natgillin/translations-raw huggingface dataset:
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Srčni bolniki Srčne bolnike, bolnike z dejavniki tveganja za odpoved srca ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
VCR 1.3 g/m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
VCR 1,3 g/m2 i.v., 1. dan; prednizolon 60 mg/m2 peroralno, 1.-5. dan
In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
Na kraku z imatinibom so bili bolniki zdravljeni s 400 mg na dan. Na kraku z IFN so bili bolniki zdravljeni 10 dni na mesec s tarčnim odmerkom IFN 5 MIU/m2/dan subkutano v kombinaciji s subkutanim Ara-C 20 mg/m2/dan.
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides, CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Previdnost je potrebna pri uporabi imatiniba z zaviralci proteaze, azolnimi antimikotiki, določenimi makrolidi, s substrati CYP3A4 z ozkim terapevtskim oknom (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminom, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom, kinidinom) ali z varfarinom in drugimi derivati kumarina (glejte poglavje 4.5).
Some medicines can interfere with the effect of Imatinib Teva when taken together.
Nekatera zdravila lahko ob sočasnem jemanju vplivajo na delovanje zdravila Imatinib Teva.
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Snovi, ki zavirajo aktivnost izoencima CYP3A4 citokroma P450 (na primer zaviralci proteaze, kot so indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotiki vključno s ketokonazolom, itrokonazolom, posakonazolom, vorikonazolom; določenimi makrolidi kot so eritromicin, klaritromicin in telitromicin), bi lahko zmanjševale presnovo in zviševale koncentracije imatiniba.
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.
11 %, tmax pa se je podaljšal za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
Dark yellow to brownish orange round film-coated tablets with a score line on one side.
Temno rumena do rjavkastooranžna filmsko obložena tableta, okrogla in z zarezo na eni strani.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) imatiniba na dan. Do odziva je prišlo pri 5 bolnikih, pri 3 do popolnega in pri
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemia-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.
Povečanje odmerka s 340 mg/m2 na dan na 570 mg/m2 na dan (ne sme preseči celotnega odmerka 800 mg) pride v poštev pri otrocih, ki nimajo hudih neželenih učinkov na zdravilo in hude nevtropenije ali trombocitopenije, ki bi bila povezana z levkemijo, in sicer v sledečih okoliščinah: napredovanje bolezni (kadarkoli); odsotnost zadovoljivega hematološkega odziva po najmanj 3 mesecih zdravljenja;
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• bledica, občutek utrujenosti in zasoplost in temen urin (znaki pomanjkanja rdečih krvničk),
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
urtikarija, ekhimoza, nagnjenost k podplutbam, hipotrihoza, hipopigmentacija kože, eksfoliativni dermatitis, lomljenje nohtov, folikulitis, petehije, psoriaza, purpura, hiperpigmentacija kože, bulozne erupcije redki:
• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• rdečina in/ali otekanje dlani in podplatov, lahko z občutkom mravljinčenja in s pekočo bolečino,
• Use about 50 ml for each 100 mg tablet.
• Za vsako tableto po 100 mg potrebujete približno 50 ml vode.
MTX 15 mg intrathecal, day 1
MTX 15 mg intratekalno, 1. dan
VCR (1.5 mg/m2/day, IV): days 1, 29 DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 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
): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno: 1.-5. dan metotreksat (20 mg/m2/teden, peroralno): 1., 8., 15., 22., 29., 36., 43. in 50. dan G-CSF = rastni dejavnik za granulocite (granulocyte colony stimulating factor), VP-16 = etopozid, MTX = metotreksat, i.v.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until
tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z imatinibom,
Avascular necrosis/hip necrosis*, growth retardation in children* Renal and urinary disorders
avaskularna nekroza/nekroza kolka*, zaostajanje v rasti pri otrocih*
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• občutek slabosti s siljenjem na bruhanje (navzea), zadihanost, neredno bitje srca, moten urin, utrujenost in/ali bolečine v sklepih skupaj z nenormalnimi izvidi laboratorijskih preiskav (na primer z visokimi vrednostmi kalija, sečne kisline in kalcija ter nizko vrednostjo fosforja v krvi),
Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
pospešena faza KML in blastna kriza in Ph+ ALL
Table 4 Chemotherapy regimen used in combination with imatinib
Preglednica 4 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom Študija ADE10
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Odmerek je mogoče zmanjšati, če ga bolnik ne prenaša dobro (glejte poglavji 4.2 in 5.2).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• hude bolečine v trebuhu, kri v izbruhku, blatu ali urinu, črno blato (znaki bolezni prebavil),
Prednisolone 60 mg/m2/day oral
prednizolon 60 mg/m2/dan peroralno
Renal failure chronic
kronična ledvična bolezen
HES/CEL (starting dose 100 mg)
HES/CEL (pri odmerku 400 mg)
Increased intracranial pressure, convulsions, optic neuritis
zvišan intrakranialni tlak, konvulzije, optični nevritis pogostnost neznana:
Immune system disorders Not known
Bolezni imunskega sistema pogostnost neznana:
1.5 x 109/l and platelets ≥ 75 x 109/l.
1,5 x 109/l in koncentracija trombocitov ≥ 75 x 109/l.
Renal insufficiency
Insuficienca jeter
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
V študiji plodnosti na podganjih samcih, ki so dobivali zdravilo 70 dni pred parjenjem, se je pri odmerku 60 mg/kg, ki je približno enakovreden največjemu kliničnemu odmerku 800 mg/dan,
Chest pain, malaise
bolečine v prsnem košu, slabo počutje
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis občasni:
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/l) and thrombocytopenia (platelet count < 10 x 109/l) were observed in 3.6% and < 1% of patients, respectively.
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
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
ginekomastija, erektilna disfunkcija, menoragija, neredne menstrualne krvavitve, motnje spolnih funkcij, boleče bradavice, povečanje dojk, edem skrotuma redki:
The increase is approximately 1.5 to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Gre za približno 1,5 do 2-kratno zvišanje, ki ustreza 1,5
30 hard capsules 30x1 hard capsules 90 hard capsules 90x1 hard capsules
30 trdih kapsul 30x1 trdih kapsul 90 trdih kapsul 90x1 trdih kapsul
Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common
hemolitična anemija, trombotična mikroangiopatija
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Bolnike je treba pred začetkom zdravljenja z zdravilom Imatinib Teva testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Imatinib Teva, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
How to take Imatinib Teva
Kako jemati zdravilo Imatinib Teva
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 non-leukaemia-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.
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 fazi 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
Consolidation therapy
Konsolidacijsko zdravljenje
The starting dose is 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
Začetni odmerek je 600 mg, ki ga vzamete kot eno kapsulo po 400 mg in še 2 kapsuli po 100 mg enkrat na dan.
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.
Na ta način pridobljene ocene kumulativnih stopenj odziva za zdravljenje z imatinibom kot zdravilom prvega izbora so med 12. in 84. mesecem zdravljenja pokazale izboljšanje in sicer: popolni hematološki odziv s 96,4 % na
ULN = upper limit of normal for the institution AST = aspartate aminotransferase
IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan ali v odmerkih od 200 mg do 400 mg na dan.
20x1 hard capsules 60 hard capsules 60x1 hard capsules 120 hard capsules 120x1 hard capsules 180x1 hard capsules
20x1 trdih kapsul 60 trdih kapsul 60x1 trdih kapsul 120 trdih kapsul 120x1 trdih kapsul 180x1 trdih kapsul
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
dihalnega/torakalnega/mediastinalnega organskega sistema, mišičnoskeletnega/vezivno tkivnega /žilnega organskega sistema in prebavil.
• Use about 200 ml for each 400 mg tablet.
• Za vsako tableto po 400 mg potrebujete približno 200 ml vode.
The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Začetni odmerek je 600 mg, ki ga vzamete kot eno tableto po 400 mg in še 2 tableti po 100 mg ali kot 1 ½ tablete po 400 mg enkrat na dan.
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 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (3665%) or minimal (66-95%).
WBC < 10 x 109/l, trombociti < 450 x 109/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez ekstramedularne prizadetosti Kriteriji citogenetičnega odziva: popolni (0 % Ph+ metafaz), delni (1-35 %), manjši (36-65 %) ali minimalni (66-95 %).
Rare
redki:
Colitis, ileus, inflammatory bowel disease
kolitis, ileus, vnetna bolezen črevesa pogostnost neznana:
Induction therapy II
Indukcijsko zdravljenje II
The recommended dose of Imatinib Teva is 600 mg/day for adult patients with Ph+ ALL.
Priporočeni odmerek zdravila Imatinib Teva pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva,
- Če se v obdobju, ko jemljete zdravilo Imatinib Teva, pri vas pojavijo modrice, krvavitev, povišana telesna temperatura, utrujenost in zmedenost, se posvetujte z zdravnikom.
courses)
IULN)
Not known:
pogostnost neznana:
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan ali v odmerkih od 400 mg/m2 na dan do 520 mg/m2 na dan.
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach.
Tarčni organi za neoplastične spremembe so bili: ledvice, sečni mehur, sečnica, leze prepucija in klitorisa, tanko črevo, obščitnične leze, nadledvične leze in ne-lezni del želodca.
(3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
(3 ure), 1.-4. dan; mitoksantron 10 mg/m2 i.v.
a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
aANC < 0,5 x 109/l in/ali koncentracija trombocitov < 10 x 109/l
Active substances that may have their plasma concentration altered by imatinib 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.
Imatinib povečuje povprečni Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
Your doctor will tell you exactly how many tablets of Imatinib Teva to take.
Zdravnik vam bo natančno povedal, koliko tablet zdravila Imatinib Teva morate jemati.
- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
- z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph pozitivna ALL).
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
5 O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in bolnikih s transformacijo KML (kronična mieloična levkemija v pospešeni fazi: KML-AP in kronična mieloična levkemija v blastni krizi: KML-BC) kot pri bolnikih s kroničnim potekom KML.
Psychiatric disorders Common
Psihiatrične motnje pogosti:
Polyvinyl alcohol partially hydrolysed Macrogol
- Obloga tablete vsebuje polivinilalkohol delno hidroliziran, makrogol, rumeni železov oksid
Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
zdravljenje (prilagojeno na starost): 1. in 29.dan VCR (1,5 mg/m2/dan, i.v.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) ali pogosti (pojavijo se lahko pri največ
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Klinične študije pri kronični mieloični levkemiji Učinkovitost imatiniba temelji na stopnji celotnega hematološkega in citogenetičnega odziva ter preživetju brez napredovanja bolezni.
DEX 10 mg/m2 oral, days 1-5;
DEX 10 mg/m2 peroralno, 1.-5. dan;
Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Snovi, ki inducirajo aktivnost CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka), lahko znatno zmanjšajo izpostavljenost imatinibu in s tem potencialno povečajo tveganje za neuspešnost zdravljenja.
All patients received imatinib and consolidation chemotherapy (see Table 4) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Ravni transkriptov bcr-abl so bile po 8 tednih v obeh krakih enake.
The tablets are approximately 9 mm in diameter.
Premer tablet je približno 9 mm.
If any of these affects you severely, tell your doctor.
Če se pri vas kateri od zgoraj navedenih neželenih učinkov pojavi v hujši obliki, obvestite zdravnika.
Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Škatle, ki vsebujejo po 20x1, 60x1, 120x1 ali 180x1 filmsko obloženih tablet v perforiranem pretisnem omotu.
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
publikacijah so objavljeni podatki petih (5) bolnikov z MDS/MPD s preureditvijo gena za PDGFR.
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.
< 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.
Nervous system disorders Very common
Bolezni živčevja zelo pogosti:
Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Škatle, ki vsebujejo po 30x1 ali 90x1 filmsko obloženih tablet v perforiranem pretisnem omotu.
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• občutek slabosti s siljenjem na bruhanje (navzea) z drisko in bruhanjem, bolečine v trebuhu ali povišana telesna temperatura (znaki težav s črevesjem),
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
Za razliko od bolnikov s popolnim oziroma delnim citogenetičnim odzivom pri 12 mesecih, od katerih pri 96 % (za popolni odziv) oziroma 93 % (za delni odziv) ni prišlo do napredovanja bolezni v pospešeno fazo/blastno krizo po 84 mesecih, pa od bolnikov, ki so bili pri 12 mesecih brez pomembnega citogentičnega odziva, le pri 81 % ni prišlo do napredovanja bolezni v napredovalo fazo KML po 84 mesecih (p<0,001 skupno, p = 0,25 med popolnim in delnim citogenetičnim odzivom).
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
(KML), s prisotnim kromosomom Philadelphia (bcr-abl) (Ph+), pri katerih presaditev kostnega mozga kot zdravljenje prve izbire ne pride v poštev;
4 weeks and more than 20 months.
20 mesecev.
6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
Bolečine v trebuhu in krvavitev iz prebavil so najpogosteje opažali pri bolnikih z GIST.
ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l, then resume treatment at 300 mg.
dokler ni ANC ≥ 1 x 109/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 300 mg.
600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
- 400 mg vzamete kot 1 tableto enkrat na dan, 600 mg vzamete kot 1 tableto po 400 mg in še 2 tableti po 100 mg ali kot 1 ½ tablete po 400 mg enkrat na dan.
If your daily dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.
Če je vaš dnevni odmerek 800 mg (8 kapsul), morate vzeti 4 kapsule zjutraj in 4 kapsule zvečer.
The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
oziroma z napredovalimi fazami KML je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 800 mg).
Do not use any pack that is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila, če opazite vidne znake kvarjenja.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
DEX 10 mg/m2 peroralno, 1.-5. dan; CP 200 mg/m2 i.v., 3., 4., 5. dan;
The recommended dosage of Imatinib Teva is 400 mg/day for adult patients in chronic phase CML.
Priporočeno odmerjanje zdravila Imatinib Teva za odrasle bolnike v kronični fazi KML je 400 mg/dan.
If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a second capsule in the evening.
Če je vaš dnevni odmerek 800 mg (2 kapsuli), morate vzeti eno kapsulo zjutraj in eno kapsulo zvečer.