FrancophonIA/ELRC3.0 huggingface dataset:
English: In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Slovenian: Kljub temu, da klinične izkušnje s sočasno uporabo zdravila Glivec in kemoterapije pri bolnikih s Ph+ ALL obstajajo (glejte poglavje 5.1), pa interakcije med imatinibom in posameznimi kemoterapevtskimi shemami niso dobro opredeljene.
English: (24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
Slovenian: (24 ur), 4. dan; DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m i.v.
English: Chronic phase, newly diagnosed: This phase III study in adult patients compared treatment with either single-agent Glivec or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Slovenian: Kronična faza, na novo diagnosticirana: V tej študiji tretje faze z odraslimi bolniki so primerjali zdravljenje z zdravilom Glivec kot edinim zdravilom na eni strani in s kombinacijo interferona alfa (IFN) s citarabinom (Ara-C) na drugi strani.
English: Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after  4 weeks): WBC < 10 x 10
Slovenian: Molekularni odziv** pomemben odziv pri 12 mesecih (%) pomemben odziv pri 24 mesecih (%) pomemben odziv pri 84 mesecih (%) * p<0,001, Fischerjev eksaktni test ** odstotek bolnikov z molekularnim odzivom na osnovi dostopnih razpoložljivih vzorcev Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po  4 tednih): WBC < 10 x 10
English: The estimated rate of progression-free survival at 84 months was 81.2% in the Glivec arm and 60.6% in the control arm (p<0.001).
Slovenian: Ocenjeni delež preživelih brez napredovanja bolezni pri 84 mesecih je bil 81,2 % na kraku z zdravilo Glivec in 60,6 % na kontrolnem kraku (p<0,001).
English: To conduct an observational registry collecting efficacy and safety data in newly diagnosed paediatric Ph+ Acute Lymphoblastic Leukaemia (ALL) patients treated with chemotherapy + imatinib ± HSCT.
Slovenian: Izvesti opazovalni register za zbiranje podatkov o učinkovitosti in varnosti pri pediatričnih bolnikih z na novo diagnosticirano Ph+ akutno limfoblastno levkemijo (ALL), ki se zdravijo s kemoterapijo + imatinibom ± presaditvijo krvotvornih matičnih celic.
English: Table 1 Tabulated summary of adverse reactions
Slovenian: Preglednica 1 Preglednica neželenih učinkov
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: Table 3 Response in adult CML studies
Slovenian: Preglednica 3 Odziv pri odraslih bolnikih s KML v kliničnih študijah
English: These patients received Glivec for a median of 47 months (range 24 days - 60 months).
Slovenian: Ti bolniki so prejemali zdravilo Glivec mediano 47 mesecev (od 24 dni do 60 mesecev).
English: - if you experience bruising, bleeding, fever, fatigue and confusion when taking Glivec, contact your doctor.
Slovenian: - Če se v obdobju, ko jemljete zdravilo Glivec, pri vas pojavijo modrice, krvavitev, povišana telesna temperatura, utrujenost in zmedenost, se posvetujte z zdravnikom.
English: One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Slovenian: V enem odprtem multicentričnem kliničnem preskušanju faze II (študija B2225) so preskušali zdravilo Glivec pri različnih populacijah bolnikov z življensko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
English: Active substances that may have their plasma concentration altered by Glivec Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Slovenian: Učinkovine, katerih plazemske koncentracije lahko zdravilo Glivec spremeni Imatinib povečuje povprečni Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
English: Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
Slovenian: daunorubicin 30 mg/m i.v., 1.-3., 15.-16. dan;
English: Using this approach, the estimated cumulative response rates for first-line treatment with Glivec 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 Glivec 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: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Slovenian: pruritus, edem obraza, suha koža, eritem, alopecija, nočno potenje, fotosenzitivna reakcija občasni:
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 mg 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: Use in adults Your doctor will tell you exactly how many tablets of Glivec to take.
Slovenian: Uporaba pri odraslih Zdravnik vam bo natančno povedal, koliko tablet zdravila Glivec morate jemati.
English: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg. 3.
Slovenian: Če citopenija ni povezana z levkemijo, zmanjšajte odmerek zdravila Glivec na 400 mg.
English: Palpitations, tachycardia, cardiac failure congestive
Slovenian: palpitacije, tahikardija, kongestivno popuščanje srca
English: 9/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC  1.5 x 10
Slovenian: 9/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez prizadetosti zunaj kostnega mozga] in v študijah 0102 in 0109 [ANC  1,5 x 10
English: They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Slovenian: Na tržišču so v škatlah po 24, 48, 96, 120 ali 180 kapsul, vendar je možno, da na trgu ni vseh navedenih pakiranj.
English: Haemolytic anaemia, thrombotic microangiopathy
Slovenian: hemolitična anemija, trombotična mikroangiopatija
English: Pharmacokinetics of Glivec
Slovenian: Farmakokinetika zdravila Glivec
English: Glivec was administered intermittently in cohorts 1-5, with increasing duration and earlier start of Glivec from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of Glivec (longest duration in days with continuous daily Glivec dosing during the first chemotherapy treatment courses).
Slovenian: Bolnikom v kohortah 1-5 so zdravilo Glivec odmerjali intermitentno, pri čemer je bilo v vsaki nadaljnji kohorti trajanje zdravljenja daljše, začetek zdravljenja z zdravilom Glivec pa zgodnejši, tako da je bila v 1. kohorti intenzivnost zdravljenja z zdravilom Glivec najnižja, v 5. kohorti pa najvišja (najdaljše trajanje zdravljenja glede na število dni neprekinjenega enkrat dnevnega odmerjanja zdravila Glivec pri prvem poteku kemoterapije).
English: Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Slovenian: Zdravilo Glivec je statistično značilno podaljšalo preživetje brez ponovitve bolezni, saj je bilo v skupini z zdravilom Glivec 75% bolnikov brez ponovitve bolezni 38 mesecev v primerjavi z 20 meseci v skupini s placebom (95% IZ: [30 - neocenljivo] oziroma [14 - neocenljivo]); (razmerje tveganj = 0,398 [0,259-0,610], p<0,0001).
English: If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m 3.
Slovenian: Če citopenija ni povezana z levkemijo, zmanjšajte odmerek zdravila Glivec na 260 mg/m
English: Total bilirubin: >1.5-3.0 ULN AST: any
Slovenian: zmerna celotni bilirubin: > 1,5-3,0 IULN AST: kakršnakoli težka celotni bilirubin: > 3-10 IULN AST: kakršnakoli
English: Complete blood counts must be performed regularly during therapy with Glivec.
Slovenian: Med zdravljenjem z zdravilom Glivec je treba redno opravljati kompletne hemograme.
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Slovenian: Novo odkrita Ph+ ALL: V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96,3 % v primerjavi s 50 %; p=0,0001).
English: Studies on patients receiving Glivec and its effect on fertility and gametogenesis have not been performed.
Slovenian: Pri ljudeh niso opravili študij z bolniki, ki prejemajo zdravilo Glivec, da bi preučili vpliv zdravila na plodnost in na gametogenezo.
English: Very dark yellow to brownish-orange, ovaloid, biconvex film-coated tablet with bevelled edges, debossed with “glivec” on one side.
Slovenian: Zelo temno rumena do rjavkastooranžna, ovalna filmsko obložena tableta z izbočenimi stranicami in z oznako “glivec” na eni strani.
English: 9/l unrelated to therapy.
Slovenian: 9/l ne glede na zdravljenje.
English: For doses of 400 mg and above (see dosage recommendation below) a 400 mg tablet (not divisible) is available.
Slovenian: Za odmerke 400 mg in več (glejte spodaj navedeno priporočeno odmerjanje) so na voljo tablete (nedeljive) po 400 mg.
English: In addition, thirty-six (36) months of Glivec treatment significantly prolonged overall survival (OS) compared to 12 months of Glivec treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 8, Figure 2).
Slovenian: Poleg tega je šestintrideset (36) mesecev zdravljenja z zdravilom Glivec statistično značilno bolj podaljšalo celotno preživetje v primerjavi z 12-mesečnim zdravljenjem z zdravilom Glivec (razmerje tveganj = 0,45 [0,22, 0,89], p=0,0187) (preglednica 8, slika 2).
English: Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.
Slovenian: Imatinib je tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF - plateletderived growth factor), PDGF-R in dejavnik matičnih celic (SCF - stem cell factor), c-Kit, in zavira celične dogodke, ki jih posredujeta PDGF in SCF.
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Slovenian: Pediatrični bolniki: V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z zdravilom Glivec (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
English: They are supplied in packs containing 30 capsules.
Slovenian: Na tržišču so v škatlah po 30 kapsul.
English: Maintenance (8-week cycles) Cycles 6-12
Slovenian: 50. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 6.-12. ciklus
English: Ara-C 1,000 mg/m2/12 h i.v.
Slovenian: Ara-C 1.000 mg/m2/12 ur i.v.
English: Glivec 50 mg hard capsules Packs containing 30 capsules.
Slovenian: Glivec 50 mg trde kapsule Škatle, ki vsebujejo po 30 kapsul.
English: This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Glivec.
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 Glivec.
English: - Chronic myeloid leukaemia (CML).
Slovenian: - s kronično mieloično levkemijo (KML).
English: They are supplied in packs containing 10, 30 or 90 tablets, but these may not all be available in your country.
Slovenian: Na tržišču so v škatlah po 10, 30 ali 90 tablet, vendar je možno, da na trgu ni vseh navedenih pakiranj.
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Slovenian: Farmakokinetiko zdravila Glivec so ovrednotili v območju odmerjanja od 25 mg do 1.000 mg. Plazemski farmakokinetični profili so bili analizirani 1. dne, nato pa bodisi 7. bodisi 28. dne, ko so plazemske koncentracije že dosegle stanje dinamičnega ravnovesja.
English: In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
Slovenian: Rezultati načrtovane analize podatkov podskupin glede na vrsto mutacije kažejo, da je pri 36-mesečnem zdravljenju bolnikov z mutacijo eksona 11 razmerje tveganj za preživetje brez ponovitve bolezni 0,35 [95-odstotni IZ: 0,22, 0,56].
English: Packs containing 10, 30 or 90 film-coated tablets
Slovenian: Škatle, ki vsebujejo po 10, 30 ali 90 filmsko obloženih tablet.
English: 9/l, platelet < 450 x 10
Slovenian: 9/l, trombociti < 450 x 10
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, zmanjšane koncentracije nevtrofilcev in zvišanja aminotransferaz.
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 hudo 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: The dose of 340 mg/m daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Slovenian: Za otroke s kronično fazo KML oziroma z napredovalimi fazami KML je priporočeni odmerek 340 mg/m na dan (ne sme preseči celotnega odmerka 800 mg).
English: C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Slovenian: 81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
English: (3 h), day 1; Daunorubicin 60 mg/m i.v.
Slovenian: (3 ure), 1. dan; daunorubicin 60 mg/m i.v.
English: Paediatric chronic phase CML (at dose 340 mg/m
Slovenian: kronična faza KML pri pediatričnih bolnikih (ob odmerku 340 mg/m
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Slovenian: Izkušenj pri otrocih s Ph pozitivno ALL je malo, pri otrocih z MDS/MPD, DFSP, GIST ali s HES/CEL pa zelo malo.
English: 12-month treatment arm 36-month treatment arm
Slovenian: skupina z 12-mesečnim zdravljenjem skupina s 36-mesečnim zdravljenjem preživetje brez ponovitve bolezni
English: Patients had received a median of 14 months of prior IFN therapy at doses  25 x 10
Slovenian: Povprečno trajanje predhodnega zdravljenja z IFN z odmerki  25 x 10
English: Glivec is also a treatment for adults for:
Slovenian: Zdravilo Glivec je tudi zdravilo za odrasle:
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: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Slovenian: gnojen izpuščaj, kontuzije, povečano potenje, urtikarija, ekhimoza, nagnjenost k podplutbam, hipotrihoza, hipopigmentacija kože, eksfoliativni dermatitis, lomljenje nohtov, folikulitis, petehije, psoriaza, purpura, hiperpigmentacija kože, bulozne erupcije redki:
English: Hazard ratio 0.46 (95% Cl, 0.32-0.65)
Slovenian: P < 0,0001 razmerje tveganj 0,46 (95 % IZ, 0,32-0,65)
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Slovenian: Tarčni organi za neoplastične spremembe so bili: ledvice, sečni mehur, sečnica, žleze prepucija in klitorisa, tanko črevo, obščitnične žleze, nadledvične žleze in nežlezni del želodca.
English: How to take Glivec
Slovenian: Kako jemati zdravilo Glivec
English: Hazard ratio 0.45 (95% Cl, 0.22-0.89)
Slovenian: P = 0,019 razmerje tveganj 0,45 (95 % IZ, 0,22-0,89)
English: Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression.
Slovenian: Trajanje zdravljenja: V kliničnih preskušanjih so zdravljenje z zdravilom Glivec nadaljevali, dokler ni začela bolezen napredovati.
English: The doctor will tell you how many capsules of Glivec to give to your child.
Slovenian: Zdravnik vam bo povedal, koliko kapsul zdravila Glivec dajte svojemu otroku.
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 10
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 10
English: Packs containing 20, 60, 120 or 180 film-coated tablets
Slovenian: Škatle, ki vsebujejo po 20, 60, 120 ali 180 filmsko obloženih tablet.
English: The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: Začetni odmerek je 600 mg, ki ga vzamete kot eno tableto po 400 mg in še 2 tableti po 100 mg enkrat na dan.
English: only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Slovenian: 9/l (samo 0102 in 0109) RTC < 15 % blastov v BM in PB, < 30 % blastov+promielocitov v BM in PB, < 20 % bazofilcev v PB, brez bolezni zunaj kostnega mozga, razen v vranici in jetrih (samo za 0102 in 0109).
English: In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
Slovenian: Pri bolnikih, ki so po tiroidektomiji prejemali levotiroksin, je lahko ob sočasni uporabi zdravila Glivec izpostavljenost levotiroksinu v plazmi zmanjšana (glejte poglavje 4.4).
English: You may become more sensitive to the sun while taking Glivec.
Slovenian: Med jemanjem zdravila Glivec lahko postanete občutljivejši na sonce.
English: • adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Slovenian: • odraslih in pediatričnih bolnikov z na novo diagnosticirano akutno limfoblastno levkemijo, s prisotnim kromosomom Philadelphia (Ph+ ALL) skupaj s kemoterapijo;
English: Posology for MDS/MPD The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.
Slovenian: Odmerjanje pri MDS/MPD Priporočeni odmerek zdravila Glivec pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
English: Use in adults Your doctor will tell you exactly how many capsules of Glivec to take.
Slovenian: Uporaba pri odraslih Zdravnik vam bo natančno povedal, koliko kapsul zdravila Glivec morate jemati.
English: 6-MP 60 mg/m oral, days 26-46
Slovenian: 6-MP 60 mg/m peroralno, 26.-46. dan konsolidacijsko zdravljenje
English: Overall, in patients receiving first-line Glivec, the average daily dose delivered was 406 ± 76 mg.
Slovenian: Povprečni odmerek v skupini vseh bolnikov, ki so prejemali zdravilo Glivec kot zdravilo prvega izbora, je bil 406 ± 76 mg na dan.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Slovenian: pospešena faza KML in blastna kriza pri pediatričnih bolnikih (začetni odmerek 340 mg/m
English: Median time to response was 13 weeks (95% C.I.
Slovenian: Mediani čas do odziva je bil 13 tednov (95-odstotni interval zaupanja 12-23).
English: There is very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Slovenian: Izkušenj pri otrocih z MDS/MPD, DFSP, GIST in s HES/CEL je zelo malo.
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received Glivec at doses from 75 mg to 800 mg daily.
Slovenian: Nadaljnjih 162 bolnikov s HES/CEL, o katerih so poročali v 35 objavljenih opisih primerov in skupinah primerov, je prejemalo zdravilo Glivec v odmerkih od 75 mg do 800 mg na dan. Citogenetske nepravilnosti so pregledali pri 117 bolnikih od celotne populacije 176 bolnikov.
English: Treatment duration: In clinical trials in GIST patients, treatment with Glivec was continued until disease progression.
Slovenian: Trajanje zdravljenja: V kliničnih preskušanjih pri bolnikih z GIST so zdravljenje z zdravilom Glivec nadaljevali, dokler ni začela bolezen napredovati.
English: If cytopenia persists for 2 weeks, reduce further to 200 mg/m 4.
Slovenian: Če citopenija vztraja 2 tedna, odmerek zmanjšajte na 200 mg/m 4.
English: Stop Glivec until ANC  1.5 x 10
Slovenian: Prekinite zdravljenje z zdravilom Glivec dokler ni ANC  1,5 x 10