natgillin/translations-raw huggingface dataset:
Dasatinib is administered orally once daily in the form of either SPRYCEL powder for oral suspension or film-coated tablets (see Summary of Product Characteristics for SPRYCEL film-coated tablets).
Dasatinib se uporablja peroralno enkrat na dan v obliki SPRYCEL praška za peroralno suspenzijo ali SPRYCEL filmsko obloženih tablet (glejte povzetek glavnih značilnosti zdravila SPRYCEL filmsko obložene tablete).
Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML.
Druge krvavitve stopnje 3 ali 4 so se pojavile pri 2% bolnikov s KML v napredovalem obdobju.
Constituted oral suspension mixed with milk, yogurt, apple juice, or applesauce may be stored at or below 25°C for up to 1 hour.
Rekonstituirano peroralno suspenzijo, zmešano z mlekom, jogurtom, jabolčnim sokom ali jabolčno čežano, lahko shranjujete pri temperaturi do 25°C največ 1 uro.
What you need to know before you take SPRYCEL
Kaj morate vedeti, preden boste vzeli zdravilo SPRYCEL
Constituted oral suspension may be further mixed with milk, yogurt, apple juice, or applesauce.
Rekonstituirano peroralno suspenzijo se lahko nadalje zmeša z mlekom, jogurtom, jabolčnim sokom ali jabolčno čežano.
In people with ALL, white cells called lymphocytes multiply too quickly and live too long.
Pri bolnikih z ALL se bele krvne celice, imenovane limfociti, prehitro delijo in nato prepočasi propadajo.
HDPE bottle with a polypropylene child-resistant closure.
Plastenka HDPE z za otroke varno polipropilensko zaporko.
Eighty-two patients received dasatinib tablets exclusively and 24 patients received dasatinib powder for oral suspension at least once, 8 of whom received dasatinib powder for oral suspension exclusively.
Dvainosemdeset bolnikov je prejemalo dasatinib le v obliki tablet, 24 bolnikov je dasatinib vsaj enkrat prejelo v obliki praška za peroralno suspenzijo, 8 od teh pa je dasatinib prejemalo le v obliki praška za peroralno suspenzijo.
Elimination is predominantly in the faeces, mostly as metabolites.
Izločanje v glavnem poteka z blatom, večinoma v obliki presnovkov.
PROPORTION ALIVE
DELEŽ PREŽIVETJA
In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated.
Pri pediatričnih bolnikih s Ph+ ALL, ki se zdravijo z dasatinibom v kombinaciji s kemoterapijo, je treba preiskavo celotne krvne slike izvesti pred začetkom vsakega bloka kemoterapije in kot je to klinično indicirano.
SPRYCEL should be taken at the same time every day.
Zdravilo SPRYCEL jemljite vsak dan ob istem času.
Find the marking that matches the dose that was prescribed by your doctor.
Upoštevajte, da so oznake na brizgi v ml. Poiščite oznako, ki ustreza odmerku, ki ga je predpisal zdravnik.
Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.
Pri otrocih s KML v kroničnem obdobju ali Ph+ ALL odmerjanje temelji na telesni masi.
Non-haematologic adverse reactions
Nehematološki neželeni učinki
This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age.
Zdravilo uporabljamo za zdravljenje kronične mieloične levkemije (KML) pri odraslih, mladostnikih in otrocih, starih najmanj 1 leto.
In animal studies, the fertility of male and female rats was not affected by treatment with dasatinib (see section 5.3).
V študijah na živalih uporaba dasatiniba ni vplivala na plodnost samcev in samic podgan (glejte poglavje 5.3).
An open-label, randomised, non-comparative multicentre study was conducted in patients who failed initial treatment with 400 or 600 mg imatinib.
Odprta, randomizirana, neprimerjalna, multicentrična študija je bila izvedena pri bolnikih, pri katerih je bilo začetno zdravljenje z imatinibom v odmerku 400 mg ali 600 mg neuspešno.
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).
Neželene učinke, povezane z zastajanjem tekočin, so običajno zdravili s podpornimi ukrepi, ki so obsegali dajanje diuretikov in kratkotrajno zdravljenje s kortikosteroidi (glejte poglavji 4.2 in 4.8).
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanjem z zdravilom
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
Preglednica 7: Neželeni učinki, o katerih so poročali pri ≥10% pediatričnih bolnikov s Ph+ ALL, ki so se zdravili z zdravilom SPRYCEL po režimu neprekinjenega odmerjanja v kombinaciji s kemoterapijo (N=126)a
In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
Pri podganah je dasatinib in vitro zaviral agregacijo trombocitov ter in vivo podaljšal čas krvavitve iz kutikule kremplja, vendar pa ni povzročil spontanih krvavitev.
6.6 Special precautions for disposal and other handling The film-coated tablets consist of a core tablet, surrounded by a film-coating to prevent exposure of healthcare professionals to the active substance.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanjem z zdravilom Filmsko obložene tablete so sestavljene iz jedra, ki je obdano s filmsko oblogo.
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%).
Pri bolnikih, ki so se zdravili z odmerkom 100 mg enkrat na dan, je bila kumulativna pojavnost citopenij stopnje 3 ali 4 po 2 in 5 letih zdravljenja podobna, in sicer: nevtropenija (35% v primerjavi s 36%), trombocitopenija (23% v primerjavi s 24%) in anemija (13% v primerjavi s 13%).
In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
V študiji III. faze za določitev optimalnega odmerka pri bolnikih s KML v kroničnem obdobju, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali (zdravljenje je v povprečju trajalo 30 mesecev), je bila pojavnost plevralnega izliva in kongestivnega srčnega popuščanja/srčne disfunkcije pri bolnikih, ki so se zdravili z zdravilom SPRYCEL v odmerku 100 mg enkrat na dan manjša kot pri bolnikih, ki so se zdravili z zdravilom SPRYCEL v odmerku 70 mg dvakrat na dan.
The MRD negativity rates at the end of induction and consolidation as measured by flow cytometry were 66.0% and 84.0%, respectively.
Negativni delež MRD, merjen s pretočno citometrijo, je na koncu indukcije znašal 66,0%, na koncu konsolidacije pa 84,0%.
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.
Zmanjšanje apetita Utrujenost a V ključni študiji je od skupno 106 bolnikov 24 bolnikov vsaj enkrat prejelo prašek za peroralno suspenzijo, 8 od teh bolnikov pa je zdravilo prejemalo le v obliki praška za peroralno suspenzijo.
CCyRb within 24 months cCCyRa CCyRb within 36 months cCCyRa CCyRb within 48 months cCCyRa CCyRb within 60 months cCCyRa CCyRb Major molecular responsec
CCyRb v 48 mesecih cCCyRa CCyRb v 60 mesecih cCCyRa
They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Bolniki so bili randomizirani (2:1) tako, da so bodisi prejemali dasatinib (70 mg dvakrat na dan) ali imatinib (400 mg dvakrat na dan).
In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarisation (QT Interval) (see section 5.3).
Podatki, pridobljeni in vitro kažejo, da je uporaba dasatiniba lahko povezana s podaljšanjem repolarizacije ventriklov (interval QT) (glejte poglavje 5.3).
Stevens-Johnson syndromef Musculoskeletal and connective tissue disorders Very common musculoskeletal paing
Stevens-Johnsonov sindromf Bolezni mišično-skeletnega sistema in vezivnega tkiva
If SPRYCEL is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt SPRYCEL until the inhibitor is discontinued.
Če bolnik zdravila SPRYCEL po zmanjšanju odmerka ne prenaša, ukinite močan zaviralec CYP3A4 ali pa prekinite zdravljenje z zdravilom SPRYCEL, dokler se zaviralec ne ukine.
Chronic phase (n= 165)b
Kronično obdobje (n = 165)b
After a minimum of 60 months follow-up the cumulative rate of grade 3 or 4 hypophosphataemia was 7%, grade 3 or 4 elevations of creatinine and bilirubin was 1% and grade 3 or 4 elevations of transaminases remained 1%.
Po najmanj 60-mesečnem obdobju spremljanja je kumulativni delež hipofosfatemije stopnje 3 ali 4 znašal 7%, kumulativni delež zvišanja vrednosti kreatinina in bilirubina stopnje 3 ali 4 je znašal 1%, kumulativni delež zvišanja transaminaz stopnje 3 ali 4 pa je ostal 1%.
Most bleeding related adverse reactions in these patients were typically associated with grade 3 or 4 thrombocytopaenia (see section 4.8).
Pri teh bolnikih je bila večina neželenih učinkov, povezanih s krvavitvami, značilno povezanih s trombocitopenijo stopnje 3 ali 4 (glejte poglavje 4.8).
There is insufficient/limited information on the excretion of dasatinib in human or animal breast milk.
Podatki o izločanju dasatiniba s človeškim ali z živalskim mlekom so nezadostni/omejeni.
Dose reduction for concomitant use of strong CYP3A4 inhibitors
Zmanjšanje odmerka pri sočasni uporabi močnih zaviralcev CYP3A4
Grade 3 or 4 hypocalcaemia, hypokalaemia, and hypophosphataemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL.
O hipokalciemiji, hipokaliemiji in hipofosfatemiji stopnje 3 ali 4 so poročali pri bolnikih s KML v vseh obdobjih, vendar pa so bila poročila pogostejša pri bolnikih s KML v obdobju mieloblastne ali limfoblastne preobrazbe in bolnikih s Ph+ ALL.
There was no significant difference of dasatinib PK between children and adolescents.
Pri otrocih in mladostnikih ni bilo pomembne razlike v farmakokinetiki dasatiniba.
In all SPRYCEL treated patients with chronic phase CML, severe fluid retention occurred in 32 patients (6%) receiving SPRYCEL at the recommended dose (n=548).
Od vseh bolnikov s KML v kroničnem obdobju, ki so se zdravili z zdravilom SPRYCEL, se je hudo zastajanje tekočin pojavilo pri 32 bolnikih (6%), ki so zdravilo SPRYCEL prejemali v priporočenem odmerku (n=548).
Among dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions and 30 (41%) had dose reductions.
Pri bolnikih s plevralnim izlivom zaradi zdravljenja z dasatinibom (n=73) je bilo zdravljenje prekinjeno pri 45 (62%) bolnikih, odmerek pa je bil zmanjšan pri 30 (41%) bolnikih.
Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
Pri sočasni uporabi dasatiniba in substratov za CYP3A4 se lahko poveča izpostavljenost substratu za CYP3A4.
Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
Redki pljučno srce, miokarditis, akutni koronarni sindrom, srčni zastoj, podaljšanje intervala PR na elektrokardiogramu, koronarna arterijska bolezen, plevroperikarditis
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Bolnike je treba pred začetkom zdravljenja z zdravilom SPRYCEL testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo)
Once constituted by your pharmacist or healthcare professional, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Po rekonstituciji, ki jo je izvedel farmacevt ali zdravstveni delavec, se peroralno suspenzijo lahko daje le s pomočjo brizge za peroralno dajanje, ki je priložena vsakemu pakiranju.
Excipients: contains sucrose, sodium, sodium benzoate, benzoic acid, benzyl alcohol and sulphur dioxide (E220).
Pomožne snovi: vsebuje saharozo, natrij, natrijev benzoat, benzojsko kislino, benzilalkohol in žveplov dioksid (E220).
Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
Pogosti kongestivno srčno popuščanje/srčna disfunkcija*c, perikardialni izliv*, aritmije (vključno s tahikardijo), palpitacije
• If unable to fill with one bottle, use the second bottle to complete the full prescribed dose.
• Če celotnega predpisanega odmerka ne morete dobiti iz ene plastenke, uporabite še drugo plastenko.
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).
Za dosego priporočenega odmerka je zdravilo SPRYCEL na voljo v obliki 20 mg, 50 mg, 70 mg, 80 mg, 100 mg in 140 mg filmsko obloženih tablet in v obliki praška za peroralno suspenzijo (10 mg/ml suspenzije po rekonstituciji).
The rates of MMR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (8% and 0.4%), 6 months (27% and 8%), 9 months (39% and 18%), 12 months (46% and 28%), 24 months (64% and 46%) , 36 months (67% and 55%), 48 months (73% and 60%) and 60 months (76% and 64%)were also consistent with the primary endpoint.
Deleži MMR v skupini, ki je prejemala zdravilo SPRYCEL in v skupini, ki je prejemala imatinib, so bili v 3 mesecih (8% oziroma 0,4%), 6 mesecih (27% oziroma 8%), 9 mesecih (39% oziroma 18%), 12 mesecih (46% oziroma 28%), 24 mesecih (64% oziroma 46%), 36 mesecih (67% in 55%), 48 mesecih (73% in 60%) in 60 mesecih (76% in 64%) prav tako konsistentni s primarnim opazovanim dogodkom.
Key efficacy endpoints were: complete cytogenetic response (CCyR), major cytogenetic response (MCyR) and major molecular response (MMR).
Ključni opazovani dogodki učinkovitosti so: popoln citogenetski odziv (CCyR - complete cytogenetic response), pomemben citogenetski odziv (MCyR - major cytogenetic response) in pomemben molekularni odziv (MMR - major molecular response).
Remove child-resistant closure and foil seal.
Odstranite za otroke varno zaporko in tesnilno folijo.
Make sure the adapter provided on the bottle for syringe placement is firmly pressed into the bottle.
Prepričajte se, da je nastavek na plastenki za namestitev brizge trdno pritrjen v plastenko.
SPRYCEL 10 mg/mL powder for oral suspension dasatinib
SPRYCEL 10 mg/ml prašek za peroralno suspenzijo dasatinib
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
Sedemindevetdeset od 130 pediatričnih bolnikov s KML-KO se je zdravilo z zdravilom SPRYCEL v obliki tablet v odmerku 60 mg/m2 enkrat na dan (največji odmerek 100 mg enkrat na dan pri bolnikih z veliko telesno površino).
Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Zelo pogosti mielosupresija (vključno z anemijo, nevtropenijo in trombocitopenijo)
SPRYCEL is administered orally once daily in the form of either SPRYCEL tablets or SPRYCEL powder for oral suspension.
Zdravilo SPRYCEL se uporablja peroralno enkrat na dan v obliki SPRYCEL tablet ali SPRYCEL praška za peroralno suspenzijo.
SPRYCEL will only be prescribed to you by a doctor with experience in treating leukaemia.
Zdravilo SPRYCEL vam sme predpisati le zdravnik z izkušnjami pri zdravljenju levkemije.
If marrow cellularity is <10%, treatment with SPRYCEL should be interrupted until ANC >500/μL (0.5 x 109/L), at which time treatment may be resumed at full dose.
Če je celularnost kostnega mozga <10%, je treba zdravljenje z zdravilom SPRYCEL prekiniti, dokler absolutno število nevtrofilcev ne doseže >500/μl (0,5 x 109/l), v tem trenutku pa se zdravljenje lahko nadaljuje v celotnem odmerku.
How to store SPRYCEL 6.
Shranjevanje zdravila SPRYCEL 6.
In clinical studies in patients with advanced phase CML receiving the recommended dose of SPRYCEL (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients.
V kliničnih študijah pri bolnikih s KML v napredovalem obdobju, ki so prejemali priporočeni odmerek zdravila SPRYCEL (n=304), so se hujše krvavitve v osrednjem živčevju pojavile pri 1% bolnikov.
Contains 0.29 g of sucrose per mL of oral suspension.
Vsebuje 0,29 g saharoze na ml peroralne suspenzije.
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Pred izdajo zdravila bolniku mora SPRYCEL prašek za peroralno suspenzijo pripraviti farmacevt ali ustrezno usposobljen zdravstveni delavec.
Make sure the second bottle is shaken before use.
Poskrbite, da boste pred uporabo pretresli tudi drugo plastenko.
It can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2).
Bolnik mora zdravilo dosledno jemati zjutraj ali zvečer (glejte poglavje 5.2).
Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Pri in vitro testih na bakterijskih celicah (Amesov test) dasatinib ni deloval mutageno in tudi ni bil genotoksičen pri in vivo študiji s podganjimi mikronukleusi.
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.
Po najmanj 12-mesečnem spremljanju je 85% bolnikov, ki so bili randomizirani v skupino z zdravilom SPRYCEL, in 81% bolnikov, ki so bili randomizirani v skupino z imatinibom, še vedno prejemalo zdravilo prve izbire.
SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg.
Zdravilo SPRYCEL je na voljo tudi v obliki tablet za uporabo pri odraslih in otrocih, starejših od enega leta, in s telesno maso najmanj 10 kg.
Febrile neutropaenia Nausea
Febrilna nevtropenija Navzea
Mix the SPRYCEL oral suspension in the closed bottle by shaking for 30 seconds.
Peroralno suspenzijo zdravila SPRYCEL v zaprti plastenki zmešajte s 30 sekundnim stresanjem.
SPRYCEL is prescribed for adults and children at least 1 year of age.
Zdravilo SPRYCEL se lahko predpiše odraslim in otrokom, starim najmanj 1 leto.
newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.
z na novo diagnosticirano Ph+ akutno limfoblastno anemijo (ALL) v kombinaciji s kemoterapijo.
Not known interstitial lung disease
Neznana pogostnost intersticijska pljučna bolezen
Step 5: Dispense the bottle with inserted PIBA, package leaflet, and oral dosing syringe in the original carton to the patient or caregiver.
5. korak: Plastenko z vstavljenim nastavkom, navodilom za uporabo in brizgo za peroralno dajanje v originalni ovojnini izdajte bolniku ali osebi, ki zanj skrbi.
Thirty-eight percent of patients had baseline mutations known to confer imatinib resistance.
Pri 38% bolnikov so bile v izhodišču prisotne mutacije, povezane z odpornostjo na imatinib.
3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
3 Če se število trombocitov zmanjša pod 25 x 109/l in/ali absolutno število nevtrofilcev ponovno zmanjša pod 0,5 x 109/l za > 7 dni, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 80 mg enkrat na dan (druga ponovitev).
Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Občasni miokardni infarkt (tudi s smrtnim izidom)*, podaljšanje intervala QT na elektrokardiogramu*, perikarditis, ventrikularna aritmija (vključno z ventrikularno tahikardijo), angina pektoris, kardiomegalija, nenormalni val T na elektrokardiogramu, zvišana vrednost troponina
A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and of prostate adenoma in low-dose males was noted.
Opazili so statistično značilno povečanje v skupni pojavnosti ploščatoceličnega karcinoma in papiloma maternice in materničnega vratu pri samicah, ki so prejemale velike odmerke in adenoma prostate pri samcih, ki so prejemali majhne odmerke.
Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you.
Pred izdajo zdravila bo farmacevt ali ustrezno usposobljen zdravstveni delavec SPRYCEL prašek za peroralno suspenzijo najprej pripravil (zmešal tako, da nastane tekočina) in vam zdravilo nato izdal v obliki SPRYCEL peroralne suspenzije.
For patients with chronic phase CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended.
Pri bolnikih s KML v kroničnem obdobju, ki so prejemali odmerek 100 mg enkrat na dan, se priporoča zmanjšanje odmerka na 80 mg enkrat na dan in nato po potrebi nadaljnje zmanjšanje z odmerka 80 mg enkrat na dan na odmerek 50 mg enkrat na dan.
OUTER CARTON AND LABEL FOR BOTTLE PACK
ŠKATLA IN NALEPKA ZA VSEBNIK ŠKATLA ZA PRETISNE OMOTE
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat hidroksipropilceluloza magnezijev stearat
The starting dose of SPRYCEL is calculated by body weight as shown below:
Začetni odmerek zdravila SPRYCEL se izračuna na osnovi telesne mase, kot je prikazano v nadaljevanju:
Accelerated phase (n= 157)c
Obdobje pospešenega poteka (n= 157)c
In clinical studies, treatment with SPRYCEL in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years.
V kliničnih študijah je zdravljenje z zdravilom SPRYCEL pri pediatričnih bolnikih s Ph+ ALL trajalo neprekinjeno, dodano je bilo k zaporednim blokom osnovne kemoterapije, zdravljenje pa je trajalo največ dve leti.
Minimum of 7 years follow up
Najmanj 7-letno spremljanje
Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables.
Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednici.
Lymphoid blast phase and Ph+ ALL (n= 168)c
Obdobje limfoblastne preobrazbe in Ph+ ALL (n= 168)c
The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group.
V skupini, ki je prejemala dasatinib je od diagnoze do randomizacije minilo v povprečju 64 mesecev, v skupini, ki je prejemala imatinib, pa 52 mesecev.
Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Redki hipertiroidizem, tiroiditis Presnovne in prehranske motnje
How to take SPRYCEL
Kako jemati zdravilo SPRYCEL
PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Preživetje brez napredovanja bolezni je bilo analizirano po principu vseh vključenih bolnikov (“intent-to-treat”), bolnike pa so spremljali do pojava dogodkov, vključno s kasnejšim zdravljenjem.