natgillin/translations-raw huggingface dataset:
The starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day. 
Početna doza iznosi 600 mg, a uzima se jednom na dan kao 6 kapsula od 100 mg (ili 1 kapsula od 400 mg i 2 kapsule od 100 mg).
Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate. 
Imatinib medac 400 mg tvrde kapsule Svaka tvrda kapsula sadrži 50,072 mg laktoze hidrata.
The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily. 
Pedijatrijski bolesnici primali su 400 mg/m² na dan, kasnije je doza povećana na 520 mg/m² na dan.
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). 
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 u bolesnika s transformiranim KML-om (KML-ubrzana faza i KML-blastična kriza).
Dose adjustments for neutropenia and thrombocytopenia: 
Prilagođavanje doze zbog neutropenije i trombocitopenije:
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red 
• blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica)
• Swelling such as round your ankles or puffy eyes. 
• oticanje kao što je oticanje gležnjeva ili otečene oči
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema 
Ginekomastija, erektilna disfunkcija, menoragija, nepravilne mjesečnice, poremećaj seksualne funkcije, bol u bradavicama, povećanje dojki, edem
8) Some fatal cases of hepatic failure and of hepatic necrosis have been reported. 
8) Zabilježeno je nekoliko smrtnih slučajeva zbog zatajenja jetre i nekroze jetre.
However if it is nearly time for the next 
Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema 
Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry 
Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija,
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane Često:
Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate. 
Imatinib medac 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 12,518 mg laktoze hidrata.
Packs containing 30 hard capsules. 
Pakiranja sadrže 30 tvrdih kapsula.
• Feeling light-headed, dizzy or fainting (signs of low blood pressure). 
• osjećaj da Vam se vrti u glavi, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka)
• Feeling dizzy or weak. 
• omaglica ili slabost
Triple IT therapy (age-adjusted): days 1, 29 
Trostruka i.t. terapija (prilagođena dobi): dani 1, 29
Biochemistry 
Biokemija
Laboratory test abnormalities 
Abnormalne vrijednosti laboratorijskih testova
Imatinib medac is a treatment for adults and children and adolescents for: 
Imatinib medac se koristi kod odraslih osoba, djece i adolescenata za liječenje:
9, arthralgia, bone 
9, artralgiju,
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of 
• teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi probavnih problema)
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival. 
Klinička ispitivanja kod kronične mijeloične leukemije Učinkovitost imatiniba temelji se na općim hematološkim i citogenetskim stopama odgovora i preživljenju bez progresije.
What Imatinib medac contains 
Što Imatinib medac sadrži
Intensification block 2 (9 weeks) 
Intenzifikacijska terapija 2 (9 tjedana)
Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP. 
U patogenezu MDS/MPD-a, HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl protein-tirozin kinaza koja nastaje kao posljedica fuzije pri čemu se javljaju različiti partnerski proteini ili konstitutivno stvaranje PDGF-a.
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m daily or doses ranging from 200 to 400 mg daily. 
Dob tih bolesnika bila je u rasponu od 2 do 16 godina, a imatinib se primjenjivao u dozi od 300 mg/m na dan ili u dozama u rasponu od 200 do 400 mg na dan.
Marketing Authorisation Holder medac 
Nositelj odobrenja za stavljanje lijeka u promet medac
Therapeutic indication 
Indukcijska terapija
The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of 
Doza je 800 mg na dan, a uzima se kao 1 kapsula od 400 mg ujutro i 1 kapsula od 400 mg navečer.
Intensification block 1 (9 weeks) 
Intenzifikacijska terapija 1 (9 tjedana)
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, 
Trombocitemija, limfopenija, depresija koštane srži, eozinofilija,
Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay. 
Pozitivni su genotoksični učinci dobiveni za imatinib u in vitro testu na stanicama sisavca (jajnik kineskog hrčka) na klastogenost (aberacija kromosoma) u prisutnosti metaboličke aktivacije pri koncentracijama od 125 μg/ml.
How to store Imatinib medac 
Kako čuvati Imatinib medac
Triple IT therapy (age-adjusted): day 1 
Trostruka i.t. terapija (prilagođena dobi): dan 1
DEX 10 mg/m oral, days 1-5; 
DEX 10 mg/m² peroralno, dani 1-5;
DEX (6 mg/m2/day, PO): days 1-7 and 15-21 
DEX (6 mg/m²/dan, p.o.): dani 1-7 i 15-21
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8). 
U slučajevima kada se imatinib kombinira s režimima kemoterapije za koje je poznato da su povezani s poremećajem funkcije jetre, potrebno je pažljivo praćenje jetrene funkcije (vidjeti dijelove 4.5 i 4.8).
Isolated cases of imatinib overdose have been reported spontaneously and in the literature. 
Zabilježeni su spontani i literaturni izolirani slučajevi predoziranja imatinibom.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or 
• iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid
Imatinib medac 100 mg hard capsules EU/1/13/876/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Imatinib medac 100 mg tvrde kapsule EU/1/13/876/001
Imatinib medac is also a treatment for children and adolescents with CML. 
Imatinib medac koristi se također za liječenje KML-a u djece i adolescenata.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily. 
Dob tih bolesnika bila je u rasponu od novorođenačke do 14 godina, a imatinib se primjenjivao u dozi od 50 mg na dan ili u dozama u rasponu od 400 do 520 mg/m na dan.
Posology for MDS/MPD in adult patients The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD. 
Za odrasle bolesnike s MDS/MPD-om preporučena doza imatiniba iznosi 400 mg/dan.
Severe 
Teški
• Severely decreased urine output, feeling thirsty (signs of kidney problems). 
• jako smanjeno mokrenje, žeđ (znakovi bubrežnih problema)
Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure. 
Djelatne tvari koje mogu smanjiti koncentracije imatiniba u plazmi Tvari koje induciraju djelovanje CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ili Hypericum perforatum, poznat također kao gospina trava) mogu značajno smanjiti izloženost imatinibu, čime se potencijalno povećava rizik od neuspjeha terapije.
CPM (300 mg/m2, IV): days 29-33 
CPM (300 mg/m², i.v.): dani 29-33
• Chronic renal failure. 
• kronično zatajenje bubrega.
7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis 
7, podrigivanje, melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija,
• Pain or swelling in your abdomen, flatulence, heartburn or constipation. 
• bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor
Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash 
Periorbitalni edem, dermatitis/ekcem/osip
Complete blood counts must be performed regularly during therapy with imatinib. 
Tijekom terapije imatinibom mora se redovito kontrolirati kompletna krvna slika.
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified. 
Iz ovih nalaza studije kancerogenosti u štakora još nije razjašnjen mehanizam, kao ni važnost za ljude.
• Weight gain. 
• povećanje tjelesne težine.
Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia 
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju
9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m 
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m².
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m 
Metotreksat (5 g/m² kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m² u 36. satu, i.v.; 15 mg/m² i.v. ili p.o. svakih
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications. 
U 4 publikacije zabilježeno je pet (5) bolesnika s MDS/MPD-om povezanim s preraspodjelom gena za PDGFR.
DEX (6 mg/m 2/day, PO): days 1-5; 29-33 
DEX (6 mg/m/²dan, p.o.): dani 1-5; 29-33
VP-16 (100 mg/m2/day, IV): days 1-5 
VP-16 (100 mg/m²/dan, i.v.): dani 1-5
9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg. 
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 400 mg.
What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters. 
Kako Imatinib medac izgleda i sadržaj pakiranja Imatinib medac 100 mg tvrde kapsule želatinske su kapsule veličine “3”, s narančastim tijelom i kapicom.
Ifosfamide (1.8 g/m2/day, IV): days 1-5 
Ifosfamid (1,8 g/m²/dan, i.v.): dani 1-5
Consolidation block 2 (3 weeks) 
Konsolidacijska terapija 2 (3 tjedna)
Consolidation block 1 (3 weeks) 
Konsolidacijska terapija 1 (3 tjedna)
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir 
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ABN >1500 nakon
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5). 
U bolesnika u kojih je obavljena tireoidektomija i koji primaju nadomjesnu terapiju levotiroksinom, zabilježeni su klinički slučajevi hipotireoze tijekom liječenja imatinibom (vidjeti dio 4.5).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel 
• mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema)
9/l and platelets ≥ 75 x 10 
9/l i trombociti ≥75 x 10 9/l.
CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 
CPM (250 mg/m²/doza svakih 12 sati x 4 doze, i.v.): dani 3 i 4 PEG-ASP (2500 IU/m², i.m.): dan 4
MTX 15 mg intrathecal, day 1; 
MTX 15 mg intratekalno, dan 1
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment. 
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, a uzima se kao 1 kapsula od 400 mg jednom na dan.
VP-16 (100 mg/m 2, IV): days 29-33 
VP-16 (100 mg/m², i.v.): dani 29-33
In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients. 
U ispitivanju GIST-a, primjena ispitivanog lijeka je prekinuta u 4 % bolesnika zbog nuspojava povezanih s primjenom imatiniba.
Posology for DFSP in adult patients The recommended dose of imatinib is 800 mg/day for patients with DFSP. 
Za bolesnike s DFSP-om preporučena doza imatiniba iznosi 800 mg/dan.
VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14 
I DEX 10 mg/m² peroralno, dani 1-5; VCR 2 mg i.v., dani 6, 13, 20; daunorubicin 45 mg/m² i.v., dani 6-7, 13-14
Pleural effusion 
Oticanje zglobova
9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg. 
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 300 mg.
9/l and/or platelets < 10 x 10 
9/l i/ili trombociti <10 x 10
9/l and/or platelets < 50 x 10 
9/l i/ili trombociti <50 x 10
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications. 
U 3 publikacije zabilježeno je pet (5) bolesnika s DFSP-om i preraspodjelom gena za PDGFR.
• 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,
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications. 
U 3 publikacije zabilježena su tri (3) bolesnika s HES-om i KEL-om povezanim s preraspodjelom gena za PDGFR.
Study AUS01 
Studija AJP01
Liver dysfunction 
Oštećenje funkcije bubrega
Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate). 
Imatinib medac 400 mg tvrde kapsule Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172). 
Ovojnica kapsule za kapsule od 100 mg sastoji se od želatine, žutog željezovog oksida (E172), titanijevog dioksida (E171) i crvenog željezovog oksida (E172).
Reinduction block 2 (3 weeks) 
Reindukcijska terapija 2 (3 tjedna)
Theaterstr. 
BROJ SERIJE
Very common: Headache Common: 
Poremećaji oka Često:
The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172). 
Ovojnica kapsule za kapsule od 400 mg sastoji se od želatine, žutog željezovog oksida (E172), titanijevog dioksida (E171), crvenog željezovog oksida (E172) i crnog željezovog oksida (E172).
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily. 
400 mg jedanput na dan) ili 340 mg/m jedanput na dan (najviše 600 mg jedanput na dan) bila slična onoj u odraslih bolesnika koji su primali imatinib 400 mg ili 600 mg jedanput na dan.
• Joint pain with swelling. 
• bolovi u zglobovima s oticanjem
9) Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing 
9) Nakon stavljanja lijeka u promet primijećena je mišićno-koštana bol koja se javlja tijekom liječenja imatinibom, kao i nakon prekida liječenja.
Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered. 
Prije primjene imatiniba u bolesnika s HES/KEL-om i u bolesnika s MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o pregledu kod specijalista kardiologa, obavljanju ehokardiograma i određivanju serumskog troponina.
When and how to take Imatinib medac • Take Imatinib medac with a meal. 
Kada i kako uzimati Imatinib medac
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29 
Kranijalna iradijacija (samo blok br. 5) 12 Gy u 8 frakcija za sve bolesnike koji imaju CNS1 i CNS2 u trenutku dijagnoze
Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1; 
DEX 10 mg/m² peroralno, dani 1-5; vindezin 3 mg/m² i.v., dan 1;
No patient developed grade 4 thrombocytopenia. 
Trombocitopenija 4. stupnja nije nastupila niti u jednog bolesnika.
DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 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 
= u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA = natrijev 2-merkaptoetan sulfonat, iii = ili dok vrijednost MTX-a ne bude <0,1 μM, Gy = Gray
Reinduction block 1 (3 weeks) 
Reindukcijska terapija 1 (3 tjedan)
200 mg/m 
(doza od 340 mg/m²)
Breast-feeding 
Cerebralni edem*
monthly for 13 months; 
VCR 2 mg i.v. mjesečno tijekom 13 mjeseci;
Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision 
Edem kapaka, pojačano suzenje, konjunktivalno krvarenje, konjunktivitis, suhe oči, zamagljen vid
Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules 
Imatinib medac 100 mg tvrde kapsule Imatinib medac 400 mg tvrde kapsule
9/l) and thrombocytopenias (platelet count < 50 x 10 
9/l) i trombocitopenija (broj trombocita <50 x 10
• Rash. 
• osip
VCR (1.5 mg/m 2/day, IV): days 1, 29 
VCR (1,5 mg/m², i.v.): dani 1, 29
Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap. 
Imatinib medac 100 mg tvrde kapsule Tvrde kapsule veličine “3” narančastog tijela i kapice.
Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate). 
Svaka tvrda kapsula Imatinib medaca od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The dose of 
NAZIV LIJEKA
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) 
Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172)
9/l) and thrombocytopenia (platelet count < 10 x 10 
9/l) i trombocitopenija (broj trombocita <10 x 10
(24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v. 
DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m² i.v. (24 h), dan 1, Ara-C 1 g/m² i.v. (2 h, svakih 12 h), dani 2-3 (ukupno
Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v. 
Indukcija remisije DEX 10 mg/m² peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14;
Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate). 
Svaka tvrda kapsula Imatinib medaca od 400 mg sadrži 400 mg imatiniba (u obliku imatinibmesilata).
G-CSF (5 μg/kg, SC): days 34-43 
MESNA i.v.: dani 29-33 G-CSF (5 μg/kg, s.c.): dani 34-43
IV or PO q6h x 6 doses)iii: 
6 sati x 6 doza)iii: dani 2 i 3
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v. 
Ara-C 1000 mg/m²/12 h i.v.(3 h), dani 1-4; mitoksantron 10 mg/m² i.v. dani 3-5;
• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) 
• pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja,
(n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5). 
Bolesnici su liječeni dozama imatiniba od 260 mg/m²/dan (n=5), 340 mg/m²/dan (n=9), 440 mg/m²/dan (n=7), te 570 mg/m²/dan (n=5).
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172) 
Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni E172)
2/day, IV): days 1, 8 and 15 2/day bolus, IV): days 1 and 2 2/dose q12h x 4 doses, iv): Days 3 and 4 2, IM): day 4 G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 2/day, PO): days 1-7 and 15-21 
ARA-C (3 g/m²/doza svakih 12 sati x 4, i.v.): dani 2 i 3 G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ABN >1500 nakon najniže izmjerene vrijednosti
Imatinib medac 400 mg hard capsules Capsule content 
Imatinib medac 400 mg tvrde kapsule imatinib
Imatinib medac 100 mg hard capsules Capsule content 
Imatinib medac 100 mg tvrde kapsule imatinib
Renal failure chronic Reproductive system and breast disorders 
Poremećaji reproduktivnog sustava i dojki Manje često:
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate). 
NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain). 
• teška glavobolja, slabost ili paraliza udova ili lica, otežan govor, iznenadni gubitak svijesti
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 400 mg of imatinib (as mesilate). 
NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Table 1 Tabulated summary of adverse reactions Infections and infestations 
Terapijska indikacija Toksični učinci: neutropenija i
Haematological adverse reactions 
Hematološke nuspojave
(1 h), days 28-31, 35-38, 42-45; 
Ara-C 75 mg/m² i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m² peroralno, dani 26-46
Mild 
Umjereni
Avascular necrosis/hip necrosis*, growth retardation in children* Renal and urinary disorders 
Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece* Poremećaji bubrega i mokraćnog sustava Manje često:
months (range 24 days - 60 months). 
Ti su bolesnici primali imatinib za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
Eye disorders 
• oslabljen sluh
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg. 
• mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 
Ara-C 2x 2 g/m² i.v. (3 h, svakih 12 h), dan 5
Chest pain, malaise 
Bol u prsnom košu, malaksalost
9/l. 
9/l) bila između 4 i
• Mouth ulcers. 
• čirevi u ustima
Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain 
Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu