natgillin/translations-raw huggingface dataset:
Imatinib Teva B.V. is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD). 
Imatinib Teva B.V. se kod odraslih osoba također koristi za liječenje: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
What Imatinib Teva B.V. looks like and contents of the pack 
Kako Imatinib Teva B.V. izgleda i sadržaj pakiranja
A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day imatinib 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity. 
Drugo otvoreno multicentrično ispitivanje faze III (SSG XVIII/AIO) uspoređivalo je 12 mjeseci liječenja imatinibom 400 mg/dan u odnosu na 36 mjeseci liječenja u bolesnika nakon kirurške resekcije GIST-a i jednog od sljedećeg: promjer tumora >5 cm i broj mitoza >5/50 u vidnom polju mikroskopa pri velikom povećanju (HPF, engl. high power fields); ili promjer tumora >10 cm i bilo koji broj mitoza ili tumor bilo koje veličine s brojem mitoza >10/50 HPF ili ruptura tumora u peritonealnu šupljinu.
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (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. 
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 preživljavanja 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%).
In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56]. 
U planiranoj analizi podskupine prema vrsti mutacije je omjer rizika za preživljenje bez recidiva bolesti kod 36-mjesečnog liječenja bolesnika s mutacijama na 11. eksonu bio 0,35 [95% CI: 0,22, 0,56].
Anaphylactic shock* Blood and lymphatic system disorders 
Poremećaji imunološkog sustava Poremećaji krvi i limfnog sustava
• Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in 
• Pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom-alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study 
3 Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
They are usually 
Manje često
Imatinib Teva B.V. may cause your body to retain water (severe fluid retention). 
Imatinib Teva B.V. može izazvati zadržavanje vode u tijelu (teška retencija
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day. 
U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at 
Kranijalna iradijacija (Samo blok br. 5) 12 Gy u 8 frakcija za sve bolesnike koji imaju CNS1 i CNS2 u trenutku
Imatinib Teva B.V. is a medicine containing an active substance called imatinib. 
Imatinib Teva B.V. je lijek koji sadrži djelatnu tvar zvanu imatinib.
In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months. 
U to je ispitivanje uključeno i randomizirano 147 bolesnika kako bi na dan primali bilo 400 mg bilo 600 mg peroralno tijekom razdoblja do 36 mjeseci.
(1 h) day 1; 
i.v.(1 h) dan 1;
At the time of analysis, the treatment duration was a median of 47 
U vrijeme analize, medijan trajanja liječenja bio je
(≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
(≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL. 
Postoji ograničeno iskustvo kod djece s Ph pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-omi HES/KEL-om.
What Imatinib Teva B.V. is and what it is used for 
Što je Imatinib Teva B.V. i za što se koristi
The effect of prior gastrointestinal surgery on drug absorption has not been investigated. 
Učinak prethodnog gastrointestinalnog kirurškog zahvata na apsorpciju lijeka nije
All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 
Svih 65 bolesnika s pozitivnom FIP1L1-PDGFRα fuzijskom kinazom postiglo je CHR koji se održao mjesecima (raspon od 1+ do 44+ mjeseci, izostavljeno u trenutku izvještavanja).
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolobenzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. 
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.).
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved. 
Ako se tijekom primjene imatinibom razvije teška nehematološka nuspojava, liječenje se mora prekinuti sve do oporavka od nuspojave.
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is 
Za doze različite od doza od 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta od 100 mg.
The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm. 
Duljina kapsule je od 19,1 mm do 19,7 mm, a širina iznosi 6,91 mm Imatinib Teva B.V.
The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes. 
GIST-a nije imala podatke koji bi potvrdili c-Kit ili PDGFR mutacije koje su možda dovele do miješanih kliničkih ishoda.
The diameter of the film-coated tablet is 
Promjer filmom obložene tablete je približno
1200 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, 
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,
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 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. 
Analizom je potvrđeno da je izloženost imatinibu u pedijatrijskih bolesnika koji su primali 260 mg/m jedanput na dan (najviše 400 mg jedanput na dan) ili 340 mg/m2 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.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib until 
Ako citopenija potraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve
Frequency categories are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Kategorije učestalosti se definiraju kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients. 
Izloženost imatinibu u plazmi je izgleda viša kod bolesnika s oštećenom funkcijom bubrega, vjerojatno zbog povišene razine alfa-kiselog glikoproteina (AGP) u plazmi, proteina koji veže imatinib, u tih bolesnika.
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract 
Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
CML (CML-AP and CML-BC) than in patients with chronic CML. 
KML-om (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in 
10 Mišićno-koštana bol i vezane nuspojave su češće uočeni u bolesnika s KML-om, nego u
During treatment with Imatinib Teva B.V., tell your doctor straight away if you put on weight very quickly. 
Tijekom liječenja Imatinibom Teva B.V. odmah obavijestite svog liječnika ako vrlo brzo dobivate na težini.
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). 
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).
Imatinib Teva B.V. is a treatment for: - Chronic myeloid leukaemia (CML). 
Imatinib Teva B.V. se koristi za liječenje: - Kronične mijeloične leukemije (KML).
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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. 
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.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V. 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva B.V.
100 vs. 98.7 100 vs. 95.5 0.59 (0.17; 2.10) 100 vs. 94.8 97.8 vs. 89.5 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.7 vs. 46.6 N.E. 
100 vs. 98,7 100 vs. 95,5 0,59 (0,17; 2,10) 100 vs. 94,8 97.8 vs. 89,5 44,8 21/140 vs. 51/127 0,29 (0,18; 0,49) 94.8 vs. 64,0 80.7 vs. 46,6 NP
• 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). 
• Kombinacija teškog proširenog osipa, mučnine, vrućice, visoke razine određenih bijelih krvnih stanica ili žutila kože ili očiju (znakovi žutice) s nedostatkom zraka, bol/nelagoda u prsnom košu, jako smanjenim mokrenjem i žeđi itd. (znakovi alergijske reakcije povezane s liječenjem).
Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol. 
Izgleda da prilagođavanje doze nije neophodno kada se imatinib istodobno primjenjuje sa supstratima CYP2D6, međutim, savjetuje se oprez kod supstrata
Description of selected adverse reactions Hepatitis B reactivation 
Ponovna aktivacija hepatitisa B
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival. 
Učinkovitost imatiniba temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez znakova progresije bolesti.
• 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
If this applies to you, tell your doctor without taking Imatinib Teva B.V. 
Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Teva B.V..
• 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
- The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate. 
- Ostali sastojci su bezvodni kalcijev hidrogenfosfat, krospovidon i magnezijev stearat.
- Imatinib Teva B.V. is not recommended during pregnancy unless clearly necessary as it may harm your baby. 
- Imatinib Teva B.V. se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno.
- Myelodysplastic/myeloproliferative diseases (MDS/MPD). 
- Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance. 
Iz skupine potencijalnih lijekova za istodobnu primjenu (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksiureja, norfloksacin, penicilin V) samo su eritromicin (IC50 50 µM) i flukonazol (IC50 118 µM) pokazali da inhibiraju metabolizam imatiniba što bi moglo biti klinički značajno.
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14 
Daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years). 
(199 bolesnika u 12-mjesečni krak i 198 bolesnika u 36-mjesečni krak), pri čemu je medijan starosti bio 61 godina (raspon od 22 do 84 godina).
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; 
Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16;
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 
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).
ULN = upper limit of normal for the institution 
GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4). 
nekim je slučajevima došlo do akutnog zatajenja jetre ili fulminantnog hepatitisa, što je dovelo do transplantacije jetre ili smrtnog ishoda (vidjeti dio 4.4).
Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1). 
Trideset i šest (36) mjeseci liječenja imatinibom značajno je produljilo preživljenje bez recidiva bolesti u usporedbi s 12 mjeseci liječenja imatinibom (uz ukupan omjer rizika = 0,46 [0,32, 0,65], p<0,0001) (Tablica 7, Slika 1).
Start 6-MP the 1st day after cranial irradiation completion.) 
6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
Imatinib is a small molecule protein-tyrosine 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). 
Imatinib je mala molekula, inhibitor protein-tirozin kinaze, koji 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).
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.
Clinical studies in adjuvant GIST 
Klinička ispitivanja kod adjuvantnog liječenja GIST-a
For doses of 400 mg and above (see dosage recommendation below) a 400 mg film-coated tablet is available. 
Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed 
Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim
CHR: In study 0102 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] 
CHR: Studija 0102 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i nema ekstramedularne bolesti]
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 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,
• Itching. 
• Osip.
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with 
1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s
Imatinib Teva B.V. is indicated for 
Imatinib Teva B.V. je indiciran za
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study). 
Abnormalne vrijednosti laboratorijskih testova U KML-u, citopenije su, osobito neutropenija i trombocitopenija, bile stalan nalaz u svim ispitivanjima, s naznakom da je učestalost veća uz visoke doze ≥750 mg (ispitivanje faze I).
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 (based on AUC) at 340 mg/m2/day. 
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 dozu od 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan,
VCR 1 mg i.v., days 7, 14; 
VCR 1 mg i.v., dani 7, 14;
Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial) 
Tablica 7 12-mjesečno i 36-mjesečno liječenje imatinibom (SSGXVIII/AIO ispitivanje) Krak s 36-mjesečnim liječenjem
Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses). 
Imatinib je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene imatiniba od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet
could cause hepatitis B to become active again, which can be fatal in some cases. 
Imatinib Teva B.V. može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim slučajevima može rezultirati smrtnim ishodom.
After correcting for the BSA effect, other demographics such as age, body weight and body mass index did not have clinically significant effects on the exposure of imatinib. 
Nakon korekcije s obzirom na učinak tjelesne površine, ostale demografske odrednice kao što su dob, tjelesna težina i indeks tjelesne mase,
Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia. 
Teška jetrena toksičnost zapažena je u pasa koji su liječeni 2 tjedna, uz povišene jetrene enzime, hepatocelularnu nekrozu, nekrozu žučnih vodova te
Active substances that may increase imatinib plasma concentrations: 
Djelatne tvari čije bi koncentracije u plazmi imatinib mogao promijeniti
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
Prednisolone 200 mg oral, 5 days per month for 13 
Prednizolon 200 mg peroralno, 5 dana na mjesec
Table 1 Tabulated summary of adverse reactions 
Tablica 1 Tablični sažetak nuspojava
Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates. 
Klinička ispitivanja kod MDS/MPB-a Iskustvo s imatinibom u ovoj indikaciji je vrlo ograničeno te se temelji na hematološkom i citogenetskom odgovoru.
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). 
Novodijagnosticirana Ph+ ALL: U kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib je kao monoterapija izazvao značajno višu stopu kompletnog hematološkog odgovora od kemoterapije (96,3% u odnosu na 50%; p=0,0001).
0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5 
100 vs. 100 97,8 vs. 100 0,16 (0,03; 0,70) 97,9 vs. 90,8 97,9 vs. 73,3 29,7 16/84 vs. 39/81 0,27 (0,15; 0,48) 98,7 vs. 56,1 79,9 vs. 41,5
Imatinib Teva B.V. inhibits the growth of these cells. 
Imatinib Teva B.V. inhibira rast ovih stanica.