natgillin/translations-raw huggingface dataset:
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 Accord 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 epatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Imatinib Accord, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glejte poglavje
A total of 1,106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms. 
Randomiziranih je bilo skupno 1.106 bolnikov, 553 na vsak krak.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/009-011 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/845/009-011
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
Keep taking Imatinib Accord every day for as long as your doctor tells you. 
Koliko časa jemati zdravilo Imatinib Accord Zdravilo Imatinib Accord jemljite vsak dan, dokler vam zdravnik ne naroči, da ga prenehate jemati.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/845/001-004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/845/001-004
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 oziroma v odmerkih od 200 do 400 mg na dan.
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. 
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 do 340 mg/m2 na dan.
Study ADE10 Prephase 
Študija ADE10
If any of these apply to you, tell your doctor before taking Imatinib Accord. 
Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib Accord posvetujte s svojim zdravnikom.
Confusional state Nervous system disorders Very common Headache2 
Bolezni živčevja zelo pogosti glavobol2
Ara-C 60 mg/ m2 i.v., days 22-25, 29-32 
Ara-C 60 mg/m2 i.v., 22.-25., 29.-32. dan konsolidacijska terapija I, III, V
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine). 
Zato je pri uporabi imatiniba skupaj s substrati CYP3A4 z ozko terapevtsko širino (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminov, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom in kinidinom) priporočljiva previdnost.
Depending on your condition the usual starting dose is either 400 mg or 600 mg: - 400 mg to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg once a day - 600 mg to be taken as 6 tablets of 100 mg or 1 tablet of 400 mg plus 2 tablets of 100 mg once a day. 
Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot 4 tablete po 100 mg ali 1 tableto po 400 mg enkrat na dan, 600 mg vzamete kot 6 tablet po 100 mg ali 1 tableto po 400 mg plus 2 tableti po 100 mg enkrat na dan.
Methotrexate (5 g/m2 over 24 hours, IV): day 1 
metotreksat (5 g/m2 v času 24 ur, i.v.
If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 6 tablets of 100 mg or one tablet of 400 mg plus 2 tablets of 100 mg once a day. 
- Če se zdravite zaradi Ph pozitivne ALL Začetni odmerek je 600 mg, kar vzamete kot 6 tablet po 100 mg ali eno tableto po 400 mg plus 2 tableti po 100 mg enkrat na 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 zdravilom Imatinib Accord 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.
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 zmanjša izpostavljenost imatinibu in s tem potencialno poveča tveganje za neuspešnost zdravljenja.
(24 h), day 1, Ara-C 1 g/ m2 i.v. 
(24 ur), 1. dan, Ara-C 1 g/m2 i.v.
(NEL) Return to chronic phase 
se smiselno ne uporablja vrnitev v kronično fazo (RTC)
SPECIAL STORAGE CONDITIONS For PVC/PVdC/Alu blisters Do not store above 30C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Za pretisne omote iz PVC/PVdC/aluminija Shranjujte pri temperaturi do 30 C.
The dose is 800 mg per day (to be taken as 4 tablets of 100 mg or 1 tablet of 400 mg in the morning and 4 tablets of 100 mg or 1 tablet of 400 mg in the evening. 
Odmerek je 800 mg na dan (kar vzamete kot 4 tablete po 100 mg ali 1 tableto po 400 mg zjutraj in 4 tablete po 100 mg ali 1 tableto po 400 mg zvečer).
* p< 0.001, Fischer's exact test ** molecular response percentages are based on available samples 
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
• Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet. 
• Za vsako tableto po 100 mg potrebujete približno 50 ml vode, za vsako tableto po 400 mg pa približno 200 ml vode.
Additionally Imatinib Accord 100 mg tablets are also available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1, 90x1, 120x1 or 180x1 film-coated tablets. 
Imatinib Accord 100 mg tablete so na voljo tudi v perforiranem pretisnem omotu za enkratni odmerek (PVC/ PVdC/aluminij) v pakiranjih po 30 x 1, 60 x 1, 90 x 1, 120 x 1 ali 180 x 1 filmsko obložena tableta.
• For PVC/PVdC/Alu blisters Do not store above 30C. 
• Za pretisne omote iz PVC/PVdC/aluminija • Shranjujte pri temperaturi do 30 C.
Hyper-CVAD regimen: CP 300 mg/ m2 i.v. 
Študija AUS01 indukcijskokonsolidacijsko zdravljenje hyper-CVAD shema: CP 300 mg/m2 i.v.
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 failure or renal failure should be evaluated and treated. 
Srčni bolniki Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
The dose of 340 mg/m2 daily is recommended for children and adolescents with Ph+ ALL (not to exceed the total dose of 600 mg). 
Za otroke in mladostnike s Ph+ ALL je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka
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).
The recommended dose of Imatinib is 600 mg/day for adults patients with Ph+ ALL. 
Priporočeni odmerek zdravila Imatinib pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
Major response at 24 months (%) 
Molekularni odziv** pomemben odziv pri 12 mesecih (%) pomemben odziv pri 24 mesecih (%) pomemben odziv pri 84
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 oziroma v odmerkih od 400 do 520 mg/m2 na dan.
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;
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion 
Srčne bolezni občasni palpitacije, tahikardija, kongestivno popuščanje srca3, pljučni edem redki aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris,
• 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). 
utrujenost in/ali bolečine v sklepih skupaj z nenormalnimi izvidi laboratorijskih preiskav (na primer z visokimi vrednostmi kalija, sečne kisline in fosforja ter nizko vrednostjo kalcija v krvi).
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.In addition, children and adolescents have been treated in two phase I studies and one phase II study. 
Eno veliko odprto, multicentrično, mednarodno randomizirano študijo tretje faze so opravili pri bolnikih z na novo diagnosticirano Ph+ KML.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision. 
• izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje ali zamegljen vid,
- The other ingredients are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica.The tablet coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172). 
Oblogo tablete sestavljajo hipromeloza 6 cps (E464), smukec (E553b), polietilenglikol, rumeni železov oksid (E172) in rdeči železov oksid (E172).
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. 
Učinkovine, katerih plazemske koncentracije lahko imatinib spremeni Imatinib povečuje povprečno Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
(24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20 
(24 ur), 1., 15. dan; 6-MP 25 mg/m2 peroralno, 1.-20. dan konsolidacijska terapija II, IV
(3h), days1-4; Mitoxantrone 10 mg/m2 i.v. 
(3 ure), 1.-4. dan; mitoksantron 10 mg/m2 i.v.
DEX 10 mg/ m2 oral, days 1-5; 
DEX 10 mg/m2 peroralno, 1.-5. dan;
Very common (may affect more than 1 in 10 people) 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and 
Če bolnik odmerek dobro prenaša, ga je mogoče v primeru nezadostnega učinka povečati (glejte poglavji 4.4 in 5.2).
Organ function impairment 
Motnje v delovanju organov
6 doses)iii: days 2, 3, 16, and 17 
ali peroralno vsakih 6 ur x 6 odmerkov) iii: 2., 3., 16. in 17. dan trojno i.t.
ANC < 1.0x109/l and/or platelets < 50 x 109/l 
ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l
The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase. 
Priporočeno odmerjanje zdravila Imatinib Accord za odrasle bolnike v pospešeni fazi je 600 mg/dan.
Additionally Imatinib Accord 400 mg tablets are available in perforated unit dose blister packs (PVC/PVdC/Alu) containing 30x1, 60x1or 90x1 film-coated tablets. 
Imatinib Accord 400 mg tablete so na voljo tudi v perforiranem pretisnem omotu za enkratni odmerek (PVC/ PVdC/aluminij) v pakiranjih po 30 x 1, 60 x 1, 90 x 1 filmsko obložena tableta.
(3 h, q 12 h), days 1-3; Vincristine 2 mg i.v., days 4, 11; 
(3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
In the event of recurrence of ANC < 1.0 x 109/1 and/or platelets < 50 x 109/1, repeat step 1 and resume Imatinib Accord at reduced dose of 260 mg/m2. 
Če se pojav/a ANC  1,0 x 109/l in/ali koncentracija trombocitov  50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Accord z zmanjšanim odmerkom 260 mg/m2.
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered. 
Poleg tega so v okviru izkušenj v obdobju trženja zdravila pri bolnikih s KML, ALL in drugimi boleznimi poročali o žilnih ektazijah antruma želodca (GAVE - gastric antral vascular ectasia), redkem vzroku gastrointestinalne krvavitve (glejte poglavje 4.8).
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). 
- z akutno limfoblastno levkemijo s prisotnim kromosomom Philadelphia (Ph pozitivna ALL).
Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%). 
9/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 %).
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intra-tumoural bleeding in at least some of these patients. 
V študiji pri bolnikih z neresektabilnimi in/ali metastatskimi GIST so poročali o anemiji 3. in 4. stopnje pri 5,4 % oziroma 0,7 % bolnikov.
Imatinib Accord 400 mg film-coated tablets are brownish orange, oval shaped, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T2' on either side of breakline and plain on the other side. 
Imatinib Accord 400 mg filmsko obložene tablete so rjavooranžne, ovalne, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T2” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani.
PVC/PVdC/Alu blisters 
POSEBNA NAVODILA ZA SHRANJEVANJE Za pretisne omote iz PVC/PVdC/aluminija
(24 h), day 1, and Ara-C 2 g/ m2 i.v. 
(24 ur), 1.dan in Ara-C 2 g/m2 i.v.
Posology for MDS/MPD 
- Če se zdravite zaradi MDS/MPD
Maintenance (8-week cycles) Cycles 1cy 
): 44. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 1.-4. ciklus
The recommended dose of Imatinib Accord is 400 mg/day for adult patients with MDS/MPD. 
Odmerjanje pri MDS/MPD Priporočeni odmerek zdravila Imatinib Accord pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
Each 400 mg film-coated tablet of Imatinib Accord contains 400 mg imatinib (as mesilate). 
- Ena 400 mg filmsko obložena tableta zdravila Imatinib Accord vsebuje 400 mg imatiniba (v obliki mesilata).
The recommended dosage of Imatib Accord is 400 mg/day for adult patients in chronic phase CML. 
Priporočeno odmerjanje zdravila Imatinib Accord za odrasle bolnike v kronični fazi KML je
Stop Imatinib Accord until ANC ≥ 1.5x109/1 and platelets ≥ 75x109/1. 
Prekinite zdravljenje z zdravilom Imatinib Accord dokler ni ANC  1,5 x 109/l in koncentracija trombocitov  75 x 109/l.
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 and adolescents 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. 
pride v poštev pri otrocih in mladostnikih, ki nimajo hudih neželenih učinkov na zdravilo in hude nevtropenije ali trombocitopenije, ki ni povezana z levkemijo, in sicer 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 ali citogenetičnega odziva ali obojega.
• 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),
Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing. 
9 V obdobju trženja zdravila so opažali mišično-skeletne bolečine med zdravljenjem z imatinibom ali po prekinitvi zdravljenja.
days3-5; 
3.-5. dan;
You may become more sensitive to the sun while taking Imatinib Accord. 
Med jemanjem zdravila Imatinib Accord lahko postanete občutljivejši na sonce.
However, always take this medicine exactly as your doctor or pharmacist has told you. 
Seveda pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
MTX 15 mg intrathecal, days 1, 8, 15, 22; 
MTX 15 mg intratekalno,1., 8., 15., 22. dan; Ara-C 40 mg intratekalno, 1., 8., 15., 22. dan;
MTX 15 mg intrathecal, day1; 
MTX 15 mg intratekalno, 1. dan indukcijsko zdravljenje I
The recommended dose of Imatinib is 800 mg/day for adult patients with DFSP. 
Odmerjanje pri DFSP Priporočeni odmerek zdravila Imatinib pri odraslih bolnikih z DFSP je 800 mg/dan.
Table 1 Tabulated summary of adverse reactions Infections and infestations Uncommon 
Preglednica 1 Preglednica neželenih učinkov
How to store Imatinib Accord 
Shranjevanje zdravila Imatinib Accord
Imatinib Accord 100 mg film-coated tablets Imatinib Accord 400 mg film-coated tablets imatinib 
Imatinib Accord 100 mg filmsko obložene tablete Imatinib Accord 400 mg filmsko obložene tablete imatinib
An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib. 
Pri bolnikih z mieloproliferativnimi neoplazmami s preureditvijo PDGFR-β, ki so se zdravili z zdravilom imatiniba, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
aANC < 0.5x109/1 and/or platelets < 10 x 109/1 
aANC < 0,5 x 109/l in/ali koncentracija trombocitov < 10 x 109/l
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis 
pogosti flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha usta, gastritis občasni stomatitis, razjede ustne sluznice, krvavitev iz prebavil7, spahovanje, melena, ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija, pankreatitis redki kolitis, ileus, vnetna bolezen črevesa pogostnost neznana ileus/zapora črevesja*, gastrointestinalna perforacija*, divertikulitis*, žilne ektazije antruma želodca (GAVE)*
Imatinib Accord 100 mg film-coated tablets are brownish orange, round biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side. 
Izgled zdravila Imatinib Accord in vsebina pakiranja Imatinib Accord 100 mg filmsko obložene tablete so rjavooranžne, okrogle, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T1” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani
In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume Imatinib Accord at reduced dose of 300 mg. 
Če se pojav/a ANC  1,0 x 109/l in/ali koncentracija trombocitov  50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Accord z zmanjšanim odmerkom 300 mg.
Consolidation therapy DEX 10 mg/ m2oral, days 1-5; Vindesine 3 mg/ m2 i.v., day 1; 
DEX 10 mg/m2 peroralno, 1.-5. dan; vindezin 3 mg/m2 i.v., 1. dan;
Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172) 
Obloga tablete hipromeloza 6 cps (E464) smukec (E553b) polietilenglikol rumeni železov oksid (E172) rdeči železov oksid (E172)
You may feel dizzy or drowsy or get blurred vision while taking this medicine. 
Vpliv na sposobnost upravljanja vozil in strojev V času jemanja tega zdravila lahko postanete omotični ali zaspani ali se vam zamegli vid.
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15 DAUN (45 mg/m2/day bolus, IV): days 1 and 2 
): 1., 8. in 15. dan DAUN (45 mg/m2/dan bolus, i.v.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3publications. 
V 3 publikacijah so objavljeni podatki treh (3) bolnikov s HES oziroma CEL s preureditvijo gena za PDGFR.
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir 
in 3. dan G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
For PVC/PVdC/Alu blisters Do not store above 30C. 
Pretisni omoti iz PVC/PVdC/aluminija Shranjujte pri temperaturi do 30 C.
urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach. 
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.
Imatinib Accord 100 mg film-coated tablets 
Imatinib Accord 100 mg filmsko obložene tablete
• Muscle cramps or joint, muscle or bone pain, during Imatinib Accord treatment or after you have stopped taking Imatinib Accord. 
• mišični krči ali bolečine v sklepih, mišicah ali kosteh v obdobju, ko se zdravite z zdravilom
The recommended dose of Imatinib Accord is 100 mg/day for adult patients with HES/CEL. 
Odmerjanje pri HES/CEL Priporočeni odmerek zdravila Imatinib Accord pri odraslih bolnikih s HES/CEL je 100 mg/dan.
Each 100 mg film-coated tablet of Imatinib Accorcd ontains 100 mg imatinib (as mesilate). 
- Ena 100 mg filmsko obložena tableta zdravila Imatinib Accord vsebuje 100 mg imatiniba (v obliki mesilata).
Newly diagnosed Ph+ ALL 
Novo odkrita Ph+ ALL
Brownish orange, round, biconvex, film-coated tablets, debossed on one side with ‘IM' and ‘T1' on either side of breakline and plain on the other side. 
Rjavooranžne, okrogle, bikonveksne filmsko obložene tablete z vtisnjenima oznakama “IM” in “T1” na vsaki strani zareze na eni strani tablete in brez oznake na drugi strani.
During treatment with Imatinib Accord, tell your doctor straight away if you put on weight very quickly. 
Če med jemanjem zdravila Imatinib Accord začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis. 
Priporočeni odmerek zdravila Imatinib Accord za odrasle bolnike v blastni krizi je 600 mg/dan.
Imatinib Accord 400 mg film-coated tablets 
Imatinib Accord 400 mg filmsko obložene tablete