natgillin/translations-raw huggingface dataset:
In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Pri pediatričnih bolnikih s KML so izmed toksičnih učinkov najpogosteje opažali citopenije 3. ali 4. stopnje, ki vključuje nevtropenijo, trombocitopenijo in anemijo.
Considering the limited safety database, the adverse events thus far reported in children are consistent with the known safety profile in adult patients with Ph+ ALL.
Baza podatkov do zdaj sporočenih neželenih dogodkov pri otrocih je majhna, vendar se podatki v njej ujemajo z varnostnimi lastnostmi zdravila pri odraslih bolnikih s Ph+ ALL.
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.
Pri odraslih in pediatričnih bolnikih temelji učinkovitost imatiniba na celotni hematološki in citogenetični odzivnosti in preživetju brez napredovanja bolezni pri KML, na hematološki in citogenetični odzivnosti pri Ph+ ALL in MDS/MPD, na hematološki odzivnosti pri HES/CEL ter na objektivni odzivnosti odraslih bolnikov z neresektabilnimi in/ali metastatskimi DFSP.
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day can be given until disease progression occurs.
Odrasli bolniki z relapsom ali neodzivno Ph+ ALL lahko imatinib kot monoterapijo v odmerku 600 mg/dan prejemajo, dokler ne pride do napredovanja bolezni.
Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Imatinib je zaviralec proteinskih kinaz, ki močno zavira Bcr-Abl tirozin-kinazo na in vitro, celični in in vivo ravni.
Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Zato je pri sočasni uporabi visokih odmerkov imatiniba in paracetamola potrebna previdnost.
In an observational study in the CML paediatric population, a statistically significant decrease (but of uncertain clinical relevance) in median height standard deviation scores after 12 and 24 months of treatment was reported in two small subsets irrespective of pubertal status or gender.
V opazovalni študiji pri pediatrični populaciji s kronično mieloično levkemijo so po 12 in 24 mesecih zdravljenja poročali o statistično značilnem zmanjšanju (klinična pomembnost tega zmanjšanja ni znana) v vrednostih standardnega odklona mediane telesne višine pri dveh manjših podskupinah, ne glede na spolno dozorelost in spol.
1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Odmerki od 1800 mg do 3200 mg (tudi do 3200 mg na dan 6 dni): oslabelost, mialgija, zvišana kreatin-kinaza, zvišan bilirubin, bolečine v prebavilih.
Liver dysfunction classification:
Razvrstitev disfunkcije jeter:
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
In vivo spojina kaže protitumorsko aktivnost, če se uporablja kot edino sredstvo, v živalskih modelih z Bcr-Abl pozitivnimi tumorskimi celicami.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) imatiniba dnevno.
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.
Študija AIT07 je bila multicentrična, odprta, randomizirana študija faze II/III, v katero so vključili 128 bolnikov (starih od 1 do manj kot 18 let) in jih zdravili z imatinibom v kombinaciji s kemoterapijo.
• Pain in your hips or difficulty walking.
• bolečine v kolkih ali težave pri hoji,
Therefore, caution should be exercised in patients with cardiac dysfunction.
Zato je pri bolnikih z motnjami delovanja srca potrebna previdnost.
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
In vitro imatinib zavira paracetamol O-glukuronidacijo z vrednostjo Ki 58,5 mikromolov/l.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
V tej študiji je 14 bolnikov s HES/CEL prejemalo od 100 mg do 1.000 mg imatiniba na dan.
Imatinib medac 400 mg hard capsules EU/1/13/876/002
Imatinib medac 400 mg trde kapsule EU/1/13/876/002
These are a group of blood diseases in which some blood cells start growing out of control.
Te bolezni sodijo v skupino krvnih bolezni, pri katerih se začnejo nenadzorovano razraščati nekatere krvne celice.
There were no special safety findings in paediatric clinical trials.
V pediatričnih kliničnih preskušanjih ni bilo posebnih ugotovitev o varnosti.
• Newly diagnosed CML for whom bone marrow transplantation is not considered as the first line of treatment;
• z novo odkrito KML, za katero presaditev kostnega mozga kot zdravilo prve izbire ne pride v poštev;
There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Ni kontroliranih kliničnih preskušanj, ki bi dokazovala klinično koristnost, na primer izboljšanje bolezenskih simptomov ali povečano preživetje.
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.
Kaže, da je pri bolnikih z okvarjenim delovanjem ledvic izpostavljenost imatinibu v plazmi višja kot pri bolnikih z normalnim delovanjem ledvic, verjetno zato, ker je pri teh bolnikih zvišana vrednost alfa kislega glikoproteina (AGP-alpha-acid glycoprotein), proteina, ki veže imatinib, v plazmi.
Imatinib medac 100 mg hard capsules EU/1/13/876/001
Imatinib medac 100 mg trde kapsule EU/1/13/876/001
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
V primeru nenormalnega izvida katere od teh preiskav je potrebno razmisliti o kontrolnem pregledu pri kardiologu in sočasni profilaktični uporabi steroidov s sistemskim delovanjem (1-2 mg/kg) ob uvedbi zdravljenja z imatinibom, v obdobju enega do dveh tednov.
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.
Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr-Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s KML, s prisotnim kromosomom Philadelphia, in z ALL.
Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Bolniki so bili zdravljeni z odmerki imatiniba 340 mg/m²/dan brez prekinitev; toksičnih učinkov, zaradi katerih bi zmanjševali odmerjanje, ni bilo.
• adult and paediatric patients with Ph+ CML in blast crisis.
• odraslih in pediatričnih bolnikov s Ph+ KML v blastni krizi,
There is no effect of gender on the kinetics of imatinib.
Spol na kinetiko imatiniba ne vpliva.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. Do not store above 30 °C.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Če pride do zvišanja bilirubina na > 3-kratno zgornjo mejo normalnih vrednosti, specifično za ustanovo (IULN-institutional upper limit of normal) ali zvišanja jetrnih aminotransferaz na > 5-kratno IULN, je treba zdravljenje z imatinibom prekiniti, dokler se koncentracija bilirubina ne vrne na < 1,5-kratno IULN oziroma koncentracija aminotransferaz na < 2,5-kratno IULN.
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Imatinib je bil teratogen pri podganah, če so ga dobivale med organogenezo v odmerkih ≥ 100 mg/kg, kar je približno enako največjemu kliničnemu odmerku 800 mg/dan, izračunanemu na podlagi telesne površine.
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• zelo zmanjšano odvajanje urina, občutek žeje (znaki težav z ledvicami),
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Po rezultatih populacijske farmakokinetične analize združenih podatkov pediatričnih bolnikov s hematološkimi boleznimi (s KML, s Ph+ ALL ali s katero od drugih hematoloških bolezni, pri katerih se pri zdravljenju uporablja imatinib), se očistek imatiniba zvišuje z večanjem telesne površine.
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.
V 2-letni študiji karcinogenosti pri podganah je odmerjanje imanitiba 15, 30 in 60 mg/kg/dan povzročilo statistično značilno skrajšanje življenjske dobe samcev pri 60 mg/kg/dan in samic pri ≥ 30 mg/kg/dan.
These changes are not considered sufficient to warrant dose adjustment based on kg bodyweight.
Te spremembe pa niso dovolj velike, da bi bilo potrebno prilagajanje odmerjanja telesni masi.
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 (see section 4.5).
Od skupine možnih zdravil za sočasno uporabo (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksisečnina, norfloksacin, penicilin V) sta samo eritromicin (IC50 50 μM) in flukonazol (IC50 118 μM) pokazala inhibicijo presnove imatiniba, ki bi bila lahko klinično pomembna (glejte poglavje 4.5).
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Plodnost F1 ni bila prizadeta, pač pa se je pri odmerku 45 mg/kg/dan povečalo število resorpcij in zmanjšalo število za življenje sposobnih plodov.
The age of these patients ranged from 2 to 79 years.
Starost teh bolnikov je bila od 2 do 79 let.
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Opravili so veliko mednarodno odprto nekontrolirano študijo faze II pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v fazi blastne krize bolezni.
• Hot flushes, chills or night sweats.
• navali vročine, mrazenje ali nočno znojenje.
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
• pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa,
In addition a further 24 patients with MDS/MPD were reported in 13 publications.
Poleg tega so v 13 publikacijah poročali o nadaljnjih 24 bolnikih z MDS/MPD.
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Imatinib je v kombinaciji z indukcijo s kemoterapijo (glejte preglednico 3) povzročil popolni hematološki odziv pri 93 % (147 od 158 za oceno primernih bolnikov) in pomembni citogenetični odziv pri 90 % (19 od 21 za oceno primernih bolnikov).
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Učinkovitost imatiniba temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
In vitro imatinib zavira aktivnost izoencima CYP2D6 citokroma P450 pri koncentracijah, ki so podobne tistim, ki vplivajo na aktivnost CYP3A4.
At a dose of 60 mg/kg, female rats had significant postimplantation foetal loss and a reduced number of live foetuses.
Pri odmerku 60 mg/kg je prišlo pri samicah do znatne izgube plodov po vgnezditvi in do zmanjšanja števila živih plodov.
Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19 - 60) and 47 months (range 16-59), respectively.
Hematološki odzivi so ostali enaki mediano 49 mesecev (razpon 19 - 60), citogenetični odzivi pa 47 mesecev (razpon 16 - 59).
The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
Otrok lahko zdravilo vzame v enem samem dnevnem odmerku ali pa lahko dnevni odmerek razdelimo na dva dela (polovico damo otroku zjutraj, polovico pa zvečer).
Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12 % increase in patients > 65 years old).
Na podlagi analize populacijske farmakokinetike pri bolnikih s KML so ugotovili majhen učinek starosti na volumen porazdelitve (12-odstotno povečanje pri bolnikih, starejših od 65 let), vendar ta sprememba ni klinično pomembna.
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Pri vseh bolnikih je prišlo do popolnega hematološkega odziva, do popolnega citogenetičnega odziva in/ali do popolnega molekularnega odziva.
The no observed effect level (NOEL) was 15 mg/kg/day.
Odmerek brez opaženega učinka (NOEL) je bil 15 mg/kg/dan.
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Navajali so izboljšanje na področju srca, živčevja, kože/podkožnega tkiva, dihalnega/torakalnega/mediastinalnega organskega sistema, mišičnoskeletnega/vezivnotkivnega/žilnega organskega sistema in prebavil.
When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Kadar so imatinib uporabljali v kombinaciji z visokoodmerno kemoterapevtsko shemo pri bolnikih s Ph+ ALL, je prišlo do prehodne toksičnosti za jetra v obliki zvišanja aminotransferaz in hiperbilirubinemije.
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).
Zaradi možnosti, da pride do sindroma tumorske lize, je pred začetkom zdravljenja z imatinibom priporočeno odpraviti klinično pomembno dehidriranost in visoko koncentracijo sečne kisline (glejte poglavje 4.8).
(24 h), days 1, 15;
(24 ur), 1., 15. dan;
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).
Pri bolnikih v 5. kohorti (n=50) je neprekinjena vsakodnevna izpostavljenost imatinibu zgodaj v poteku zdravljenja v kombinaciji s kemoterapijo povečala delež bolnikov s 4-letnim preživetjem brez dogodkov (EFSevent-free survival) v primerjavi z zgodovinskimi kontrolami (n=120), ki so prejemale standardno kemoterapijo brez imatiniba (69,6 % v primerjavi z 31,6 %).
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.
Kaže, da pri sočasni uporabi imatiniba s substrati CYP2D6 prilagajanje odmerkov ni potrebno, vendar pa je potrebna previdnost pri substratih CYP2D6 z ozkim terapevtskim oknom, kot je metoprolol.
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.
Pri enem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 400 mg, je prišlo do bruhanja, driske in anoreksije, pri drugem 3 leta starem dečku, ki je bil izpostavljen enkratnemu odmerku 980 mg, pa je prišlo do znižane koncentracije levkocitov in driske.
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.
Največje koncentracije imatiniba v plazmi bolnikov so 2-4 μmol/l, zato je možna inhibicija sočasno uporabljanih zdravil s presnovo, ki poteka preko CYP2D6 in/ali CYP3A4/5.
There is very limited experience in children with MDS/MPD and DFSP.
Izkušenj pri otrocih z MDS/MPD in DFSP je zelo malo.
• The active substance is imatinib (as mesilate).
• Učinkovina je imatinib (v obliki mesilata).
Very common: Headache Common:
glavobol pogosti:
Table 3 Chemotherapy regimen used in combination with imatinib
Preglednica 3 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Občasni (lahko prizadenejo do 1 bolnika od 100 bolnikov) ali redki (lahko prizadenejo do 1 bolnika od 1.000 bolnikov):
• Chronic myeloid leukaemia (CML) in blast crisis.
• s kronično mieloično levkemijo (KML) v blastni krizi.
There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
V obdobju trženja zdravila so poročali o spontanih splavih in prirojenih nepravilnostih pri dojenčkih mater, ki so med nosečnostjo prejemale zdravilo Imatinib medac.
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).
Imatinib je majhna molekula in je zaviralec proteinskih kinaz, ki močno zavira aktivnost Bcr-Abl tirozin-kinaze, pa tudi nekaj receptorskih tirozin-kinaz: pri receptorju Kit, ki je receptor za dejavnik matičnih celic (stem cell factor, SCF), ki ga kodira protoonkogen c-Kit, pri receptorjih za diskoidinsko domeno (DDR1 in DDR2), pri receptorju za kolonije stimulirajoči faktor (CSF-1R) in pri receptorjih za rastni faktor iz trombocitov alfa in beta (platelet-derived growth factor PDGFR-alfa in PDGFR-beta).
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.
Pri podganah so v 13-tedenski študiji pri odmerkih > 6 mg/kg našli hiperplazijo prehodnega epitela v ledvični papili in v sečnem mehurju, brez sprememb serumskih ali urinskih parametrov.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”.
Različne neželene reakcije, na primer plevralni izliv, ascites, pljučni edem in hitro naraščanje telesne mase, bodisi s površinskimi edemi bodisi brez njih, imenujemo s skupnim izrazom “retenca tekočine”.
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95 % on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Pri klinično pomembnih koncentracijah imatiniba je bila vezava na plazemske beljakovine na podlagi poskusov in vitro približno 95-odstotna, večina imatiniba se je vezala na albumine in kisli glikoprotein alfa, malo pa na lipoproteine.
What you need to know before you take Imatinib medac
Kaj morate vedeti, preden boste vzeli zdravilo Imatinib medac
The no observed effect level (NOEL) was 30 mg/kg/day.
Odmerek brez opaženega učinka (NOEL) je bil 30 mg/kg/dan.
Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
Imatinib se ni izkazal za genotoksičnega pri in vitro testiranju na bakterijskih celicah (Amesov test), in vitro testiranju na sesalskih celicah (mišji limfom) in in vivo podganjem mikronukleusnem testu.
Imatinib medac inhibits the growth of these cells.
Zdravilo Imatinib medac zavira rast teh celic.
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.).
Imatinib lahko zviša plazemske koncentracije drugih zdravil, ki jih presnavlja CYP3A4 (na primer triazolo-benzodiazepinov, dihidropiridinskih blokatorjev kalcijevih kanalčkov, nekaterih zaviralcev reduktaze HMG-CoA, tj. statinov, itn.).
When imatinib is co-administered with other medicinal products, there is a potential for drug interactions.
Ob sočasni uporabi imatiniba z drugimi zdravili obstaja možnost njihovega medsebojnega delovanja.
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Ker so občasno poročali o s srcem povezanih neželenih dogodkih z imatinibom, je treba pri populaciji bolnikov s HES/CEL pred uvedbo zdravljenja pretehtati razmerje med koristjo in tveganjem.
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• kašelj, težave z dihanjem ali bolečine pri dihanju (znaki težav s pljuči),
NAME OF THE MARKETING AUTHORISATION HOLDER medac GmbH
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM medac GmbH
• Chronic renal failure.
• kronična ledvična bolezen.
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.
Če je vaš dnevni odmerek 800 mg, morate vzeti 1 kapsulo po 400 mg zjutraj in 1 kapsulo po 400 mg zvečer.
Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
Vse faze zdravljenja morajo nadzorovati hematološki strokovnjaki za zdravljenje te bolezni.
Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Bolniki z blago, zmerno ali težko disfunkcijo jeter naj prejmejo najmanjši priporočeni odmerek 400 mg na dan.
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).
Očistek nevezane učinkovine je pri imatinibu verjetno podoben pri bolnikih z okvaro ledvic in pri tistih z normalnim delovanjem ledvic, saj predstavlja izločanje skozi ledvice manj pomemben način izločanja za imatinib (glejte poglavji 4.2 in 4.4).