natgillin/translations-raw huggingface dataset:
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 Actavis because you suffer from a serious condition.
Zdravnik vam je predpisal zdravilo Imatinib Actavis, ker imate resno bolezen.
The overall survival is 65 months since diagnosis (range 25-234).
Celotno preživetje je 65 mesecev od postavitve diagnoze (od 25 do 234 mesecev).
This clinical effect was associated with a higher reduction in bcrabl 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).
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving imatinib.
Delovanje jeter (aminotransferaza, bilirubin, alkalna fosfataza) je treba pri bolnikih, ki dobivajo imatinib, redno spremljati.
of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
Return to chronic phase (RTC) Major cytogenetic response2
vrnitev v kronično fazo (RTC) Pomemben citogenetični odziv2
* 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 Actavis.
This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
To so lahko znaki poškodbe krvnih žil, znani kot trombotična mikroangiopatija.
- Unusual hair loss or thinning.
- neobičajno izpadanje ali tanjšanje las,
Consolidation therapy I, III, V
Dan konsolidacijska terapija I, III, V
- if you are allergic to imatinib, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na imatinib, sojo, arašide ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
How much Imatinib Actavis to take Use in adults
Koliko zdravila Imatinib Actavis jemati Uporaba pri odraslih
The suspension should be administered immediately after complete disintegration of the tablet(s).
Suspenzijo je treba zaužiti takoj, ko se tableta (tablete) popolnoma razkroji (razkrojijo).
- Blood clots in small blood vessels (thrombotic microangiopathy).
- krvni strdki v majhnih krvnih žilah (trombotična mikroangiopatija).
Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki - 34.7 µM).
Imatinib ni oviral biotransformacije 5-fluorouracila, je pa zaviral presnovo paklitaksela zaradi kompetitivne inhibicije CYP2C8 (Ki = 34,7 μM).
Contains lecithin (soya) (E322).
Vsebuje sojin lecitin (E322).
If this applies to you, tell your doctor without taking Imatinib Actavis.
Če to velja za vas, povejte zdravniku in ne jemljite zdravila Imatinib Actavis.
- Unexpected bleeding or bruising (when you have not hurt yourself).
- nepričakovana krvavitev ali modrica (ne da bi se prej poškodovali).
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.
Table 4 Chemotherapy regimen used in combination with imatinib in study I2301
Preglednica 4 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom v študiji I2301
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).
Pri bolnikih z disfunkcijo jeter (blago, zmerno ali hudo) je treba skrbno spremljati periferno krvno sliko in jetrne encime (glejte poglavja 4.2, 4.8 in 5.2).
8 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 score line is not intended for breaking the tablet.
Zareza ni namenjena lomljenju tablet.
In children and adolescents, Imatinib Actavis can be used in different phases of the disease (chronic, accelerated phase and blast crisis).
Pri otrocih in mladostnikih se lahko zdravilo uporablja za zdravljenje različnih faz te bolezni (kronično, pospešeno fazo in blastno krizo).
They may increase or decrease the effect of Imatinib Actavis, either leading to increased side effects or making Imatinib Actavis less effective.
Lahko povečajo ali zmanjšajo učinek zdravila Imatinib Actavis in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib Actavis.
- Women who might become pregnant are advised to use effective contraception during treatment.
- Ženskam, ki bi lahko zanosile, med zdravljenjem priporočamo uporabo učinkovite kontracepcijske metode.
- Swallow the tablets whole with a large glass of water.
- Tablete pogoltnite cele z velikim kozarcem vode.
Your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Vaš zdravnik vam lahko zdravnik predpiše večji ali manjši odmerek, odvisno od tega, kako se odzivate na zdravljenje.
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.
Bolniki z napredovalimi stadiji malignih bolezni imajo lahko številna sočasna medicinska stanja, ki lahko zakrijejo in ovirajo oceno vzročnosti neželenih reakcij zaradi različnih simptomov, povezanih z osnovno boleznijo, njenim napredovanjem in sočasnim dajanjem številnih zdravil.
2 Headache was the most common in GIST patients.
2 Glavobol je bil najpogostejši pri bolnikih z GIST.
In clinical trials, there was an increased incidence of these events in elderly patients and those with a prior history of cardiac disease.
V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših bolnikih in pri bolnikih z anamnezo bolezni srca.
There are limited data on the use of imatinib in pregnant women.
Podatkov o uporabi imatiniba pri nosečnicah je malo.
- If you are being treated for MDS/MPD:
- Če se zdravite zaradi MDS/MPD:
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
Upoštevati je treba, da imajo lahko bolniki z GIST metastaze v jetrih, ki lahko povzročijo okvaro jeter.
Table 3 Chemotherapy regimen used in combination with imatinib Study ADE10
Preglednica 3 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom Študija ADE10
- If you are being treated for DFSP:
- Če se zdravite zaradi DFSP:
- Imatinib Actavis is not recommended during pregnancy unless clearly necessary as it may harm your baby.
- Uporabe zdravila Imatinib Actavis v nosečnosti ne priporočamo, če to ni nujno potrebno, saj lahko škoduje vašemu otroku.
(24 h), day 4;
(24 ur), 4. dan;
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 drug accumulation after repeated once-daily dosing.
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.
Imatinib Actavis inhibits the growth of these cells in a certain subtype of these diseases.
Zdravilo Imatinib Actavis zavira rast teh celic pri določenih podskupinah teh bolezni.
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.
Ob veliki stopnji popolnega hematološkega odziva je prišlo tudi do popolnega citogenetičnega odziva (CCyR - complete cytogenetic response) v 65 %, kar je primerljivo z zabeleženimi rezultati pri odraslih.
Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Na podlagi razpoložljivih podatkov niso ugotovili nikakršnih predispozicijskih dejavnikov (na primer velikost tumorja, lokacija tumorja, motnje koagulacije), ki bi pri bolnikih z GIST povečali tveganje katere od teh dveh vrst krvavitev.
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).
23 bolnikov, ki so bili vključeni v register, je prejemalo imatinib 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).
Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
Nespremenjeni imatinib je predstavljal 25 % odmerka (5 % v urinu, 20 % v blatu), preostanek pa so predstavljali presnovki.
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.
Pri bolnikih z GIST (študija B2222) so ugotovili 6,8 % zvišanj ALT (alanin-aminotransferaza) stopnje 3 ali 4 in 4,8 % zvišanj AST (aspartat-aminotransferaza) stopnje 3 ali 4.
- If you are being treated for CML:
- Če se zdravite zaradi KML:
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: 6merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost, dojenje in plodnost - Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
The effect of prior gastrointestinal surgery on drug absorption has not been investigated.
Učinka predhodne operacije prebavil na absorpcijo zdravila niso raziskali.
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.
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.
For adult patients with relapsed or refractory Ph+ALL imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Za odrasle bolnike z relapsom ali neodzivno Ph+ ALL je zdravilo Imatinib Actavis kot monoterapija v odmerku 600 mg/dan varno in učinkovito ter ga lahko prejemajo dokler ne pride do napredovanja bolezni.
NEL Same criteria as for CHR but ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB,
NEL enaki kriteriji kot za CHR, a ANC ≥ 1 x 109/L in trombociti ≥ 20 x 109/L RTC < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v
Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
- adult patients with Ph+ CML in blast crisis.
- odraslih bolnikov s Ph+ KML v blastni krizi.
Tell your doctor straight away if you get any of the following:
takoj obvestite zdravnika:
The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Ocenjen delež bolnikov s 4-letnim celokupnim preživetjem (OS - overall survival) v 5. kohorti je bil 83,6 % v primerjavi s 44,8 % pri zgodovinskih kontrolah.
What Imatinib Actavis is and what it is used for What you need to know before you take Imatinib Actavis How to take Imatinib Actavis Possible side effects
Kaj je zdravilo Imatinib Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Actavis Kako jemati zdravilo Imatinib Actavis
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).
Pediatrična uporaba: Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
- paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
- pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa, ali v pospešeni fazi ali blastni krizi.
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE01
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Pri mnogih od teh živali sta se zvišala dušik sečnine v krvi (BUN - blood urea nitrogen) in kreatinin.
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.
Rezultati analize potrjujejo, da je pri pediatričnih bolnikih, ki prejemajo 260 mg/m2 enkrat na dan (pri čemer odmerek ne presega 400 mg na dan) ali 340 mg/m2 enkrat na dan (pri čemer odmerek ne presega 600 mg na dan) izpostavljenost imatinibu podobna kot pri odraslih bolnikih, ki prejemajo imatinib v odmerkih 400 mg oziroma 600 mg enkrat na dan.
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Actavis should not be resumed.
primeru, da je koncentracija protiteles proti ADAMTS13 zvišana, aktivnost ADAMTS13 pa nizka, se zdravljenja z zdravilom Imatinib Actavis ne sme nadaljevati.
If you have accidentally taken too many tablets, talk to your doctor straight away.
Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
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 škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3), možno tveganje za plod pa ni znano.
MDS/MPD (starting dose 400 mg)
MDS/MPD (začetni odmerek 400 mg)
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Pri GIST so preskušano zdravilo ukinili zaradi neželenih reakcij, povezanih z zdravilom, pri 4 % bolnikov.
It is important that you do this as long as your doctor or pharmacist tells you to.
Pomembno je, da zdravilo jemljete tako dolgo, kot vam naroči zdravnik ali farmacevt.
Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Presnova imatiniba poteka predvsem v jetrih in le 13 % imatiniba se izloča skozi ledvice.
Thyroid stimulating hormone (TSH) levels should be closely monitored in such patients.
Pri takih bolnikih je treba skrbno spremljati vrednosti tiroideo stimulirajočega hormona (TSH).
In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3).
Predklinične študije niso pokazale vpliva na plodnost pri podganjih samcih in samicah (glejte poglavje 5.3).
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Bolnikom, ki ne morejo pogoltniti filmsko obloženih tablet, lahko tablete raztopimo v kozarcu navadne vode ali jabolčnega soka.
Imatinib Actavis will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Zdravilo Imatinib Actavis vam lahko predpiše samo zdravnik, ki ima izkušnje z zdravili za zdravljenje krvnih rakov ali solidnih tumorjev.
Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
Pri seštevku koncentracij imatiniba in njegovega presnovka je pri največji zaužiti količini materinega mleka na dan mogoče pričakovati nizko skupno izpostavljenost dojenčka zdravilu in presnovku (~10 % terapevtskega odmerka).
Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Imatinib je zaviralec protein-tirozin-kinaze, ki močno zavira Bcr-Abl tirozin-kinazo na in vitro, celični in in vivo ravni.
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.
14 dni pred parjenjem in nato ves čas do 6. dne brejosti, ni bilo nikakršnega učinka na parjenje ali na število brejih samic.
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.
Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Zdravljenje z zdravilom Imatinib Actavis povzroči hiter odziv pri na novo diagnosticiranih pediatričnih bolnikih s popolnim hematološkim odzivom 78 % po 8 tednih zdravljenja.
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).
Odmerek brez opaženega učinka (NOEL - no observed effect level) tako na samice-matere kot na generacijo F1 je bil 15 mg/kg/dan (ena četrtina največjega odmerka za človeka, ki je 800 mg).
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.
HES/CEL (at dose 400 mg)
HES/CEL (pri odmerku 400 mg)
Imatinib Actavis is a medicine containing an active substance called imatinib.
Imatinib Actavis je zdravilo, ki vsebuje zdravilno učinkovino z imenom imatinib.
Imatinib Actavis is indicated for - the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
Zdravilo Imatinib Actavis je indicirano za - zdravljenje odraslih bolnikov z neresektabilnim protuberantnim dermatofibrosarkomom (DFSP dermatofibrosarcoma protuberans) in tistih odraslih bolnikov z rekurentnim in/ali metastatskim DFSP, ki niso primerni za operacijo.
Non-haematological adverse reactions
Hematološke neželene reakcije
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 majhna molekula in je zaviralec protein-tirozin-kinaze, ki močno zavira aktivnost Bcr-Abl tirozin-kinaze, pa tudi nekaj receptorskih tirozin-kinaz: pri receptorju Kit, ki je receptor za dejavnik matičnih celic (SCF - stem cell factor), 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 (PDGFR-alfa in PDGFR-beta - platelet-derived growth factor receptors).
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).
Bolniki so bili zdravljeni z odmerki imatiniba 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9), 440 mg/m2/dan (n=7) in 570 mg/m2/dan (n=5).
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Trajanje zdravljenja: V edinem do zdaj izvedenem kliničnem preskušanju so zdravljenje z zdravilom Imatinib Actavis nadaljevali do napredovanja bolezni (glejte poglavje 5.1).
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) v plazmi, proteina, ki veže imatinib.
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Če so imanitib dajali z zelo mastnim obrokom, se je obseg njegove absorpcije minimalno zmanjšal (Cmax se je zmanjšala za 11 %, tmax pa se je podaljšal za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
V študiji pri bolnikih z neresektabilnimi in/ali metastatskimi GIST je imelo 7 (5 %) bolnikov gastrointestinalne krvavitve CTC stopnje 3/4 (3 bolniki), intratumorske krvavitve (3 bolniki) ali obe vrsti krvavitev (1 bolnik).
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
Close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).
Pri otrocih, ki prejemajo imatinib, je priporočeno natančno spremljanje njihove rasti (glejte poglavje 4.8).
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
Nehematološke neželene reakcije Če med uporabo imatiniba nastopi huda nehematološka neželena reakcija, je treba zdravljenje prekiniti, dokler reakcija ne izzveni.
Myelodysplastic/myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Mielodisplastične/mieloproliferativne bolezni s preureditvijo gena za PDGFR so lahko povezane z velikimi koncentracijami eozinofilcev.
Patients with mild, moderate or severe liver dysfunction should be given the minimum recommended dose of 400 mg daily.
Bolniki z blago, zmerno ali hudo disfunkcijo jeter naj prejmejo najmanjši priporočeni odmerek 400 mg na dan.
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Izkušenj z uporabo zdravila Imatinib Actavis pri bolnikih MDS/MPD v povezavi s preureditvijo genov za PDGFR je malo (glejte poglavje 5.1).
One blister contains 10 capsules.
En pretisni omot vsebuje 10 kapsul.