natgillin/translations-raw huggingface dataset:
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.
Po korekciji zaradi telesne površine drugi demografski dejavniki, kot so starost, telesna masa in indeks telesne mase, niso klinično pomembno vplivali na izpostavljenost imatinibu.
• Dry mouth, dry skin or dry eye.
• suha usta, suha koža ali suhe oči,
Clinical studies in Ph+ ALL
Klinične študije pri Ph+ ALL
The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Varnost in učinkovitost imatiniba pri otrocih z MDS/MPD, DFSP in HES/CEL, starih manj kot 18 let, v kliničnih preskušanjih nista bili dokazani.
Pharmacotherapeutic group: protein kinase inhibitor, ATC code: L01XE01
Farmakoterapevtska skupina: zaviralec proteinskih kinaz, oznaka ATC: L01XE01
No histopathological changes were seen in rat liver.
V podganjih jetrih niso opazili histopatoloških sprememb.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in theagreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Treatment with imatinib may then be continued at a reduced daily dose.
Nato se lahko zdravljenje z imatinibom nadaljuje z zmanjšanim dnevnim odmerkom.
In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32 - 38 months).
Nedavno objavljeni dopolnjeni podatki za 6 od teh 11 bolnikov razkrivajo, da so vsi ti bolniki ostali v citogenetični remisiji (po 32 - 38 mesecih).
At the same dose, the number of stillborn pups as well as those dying between postpartum days 0 and 4 was increased.
Pri enakem odmerku se je povečalo število mrtvorojenih mladičev in tistih, ki so poginili med dnevoma 0 in 4 po skotitvi.
However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of imatinib.
Vendar so bili ti edemi redko težki in jih lahko zdravimo z diuretiki, drugimi podpornimi ukrepi ali z zmanjšanjem odmerka imatiniba.
One of these intermediates was also positive in the mouse lymphoma assay.
Eden od teh vmesnih produktov je bil pozitiven tudi v testu mišjega limfoma.
Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Popoln citogenetični odziv, potrjen z drugo citogenetično oceno kostnega mozga, opravljeno vsaj en mesec po prvi študiji kostnega mozga.
However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Vendar so nekatere od teh reakcij lahko resne ali smrtno nevarne.Več bolnikov z blastno krizo je namreč umrlo z zapleteno klinično anamnezo plevralnega izliva, kongestivnega popuščanja srca in ledvične odpovedi.
Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
Preverite, ali je citopenija povezana z levkemijo (aspirat ali biopsija kostnega mozga).
Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) in možno tveganje za plod ni znano.
At the time of analysis, the median treatment duration was 47 months (24 days - 60 months).
V času analize je bilo mediano trajanje zdravljenja 47 mesecev (24 dni - 60 mesecev).
• Imatinib medac is not recommended during pregnancy unless clearly necessary as it may harm your baby.
• Uporaba zdravila Imatinib medac v nosečnosti ni priporočena, če to ni nujno potrebno, saj lahko škoduje vašemu otroku.
Therefore, the use of imatinib in combination with other chemotherapeutic agents requires special precaution.
Zato je pri uporabi imatiniba v kombinaciji z drugimi kemoterapevtiki potrebna posebna previdnost.
The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Pri populaciji 211 bolnikov z novo odkrito Ph+ ALL iz štirih nekontroliranih kliničnih študij (AAU02, ADE04, AJP01 in AUS01) se rezultati ujemajo z zgoraj opisanimi.
A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Nadaljnjih 6 bolnikov z DFSP, zdravljenih z imatinibom, so opisali v 5 publikacijah opisov primera, njihova starost se je gibala med 18 meseci in 49 leti.
In the event of overdose, the patient should be observed and appropriate supportive treatment given.
V primeru prevelikega odmerjanja je treba bolnika opazovati in mu nuditi ustrezno podporno zdravljenje.
• The other ingredients are crospovidone (type A), lactose monohydrate, magnesium stearate.
• Druge sestavine zdravila so krospovidon (tip A), laktoza monohidrat, magnezijev stearat.
Clinical studies in HES/CEL
Klinične študije pri HES/CEL
These events can usually be managed with either a reduction of the dose or an interruption of treatment with imatinib, but can in rare cases lead to permanent discontinuation of treatment.
Ti dogodki se lahko odpravljajo bodisi z zmanjšanjem odmerka bodisi z začasno prekinitvijo zdravljenja z imatinibom, v redkih primerih pa so lahko razlog za trajno prekinitev zdravljenja.
Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Študije pri dveh doječih materah so pokazale, da se tako imatinib kot njegov aktivni presnovek pri človeku lahko izločata v materino mleko.
The complete molecular response rate was 48 % (49 out of 102 evaluable patients).
Delež bolnikov s popolnim molekularnim odzivom je bil 48 % (49 od 102 za oceno primernih bolnikov).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je na recept le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• Unexpected bleeding or bruising (when you have not hurt yourself).
• nepričakovana krvavitev ali modrica (ne da bi se prej poškodovali).
The effect of stopping treatment after the achievement of a complete cytogenetic response has not been investigated.
Učinek prekinitve zdravljenja po doseženem popolnem citogenetičnem odzivu ni raziskan.
There is limited experience in children and adolescents with Ph-positive ALL.
Izkušenj pri otrocih in mladostnikih s Ph-pozitivno ALL je malo.
These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Te reakcije lahko navadno zdravimo z začasno ukinitvijo imatiniba, z diuretiki in drugimi ustreznimi podpornimi negovalnimi ukrepi.
• Eye pain or deterioration in vision, bleeding in the eyes.
• bolečine v očeh ali poslabšanje vida, krvavitve v očeh,
Transformed CML is the stage of the disease after its progression from chronic phase to accelerated phase (AP) or blast crisis (BC).
Transformacija KML je stadij bolezni po napredovanju iz kronične faze v pospešeno fazo (AP) ali blastno krizo (BC).
GI and tumoural bleeding may be serious and sometimes fatal.
Krvavitve iz prebavil in tumorja so lahko resne in včasih življenje ogrožajoče.
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is >ULN)
AST: > ULN (lahko je normalna ali < ULN, če je celotni bilirubin >ULN)
Therapeutic indication
Terapevtska indikacija
The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Povprečno trajanje nevtropeničnih oziroma trombocitopeničnih epizod je bilo navadno 2-3 tedne oziroma 3-4 tedne.
Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Bolniki, ki se zdravijo z imatinibom in jih skrbi glede njihove plodnosti, naj se posvetujejo s svojim zdravnikom.
In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
Pri potomcih F1 se je pri enakem odmerku povprečna telesna masa zmanjšala od skotitve do terminalnega žrtvovanja, število mladičev, ki so dosegli kriterij za ločitev prepucija, pa se je rahlo zmanjšalo.
Blast crisis is defined as blasts ≥ 30 % in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Blastno krizo opredeljuje ≥ 30 % blastov v krvi ali kostnem mozgu ali ekstramedularna bolezen, ki ni hepatosplenomegalija.
20 out of the 50 (40 %) patients in cohort 5 received haematopoietic stem cell transplant.
20 od 50 bolnikov (40 %) v 5. kohorti so presadili krvotvorne matične celice.
• Women who might become pregnant are advised to use effective contraception during
• Ženskam, ki bi lahko zanosile, med zdravljenjem priporočamo uporabo učinkovite
Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Mieloidna blastna kriza: Vključili so 260 bolnikov z mieloidno blastno krizo.
BATCH NUMBER Lot:
ŠTEVILKA SERIJE Lot
Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
Reaktivacija hepatitisa B pri bolnikih, ki so kronični prenašalci tega virusa, se je pojavila, potem ko so ti bolniki prejeli zaviralce tirozinske kinaze BCR-ABL1.
In clinical trials in CML, discontinuation of the investigational medicinal product for treatment-related adverse reactions was observed in 2.4 % of newly diagnosed patients, 4 % of patients in late chronic phase after failure of interferon therapy, 4 % of patients in accelerated phase after failure of interferon therapy and 5 % of blast crisis patients after failure of interferon therapy.
V kliničnih preskušanjih pri KML so prekinitev dajanja raziskovanega zdravila zaradi neželenih učinkov, povezanih z zdravljenjem, zabeležili pri 2,4 % na novo diagnosticiranih bolnikov, 4 % bolnikov v pozni kronični fazi po neuspelem zdravljenju z interferonom, 4 % bolnikov v pospešeni fazi po neuspelem zdravljenju z interferonom in 5 % bolnikov v blastni krizi po neuspelem zdravljenju z interferonom.
The active substance imatinib demonstrates an environmental risk for sediment organisms.
Zdravilna učinkovina imatinib kaže okoljsko tveganje za sedimentne organizme.
If you take more Imatinib medac than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Če ste vzeli večji odmerek zdravila Imatinib medac, kot bi smeli Če ste pomotoma vzeli preveč kapsul, se nemudoma posvetujte s svojim zdravnikom.
• If you are a woman who is pregnant or might get pregnant and are trying to open the capsules for your children or another patient unable to swallow, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
• Če ste noseči ali bi lahko zanosili in odpirate kapsule za svoje otroke ali kakega drugega bolnika, ki ne more požirati, ravnajte pri odpiranju kapsule z vsebino pazljivo in se izogibajte stiku zdravila z očmi preko rok ali vdihavanju zdravila.
In study 0102 [ANC ≥ 1.5 x 10
V študiji 0102 [ANC ≥ 1,5 x 10
When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
Ko so podganje samice dobivale zdravilo 14 dni pred parjenjem in nato ves čas do 6. dne brejosti, ni bilo nikakršnega učinka na parjenje ali na število brejih samic.
8 g to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Odmerki od 8 g do 10 g (enkratni odmerki): opisovali so bruhanje in bolečine v prebavilih.
The doctor will tell you how many capsules of Imatinib medac to give to your child.
Zdravnik vam bo povedal, koliko kapsul zdravila Imatinib medac dajte svojemu otroku.
While you are taking Imatinib medac, your doctor will regularly check whether the medicine is working.
Med jemanjem zdravila Imatinib medac bo zdravnik redno spremljal, ali zdravilo deluje.
They may increase or decrease the effect of Imatinib medac, either leading to increased side effects or making Imatinib medac less effective.
Lahko povečajo ali zmanjšajo učinek zdravila Imatinib medac in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib medac.
Teratogenic effects included exencephaly or encephalocele, absent/reduced frontal and absent parietal bones.
Teratogeni učinki so obsegali eksencefalijo ali encefalokelo, odsotnost ali zmanjšanje frontalnih kosti ter odsotnost parietalnih kosti.
Accelerated phase is an intermediate phase among the chronic phase and the onset of the blast crisis; it is considered as the first manifestation of resistance to therapy.
Pospešena faza je vmesna faza med kronično fazo in nastopom blastne krize; velja za prvi znak odpornosti proti zdravljenju.
As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p = 0.01) and disease-free survival (p = 0.02).
Kot je bilo pričakovati glede na načrt študije, ni bilo nobene razlike v trajanju remisij, preživetju brez bolezni ali preživetju nasploh, čeprav so imeli bolniki s popolnim molekularnim odzivom in tisti z minimalno rezidualno boleznijo boljši izid glede trajanja remisije (p = 0,01) in preživetja brez bolezni (p = 0,02).
However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.
Vendar učinki izpostavljenosti dojenčka nizkim odmerkom imatiniba niso znani, zato ženske, ki jemljejo imatinib ne smejo dojiti.
Use in adults Your doctor will tell you exactly how many capsules of Imatinib medac to take.
Uporaba pri odraslih Zdravnik vam bo natančno povedal, koliko kapsul zdravila Imatinib medac morate jemati.
The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 l/h, while for a patient weighing 100 kg the clearance will rise to 11.8 l/h.
Vpliv telesne mase na očistek imatiniba je takšen, da je pri bolniku, ki tehta 50 kg, pričakovani povprečni očistek 8,5 l/h, pri bolniku, ki tehta 100 kg, pa se očistek poveča na 11,8 l/h.
Posology modification
Sprememba odmerjanja
Cytogenetic response criteria:
Kriteriji citogenetičnega odziva:
Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Sočasni uporabi rifampicina ali drugih močnih induktorjev CYP3A4 in imatiniba se je treba izogibati.
The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Mediani čas do napredovanja bolezni je bil pri vseh 411 bolnikih z relapsom/neodzivno Ph+ ALL v obsegu od 2,6 do 3,1 meseca, mediano preživetje nasploh pa je bilo pri 401 za oceno primernih bolnikov v obsegu od 4,9 do 9 mesecev.
DFSP (at dose 800 mg)
DFSP (ob odmerku 800 mg)
Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Za to indikacijo so izkušnje z imatinibom zelo omejene in temeljijo na hematološki in citogenetični odzivnosti.
The majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Večina bolnikov, ki je dosegla popolni citogenetični odziv, ga je dosegla med 3. in 10. mesecem z medianim časom do odziva 5,6 meseca glede na Kaplan-Meierjevo oceno.
95 (37 %) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63 %) had not (“untreated patients”).
95 bolnikov (37 %) je imelo predhodno kemoterapijo za zdravljenje bodisi pospešene faze bodisi blastne krize (»predhodno zdravljeni bolniki«), medtem ko 165 bolnikov (63 %) ni bilo predhodno zdravljenih (»nezdravljeni bolniki«).
Your doctor has prescribed Imatinib medac because you suffer from a serious condition.
Zdravnik vam je predpisal zdravilo Imatinib medac, ker imate resno bolezen.
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Ara-C: citozin arabinozid; CP: ciklofosfamid; DEX: deksametazon; MTX: metotreksat; 6-MP: 6-merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.
Imatinib can also inhibit cellular events mediated by activation of these receptor kinases.
Imatinib lahko zavira tudi celične dogodke, ki jih omogoča aktivacija navedenih receptorskih kinaz.
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Delovanje jeter (aminotransferaze, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo imatinib, redno spremljati.
Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1 % of CML patients.
Zaradi jetrnih laboratorijskih nenormalnosti so zdravljenje trajno prekinili pri manj kot 1 % bolnikov s KML.
Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Dolgotrajno zdravljenje z imatinibom je lahko povezano s klinično pomembnim zmanjšanjem ledvične funkcije.
Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Zato se je treba sočasni uporabi močnih induktorjev CYP3A4 in imatiniba izogibati (glejte poglavje 4.5).
This was a population of heavily pretreated patients, as 46 % had received prior BMT and 73 % a prior multi-agent chemotherapy.
To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom raziskave 46 % prejelo BMT, 73 % pa kemoterapijo z več zdravili.
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• nenadna oteklina in pordelost kože (znaki kožne okužbe z imenom flegmona (celulitis),
Imatinib and the N-demethyl metabolite together accounted for about 65 % of the circulating radioactivity (AUC(0-48h)).
Imatinib in N-demetilirani presnovek sta skupaj prispevala okrog 65 % radioaktivnosti v krvi (AUC(0-48h)).
The remaining circulating radioactivity consisted of a number of minor metabolites.
Preostalo radioaktivnost v krvi je tvorilo več manj pomembnih presnovkov.
Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Trajanje zdravljenja: V kliničnih preskušanjih so zdravljenje z imatinibom nadaljevali, dokler ni začela bolezen napredovati.
21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
21 bolnikov je prejemalo imatinib v odmerku 400 mg na dan, drugi 3 bolniki pa so prejemali nižje odmerke.
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.
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.
Superficial oedemas were a common finding in all studies and were described primarily as periorbital or lower limb oedemas.
Površinski edemi so bili v vseh študijah pogosti, opisali so jih predvsem kot periorbitalne ali kot edeme spodnjih udov.
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).
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).
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Če med uporabo imatiniba nastopi huda nehematološka neželena reakcija, je treba zdravljenje prekiniti, dokler reakcija ne izzveni.
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Razen za novo diagnosticirano KML v kronični fazi ni kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh bolezni.
The dose can be reduced if not tolerated.
Odmerek je mogoče zmanjšati, če ga bolnik ne prenaša dobro.
Experience with doses higher than the recommended therapeutic dose is limited.
Izkušenj z odmerki, večjimi od terapevtskih, ni veliko.
Three of the partial responders were subsequently rendered disease free by surgery.
Trije od bolnikov z delnim odzivom so bili naknadno kirurško ozdravljeni.
• Difficulty hearing.
• težave s sluhom,
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).
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).
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.
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.
If renal dysfunction is observed, appropriate management and treatment should be prescribed in accordance with standard treatment guidelines.
Če je ugotovljeno poslabšanje ledvične funkcije, je treba uvesti ustrezne ukrepe in predpisati zdravljenje v skladu s standardnimi smernicami zdravljenja.
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 %.
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.
In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših ljudeh in pri bolnikih z anamnezo bolezni srca.
When needed, discontinuation of imatinib treatment may be considered.
Če je treba, velja razmisliti o prekinitvi zdravljenja z zdravilom imatinib.
* These types of reactions have been reported mainly from post-marketing experience with imatinib.
* O teh vrstah neželenih učinkov so poročali večinoma v okviru izkušenj v obdobju trženja zdravila z zdravilom imatinib.