FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 90 filmom obloženih tableta 30x1 filmom obložena tableta 60x1 filmom obložena tableta 90x1 filmom obložena tableta
English: • Headache or feeling tired.
Croatian: • glavobolja ili umor.
English: Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Croatian: Dok je otprilike 96% bolesnika s CCyR-om, odnosno 93% bolesnika s PCyRom nakon 12 mjeseci bilo bez progresije u ubrzanu fazu/blastičnu krizu nakon 84 mjeseca, samo je 81% bolesnika bez MCyR nakon 12 mjeseci bilo bez progresije u uznapredovali KML nakon 84 mjeseca (p<0,001 ukupno, p=0,25 između CCyR-a i PCyR-a).
English: There is very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
Croatian: Postoji ograničeno iskustvo kod djece i adolescenata s MDS/MPB-om, DFSP-om i HES/KEL-om.
English: When and how to take Imatinib Accord
Croatian: Kada i kako uzimati Imatinib Accord
English: Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common
Croatian: Hiperkalemija, hipomagnezemija Psihijatrijski poremećaji Često
English: Liver function tests
Croatian: Poremećaj funkcije jetre Testovi funkcije jetre
English: If you forget to take Imatinib Accord
Croatian: Ako ste zaboravili uzeti Imatinib Accord
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Croatian: Vezanje N-demetiliranog metabolita na proteine plazme je slično onom ishodne tvari.
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Imatinib and IFN arms, respectively.
Croatian: Sedam godina nakon uključivanja posljednjeg bolesnika, medijan trajanja prve linije liječenja bio je 82 mjeseca u Imatinib kraku, odnosno 8 mjeseci u INF kraku.
English: Imatinib Accord is a treatment for adults and children and adolescents for:
Croatian: Accord se kod odraslih osoba i djece i adolescenata koristi za liječenje:
English: There was a significant increase in exposure to imatinib (the mean Cmaxand AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Croatian: U zdravih je ispitanika došlo do značajnog povećanja izloženosti imatinibu (srednja vrijednost Cmax i AUC imatiniba povećali su se za 26%, odnosno 40%), kada je imatinib primjenjivan istodobno s jednokratnom dozom ketokonazola (CYP3A4 inhibitor).
English: Imatinib Accord inhibits the growth of these cells.
Croatian: Imatinib Accord inhibira rast ovih stanica.
English: Pharmacokinetics in children and adolescents
Croatian: Farmakokinetika u djece i adolescenata
English: Posology for CML in children and adolescents
Croatian: Doziranje za KML u djece i adolescenata
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Croatian: Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece i adolescenata (temeljeno na AUC) kod 340 mg/m2/dan.
English: In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
Croatian: U IFN kraku, bolesnici su liječeni ciljanom dozom IFN-a od 5 MIU/m2/dan supkutano u kombinaciji sa supkutanim Ara-C u dozi od 20 mg/m2/dan u trajanju od 10 dana/mjesec.
English: 6 doses)iii: days 2, 3, 16, and 17
Croatian: 6 doza)iii: Dani 2, 3, 16 i 17
English: Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Croatian: Povećanja doze od 400 mg do 600 mg ili 800 mg u bolesnika s kroničnom fazom bolesti, ili od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s ubrzanom fazom ili blastičnom krizom može se razmotriti u odsustvu teške nuspojave na lijek i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
English: - Do not breast-feed during the treatment with Imatinib Accord.
Croatian: - Nemojte dojiti tijekom liječenja Imatinib Accordom.
English: Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
Croatian: AST: > GGN (može biti normalan ili < GGN ako je ukupni bilirubin > GGN)
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Croatian: Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece i adolescenata (temeljeno na AUC) kod 340 mg/m2/dan.
English: Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Croatian: Imatinib Accord 100 mg filmom obložene tablete dostupne su u pakiranjima koja sadrže 20, 60, 120 ili 180 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
English: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Croatian: Kada je imatinib samostalno korišten u bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om, rezultirao je s odgovorom u 53 od 411 procijenjenih bolesnika, sa stopom hematološkog odgovora od 30% (9% potpuni) i stopom većeg citogenetskog odgovora od 23%.
English: If you are being treated for DFSP
Croatian: Ako se liječite zbog DFSP-a
English: • Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
Croatian: • Uzmite oko 50 ml za svaku tabletu od 100 mg ili 200 ml za svaku tabletu od 400 mg.
English: Depression, libido decreased, anxiety
Croatian: Manje često Depresija, smanjeni libido, anksioznost Rijetko
English: Posology for Ph+ ALL in children and adolescents
Croatian: Doziranje za Ph+ ALL u djece i adolescenata
English: • Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Croatian: • mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
English: Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Croatian: U bolesnika koji su kronični nositelji virusa hepatitisa B pojavila se reaktivacija tog virusa nakon što su primili inhibitore BCR-ABL tirozin kinaze.
English: Major response n (%) [95% CI]
Croatian: Citogenski odgovor Veliki odgovor n (%) [95% CI]
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
Croatian: 20 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta 30x1 filmom obložena tableta 60x1 filmom obložena tableta 90x1 filmom obložena tableta 120x1 filmom obložena tableta 180x1 filmom obložena tableta
English: • Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
Croatian: • crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim žarenjem.
English: A further 6DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Croatian: U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih imatinibom, s rasponom starosti od 18 mjeseci do 49 godina.
English: • Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Croatian: • osjećaj ošamućenosti, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).
English: Major response at 84 months (%)
Croatian: Veliki odgovor nakon 24 mjeseci (%) Veliki odgovor nakon 84 mjeseci (%)
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Croatian: Ako citopenija nije povezana s leukemijom, dozu Imatinib Accorda treba smanjiti na 260 mg/m2.
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Croatian: Supstancija selektivno inhibira proliferaciju te inducira apoptozu u BcrAbl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba koje boluju od kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom i od akutne limfoblastične leukemije (ALL).
English: Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare
Croatian: Nepoznato Reaktivacija hepatitisa B* Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Croatian: Flatulencija, distenzija abdomena, gastroezofagealni refluks, konstipacija, suha usta, gastritis
English: What Imatinib Accord is and what it is used for
Croatian: Što je Imatinib Accordi za što se koristi
English: Dose adjustments for neutropenia and thrombocytopenia: HES/CEL (starting dose 100 mg)
Croatian: Prilagođavanje doze zbog neutropenije i trombocitopenije: HES/KEL (početna doza 100 mg)
English: These effects were not seen at doses ≤ 30 mg/kg.
Croatian: Ti učinci nisu uočeni pri dozama od ≤ 30 mg/kg.
English: • adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Croatian: • odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije.
English: Confusional state Nervous system disorders Very common Headache2
Croatian: Konfuzno stanje Poremećaji živčanog sustava Vrlo često
English: Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Croatian: Imatinib povećava srednju vrijednost Cmaxi AUC simvastatina (CYP3A4 supstrat) za 2, odnosno 3,5-puta, što ukazuje na to da imatinib inhibira CYP3A4.
English: Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
Croatian: Daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
English: Do not take Imatinib Accord
Croatian: Nemojte uzimati Imatinib Accord
English: 4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Croatian: 4 Crvenilo uz osjećaj vrućine je bilo najčešće u GIST bolesnika, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i s transformiranim KML-om (KMLubrzana faza i KML-blastična kriza).
English: • Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
Croatian: • iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid.
English: CHR rate n (%) [95% CI]
Croatian: Hematološki odgovor CHR stopa n (%) [95% CI]
English: Posology for MDS/MPD
Croatian: Doziranje za MDS/MPD
English: The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Imatinib arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Croatian: Procijenjena stopa bolesnika bez progresije u ubrzanu fazu ili blastičnu krizu nakon 84 mjeseca bila je značajno viša u Imatinib kraku u usporedbi s IFN krakom (92,5% prema 85,1%, p<0,001).
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Croatian: Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m2)
English: Blood amylase increased * These types of reactions have been reported mainly from post-marketing experience with Imatinib.
Croatian: * Ove vrste reakcija zabilježene su uglavnom nakon stavljanja Imatiniba u promet.
English: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
Croatian: • grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema).
English: Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
Croatian: Ubrzana faza se definira prisutnošću bilo kojeg od sljedećih kriterija: blasti ≥ 15% ali < 30% u krvi ili koštanoj srži, blasti plus promijelociti ≥ 30% u krvi ili koštanoj srži (što daje <3 0% blasta), bazofili u perifernoj krvi ≥ 20%, trombociti <100 x 109/l nevezano uz terapiju.
English: PVC/PVdC/Alu or Alu/Alu blisters.
Croatian: PVC/PVdC/Alu ili Alu/Alu blisteri.
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accordto 400 mg. 3.
Croatian: Ako citopenija nije povezana s leukemijom, dozu Imatinib Accorda treba smanjiti na 400 mg.
English: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Croatian: Zbog toga se preporučuje oprezno postupati kada se imatinib primjenjuje s CYP3A4 supstratima s uskom terapijskom širinom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel i kvinidin).
English: In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Croatian: U novodijagnosticiranoj kroničnoj fazi KML-a, neutropenija 4. stupnja (ABN < 0,5 x 109/l) i trombocitopenija (broj trombocita < 10 x 109/l) zapažene su u 3,6% odnosno <1% bolesnika.
English: Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
Croatian: Ukupno gledajući, prosječna vrijednost dnevne doze dane bolesnicima koji su primali prvu liniju liječenja Imatinibom iznosila je 406 ± 76 mg.
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people)
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) ili česte (mogu se javiti u do 1 na 10 osoba)
English: 1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
Croatian: 1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s GIST-om.
English: Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Croatian: Reaktivacija hepatitisa B zabilježena je u vezi s inhibitorima BCR-ABL tirozin kinaze.
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Croatian: 10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u bolesnika s GIST-om.
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h = every 6 hours, Gy= Gray
Croatian: = u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2merkaptoetan sulfonat, iii= ili dok vrijednost MTX-a ne bude <0,1 µm, Gy= Gray
English: In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Croatian: Osim toga, gastrična antralna vaskularna ektazija (GAVE), rijetki uzrok gastrointestinalnog krvarenja, zabilježena je nakon stavljanja lijeka u promet u bolesnika s KML-om, ALL-om i drugim bolestima (vidjeti dio 4.8).
English: Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycinand telithromycin) could decrease metabolism and increase imatinib concentrations.
Croatian: Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
English: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Croatian: Najčešće zabilježene nuspojave ( 10%) koje su povezane s primjenom lijeka, bile su u obje situacije blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
English: In the Imatinib arm, patients were treated with 400 mg daily.
Croatian: U Imatinib kraku, bolesnici su liječeni dozom od 400 mg na dan.
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Croatian: VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22; CP 750 mg/m2 i.v., dani 1, 8;
English: ANC = absolute neutrophil count aoccurring after at least 1 month of treatment Special populations Hepatic insufficiency
Croatian: ABN = apsolutni broj neutrofila a javlja se nakon najmanje 1 mjeseca liječenja
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Croatian: Poboljšanja su zabilježena u srčanom, živčanom, koži/potkožnom tkivu, dišnom/prsnom košu/sredoprsju, mišićno-koštanom/vezivnom tkivu/krvožilnom i probavnom organskom sustavu.
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Croatian: Budući da su srčaništetni događaji zabilježeni manje često uz imatinib, prije početka liječenja u HES/KEL populaciji potrebno je uzeti u obzir pažljivu procjenu omjera koristi i rizika od terapije imatinibom.
English: PVC/PVdC/Alu blisters
Croatian: PVC/PVdC/Alu blisteri
English: This was not seen at doses ≤ 20 mg/kg.
Croatian: To nije uočeno pri dozama od ≤ 20 mg/kg.
English: (NEL) Return to chronic phase
Croatian: Vraćanje na kroničnu fazu (RTC)
English: Haematological response
Croatian: Hematološki odgovor1
English: Major response at 12 months (%)
Croatian: Molekularni odgovor** Veliki odgovor nakon 12 mjeseci (%)
English: Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Croatian: Trostruka i.t. terapija (prilagođena dobi): dani 1, 29 VCR (1,5 mg/m2, i.v.): dani 1, 29
English: There is no experience in children and adolescents with CML below 2 years of age.
Croatian: Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i adolescenata s KLM-om.
English: Daunorubicin 30 mg/ m2 i.v., days 1-3, 15-16;
Croatian: Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16;
English: If you are being treated for CML
Croatian: Ako se liječite zbog KML-a
English: In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
Croatian: U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥ 6 mg/kg, bez promjena parametara za serum ili mokraću.
English: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Croatian: < 18 godina bilo s kroničnom fazom KML-a (n=11), bilo s KML-om u blastičnoj krizi ili Ph+ akutnim leukemijama (n=15).
English: Hypromellose 6 cps (E464) Microcrystalline cellulose pH 102 Crospovidone
Croatian: Hipromeloza 6 cps (E464) celuloza, mikrokristalična pH 102 krospovidon silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Croatian: Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.Stoga se preporučuje oprez pri upravljanju vozilima ili radu sa strojevima.
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih imatinibom 800 mg na dan.
English: Posology for HES/CEL
Croatian: Doziranje za HES/KEL
English: What Imatinib Accord contains
Croatian: Što Imatinib Accord sadrži