika u pedijatrijskim ispitivanjima iznosio je 26,3 mjeseca (raspon 0-99,6 mjeseci).
If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.
Ako citopenija nije povezana s leukemijom, prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥75×109/l pa nastaviti liječenje početnom dozom ili smanjenom dozom.
Lymphoid blast (n= 48)
limfoidna blastna (n= 48)
Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) Srce i pluća: povećanje desne klijetke u srcu, upala srčanog mišića, skupina stanja koja proizlaze iz blokade opskrbe srčanog mišića krvlju (akutni koronarni sindrom), srčani zastoj (prekid protoka krvi iz srca), bolest koronarnih (srčanih) arterija, upala tkiva koje obavija srce i pluća, krvni ugrušci, krvni ugrušci u plućima
Decreased appetite Fatigue a In the pivotal study, among 106 total patients, 24 patients received the powder for oral suspension at least once, 8 of whom received the powder for oral suspension formulation exclusively.
Proljev pireksija glavobolja smanjen apetit umor a Od ukupno 106 bolesnika u pivotalnom ispitivanju, 24 bolesnika primila su prašak za oralnu suspenziju najmanje jednom, dok je njih 8 primalo isključivo prašak za oralnu suspenziju.
In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.
U ispitivanjima liječenja KML u pedijatrijskih bolesnika stope odstupanja u laboratorijskim nalazima odgovarale su poznatom profilu za laboratorijske parametre u odraslih.
Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Slika 2: Stope MMR tijekom vremena - svi randomizirani bolesnici u ispitivanju faze 3 provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi
In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up.
Nakon najmanje 12 mjeseci praćenja bolesnika s novodijagnosticiranom KML u kroničnoj fazi liječenih lijekom SPRYCEL u kojih je nastupila mijelosupresija 3. ili 4. stupnja oporavak je općenito nastupio nakon kratkog prekida terapije i/ili nakon smanjenja doze lijeka, dok je do trajnog prekida liječenja došlo u 1,6% bolesnika.
In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR.
U ispitivanju uznapredovale faze KML i Ph+ ALL, primarni ishod ispitivanja bio je značajan hematološki odgovor.
Do not crush, cut or chew them.
Tablete se ne smiju drobiti, lomiti ni žvakati.
Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Stoga je u bolesnika koji primaju dasatinib potrebno odabrati zamjenske lijekove s manjim potencijalom za indukciju CYP3A4 (vidjeti dio 4.5).
In Ph+ ALL paediatric patients with non-haematologic adverse reactions, if needed, one level of dose reduction should be followed, according to the dose reduction recommendations for haematologic adverse reactions that are described above.
U pedijatrijskih bolesnika s Ph+ ALL koji imaju nehematološke nuspojave po potrebi treba smanjiti dozu za jednu razinu, u skladu s prethodno navedenim preporukama za smanjenje doze u slučaju hematoloških nuspojava.
In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients.
U bolesnika koji su primali lijek u obliku tableta u pedijatrijskom ispitivanju faze II, procijenjena 24-mjesečna stopa PFS u 51 bolesnika s novodijagnosticiranim KML u kroničnoj fazi iznosila je 94,0% (82,6; 98,0), dok je u 29 bolesnika s KML u kroničnoj fazi koji su bili otporni na imatinib ili ga nisu podnosili ta stopa iznosila 81,7% (61,4; 92,0).
1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
1 Prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥50×109/l.
Instructions for constitution of powder for oral suspension
Upute za pripremu praška za oralnu suspenziju
Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients.
Prekid liječenja unutar 60 mjeseci zbog napredovanja bolesti dogodio se u 11% bolesnika liječenih lijekom SPRYCEL i 14% bolesnika liječenih imatinibom.
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets
SPRYCEL 20 mg filmom obložene tablete SPRYCEL 50 mg filmom obložene tablete SPRYCEL 70 mg filmom obložene tablete SPRYCEL 80 mg filmom obložene tablete SPRYCEL 100 mg filmom obložene tablete SPRYCEL 140 mg filmom obložene tablete dasatinib
In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Također, 46 bolesnika s Ph+ ALL primilo je dasatinib u dozi od 70 mg dvaput dnevno (44 s otpornošću i 2 s nepodnošljivošću imatiniba).
The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.
Vrijeme do MMR dosljedno je bilo kraće u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML (see section 4.4).
Te se promjene ranije i češće javljaju u bolesnika s KML u uznapredovaloj fazi i bolesnika s Ph+ ALL nego u bolesnika s KML u kroničnoj fazi (vidjeti dio 4.4).
Lymphoid blast (n= 33)
Limfoidna blastna kriza (n= 33)
Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Od 2182 bolesnika koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib i primali su SPRYCEL u kliničkim ispitivanjima, 15 (1%) je imalo produljenje QTc intervala koje je zabilježeno kao nuspojava.
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
Stoga se u bolesnika koji primaju dasatinib ne preporučuje sistemska primjena potentnog inhibitora CYP3A4 (vidjeti dio 4.2).
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Često plućni edem*, plućna hipertenzija, plućni infiltrati, pneumonitis, kašalj Manje često plućna arterijska hipertenzija, bronhospazam, astma
Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.
Kutija sadrži 56 filmom obloženih tableta u 4 kalendarska blistera sa 14 filmom obloženih tableta po blisteru.
Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down.
Držeći vrh štrcaljke čvrsto u boci, preokrenite bocu i štrcaljku.
Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Od 130 pedijatrijskih ispitanika s KML u kroničnoj fazi liječenih lijekom SPRYCEL, u 2 (1,5%) bolesnika javile su se nuspojave koje su dovele do prekida liječenja.
SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension.
SPRYCEL sadrži 0,25 mg benzoatne kiseline u jednom ml oralne suspenzije i 0,25 mg natrijeva benzoata u jednom ml oralne suspenzije.
Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the 100 mg once daily regimen demonstrated improved safety and tolerability.
Dasatinib se pokazao djelotvornim u svim skupinama koje su primale dozu jedanput dnevno, s time da mu je djelotvornost s obzirom na primarni ishod (razlika u značajnom citogenetskom odgovoru 1,9%; 95% interval pouzdanosti [-6,8% - 10,6%]); međutim, režim liječenja dozom od 100 mg jedanput dnevno pokazao je bolju sigurnost i podnošljivost.
At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Na temelju in vitro ispitivanja, vezanje dasatiniba za proteine plazme pri klinički značajnim koncentracijama iznosilo je oko 96%.
5 to less than 10 kg
od 5 do manje od 10 kg
SPRYCEL film-coated tablets
SPRYCEL filmom obložene tablete
• 20 mg daily for patients taking SPRYCEL 70 mg tablet daily.
• 20 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 70 mg dnevno
With a minimum of 60 months follow-up, 60% of patients randomised to the SPRYCEL group and 63% of patients randomised to the imatinib group were still receiving first-line treatment.
Uz najmanje 60 mjeseci praćenja, 60% bolesnika randomiziranih u skupinu koja je primala SPRYCEL i 63% bolesnika randomiziranih u skupinu koja je primala imatinib i dalje je primalo terapiju prve linije.
The proportion of patients achieving BCR-ABL ratio of ≤0.0032% (4.5-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (44% versus 34%).
Udio bolesnika koji su postigli omjer BCR-ABL ≤0,0032% (smanjenje 4,5-log) u bilo koje vrijeme bila je viša u SPRYCEL skupini u usporedbi sa imatinib skupinom (44% nasuprot 34%).
The median duration of therapy in 1,094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months).
Medijan trajanja liječenja u 1094 odrasla bolesnika s KML u uznapredovaloj fazi ili Ph+ ALL iznosio je 6,2 mjeseca (raspon 0-93,2 mjeseca).
In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction.
Od 258 bolesnika liječenih dasatinibom i 258 bolesnika liječenih imatinibom u ispitivanju faze III terapije novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, po 1 bolesnik (<1%) u svakoj skupini imao je produljenje QTc intervala koje je bilo prijavljeno kao nuspojava.
Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Jedan ml oralne suspenzije sadrži 10 mg dasatiniba (u obliku hidrata).
Among patients who had received imatinib 400 mg prior to study entry, MCyR was achieved in 61% of patients in the dasatinib arm and 50% in the imatinib arm.
Među bolesnicima koji su primali imatinib u dozi od 400 mg prije uključenja u ispitivanje, značajni citogenetski odgovor postiglo je 61% bolesnika u skupini na dasatinibu te 50% bolesnika u skupini na imatinibu.
Your doctor will check for some of these effects during your treatment.
Liječnik će Vas pregledavati tijekom trajanja liječenja na navedene nuspojave.
In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
U dodatnoj je analizi rani molekularni odgovor (definiran kao razine BCR-ABL ≤ 10% u 3. mjesecu) postigao veći broj bolesnika liječenih dasatinibom (84%) nego bolesnika liječenih imatinibom (64%).
Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag.
Svako pakiranje sadrži nastavak za bocu i dozirnu štrcaljku za usta od 12 ml u zatvorenoj plastičnoj vrećici.
It was usually managed with dose reduction or interruption.
Vrijednosti su se obično normalizirale nakon smanjenja doze ili privremenog prekida liječenja.
One-level dose reduction
Smanjenje doze za jednu razinu
What you need to know before you take SPRYCEL 3.
Što morate znati prije nego počnete uzimati SPRYCEL 3. Kako uzimati SPRYCEL 4. Moguće nuspojave
In the Phase III clinical study in patients with newly diagnosed chronic phase CML, grade 3 or 4 fluid retention was reported in 13 patients (5%) in the dasatinib-treatment group and in 2 patients (1%) in the imatinib-treatment group after a minimum of 60 months follow-up (see section 4.8).
U kliničkom ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, 3. ili 4. stupanj zadržavanja tekućine bio je zabilježen u 13 bolesnika (5%) u skupini liječenoj dasatinibom te u 2 bolesnika (1%) u skupini liječenoj imatinibom (vidjeti dio 4.8).
Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML
Tablica 9: Rezultati djelotvornosti u novodijagnosticiranih bolesnika s KML u kroničnoj fazi iz ispitivanja faze 3
In paediatric trials of SPRYCEL in combination with chemotherapy in newly diagnosed Ph+ ALL paediatric patients after a maximum of 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 1 (0.6%) patient.
U ispitivanjima lijeka SPRYCEL u kombinaciji s kemoterapijom provedenima u pedijatrijskih bolesnika s novodijagnosticiranim Ph+ ALL, lijekom uzrokovani štetni događaji povezani s rastom i razvojem kostiju su nakon najviše 2 godine liječenja prijavljeni u 1 (0,6%) bolesnika.
MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Rezultati djelotvornosti prikazani su u tablici 11. Značajni citogenetski odgovor postigao se u 55% bolesnika otpornih na imatinib i 82% bolesnika koji nisu podnosili imatinib.
A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Značajni citogenetski odgovor na prethodno liječenje imatinibom postiglo je 28% bolesnika u skupini koja je primala dasatinib i 29% bolesnika u skupini koja je primala imatinib.
HAZARD RATIO (95% CI)
OMJER HAZARDA (95% CI)
At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively).
Stratifikacija po Hasfordu na početku ispitivanja bila je slična u obje terapijske skupine (niski rizik: 33% u skupini koja je primala SPRYCEL i 34% u skupini koja je primala imatinib; umjereni rizik: 48% u skupini koja je primala SPRYCEL i 47% u skupini koja je primala imatinib; visoki rizik: 19% u skupini koja je primala SPRYCEL i 19% u skupini koja je primala imatinib).
Excipients: contains lactose monohydrate.
Pomoćne tvari: sadrži laktozu hidrat.
Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Provedena su dva randomizirana ispitivanja otvorenog tipa da bi se ispitala djelotvornost primjene dasatiniba jedanput dnevno u usporedbi s primjenom dvaput dnevno.
They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Bolesnici su bili randomizirani (2:1) u dvije skupine, jednu koja je primala dasatinib (70 mg dvaput dnevno) i drugu koja je primala imatinib (400 mg dvaput dnevno).