FrancophonIA/ELRC3.0 huggingface dataset:
English: In the paediatric CML studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults.
Croatian: U ispitivanjima liječenja KML u pedijatrijskih bolesnika stope odstupanja u laboratorijskim nalazima odgovarale su poznatom profilu za laboratorijske parametre u odraslih.
English: Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Croatian: Slika 2: Stope MMR tijekom vremena - svi randomizirani bolesnici u ispitivanju faze 3 provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi
English: In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up.
Croatian: Nakon najmanje 12 mjeseci praćenja bolesnika s novodijagnosticiranom KML u kroničnoj fazi liječenih lijekom SPRYCEL u kojih je nastupila mijelosupresija 3. ili 4. stupnja oporavak je općenito nastupio nakon kratkog prekida terapije i/ili nakon smanjenja doze lijeka, dok je do trajnog prekida liječenja došlo u 1,6% bolesnika.
English: In the study in advanced phase CML and Ph+ ALL, the primary endpoint was MaHR.
Croatian: U ispitivanju uznapredovale faze KML i Ph+ ALL, primarni ishod ispitivanja bio je značajan hematološki odgovor.
English: Do not crush, cut or chew them.
Croatian: Tablete se ne smiju drobiti, lomiti ni žvakati.
English: Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Croatian: Stoga je u bolesnika koji primaju dasatinib potrebno odabrati zamjenske lijekove s manjim potencijalom za indukciju CYP3A4 (vidjeti dio 4.5).
English: In Ph+ ALL paediatric patients with non-haematologic adverse reactions, if needed, one level of dose reduction should be followed, according to the dose reduction recommendations for haematologic adverse reactions that are described above.
Croatian: U pedijatrijskih bolesnika s Ph+ ALL koji imaju nehematološke nuspojave po potrebi treba smanjiti dozu za jednu razinu, u skladu s prethodno navedenim preporukama za smanjenje doze u slučaju hematoloških nuspojava.
English: In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients.
Croatian: U bolesnika koji su primali lijek u obliku tableta u pedijatrijskom ispitivanju faze II, procijenjena 24-mjesečna stopa PFS u 51 bolesnika s novodijagnosticiranim KML u kroničnoj fazi iznosila je 94,0% (82,6; 98,0), dok je u 29 bolesnika s KML u kroničnoj fazi koji su bili otporni na imatinib ili ga nisu podnosili ta stopa iznosila 81,7% (61,4; 92,0).
English: 1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
Croatian: 1 Prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥50×109/l.
English: Instructions for constitution of powder for oral suspension
Croatian: Upute za pripremu praška za oralnu suspenziju
English: Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients.
Croatian: Prekid liječenja unutar 60 mjeseci zbog napredovanja bolesti dogodio se u 11% bolesnika liječenih lijekom SPRYCEL i 14% bolesnika liječenih imatinibom.
English: SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets
Croatian: SPRYCEL 20 mg filmom obložene tablete SPRYCEL 50 mg filmom obložene tablete SPRYCEL 70 mg filmom obložene tablete SPRYCEL 80 mg filmom obložene tablete SPRYCEL 100 mg filmom obložene tablete SPRYCEL 140 mg filmom obložene tablete dasatinib
English: In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Croatian: Također, 46 bolesnika s Ph+ ALL primilo je dasatinib u dozi od 70 mg dvaput dnevno (44 s otpornošću i 2 s nepodnošljivošću imatiniba).
English: The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.
Croatian: Vrijeme do MMR dosljedno je bilo kraće u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
English: Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML (see section 4.4).
Croatian: Te se promjene ranije i češće javljaju u bolesnika s KML u uznapredovaloj fazi i bolesnika s Ph+ ALL nego u bolesnika s KML u kroničnoj fazi (vidjeti dio 4.4).
English: Lymphoid blast (n= 33)
Croatian: Limfoidna blastna kriza (n= 33)
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.
Croatian: Od 2182 bolesnika koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib i primali su SPRYCEL u kliničkim ispitivanjima, 15 (1%) je imalo produljenje QTc intervala koje je zabilježeno kao nuspojava.
English: Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
Croatian: Stoga se u bolesnika koji primaju dasatinib ne preporučuje sistemska primjena potentnog inhibitora CYP3A4 (vidjeti dio 4.2).
English: Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Croatian: Često plućni edem*, plućna hipertenzija, plućni infiltrati, pneumonitis, kašalj Manje često plućna arterijska hipertenzija, bronhospazam, astma
English: Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.
Croatian: Kutija sadrži 56 filmom obloženih tableta u 4 kalendarska blistera sa 14 filmom obloženih tableta po blisteru.
English: Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down.
Croatian: Držeći vrh štrcaljke čvrsto u boci, preokrenite bocu i štrcaljku.
English: Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Croatian: Od 130 pedijatrijskih ispitanika s KML u kroničnoj fazi liječenih lijekom SPRYCEL, u 2 (1,5%) bolesnika javile su se nuspojave koje su dovele do prekida liječenja.
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.
Croatian: SPRYCEL sadrži 0,25 mg benzoatne kiseline u jednom ml oralne suspenzije i 0,25 mg natrijeva benzoata u jednom ml oralne suspenzije.
English: Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the 100 mg once daily regimen demonstrated improved safety and tolerability.
Croatian: Dasatinib se pokazao djelotvornim u svim skupinama koje su primale dozu jedanput dnevno, s time da mu je djelotvornost s obzirom na primarni ishod (razlika u značajnom citogenetskom odgovoru 1,9%; 95% interval pouzdanosti [-6,8% - 10,6%]); međutim, režim liječenja dozom od 100 mg jedanput dnevno pokazao je bolju sigurnost i podnošljivost.
English: At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Croatian: Na temelju in vitro ispitivanja, vezanje dasatiniba za proteine plazme pri klinički značajnim koncentracijama iznosilo je oko 96%.
English: 5 to less than 10 kg
Croatian: od 5 do manje od 10 kg
English: SPRYCEL film-coated tablets
Croatian: SPRYCEL filmom obložene tablete
English: • 20 mg daily for patients taking SPRYCEL 70 mg tablet daily.
Croatian: • 20 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 70 mg dnevno
English: With a minimum of 60 months follow-up, 60% of patients randomised to the SPRYCEL group and 63% of patients randomised to the imatinib group were still receiving first-line treatment.
Croatian: Uz najmanje 60 mjeseci praćenja, 60% bolesnika randomiziranih u skupinu koja je primala SPRYCEL i 63% bolesnika randomiziranih u skupinu koja je primala imatinib i dalje je primalo terapiju prve linije.
English: The proportion of patients achieving BCR-ABL ratio of ≤0.0032% (4.5-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (44% versus 34%).
Croatian: Udio bolesnika koji su postigli omjer BCR-ABL ≤0,0032% (smanjenje 4,5-log) u bilo koje vrijeme bila je viša u SPRYCEL skupini u usporedbi sa imatinib skupinom (44% nasuprot 34%).
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).
Croatian: Medijan trajanja liječenja u 1094 odrasla bolesnika s KML u uznapredovaloj fazi ili Ph+ ALL iznosio je 6,2 mjeseca (raspon 0-93,2 mjeseca).
English: In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction.
Croatian: Od 258 bolesnika liječenih dasatinibom i 258 bolesnika liječenih imatinibom u ispitivanju faze III terapije novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, po 1 bolesnik (<1%) u svakoj skupini imao je produljenje QTc intervala koje je bilo prijavljeno kao nuspojava.
English: Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Croatian: Jedan ml oralne suspenzije sadrži 10 mg dasatiniba (u obliku hidrata).
English: Among patients who had received imatinib 400 mg prior to study entry, MCyR was achieved in 61% of patients in the dasatinib arm and 50% in the imatinib arm.
Croatian: Među bolesnicima koji su primali imatinib u dozi od 400 mg prije uključenja u ispitivanje, značajni citogenetski odgovor postiglo je 61% bolesnika u skupini na dasatinibu te 50% bolesnika u skupini na imatinibu.
English: Your doctor will check for some of these effects during your treatment.
Croatian: Liječnik će Vas pregledavati tijekom trajanja liječenja na navedene nuspojave.
English: In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
Croatian: U dodatnoj je analizi rani molekularni odgovor (definiran kao razine BCR-ABL ≤ 10% u 3. mjesecu) postigao veći broj bolesnika liječenih dasatinibom (84%) nego bolesnika liječenih imatinibom (64%).
English: Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag.
Croatian: Svako pakiranje sadrži nastavak za bocu i dozirnu štrcaljku za usta od 12 ml u zatvorenoj plastičnoj vrećici.
English: It was usually managed with dose reduction or interruption.
Croatian: Vrijednosti su se obično normalizirale nakon smanjenja doze ili privremenog prekida liječenja.
English: One-level dose reduction
Croatian: Smanjenje doze za jednu razinu
English: What you need to know before you take SPRYCEL 3.
Croatian: Što morate znati prije nego počnete uzimati SPRYCEL 3. Kako uzimati SPRYCEL 4. Moguće nuspojave
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).
Croatian: U kliničkom ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 60 mjeseci praćenja, 3. ili 4. stupanj zadržavanja tekućine bio je zabilježen u 13 bolesnika (5%) u skupini liječenoj dasatinibom te u 2 bolesnika (1%) u skupini liječenoj imatinibom (vidjeti dio 4.8).
English: Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML
Croatian: Tablica 9: Rezultati djelotvornosti u novodijagnosticiranih bolesnika s KML u kroničnoj fazi iz ispitivanja faze 3
English: In paediatric trials of SPRYCEL in combination with chemotherapy in newly diagnosed Ph+ ALL paediatric patients after a maximum of 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 1 (0.6%) patient.
Croatian: U ispitivanjima lijeka SPRYCEL u kombinaciji s kemoterapijom provedenima u pedijatrijskih bolesnika s novodijagnosticiranim Ph+ ALL, lijekom uzrokovani štetni događaji povezani s rastom i razvojem kostiju su nakon najviše 2 godine liječenja prijavljeni u 1 (0,6%) bolesnika.
English: MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Croatian: Rezultati djelotvornosti prikazani su u tablici 11. Značajni citogenetski odgovor postigao se u 55% bolesnika otpornih na imatinib i 82% bolesnika koji nisu podnosili imatinib.
English: A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Croatian: Značajni citogenetski odgovor na prethodno liječenje imatinibom postiglo je 28% bolesnika u skupini koja je primala dasatinib i 29% bolesnika u skupini koja je primala imatinib.
English: HAZARD RATIO (95% CI)
Croatian: OMJER HAZARDA (95% CI)
English: At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively).
Croatian: Stratifikacija po Hasfordu na početku ispitivanja bila je slična u obje terapijske skupine (niski rizik: 33% u skupini koja je primala SPRYCEL i 34% u skupini koja je primala imatinib; umjereni rizik: 48% u skupini koja je primala SPRYCEL i 47% u skupini koja je primala imatinib; visoki rizik: 19% u skupini koja je primala SPRYCEL i 19% u skupini koja je primala imatinib).
English: Excipients: contains lactose monohydrate.
Croatian: Pomoćne tvari: sadrži laktozu hidrat.
English: Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Croatian: Provedena su dva randomizirana ispitivanja otvorenog tipa da bi se ispitala djelotvornost primjene dasatiniba jedanput dnevno u usporedbi s primjenom dvaput dnevno.
English: They were randomised (2:1) to either dasatinib (70 mg twice daily) or imatinib (400 mg twice daily).
Croatian: Bolesnici su bili randomizirani (2:1) u dvije skupine, jednu koja je primala dasatinib (70 mg dvaput dnevno) i drugu koja je primala imatinib (400 mg dvaput dnevno).
English: Efficacy of SPRYCEL was consistently demonstrated across different subgroups, including age, gender, and baseline Hasford score.
Croatian: Djelotvornost lijeka SPRYCEL dosljedno je pokazana u svim podskupinama prema dobi, spolu i početnoj razini rizika po Hasfordu.
English: Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet, headache, feeling tired or weak, bleeding
Croatian: Probavni problemi: proljev, loše osjećanje (mučnina, povraćanje) Koža, kosa, oko, općenito: kožni osip, vrućica, oticanje lica, šaka i stopala, glavobolja, osjećaj umora ili slabosti, krvarenje
English: Dose adjustment for adverse reactions Myelosuppression
Croatian: Prilagodba doze lijeka zbog nuspojava Mijelosupresija
English: A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Croatian: Ukupno 48 bolesnika u limfoidnoj blastnoj fazi KML primilo je dasatinib u dozi 70 mg dvaput dnevno (42 s otpornošću na imatinib i 6 s nepodnošljivošću).
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.
Croatian: 2 Ako citopenija nije povezana s leukemijom, prekinuti liječenje dok ABN ne bude ≥1,0×109/l i trombociti ≥20×109/l pa nastaviti liječenje dozom kojom se i započelo.
English: Uncommon hypersensitivity (including erythema nodosum)
Croatian: Poremećaji imunološkog sustava Manje često preosjetljivost (uključujući nodozni eritem)
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.
Croatian: Pri rukovanju nenamjerno zdrobljenim ili prelomljenim tabletama preporučuje se koristiti rukavice od lateksa ili nitrila, kako bi se minimalizirao rizik od izlaganja putem kože.
English: • 20 mg daily for patients taking SPRYCEL 100 mg tablet daily.
Croatian: • 20 mg na dan u bolesnika koji uzimaju SPRYCEL tablete u dozi od 100 mg dnevno
English: oral syringe bottle
Croatian: štrcaljka za usta boca
English: Warnings and precautions Talk to your doctor or pharmacist before using SPRYCEL if you are taking medicines to thin the blood or prevent clots (see "Other medicines and SPRYCEL") if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection.
Croatian: “Drugi lijekovi i SPRYCEL”) ako imate ili ste imali problema s jetrom ili srcem ako počnete otežano disati, osjetite bol u prsištu ili počnete kašljati dok uzimate SPRYCEL: to može biti znak da se u plućima ili prsištu zadržava voda (što se zna češće javljati u bolesnika u dobi od 65 godina i starijih) ili znak promjena na krvnim žilama koje opskrbljuju pluća ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B.
English: In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see section 4.4).
Croatian: U ispitivanju faze III u bolesnika s novodijagnosticiranom KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja (vidjeti dio 4.4), jedan bolesnik (<1%) u skupini liječenoj lijekom SPRYCEL imao je QTcF >500 msek.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat mikrokristalična celuloza, karmelozanatrij, umrežena hidroksipropilceluloza magnezijev stearat
English: There were no mutations detected in newly diagnosed CML-CP patients at the end of treatment.
Croatian: Među bolesnicima s novodijagnosticiranim KML u kroničnoj fazi nisu pronađene nikakve mutacije na kraju razdoblja liječenja.
English: Concomitant use of dasatinib and medicinal products or substances which potently inhibit CYP3A4 (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib.
Croatian: Istodobna primjena dasatiniba i lijekova ili tvari koje potentno inhibiraju CYP3A4 (npr. ketokonazol, itrakonazol, eritromicin, klaritromicin, ritonavir, telitromicin, sok od grejpa) može povećati izloženost dasatinibu.
English: The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months.
Croatian: Stopa značajnog molekularnog odgovora (MMR) (određenog u 19 bolesnika s CCyR) bila je 68% nakon 24 mjeseca.
English: Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
Croatian: U bolesnika koji su uzimali SPRYCEL zabilježene su nuspojave krvarenje povezane s lijekom u rasponu od petehija i epistakse do gastrointestinalnog krvarenja i krvarenja u središnji živčani sustav (CNS) 3. ili 4. stupnja (vidjeti dio 4.4).
English: Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Croatian: Kutija sadrži 30 x 1 filmom obloženu tabletu u perforiranim blisterima djeljivima na jedinične doze.
English: Figure 3: MR4.5 rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Croatian: Stope MR4,5 tijekom vremena - svi randomizirani bolesnici u ispitivanju faze 3 provedenom u bolesnika s novodijagnosticiranom KML u kroničnoj fazi
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).
Croatian: U ispitivanjima lijeka SPRYCEL provedenima u pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi koji su bili otporni na imatinib/nisu podnosili imatinib i prethodno neliječenih pedijatrijskih bolesnika s Ph+ KML u kroničnoj fazi, lijekom uzrokovani štetni događaji povezani s rastom i razvojem kostiju su nakon najmanje 2 godine liječenja prijavljeni u 6 (4,6%) bolesnika, a jedan od njih bio je teškog intenziteta (zastoj u rastu 3. stupnja).
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
Croatian: Tablica 13: Dugoročna djelotvornost lijeka SPRYCEL u ispitivanju optimizacije doze faze 3: bolesnici s KML u kroničnoj fazi koji su otporni na imatinib ili ga ne podnosea Minimalno razdoblje praćenja
English: Concentration data in 32 paediatric patients treated with the powder for oral suspension dose of 72 mg/m2 was pooled with data from the tablet for a population pharmacokinetic
Croatian: Podaci o koncentracijama prikupljeni u 32 pedijatrijska bolesnika liječena praškom za oralnu suspenziju u dozi od 72 mg/m2
English: Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Croatian: Kutija sadrži 60 x 1 filmom obloženu tabletu u perforiranim blisterima djeljivima na jedinične doze.
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.
Croatian: Istodobna primjena dasatiniba i lijekova koji induciraju CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ili biljni pripravci koji sadrže Hypericum perforatum, također poznatu pod imenom „gospina trava“) mogu znatno smanjiti izloženost dasatinibu i time povećati rizik od neuspjeha liječenja.
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%]).
Croatian: Potpuni citogenetski odgovor (CCyR) tijekom 1 godine održalo je 97% bolesnika (95% CI: [94%-99%]) a tijekom 2 godine 90% bolesnika (95% CI: [86%-95%]).
English: Among the 126 Ph+ ALL paediatric patients treated with SPRYCEL on a continuous dosing regimen, the median duration of therapy was 23.6 months (range 1.4 to 33 months).
Croatian: Medijan trajanja liječenja među 126 pedijatrijskih bolesnika s Ph+ ALL liječenih lijekom SPRYCEL prema režimu kontinuirane primjene iznosio je 23,6 mjeseci (raspon 1,4 do 33 mjeseca).
English: 30 to less than 45 kg
Croatian: od 30 do manje od 45 kg