FrancophonIA/ELRC3.0 huggingface dataset:
English: The data described below reflect the exposure to SPRYCEL as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly diagnosed chronic phase CML, 2,388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 188 paediatric patients.
Slovenian: V nadaljevanju navedeni podatki odražajo izpostavljenost zdravilu SPRYCEL, pri samostojnem zdravljenju, pri vseh odmerkih, ki so jih preskusili v kliničnih študijah (n=2.900), vključno s 324 odraslimi bolniki z na novo diagnosticirano KML v kroničnem obdobju, 2.388 odraslimi bolniki s KML v kroničnem obdobju ali obdobju pospešenega poteka, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali ali s Ph+ ALL in 188 pediatričnimi bolniki.
English: 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.
Slovenian: Zdravilo SPRYCEL vsebuje benzojsko kislino in natrijev benzoat Zdravilo SPRYCEL vsebuje 0,25 mg benzojske kisline v enem ml peroralne suspenzije in 0,25 mg natrijevega benzoata v enem ml peroralne suspenzije.
English: The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Slovenian: Pri 1.618 odraslih bolnikih s KML v kroničnem obdobju je mediana trajanja zdravljenja znašala 29 mesecev (razpon 0 do 92,9 meseca).
English: One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Slovenian: Ena plastenka praška za peroralno suspenzijo vsebuje 990 mg dasatiniba (v obliki monohidrata).
English: 2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose.
Slovenian: 2 Če citopenija ni povezana z levkemijo, prekinite zdravljenje, dokler absolutno število nevtrofilcev ne doseže ≥ 1,0 x 109/l in trombocitov ≥ 20 x 109/l in nato ponovno uvedite običajni začetni odmerek.
English: CCyR (95% CI)
Slovenian: CCyR (95% IZ)
English: 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.
Slovenian: Če citopenija ni povezana z levkemijo, prekinite zdravljenje, dokler absolutno število nevtrofilcev ne doseže ≥1,0 × 109/l in trombocitov ≥75 × 109/l in nato ponovno uvedite zdravljenje z običajnim začetnim odmerkom ali zmanjšanim odmerkom.
English: Powder Store below 25°C.
Slovenian: Prašek Shranjujte pri temperaturi do 25 °C.
English: Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Slovenian: Pri blagih/zmernih neželenih učinkih (≤ stopnje 2) se zdravljenje z dasatinibom lahko nadaljuje v predhodnem odmerku, pri hujših neželenih učinkih (≥ stopnje 3) pa z zmanjšanim odmerkom (glejte poglavje 4.2).
English: Outer Carton: sprycel 140 mg
Slovenian: Škatla: sprycel 140 mg
English: Haematologic response rateb (%) MaHR (95% CI)
Slovenian: Delež hematološkega odzivab (%) MaHR (95% IZ)
English: MCyR (95% CI) Newly diagnosed (N = 51)a
Slovenian: MCyR (95% IZ) Na novo diagnosticirana (N = 51)a
English: The median time from diagnosis to start of treatment was 61 months.
Slovenian: Od diagnoze do začetka zdravljenja je v povprečju minilo 61 mesecev.
English: In 865 patients with leukaemia treated with dasatinib in Phase II clinical studies, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Slovenian: faze so bile pri 865 bolnikih z levkemijo, zdravljenih z dasatinibom, srednje vrednosti sprememb intervala QTc (z metodo po Fridericiju; QTcF) v primerjavi z izhodiščem 4-6 milisekund; zgornja meja 95% intervala zaupanja je bila pri vseh srednjih vrednostih sprememb v primerjavi z izhodiščem manjša od 7 milisekund (glejte poglavje 4.8).
English: 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.
Slovenian: Pri 15 (1%) od 2.182 bolnikov, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, in so v kliničnih študijah prejemali dasatinib, so o podaljšanju intervala QTc poročali kot o neželenem učinku.
English: Outer Carton: sprycel 70 mg
Slovenian: Škatla: sprycel 70 mg
English: SPRYCEL powder for oral suspension is to be constituted as follows: Note: If you have to constitute more than one bottle, complete one bottle at a time.
Slovenian: Opomba: Če morate rekonstituirati več kot eno plastenko, najprej dokončajte z rekonstitucijo ene plastenke.
English: 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.
Slovenian: Zdravilo SPRYCEL vsebuje 0,25 mg benzojske kisline v enem ml peroralne suspenzije in 0,25 mg natrijevega benzoata v enem ml peroralne suspenzije.
English: Persons other than the patient should use gloves when handling SPRYCEL.
Slovenian: Posebna navodila za ravnanje z zdravilom SPRYCEL Priporočljivo je, da osebe, ki niso bolniki, pri rokovanju z zdravilom SPRYCEL uporabljajo rokavice.
English: The use of latex or nitrile gloves is recommended when handling any powder that is inadvertently spilled from the bottle, for appropriate disposal in order to minimise the risk of dermal exposure.
Slovenian: Pri rokovanju s praškom, ki se po nesreči raztrese iz plastenke, se priporoča uporabo rokavic iz lateksa ali nitrila za ustrezno odstranjevanje, da se zmanjša tveganje izpostavljenosti koži.
English: 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
Slovenian: Naslednji znaki so lahko znaki resnih neželenih učinkov: bolečina v prsih, težko dihanje, kašelj ali omedlevica; nepojasnjena krvavitev ali nastanek modrice brez predhodne poškodbe; kri v izbljuvku, blatu ali urinu ali blato črne barve; bolezenski znaki okužbe, kot sta zvišana telesna temperatura ali huda mrzlica; zvišana telesna temperatura, vnetje ustne votline ali žrela, pojav mehurjev ali luščenja na koži in/ali sluznicah.
English: Powder for oral suspension Outer Carton:
Slovenian: Prašek za peroralno suspenzijo Škatla:
English: Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose
Slovenian: Preglednica 2: Povečevanje odmerka pri pediatričnih bolnikih s Ph+ KML-KO Odmerek (največji odmerek na dan) Začetni odmerek
English: Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Slovenian: s Ph+ akutno limfoblastno levkemijo (ALL) in KML v obdobju limfoblastne preobrazbe, ki se na predhodna zdravljenja niso odzvali ali jih niso prenašali.
English: Dasatinib over imatinib
Slovenian: Dasatinib proti imatinibu
English: d Major molecular response criteria: Defined as BCR-ABL/control transcripts ≤0.1% by RQ-PCR in peripheral blood samples
Slovenian: d Kriteriji dobrega molekularnega odziva: definiran z vrednostjo prepisa BCR-ABL/kontrola ≤ 0,1% pri kvantitativni polimerazni verižni reakciji v realnem času (RQ-PCR) v vzorcu periferne krvi
English: Uncommon pancreatitis (including acute pancreatitis), upper gastrointestinal ulcer, oesophagitis, ascites*, anal fissure, dysphagia, gastroesophageal reflux disease
Slovenian: Občasni vnetje trebušne slinavke (vključno z akutnim vnetjem trebušne slinavke), razjeda zgornjih prebavil, vnetje požiralnika, ascites*, analna fisura, disfagija, gastroezofagealna refluksna bolezen
English: ANC: absolute neutrophil count *lower tablet dose not available
Slovenian: *manjši odmerek v obliki tablet ni na voljo
English: See section 4.4 for further information on patients with chronic phase CML and advanced phase CML or Ph+ ALL.
Slovenian: Za nadaljnje informacije o bolnikih s KML v kroničnem obdobju in KML v napredovalem obdobju ali s Ph+ ALL glejte poglavje 4.4.
English: Myeloid blast (n= 75)
Slovenian: Obdobje mieloblastne preobrazbe (n= 75)
English: In paediatric trials of SPRYCEL in imatinib-resistant/intolerant Ph+ CML-CP paediatric patients and treatment-naive Ph+ CML-CP paediatric patients after at least 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 6 (4.6%) patients, one of which was severe in intensity (Growth Retardation Grade 3).
Slovenian: V pediatričnih preskušanjih zdravila SPRYCEL so pri pediatričnih bolnikih s Ph+ KML-KO, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali in pri predhodno nezdravljenih pediatričnih bolnikih s Ph+ KML-KO po najmanj 2 letih zdravljenja poročali o z zdravljenjem povezanih neželenih učinkih na rast in razvoj kosti pri 6 (4,6%) bolnikih, pri enem hude intenzitete (zaostanek v rasti stopnje 3).
English: If you have accidentally taken too much SPRYCEL, talk to your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila SPRYCEL, kot bi smeli Če ste slučajno vzeli prevelik odmerek, se nemudoma posvetujte z zdravnikom.
English: By 5 years 76%, p<.0022
Slovenian: V 5 letih p<0,0022
English: A statistically significantly greater proportion of patients in the SPRYCEL group achieved a cCCyR compared with patients in the imatinib group within the first 12 months of treatment.
Slovenian: V prvih 12 mesecih zdravljenja je bil cCCyR dosežen pri statistično pomembno večjem deležu bolnikov v skupini, ki je prejemala zdravilo SPRYCEL, kot pa v skupini, ki je prejemala imatinib.
English: 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.
Slovenian: Na osnovi Kaplan-Meierjeve ocene je bil pri zdravljenju z dasatinibom delež bolnikov z 1-letnim preživetjem brez progresije bolezni 91% (95% interval zaupanja: [85% - 97%]), pri zdravljenju z imatinibom pa 73% (95% interval zaupanja: [54%-91%]).
English: Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
Slovenian: Pri sočasni uporabi dasatiniba in zdravil, ki inducirajo CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ali zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum)), se lahko izpostavljenost dasatinibu bistveno zmanjša, kar lahko poveča tveganje za neuspešnost zdravljenja.
English: 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.
Slovenian: 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.
English: The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months.
Slovenian: Delež dobrega molekularnega odziva (ovrednoten pri 19 bolnikih s popolnim citogenetskim odzivom) je bil po 24 mesecih 68%.
English: Efficacy results are reported in Table 11.
Slovenian: Rezultati učinkovitosti so predstavljeni v preglednici 11.
English: Haematopoietic growth factor has been used in patients with resistant myelosuppression.
Slovenian: Bolniki z rezistentno mielosupresijo so prejeli hematopoetski rastni faktor.
English: 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.
Slovenian: O zvišanju vrednosti kreatinina stopnje 3 ali 4 so poročali pri < 1% bolnikov s KML v kroničnem obdobju.
English: Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Slovenian: 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.
English: An international open-label, multicentre, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
Slovenian: Pri odraslih bolnikih z na novo diagnosticirano KML v kroničnem obdobju je bila izvedena mednarodna, odprta, multicentrična, randomizirana primerjalna študija III. faze.
English: 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.
Slovenian: 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
English: 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%]).
Slovenian: 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%]).
English: 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.
Slovenian: Podatki, pridobljeni in vitro kažejo, da dasatinib ni aktiven proti mutaciji T315I.
English: Very common diarrhoea, vomiting, nausea, abdominal pain
Slovenian: Zelo pogosti driska, bruhanje, navzea, bolečine v trebuhu
English: 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).
Slovenian: 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).
English: Time-to cCCyR
Slovenian: Čas do cCCyR
English: 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.
Slovenian: 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.
English: The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Slovenian: Delež dobrega molekularnega odziva (vseh 25 zdravljenih bolnikov s popolnim citogenetskim odzivom) je bil po 24 mesecih 52%.
English: # DEATHS / # Land Patient
Slovenian: SMRTI / Št. zajetih bolnikov
English: 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.
Slovenian: 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%]).
English: chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
Slovenian: 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.
English: Outer Carton: sprycel 20 mg
Slovenian: Škatla: sprycel 20 mg
English: 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).
Slovenian: 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).
English: Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Slovenian: Škatla s 60 x 1 filmsko obloženo tableto v perforiranih, enoodmernih pretisnih omotih.
English: The primary endpoint was MCyR at 12 weeks.
Slovenian: Primarni opazovani dogodek je bil dober citogenetski odziv po 12 tednih.
English: A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Slovenian: 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).
English: Allow a washout period of approximately 1 week after the inhibitor is stopped before the SPRYCEL dose is increased.
Slovenian: Pred povečanjem odmerka zdravila SPRYCEL naj obdobje izpiranja po prekinitvi zdravljenja z zaviralcem traja približno 1 teden.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Lymphoid blast phase CML and Ph+ ALL
Slovenian: KML v obdobju limfoblastne preobrazbe in Ph+ ALL
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Izpostavljenost je ustrezala do 3-kratni izpostavljenosti človeka po prejetju priporočenega terapevtskega odmerka (na osnovi AUC).
English: 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
Slovenian: 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
English: The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z dasatinibom, je bil čas do MMR konsistentno krajši kot pri bolnikih, ki so se zdravili z imatinibom.
English: 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.
Slovenian: Prav tako je dasatinib pri študijah embriofetalnega razvoja pri podganah povzročal smrtnost zarodkov in s tem povezano manjše število mladičev.
English: Nine (12%) patients underwent therapeutic thoracentesis.
Slovenian: Terapevtska torakocenteza je bila opravljena pri 9 (12%) bolnikih.
English: 20 to less than 30 kg
Slovenian: 20 do manj kot 30 kg
English: Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z dasatinibom, so bili deleži MMR konsistentno višji kot pri bolnikih, ki so se zdravili z imatinibom.
English: 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
Slovenian: 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.