natgillin/translations-raw huggingface dataset:
Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Često hipertenzija, naleti crvenila Manje često hipotenzija, tromboflebitis, tromboza
The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Stopa značajnog molekularnog odgovora (svih 25 liječenih bolesnika s potpunim citogenetskim odgovorom) iznosila je 52% nakon 24 mjeseca.
Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib
Klinička ispitivanja faze III u bolesnika s KML u kroničnoj fazi, uznapredovaloj fazi ili fazi mijeloične blastne krize i Ph+ ALL koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib
Outer Carton: sprycel 100 mg
Kutija: sprycel 100 mg
BRISTOL-MYERS SQUIBB PHARMA EEIG
SQUIBB PHARMA EEIG
Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI: [84%-92%]) at 1 year and 75% (95% CI: [69%-81%]) at 2 years.
Među bolesnicima otpornima na imatinib, procijenjena stopa preživljenja bez progresije bolesti (PFS) iznosila je 88% (95% CI: [84%-92%]) nakon 1 godine i 75% (95% CI: [69%-81%]) nakon 2 godine.
The following can all be signs of serious side effects: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills if you get fever, sore mouth or throat, blistering or peeling of your skin and/or mucous membranes Contact your doctor immediately if you notice any of the above.
Neočekivano krvarenje ili modrice, a da se niste ozlijedili Krv u povraćenom sadržaju, stolici ili mokraći ili crna stolica Znakovi infekcije poput vrućice i jake zimice Vrućica, upala usta ili grla, pojava mjehurića ili ljuštenje kože i/ili sluznica Odmah obavijestite liječnika ako primijetite nešto od gore navedenog.
In the Phase III dose-optimisation study in chronic phase CML, grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
U ispitivanju optimizacije doze faze III, povišenje 3. ili 4. stupnja vrijednosti transaminaza ili bilirubina bilo je prijavljeno u ≤1% bolesnika s KML u kroničnoj fazi uz slično nisku incidenciju u sve četiri liječene skupine.
SPRYCEL 70 mg tablets dasatinib
SPRYCEL 70 mg tablete dasatinib
Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Jedna filmom obložena tableta sadrži 94,5 mg laktoza hidrata.
Efficacy results are presented in Table 9.
Rezultati ispitivanja djelotvornosti prikazani su u Tablici 9.
10 to less than 20 kg
od 10 do manje od 20 kg
c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular failure, right ventricular failure, and ventricular hypokinesia.
disfunkciju lijeve klijetke, disfunkciju desne klijetke, srčano zatajenje, akutno zatajenje srca, kronično zatajenje srca, kongestivno zatajenje srca, kardiomiopatiju, kongestivnu kardiomiopatiju, dijastoličku disfunkciju, smanjenje ejekcijske frakcije i zatajenje klijetke, zatajenje lijeve klijetke, zatajenje desne klijetke i ventrikularnu hipokineziju.
Outer Carton: sprycel 80 mg
Kutija: sprycel 80 mg
20 to less than 30 kg
od 20 do manje od 30 kg
The median time from diagnosis to start of treatment was 28 months.
Medijan vremena od dijagnoze do početka liječenja iznosio je 28 mjeseci.
CCyR (95% CI) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69)
2 godine n/p Citogenetski odgovorc (%) Značajan (95% CI) 62% (5767) 40% (33-48) 34% (25-44) 52% (37-67) 57% (41-71) Potpun (95%
Laboratory test abnormalities Haematology
Poremećaji laboratorijskih nalaza Hematologija
within 48 months (95% CI)
unutar 48 mjeseci (95% CI)
A 70 mg twice daily regimen was also studied.
Ispitivan je i režim liječenja dozom od 70 mg dvaput dnevno.
Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose
Tablica 2: Postupno povećanje doze za pedijatrijske bolesnike Ph+ KML u kroničnoj fazi Doza (maksimalna dnevna doza) Početna doza
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Medijan trajanja liječenja dasatinibom iznosio je 3,5 mjeseci s time da je 12% bolesnika do tada bilo liječeno >24 mjeseca.
Uncommon side effects (may affect up to 1 in 100 people) Heart and lungs: heart attack (including fatal outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, inflammation of the gallbladder, blockage of bile ducts, gastro-oesophageal reflux (a condition where acid and other stomach contents come back up into the throat) Skin, hair, eye, general: allergic reaction including tender, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting, tremor, inflammation of the eye which causes redness or pain, a skin disease characterized by tender, red, well-defined blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to light, visual impairment, increased eye tearing, disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail disorder, hair disorder, hand-foot disorder, renal failure, urinary frequency, breast enlargement in men, menstrual disorder, general weakness and discomfort, low thyroid function, losing balance while walking, osteonecrosis (a disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body
Probavni problemi: upala gušterače, peptički ulkus, upala jednjaka, otečen trbuh, rascjep kože na analnom kanalu, poteškoće pri gutanju, upala žučnog mjehura, začepljenje žučnih kanala, gastroezofagealni refluks (stanje kod kojega se želučana kiselina i sadržaj želuca vraćaju u grlo) Koža, kosa, oko, općenito: alergijska reakcija, uključujući blage, crvene kvržice na koži (erythema nodosum), anksioznost, zbunjenost, promjene raspoloženja, smanjenje seksualnog nagona, malaksalost, tremor, upala oka koja uzrokuje crvenilo ili bol, kožna bolest karakterizirana mekim, crvenim, dobro definiranim mrljama s iznenadnim nastupom vrućice i povišenjem bijelih krvnih stanica (neutrofilna dermatoza), gubitak sluha, osjetljivost na svjetlo, oštećenje vida, pojačano suzenje oka, poremećaj u boji kože, upala potkožnog masnog tkiva, ulkus kože, plikovi na koži, poremećaj noktiju, poremećaj kose, poremećaj ruku-nogu, zatajenje bubrega, učestalo mokrenje, povećanje grudi u muškaraca, poremećaj mjesečnice, opća slabost i nelagoda, smanjena funkcija štitnjače, gubitak ravnoteže u hodu, osteonekroza (bolest kod koje je smanjen dotok krvi u kosti, što može uzrokovati gubitak i odumiranje kosti), artritis, oticanje kože na bilo kojem dijelu tijela
The median time from diagnosis to start of treatment was 48 months.
Medijan vremena od dijagnoze do početka liječenja iznosio je 48 mjeseci.
DO NOT USE A DISHWASHER
Nemojte uzimati SPRYCEL
Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib.
Na temelju procjene preživljenja po Kaplan-Meieru, PFS tijekom 1 godine iznosilo je 91% (95% CI: [85%-97%]) za dasatinib i 73% (95% CI: [54%-91%]) za imatinib.
Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia
Često febrilna neutropenija Manje često limfadenopatija, limfopenija
In patients with accelerated phase CML treated with the 140 mg once daily regimen, the median duration of MaHR and the median overall survival was not reached and the median PFS was 25 months.
U bolesnika s KML u fazi ubrzanja liječenih dozom od 140 mg jedanput dnevno nije postignut ni medijan trajanja
SPRYCEL contains lactose
SPRYCEL sadrži laktozu.
SPRYCEL 20 mg tablets dasatinib
SPRYCEL 20 mg tablete dasatinib
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Na temelju procjene po Kaplan-Meieru, udio bolesnika u kojih se održao značajni citogenetski odgovor tijekom 1 godine iznosio je 92% (95% CI: [85%-100%]) za dasatinib (potpuni citogenetski odgovor, 97%; 95% CI: [92%-100%]) te 74% (95% CI: [49%-100%]) u skupini za imatinib (potpuni citogenetski odgovor, 100%).
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3.
NEL: isti kriteriji kao i za CHR, ali ABN ≥ 500/mm3 i < 1000/mm3, ili trombociti ≥ 20 000/mm3 i ≤ 100 000/mm3. c MCyR uključuje i potpun (0% Ph+ metafaze) i djelomičan (> 0%-35%) odgovor.
PROPORTION ALIVE
UDIO ŽIVIH ISPITANIKA
Myeloid blast phase CML
Mijeloidna blastna kriza KML
SPRYCEL 140 mg film-coated tablets
SPRYCEL 140 mg filmom obložene tablete
The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months.
Stopa značajnog molekularnog odgovora (sva 22 liječena bolesnika s potpunim citogenetskim odgovorom) iznosila je 50% nakon 24 mjeseca.
Results are available for 150 patients:
Rezultati su dostupni za 150 bolesnika: 101 bolesnika u skupini koja je primala dasatinib i
SPRYCEL 50 mg tablets dasatinib
SPRYCEL 50 mg tablete dasatinib
SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
SPRYCEL 140 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 140 mg dasatiniba (u obliku hidrata).
Sucrose Carmellose sodium Simethicone emulsion consisting of: simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid.
6.1 Popis pomoćnih tvari saharoza karmelozanatrij simetikon emulzija koja se sastoji od: simetikona polietilenglikolsorbitantristearata polietoksilatstearata glicerida metilceluloze ksantanske gume benzoatne kiseline,
Table 12: Efficacy of SPRYCEL in phase III dose-optimization study: imatinib resistant or intolerant chronic phase CML (2-year results)a
Tablica 12: Djelotvornost lijeka SPRYCEL u ispitivanju optimizacije doze faze III: bolesnici s KML u kroničnoj fazi koji su otporni na imatinib ili ga ne podnose (2-godišnji rezultati)a
The median time from diagnosis to start of treatment was 18 months.
Medijan vremena od dijagnoze do početka liječenja iznosio je 18 mjeseci.
within 24 months (95% CI)
unutar 24 mjeseca (95% CI)
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Medijan trajanja liječenja dasatinibom iznosio je 14 mjeseci uz 31% bolesnika liječenih >24 mjeseca do tada.
MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI)
Značajan (MCyR) svi bolesnici bolesnici otporni na imatinib Potpun (CCyR) svi bolesnici bolesnici otporni na imatinib
Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350)
KGaA Tel: + 0800 0752002 (+49 (0)89 121 42 350)
Not known hepatitis B reactivation
Nepoznato ponovna aktivacija hepatitisa B Poremećaji krvi i limfnog sustava
NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bristol-Myers Squibb Pharma EEIG
Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a
Tablica 6a: Odabrane nuspojave prijavljene u ispitivanju optimizacije doze faze 3 (bolesnici s KML u kroničnoj fazi koji ne podnose imatinib ili su otporni na njega)a Minimalno 2 godine praćenja
SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side.
SPRYCEL 140 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS 140” utisnutom s jedne i oznakom “857” s druge strane.
within 36 months (95% CI)
unutar 36 mjeseci (95% CI)
If a moderate, grade 2, non-haematologic adverse reaction develops with dasatinib, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
Ako se javi umjerena, nehematološka nuspojava 2. stupnja na dasatinib, liječenje treba obustaviti sve do povlačenja nuspojave ili povratka na početno stanje.
Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Stope MMR dosljedno su bile više u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
SPRYCEL 70 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 70 mg dasatiniba (u obliku hidrata).
Imatinib-resistant patients
Bolesnici otporni na imatinib
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Prije izdavanja bolesniku SPRYCEL prašak za oralnu suspenziju mora rekonstituirati ljekarnik ili kvalificirani zdravstveni radnik.
Non-haematologic adverse reactions
Nehematološke nuspojave
The median time from diagnosis to start of treatment was 82 months.
Medijan vremena od dijagnoze do početka liječenja iznosio je 82 mjeseca.
SPRYCEL 70 mg film-coated tablets
SPRYCEL 70 mg filmom obložene tablete
Time-to cCCyR
Vrijeme do cCCyR
SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
SPRYCEL 80 mg filmom obložene tablete EU/1/06/363/013
Based on the Kaplan-Meier estimates, the proportion of patients treated with dasatinib 100 mg once daily who maintained MCyR for 18 months was 93% (95% CI: [88%-98%]).
Na temelju procjene po Kaplan-Meieru, značajan citogenetski odgovor održao se tijekom 18 mjeseci u 93% (95% CI: [88%-98%]).
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
SPRYCEL je indiciran u liječenju pedijatrijskih bolesnika kod: novodijagnosticirane kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi ili Ph+ KML u kroničnoj fazi u bolesnika koji ne podnose ili su otporni na prethodnu terapiju, uključujući imatinib. novodijagnosticirane Ph+ akutne limfoblastične leukemije (ALL) u kombinaciji s kemoterapijom.
SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
SPRYCEL 70 mg filmom obložene tablete EU/1/06/363/006
Haematologic response rateb (%) (95% CI)
Stopa hematološkog odgovorab (%) (95% CI)
SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
SPRYCEL 140 mg filmom obložene tablete EU/1/06/363/015
within 60 months (95% CI)
unutar 60 mjeseci (95% CI)
Grade
Nuspojava
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
SPRYCEL 80 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, trokutasta, s oznakom “BMS 80” utisnutom s jedne i oznakom “855” s druge strane.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
SPRYCEL 70 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS” utisnutom s jedne i oznakom “524” s druge strane.
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
l Oticanje genitalija, edem na mjestu incizije, genitalni edem, edem penisa, oticanje penisa, edem skrotuma, oticanje kože,
SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
SPRYCEL 50 mg filmom obložene tablete EU/1/06/363/005
SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
SPRYCEL 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 20 mg dasatiniba (u obliku hidrata).
White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS 140" utisnutom s jedne i oznakom"857" s druge strane.
85% of the radioactivity recovered in the urine and faeces, respectively.
dana, s time da je 4% radioaktivnosti bilo otkriveno u mokraći, a 85% u stolici.
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Jedna filmom obložena tableta sadrži 70 mg dasatiniba (u obliku hidrata).
SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
SPRYCEL 80 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 80 mg dasatiniba (u obliku hidrata).
SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
SPRYCEL 100 mg filmom obložene tablete EU/1/06/363/011
Cardiac adverse reactions
Srčane nuspojave
SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
SPRYCEL 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg dasatiniba (u obliku hidrata).
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Medijan trajanja liječenja dasatinibom iznosio je 24 mjeseca s time da je 51% bolesnika do tada bilo liječeno >24 mjeseca.
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
SPRYCEL je indiciran u liječenju pedijatrijskih bolesnika kod: novodijagnosticiranog Ph+ KML u kroničnoj fazi ili Ph+ KML u kroničnoj fazi u bolesnika koji ne podnose ili su otporni na prethodnu terapiju, uključujući imatinib. novodijagnosticiranog Ph+ ALL u kombinaciji s kemoterapijom.
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Nakon dugotrajnijeg liječenja i praćenja (medijan trajanja, 24 mjeseca), značajni citogenetski odgovor postiglo je 53% bolesnika liječenih dasatinibom (potpuni citogenetski odgovor u 44%) te 33% bolesnika liječenih imatinibom (potpuni citogenetski odgovor u 18%) prije prelaska u suprotnu skupinu.
SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
SPRYCEL 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg dasatiniba (u obliku hidrata).
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Jedna filmom obložena tableta sadrži 20 mg dasatiniba (u obliku hidrata).
SPRYCEL 50 mg film-coated tablets
SPRYCEL 50 mg filmom obložene tablete
In patients with myeloid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 8 months, the median PFS was 4 months, and the median overall survival was 8 months.
MaHR iznosio je 8 mjeseci, medijan PFS 4 mjeseca, a medijan ukupnog preživljenja 8 mjeseci.
Cytogenetic responsec (%)
Major Cytogenetic Response - MCyR).
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
SPRYCEL 100 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, ovalna, s oznakom “BMS 100” utisnutom s jedne i oznakom “852” s druge strane.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
CHR (uznapredovala KML/Ph+ ALL): broj leukocita ≤ GGN za laboratorij, ABN ≥ 1000/mm3, trombociti ≥ 100 000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasti u koštanoj srži ≤ 5%, < 5% mijelociti plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months.
MaHR iznosio je 5 mjeseci, medijan PFS 4 mjeseca, a medijan ukupnog preživljenja 7 mjeseci.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
CHR: broj leukocita ≤ GGN za laboratorij, ABN ≥ 1000/mm3, trombociti ≥ 100 000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasti u koštanoj srži ≤ 5%, < 5% mijelocita plus metamijelocita u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne infiltracije.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
SPRYCEL 50 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, ovalna, s oznakom “BMS” utisnutom s jedne i oznakom“528” s druge strane.
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Jedna filmom obložena tableta sadrži 50 mg dasatiniba (u obliku hidrata).
A reaction with fever, blisters on the skin, and ulceration of the mucous membranes Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots
Ostale prijavljene nuspojave čija učestalost nije poznata (ne može se procijeniti iz dostupnih podataka) uključuju: upalu pluća krvarenje u želucu ili crijevima koje može dovesti do smrti ponovnu pojavu (ponovnu aktivaciju) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre) reakciju s vrućicom, mjehurićima na koži i ulceracijom sluznica bolesti bubrega sa simptomima koji uključuju edeme i odstupanja u rezultateima laboratorijskih testova kao što su proteini u urinu i niska razina proteina u krvi oštećenje krvnih žila koje se zove trombotična mikroangiopatija (TMA), uključujući smanjen broj crvenih krvnih stanica, smanjen broj krvnih pločica i stvaranje krvnih ugrušaka
An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Multicentrično ispitivanje otvorenog tipa u jednoj skupini provelo se u bolesnika u limfoidnoj blastnoj krizi KML ili Ph+ ALL koji su otporni na imatinib ili ga ne podnose.
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover.
Prije prelaska u suprotnu skupinu, 93% bolesnika koji su primali dasatinib i 82% bolesnika koji su primali imatinib postiglo je potpuni hematološki odgovor.
SPRYCEL 80 mg film-coated tablets
SPRYCEL 80 mg filmom obložene tablete
SPRYCEL 100 mg film-coated tablets
SPRYCEL 100 mg filmom obložene tablete