FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: PFS nakon 2 godine iznosilo je 86% (95% CI: [78%-93%]) za dasatinib i 65% (95% CI: [43%-87%]) za imatinib.
English: This dose represents 30% lower exposure compared to the recommended dose (see section 5.2. of Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Croatian: Uz tu je dozu postignuta 30% manja izloženost od one koja se postiže uz preporučenu dozu (vidjeti dio 5.2 sažetka opisa svojstava lijeka za
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
Croatian: Koža, kosa, oko, općenito: grčevi, upala optičkog živca koja može izazvati potpuni ili djelomični gubitak vida, plavo ljubičaste mrlje na koži, neuobičajeno pojačana funkcija štitnjače, upala štitnjače, ataksija (stanje povezano s nedostatkom mišićne koordinacije), poteškoće pri hodanju, spontani pobačaj, upala krvnih žila u koži, kožna fibroza
English: MCyR (95% CI) Newly diagnosed (N = 51)a
Croatian: MCyR (95% CI) Novodijagnosticira na bolest (N = 51)a
English: MMR (95% CI) Newly diagnosed (N = 51)a
Croatian: MMR (95% CI) Novodijagnosticira na bolest (N = 51)a
English: Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
Croatian: sorbatne kiseline sumporne kiseline tartaratna kiselina trinatrijev citrat, bezvodni natrijev benzoat (E211) silicijev dioksid, hidrofobni, koloidni aroma miješanog bobičastog voća [sadrži benzilni alkohol, sumporov dioksid (E220)] 6.2 Inkompatibilnosti
English: Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Croatian: Oralna suspenzija se nakon rekonstitucije smije primijeniti samo štrcaljkom za usta koja dolazi u svakom pakiranju lijeka.
English: Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Croatian: Često artralgija, mialgija, mišićna slabost, mišićno-koštana ukočenost, spazam mišića Manje često rabdomioliza, osteonekroza, upala mišića, tendinitis, artritis
English: The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily.
Croatian: Preporučena početna doza dasatiniba u kroničnoj fazi KML iznosi 100 mg jedanput dnevno.
English: Pain: inflammation of vein which can cause redness, tenderness and swelling, inflammation of the tendon
Croatian: Bol: upala vena koja može uzrokovati crvenilo, osjetljivost i oteklinu, upala tetiva Mozak: gubitak pamćenja
English: Myeloid blast (n= 75)
Croatian: Mijeloidna blastna kriza (n= 75)
English: Outer Carton: sprycel 140 mg
Croatian: Kutija: sprycel 140 mg
English: Number of patients (%) Transformation at 60 months, n/N (%) Rate of PFS at 60 months (95% CI) Rate of OS at 60 months (95% CI)
Croatian: Stopa PFS-a u 60. mjesecu (95% CI) Stopa OS-a u 60. mjesecu (95% CI)
English: A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Croatian: Ukupno su 174 bolesnika primila dasatinib u dozi od 70 mg dvaput dnevno (161 s otpornošću i 13 s nepodnošljivošću na imatinib).
English: Make sure the adapter provided on the bottle for syringe placement is firmly pressed into the bottle.
Croatian: Provjerite je li nastavak na boci namijenjen za uvođenje štrcaljke čvrsto uglavljen u grlo boce.
English: Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation
Croatian: Prethodno liječenje imatinibom (N = 46)b a Bolesnici s novodijagnosticiranim KML u kroničnoj fazi iz pedijatrijskog ispitivanja faze II koji su primali lijek peroralno u obliku tablete b Bolesnici s KML u kroničnoj fazi iz pedijatrijskih ispitivanja faze I i faze II koji su bili otporni na liječenje imatinibom ili ga nisu podnosili, a primali su lijek peroralno u obliku tablete
English: Rate of OS was consistently higher in dasatinib treated patients who achieved BCR-ABL level ≤ 10% at 3 months than those who did not.
Croatian: Stopa OS u specifičnim vremenskim točkama grafički je prikazana na Slici 4. Stopa OS dosljedno je bila viša u bolesnika liječenih dasatinibom koji su postigli razinu BCR-ABL ≤ 10% u 3. mjesecu nego u onih koji nisu.
English: The median time from diagnosis to start of treatment was 61 months.
Croatian: Medijan vremena od dijagnoze do početka liječenja iznosio je 61 mjesec.
English: Outer Carton: sprycel 70 mg
Croatian: Kutija: sprycel 70 mg
English: Powder for oral suspension Outer Carton:
Croatian: Prašak za oralnu suspenziju Kutija:
English: Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Croatian: Daljnji rezultati djelotvornosti prikazani su u Tablici 11. Valja napomenuti da se značajan hematološki odgovor (engl. major hematologic response, MaHR) brzo dostigao (uglavnom unutar 35 dana od prve primjene dasatiniba u bolesnika s KML u limfocitnoj blastnoj krizi te unutar 55 dana u bolesnika s Ph+ ALL).
English: CCyR (95% CI) Newly diagnosed (N = 51)a
Croatian: CCyR (95% CI) Novodijagnosticira na bolest (N = 51)a
English: In CML-CP paediatric patients with non-haematologic adverse reactions, the dose reduction recommendations for haematologic adverse reactions that are described above should be followed.
Croatian: U pedijatrijskih bolesnika s KML u kroničnoj fazi koji imaju nehematološke nuspojave treba se pridržavati prethodno navedenih preporuka za smanjenje doze u slučaju hematoloških nuspojava.
English: Fluid retention Superficial oedema Pleural effusion Generalised oedema Congestive heart failure /cardiac dysfunctionb
Croatian: Zadržavanje tekućine površinski edem pleuralni izljev generalizirani edem kongestivno zatajenje srca /srčana disfunkcijab perikardijalni izljev plućni edem
English: Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5).
Croatian: Stoga se u bolesnika koji primaju dasatinib ne preporučuje istodobna primjena potentnih inhibitora CYP3A4 (vidjeti dio 4.5).
English: Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment.
Croatian: Vaše tjelesne težine, bilo kakvih nuspojava i odgovora na liječenje.
English: Twenty-one of these patients (1%) experienced a QTcF > 500 msec.
Croatian: U 21 bolesnika (<1%) zabilježen je QTcF >500 msek.
English: Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis
Croatian: Srce i pluća: palpitacije (jako lupanje srca), nepravilni otkucaji srca, zastojno zatajenje srca, oslabljen srčani mišić, visoki krvni tlak, povišen krvni tlak u plućima, kašalj Probavni problemi: poremećaj apetita, poremećaj osjeta okusa, nadutost ili nadimanje trbuha, upala debelog crijeva, zatvor, žgaravica, vrijed u ustima, povećanje tjelesne težine, gubitak tjelesne težine, gastritis
English: A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Croatian: Ukupno je randomizirano 611 bolesnika u dvije skupine, jednu koja je primala 140 mg dasatiniba jedanput dnevno i drugu koja je primala 70 mg dasatiniba dvaput dnevno.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Croatian: SPRYCEL 10 mg/ml prašak za oralnu suspenziju 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna boca praška za oralnu suspenziju sadrži 990 mg dasatiniba (u obliku hidrata).
English: Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Croatian: Često upala pluća (uključujući bakterijsku, virusnu i gljivičnu), infekcije/upale gornjih dišnih putova, infekcija herpes virusom (uključujući citomegalovirus - CMV),
English: A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Croatian: Ukupno je 109 bolesnika primilo dasatinib u dozi od 70 mg dvaput dnevno (99 s otpornošću i 10 s nepodnošljivošću na imatinib).
English: Each film-coated tablet contains 27 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 27 mg laktoza hidrata.
English: NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and
Croatian: Nema dokaza leukemije: isti kriteriji kao i za CHR, ali ABN ≥ 500/mm3 i < 1000/mm3, ili trombociti ≥ 20 000/mm3 i
English: The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months.
Croatian: Stopa MMR (određenog u 41 bolesnika s CCyR) iznosila je 46% nakon 24 mjeseca.
English: In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients.
Croatian: Među tim je bolesnicima plućni edem 3. ili 4. stupnja bio prijavljen u 1% bolesnika, jednako kao i plućna hipertenzija.
English: Outer Carton: sprycel 20 mg
Croatian: Kutija: sprycel 20 mg
English: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 135,0 mg laktoza hidrata.
English: Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders
Croatian: Nepoznato fatalno gastrointestinalno krvarenje
English: Each film-coated tablet contains 67.5 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 67,5 mg laktoza hidrata.
English: Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI: [95%-100%]) at 1 year and 94% (95% CI: [88%-99%]) at 2 years.
Croatian: U bolesnika koji nisu podnosili imatinib, procijenjena stopa PFS iznosila je 98% (95% CI: [95%-100%]) nakon 1 godine i 94% (95% CI: [88%-99%]) nakon 2 godine.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: How to store SPRYCEL
Croatian: Kako čuvati SPRYCEL
English: Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal
Croatian: Često astenija, bol, bol u prsištu, generalizirani edem*k, zimice Manje često malaksalost, drugi površinski edemil
English: j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face.
Croatian: j Edem konjunktiva, edem oka, oticanje oka, edem vjeđa, edem lica, edem usana, makularni edem, edem usta, orbitalni edem, periorbitalni edem, oticanje lica.
English: 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
Croatian: Koža, kosa, oko, općenito: trnci u koži, svrbež, suha koža, akne, upalne promjene na koži, neprekidni šum u ušima, gubitak kose, obilno znojenje, poremećaji vida (uključujući zamagljen vid i poremećaj vida), suhoća oka, modrice, depresija, nesanica, naleti crvenila, omaglica, nagnječenja (modrice), anoreksija, pospanost, generalizirani edem Bol: bol u zglobovima, slabost mišića, bol u prsištu, bol u šakama i stopalima, zimica, ukočenost mišića i zglobova, spazam mišića
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.
Croatian: Pri rukovanju nenamjerno rasutim praškom preporučuje se koristiti rukavice od lateksa ili nitrila, kako bi se minimalizirao rizik od izlaganja putem kože.
English: Each film-coated tablet contains 189 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 189 mg laktoza hidrata.
English: An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib.
Croatian: Multicentrično ispitivanje otvorenog tipa u jednoj skupini provedeno je u bolesnika koji ne podnose ili su otporni na imatinib.
English: After 60 months of follow-up, median time to cCCyR was 3.1 months in the SPRYCEL group and 5.8 months in the imatinib group in patients with a confirmed CCyR.
Croatian: U bolesnika s potvrđenim CCyR, nakon 60 mjeseci praćenja, medijan vremena do cCCyR iznosio je 3,1 mjesec u skupini koja je primala SPRYCEL i 5,8 mjeseci u skupini koja je primala imatinib.
English: SPRYCEL contains sucrose
Croatian: SPRYCEL sadrži saharozu
English: Each film-coated tablet contains 108 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 108 mg laktoza hidrata.
English: Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Croatian: Smjernice za prilagodbu doze u odraslih sažeto su prikazane u Tablici 3, a za pedijatrijske bolesnike s Ph+ KML u kroničnoj fazi u Tablici 4. Smjernice za pedijatrijske bolesnike s Ph+ ALL liječene u kombinaciji s kemoterapijom navedene su u zasebnom odlomku ispod tablica.
English: 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.
Croatian: U ispitivanju novodijagnosticirane KML u kroničnoj fazi, nakon najmanje 12 mjeseci praćenja, hipofosfatemija 3. ili 4. stupnja bila je zabilježena u 4% bolesnika liječenih lijekom SPRYCEL, dok su povišene vrijednosti transaminaza, kreatinina i bilirubina 3. ili 4. stupnja bile zabilježene u ≤1% bolesnika.
English: The primary endpoint was MCyR at 12 weeks.
Croatian: Primarni ishod bio je značajni citogenetski odgovor (MCyR) u 12. tjednu liječenja.
English: 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%).
Croatian: Udio bolesnika u kojih se održao značajni citogenetski odgovor tijekom 18 mjeseci iznosio je 90% (95% CI: [82%-98%]) za dasatinib (potpuni citogenetski odgovor, 94%; 95% CI: [87%-100%]) te 74% (95% CI: [49%-100%]) za imatinib (potpuni citogenetski odgovor,
English: Table 2: Dose escalation for patients with Ph+CML-CP Dose (maximum dose per day) Starting dose
Croatian: Tablica 2: Postupno povećanje doze za bolesnike s Ph+ KML u kroničnoj fazi Doza (maksimalna dnevna doza) Početna doza
English: Breast-feeding should be stopped during treatment with SPRYCEL.
Croatian: Za vrijeme liječenja lijekom SPRYCEL dojenje se mora prekinuti.
English: Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Croatian: Stope MR4,5 dosljedno su bile više u bolesnika liječenih dasatinibom nego u onih liječenih imatinibom.
English: Survival (%; Kaplan-Meier estimates) Progression-Free 1 year 2 year Overall 1 year 2 year
Croatian: Bez progresije 1 godina 2 godine Ukupno 1 godina 2 godine
English: Not known interstitial lung disease
Croatian: Nepoznato intersticijska bolest pluća Poremećaji probavnog sustava
English: Outer Carton: sprycel 50 mg
Croatian: Kutija: sprycel 50 mg
English: In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma.
Croatian: neizmijenjen dasatinib činio je 29% cirkulirajuće radioaktivnosti u plazmi.
English: Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Croatian: Često hipertenzija, naleti crvenila Manje često hipotenzija, tromboflebitis, tromboza
English: The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Croatian: Stopa značajnog molekularnog odgovora (svih 25 liječenih bolesnika s potpunim citogenetskim odgovorom) iznosila je 52% nakon 24 mjeseca.
English: Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib
Croatian: Klinička ispitivanja faze III u bolesnika s KML u kroničnoj fazi, uznapredovaloj fazi ili fazi mijeloične blastne krize i Ph+ ALL koji ne podnose prethodnu terapiju imatinibom ili su otporni na imatinib
English: Outer Carton: sprycel 100 mg
Croatian: Kutija: sprycel 100 mg
English: BRISTOL-MYERS SQUIBB PHARMA EEIG
Croatian: SQUIBB PHARMA EEIG
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.
Croatian: Među bolesnicima otpornima na imatinib, procijenjena stopa preživljenja bez progresije bolesti (PFS) iznosila je 88% (95% CI: [84%-92%]) nakon 1 godine i 75% (95% CI: [69%-81%]) nakon 2 godine.
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 Contact your doctor immediately if you notice any of the above.
Croatian: Neočekivano krvarenje ili modrice, a da se niste ozlijedili Krv u povraćenom sadržaju, stolici ili mokraći ili crna stolica Znakovi infekcije poput vrućice i jake zimice Vrućica, upala usta ili grla, pojava mjehurića ili ljuštenje kože i/ili sluznica Odmah obavijestite liječnika ako primijetite nešto od gore navedenog.
English: In the Phase III dose-optimisation study in chronic phase CML, grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
Croatian: U ispitivanju optimizacije doze faze III, povišenje 3. ili 4. stupnja vrijednosti transaminaza ili bilirubina bilo je prijavljeno u ≤1% bolesnika s KML u kroničnoj fazi uz slično nisku incidenciju u sve četiri liječene skupine.
English: SPRYCEL 70 mg tablets dasatinib
Croatian: SPRYCEL 70 mg tablete dasatinib
English: Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Croatian: Jedna filmom obložena tableta sadrži 94,5 mg laktoza hidrata.
English: Efficacy results are presented in Table 9.
Croatian: Rezultati ispitivanja djelotvornosti prikazani su u Tablici 9.
English: 10 to less than 20 kg
Croatian: od 10 do manje od 20 kg
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.
Croatian: disfunkciju lijeve klijetke, disfunkciju desne klijetke, srčano zatajenje, akutno zatajenje srca, kronično zatajenje srca, kongestivno zatajenje srca, kardiomiopatiju, kongestivnu kardiomiopatiju, dijastoličku disfunkciju, smanjenje ejekcijske frakcije i zatajenje klijetke, zatajenje lijeve klijetke, zatajenje desne klijetke i ventrikularnu hipokineziju.
English: Outer Carton: sprycel 80 mg
Croatian: Kutija: sprycel 80 mg
English: 20 to less than 30 kg
Croatian: od 20 do manje od 30 kg
English: The median time from diagnosis to start of treatment was 28 months.
Croatian: Medijan vremena od dijagnoze do početka liječenja iznosio je 28 mjeseci.
English: CCyR (95% CI) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69)
Croatian: 2 godine n/p Citogenetski odgovorc (%) Značajan (95% CI) 62% (5767) 40% (33-48) 34% (25-44) 52% (37-67) 57% (41-71) Potpun (95%
English: Laboratory test abnormalities Haematology
Croatian: Poremećaji laboratorijskih nalaza Hematologija
English: within 48 months (95% CI)
Croatian: unutar 48 mjeseci (95% CI)
English: A 70 mg twice daily regimen was also studied.
Croatian: Ispitivan je i režim liječenja dozom od 70 mg dvaput dnevno.
English: Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose
Croatian: Tablica 2: Postupno povećanje doze za pedijatrijske bolesnike Ph+ KML u kroničnoj fazi Doza (maksimalna dnevna doza) Početna doza
English: Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Croatian: Medijan trajanja liječenja dasatinibom iznosio je 3,5 mjeseci s time da je 12% bolesnika do tada bilo liječeno >24 mjeseca.