FrancophonIA/ELRC3.0 huggingface dataset:
English: The free drug clearance of imatinib is probably similar between 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).
Slovenian: 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).
English: - Do not breast-feed during the treatment with Imatinib Accord.
Slovenian: - Med zdravljenjem z zdravilom Imatinib Accord ne dojite.
English: In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Slovenian: V študiji toksičnih učinkov na razvoj mladičev so opažali vpliv na rast ter zakasnjeno odpiranje nožnice in ločevanje prepucija pri izpostavljenosti, ki ustreza približno 0,3 do 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo najvišji priporočeni odmerek 340 mg/m2.
English: 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.
Slovenian: Od skupine možnih zdravil za sočasno uporabo (paracetamol, 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.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Slovenian: Adenome/karcinome ledvic, papilome sečnega mehurja in sečnice, adenokarcinome tankega črevesa, adenome obščitničnih žlez, benigne in maligne medularne tumorje nadlevičnih žlez in papilome/karcinome ne-žleznega dela želodca so opazili pri odmerku 60 mg/kg/dan, kar predstavlja približno 1,7 do 1-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan in 1,2-kratnik dnevne izpostavljenosti otrok in mladostnikov (na podlagi AUC) pri 340 mg/m2/dan.
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Slovenian: Papilome/karcinome prepucijske/klitorisne žleze so opazili pri odmerkih od 30 mg/kg/dan naprej, kar predstavlja približno 0,5-kratnik oziroma 0,3-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan, in 0,4-kratnik dnevne izpostavljenosti otrok in mladostnikov (na podlagi AUC) pri 340 mg/m2/dan.
English: Studies on patients receiving Imatinib Accord and its effect on fertility and gametogenesis have not been performed.
Slovenian: Pri ljudeh niso opravili študij z bolniki, ki prejemajo imatinib, da bi preučili vpliv zdravila na plodnost in na gametogenezo.
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 zdravljenju KML in 600 mg pri zdravljenju Ph pozitivne ALL.
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/m2.
Slovenian: Pri mladih živalih (okrog obdobja odstavljanja) so opažali tudi povečano smrtnost pri približno 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo najvišji priporočeni odmerek 340 mg/m2.
English: (0.5 h), days 7, 8, 14, 15; CP 500 mg/ m2 i.v.
Slovenian: (0,5 ur), 7., 8., 14., 15. dan; CP 500 mg/m2 i.v.
English: Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Slovenian: Povečanje odmerka s 400 mg na 600 mg ali 800 mg pri bolnikih s kronično fazo bolezni ali s 600 mg na največ 800 mg (odmerjanih po 400 mg dvakrat na dan) pri bolnikih v pospešeni ali v blastni krizi lahko pride v poštev, če bolnik nima hude neželene reakcije na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja; odsotnost citogenetičnega odziva po 12 mesecih zdravljenja; ali izguba že prej doseženega hematološkega in/ali citogenetičnega odziva.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59), respectively.
Slovenian: Hematološki odzivi so ostali enaki mediano 49 mesecev (od 19 do 60), citogenetični odzivi pa 47 mesecev (od 16 do 59).
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/ m2 i.v.
Slovenian: DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m2 i.v.
English: Some medicines can interfere with the effect of Imatinib Accord when taken together.
Slovenian: Nekatera zdravila lahko ob sočasnem jemanju vplivajo na delovanje zdravila Imatinib Accord.
English: • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Slovenian: • odraslih bolnikov z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD) v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFR - platelet derived growth factor receptor);
English: Disease-free survival (DFS) and overall survival (OS) constantly exceeded 1 year and were superior to historical control (DFS p<0.001; OS p<0.0001) in two studies (AJP01 and AUS01).
Slovenian: V dveh študijah (AJP01 in AUS01) sta preživetje brez bolezni (DSFdisease-free survival) in celokupno preživetje (OS - overall survival) pogosto presegala 1 leto in sta bila daljša kot pri zgodovinskih kontrolah (DFS p<0,001; OS p<0,0001).
English: The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Slovenian: Pediatrični bolniki so prejemali po 400 mg/m2/dan, kasneje pa zvečan odmerek 520 mg/m2/dan.
English: Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo9, artralgijo in bolečinami v kosteh10
English: There is no experience in children and adolescents with CML below 2 years of age.
Slovenian: Izkušenj pri otrocih s KML, mlajših od 2 let, ni.
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Slovenian: Imatinib je tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF-plateletderived growth factor), PDGF-R in zavira celične dogodke, ki jih posreduje PDGF.
English: • Chronic renal failure
Slovenian: • kronična odpoved ledvic.
English: Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Slovenian: Opravili so tri velike mednarodne odprte nekontrolirane študije druge faze pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v napredovali, blastni ali pospešeni fazi bolezni, z drugimi Ph+ levkemijami ali s KML v kronični fazi, a po predhodnem neuspešnem zdravljenju z interferonom alfa (IFN).
English: The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Imatinib arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Slovenian: Ocenjeni odstotek bolnikov, ki niso napredovali v pospešeno fazo ali blastno krizo pri 84 mesecih, je bil bistveno večji na kraku z zdravilom Imatinib Accord v primerjavi s krakom z IFN (92,5 % proti 85,1 %, p < 0,001).
English: Similar findings were found based on a 18-months landmark analysis.
Slovenian: Izsledki so bili podobni, če so odziv in število transkriptov ocenjevali pri 18 mesecih.
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) ali redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Imatinib and IFN arms, respectively.
Slovenian: Sedem let po vključitvi zadnjega bolnika je bilo mediano trajanje zdravljenja z zdravili prvega izbora v kraku z zdravilom Imatinib Accord 82 mesecev, v kraku z IFN pa 8 mesecev.
English: Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
Slovenian: Študija 0110 podatki pri 37 mesecih kronična faza, neuspeh IFN (n=532)
English: This phase III study in adult patients compared treatment with either single-agent Imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Slovenian: V tej študiji tretje faze z odraslimi bolniki so primerjali zdravljenje z zdravilom Imatinib Accord kot edinim zdravilom na eni strani in s kombinacijo interferona alfa (IFN) s citarabinom (Ara-C) na drugi strani.
English: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Slovenian: Začetni odmerek je 100 mg, kar vzamete kot eno tableto po 100 mg enkrat na dan.
English: Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Slovenian: Kaže, da je pri bolnikih z blago in zmerno okvaro v delovanju ledvic izpostavljenost imatinibu v plazmi višja kot pri bolnikih znormalnim delovanjem ledvic.
English: • Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
Slovenian: • oslabelost mišic in mišični spazmi z nepravilnim ritmom bitja srca (znaki spremenjenih vrednosti kalija v krvi),
English: Imatinib Accord is indicated for the treatment of
Slovenian: Zdravilo Imatinib Accord je indicirano za zdravljenje
English: There was a significant increase in exposure to imatinib (the mean Cmaxand AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Slovenian: Pri zdravih osebah se je izpostavljenost imatinibu značilno povečala (povprečna Cmax in AUC imatiniba sta se povečali za 26 % oziroma 40 %), kadar je bil uporabljen z enim samim odmerkom ketokonazola (zaviralec CYP3A4).
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Slovenian: • odraslih bolnikov z napredovalim hipereozinofilnim sindromom (HES) ali s kronično eozinofilno levkemijo (CEL) s premestitvijo FIP1L1-PDGFR ali z obojim;
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Slovenian: Odmerki od 1200 do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska, izpuščaj, eritem, edemi, otekanje, utrujenost, mišični spazmi, trombocitopenija, pancitopenija, bolečine v trebuhu, glavobol, zmanjšan tek.
English: Imatinib Accord 400 mg film-coated tablets are supplied in packs containing 10, 30, or 90 tablets, but these may not all be available in your country.
Slovenian: Imatinib Accord 400 mg filmsko obložene tablete so na tržišču v škatlah po 10, 30 ali 90 tablet, vendar je možno, da na trgu v vaši državi ni vseh navedenih pakiranj.
English: • adult patients with relapsed or refractory Ph+ ALL as monotherapy.
Slovenian: • odraslih bolnikov z relapsom ali neodzivno Ph+ ALL v monoterapiji;
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accordto 400 mg. 3.
Slovenian: Če citopenija ni povezana z levkemijo, zmanjšajte odmerek zdravila Imatinib Accord na 400 mg.
English: Patients with Renal impairment should be given the minimum starting dose.
Slovenian: Bolniki z okvarjenim delovanjem ledvic naj prejmejo najmanjši priporočeni začetni odmerek.
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Slovenian: Bolnikom v kohortah 1-5 so zdravilo imatinib odmerjali intermitentno, pri čemer je bilo v vsaki nadaljnji kohorti trajanje zdravljenja daljše, začetek zdravljenja z zdravilom imatinib pa zgodnejši, tako da je bila v 1. kohorti intenzivnost zdravljenja z zdravilom imatinib najnižja, v 5. kohorti pa najvišja (najdaljše trajanje zdravljenja glede na število dni neprekinjenega enkrat dnevnega odmerjanja zdravila imatinib pri prvem poteku kemoterapije).
English: How much Imatinib Accord to take
Slovenian: Koliko zdravila Imatinib Accord jemati
English: How to store Imatinib Accord Contents of the pack and other information
Slovenian: Shranjevanje zdravila Imatinib Accord Vsebina pakiranja in dodatne informacije
English: Total bilirubin: > 1.5-3.0 ULN AST: any
Slovenian: zmerna celotni bilirubin: > 1,5-3,0 IULN AST: kakršnakoli huda celotni bilirubin: > 3-10 IULN AST: kakršnakoli
English: Chronic myeloid leukaemia (CML).
Slovenian: - s kronično mieloično levkemijo (KML).
English: Using this approach, the estimated cumulative response rates for first-line treatment with Imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Slovenian: Na ta način pridobljene ocene kumulativnih stopenj odziva za zdravljenje z zdravilom Imatinib Accord kot zdravilom prvega izbora so med 12. in 84. mesecem zdravljenja pokazale izboljšanje in sicer: popolni hematološki odziv s 96,4 % na 98,4 % in popolni citogeneteični odziv z 69,5 % na 87,2 %.
English: Imatinib Accord is a treatment for adults for:
Slovenian: Zdravilo Imatinib Accord je zdravilo za odrasle:
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Slovenian: Poleg tega so zabeležili tudi delen citogenetični odziv (PCyR) pri 16 % bolnikov ob 81 % s pomembnim citogentičnim odzivom.
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/ m2 oral, days 26-46
Slovenian: (1 ura), 28.-31., 35.-38., 42.-45. dan; 6-MP 60 mg/m2 peroralno, 26.-46. dan konsolidacijsko zdravljenje
English: Resume treatment with Imatinib Accord at 600 mg.
Slovenian: Spet začnite zdravljenje z zdravilom Imatinib Accord z odmerkom 600 mg.
English: Daunorubicin 30 mg/ m2 i.v., days 1-3, 15-16;
Slovenian: daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
English: Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81%
Slovenian: Izločanje Na podlagi izločenih spojin(e) po peroralnem odmerku imatiniba, označenega s 14C, se je približno
English: In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Slovenian: V na novo diagnosticirani kronični fazi KML sta bili odkriti nevtropenija 4. stopnje (ANC  0,5 x 109/l) in trombocitopenija 4. stopnje ( 10 x 109/l) pri 3,6 % oziroma  1 % bolnikov.
English: 6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Slovenian: Odmerek 6400 mg (enkraten odmerek): V literaturi je opisan en primer pri enem bolniku, pri katerem je prišlo do navzee, bruhanja, bolečin v trebuhu, zvišane telesne temperature, otekanja v obraz, znižane koncentracije nevtrofilcev in zvišanja aminotransferaz.
English: MTX 12 mg intrathecal, day 1 Remission induction DEX 10 mg/ m2 oral, days 6-7, 13-16;
Slovenian: MTX 12 mg intratekalno, 1. dan indukcija remisije DEX 10 mg/m2 peroralno, 6.-7., 13.-16. dan;
English: • Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Slovenian: • kombinacija razširjenega hudega izpuščaja, slabosti s siljenjem na bruhanje, povišane telesne temperature, visoke vrednosti nekaterih vrst belih krvnih celic ali rumene obarvanosti kože ali oči (znaka zlatenice) z zasoplostjo, bolečino/neugodjem v prsnem košu, izrazito zmanjšanim izločanjem urina in žejo itd. (znaki alergijske reakcije na zdravljenje);
English: This is because Imatinib Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: - če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib Accord namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
English: If you have accidentally taken too many tablets, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Imatinib Accord, kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte s svojim zdravnikom.
English: If you are being treated for HES/CEL
Slovenian: - Če se zdravite zaradi HES/CEL
English: Your doctor will tell you exactly how many tablets of Imatinib Accord to take.
Slovenian: Uporaba pri odraslih Zdravnik vam bo natančno povedal, koliko tablet zdravila Imatinib Accord morate jemati.
English: Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Slovenian: - z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Accord, contact your doctor.
Slovenian: - Če se v obdobju, ko jemljete zdravilo Imatinib Accord, pri vas pojavijo modrice, krvavitev, povišana telesna temperatura, utrujenost in zmedenost, se posvetujte z zdravnikom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA ZA PRETISNI OMOT
English: (q 12 h), days 2-3, for 4 cycles
Slovenian: (na 12 ur), 2.-3. dan, v 4 ciklusih vzdrževanje
English: Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
Slovenian: Povprečni odmerek v skupini vseh bolnikov, ki so prejemali zdravilo Imatinib Accord kot zdravilo prvega izbora, je bil 406 ± 76 mg na dan.
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h = every 6 hours, Gy= Gray
Slovenian: = intramuskularno, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2-merkaptoetan sulfonat, iii= oziroma dokler koncentracija MTX ni < 0,1 µM, Gy= Gray
English: This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Imatinib.
Slovenian: Na ta opazovani dogodek, ki se veže na čas do dogodka, je močno vplival velik delež bolnikov, ki so z zdravljenja z IFN+Ara-C prešli na zdravilo Imatinib Accord.
English: 3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Slovenian: 3 Dogodke v zvezi s srcem, vključno s kongestivnim srčnim popuščanjem, so na podlagi enote bolnik-leto pogosteje opažali pri bolnikih s transformacijo KML kot pri bolnikih s kroničnim potekom KML.
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Slovenian: Učinkovina imatinib predstavlja tveganje za okolje, in sicer za organizme v usedlinah.
English: Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Slovenian: Imatinib Accord 100 mg filmsko obložene tablete so na tržišču v škatlah po 20, 60, 120 ali 180 tablet, vendar je možno, da na trgu v vaši državi ni vseh navedenih pakiranj.
English: (1 h), days 1-5; VM26 60 mg/ m2 i.v.
Slovenian: (1 ura), 1.-5. dan; VM26 60 mg/m2 i.v.
English: • Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
Slovenian: • izpuščaj, rdeča koža z mehurčki na ustnicah, očeh, koži ali v ustih, luščenje kože, povišana telesna temperatura, rdeče ali vijolične lise nad nivojem kože, srbenje, pekoč občutek, gnojni izpuščaj (znaki težav s kožo),
English: Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
Slovenian: Pospešeno fazo opredeljuje eno ali več sledečih meril: blasti v krvi ali kostnem mozgu ≥ 15 %, vendar < 30 %, blasti in promielociti skupaj ≥ 30 % v krvi ali kostnem mozgu (pogoj: blasti < 30 %), bazofilci v periferni krvi ≥ 20 %, trombociti < 100 x 109/l ne glede na zdravljenje.
English: Hypromellose 6 cps (E464) Microcrystalline cellulose pH 102 Crospovidone
Slovenian: Jedro tablete hipromeloza 6 cps (E464) mikrokristalna celuloza pH 102 krospovidon brezvodni koloidni silicijev dioksid magnezijev stearat
English: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Slovenian: Bolniki z okvarjenim delovanjem ledvic ali bolniki na dializi naj za začetni odmerek prejmejo najmanjši priporočeni odmerek 400 mg na dan.
English: Patients with Severe renal impairment should be treated with caution.
Slovenian: Pri zdravljenju bolnikov s hudo okvarjenim delovanjem ledvic je potrebna previdnost.
English: Blood amylase increased * 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.