natgillin/translations-raw huggingface dataset:
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 DFSP. 
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 i MDS/MPB-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om, te na objektivnim stopama odgovora u odraslih bolesnika s DFSP-om.
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems). 
• Mučnina uz gubitak apetita, tamna boja mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
ANC < 0.5 x 10 
<1,0 x 10
For patients (children) unable to swallow the capsules, their content may be diluted in a glass of either still water or apple juice. 
Bolesnicima (djeci) koji ne mogu progutati kapsule, njihov sadržaj se može otopiti u čaši negazirane vode ili soka od jabuke.
If cytopenia persists for 2 weeks, reduce further to 200 mg/m2. 
Ako citopenija potraje 2 tjedna, dozu dodatno smanjiti na 200 mg/m2.
Table 3 Response in adult CML study 
Tablica 3 Odgovor u ispitivanju KML-a u odraslih
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. 
U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili i mokraćnom mjehuru uz doze ≥6 mg/kg, bez promjena laboratorijskih parametara u serumu ili urinu.
Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 109/l. 
Kronična faza KML-a se definira kada su ispunjeni svi navedeni kriteriji: blasti < 15% u krvi i koštanoj srži, bazofili u perifernoj krvi < 20%, trombociti > 100 x 109/l.
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. 
1200 mg do 1600 mg (trajanje je variralo između jednog i 10 dana): mučnina, povraćanje, proljev, osip, eritem, edem, oticanje, umor, mišićni spazam, trombocitopenija, pancitopenija, bol u trbuhu,
In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily. 
U toj studiji, dozvoljena su povišenja doze od 400 mg na dan na 600 mg na dan, zatim od 600 mg na dan na 800 mg na dan.
doses)iii: days 2, 3, 16, and 17 
6 doza)iii: Dani 2, 3, 16 i 17
• Adult patients with relapsed or refractory Ph+ ALL as monotherapy. 
• Odraslih bolesnika s recidivirajućom ili refraktornom Ph+ ALL kao monoterapija.
6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients. 
6+7 Bol u trbuhu i gastrointestinalno krvarenje su najčešće uočeni u bolesnika s GIST-om.
No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats. 
Nisu bili uočeni novi ciljni organi u toksikološkom ispitivanju juvenilnog razvoja u štakora (10 do
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice. 
Ako niste u stanju progutati kapsule, možete ih otvoriti i istresti prašak u čašu negazirane vode ili soka od jabuke.
Events that have been reported at different dose ranges are as follows: 
Zabilježeni su sljedeći događaji u različitim rasponima doza: Populacija odraslih osoba
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening. 
Doze od 400 mg ili 600 mg trebaju se primijeniti jednom na dan, dok se dnevna doza od 800 mg treba primijeniti kao 400 mg dvaput na dan, ujutro i navečer.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision. 
• Iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid.
• 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. 
• Crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim žarenjem.
When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected. 
Kada se imatinib kombinirao s agresivnim kemoterapijskim protokolima zabilježeno je povećanje teških jetrenih reakcija.
Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors. 
Ponovna aktivacija hepatitisa B U bolesnika koji su kronični nositelji virusa hepatitisa B pojavila se ponovna aktivacija tog virusa nakon što su primili inhibitore BCR-ABL tirozin kinaze.
Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10 
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju9, artralgiju,
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to imatinib. 
Na to vrijeme-do događaja kao cilj ispitivanja je snažno utjecala visoka stopa prelazaka sa IFN+Ara-C na imatinib.
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. 
(KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja.
Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l. 
Ukinuti imatinib sve dok ABN ne bude ≥1,5 x 109/l i trombociti ≥75 x 109/l.
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 non-leukaemia-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. 
Povećanja doze sa 400 mg na 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 s blastičnom krizom može se razmotriti u odsustvu teške nuspojave povezane s lijekom i teške neutropenije ili trombocitopenije nepovezane 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.
- The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate. 
- Ostali sastojci su kalcijev hidrogenfosfat, krospovidon i magnezijev stearat
The capsules are approximately 19 mm long and 7 mm wide. 
Kapsule su približno 19 mm dugačke i 7 mm široke.
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. 
• Znakovi infekcije kao što su vrućica, teška zimica, grlobolja ili čirevi u ustima.
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems). 
• Grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema).
HES/CEL (starting dose 100 mg) 
HES/KEL (doza od 400 mg)
There is very limited experience in children with MDS/MPD, DFSP and HES/CEL. 
Postoji vrlo ograničeno iskustvo kod djece s MDS/MPB-om, DFSP-om i
A limited number of patients were enrolled in phase I studies (n=10). 
Limfatična blastična kriza U ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
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 ALL patients. 
Supstancija selektivno inhibira proliferaciju te inducira apoptozu u Bcr-Abl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba s Ph+KML-om i ALL
9/l) and thrombocytopenias frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10 (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia). 
stupnja (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (59-64% i 44-63% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9%
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound. 
Vezanje N-demetiliranog metabolita za bjelančevine plazme je slično onom ishodne tvari.
An increased rate of opportunistic infections was observed with chronic imatinib treatment. 
Kod kroničnog liječenja imatinibom zapažena je povećana stopa oportunističkih infekcija.
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. 
Sedam godina nakon uključivanja posljednjeg bolesnika, medijan trajanja prve linije liječenja bio je 82 mjeseca u kraku koji je primao imatinib, odnosno 8 mjeseci u kraku koji je primao IFN.
Rates of complete haematological response, major cytogenetic response and complete cytogenetic response on first-line treatment were estimated using the Kaplan-Meier approach, for which nonresponses were censored at the date of last examination. 
Stope potpunog hematološkog odgovora, velikog citogenetskog odgovora (MCyR) i potpunog citogenetskog odgovora (CCyR) za prvu liniju liječenja procijenjene su korištenjem KaplanMeierovog pristupa, pri čemu su izostanci odgovora izostavljeni kod datuma zadnjeg pregleda.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF- mediated cellular events. 
Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanična zbivanja posredovana PDGF-om.
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction 
Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje,
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. 
<18 godina bilo s kroničnom fazom KML-a (n=11), bilo s KML-om u blastičnoj krizi ili Ph+ akutnim leukemijama (n=15).
If cytopenia persists for 2 weeks, reduce further to 300 mg. 
Ako citopenija potraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
Overall, in patients receiving first-line imatinib, the average daily dose delivered was 406 ±76 mg. 
Ukupno gledajući, prosječna vrijednost dnevne doze dane bolesnicima koji su primali prvu liniju liječenja imatinibom iznosila je 406 ± 76 mg.
Imatinib Teva is indicated for 
Teva je indiciran za
PLIVA Croatia Ltd. Prilaz baruna Filipovica 25 
Prilaz baruna Filipovića 25
30 film-coated tablets 30x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets 
30 filmom obloženih tableta 30x1 filmom obloženih tableta 90 filmom obloženih tableta 90x1 filmom obloženih tableta
If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice: 
Ako niste u stanju progutati tablete, možete ih otopiti u čaši negazirane vode ili soka od jabuke:
The capsules are approximately 23 mm long and 9 mm wide. 
Kapsule su približno 23 mm dugačke i 9 mm široke.
Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients. 
U takvih bolesnika trebaju se pažljivo pratiti razine tireotropina (TSH).
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease. 
U bolesnika s KML-om uočen je veći postotak mijelosupresije, nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
FIP1L1-PDGFRα fusion kinase was identified. 
U 61 od tih 117 bolesnika identificirana je fuzijska kinaza FIP1L1-PDGFRα.
20x1 hard capsules 60 hard capsules 60x1 hard capsules 120 hard capsules 120x1 hard capsules 180x1 hard capsules 
20x1 tvrdih kapsula 60 tvrdih kapsula 60x1 tvrdih kapsula 120 tvrdih kapsula 120x1 tvrdih kapsula 180x1 tvrdih kapsula
Imatinib Teva inhibits the growth of these cells. 
Imatinib Teva inhibira rast ovih stanica.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): 
Vrlo česte (mogu se javiti kod više od 1 na 10 ljudi) ili česte (mogu se javiti kod manje od 1 na 10 ljudi):
Isolated cases of imatinib overdose have been reported spontaneously and in the literature. 
Zabilježeni su izolirani spontani i literaturni slučajevi predoziranja imatinibom.
31-546, Krakow Poland 
Mogilska 80. 31-546, Krakow Poljska
There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1). 
Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i djece mlađe od 1 godine s Ph+ ALL
Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline. 
Kriteriji velikog molekularnog odgovora: u perifernoj krvi, sniženje ≥3 logaritma u količini Bcr
Teva Pharma Belgium N.V./S.A./AG 
Teva Pharma Belgium N.V./S.A./AG , Belgique/Belgien
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use). 
Europska Agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka imatiniba u svim podskupinama pedijatrijske populacije s Ph+KML-om (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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. 
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 <30% blasta), bazofili u perifernoj krvi ≥20%, trombociti <100 x 109/l nevezano uz terapiju.
doses)iii: days 2 and 3 
6 doza)iii: Dani 2 i 3
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems). 
• Osip, crvenilo kože s mjehurićima na usnama, očima, koži ili u ustima, ljuštenje kože, vrućica, izdignuti crveni ili ljubičasti plikovi na koži, svrbež, osjećaj žarenja, pojava gnojnih mjehurića
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). 
4 Crvenilo uz osjećaj vrućine je bilo najčešće u bolesnika s GIST-om, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i s transformiranim KML-om (ubrzana faza i blastična kriza).
How to take Imatinib Teva 
Kako uzimati Imatinib Teva
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia-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. 
U djece se može razmotriti povećanje doze od 340 mg/m2 na dan do 570 mg/m2 na dan (ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teških nuspojava povezanih s lijekom i teške neutropenije ili trombocitopenije nepovezane s leukemijom u slijedećim 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.
The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol. 
Tinta za označavanje se sastoji od šelaka, crnog željezovog oksida (E172) i propilenglikola.
This inhibition has not been observed in vivo after the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied. 
Ovakva inhibicija nije uočena in vivo nakon primjene imatiniba u dozi od 400 mg i paracetamola u dozi od
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine). 
Zbog toga se preporučuje oprezno postupati kada se imatinib primjenjuje sa supstratima CYP3A4 s uskom terapijskom širinom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib,
20x1 film-coated tablets 60 film-coated tablets 60x1 film-coated tablets 120 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets 
20x1 filmom obloženih tableta 60 filmom obloženih tableta 60x1 filmom obloženih tableta 120 filmom obloženih tableta 120x1 filmom obloženih tableta 180x1 filmom obloženih tableta
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5). 
Potreban je oprez kada se imatinib uzima s inhibitorima proteaze, azolnim antimikoticima, određenim makrolidima, CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kvinidin) ili varfarinom i drugim derivatima kumarina (vidjeti dio 4.5).
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML. 
5 Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim KML-om (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders Very common 
Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava Vrlo često
If any of these apply to you, tell your doctor before taking Imatinib Teva 
Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Imatinib
Pack sizes of 60 or 120 film-coated tablets in blisters. 
Veličine pakiranja od 60 ili 120 filmom obloženih tableta u blisterima.
The tablets are approximately 20 mm long and 10 mm wide. 
Tablete su približno 20 mm dugačke i 10 mm široke.
Complete CyR n (%) Partial CyR n (%) 
Potpuni CyR n (%)
Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5). 
340 mg/m2/dan (n=9), 440 mg/m2/dan (n=7), te 570 mg/m2/dan (n=5).
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. 
Najčešće zabilježene nuspojave (≥10%), u obje bolesti koje su povezane s primjenom lijeka, bile su blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily. 
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih imatinibom u dozi od 800 mg na dan.
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). 
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).
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach. 
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani dio želuca.
Resume treatment with imatinib at 600 mg. 
Nastaviti imatinib u dozi od 600 mg.
6-MP (75 mg/m2/day, PO): days 8-28 
6-MP (75 mg/m2/dan, p.o.): dani 8-28
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients. 
10 Mišićno-koštana bol i vezane nuspojave su češće uočeni u bolesnika s KML-om, nego u bolesnika s GIST-om.
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells). 
• Blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica).
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib. 
U bolesnika koji primaju imatinib potrebno je redovito kontrolirati parametre jetrene funkcije (transaminaze, bilirubin, alkalna fosfataza).
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U
Iron oxide black (E172) Propylene glycol 
crnog željezovog oksida (E172) i propilenglikola.
9/l. 
9/l i trombociti
• Feeling dizzy or weak. 
• Omaglica ili slabost.
Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL. 
600 mg/ dan u kombinaciji s kemoterapijom u indukcijskoj, konsolidacijskoj te fazi održavanja kemoterapije (vidjeti dio 5.1) u odraslih bolesnika s novodijagnosticiranom Ph+ ALL.
600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day. 
600 mg se uzima kao 1 tableta od 400 mg plus 2 tablete od 100 mg ili kao 1 ½ tableta od 400 mg jednom na dan.