FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicinal product contains lecithin (soya).
Slovenian: Zdravilo vsebuje sojin lecitin.
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Slovenian: Pri teh bolnikih se je AUC imatiniba v plazmi zmanjšal za 73 % v primerjavi z bolniki, ki niso jemali antiepileptičnih zdravil, ki inducirajo encime.
English: There was a significant increase in exposure to imatinib (the mean Cmax and 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: (povprečna Cmax in AUC imatiniba sta se povečali za 26 % oziroma 40 %), kadar je bil uporabljen z enim samim odmerkom ketokonazola (zaviralec CYP3A4).
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: The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Slovenian: Z zdravilom povezane neželene reakcije, o katerih so najpogosteje poročali (≥ 10 %), so bile blaga navzea, bruhanje, driska, bolečine v trebuhu, utrujenost, mialgija, mišični krči in izpuščaj.
English: However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Slovenian: Stopnje (ANC < 1,0 x 109/L) in trombocitopenija (koncentracija trombocitov < 50 x 109/L) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
English: EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
Slovenian: EU/1/13/825/001 30 kapsul EU/1/13/825/002 90 kapsul
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Slovenian: Izkušenj pri otrocih s Ph pozitivno ALL je malo, pri otrocih z MDS/MPD, DFSP ali s HES/CEL pa zelo malo.
English: (3 h, q 12 h), days 1-3; vincristine 2 mg i.v., days 4, 11; doxorubicine 50 mg/m2 i.v.
Slovenian: (3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
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 ne žlezni del želodca.
English: The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Slovenian: Za otroke s Ph+ ALL je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 600 mg).
English: 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
Slovenian: 10 Mišično-skeletne bolečine in z njimi povezane dogodke so pogosteje opažali pri bolnikih s
English: Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Slovenian: indukcijskokonsolidacijsko zdravljenje hyper-CVAD shema: CP 300 mg/m2 i.v.
English: - Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Slovenian: - stemnitev pred očmi, omotičnost ali izguba zavesti (znaki nizkega krvnega tlaka),
English: (1 h), days 26, 46; Ara-C 75 mg/m2 i.v.
Slovenian: (1 ura), 26., 46. dan; Ara-C 75 mg/m2 i.v.
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: Klinične študije pri Ph+ ALL 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: There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Slovenian: Kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh boleznih, ni.
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Slovenian: Pri obeh živalskih vrstah so opazili blago do zmerno zvišanje aminotransferaz in rahlo zmanjšanje koncentracij holesterola, trigliceridov, celotnih beljakovin in albuminov.
English: The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Slovenian: Pri proučevanju prehajanja pri eni doječi materi so za imatinib določili razmerje med koncentracijama v mleku in plazmi 0,5, za njegov presnovek pa 0,9, kar kaže, da se presnovek v večji meri izloča v materinem mleku kot imatinib.
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Slovenian: 18 Gy v 10 frakcijah za bolnike, ki imajo ob postavitvi diagnoze CNS3 VCR (1,5 mg/m2/dan, i.v.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Slovenian: Ph+ ALL, je prišlo do prehodne toksičnosti za jetra v obliki zvišanja aminotransferaz in hiperbilirubinemije.
English: The doctor will tell you how many tablets of Imatinib Actavis to give to your child.
Slovenian: Zdravnik vam bo povedal, koliko tablet zdravila Imatinib Actavis dajte svojemu otroku.
English: Imatinib Actavis 400 mg film-coated tablets Pack containing either 10, 30, 60 or 90 film-coated tablets
Slovenian: Imatinib Actavis 400 mg filmsko obložene tablete Pakiranje, ki vsebuje po 10, 30, 60 ali 90 filmsko obloženih tablet.
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Slovenian: In vitro so pokazali, da je imatinib kompetitiven inhibitor markerskih substratov za CYP2C9,
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Slovenian: Ugotovili so, da je plazemska AUC tega presnovka samo 16 %
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib 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 Imatinib Actavis v odmerkih od 75 mg do 800 mg na dan. Citogenetske nepravilnosti so pregledali pri 117 bolnikih od celotne populacije 176 bolnikov.
English: 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: Imatinib povečuje povprečni Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
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: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
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: The tablets are supplied in aluminium blister packs of 10, 20, 30, 60, 90, 120 or 180 film-coated tablets.
Slovenian: Tablete so na voljo v aluminiastih pretisnih omotih, pakiranih po 10, 20, 30, 60, 90, 120 ali 180 filmsko obloženih tablet.
English: 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.
Slovenian: Učinkovine, katerih plazemske koncentracije lahko imatinib 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: The dose can be reduced if not tolerated (see sections 4.2 and 5.2).
Slovenian: Odmerek je mogoče zmanjšati, če ga bolnik ne prenaša dobro (glejte poglavji 4.2 in 5.2).
English: As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Slovenian: Farmakokinetika pri pediatrični populaciji Tako kot pri odraslih bolnikih, se je pri pediatričnih bolnikih v študijah tako prve kot druge faze imatinib po peroralni uporabi hitro absorbiral.
English: One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib 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 Imatinib Actavis pri različnih populacijah bolnikov z življensko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
English: 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).
Slovenian: Za otroke s kronično fazo KML oziroma z napredovalimi fazami KML je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 800 mg).
English: 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.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Imatinib Actavis 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 Actavis, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria*
Slovenian: levkocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana eksantemska pustuloza (AGEP) pogostnost neznana: sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)*, psevdoporfirija*
English: 9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Slovenian: 9 V obdobju trženja zdravila so opažali mišično-skeletne bolečine med zdravljenjem z imatinibom ali po prekinitvi zdravljenja.
English: Imatinib Actavis 100 mg film-coated tablets Pack containing either 10, 20, 30, 60, 90, 120 or 180 film-coated tablets
Slovenian: Imatinib Actavis 100 mg filmsko obložene tablete Pakiranje, ki vsebuje po 10, 20, 30, 60, 90, 120 ali 180 filmsko obloženih tablet.
English: - The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
Slovenian: - Druge sestavine zdravila so: Vsebina kapsule: mikrokristalna celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev hidroksid (hidrofoben koloidni in brezvodni koloidni).
English: (3 h), day 1; daunorubicin 60 mg/m2 i.v.
Slovenian: (3 ure), 1. dan; daunorubicin 60 mg/m2 i.v.
English: Resume treatment with imatinib at 600 mg.
Slovenian: Spet začnite zdravljenje z zdravilom Imatinib Actavis z odmerkom 600 mg.
English: Active substances that may increase imatinib plasma concentrations:
Slovenian: Učinkovine, ki lahko zvišajo plazemske koncentracije imatiniba:
English: - The active substance is imatinib (as mesilate).
Slovenian: - Učinkovina je imatinib (v obliki mesilata).
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), - modrice,
English: Active substances that may decrease imatinib plasma concentrations:
Slovenian: Učinkovine, ki lahko znižajo plazemske koncentracije imatiniba:
English: Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Slovenian: Ker sta povečana vaskularnost in nagnjenje h krvavitvam del narave in kliničnega poteka
English: VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
Slovenian: VCR 1,3 g/m2 i.v., 1. dan; prednizolon 60 mg/m2 peroralno, 1.-5. dan
English: How long to take Imatinib Actavis
Slovenian: Koliko časa jemati zdravilo Imatinib Actavis
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Slovenian: Zdravilna učinkovina imatinib predstavlja tveganje za okolje, in sicer za organizme v usedlinah.
English: In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
Slovenian: V 39-tedenski študiji na opicah pri najmanjšem odmerku 15 mg/kg, kar je približno ena tretjina največjega odmerka za človeka (ki je 800 mg, izračunan na podlagi telesne površine), niso našli odmerka brez opaženih neželenih učinkov (NOAEL - no observed adverse effect level).
English: In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
Slovenian: Pri enajstih bolnikih so odkrili preureditev gena za PDGFR, 9 izmed njih je doseglo popolni hematološki odziv, 1 pa delni hematološki odziv.
English: However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Slovenian: Več bolnikov z blastno krizo je namreč umrlo z zapleteno klinično anamnezo plevralnega izliva, kongestivnega popuščanja srca in ledvične odpovedi.
English: Haemolytic anaemia, thrombotic microangiopathy
Slovenian: limfadenopatija redki hemolitična anemija, trombotična mikroangiopatija
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 največji priporočeni odmerek
English: 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.
Slovenian: 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; določeni makrolidi kot so eritromicin, klaritromicin in telitromicin), bi lahko zmanjševale presnovo in zviševale koncentracije imatiniba.
English: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obložene tablete, kar v bistvu pomeni ‘brez natrija'.
English: This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na trdo kapsulo, kar v bistvu pomeni ‘brez natrija'.
English: 10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
Slovenian: 10 trdih kapsul 30 trdih kapsul 60 trdih kapsul 90 trdih kapsul
English: - Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
Slovenian: - suha usta, suha koža ali suhe oči, - zmanjšana ali povečana občutljivost kože, - navali vročine, mrazenje ali nočno znojenje.
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Slovenian: DAUN (45 mg/m2/dan bolus, i.v.
English: Not known (frequency cannot be estimated from the available data): - 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.
Slovenian: Pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - rdečina in/ali otekanje dlani in podplatov, lahko z občutkom mravljinčenja in s pekočo bolečino,
English: 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.
Slovenian: Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan oziroma v odmerkih od 200 mg do 400 mg na dan.
English: 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.
Slovenian: Srčni bolniki Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
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: Total bilirubin: = 1.5 ULN
Slovenian: Testi jetrnih funkcij blaga celotni bilirubin: = 1,5 IULN
English: - Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
Slovenian: - mišični spazmi z vročino, rdeče-rjavo obarvan urin, boleče ali oslabele mišice (znaki težav z mišicami),
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Slovenian: Ti bolniki so bili stari od 3 mesece do 4 leta, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 92,5 mg/m2 do 340 mg/m2 na dan.
English: Depression, libido decreased, anxiety
Slovenian: Psihiatrične motnje pogosti nespečnost občasni depresija, zmanjšan libido, anksioznost redki zmedenost
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 10
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
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,
English: The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Slovenian: Farmakokinetiko imatiniba so ovrednotili v območju odmerjanja od 25 mg do 1.000 mg. Plazemski farmakokinetični profili so bili analizirani 1.
English: The doctor will tell you how many capsules of Imatinib Actavis to give to your child.
Slovenian: Zdravnik vam bo povedal, koliko kapsul zdravila Imatinib Actavis dajte svojemu otroku.
English: What Imatinib Actavis looks like and contents of the pack
Slovenian: Izgled zdravila Imatinib Actavis in vsebina pakiranja
English: (1 h) days 4-5; Ara- C 2x 2 g/m2 i.v.
Slovenian: (1 ura) 4.-5. dan; Ara-C 2x 2 g/m2 i.v.
English: 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.
Slovenian: Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 mg/m2 na dan do 520 mg/m2 na dan.
English: Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Slovenian: Klinične študije pri protuberantnem dermatofibrosarkomu (DFSP) Eno odprto, multicentrično klinično preskušanje faze II (študija B2225) je vključevalo 12 bolnikov z DFSP, zdravljenih z zdravilom Imatinib Actavis 800 mg na dan. Starost bolnikov z DFSP se je gibala med 23 in 75 leti.
English: Complete haematological response (CHR)
Slovenian: Hematološki odziv1 popolni hematološki odziv (CHR) nobenih znakov levkemije (NEL)
English: The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Slovenian: Priporočeni odmerek zdravila Imatinib Actavis pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
English: In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/kg/day group on either day 14 or day 15 of gestation.
Slovenian: V peroralni študiji predporodnega in poporodnega razvoja pri podganah so pri skupini s 45 mg/kg/dan
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): - Rapid weight gain.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) ali pogosti (pojavijo se lahko pri največ
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Slovenian: 1,5-kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
English: - Chronic renal failure.
Slovenian: - kronična ledvična bolezen,
English: Posology for MDS/MPD The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Slovenian: Priporočeni odmerek zdravila Imatinib Actavis pri odraslih bolnikih z MDS/MPD je 400 mg/dan.