natgillin/translations-raw huggingface dataset:
SPRYCEL powder for oral suspension is also available for paediatric Ph+ CML-CP and Ph+ ALL patients, and adult CML-CP patients, who cannot swallow tablets.
Zdravilo SPRYCEL je na voljo tudi v obliki praška za peroralno suspenzijo za uporabo pri pediatričnih bolnikih s Ph+ KML-KO in Ph+ ALL ter odraslih bolnikih s KML-KO, ki ne morejo pogoltniti tablet.
The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months.
Delež dobrega molekularnega odziva (ovrednoten pri 19 bolnikih s popolnim citogenetskim odzivom) je bil po 24 mesecih 68%.
Efficacy results are reported in Table 11.
Rezultati učinkovitosti so predstavljeni v preglednici 11.
Haematopoietic growth factor has been used in patients with resistant myelosuppression.
Bolniki z rezistentno mielosupresijo so prejeli hematopoetski rastni faktor.
Grade 3 or 4 elevations in creatinine were reported in < 1% of patients with chronic phase CML and were reported with an increased frequency of 1 to 4% of patients with advanced phase CML.
O zvišanju vrednosti kreatinina stopnje 3 ali 4 so poročali pri < 1% bolnikov s KML v kroničnem obdobju.
Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Od 130 pediatričnih bolnikov s KML-KO, ki so se zdravili z zdravilom SPRYCEL, je bilo zaradi pojava neželenih učinkov zdravljenje treba prekiniti pri 2 (1,5%) bolnikih.
An international open-label, multicentre, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
Pri odraslih bolnikih z na novo diagnosticirano KML v kroničnem obdobju je bila izvedena mednarodna, odprta, multicentrična, randomizirana primerjalna študija III. faze.
Crossover to the alternative treatment arm was allowed if patients showed evidence of disease progression or intolerance that could not be managed by dose modification.
Če so se pri bolnikih pokazali znaki napredovanja bolezni ali intolerance, ki jih s prilagoditvijo odmerka ni bilo mogoče nadzirati, jim je bil omogočen prehod v skupino z alternativnim
The proportion of patients who maintained CCyR for 1 year was 97% (95% CI: [94%-99%]) and for 2 years was 90% (95% CI: [86%-95%]).
Popoln citogenetski odziv se je 1 leto ohranil pri 97% bolnikov (95% interval zaupanja: [94% - 99%]), 2 leti pa pri 90% bolnikov (95% interval zaupanja: [86% - 95%]).
A different spectrum of mutation was detected in the imatinib treatment arm. Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.
Podatki, pridobljeni in vitro kažejo, da dasatinib ni aktiven proti mutaciji T315I.
Very common diarrhoea, vomiting, nausea, abdominal pain
Zelo pogosti driska, bruhanje, navzea, bolečine v trebuhu
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).
V klinični študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju so po najmanj 60-mesečnem obdobju spremljanja o zastajanju tekočin stopnje 3 ali 4 poročali pri 13 bolnikih (5%) iz skupine, ki se je zdravila z dasatinibom, in 2 bolnikih (1%) iz skupine, ki se je zdravila z imatinibom (glejte poglavje 4.8).
In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months.
V študiji I. faze pri prvih 84 zdravljenih bolnikih, ki so jih spremljali do 27 mesecev, so hematološke in citogenetske odzive opazili v vseh obdobjih KML in Ph+ ALL.
The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Delež dobrega molekularnega odziva (vseh 25 zdravljenih bolnikov s popolnim citogenetskim odzivom) je bil po 24 mesecih 52%.
# DEATHS / # Land Patient
SMRTI / Št. zajetih bolnikov
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.
Pri na imatinib odpornih bolnikih je bil ocenjen delež preživetja brez progresije bolezni po 1 letu 88% (95% interval zaupanja: [84% - 92%]), po 2 letih pa 75% (95% interval zaupanja: [69%-81%]).
chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
s KML v kroničnem obdobju, obdobju pospešenega poteka ali obdobju blastne preobrazbe, ki se na predhodna zdravljenja, vključno z imatinibom, niso odzvali ali jih niso prenašali.
Outer Carton: sprycel 20 mg
Škatla: sprycel 20 mg
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).
Pri 1.094 odraslih bolnikih s KML v obdobju pospešenega poteka ali Ph+ ALL je mediana trajanja zdravljenja znašala 6,2 meseca (razpon 0 do 93,2 meseca).
Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Škatla s 60 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
The primary endpoint was MCyR at 12 weeks.
Primarni opazovani dogodek je bil dober citogenetski odziv po 12 tednih.
A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo 48 bolnikov s KML v obdobju limfoblastne preobrazbe (42 rezistentnih in 6 intolerantnih na imatinib).
Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased.
Pred povečanjem odmerka zdravila SPRYCEL naj obdobje izpiranja po prekinitvi zdravljenja z zaviralcem traja približno 1 teden.
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.
disfunkcijo desnega prekata, srčno popuščanje, akutno srčno popuščanje, kronično srčno popuščanje, kongestivno srčno popuščanje, kardiomiopatijo, kongestivno kardiomiopatijo, diastolno disfunkcijo, zmanjšanje iztisnega deleža in ventrikularno popuščanje, odpoved levega prekata, odpoved desnega prekata in ventrikularno hipokinezijo.
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.
Če se med zdravljenjem z dasatinibom pojavi zmerni nehematološki neželeni učinek (stopnje 2), je treba zdravljenje prekiniti, dokler neželeni učinek ne mine oziroma se vrednosti ne vrnejo na izhodiščne vrednosti.
Lymphoid blast phase CML and Ph+ ALL
KML v obdobju limfoblastne preobrazbe in Ph+ ALL
The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimise the risk of dermal exposure.
Slednja zdravstveno osebje varuje pred stikom z učinkovino, vendar pa je kljub temu pri rokovanju s tabletami priporočljiva uporaba rokavic iz lateksa ali nitrila za ustrezno odstranjevanje v primeru zdrobitve ali poškodbe tablete, da se tveganje za izpostavljenost kože kar najbolj zmanjša.
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).
Izpostavljenost je ustrezala do 3-kratni izpostavljenosti človeka po prejetju priporočenega terapevtskega odmerka (na osnovi AUC).
Table 13: Long term efficacy of SPRYCEL in phase 3 dose optimisation study: imatinib resistant or intolerant chronic phase CML patientsa Minimum follow-up period
Preglednica 13: Dolgoročna učinkovitost zdravila SPRYCEL v študiji 3. faze za določitev optimalnega odmerka: bolniki s KML v kroničnem obdobju, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašalia Minimalno obdobje spremljanja
The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.
Pri bolnikih, ki so se zdravili z dasatinibom, je bil čas do MMR konsistentno krajši kot pri bolnikih, ki so se zdravili z imatinibom.
In embryofoetal development studies, dasatinib likewise induced embryolethality with associated decreases in litter size in rats, as well as foetal skeletal alterations in both rats and rabbits.
Prav tako je dasatinib pri študijah embriofetalnega razvoja pri podganah povzročal smrtnost zarodkov in s tem povezano manjše število mladičev.
Nine (12%) patients underwent therapeutic thoracentesis.
Terapevtska torakocenteza je bila opravljena pri 9 (12%) bolnikih.
20 to less than 30 kg
20 do manj kot 30 kg
Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Pri bolnikih, ki so se zdravili z dasatinibom, so bili deleži MMR konsistentno višji kot pri bolnikih, ki so se zdravili z imatinibom.
Skin, hair, eye, general: convulsion, inflammation of the optic nerve that may cause a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, inflammation of the skin blood vessels, skin fibrosis
Koža, lasje, oči in splošno: krči, vnetje očesnega živca s posledično popolno ali delno izgubo vida, pojav škrlatno-modrih lis na koži, nenormalno močno delovanje ščitnice, vnetje ščitnice, ataksija (motena usklajenost mišičnih gibov), težave pri hoji, spontani splav, vnetje kožnih krvnih žil in razraščanje kožnega veziva.
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
Koža, lasje, oči in splošno: alergijska reakcija, vključno s pojavom občutljivih rdečih vozličev na koži (nodozni eritem), tesnoba, zmedenost, nihanje razpoloženja, zmanjšanje želje po spolnosti, omedlevica, tresenje, vnetje oči z rdečino ali bolečino, bolezen kože, za katero je značilen pojav občutljivih, rdečih, dobro omejenih sprememb na koži, ki ga spremlja nenadno zvišanje telesne temperature in povečanje števila belih krvnih celic (nevtrofilna dermatoza), izguba sluha, občutljivost za svetlobo, okvara vida, povečano solzenje, spremembe obarvanosti kože, vnetje podkožnega maščevja, kožna razjeda, pojav mehurjev na koži, spremembe na nohtih, spremembe na laseh, kožna reakcija na dlaneh in stopalih, odpoved ledvic, pogosto uriniranje, čezmeren razvoj tkiva dojke pri moških, težave z menstruacijo, splošna oslabelost in slabo počutje, zmanjšano delovanje ščitnice, izguba ravnotežja pri hoji, osteonekroza (bolezen z zmanjšano prekrvavljenostjo kosti, kar lahko povzroči izgubo in odmrtje kosti), vnetje sklepov in oteklina kože kjer koli na telesu.
In the newly diagnosed chronic phase CML study, grade 3 or 4 hypophosphataemia was reported in 4% of SPRYCEL-treated patients, and grade 3 or 4 elevations of transaminases, creatinine, and bilirubin were reported in ≤ 1% of patients after a minimum of 12 months follow-up.
V študiji pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju so po najmanj 12-mesečnem obdobju spremljanja pri 4% bolnikov, ki so se zdravili z zdravilom SPRYCEL, poročali o hipofosfatemiji stopnje 3 ali 4, o zvišanju vrednosti transaminaz, kreatinina in bilirubina stopnje 3 ali 4 pa pri ≤ 1% bolnikov.
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.
Izgled zdravila SPRYCEL in vsebina pakiranja Zdravilo SPRYCEL je na voljo v obliki belega do sivobelega praška za peroralno suspenzijo.
A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Na dasatinib v odmerku 140 mg enkrat na dan ali 70 mg dvakrat na dan je bilo skupaj randomiziranih 611 bolnikov.
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
Izgled zdravila SPRYCEL in vsebina pakiranja SPRYCEL 20 mg: bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako “BMS” na eni in “527” na drugi strani.
Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a
Preglednica 6a: Izbrani neželeni učinki, o katerih so poročali v študiji 3. faze za določitev optimalnega odmerka (bolniki s KML v kroničnem obdobju, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali)a
The film-coated tablets must not be crushed, cut or chewed in order to maintain dosing consistency and minimise the risk of dermal exposure; they must be swallowed whole.
Za ohranitev doslednosti odmerjanja in da bi se tveganje za izpostavljenost kože učinkovini kar se da zmanjšalo, se filmsko obloženih tablet ne sme drobiti,razpolavljati ali žvečiti.
The starting dose was 70 mg dasatinib twice daily.
Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo tudi
See the "Instructions for administration to the patient" at the end of the package leaflet for how to give a dose of SPRYCEL oral suspension.
Za navodila za dajanje odmerka SPRYCEL peroralne suspenzije glejte "Navodila za dajanje bolniku" na koncu tega navodila.
Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Škatla s 30 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months.
Delež dobrega molekularnega odziva (vseh 22 zdravljenih bolnikov s popolnim citogenetskim odzivom) je bil po 24 mesecih 50%.
Table 4: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Preglednica 4: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri pediatričnih bolnikih s Ph+ KML-KO
Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not.
Pri bolnikih, ki so se zdravili z dasatinibom, in so v 3. mesecu dosegli vrednost BCR-ABL ≤ 10%, je bil delež celokupnega preživetja konsistentno višji kot pri bolnikih, ki te vrednosti niso dosegli.
The median time from diagnosis to start of treatment was 28 months.
Od diagnoze do začetka zdravljenja je v povprečju minilo 28 mesecev.
You will also have blood tests regularly while you are taking SPRYCEL.
Med jemanjem zdravila SPRYCEL je treba redno opravljati krvne preiskave.
Outer Carton: sprycel 50 mg
Škatla: sprycel 50 mg
Each film-coated tablet contains 189 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 189 mg laktoze monohidrata.
The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets.
Pri bolnikih s telesno maso, manjšo od 10 kg in bolnikih, ki ne morejo pogoltniti tablet, je treba uporabljati prašek za peroralno suspenzijo.
One randomised non-comparative study was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib.
Pri bolnikih v kroničnem obdobju, ki se na začetno zdravljenje z imatinibom v odmerku 400 mg ali 600 mg niso odzvali, je bila izvedena ena randomizirana neprimerjalna študija.
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Preglednica 3: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri pediatričnih bolnikih s Ph+ KML-KO
Each film-coated tablet contains 108 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 108 mg laktoze monohidrata.
Rare epiphyses delayed fusion,h growth retardationh
Redki zapoznelo zaprtje epifizgh, zaostanek v rastih
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Pogosti pljučni edem*, pljučna hipertenzija*, pljučni infiltrati, pnevmonitis, kašelj
Outer Carton: sprycel 100 mg
Škatla: sprycel 100 mg
Baseline characteristics were well balanced between the two treatment groups with respect to age (median age was 46 years for the SPRYCEL group and 49 years for the imatinib group with 10% and 11% of patients 65 years of age or older, respectively), gender (women 44% and 37%, respectively), and race (Caucasian 51% and 55%; Asian 42% and 37%, respectively).
V skupini, ki se je zdravila z imatinibom, je bila srednja starost bolnikov 49 let, 11% bolnikov je bilo starih 65 let ali starejših, 37% vključenih oseb je bilo ženskega spola, 55% bolnikov je bilo belcev in 37% bolnikov aziatov.
Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm
Koža, lasje, oči in splošno: zbadanje v koži, srbenje, suha koža, akne, vnetje kože, nenehno piskanje ali zvenenje v ušesih, izguba las, prekomerno znojenje, motnje vida (vključno z zamegljenim in okrnjenim vidom), suhe oči, modrice, depresija, nespečnost, rdečica, omotica, obtolčenine (modrice), neješčnost, somnolenca (bolezenska zaspanost) in generalizirani edem.
Each film-coated tablet contains 67.5 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 67,5 mg laktoze monohidrata.
Refer to the package leaflet (see section 5 ‘How to store SPRYCEL') for instructions on discarding any unused medicine, syringe and bottle.
Za navodila glede odstranjevanja neuporabljenega zdravila, brizge in plastenke glejte navodilo za uporabo (poglavje 5 ‘Shranjevanje zdravila SPRYCEL').
Each film-coated tablet contains 27 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 27 mg laktoze monohidrata.
SPRYCEL contains lactose
Zdravilo SPRYCEL vsebuje laktozo
The proportion of patients who had PFS at 2 years was 86% (95% CI: [78%-93%]) for dasatinib and 65% (95% CI: [43%-87%]) for imatinib.
Delež bolnikov z 2-letnim preživetjem brez progresije bolezni je bil pri zdravljenju z dasatinibom 86% (95% interval zaupanja: [78% - 93%]), pri zdravljenju z imatinibom pa 65% (95% interval zaupanja: [43%-87%]).
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.
Pri bolnikih s KML v obdobju pospešenega poteka, ki so se zdravili z odmerkom 140 mg enkrat na dan, srednja vrednost trajanja dobrega hematološkega odziva in srednja vrednost celokupnega preživetja nista bili doseženi, srednja vrednost preživetja brez napredovanja bolezni pa je znašala 25 mesecev.
Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders
Občasni hepatitis, vnetje žolčnika, holestaza Bolezni kože in podkožja
10 to less than 20 kg
10 do manj kot 20 kg
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Zdravljenje z dasatinibom je v povprečju trajalo 24 mesecev, pri 51% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
The proportion of patients who maintained MCyR for 18 months was 90% (95% CI: [82%-98%]) for dasatinib (CCyR 94%, 95% CI: [87%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Pri zdravljenju z dasatinibom se je dober citogenetski odziv ohranil 18 mesecev pri 90% bolnikov (95% interval zaupanja: [82% - 98%]) (popoln citogenetski odziv pri 94% bolnikov, 95% interval zaupanja: [87% - 100%]), pri zdravljenju z imatinibom pa pri 74% bolnikov (95% interval zaupanja: [49% - 100%]) (popoln citogenetski odziv pri 100% bolnikov).
Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Ena filmsko obložena tableta vsebuje 135,0 mg laktoze monohidrata.
Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
En ml peroralne suspenzije vsebuje 10 mg dasatiniba (v obliki monohidrata).
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.).
Neuspeh zdravljenja je bil definiran kot napredovanje bolezni ali prehod na drugo obliko zdravljenja (pomanjkanje odziva, neprenašanje študijskega zdravila, itd.).
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder
Pogosti krvavitve v prebavilih*, kolitis (vključno z nevtropeničnim kolitisom), gastritis, vnetje sluznic (vključno z mukozitisom/stomatitisom), dispepsija, napihnjenost trebuha, obstipacija, spremembe na mehkih tkivih ust
within 24 months (95% CI)
v 24 mesecih (95% IZ)
within 48 months (95% CI)
v 48 mesecih (95% IZ)
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 osnovi Kaplan-Meierjeve ocene se je dober citogenetski odziv ohranil 18 mesecev pri 93% bolnikov (95% IZ: [88% - 98%]), ki so dasatinib prejemali v odmerku 100 mg enkrat na dan.
Six percent of dasatinib-treated patients discontinued treatment due to drug-related pleural effusion.
Zaradi z zdravilom povezanega plevralnega izliva je bilo zdravljenje z dasatinibom prekinjeno pri 6% bolnikov.
1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
1 Prekinite zdravljenje, dokler absolutno število nevtrofilcev ne doseže ≥ 1,0 x 109/l in trombocitov ≥ 50 x 109/l.