FrancophonIA/ELRC3.0 huggingface dataset:
English: Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Slovenian: Imatinib lahko zavira tudi celične dogodke, ki jih omogoča aktivacija navedenih receptorskih kinaz.
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Slovenian: Delovanje jeter (aminotransferaze, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo imatinib, redno spremljati.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Slovenian: Zaradi jetrnih laboratorijskih nenormalnosti so zdravljenje trajno prekinili pri manj kot 1 % bolnikov s KML.
English: Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Slovenian: Dolgotrajno zdravljenje z imatinibom je lahko povezano s klinično pomembnim zmanjšanjem ledvične funkcije.
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Slovenian: Zato se je treba sočasni uporabi močnih induktorjev CYP3A4 in imatiniba izogibati (glejte poglavje 4.5).
English: This was a population of heavily pretreated patients, as 46 % had received prior BMT and 73 % a prior multi-agent chemotherapy.
Slovenian: To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom raziskave 46 % prejelo BMT, 73 % pa kemoterapijo z več zdravili.
English: • Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
Slovenian: • nenadna oteklina in pordelost kože (znaki kožne okužbe z imenom flegmona (celulitis),
English: Imatinib and the N-demethyl metabolite together accounted for about 65 % of the circulating radioactivity (AUC(0-48h)).
Slovenian: Imatinib in N-demetilirani presnovek sta skupaj prispevala okrog 65 % radioaktivnosti v krvi (AUC(0-48h)).
English: The remaining circulating radioactivity consisted of a number of minor metabolites.
Slovenian: Preostalo radioaktivnost v krvi je tvorilo več manj pomembnih presnovkov.
English: Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Slovenian: Trajanje zdravljenja: V kliničnih preskušanjih so zdravljenje z imatinibom nadaljevali, dokler ni začela bolezen napredovati.
English: 21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
Slovenian: 21 bolnikov je prejemalo imatinib v odmerku 400 mg na dan, drugi 3 bolniki pa so prejemali nižje odmerke.
English: When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Slovenian: Ob konzervativni oceni, da gre pri bolnikih z manjkajočimi podatki za bolnike brez odgovora na zdravljenje, je bil CHR opažen pri 20/23 (87 %) bolnikov, CCyR pri 9/23 (39,1 %) bolnikov in MR pri 11/23 (47,8 %) bolnikov.
English: Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
Slovenian: Površinski edemi so bili v vseh študijah pogosti, opisali so jih predvsem kot periorbitalne ali kot edeme spodnjih udov.
English: This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p = 0.02).
Slovenian: Ta klinični učinek je bil povezan z večjim zmanjšanjem količine transkriptov bcr-abl pri bolnikih, zdravljenih z imatinibom, kot pri skupini, zdravljeni s kemoterapijo po 2 tednih zdravljenja (p = 0,02).
English: If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Slovenian: Če med uporabo imatiniba nastopi huda nehematološka neželena reakcija, je treba zdravljenje prekiniti, dokler reakcija ne izzveni.
English: Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Slovenian: Razen za novo diagnosticirano KML v kronični fazi ni kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh bolezni.
English: The dose can be reduced if not tolerated.
Slovenian: Odmerek je mogoče zmanjšati, če ga bolnik ne prenaša dobro.
English: Experience with doses higher than the recommended therapeutic dose is limited.
Slovenian: Izkušenj z odmerki, večjimi od terapevtskih, ni veliko.
English: Three of the partial responders were subsequently rendered disease free by surgery.
Slovenian: Trije od bolnikov z delnim odzivom so bili naknadno kirurško ozdravljeni.
English: • Difficulty hearing.
Slovenian: • težave s sluhom,
English: Paediatric use: 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).
Slovenian: Uporaba v pediatriji: Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
English: The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Slovenian: Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije (tj., izginotje blastov iz kostnega mozga in krvi, a brez popolnega okrevanja periferne krvi kot pri popolnem odzivu) ali kot vrnitev v kronično fazo KML.
English: If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines.
Slovenian: Če je ugotovljeno poslabšanje ledvične funkcije, je treba uvesti ustrezne ukrepe in predpisati zdravljenje v skladu s standardnimi smernicami zdravljenja.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44 %) and 3 (33 %) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77 %.
Slovenian: Od 9 bolnikov s kronično fazo KML in razpoložljivimi citogenetičnimi podatki so 4 (44 %) in 3 (33 %) bolniki dosegli popolni oziroma delni citogenetični odziv pri 77-odstotni stopnji MCyR.
English: In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Slovenian: V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših ljudeh in pri bolnikih z anamnezo bolezni srca.
English: When needed, discontinuation of imatinib treatment may be considered.
Slovenian: Če je treba, velja razmisliti o prekinitvi zdravljenja z zdravilom imatinib.
English: * These types of reactions have been reported mainly from post-marketing experience with imatinib.
Slovenian: * O teh vrstah neželenih učinkov so poročali večinoma v okviru izkušenj v obdobju trženja zdravila z zdravilom imatinib.
English: Patients with advanced stages of malignancies may have numerous confounding medical conditions that make causality of adverse reactions difficult to assess due to the variety of symptoms related to the underlying disease, its progression, and the co-administration of numerous medicinal products.
Slovenian: Bolniki z napredovalimi oblikami raka imajo lahko številna spremljajoča zdravstvena stanja, zaradi katerih je pojav neželenih učinkov težko oceniti zaradi različnih simptomov, ki so povezani z osnovno boleznijo, njenim napredovanjem in sočasnim zdravljenjem s številnimi zdravili.
English: Name and address of the manufacturers responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a
Slovenian: • upočasnjena rast pri otrocih in mladostnikih, • ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold accumulation after repeated once-daily dosing.
Slovenian: Primerjava AUC(0-24) 8. dne in 1. dne ob odmerku 340 mg/m² je pokazala 1,7-kratno kopičenje zdravila po ponavljajočem se odmerjanju enkrat na dan.
English: Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Slovenian: Od 12 vključenih bolnikov je do odziva prišlo pri 9 bolnikih, pri enem do popolnega in pri 8 do delnega.
English: Clinical studies in chronic myeloid leukaemia
Slovenian: Klinične študije pri kronični mieloični levkemiji
English: Unchanged imatinib accounted for 25 % of the dose (5 % urine, 20 % faeces), the remainder being metabolites.
Slovenian: Nespremenjeni imatinib je predstavljal 25 % odmerka (5 % v urinu, 20 % v blatu), preostanek pa so predstavljali presnovki.
English: Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Slovenian: Zdravljenje mora začeti zdravnik, izkušen v zdravljenju bolnikov s hematološkimi malignimi boleznimi oziroma z malignimi sarkomi.
English: In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
Slovenian: Pri bolnikih z disfunkcijo jeter (blago, zmerno ali težko) je treba skrbno spremljati periferno krvno sliko in jetrne encime (glejte poglavja 4.2, 4.8 in 5.2).
English: Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Slovenian: Imatinib in njegovi presnovki se skozi ledvice ne izločajo v pomembni meri.
English: 9/l, no blood blasts, BM blasts < 5 % and no extramedullary disease] NEL: Same criteria as for CHR but ANC ≥ 1 x 10
Slovenian: 9/l, brez blastov v krvi, BM blasti < 5 % in brez obolelosti zunaj kostnega mozga] NEL: enaki kriteriji kot za CHR, a ANC ≥ 1 x 10
English: Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to imatinib exposure.
Slovenian: Ker so o teh neželenih učinkih poročali pri bolnikih iz populacij nedoločljive velikosti, ni vedno mogoče zanesljivo določiti pogostnosti teh neželenih učinkov oziroma ugotoviti njihove vzročne povezave z izpostavljenostjo imatinibu.
English: Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Slovenian: Čeprav so rezultati farmakokinetične analize pokazali, da so razlike med posamezniki precejšnje, se povprečna izpostavljenost imatinibu pri bolnikih z različnimi stopnjami disfunkcije jeter v primerjavi z bolniki z normalno funkcijo jeter ni povečala (glejte poglavja 4.2, 4.4 in 4.8).
English: Renal function should, therefore, be evaluated prior to the start of imatinib therapy and closely monitored during therapy, with particular attention to those patients exhibiting risk factors for renal dysfunction.
Slovenian: Delovanje ledvic je zato treba oceniti pred začetkom zdravljenja z imatinibom in ga nato skrbno spremljati tekom zdravljenja, še posebno pozorno je treba spremljati bolnike z dejavniki tveganja za poslabšanje ledvične funkcije.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Slovenian: V isti publikaciji poročajo o podatkih z dolgoročnih kontrolnih pregledov za 12 bolnikov z MDS/MPD s preureditvijo gena za PDGFR (5 bolnikov iz študije B2225).
English: The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65 % which is comparable to the results observed in adults.
Slovenian: Ob veliki stopnji popolnega hematološkega odziva je prišlo tudi do popolnega citogenetičnega odziva (CCyR) v 65 %, kar je primerljivo z zabeleženimi rezultati pri odraslih.
English: 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.
Slovenian: Konstitutivna aktivacija receptorja za rastni faktor iz trombocitov, ali Abl protein-tirozin-kinaze kot posledica združitve različnih sodelujočih proteinov ali konstitutivna tvorba PDGF sta vpleteni v patogenezo MDS/MPD, HES/CEL in DFSP.
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Slovenian: FIP1L1-PDGFRα pozitivni so bili še štirje bolniki s HES, ki so jih opisovali v drugih 3 objavljenih poročilih.
English: • Numb or cold toes and fingers (signs of Raynaud's syndrome).
Slovenian: • otrpli ali hladni prsti (znaki Raynaudovega sindroma),
English: There are limited data on the use of imatinib in pregnant women.
Slovenian: Podatki o uporabi imatiniba pri nosečnicah so omejeni.
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 10
Slovenian: Če citopenija vztraja 4 tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1 x 10
English: • If you are being treated for HES/CEL:
Slovenian: • Če se zdravite zaradi HES/CEL:
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Slovenian: Gre za približno 1,5- do 2-kratno zvišanje, ki ustreza 1,5-kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
English: Imatinib medac is a medicine containing an active substance called imatinib.
Slovenian: Imatinib medac je zdravilo, ki vsebuje zdravilno učinkovino z imenom imatinib.
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Slovenian: Če se delež odziva izračuna pri bolnikih z vsaj eno veljavno oceno je delež odziva 20/22 (90,9 %) za CHR, 9/9 (100 %) za CCyR in 11/17 (64,7 %) za MR.
English: Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
Slovenian: Zdravljenje lahko poteka v obliki enega samega dnevnega odmerka ali pa dnevni odmerek razdelimo na dva - enega zjutraj in enega zvečer.
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Slovenian: Odmerek brez opaženega učinka (NOEL) tako na samice-matere kot na generacijo F1 je bil 15 mg/kg/dan (ena četrtina največjega odmerka za človeka, ki je 800 mg).
English: 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.
Slovenian: Vaš zdravnik se lahko odloči za zvišanje odmerka na 400 mg, kar vzamete kot 1 kapsulo po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.
English: Thyroid-stimulating hormone (TSH) levels should be closely monitored in such patients.
Slovenian: Pri takih bolnikih je treba skrbno spremljati vrednosti tiroideo stimulirajočega hormona (TSH).
English: 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).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z imatinibom za vse skupine pediatrične populacije s kronično mieloično levkemijo s prisotnim kromosomom Philadelphia (s translokacijo bcr-abl) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: There is no experience in children with CML below 2 years of age.
Slovenian: Izkušenj pri otrocih s KML, mlajših od 2 let, ni.
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Slovenian: 23 bolnikov, ki so bili vključeni v register, je prejemalo zdravilo Imatinib medac z mediano dnevnega odmerka 264 mg (v razponu od 100 do 400 mg) in z mediano trajanja zdravljenja 7,2 leti (v razponu od 0,1 do 12,7 leta).
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia
Slovenian: herpes zoster, herpes simpleks, nazofaringitis, pljučnica
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg capsule (not divisible) is available.
Slovenian: Za 400-miligramske in večje odmerke (glejte priporočila za odmerjanje spodaj) je na voljo 400-miligramska (nedeljiva) kapsula.
English: No patient developed grade 4 thrombocytopenia.
Slovenian: Pri nobenem bolniku se ni razvila trombocitopenija 4. stopnje.
English: imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78 % after 8 weeks of therapy.
Slovenian: Zdravljenje z imatinibom povzroči hiter odziv pri na novo diagnosticiranih pediatričnih bolnikih z 78 % popolnim hematološkim odzivom po 8 tednih zdravljenja.
English: There have been cases of cytolytic and cholestatic hepatitis and hepatic failure; in some of them outcome was fatal, including one patient on high dose paracetamol.
Slovenian: Nekaj je bilo primerov citolitičnega in holestatičnega hepatitisa in odpovedi jeter, nekateri primeri so se končali s smrtjo, vključno z enim bolnikom, ki je jemal velike odmerke paracetamola.
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8 %) out of 11 achieving a complete haematological response.
Slovenian: Ko so imatinib uporabili kot reševalno zdravljenje pri bolnikih, pri katerih ni bilo odziva ali pa je bil odziv na kemoterapijo slab, je 9 bolnikov od 11 (81,8 %) doseglo popolni hematološki odziv.
English: Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Slovenian: prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev Vse terapevtske sheme vključujejo aplikacijo kortikosteroidov za zaščito centralnega živčnega sistema.
English: There is no experience in children or adolescents with HES/CEL.
Slovenian: Pri otrocih ali mladostnikih s HES/CEL ni izkušenj.
English: • CML in the chronic phase after failure of interferon-alpha therapy, or in the accelerated phase.
Slovenian: • s KML v kronični fazi, potem ko odpove zdravljenje z interferonom alfa, ali v pospešeni fazi.
English: Imatinib medac inhibits the growth of these cells in a certain subtype of these diseases.
Slovenian: Zdravilo Imatinib medac zavira rast teh celic pri določenih podskupinah teh bolezni.
English: HES/CEL (starting dose 100 mg)
Slovenian: HES/CEL (začetni odmerek 100 mg)
English: Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Slovenian: Trajanje zdravljenja: V edinem do zdaj izvedenem kliničnem preskušanju so zdravljenje z imatinibom nadaljevali do napredovanja bolezni (glejte poglavje 5.1).
English: Do not store above 30 ºC.
Slovenian: Shranjujte pri temperaturi do 30 °C.
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Slovenian: Neželeni učinki, o katerih so poročali več kot enkrat, so navedeni spodaj po organskih sistemih in po pogostnosti.
English: The plasma AUC for this metabolite was found to be only 16 % of the AUC for imatinib.
Slovenian: Ugotovili so, da je plazemska AUC tega presnovka samo 16 % AUC imatiniba.
English: Imatinib medac will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Slovenian: Zdravilo Imatinib medac vam lahko predpiše samo zdravnik, ki ima izkušnje z zdravili za zdravljenje krvnih rakov in solidnih tumorjev.
English: • Unusual hair loss or thinning.
Slovenian: • neobičajno izpadanje ali tanjšanje las,
English: Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Slovenian: pospešena faza KML in blastna kriza in Ph+ ALL (začetni odmerek 600 mg)
English: Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Slovenian: Insuficienca jeter: Imatinib se presnavlja predvsem v jetrih.
English: What Imatinib medac is and what it is used for What you need to know before you take Imatinib medac
Slovenian: Kaj je zdravilo Imatinib medac in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Imatinib medac
English: In GIST patients (study B2222), 6.8 % of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8 % of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Slovenian: Pri bolnikih z GIST (študija B2222) so dvig vrednosti ALT (alanin aminotransferaze) 3. oziroma 4. stopnje opazili pri 6,8 % bolnikov ter dvig vrednosti AST (aspartat aminotransferaze) 3. oziroma 4. stopnje pri 4,8 % bolnikov.
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5
Slovenian: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5 Str. 95-200 Pabianice
English: MARKETING AUTHORISATION NUMBER (S) EU/1/13/876/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/876/001
English: In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m
Slovenian: Poleg tega so pri mladih živalih (okrog faze odstavljanja od prsi) opazili smrtnost pri izpostavljenosti, približno dvakrat večji od povprečne pediatrične izpostavljenosti, pri največjem priporočenem odmerku 340 mg/m².
English: 9/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).
Slovenian: 9/l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
English: • Patients who are concerned about their fertility while taking Imatinib medac are advised to
Slovenian: • Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Imatinib medac, naj
English: Grade 3 and 4 neutropenia was seen in 7.5 % and 2.7 % of patients, respectively, and grade 3 thrombocytopenia in 0.7 % of patients.
Slovenian: Nevtropenijo 3. oziroma 4. stopnje so opazili pri 7,5 % oziroma 2,7 % bolnikov, trombocitopenijo 3. stopnje pa pri 0,7 % bolnikov.
English: Metabolism of imatinib is mainly hepatic, and only 13 % of excretion is through the kidneys.
Slovenian: Presnova imatiniba poteka predvsem v jetrih in le 13 % zdravila se izloča skozi ledvice.
English: The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Slovenian: Celotni dnevni odmerek pri otrocih in mladostnikih ne sme preseči 800 mg pri KML in 600 mg pri Ph-pozitivni ALL.
English: The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Slovenian: Poglavitni po krvi krožeči presnovek pri ljudeh je N-demetilirani piperazinov derivat, ki kaže podobno potenco in vitro kot sama učinkovina.