FrancophonIA/ELRC3.0 huggingface dataset:
English: Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy.
Croatian: Ispitivanje AIT07 bilo je multicentrično, otvoreno, randomizirano ispitivanje faze II/III u kojem je sudjelovalo 128 bolesnika (od 1 do <18 godina) liječenih imatinibom u kombinaciji s kemoterapijom.
English: Imatinib medac 400 mg capsules are supplied in packs containing 30 capsules in blisters.
Croatian: Imatinib medac 400 mg kapsule dostupne su u pakiranjima koja sadrže 30 kapsula u blisterima.
English: • Muscle cramps or joint, muscle or bone pain, during Imatinib medac treatment or after you have stopped taking Imatinib medac
Croatian: • grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinib medacom ili nakon prekida uzimanja Imatinib medaca
English: Other medicines and Imatinib medac
Croatian: Drugi lijekovi i Imatinib medac
English: GERMANY
Croatian: Njemačka
English: • Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Croatian: • znakovi infekcije kao što su vrućica, teška zimica, grlobolja ili čirevi u ustima.
English: These effects were not seen at doses ≤ 30 mg/kg.
Croatian: Ti učinci nisu uočeni pri dozama od ≤30 mg/kg.
English: • Headache or feeling tired.
Croatian: • glavobolja ili umor
English: In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
Croatian: Supstancija pokazuje in vivo antitumorsko djelovanje kao samostalni agens na životinjskim modelima u kojima se koriste Bcr-Abl pozitivne tumorske stanice.
English: A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Croatian: Ukupno 51 pedijatrijski bolesnik s novodijagnosticiranim i neliječenim KML-om u kroničnoj fazi uključen je u otvoreno, multicentrično, ispitivanje faze II s jednim krakom.
English: Clinical studies in HES/CEL
Croatian: Klinička ispitivanja kod HES/KEL-a
English: Imatinib is a small molecule protein kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Croatian: Imatinib je mala molekula, inhibitor protein kinaze, koja potentno inhibira aktivnost Bcr-Abl tirozin kinaze (TK), kao i nekoliko TK receptora: Kit, receptor za faktor matičnih stanica (SCF, engl. stem cell factor) kodiran c-Kit protoonkogenom, receptore za diskoidinsku domenu (DDR1 i DDR2, engl. discoidin domain receptors), receptor za faktor stimulacije kolonija (CSF-1R, engl. colony stimulating factor receptor) te alfa i beta receptore za faktor rasta koji potječe od trombocita (PDGFR-alfa i PDGFR-beta).
English: Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Croatian: Bolesnici s blagim, umjerenim ili teškim poremećajem funkcije jetre trebaju primati minimalnu preporučenu dozu od 400 mg na dan.
English: The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Croatian: Klirens slobodnog imatiniba vjerojatno je u bolesnika s oštećenjem funkcije bubrega sličan onome u osoba s normalnom funkcijom bubrega jer izlučivanje putem bubrega predstavlja samo manje značajan put eliminacije za imatinib (vidjeti dijelove 4.2 i 4.4).
English: In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Croatian: U pedijatrijskih bolesnika s KML-om najčešće uočene toksičnosti bile su citopenije 3. ili 4. stupnja uključujući neutropeniju, trombocitopeniju i anemiju.
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Croatian: Proveden je opservacijski registar (ispitivanje L2401) da bi se prikupili podaci o dugoročnoj sigurnosti primjene i djelotvornosti u bolesnika s mijeloproliferativnim novotvorinama s PDGFR- β preraspodjelom, a koji su liječeni Imatinib medacom.
English: If your daily dose is 800 mg, you should take 1 capsule of 400 mg in the morning and 1 capsule of 400 mg in the evening.
Croatian: Ako Vaša dnevna doza iznosi 800 mg morate uzeti 1 kapsulu od 400 mg ujutro i 1 kapsulu od 400 mg navečer.
English: Stop imatinib until ANC ≥ 1.5 x 10
Croatian: Ukinuti imatinib sve dok ABN ne bude ≥1,5 x 10
English: There was a significant increase in exposure to imatinib (the mean Cmax and 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 (srednji Cmax i AUC imatiniba povećali su se za 26 %, odnosno 40 %), kada je imatinib primjenjivan istodobno s jednokratnom dozom ketokonazola (CYP3A4 inhibitor).
English: 1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Croatian: 1200 mg do 1600 mg (trajanje je variralo između 1 do 10 dana): mučnina, povraćanje, proljev, osip, eritem, edem, oticanje, umor, mišićni spazam, trombocitopenija, pancitopenija, bol u trbuhu, glavobolja, smanjeni apetit.
English: • paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Croatian: • pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom alfa, ili u ubrzanoj fazi,
English: Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralisation and dilation of the renal tubules and tubular nephrosis.
Croatian: Bubrežna toksičnost je uočena u majmuna koji su liječeni 2 tjedna, uz fokalnu mineralizaciju i dilataciju bubrežnih kanalića i tubularnu nefrozu.
English: Pharmacokinetics in paediatric patients
Croatian: Farmakokinetika u pedijatrijskih bolesnika
English: It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Croatian: Potrebno je imati na umu da bolesnici s GIST-om mogu imati metastaze u jetri koje mogu dovesti do oštećenja jetre.
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Croatian: • kombinacija teškog proširenog osipa, mučnine, vrućice, visoke razine određenih bijelih krvnih stanica ili žutila kože ili očiju (znakovi žutice) s nedostatkom zraka, bolovima/nelagodom u prsima, jako smanjenim mokrenjem i žeđi itd. (znakovi alergijske reakcije povezane s liječenjem).
English: Study ADE10 Prephase
Croatian: Studija ADE10 Predfaza
English: Gastrointestinal haemorrhage
Croatian: Gastrointestinalna krvarenja
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Croatian: Nuspojave zabilježene u više od jednoga izoliranog slučaja navedene su niže u tekstu po klasifikaciji organskih sustava i učestalosti.
English: One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhoea.
Croatian: Kod jednog trogodišnjeg dječaka izloženog jednokratnoj dozi od 400 mg došlo je do povraćanja, proljeva i anoreksije, dok je kod drugog trogodišnjeg dječaka izloženog jednokratnoj dozi od 980 mg došlo do smanjenog broja leukocita i proljeva.
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6 % vs. 31.6 %, respectively).
Croatian: Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljenja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6 % u odnosu na 31,6 %).
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Croatian: U ispitivanju I2301 ukupno 93 djece, adolescenata i mladih odraslih osoba (u dobi od 1 do 22 godine) s Ph+ ALL-om bilo je uključeno u otvoreno, multicentrično, sekvencijsko kohortno, nerandomizirano ispitivanje faze III u kojem su primali imatinib (340 mg/m²/dan) u kombinaciji s intenzivnom kemoterapijom nakon indukcijskog liječenja.
English: 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Croatian: 6400 mg (jednokratna doza): u literaturi je zabilježen jedan slučaj jednog bolesnika s mučninom, povraćanjem, bolovima u trbuhu, vrućicom, oticanjem lica, smanjenim brojem neutrofila, povišenjem vrijednosti transaminaza.
English: The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Croatian: Učinak imatiniba na ishod transplantacije koštane srži nije utvrđen.
English: • Cough, having difficulty breathing or painful breathing (signs of lung problems).
Croatian: • kašalj, otežano disanje ili bolno disanje (znakovi plućnih problema)
English: 6+7) Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Croatian: 6+7) Bol u trbuhu i gastrointestinalno krvarenje najčešće su uočeni u bolesnika s GIST-om.
English: Close monitoring of growth in paediatric patients under treatment with imatinib is recommended (see section 4.8).
Croatian: Preporučuje se pažljivo praćenje rasta u pedijatrijskih bolesnika koji se liječe imatinibom (vidjeti dio 4.8).
English: Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Croatian: Imatinib može povećati koncentraciju drugih lijekova u plazmi koje metabolizira CYP3A4 (npr. triazolo-benzodiazepini, dihidropiridinski blokatori kalcijevih kanala, određeni inhibitori HMG-CoA reduktaze odnosno statini, itd.).
English: Dosing in paediatric patients at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Croatian: Doziranje u pedijatrijskih bolesnika od 260 odnosno 340 mg/m²/dan postiglo je istu izloženost kao i doze od 400 mg i 600 mg u odraslih bolesnika.
English: Imatinib medac may cause your body to retain water (severe fluid retention).
Croatian: Imatinib medac može izazvati zadržavanje vode u tijelu (teška retencija tekućine).
English: In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Croatian: U slučaju predoziranja, potrebno je promatrati bolesnika i provoditi odgovarajuće suportivno liječenje.
English: In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/kg/day group on either day 14 or day 15 of gestation.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja u štakora, uočen je crveni vaginalni iscjedak u skupini koja je peroralno primala 45 mg/kg/dan bilo na 14. bilo na 15. dan gestacije.
English: There are no controlled trials in paediatric patients with MDS/MPD.
Croatian: Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s MDS/MPD-om.
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Croatian: Povećanje je od približno 1,5 do 2 puta što odgovara povećanju alfakiselog glikoproteina (AGP) u plazmi, proteina na koji se imatinib čvrsto veže, od 1,5 puta.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Croatian: Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m²)
English: Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Croatian: Zbog moguće pojave sindroma lize tumora, prije početka terapije imatinibom preporučuje se korekcija klinički značajne dehidracije i liječenje visokih razina mokraćne kiseline (vidjeti dio 4.8).
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Croatian: Učinkovitost imatiniba u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om, na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim DFSP-om.
English: Your doctor will discuss with you the possible risks of taking Imatinib medac during
Croatian: Liječnik će Vam objasniti moguće rizike od uzimanja Imatinib medaca tijekom trudnoće.
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Croatian: • odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPD) povezanim s preraspodjelom gena za receptor za faktor rasta koji potječe od trombocita (PDGFR),
English: 3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Croatian: 3) Na temelju procjene bolesnik-godina, srčani događaji uključujući kongestivno zatajenje srca bili su češće uočeni u bolesnika s transformiranim KML-om, nego u bolesnika s kroničnim KML-om.
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Croatian: Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, i za faktor matičnih stanica (SCF), c-Kit, te inhibira stanične događaje do kojih dolazi posredstvom PDGF-a i SCF-a.
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Croatian: Djelatna tvar imatinib predstavlja rizik za okoliš za organizme koji žive u sedimentnom tlu.
English: There are no controlled trials in paediatric patients with DFSP.
Croatian: Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s DFSP-om.
English: Pericarditis*, cardiac tamponade* Vascular disorders
Croatian: Perikarditis*, tamponada srca*
English: The age of these patients ranged from 25 to 72 years.
Croatian: Dob tih bolesnika kretala se od 25 do 72 godine.
English: This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Croatian: Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni imatinibom od 400 mg na dan.
English: Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients.
Croatian: U takvih bolesnika treba pažljivo pratiti razine tireotropina (TSH).
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Croatian: Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 µmol/l pa je prema tome moguća inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
English: The age of these patients ranged from 2 to 79 years.
Croatian: Dob tih bolesnika kretala se od 2 do 79 godina.
English: If you take more Imatinib medac than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Croatian: Ako ste zabunom uzeli previše kapsula, odmah se obratite liječniku.
English: The no observed effect level (NOEL) was 30 mg/kg/day.
Croatian: Razina kod koje se ne uočava učinak (NOEL) iznosila je 30 mg/kg/dan.
English: • Patients who are concerned about their fertility while taking Imatinib medac are advised to
Croatian: • Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatinib medaca preporučuje se da se posavjetuju sa svojim liječnikom.
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 ponovna aktivacija tog virusa nakon što su primili inhibitore BCR-ABL tirozin kinaze.
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Croatian: Imatinib in vitro inhibira aktivnost CYP2D6 izoenzima citokroma P450 u koncentracijama koje su slične onima što utječu na djelovanje CYP3A4.
English: In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
Croatian: U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om zabilježena su i gastrointestinalna i intratumorska krvarenja (vidjeti dio 4.8).
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: Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Croatian: Omaglica, parestezija, poremećaj okusa, hipoestezija
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 paediatric patients (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 pedijatrijskih bolesnika (temeljeno na AUC) kod 340 mg/m²/dan.
English: Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
Croatian: U svim su ispitivanjima površinski edemi bili čest nalaz, a opisani su u prvome redu kao periorbitalni edemi ili kao edemi donjih ekstremiteta.
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 paediatric patients (based on AUC) at 340 mg/m2/day.
Croatian: Papilom/karcinom žlijezde prepucija/klitorisa zabilježeni su 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 pedijatrijskih bolesnika (temeljeno na AUC) kod 340 mg/m²/dan.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Croatian: 6-MP (75 mg/m²/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1. dana nakon završetka kranijalne iradijacije.)
English: 9/l, then resume treatment at 200 mg/m
Croatian: 9/l, nakon toga nastaviti liječenje u dozi od 200 mg/m².
English: Chronic phase CML, MDS/MPD (starting dose 400 mg)
Croatian: Kronična faza KML-a, MDS/MPD-a (početna doza 400 mg) HES/KEL (doza od 400 mg)
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
English: A further 6 DFSP 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 dobi od 18 mjeseci do 49 godina.
English: There were no special safety findings in paediatric clinical trials.
Croatian: U pedijatrijskim kliničkim ispitivanjima nije bilo posebnih nalaza o sigurnosti primjene.
English: The age of these patients ranged from 20 to 72 years.
Croatian: Dob tih bolesnika se kretala od 20 do 72 godine.
English: The no observed effect level (NOEL) was 15 mg/kg/day.
Croatian: Razina kod koje se ne uočava učinak (NOEL) iznosila je 15 mg/kg/dan.
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3 % vs. 50 %; p = 0.0001).
Croatian: Novodijagnosticirani Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib korišten samostalno izazvao je značajno višu stopu potpunog hematološkog odgovora nego kemoterapija (96,3 % u odnosu na 50 %; p=0,0001).
English: 2) Headache was the most common in GIST patients.
Croatian: 2) Glavobolja je bila najčešća u bolesnika s GIST-om.
English: NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET medac GmbH
English: If cytopenia persists for 2 weeks, reduce further to 300 mg.
Croatian: 3. Ako citopenija ustraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
English: Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control.
Croatian: Akutna limfoblastična leukemija je oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane limfoblasti) počinju nekontrolirano rasti.